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Breast cancer survivors should try glycerin-containing products
“UPDATE ON SEXUAL DYSFUNCTION”
BARBARA S. LEVY, MD (SEPTEMBER 2014)
Breast cancer survivors should try glycerin-containing products
Dr. Levy’s well-written article on dyspareunia said everything I would tell a patient, until I had breast cancer and started estrogen antagonist therapy. Not only does the vagina lose elasticity but there is a similar sensation to spilling a strong acid on your skin in chemistry lab!
The silicone products Dr. Levy suggests may not be enough. Online support groups suggest a glycerin-containing product called “Probe Personal Lubricant.” If women find it too slippery to handle, they can mix it with an unscented petroleum gel product, such as “Albolene” [Albolene Moisturizing Cleanser] or “Aquaphor” [Aquaphor Healing Ointment]. I cannot tell you how many marriages this has saved for my patients and our local breast cancer survivors.
Joan Eggert, MD, MPH
St. George, Utah
Dr. Levy responds
I thank Dr. Eggert for sharing her personal experience and offering readers excellent practical advice. There is no substitute for listening to our patients and modifying recommendations based on their input and feedback. This is an important part of continuous quality improvement and experiential learning. I truly appreciate the suggestion from someone far more expert than I.
I do want to express a concern about using a petroleum jelly or mineral oil–based product as a lubricant with condoms. Albolene and Aquaphor dissolve latex and increase the chance of rupture. I do not recommend their use when a woman is using a condom for birth control or prevention of sexually transmitted disease.
Clarification requested
In the February issue of OBG Management, you quoted me as saying that the recent FDA analysis of power morcellation was inadequate. Actually, what I said was that the “FDA did an inadequate and irresponsible analysis and it has been a disservice to women.” I didn’t mince words when I spoke and I am appalled by the FDA’s lack of rigor in this important matter.
William H. Parker, MD
Santa Monica, California
The editors respond
We thank Dr. Parker for expressing his concern to us. Although the full title of Dr. Parker’s Web exclusive audio was included online, it was truncated in print due to space and may have not conveyed his full meaning to print readers. Dr. Parker’s voice, and how it is portrayed within the journal’s pages and online, is very important to us.
ANSWERING YOUR CODING QUESTIONS
A reader recently requested assistance for a specific coding challenge. We’ve asked our reimbursement specialist, Melanie Witt, RN, CPC, COBGC, MA, to provide her insight.
What billing code for patients with inconclusive viability?
Dr. Barbieri’s editorial on suspected nonviable pregnancy (“Stop using the hCG discriminatory zone of 1,500 to 2,000 mIU/mL to guide intervention during early pregnancy,” January 2015) and other recent articles help guide our trainees to not “pull the trigger,” so to speak, so quickly on early pregnancies with uncertain viability. It confirms our teaching to be patient and let the pregnancy develop, or not, especially when patients are stable.
I find billing for these encounters to be difficult, however. What do you recommend as the billing code for patients with inconclusive viability—V23.87? Is there anything other than a V-code?
Rana Snipe Berry, MD
Indianapolis, Indiana
Ms. Witt responds
Currently there is only one ICD-9-CM code that describes uncertain fetal viability: V23.87 (Pregnancy with inconclusive fetal viability). This code represents the supervision of a high-risk pregnancy for this reason, and it helps to explain additional testing that may be required. Unlike other “V” codes that many payers ignore, the V codes for pregnancy care, whether for routine supervision, high-risk supervision, or antenatal screening, are accepted by payers as reasons for care.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
“UPDATE ON SEXUAL DYSFUNCTION”
BARBARA S. LEVY, MD (SEPTEMBER 2014)
Breast cancer survivors should try glycerin-containing products
Dr. Levy’s well-written article on dyspareunia said everything I would tell a patient, until I had breast cancer and started estrogen antagonist therapy. Not only does the vagina lose elasticity but there is a similar sensation to spilling a strong acid on your skin in chemistry lab!
The silicone products Dr. Levy suggests may not be enough. Online support groups suggest a glycerin-containing product called “Probe Personal Lubricant.” If women find it too slippery to handle, they can mix it with an unscented petroleum gel product, such as “Albolene” [Albolene Moisturizing Cleanser] or “Aquaphor” [Aquaphor Healing Ointment]. I cannot tell you how many marriages this has saved for my patients and our local breast cancer survivors.
Joan Eggert, MD, MPH
St. George, Utah
Dr. Levy responds
I thank Dr. Eggert for sharing her personal experience and offering readers excellent practical advice. There is no substitute for listening to our patients and modifying recommendations based on their input and feedback. This is an important part of continuous quality improvement and experiential learning. I truly appreciate the suggestion from someone far more expert than I.
I do want to express a concern about using a petroleum jelly or mineral oil–based product as a lubricant with condoms. Albolene and Aquaphor dissolve latex and increase the chance of rupture. I do not recommend their use when a woman is using a condom for birth control or prevention of sexually transmitted disease.
Clarification requested
In the February issue of OBG Management, you quoted me as saying that the recent FDA analysis of power morcellation was inadequate. Actually, what I said was that the “FDA did an inadequate and irresponsible analysis and it has been a disservice to women.” I didn’t mince words when I spoke and I am appalled by the FDA’s lack of rigor in this important matter.
William H. Parker, MD
Santa Monica, California
The editors respond
We thank Dr. Parker for expressing his concern to us. Although the full title of Dr. Parker’s Web exclusive audio was included online, it was truncated in print due to space and may have not conveyed his full meaning to print readers. Dr. Parker’s voice, and how it is portrayed within the journal’s pages and online, is very important to us.
ANSWERING YOUR CODING QUESTIONS
A reader recently requested assistance for a specific coding challenge. We’ve asked our reimbursement specialist, Melanie Witt, RN, CPC, COBGC, MA, to provide her insight.
What billing code for patients with inconclusive viability?
Dr. Barbieri’s editorial on suspected nonviable pregnancy (“Stop using the hCG discriminatory zone of 1,500 to 2,000 mIU/mL to guide intervention during early pregnancy,” January 2015) and other recent articles help guide our trainees to not “pull the trigger,” so to speak, so quickly on early pregnancies with uncertain viability. It confirms our teaching to be patient and let the pregnancy develop, or not, especially when patients are stable.
I find billing for these encounters to be difficult, however. What do you recommend as the billing code for patients with inconclusive viability—V23.87? Is there anything other than a V-code?
Rana Snipe Berry, MD
Indianapolis, Indiana
Ms. Witt responds
Currently there is only one ICD-9-CM code that describes uncertain fetal viability: V23.87 (Pregnancy with inconclusive fetal viability). This code represents the supervision of a high-risk pregnancy for this reason, and it helps to explain additional testing that may be required. Unlike other “V” codes that many payers ignore, the V codes for pregnancy care, whether for routine supervision, high-risk supervision, or antenatal screening, are accepted by payers as reasons for care.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
“UPDATE ON SEXUAL DYSFUNCTION”
BARBARA S. LEVY, MD (SEPTEMBER 2014)
Breast cancer survivors should try glycerin-containing products
Dr. Levy’s well-written article on dyspareunia said everything I would tell a patient, until I had breast cancer and started estrogen antagonist therapy. Not only does the vagina lose elasticity but there is a similar sensation to spilling a strong acid on your skin in chemistry lab!
The silicone products Dr. Levy suggests may not be enough. Online support groups suggest a glycerin-containing product called “Probe Personal Lubricant.” If women find it too slippery to handle, they can mix it with an unscented petroleum gel product, such as “Albolene” [Albolene Moisturizing Cleanser] or “Aquaphor” [Aquaphor Healing Ointment]. I cannot tell you how many marriages this has saved for my patients and our local breast cancer survivors.
Joan Eggert, MD, MPH
St. George, Utah
Dr. Levy responds
I thank Dr. Eggert for sharing her personal experience and offering readers excellent practical advice. There is no substitute for listening to our patients and modifying recommendations based on their input and feedback. This is an important part of continuous quality improvement and experiential learning. I truly appreciate the suggestion from someone far more expert than I.
I do want to express a concern about using a petroleum jelly or mineral oil–based product as a lubricant with condoms. Albolene and Aquaphor dissolve latex and increase the chance of rupture. I do not recommend their use when a woman is using a condom for birth control or prevention of sexually transmitted disease.
Clarification requested
In the February issue of OBG Management, you quoted me as saying that the recent FDA analysis of power morcellation was inadequate. Actually, what I said was that the “FDA did an inadequate and irresponsible analysis and it has been a disservice to women.” I didn’t mince words when I spoke and I am appalled by the FDA’s lack of rigor in this important matter.
William H. Parker, MD
Santa Monica, California
The editors respond
We thank Dr. Parker for expressing his concern to us. Although the full title of Dr. Parker’s Web exclusive audio was included online, it was truncated in print due to space and may have not conveyed his full meaning to print readers. Dr. Parker’s voice, and how it is portrayed within the journal’s pages and online, is very important to us.
ANSWERING YOUR CODING QUESTIONS
A reader recently requested assistance for a specific coding challenge. We’ve asked our reimbursement specialist, Melanie Witt, RN, CPC, COBGC, MA, to provide her insight.
What billing code for patients with inconclusive viability?
Dr. Barbieri’s editorial on suspected nonviable pregnancy (“Stop using the hCG discriminatory zone of 1,500 to 2,000 mIU/mL to guide intervention during early pregnancy,” January 2015) and other recent articles help guide our trainees to not “pull the trigger,” so to speak, so quickly on early pregnancies with uncertain viability. It confirms our teaching to be patient and let the pregnancy develop, or not, especially when patients are stable.
I find billing for these encounters to be difficult, however. What do you recommend as the billing code for patients with inconclusive viability—V23.87? Is there anything other than a V-code?
Rana Snipe Berry, MD
Indianapolis, Indiana
Ms. Witt responds
Currently there is only one ICD-9-CM code that describes uncertain fetal viability: V23.87 (Pregnancy with inconclusive fetal viability). This code represents the supervision of a high-risk pregnancy for this reason, and it helps to explain additional testing that may be required. Unlike other “V” codes that many payers ignore, the V codes for pregnancy care, whether for routine supervision, high-risk supervision, or antenatal screening, are accepted by payers as reasons for care.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Physician-patient communication, terminology play important role in CPM decisions
BIRMINGHAM, ALA. – The perception that one’s physician had recommended contralateral prophylactic mastectomy was a particularly important factor in the decision to undergo the procedure among BRCA1/2 mutation noncarriers with newly diagnosed breast cancer in a prospective study.
Of 90 BRCA noncarriers with newly diagnosed breast cancer, a “sizable minority” (24.4%) chose to undergo contralateral prophylactic mastectomy (CPM) after learning their mutation status, Jada G. Hamilton, Ph.D., reported at the annual meeting of the American Society of Preventive Oncology.
By comparison, 88% of eight BRCA1/2 carriers who participated in the study chose to undergo CPM, and neither of two women with a BRCA1/2 variant of undetermined significance chose to undergo CPM.
On multivariate analysis, the perception that one’s physician had recommended CPM was most strongly associated with the decision to undergo the procedure (odds ratio, 11.1), said Dr. Hamilton of Memorial Sloan-Kettering Cancer Center, New York.
Other factors associated with the decision were a perception of greater risk for contralateral breast cancer (OR, 6.46) and a perception of greater pros of CPM (OR, 1.37), she said, noting that those who indicated they would feel good about having CPM and those who indicated they might feel regret if they didn’t have CPM were most likely to elect CPM.
Age, Ashkenazi Jewish ethnicity, breast cancer–related distress, perceived cons of CPM (such as disfigurement and concerns regarding a negative impact on one’s sex life), and decisional conflict regarding CPM were not significantly associated with the decision.
Presurgical genetic testing provides valuable information to women with newly diagnosed breast cancer as they begin to make decisions about treatment, Dr. Hamilton said. Although BRCA1/2 mutation noncarriers have a low (3%-10%) risk, compared with carriers (27%-37%), studies suggest that about 18% nevertheless choose to undergo CPM.
The psychosocial factors that may affect the decision are not well understood, Dr. Hamilton said.
For the current analysis, participants who were part of a larger prospective study on presurgical BRCA1/2 testing completed a questionnaire, and the frequency and psychosocial correlates of the decision to undergo a CPM were assessed. The participants were adult women with a median age of 43 years (range of 29-59 years).
The findings raise interesting questions for future work, Dr. Hamilton said.
“I think it’s really critical for future studies to dig in to what’s happening in terms of physician-patient communication around CPM,” she said, noting that it will be important to explore how such communication interacts with a woman’s past experiences, emotions, and beliefs to shape her cancer prevention decisions.
Further, the women who undergo CPM should be followed to assess their long-term outcomes with respect to factors such as quality of life, satisfaction, and decisional regret, she concluded.
The decision to undergo CPM and the effects of physician-patient communication on that decision were also addressed in another study presented at the meeting.
In that study – a mixed methods pilot study looking mainly at factors affecting informed decision making in women who had ductal carcinoma in situ (DCIS) or who were considered to be at increased risk of invasive breast cancer risk because of a diagnosis of lobular carcinoma in situ (LCIS), BRCA positivity, or 20% or greater calculated lifetime risk – anxiety about cancer recurrence was the top reason for pursuing CPM.
Despite a lack of survival benefit, an increasing number of women with DCIS are undergoing CPM, but little is known about the decision-making process, said Jessica Valente of Emory University, Atlanta.
She and her colleagues sought to identify factors impacting risk comprehension and decision making. Of 68 women with DCIS or who were at high risk for development of invasive breast cancer, 33 considered CPM and 11 underwent the procedure.
The choice to undergo CPM was significantly associated with plastic surgery consultation, increased 10-year breast cancer risk, genetic counseling, genetic testing, and higher income, she said.
The study also highlighted a lack of health literacy and understanding of related terminology.
Most participants (nearly 84%) stated that DCIS qualified as breast cancer, but only about 40% correctly defined DCIS, Ms. Valente said.
When asked what they would recommend as a treatment strategy for a friend with DCIS, 35% thought surgery would be best. A similar percentage would recommend surgery for LCIS.
“When we looked at ductal hyperplasia, fewer people thought that that qualified as cancer, and they were more likely to recommend observation,” she said.
Further, when asked to interpret the phrase “indolent lesion of epithelial origin,” which is a phrase that has been promoted as a replacement for “DCIS” in light of concerns that women are increasingly electing CPM for DCIS because of fear of the word “carcinoma” despite a 99% survival rate, only 28% of patients believed it referred to cancer.
Observation was one of the highly recommended interventions for “indolent lesion of epithelial origin,” followed by biopsy, she said, noting that only 13% recommended surgery when this phrase was used.
“Interestingly, 7.4% said an oral or topical medication [should be used for “indolent lesion of epithelial origin]” – a finding likely explained by the fact that some women interpreted the word “lesion” to mean a wound or sore on the skin, she said.
Additionally, few women were able to define contralateral prophylactic mastectomy.
Overall, despite the study population being very well educated and from a higher socioeconomic status, they had low scores for understanding terminology (8.21 out of 20), Ms. Valente noted.
The findings demonstrate that decision making in the context of DCIS remains complex and underscore the importance of recognizing patients’ knowledge of risk communication and terminology for supporting shared and informed surgical decision making, she said.
The findings also demonstrate that while fewer women felt that surgery was appropriate when the term “indolent lesion of epithelial origin” was used instead of “DCIS,” the proposed new terminology doesn’t necessarily provide the desired clarity, she noted.
“They still came up with such a broad range of interpretations that we really might be introducing a new set of conflicts and confusion when we think about changing to that terminology when we talk to patients,” she concluded.
Dr. Hamilton and Ms. Valente each reported having no disclosures.
BIRMINGHAM, ALA. – The perception that one’s physician had recommended contralateral prophylactic mastectomy was a particularly important factor in the decision to undergo the procedure among BRCA1/2 mutation noncarriers with newly diagnosed breast cancer in a prospective study.
Of 90 BRCA noncarriers with newly diagnosed breast cancer, a “sizable minority” (24.4%) chose to undergo contralateral prophylactic mastectomy (CPM) after learning their mutation status, Jada G. Hamilton, Ph.D., reported at the annual meeting of the American Society of Preventive Oncology.
By comparison, 88% of eight BRCA1/2 carriers who participated in the study chose to undergo CPM, and neither of two women with a BRCA1/2 variant of undetermined significance chose to undergo CPM.
On multivariate analysis, the perception that one’s physician had recommended CPM was most strongly associated with the decision to undergo the procedure (odds ratio, 11.1), said Dr. Hamilton of Memorial Sloan-Kettering Cancer Center, New York.
Other factors associated with the decision were a perception of greater risk for contralateral breast cancer (OR, 6.46) and a perception of greater pros of CPM (OR, 1.37), she said, noting that those who indicated they would feel good about having CPM and those who indicated they might feel regret if they didn’t have CPM were most likely to elect CPM.
Age, Ashkenazi Jewish ethnicity, breast cancer–related distress, perceived cons of CPM (such as disfigurement and concerns regarding a negative impact on one’s sex life), and decisional conflict regarding CPM were not significantly associated with the decision.
Presurgical genetic testing provides valuable information to women with newly diagnosed breast cancer as they begin to make decisions about treatment, Dr. Hamilton said. Although BRCA1/2 mutation noncarriers have a low (3%-10%) risk, compared with carriers (27%-37%), studies suggest that about 18% nevertheless choose to undergo CPM.
The psychosocial factors that may affect the decision are not well understood, Dr. Hamilton said.
For the current analysis, participants who were part of a larger prospective study on presurgical BRCA1/2 testing completed a questionnaire, and the frequency and psychosocial correlates of the decision to undergo a CPM were assessed. The participants were adult women with a median age of 43 years (range of 29-59 years).
The findings raise interesting questions for future work, Dr. Hamilton said.
“I think it’s really critical for future studies to dig in to what’s happening in terms of physician-patient communication around CPM,” she said, noting that it will be important to explore how such communication interacts with a woman’s past experiences, emotions, and beliefs to shape her cancer prevention decisions.
Further, the women who undergo CPM should be followed to assess their long-term outcomes with respect to factors such as quality of life, satisfaction, and decisional regret, she concluded.
The decision to undergo CPM and the effects of physician-patient communication on that decision were also addressed in another study presented at the meeting.
In that study – a mixed methods pilot study looking mainly at factors affecting informed decision making in women who had ductal carcinoma in situ (DCIS) or who were considered to be at increased risk of invasive breast cancer risk because of a diagnosis of lobular carcinoma in situ (LCIS), BRCA positivity, or 20% or greater calculated lifetime risk – anxiety about cancer recurrence was the top reason for pursuing CPM.
Despite a lack of survival benefit, an increasing number of women with DCIS are undergoing CPM, but little is known about the decision-making process, said Jessica Valente of Emory University, Atlanta.
She and her colleagues sought to identify factors impacting risk comprehension and decision making. Of 68 women with DCIS or who were at high risk for development of invasive breast cancer, 33 considered CPM and 11 underwent the procedure.
The choice to undergo CPM was significantly associated with plastic surgery consultation, increased 10-year breast cancer risk, genetic counseling, genetic testing, and higher income, she said.
The study also highlighted a lack of health literacy and understanding of related terminology.
Most participants (nearly 84%) stated that DCIS qualified as breast cancer, but only about 40% correctly defined DCIS, Ms. Valente said.
When asked what they would recommend as a treatment strategy for a friend with DCIS, 35% thought surgery would be best. A similar percentage would recommend surgery for LCIS.
“When we looked at ductal hyperplasia, fewer people thought that that qualified as cancer, and they were more likely to recommend observation,” she said.
Further, when asked to interpret the phrase “indolent lesion of epithelial origin,” which is a phrase that has been promoted as a replacement for “DCIS” in light of concerns that women are increasingly electing CPM for DCIS because of fear of the word “carcinoma” despite a 99% survival rate, only 28% of patients believed it referred to cancer.
Observation was one of the highly recommended interventions for “indolent lesion of epithelial origin,” followed by biopsy, she said, noting that only 13% recommended surgery when this phrase was used.
“Interestingly, 7.4% said an oral or topical medication [should be used for “indolent lesion of epithelial origin]” – a finding likely explained by the fact that some women interpreted the word “lesion” to mean a wound or sore on the skin, she said.
Additionally, few women were able to define contralateral prophylactic mastectomy.
Overall, despite the study population being very well educated and from a higher socioeconomic status, they had low scores for understanding terminology (8.21 out of 20), Ms. Valente noted.
The findings demonstrate that decision making in the context of DCIS remains complex and underscore the importance of recognizing patients’ knowledge of risk communication and terminology for supporting shared and informed surgical decision making, she said.
The findings also demonstrate that while fewer women felt that surgery was appropriate when the term “indolent lesion of epithelial origin” was used instead of “DCIS,” the proposed new terminology doesn’t necessarily provide the desired clarity, she noted.
“They still came up with such a broad range of interpretations that we really might be introducing a new set of conflicts and confusion when we think about changing to that terminology when we talk to patients,” she concluded.
Dr. Hamilton and Ms. Valente each reported having no disclosures.
BIRMINGHAM, ALA. – The perception that one’s physician had recommended contralateral prophylactic mastectomy was a particularly important factor in the decision to undergo the procedure among BRCA1/2 mutation noncarriers with newly diagnosed breast cancer in a prospective study.
Of 90 BRCA noncarriers with newly diagnosed breast cancer, a “sizable minority” (24.4%) chose to undergo contralateral prophylactic mastectomy (CPM) after learning their mutation status, Jada G. Hamilton, Ph.D., reported at the annual meeting of the American Society of Preventive Oncology.
By comparison, 88% of eight BRCA1/2 carriers who participated in the study chose to undergo CPM, and neither of two women with a BRCA1/2 variant of undetermined significance chose to undergo CPM.
On multivariate analysis, the perception that one’s physician had recommended CPM was most strongly associated with the decision to undergo the procedure (odds ratio, 11.1), said Dr. Hamilton of Memorial Sloan-Kettering Cancer Center, New York.
Other factors associated with the decision were a perception of greater risk for contralateral breast cancer (OR, 6.46) and a perception of greater pros of CPM (OR, 1.37), she said, noting that those who indicated they would feel good about having CPM and those who indicated they might feel regret if they didn’t have CPM were most likely to elect CPM.
Age, Ashkenazi Jewish ethnicity, breast cancer–related distress, perceived cons of CPM (such as disfigurement and concerns regarding a negative impact on one’s sex life), and decisional conflict regarding CPM were not significantly associated with the decision.
Presurgical genetic testing provides valuable information to women with newly diagnosed breast cancer as they begin to make decisions about treatment, Dr. Hamilton said. Although BRCA1/2 mutation noncarriers have a low (3%-10%) risk, compared with carriers (27%-37%), studies suggest that about 18% nevertheless choose to undergo CPM.
The psychosocial factors that may affect the decision are not well understood, Dr. Hamilton said.
For the current analysis, participants who were part of a larger prospective study on presurgical BRCA1/2 testing completed a questionnaire, and the frequency and psychosocial correlates of the decision to undergo a CPM were assessed. The participants were adult women with a median age of 43 years (range of 29-59 years).
The findings raise interesting questions for future work, Dr. Hamilton said.
“I think it’s really critical for future studies to dig in to what’s happening in terms of physician-patient communication around CPM,” she said, noting that it will be important to explore how such communication interacts with a woman’s past experiences, emotions, and beliefs to shape her cancer prevention decisions.
Further, the women who undergo CPM should be followed to assess their long-term outcomes with respect to factors such as quality of life, satisfaction, and decisional regret, she concluded.
The decision to undergo CPM and the effects of physician-patient communication on that decision were also addressed in another study presented at the meeting.
In that study – a mixed methods pilot study looking mainly at factors affecting informed decision making in women who had ductal carcinoma in situ (DCIS) or who were considered to be at increased risk of invasive breast cancer risk because of a diagnosis of lobular carcinoma in situ (LCIS), BRCA positivity, or 20% or greater calculated lifetime risk – anxiety about cancer recurrence was the top reason for pursuing CPM.
Despite a lack of survival benefit, an increasing number of women with DCIS are undergoing CPM, but little is known about the decision-making process, said Jessica Valente of Emory University, Atlanta.
She and her colleagues sought to identify factors impacting risk comprehension and decision making. Of 68 women with DCIS or who were at high risk for development of invasive breast cancer, 33 considered CPM and 11 underwent the procedure.
The choice to undergo CPM was significantly associated with plastic surgery consultation, increased 10-year breast cancer risk, genetic counseling, genetic testing, and higher income, she said.
The study also highlighted a lack of health literacy and understanding of related terminology.
Most participants (nearly 84%) stated that DCIS qualified as breast cancer, but only about 40% correctly defined DCIS, Ms. Valente said.
When asked what they would recommend as a treatment strategy for a friend with DCIS, 35% thought surgery would be best. A similar percentage would recommend surgery for LCIS.
“When we looked at ductal hyperplasia, fewer people thought that that qualified as cancer, and they were more likely to recommend observation,” she said.
Further, when asked to interpret the phrase “indolent lesion of epithelial origin,” which is a phrase that has been promoted as a replacement for “DCIS” in light of concerns that women are increasingly electing CPM for DCIS because of fear of the word “carcinoma” despite a 99% survival rate, only 28% of patients believed it referred to cancer.
Observation was one of the highly recommended interventions for “indolent lesion of epithelial origin,” followed by biopsy, she said, noting that only 13% recommended surgery when this phrase was used.
“Interestingly, 7.4% said an oral or topical medication [should be used for “indolent lesion of epithelial origin]” – a finding likely explained by the fact that some women interpreted the word “lesion” to mean a wound or sore on the skin, she said.
Additionally, few women were able to define contralateral prophylactic mastectomy.
Overall, despite the study population being very well educated and from a higher socioeconomic status, they had low scores for understanding terminology (8.21 out of 20), Ms. Valente noted.
The findings demonstrate that decision making in the context of DCIS remains complex and underscore the importance of recognizing patients’ knowledge of risk communication and terminology for supporting shared and informed surgical decision making, she said.
The findings also demonstrate that while fewer women felt that surgery was appropriate when the term “indolent lesion of epithelial origin” was used instead of “DCIS,” the proposed new terminology doesn’t necessarily provide the desired clarity, she noted.
“They still came up with such a broad range of interpretations that we really might be introducing a new set of conflicts and confusion when we think about changing to that terminology when we talk to patients,” she concluded.
Dr. Hamilton and Ms. Valente each reported having no disclosures.
AT THE ASPO ANNUAL MEETING
Key clinical point: Physician-patient communication plays an important role in a woman’s decision to undergo CPM.
Major finding: Of 90 women with invasive breast cancer and without BRCA mutations, 24% chose to undergo CPM; of 68 women with DCIS, 33 considered CPM and 11 underwent the procedure.The choice to undergo CPM was significantly associated with the perception that one’s physician had recommended CPM in the first study, and with a plastic surgery consultation, increased 10-year breast cancer risk, genetic counseling, genetic testing, and higher income in the DCIS study.
Data source: A prospective study of 90 patients with invasive breast cancer and a mixed methods pilot study of 68 patients with DCIS.
Disclosures: Dr. Hamilton and Ms. Valente each reported having no disclosures.
Nurses’ Health Study: No link between depression and breast cancer
BIRMINGHAM, ALA. – Neither depression nor antidepressant use are associated with an increased risk of breast cancer among participants in the Nurses’ Health Study, according to an analysis of data from 67,120 women enrolled in the ongoing prospective cohort study.
Of the women included in the analysis, 2,904 had confirmed breast cancer as of the end of December 2012, including 2,333 with invasive disease. After adjusting for age, body mass index, and menopausal status, no statistically significant associations were seen between invasive or in situ breast cancer and depression or antidepressant use, Katherine W. Reeves, Ph.D. reported at the annual meeting of the American Society of Preventive Oncology.
The point estimates for the odds ratios were all below 1 for in situ disease, indicating a potential protective effect of depression, Dr. Reeves said.
“These were not statistically significant, so I would caution against overinterpreting the results, but it is kind of curious,” she said, noting that the finding may indicate that depressed women are less likely than nondepressed women are to have a mammogram – and thus are less likely to have the opportunity to be diagnosed with in situ disease.
When depression and antidepressant use were included together in the same model, they remained unassociated with breast cancer risk (odds ratio, 0.87), said Dr. Reeves of the University of Massachusetts Amherst.
Study subjects were an average age of 66 years, 8.7% were clinically depressed, and 9.7% used antidepressants. Data on depression and antidepressant use among Nurses’ Health Study participants were collected simultaneously beginning in 2000.
Depression and antidepressant use were self-reported, and depressive symptoms were confirmed using the five-item Mental Health Inventory.
The findings are encouraging; depression and antidepressant use are common and both have been hypothesized to increase breast cancer risk. Some prior studies have found a link between either depression or antidepressant use and breast cancer, and others have not – but most have had important limitations, including retrospective design and inclusion of major depression only, among others, she said.
“To me, though, the most important limitation is that previous studies have not evaluated depression and antidepressant use together,” Dr. Reeves said.
In the current study, which did consider both, no evidence was seen to suggest that depression or antidepressant use affects breast cancer risk.
“It’s typically very unexciting to have to report null results, but in this case, I think this is excellent news and really the best we could have hoped for,” she said, adding that although they are preliminary, the findings should be “very reassuring for the millions of women with depression and/or those using antidepressants.”
“Depression is a very serious medical condition. It deserves to be treated, and it’s nice that these women can take the antidepressants, which so effectively treat this condition without worry that they’re doing something that would adversely affect their breast cancer risk in the future,” she concluded, noting that more sophisticated analyses of the data are planned to consider additional variables, including treatment duration. The analyses will also be repeated in the Nurses’ Health Study II cohort, which is a younger cohort with a higher incidence of premenopausal breast cancer and a greater prevalence of both depression and antidepressant use.
BIRMINGHAM, ALA. – Neither depression nor antidepressant use are associated with an increased risk of breast cancer among participants in the Nurses’ Health Study, according to an analysis of data from 67,120 women enrolled in the ongoing prospective cohort study.
Of the women included in the analysis, 2,904 had confirmed breast cancer as of the end of December 2012, including 2,333 with invasive disease. After adjusting for age, body mass index, and menopausal status, no statistically significant associations were seen between invasive or in situ breast cancer and depression or antidepressant use, Katherine W. Reeves, Ph.D. reported at the annual meeting of the American Society of Preventive Oncology.
The point estimates for the odds ratios were all below 1 for in situ disease, indicating a potential protective effect of depression, Dr. Reeves said.
“These were not statistically significant, so I would caution against overinterpreting the results, but it is kind of curious,” she said, noting that the finding may indicate that depressed women are less likely than nondepressed women are to have a mammogram – and thus are less likely to have the opportunity to be diagnosed with in situ disease.
When depression and antidepressant use were included together in the same model, they remained unassociated with breast cancer risk (odds ratio, 0.87), said Dr. Reeves of the University of Massachusetts Amherst.
Study subjects were an average age of 66 years, 8.7% were clinically depressed, and 9.7% used antidepressants. Data on depression and antidepressant use among Nurses’ Health Study participants were collected simultaneously beginning in 2000.
Depression and antidepressant use were self-reported, and depressive symptoms were confirmed using the five-item Mental Health Inventory.
The findings are encouraging; depression and antidepressant use are common and both have been hypothesized to increase breast cancer risk. Some prior studies have found a link between either depression or antidepressant use and breast cancer, and others have not – but most have had important limitations, including retrospective design and inclusion of major depression only, among others, she said.
“To me, though, the most important limitation is that previous studies have not evaluated depression and antidepressant use together,” Dr. Reeves said.
In the current study, which did consider both, no evidence was seen to suggest that depression or antidepressant use affects breast cancer risk.
“It’s typically very unexciting to have to report null results, but in this case, I think this is excellent news and really the best we could have hoped for,” she said, adding that although they are preliminary, the findings should be “very reassuring for the millions of women with depression and/or those using antidepressants.”
“Depression is a very serious medical condition. It deserves to be treated, and it’s nice that these women can take the antidepressants, which so effectively treat this condition without worry that they’re doing something that would adversely affect their breast cancer risk in the future,” she concluded, noting that more sophisticated analyses of the data are planned to consider additional variables, including treatment duration. The analyses will also be repeated in the Nurses’ Health Study II cohort, which is a younger cohort with a higher incidence of premenopausal breast cancer and a greater prevalence of both depression and antidepressant use.
BIRMINGHAM, ALA. – Neither depression nor antidepressant use are associated with an increased risk of breast cancer among participants in the Nurses’ Health Study, according to an analysis of data from 67,120 women enrolled in the ongoing prospective cohort study.
Of the women included in the analysis, 2,904 had confirmed breast cancer as of the end of December 2012, including 2,333 with invasive disease. After adjusting for age, body mass index, and menopausal status, no statistically significant associations were seen between invasive or in situ breast cancer and depression or antidepressant use, Katherine W. Reeves, Ph.D. reported at the annual meeting of the American Society of Preventive Oncology.
The point estimates for the odds ratios were all below 1 for in situ disease, indicating a potential protective effect of depression, Dr. Reeves said.
“These were not statistically significant, so I would caution against overinterpreting the results, but it is kind of curious,” she said, noting that the finding may indicate that depressed women are less likely than nondepressed women are to have a mammogram – and thus are less likely to have the opportunity to be diagnosed with in situ disease.
When depression and antidepressant use were included together in the same model, they remained unassociated with breast cancer risk (odds ratio, 0.87), said Dr. Reeves of the University of Massachusetts Amherst.
Study subjects were an average age of 66 years, 8.7% were clinically depressed, and 9.7% used antidepressants. Data on depression and antidepressant use among Nurses’ Health Study participants were collected simultaneously beginning in 2000.
Depression and antidepressant use were self-reported, and depressive symptoms were confirmed using the five-item Mental Health Inventory.
The findings are encouraging; depression and antidepressant use are common and both have been hypothesized to increase breast cancer risk. Some prior studies have found a link between either depression or antidepressant use and breast cancer, and others have not – but most have had important limitations, including retrospective design and inclusion of major depression only, among others, she said.
“To me, though, the most important limitation is that previous studies have not evaluated depression and antidepressant use together,” Dr. Reeves said.
In the current study, which did consider both, no evidence was seen to suggest that depression or antidepressant use affects breast cancer risk.
“It’s typically very unexciting to have to report null results, but in this case, I think this is excellent news and really the best we could have hoped for,” she said, adding that although they are preliminary, the findings should be “very reassuring for the millions of women with depression and/or those using antidepressants.”
“Depression is a very serious medical condition. It deserves to be treated, and it’s nice that these women can take the antidepressants, which so effectively treat this condition without worry that they’re doing something that would adversely affect their breast cancer risk in the future,” she concluded, noting that more sophisticated analyses of the data are planned to consider additional variables, including treatment duration. The analyses will also be repeated in the Nurses’ Health Study II cohort, which is a younger cohort with a higher incidence of premenopausal breast cancer and a greater prevalence of both depression and antidepressant use.
AT THE ASPO ANNUAL MEETING
Key clinical point: Depression and antidepressant use do not appear to increase breast cancer risk.
Major finding: No statistically significant associations were seen between either invasive or in situ breast cancer and depression or antidepressant use.
Data source: 67,120 women fromthe Nurses’ Health Study.
Disclosures: The investigator reported no conflicts.
Indocyanine green technique detects sentinel nodes in breast cancers
Indocyanine green dye caused no major side effects and was almost 99% concordant with radioisotope technetium for sentinel lymph node detection in early-stage breast cancer, according to researchers.
The results extend promising findings from an earlier meta-analysis of the tracer in a variety of tumor types, said Dr. Domenico Samorani of Santarcangelo di Romagna Hospital, Rimini, Italy.
“The method seems reproducible, safe, eliminates exposure to ionizing radiation, and is potentially cost-saving, despite requiring specialist training. [Also,] it could be an option for breast cancer centers with no nuclear medicine supply,” wrote Dr. Samorani and colleagues.
Sentinel lymph node biopsy has largely replaced axillary lymph node dissection for staging breast cancer, as it causes much less morbidity and is associated with similar rates of survival and locoregional recurrence. Vital blue dyes and radioisotope technetium (99mTc) are the most commonly used enhancers, but the blue dyes can cause allergic reactions and skin necrosis, and 99mTc is costly and requires special logistics and handling because of its radioactivity, the investigators noted. For these reasons, there has been renewed interest in indocyanine green dye (ICG) as an alternative, they said (Eur. J. Surg. Oncol. 2015;41:64-70).
For the study, the investigators evaluated 589 lymph nodes from 301 patients with clinically node-negative, invasive or microinvasive early breast cancer confirmed by core biopsy. All patients underwent 99mTc-guided sentinel node detection, which served as the gold standard for comparison. To perform ICG-guided detection, the researchers diluted 25 mg of ICG PULSION with 5 mL distilled water and then injected empirical doses of 0.4 to 1.2 mL of the solution subcutaneously above the tumor site for unicentric cancers, or around the areola for multicentric disease. Then the researchers used an infrared-emitting camera (Photodynamic Eye, Hamamatsu Photonics, Hamamatsu, Japan) to visualize the lymphatic drainage pathway and localize sentinel nodes for removal.
Overall, 98.7% of sentinel nodes that were 99mTc positive also were ICG positive (95% confidence interval, 97.1%-99.5%), a high degree of concordance that reflected past study results, the investigators said. Notably, the ICG-guided technique identified at least one sentinel node for 297 patients (98.7%), compared with 287 patients (95.4%) for the 99mTc method (P < .05). Thus, the use of ICG prevented removal of the entire axilla for 10 patients, the researchers wrote.
For six patients, the ICG method identified a metastatic node that 99mTc failed to identify. Therefore, ICG provided an advantage for 16 cases (5.3%). No patients experienced allergic reactions, 3.2% developed seromas, and 2.5% developed paresthesia, the researchers added.
Use of ICG instead of 99mTc for sentinel lymph node detection has several advantages: It does not require involving a nuclear medicine department, uses less radioactive material, minimizes issues around waste disposal, and can be performed in the operating room immediately after the induction of general anesthesia, said the researchers. And if combined with radio-guided occult lesion localization (ROLL), it avoids placing two radioactive tracings at the injection site, thereby facilitating tumor detection, the researchers noted.
Clinicians who are implementing ICG-guided sentinel node detection should consider combining it with 99mTc to avoid missing nodes during the learning process, the researchers emphasized.
They reported no funding sources and no conflicts of interest.
Indocyanine green dye caused no major side effects and was almost 99% concordant with radioisotope technetium for sentinel lymph node detection in early-stage breast cancer, according to researchers.
The results extend promising findings from an earlier meta-analysis of the tracer in a variety of tumor types, said Dr. Domenico Samorani of Santarcangelo di Romagna Hospital, Rimini, Italy.
“The method seems reproducible, safe, eliminates exposure to ionizing radiation, and is potentially cost-saving, despite requiring specialist training. [Also,] it could be an option for breast cancer centers with no nuclear medicine supply,” wrote Dr. Samorani and colleagues.
Sentinel lymph node biopsy has largely replaced axillary lymph node dissection for staging breast cancer, as it causes much less morbidity and is associated with similar rates of survival and locoregional recurrence. Vital blue dyes and radioisotope technetium (99mTc) are the most commonly used enhancers, but the blue dyes can cause allergic reactions and skin necrosis, and 99mTc is costly and requires special logistics and handling because of its radioactivity, the investigators noted. For these reasons, there has been renewed interest in indocyanine green dye (ICG) as an alternative, they said (Eur. J. Surg. Oncol. 2015;41:64-70).
For the study, the investigators evaluated 589 lymph nodes from 301 patients with clinically node-negative, invasive or microinvasive early breast cancer confirmed by core biopsy. All patients underwent 99mTc-guided sentinel node detection, which served as the gold standard for comparison. To perform ICG-guided detection, the researchers diluted 25 mg of ICG PULSION with 5 mL distilled water and then injected empirical doses of 0.4 to 1.2 mL of the solution subcutaneously above the tumor site for unicentric cancers, or around the areola for multicentric disease. Then the researchers used an infrared-emitting camera (Photodynamic Eye, Hamamatsu Photonics, Hamamatsu, Japan) to visualize the lymphatic drainage pathway and localize sentinel nodes for removal.
Overall, 98.7% of sentinel nodes that were 99mTc positive also were ICG positive (95% confidence interval, 97.1%-99.5%), a high degree of concordance that reflected past study results, the investigators said. Notably, the ICG-guided technique identified at least one sentinel node for 297 patients (98.7%), compared with 287 patients (95.4%) for the 99mTc method (P < .05). Thus, the use of ICG prevented removal of the entire axilla for 10 patients, the researchers wrote.
For six patients, the ICG method identified a metastatic node that 99mTc failed to identify. Therefore, ICG provided an advantage for 16 cases (5.3%). No patients experienced allergic reactions, 3.2% developed seromas, and 2.5% developed paresthesia, the researchers added.
Use of ICG instead of 99mTc for sentinel lymph node detection has several advantages: It does not require involving a nuclear medicine department, uses less radioactive material, minimizes issues around waste disposal, and can be performed in the operating room immediately after the induction of general anesthesia, said the researchers. And if combined with radio-guided occult lesion localization (ROLL), it avoids placing two radioactive tracings at the injection site, thereby facilitating tumor detection, the researchers noted.
Clinicians who are implementing ICG-guided sentinel node detection should consider combining it with 99mTc to avoid missing nodes during the learning process, the researchers emphasized.
They reported no funding sources and no conflicts of interest.
Indocyanine green dye caused no major side effects and was almost 99% concordant with radioisotope technetium for sentinel lymph node detection in early-stage breast cancer, according to researchers.
The results extend promising findings from an earlier meta-analysis of the tracer in a variety of tumor types, said Dr. Domenico Samorani of Santarcangelo di Romagna Hospital, Rimini, Italy.
“The method seems reproducible, safe, eliminates exposure to ionizing radiation, and is potentially cost-saving, despite requiring specialist training. [Also,] it could be an option for breast cancer centers with no nuclear medicine supply,” wrote Dr. Samorani and colleagues.
Sentinel lymph node biopsy has largely replaced axillary lymph node dissection for staging breast cancer, as it causes much less morbidity and is associated with similar rates of survival and locoregional recurrence. Vital blue dyes and radioisotope technetium (99mTc) are the most commonly used enhancers, but the blue dyes can cause allergic reactions and skin necrosis, and 99mTc is costly and requires special logistics and handling because of its radioactivity, the investigators noted. For these reasons, there has been renewed interest in indocyanine green dye (ICG) as an alternative, they said (Eur. J. Surg. Oncol. 2015;41:64-70).
For the study, the investigators evaluated 589 lymph nodes from 301 patients with clinically node-negative, invasive or microinvasive early breast cancer confirmed by core biopsy. All patients underwent 99mTc-guided sentinel node detection, which served as the gold standard for comparison. To perform ICG-guided detection, the researchers diluted 25 mg of ICG PULSION with 5 mL distilled water and then injected empirical doses of 0.4 to 1.2 mL of the solution subcutaneously above the tumor site for unicentric cancers, or around the areola for multicentric disease. Then the researchers used an infrared-emitting camera (Photodynamic Eye, Hamamatsu Photonics, Hamamatsu, Japan) to visualize the lymphatic drainage pathway and localize sentinel nodes for removal.
Overall, 98.7% of sentinel nodes that were 99mTc positive also were ICG positive (95% confidence interval, 97.1%-99.5%), a high degree of concordance that reflected past study results, the investigators said. Notably, the ICG-guided technique identified at least one sentinel node for 297 patients (98.7%), compared with 287 patients (95.4%) for the 99mTc method (P < .05). Thus, the use of ICG prevented removal of the entire axilla for 10 patients, the researchers wrote.
For six patients, the ICG method identified a metastatic node that 99mTc failed to identify. Therefore, ICG provided an advantage for 16 cases (5.3%). No patients experienced allergic reactions, 3.2% developed seromas, and 2.5% developed paresthesia, the researchers added.
Use of ICG instead of 99mTc for sentinel lymph node detection has several advantages: It does not require involving a nuclear medicine department, uses less radioactive material, minimizes issues around waste disposal, and can be performed in the operating room immediately after the induction of general anesthesia, said the researchers. And if combined with radio-guided occult lesion localization (ROLL), it avoids placing two radioactive tracings at the injection site, thereby facilitating tumor detection, the researchers noted.
Clinicians who are implementing ICG-guided sentinel node detection should consider combining it with 99mTc to avoid missing nodes during the learning process, the researchers emphasized.
They reported no funding sources and no conflicts of interest.
FROM THE EUROPEAN JOURNAL OF SURGICAL ONCOLOGY
Key clinical point: The fluorescent dye indocyanine green tracer showed promise in detecting sentinel lymph nodes in early-stage breast cancer.
Major finding: The dye caused no major side effects and was almost 99% concordant with radioisotope technetium.
Data source: Prospective validation trial evaluating 589 lymph nodes from 301 patients with clinically node-negative, invasive early breast cancer.
Disclosures: The investigators reported no funding sources and no conflicts of interest.
Medicare advisers: Cancer prognostic tests not ready for prime time
BALTIMORE – While prognostic tests tied to specific chemotherapy agents may offer a clear benefit in guiding treatment and improving outcomes for certain malignancies, applying the tests more broadly may not offer information that is clinically relevant.
Members of the Medicare Evidence Development & Coverage Advisory Committee were asked to examine prognostic tests for three types of cancers – adenocarcinoma of the colon and rectum, breast cancer (both invasive duct and lobular cancers), and non–small cell lung cancers – in a preliminary effort to determine how Medicare should pay for the use of such tests. They found little evidence on how these tests could lead to better outcomes, despite evidence showing the tests did confirm the analytic and clinical validity of the biomarkers.
Turning to the usefulness of such tests in aiding clinical decision making by physicians and patients, data on “the downstream effects of these tests ... got very thin very quickly,” according to advisory committee member Dr. Beverly A. Guadagnolo of the department of radiation oncology at M.D. Anderson Cancer Center, Houston.
At its March 24 meeting, the committee found that only three tests – microsatellite instability tests in adenocarcinoma of the colon and rectum, and MammaPrint and Oncotype DX Breast – showed evidence of some level of utility in managing patients and improving outcomes; however, none reached an average of 3 (intermediate confidence) on the committee’s 5-point scale of evaluating the strength of the evidence. Oncotype DX Breast was the highest, with a 2.875 average vote across the eight voting members.
Dr. Mitchell Kamrava of the department of radiation oncology at the University of California, Los Angeles, also noted that physicians are doing their best to understand what the different biomarkers actually mean when it comes to treating patients, “but the data are just not quite there yet.”
For Medicare officials, the emphasis going forward will be how useful these tests will be for improving care.
“We approached various lab vendors and they are able to show us plenty of information in terms of analytic validity as well as clinical validity,” Dr. James Rollins, director of the Division of Items and Devices in CMS’ Coverage & Analysis Group, said. “Some of them feel that demonstrating clinical utility is something that they don’t need to provide commercial insurers. I don’t know why they feel that way. But as I said, as time goes on, we will be using more and more clinical utility.”
CMS currently does not have any open national coverage analysis decisions that relate to prognostic cancer tests.
Dr. Rollins said the agency is defining clinical utility as information that leads to improved health outcomes either due to increased benefit or reduction in harm.
BALTIMORE – While prognostic tests tied to specific chemotherapy agents may offer a clear benefit in guiding treatment and improving outcomes for certain malignancies, applying the tests more broadly may not offer information that is clinically relevant.
Members of the Medicare Evidence Development & Coverage Advisory Committee were asked to examine prognostic tests for three types of cancers – adenocarcinoma of the colon and rectum, breast cancer (both invasive duct and lobular cancers), and non–small cell lung cancers – in a preliminary effort to determine how Medicare should pay for the use of such tests. They found little evidence on how these tests could lead to better outcomes, despite evidence showing the tests did confirm the analytic and clinical validity of the biomarkers.
Turning to the usefulness of such tests in aiding clinical decision making by physicians and patients, data on “the downstream effects of these tests ... got very thin very quickly,” according to advisory committee member Dr. Beverly A. Guadagnolo of the department of radiation oncology at M.D. Anderson Cancer Center, Houston.
At its March 24 meeting, the committee found that only three tests – microsatellite instability tests in adenocarcinoma of the colon and rectum, and MammaPrint and Oncotype DX Breast – showed evidence of some level of utility in managing patients and improving outcomes; however, none reached an average of 3 (intermediate confidence) on the committee’s 5-point scale of evaluating the strength of the evidence. Oncotype DX Breast was the highest, with a 2.875 average vote across the eight voting members.
Dr. Mitchell Kamrava of the department of radiation oncology at the University of California, Los Angeles, also noted that physicians are doing their best to understand what the different biomarkers actually mean when it comes to treating patients, “but the data are just not quite there yet.”
For Medicare officials, the emphasis going forward will be how useful these tests will be for improving care.
“We approached various lab vendors and they are able to show us plenty of information in terms of analytic validity as well as clinical validity,” Dr. James Rollins, director of the Division of Items and Devices in CMS’ Coverage & Analysis Group, said. “Some of them feel that demonstrating clinical utility is something that they don’t need to provide commercial insurers. I don’t know why they feel that way. But as I said, as time goes on, we will be using more and more clinical utility.”
CMS currently does not have any open national coverage analysis decisions that relate to prognostic cancer tests.
Dr. Rollins said the agency is defining clinical utility as information that leads to improved health outcomes either due to increased benefit or reduction in harm.
BALTIMORE – While prognostic tests tied to specific chemotherapy agents may offer a clear benefit in guiding treatment and improving outcomes for certain malignancies, applying the tests more broadly may not offer information that is clinically relevant.
Members of the Medicare Evidence Development & Coverage Advisory Committee were asked to examine prognostic tests for three types of cancers – adenocarcinoma of the colon and rectum, breast cancer (both invasive duct and lobular cancers), and non–small cell lung cancers – in a preliminary effort to determine how Medicare should pay for the use of such tests. They found little evidence on how these tests could lead to better outcomes, despite evidence showing the tests did confirm the analytic and clinical validity of the biomarkers.
Turning to the usefulness of such tests in aiding clinical decision making by physicians and patients, data on “the downstream effects of these tests ... got very thin very quickly,” according to advisory committee member Dr. Beverly A. Guadagnolo of the department of radiation oncology at M.D. Anderson Cancer Center, Houston.
At its March 24 meeting, the committee found that only three tests – microsatellite instability tests in adenocarcinoma of the colon and rectum, and MammaPrint and Oncotype DX Breast – showed evidence of some level of utility in managing patients and improving outcomes; however, none reached an average of 3 (intermediate confidence) on the committee’s 5-point scale of evaluating the strength of the evidence. Oncotype DX Breast was the highest, with a 2.875 average vote across the eight voting members.
Dr. Mitchell Kamrava of the department of radiation oncology at the University of California, Los Angeles, also noted that physicians are doing their best to understand what the different biomarkers actually mean when it comes to treating patients, “but the data are just not quite there yet.”
For Medicare officials, the emphasis going forward will be how useful these tests will be for improving care.
“We approached various lab vendors and they are able to show us plenty of information in terms of analytic validity as well as clinical validity,” Dr. James Rollins, director of the Division of Items and Devices in CMS’ Coverage & Analysis Group, said. “Some of them feel that demonstrating clinical utility is something that they don’t need to provide commercial insurers. I don’t know why they feel that way. But as I said, as time goes on, we will be using more and more clinical utility.”
CMS currently does not have any open national coverage analysis decisions that relate to prognostic cancer tests.
Dr. Rollins said the agency is defining clinical utility as information that leads to improved health outcomes either due to increased benefit or reduction in harm.
AT A MEDCAC MEETING
VIDEO: Experts distill top clinical takeaways from breast cancer symposium
SAN ANTONIO – In a roundtable at the 2014 San Antonio Breast Cancer Symposium, Dr. Jame Abraham, Dr. Linda Bosserman, and Dr. Debra Patt discussed their top selections from the meeting’s presentations.
Among the topics were the promising findings in a small study involving the novel immune checkpoint inhibitor pembrolizumab in advanced triple-negative breast cancer; the SOFT trial, which looked at ovarian suppression with either tamoxifen or an aromatase inhibitor in premenopausal women with hormone receptor–positive disease; and the negative findings on the use of erythropoietin in patients with metastatic breast cancer.
The editors also highlighted findings showing no difference in disease-free survival between node-negative patients receiving six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide and those receiving four cycles of Adriamycin and cyclophosphamide; and data from the Women’s Intervention Nutrition Study, which showed that lifestyle and dietary changes can have a notable impact on outcomes in women with early-stage, treated breast cancer.
Management of therapy side effects, fertility concerns in younger patients, patient quality of life, and the cost effectiveness of treatment were a subtext to the editors’ discussions of the clinical findings, as they highlighted the importance of looking closely at the risk-benefit relationship in delivering quality, affordable, personalized care to patients with breast cancer.
Dr. Abraham is director of the breast medical oncology at the Cleveland Clinic. Dr. Bosserman is clinical assistant professor at City of Hope Cancer Center, Duarte, Calif. Dr. Patt is a partner at Texas Oncology, Austin, and director of health care informatics at McKesson Specialty Health.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – In a roundtable at the 2014 San Antonio Breast Cancer Symposium, Dr. Jame Abraham, Dr. Linda Bosserman, and Dr. Debra Patt discussed their top selections from the meeting’s presentations.
Among the topics were the promising findings in a small study involving the novel immune checkpoint inhibitor pembrolizumab in advanced triple-negative breast cancer; the SOFT trial, which looked at ovarian suppression with either tamoxifen or an aromatase inhibitor in premenopausal women with hormone receptor–positive disease; and the negative findings on the use of erythropoietin in patients with metastatic breast cancer.
The editors also highlighted findings showing no difference in disease-free survival between node-negative patients receiving six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide and those receiving four cycles of Adriamycin and cyclophosphamide; and data from the Women’s Intervention Nutrition Study, which showed that lifestyle and dietary changes can have a notable impact on outcomes in women with early-stage, treated breast cancer.
Management of therapy side effects, fertility concerns in younger patients, patient quality of life, and the cost effectiveness of treatment were a subtext to the editors’ discussions of the clinical findings, as they highlighted the importance of looking closely at the risk-benefit relationship in delivering quality, affordable, personalized care to patients with breast cancer.
Dr. Abraham is director of the breast medical oncology at the Cleveland Clinic. Dr. Bosserman is clinical assistant professor at City of Hope Cancer Center, Duarte, Calif. Dr. Patt is a partner at Texas Oncology, Austin, and director of health care informatics at McKesson Specialty Health.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – In a roundtable at the 2014 San Antonio Breast Cancer Symposium, Dr. Jame Abraham, Dr. Linda Bosserman, and Dr. Debra Patt discussed their top selections from the meeting’s presentations.
Among the topics were the promising findings in a small study involving the novel immune checkpoint inhibitor pembrolizumab in advanced triple-negative breast cancer; the SOFT trial, which looked at ovarian suppression with either tamoxifen or an aromatase inhibitor in premenopausal women with hormone receptor–positive disease; and the negative findings on the use of erythropoietin in patients with metastatic breast cancer.
The editors also highlighted findings showing no difference in disease-free survival between node-negative patients receiving six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide and those receiving four cycles of Adriamycin and cyclophosphamide; and data from the Women’s Intervention Nutrition Study, which showed that lifestyle and dietary changes can have a notable impact on outcomes in women with early-stage, treated breast cancer.
Management of therapy side effects, fertility concerns in younger patients, patient quality of life, and the cost effectiveness of treatment were a subtext to the editors’ discussions of the clinical findings, as they highlighted the importance of looking closely at the risk-benefit relationship in delivering quality, affordable, personalized care to patients with breast cancer.
Dr. Abraham is director of the breast medical oncology at the Cleveland Clinic. Dr. Bosserman is clinical assistant professor at City of Hope Cancer Center, Duarte, Calif. Dr. Patt is a partner at Texas Oncology, Austin, and director of health care informatics at McKesson Specialty Health.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM SABCS 2014
Apple’s ResearchKit
Doctors have been conjecturing about how the new Apple Watch, with its spectacular fitness and wellness tracking features, will transform health care. The real rock star at Apple’s March 9 “Spring Forward” event, however, was the opening band, ResearchKit.
What is it?
ResearchKit is Apple’s (beautiful) solution to one of the great problems of medical research: recruiting subjects. ResearchKit allows researchers to collect data in a way that before today was impossible: with just a click from their smartphones. The open-source software platform allows developers to design studies and to recruit subjects right from the app store. Researchers can leverage high-tech smartphone sensors and can push out surveys, collecting both objective and subjective data from thousands (heck, potentially millions) of participants.
Five apps were developed for the launch: mPower for Parkinson’s disease, from the University of Rochester, N.Y.; GlucoSuccess for diabetes, from Massachusetts General Hospital, Boston; MyHeart Counts for cardiovascular disease, from Stanford (Calif.) University and the University of Oxford, England; Asthma Health from Mount Sinai and Weill Medical College of Cornell University, New York, N.Y.; and Share the Journey for breast cancer, from the Dana-Farber Cancer Institute, Boston; the University of California, Los Angeles Fielding School of Public Health; and Penn Medicine, Philadelphia.
My take
I took a closer look at MyHeart Counts, which evaluates how patients’ activity levels influence their cardiovascular health. According to Stanford University, a mere 4 days after its release, the MyHeart Counts app had been downloaded 52,900 times in the United States and Canada and had more than 22,000 users who had consented to the study. Try getting that kind of response to your research study with a flyer with tear-off phone number posted in your hospital cafeteria.
I was impressed with its beautiful interface and ease of use. Designed to gather sensor and health data from your iPhone and personal devices, this app is designed to help researchers (and you) detect patterns or details about your heart health. To start, you download the app, give your consent, answer questions about your health and lifestyle, and begin recording your activity with your phone or wearable device. You do a walk test to determine your heart health and potential health risk.
What happens to the data you input? It is sent (with your permission) to a secure database, and your name is replaced with a random code. Your coded and encrypted data are then shared with scientists and physicians to use in medical research.
For this particular study, they ask you to participate 10-15 minutes per day for 1 week, then hope that you can contribute further for 1 week every 3 months answering surveys about your health, lifestyle, and physical activity. Apple reassures users that they can withdraw at any time.
Why? Who cares?
The value proposition for researchers is obvious: The platform provides access to many more subjects than even imaginable. The accelerometer, barometer, gyroscope, and GPS send interesting data to researchers friction free. The Parkinson’s app, for example, uses a cool algorithm and the phone’s microphone to detect symptoms by having patients say “ahhhh.” By pushing out questionnaires regularly, you can collect much more data with shorter intervals for longer periods of time.
The advantages for patients are equally compelling. In addition to sending their data to researchers, they also receive information back from the researchers, helping them monitor their cardiovascular health. In fact, just knowing they are participating in the study might be of benefit. As dermatologist Dr. Steve Feldman of Wake Forest Baptist Medical Center, Winston Salem, N.C., has shown, patients are more likely to adhere to therapies when they know they are being watched, a manifestation of the Hawthorne effect.
Shortcomings
Surely there is a catch? And there is. With potentially millions of participants sending self-reported data, there is the potential that ResearchKit studies glean big, beautiful, bad data. How, for example, could you verify that self-reported asthma patients actually have asthma? Maybe they just read about ResearchKit and wanted to be part of the fun.
For patients, privacy concerns are paramount. Apple promised that no one, not even Apple, will see your data without your permission. But with privacy breaches reported in the news weekly, what can Apple’s assurance mean? Didn’t Target and Aetna promise to keep your data safe as well?
The potential for interesting research is enormous. By the time you read this, I wouldn’t be surprised if a psoriasis study had already launched. In fact, a year from now, the problem might be a dozen or more interesting psoriasis studies all competing for the same patients. Ah, maybe we should be glad if we should be so lucky.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.
Doctors have been conjecturing about how the new Apple Watch, with its spectacular fitness and wellness tracking features, will transform health care. The real rock star at Apple’s March 9 “Spring Forward” event, however, was the opening band, ResearchKit.
What is it?
ResearchKit is Apple’s (beautiful) solution to one of the great problems of medical research: recruiting subjects. ResearchKit allows researchers to collect data in a way that before today was impossible: with just a click from their smartphones. The open-source software platform allows developers to design studies and to recruit subjects right from the app store. Researchers can leverage high-tech smartphone sensors and can push out surveys, collecting both objective and subjective data from thousands (heck, potentially millions) of participants.
Five apps were developed for the launch: mPower for Parkinson’s disease, from the University of Rochester, N.Y.; GlucoSuccess for diabetes, from Massachusetts General Hospital, Boston; MyHeart Counts for cardiovascular disease, from Stanford (Calif.) University and the University of Oxford, England; Asthma Health from Mount Sinai and Weill Medical College of Cornell University, New York, N.Y.; and Share the Journey for breast cancer, from the Dana-Farber Cancer Institute, Boston; the University of California, Los Angeles Fielding School of Public Health; and Penn Medicine, Philadelphia.
My take
I took a closer look at MyHeart Counts, which evaluates how patients’ activity levels influence their cardiovascular health. According to Stanford University, a mere 4 days after its release, the MyHeart Counts app had been downloaded 52,900 times in the United States and Canada and had more than 22,000 users who had consented to the study. Try getting that kind of response to your research study with a flyer with tear-off phone number posted in your hospital cafeteria.
I was impressed with its beautiful interface and ease of use. Designed to gather sensor and health data from your iPhone and personal devices, this app is designed to help researchers (and you) detect patterns or details about your heart health. To start, you download the app, give your consent, answer questions about your health and lifestyle, and begin recording your activity with your phone or wearable device. You do a walk test to determine your heart health and potential health risk.
What happens to the data you input? It is sent (with your permission) to a secure database, and your name is replaced with a random code. Your coded and encrypted data are then shared with scientists and physicians to use in medical research.
For this particular study, they ask you to participate 10-15 minutes per day for 1 week, then hope that you can contribute further for 1 week every 3 months answering surveys about your health, lifestyle, and physical activity. Apple reassures users that they can withdraw at any time.
Why? Who cares?
The value proposition for researchers is obvious: The platform provides access to many more subjects than even imaginable. The accelerometer, barometer, gyroscope, and GPS send interesting data to researchers friction free. The Parkinson’s app, for example, uses a cool algorithm and the phone’s microphone to detect symptoms by having patients say “ahhhh.” By pushing out questionnaires regularly, you can collect much more data with shorter intervals for longer periods of time.
The advantages for patients are equally compelling. In addition to sending their data to researchers, they also receive information back from the researchers, helping them monitor their cardiovascular health. In fact, just knowing they are participating in the study might be of benefit. As dermatologist Dr. Steve Feldman of Wake Forest Baptist Medical Center, Winston Salem, N.C., has shown, patients are more likely to adhere to therapies when they know they are being watched, a manifestation of the Hawthorne effect.
Shortcomings
Surely there is a catch? And there is. With potentially millions of participants sending self-reported data, there is the potential that ResearchKit studies glean big, beautiful, bad data. How, for example, could you verify that self-reported asthma patients actually have asthma? Maybe they just read about ResearchKit and wanted to be part of the fun.
For patients, privacy concerns are paramount. Apple promised that no one, not even Apple, will see your data without your permission. But with privacy breaches reported in the news weekly, what can Apple’s assurance mean? Didn’t Target and Aetna promise to keep your data safe as well?
The potential for interesting research is enormous. By the time you read this, I wouldn’t be surprised if a psoriasis study had already launched. In fact, a year from now, the problem might be a dozen or more interesting psoriasis studies all competing for the same patients. Ah, maybe we should be glad if we should be so lucky.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.
Doctors have been conjecturing about how the new Apple Watch, with its spectacular fitness and wellness tracking features, will transform health care. The real rock star at Apple’s March 9 “Spring Forward” event, however, was the opening band, ResearchKit.
What is it?
ResearchKit is Apple’s (beautiful) solution to one of the great problems of medical research: recruiting subjects. ResearchKit allows researchers to collect data in a way that before today was impossible: with just a click from their smartphones. The open-source software platform allows developers to design studies and to recruit subjects right from the app store. Researchers can leverage high-tech smartphone sensors and can push out surveys, collecting both objective and subjective data from thousands (heck, potentially millions) of participants.
Five apps were developed for the launch: mPower for Parkinson’s disease, from the University of Rochester, N.Y.; GlucoSuccess for diabetes, from Massachusetts General Hospital, Boston; MyHeart Counts for cardiovascular disease, from Stanford (Calif.) University and the University of Oxford, England; Asthma Health from Mount Sinai and Weill Medical College of Cornell University, New York, N.Y.; and Share the Journey for breast cancer, from the Dana-Farber Cancer Institute, Boston; the University of California, Los Angeles Fielding School of Public Health; and Penn Medicine, Philadelphia.
My take
I took a closer look at MyHeart Counts, which evaluates how patients’ activity levels influence their cardiovascular health. According to Stanford University, a mere 4 days after its release, the MyHeart Counts app had been downloaded 52,900 times in the United States and Canada and had more than 22,000 users who had consented to the study. Try getting that kind of response to your research study with a flyer with tear-off phone number posted in your hospital cafeteria.
I was impressed with its beautiful interface and ease of use. Designed to gather sensor and health data from your iPhone and personal devices, this app is designed to help researchers (and you) detect patterns or details about your heart health. To start, you download the app, give your consent, answer questions about your health and lifestyle, and begin recording your activity with your phone or wearable device. You do a walk test to determine your heart health and potential health risk.
What happens to the data you input? It is sent (with your permission) to a secure database, and your name is replaced with a random code. Your coded and encrypted data are then shared with scientists and physicians to use in medical research.
For this particular study, they ask you to participate 10-15 minutes per day for 1 week, then hope that you can contribute further for 1 week every 3 months answering surveys about your health, lifestyle, and physical activity. Apple reassures users that they can withdraw at any time.
Why? Who cares?
The value proposition for researchers is obvious: The platform provides access to many more subjects than even imaginable. The accelerometer, barometer, gyroscope, and GPS send interesting data to researchers friction free. The Parkinson’s app, for example, uses a cool algorithm and the phone’s microphone to detect symptoms by having patients say “ahhhh.” By pushing out questionnaires regularly, you can collect much more data with shorter intervals for longer periods of time.
The advantages for patients are equally compelling. In addition to sending their data to researchers, they also receive information back from the researchers, helping them monitor their cardiovascular health. In fact, just knowing they are participating in the study might be of benefit. As dermatologist Dr. Steve Feldman of Wake Forest Baptist Medical Center, Winston Salem, N.C., has shown, patients are more likely to adhere to therapies when they know they are being watched, a manifestation of the Hawthorne effect.
Shortcomings
Surely there is a catch? And there is. With potentially millions of participants sending self-reported data, there is the potential that ResearchKit studies glean big, beautiful, bad data. How, for example, could you verify that self-reported asthma patients actually have asthma? Maybe they just read about ResearchKit and wanted to be part of the fun.
For patients, privacy concerns are paramount. Apple promised that no one, not even Apple, will see your data without your permission. But with privacy breaches reported in the news weekly, what can Apple’s assurance mean? Didn’t Target and Aetna promise to keep your data safe as well?
The potential for interesting research is enormous. By the time you read this, I wouldn’t be surprised if a psoriasis study had already launched. In fact, a year from now, the problem might be a dozen or more interesting psoriasis studies all competing for the same patients. Ah, maybe we should be glad if we should be so lucky.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.
The need for decision and communication aids: a survey of breast cancer survivors
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Effect of ArginMax on sexual functioning and quality of life among female cancer survivors: results of the WFU CCOP Research Base Protocol 97106
Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.
Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.
Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.
Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.
Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.
Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.
Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company
Click on the PDF icon at the top of this introduction to read the full article.
Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.
Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.
Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.
Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.
Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.
Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.
Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company
Click on the PDF icon at the top of this introduction to read the full article.
Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.
Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.
Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.
Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.
Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.
Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.
Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company
Click on the PDF icon at the top of this introduction to read the full article.
Palbociclib and letrozole for ER-positive, HER2-negative advanced breast cancer
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.