CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Initial vancomycin monotherapy was associated with significantly higher rates of subsequent Clostridium difficile infection among 101 patients with inflammatory bowel disease in a retrospective observational study.

The rate of C. difficile infection (CDI) recurrence over the following year was 39.4% for patients initially treated with vancomycin (Vancocin), 14.5% for patients treated with metronidazole (Flagyl), and 13.3% for those given combination metronidazole and vancomycin. The difference was statistically significant between vancomycin and both metronidazole and combination therapy (P less than .05 for both), lead author Dr. Amar Naik said at the annual Digestive Disease Week.

No significant differences were found between groups in terms of disease duration or inflammatory bowel disease (IBD) maintenance therapy. There were 48 metronidazole patients, 38 vancomycin patients, and 15 combination patients, and each treatment group comprised almost equal numbers of men and women.

The cohort included 62 patients with Crohn’s disease and 39 patients with ulcerative colitis who were followed at a single IBD center. A total of 89% were on maintenance immunosuppression for their IBD. The overall CDI recurrence rate was 24% (24 patients), with a mean time to recurrence of 6 months.

Of the 24 patients with CDI recurrence, 7 (29%) were women and 17 (71%) were men.

Patients initially diagnosed as inpatients were also less likely to experience recurrence than were those diagnosed as outpatients, but this difference did not reach statistical significance (17% vs. 27%), he said.

Steroid use within 3 months of CDI was significantly associated with a higher recurrence rate, compared with no steroid use (32% vs. 15.7%, P less than .05), said Dr. Naik, a gastroenterologist with the Medical College of Wisconsin in Milwaukee.

In a multivariate analysis, the only two significant predictors of CDI recurrence were initial vancomycin monotherapy (odds ratio 7.45, P = .04) and female gender (OR 0.26, P = .02).

"Combination therapy with metronidazole and vancomycin in IBD immunosuppressed patients with C. difficile infection might be more efficacious at preventing CDI recurrence over the following year," Dr. Naik said.

During a discussion of the study, an attendee asked whether there is something about vancomycin that makes CDI recurrence more likely or whether severity may have played a role in the findings.

Dr. Naik replied that there may be an IBD disease severity issue, but also that vancomycin has a profound impact on the gut microbiome. He went on to say that after CDI treatment, there may also be increased rates of vancomycin-resistant enterococcus infection, which could potentially affect the microbiome.

The latest Ontario Ministry of Health report cites a sharp increase in the number of confirmed cases of vancomycin-resistant enterococcus, from 834 in 2006 to 1,154 in 2009, the latest year for which figures were available. At the same time, the rate of CDI dropped from 4,536 to 3,266, although CDI-related diarrhea caused 478 deaths in 2009. In a study cited by Dr. Naik, vancomycin was shown to be superior to metronidazole in treating patients with severe CDI-associated diarrhea (Clin. Infect. Dis. 2007;45:302-7).

Initial antibiotic treatment in the current study included a 14-day course of metronidazole 250 mg t.i.d., or vancomycin 250 mg q.i.d., or metronidazole 250 mg t.i.d. plus vancomycin 250 mg q.i.d..

Initial CDI was confirmed based on symptoms, positive ELISA toxin A/B testing, or a positive nucleic acid amplification test (NAAT). Subsequent CDI was identified according to symptom recurrence and a positive toxin A/B or NAAT test.

Finally, an attendee noted that there have been anecdotal recommendations from some of Dr. Naik’s colleagues to use vancomycin as first choice for CDI treatment, and asked whether the study findings have changed practice at the Medical College of Wisconsin. Dr. Naik said further prospective studies are needed before changing clinical practice, but added, "This actually shows [that] some caution is needed." When pressed as to what he prescribes for his patients, he said that for inpatients, combination therapy with vancomycin and metronidazole should be considered.

Dr. Naik and his coauthors reported no conflicts of interest.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute's Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

HPV Incidence

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study.

Supporting Evidence

A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don't think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

No Evidence for Screening Sexual Partners

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients' partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they've already swapped. Just because they suddenly found that one of them got cancer from it doesn't mean the other one will."

More Research Needed on Vaccines for Prevention

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Second Study: Four Assays Used to Determine HPV Status

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute's Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported.

Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute's Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

HPV Incidence

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study.

Supporting Evidence

A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don't think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

No Evidence for Screening Sexual Partners

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients' partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they've already swapped. Just because they suddenly found that one of them got cancer from it doesn't mean the other one will."

More Research Needed on Vaccines for Prevention

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Second Study: Four Assays Used to Determine HPV Status

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute's Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported.

Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute's Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

HPV Incidence

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study.

Supporting Evidence

A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don't think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

No Evidence for Screening Sexual Partners

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients' partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they've already swapped. Just because they suddenly found that one of them got cancer from it doesn't mean the other one will."

More Research Needed on Vaccines for Prevention

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Second Study: Four Assays Used to Determine HPV Status

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute's Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported.

Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Adding regional nodal irradiation to whole-breast irradiation significantly improved disease-free survival, but not overall survival in a randomized multi-center phase III trial of women with node-positive or high-risk node-negative disease treated with breast-conserving surgery and adjuvant therapy.

An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months, whole breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (P = .02; hazard ratio 0.8) and distant recurrence from 13% to 7.6% (P = .002; HR 0.64), lead investigator Dr. Timothy Whelan reported at the annual meeting of the American Society of Clinical Oncology.

Overall survival in the intergroup trial was 9.3% with WBI vs. 7.7% with the combined radiation regimen, but the difference did not reach statistical significance (P = .07; HR 0.76).

In view of the positive findings, the data safety monitoring committee recommended that the results be released, Dr. Whelan told reporters at a press briefing during the meeting.

He suggested that the findings could expand the pool of women offered RNI. Currently, ASCO and the American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines recommend locoregional radiation following mastectomy for tumors greater than 5 cm or with more than three positive axillary nodes.

Of the 1,832 women enrolled in the National Cancer Institute of Canada Clinical Trials Group MA.20 trial, 85% had one to three positive lymph nodes, and 10% had high-risk, node-negative breast cancer. All women were treated with breast-conserving surgery plus adjuvant chemotherapy or endocrine therapy.

"Results from MA.20 suggest that all women with node-positive disease be offered regional node irradiation provided they are made aware of the associated toxicities," said Dr. Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ont.

The addition of RNI to WBI significantly increased the rates of grade 2 or higher dermatitis from 40% to 50% (P less than .001), pneumonitis from 0.2% to 1.3% (P = .01), and lymphedema from 4% to 7% (P = .004). The lymphedema was primarily grade 2, Dr. Whelen pointed out.

Reporters questioned why an earlier unpublished French study did not find a benefit with RNI, while MA.20 did. Dr. Whelan responded that regional radiation in the earlier study was limited to the internal mammary lymph nodes alone, whereas MA.20 expanded the upper radiation field to include the upper internal mammary nodes, supraclavicular nodes, and high axillary nodes. He could not explain why overall survival was not improved.

Radiation dosages for WBI were 50 Gy in 25 fractions plus a boost at the discretion of the cancer center of 10 Gy in 5 fractions. The RNI dosage was 45 Gy in 25 fractions.

WBI and RNI were delivered concurrently, so the added therapy would not require additional office visits for women, and would modestly lengthen the therapy.

The researchers will continue to monitor the patients and evaluate new techniques to reduce potential side effects, he said in an interview.

MA.20 was sponsored by the Canadian Cancer Society Research Institute, National Cancer Institute/Cancer Therapy Evaluation Program, and Canadian Breast Cancer Research Alliance. Dr. Whelan and his coauthors disclosed no conflicts of interest.

CHICAGO – Adding regional nodal irradiation to whole-breast irradiation significantly improved disease-free survival, but not overall survival in a randomized multi-center phase III trial of women with node-positive or high-risk node-negative disease treated with breast-conserving surgery and adjuvant therapy.

An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months, whole breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (P = .02; hazard ratio 0.8) and distant recurrence from 13% to 7.6% (P = .002; HR 0.64), lead investigator Dr. Timothy Whelan reported at the annual meeting of the American Society of Clinical Oncology.

Overall survival in the intergroup trial was 9.3% with WBI vs. 7.7% with the combined radiation regimen, but the difference did not reach statistical significance (P = .07; HR 0.76).

In view of the positive findings, the data safety monitoring committee recommended that the results be released, Dr. Whelan told reporters at a press briefing during the meeting.

He suggested that the findings could expand the pool of women offered RNI. Currently, ASCO and the American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines recommend locoregional radiation following mastectomy for tumors greater than 5 cm or with more than three positive axillary nodes.

Of the 1,832 women enrolled in the National Cancer Institute of Canada Clinical Trials Group MA.20 trial, 85% had one to three positive lymph nodes, and 10% had high-risk, node-negative breast cancer. All women were treated with breast-conserving surgery plus adjuvant chemotherapy or endocrine therapy.

"Results from MA.20 suggest that all women with node-positive disease be offered regional node irradiation provided they are made aware of the associated toxicities," said Dr. Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ont.

The addition of RNI to WBI significantly increased the rates of grade 2 or higher dermatitis from 40% to 50% (P less than .001), pneumonitis from 0.2% to 1.3% (P = .01), and lymphedema from 4% to 7% (P = .004). The lymphedema was primarily grade 2, Dr. Whelen pointed out.

Reporters questioned why an earlier unpublished French study did not find a benefit with RNI, while MA.20 did. Dr. Whelan responded that regional radiation in the earlier study was limited to the internal mammary lymph nodes alone, whereas MA.20 expanded the upper radiation field to include the upper internal mammary nodes, supraclavicular nodes, and high axillary nodes. He could not explain why overall survival was not improved.

Radiation dosages for WBI were 50 Gy in 25 fractions plus a boost at the discretion of the cancer center of 10 Gy in 5 fractions. The RNI dosage was 45 Gy in 25 fractions.

WBI and RNI were delivered concurrently, so the added therapy would not require additional office visits for women, and would modestly lengthen the therapy.

The researchers will continue to monitor the patients and evaluate new techniques to reduce potential side effects, he said in an interview.

MA.20 was sponsored by the Canadian Cancer Society Research Institute, National Cancer Institute/Cancer Therapy Evaluation Program, and Canadian Breast Cancer Research Alliance. Dr. Whelan and his coauthors disclosed no conflicts of interest.

CHICAGO – Adding regional nodal irradiation to whole-breast irradiation significantly improved disease-free survival, but not overall survival in a randomized multi-center phase III trial of women with node-positive or high-risk node-negative disease treated with breast-conserving surgery and adjuvant therapy.

An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months, whole breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (P = .02; hazard ratio 0.8) and distant recurrence from 13% to 7.6% (P = .002; HR 0.64), lead investigator Dr. Timothy Whelan reported at the annual meeting of the American Society of Clinical Oncology.

Overall survival in the intergroup trial was 9.3% with WBI vs. 7.7% with the combined radiation regimen, but the difference did not reach statistical significance (P = .07; HR 0.76).

In view of the positive findings, the data safety monitoring committee recommended that the results be released, Dr. Whelan told reporters at a press briefing during the meeting.

He suggested that the findings could expand the pool of women offered RNI. Currently, ASCO and the American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines recommend locoregional radiation following mastectomy for tumors greater than 5 cm or with more than three positive axillary nodes.

Of the 1,832 women enrolled in the National Cancer Institute of Canada Clinical Trials Group MA.20 trial, 85% had one to three positive lymph nodes, and 10% had high-risk, node-negative breast cancer. All women were treated with breast-conserving surgery plus adjuvant chemotherapy or endocrine therapy.

"Results from MA.20 suggest that all women with node-positive disease be offered regional node irradiation provided they are made aware of the associated toxicities," said Dr. Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ont.

The addition of RNI to WBI significantly increased the rates of grade 2 or higher dermatitis from 40% to 50% (P less than .001), pneumonitis from 0.2% to 1.3% (P = .01), and lymphedema from 4% to 7% (P = .004). The lymphedema was primarily grade 2, Dr. Whelen pointed out.

Reporters questioned why an earlier unpublished French study did not find a benefit with RNI, while MA.20 did. Dr. Whelan responded that regional radiation in the earlier study was limited to the internal mammary lymph nodes alone, whereas MA.20 expanded the upper radiation field to include the upper internal mammary nodes, supraclavicular nodes, and high axillary nodes. He could not explain why overall survival was not improved.

Radiation dosages for WBI were 50 Gy in 25 fractions plus a boost at the discretion of the cancer center of 10 Gy in 5 fractions. The RNI dosage was 45 Gy in 25 fractions.

WBI and RNI were delivered concurrently, so the added therapy would not require additional office visits for women, and would modestly lengthen the therapy.

The researchers will continue to monitor the patients and evaluate new techniques to reduce potential side effects, he said in an interview.

MA.20 was sponsored by the Canadian Cancer Society Research Institute, National Cancer Institute/Cancer Therapy Evaluation Program, and Canadian Breast Cancer Research Alliance. Dr. Whelan and his coauthors disclosed no conflicts of interest.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study. A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don’t think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients’ partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they’ve already swapped. Just because they suddenly found that one of them got cancer from it doesn’t mean the other one will."

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported. Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study. A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don’t think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients’ partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they’ve already swapped. Just because they suddenly found that one of them got cancer from it doesn’t mean the other one will."

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported. Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study. A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don’t think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients’ partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they’ve already swapped. Just because they suddenly found that one of them got cancer from it doesn’t mean the other one will."

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported. Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study. A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don’t think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients’ partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they’ve already swapped. Just because they suddenly found that one of them got cancer from it doesn’t mean the other one will."

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported. Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study. A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don’t think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients’ partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they’ve already swapped. Just because they suddenly found that one of them got cancer from it doesn’t mean the other one will."

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported. Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.

CHICAGO – Human papillomavirus infection was firmly linked to the recent rise in oropharyngeal cancers in the United States, based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

If current trends continue, the incidence of HPV-related oral cancers will soon surpass that of cervical cancers, senior author Dr. Maura Gillison reported at the annual meeting of the American Society of Clinical Oncology.

The incidence of HPV-positive oropharyngeal cancers increased 225% – from 0.8 per 100,000 to 2.8 per 100,000 – between 1988 and 2004, the researchers found. At the same time, the incidence rate for HPV-negative oropharyngeal cancers, which are strongly related to tobacco and alcohol use, declined by 50% – from 2.0 per 100,000 to 1.0 per 100,000.

Consequently, the overall incidence of oropharyngeal cancers increased 28%.

Even by the conservative estimate that 70% of oropharyngeal cancers in 2020 will be HPV positive, the annual number of HPV-positive oral squamous cell carcinomas (8,653 cases) is expected to surpass cervical cancers (7,726 cases). Further, the majority will occur among men (7,426 cases), said Dr. Gillison, a medical oncologist and the Jeg Coughlin Chair in Cancer Research at Ohio State University Comprehensive Cancer Center in Columbus.

Changes in sexual behavior among recent birth cohorts and increased oral HPV exposure probably influenced the increases in incidence and prevalence, Dr. Gillison speculated. Having a high lifetime number of sexual partners is a known risk factor for HPV infection.

Although the rise in oral cancers in the United States has been attributed to HPV infection, the empirical evidence to back the contention was uncovered prior to the SEER study. A previous study by Dr. Gillison and her colleagues helped to establish that HPV infection causes an epidemiologically and clinically different form of oral cancer. Their findings documented a major increase in the incidence of HPV-related oral cancers in the United States, particularly among young, white men, and that survival rates are significantly higher in patients with HPV-related oral cancers than in those with HPV-negative cancers (J. Clin. Oncol. 2008;26:612-9).

The evidence surrounding HPV-related oral cancers has been mounting, "but I don’t think there is a lot of awareness in the general medical community," Dr. Gillison said in an interview. Most of her head-and-neck cancer patients who are nonsmokers were referred to her after undergoing months of antibiotic therapy for presumed tonsillitis.

Screening the sexual partners of oropharyngeal cancer patients has been discussed, but there is no evidence to support the practice. The risk for oral cancer is fourfold higher in HPV-positive patients’ partners, but the absolute risk is low, Dr. Gillison said. Alternatively, there are now three or four case reports of husband-wife couples with HPV16-positive tonsillar cancer.

"Probably 80% of people have HPV exposures in their life and 99.1% clear the infections without consequence," she said. "So, whatever [stable sexual partners] have swapped in terms of infection, they’ve already swapped. Just because they suddenly found that one of them got cancer from it doesn’t mean the other one will."

The researchers called for more studies to evaluate the efficacy of HPV vaccines in preventing oral HPV infections.

Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old.

It was already approved in the same age groups for the prevention of cervical, vulvar, and vaginal cancer and of genital warts caused by HPV types 6, 11, 16, and 18 in females and for the prevention of genital warts caused by HPV types 6 and 11 in males.

Invited discussant Dr. Lisa Licitra of Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, said that oral cancers are on the rise in Europe in both men and women and that a vaccine should be pursued. Data on oropharyngeal cancer from her institute did not find a greater contribution from men.

"A preventive vaccine is worth considering," she said. "In particular, when we consider the European data, I think that in this direction, action should be taken."

In their study, Dr. Gillison and her colleagues used four different assays to determine the HPV status for 271 oropharyngeal cancer cases collected from 1984 to 2004 by three population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results program in Hawaii, Iowa, and Los Angeles. Trends in HPV prevalence across four calendar periods were estimated using logistic regression.

The HPV prevalence in oropharyngeal cancer significantly increased across the time period, regardless of the assay used, and remained statistically significant, even after correcting for potential loss in assay sensitivity, Dr. Gillison reported. Genotyping with the Inno-LiPA assay appeared to be the most precise, detecting more than a fourfold increase in HPV prevalence from 16.3% in 1984-1989 to 72.7% in 2000-2004.

Median survival was significantly better for patients with HPV-positive cancer at 131 months vs. 20 months for HPV-negative patients (log rank P value less than .001). HPV-positive cases on all assays had a significant reduction in hazard of death compared with HPV-negative cases after adjustment for age, sex, race, registry, calendar period, stage, surgery, chemotherapy, and radiotherapy.

Survival of HPV-positive cases increased over the study period but remained unchanged for HPV-negative cases. Consequently, survival of all oropharyngeal cancer cases improved over time, according to the results of the study, which was led by Dr. Amil Chaturvedi, an investigator with the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

Dr. Gillison and Dr. Chaturvedi reported no conflicts of interest. A coauthor disclosed consultancy, research funding, and honoraria from Merck.