Patient advocate, oncologist weigh in
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‘Extreme’ monitoring fails to boost survival in breast cancer patients

Extreme users of disease-monitoring tests do not have significantly improved overall survival, investigators reported.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on 2,460 women older than 65 years of age with advanced breast cancer revealed that 924 patients (37.6%) were extreme users of disease-monitoring tests, defined as having had more than 12 serum-tumor marker (STM) tests and/or more than four radiographic imaging tests in a 1-year time period.

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“The objectives of this study were to identify patterns and predictors of use and extreme use of disease-monitoring tests among women with [metastatic breast cancer],” reported Dr. Melissa Accordino of Columbia University, New York, and her colleagues (JCO. 2016 May 9. [doi: 10.1200/JCO.2016.66.6313]).

The investigators reviewed SEER Medicare data on women with pathologically confirmed metastatic breast cancer diagnosed from 2002 to 2011. Costs of care were calculated from Medicare reimbursement claims from physician, hospital, outpatient, durable medical equipment, and hospice filings from the date of diagnosis through the date of death or the end of the study period. Per-patient-per-year serum tumor marker testing rate and per-patient-per-year radiographic imaging rates were calculated.

Of the 2,460-person cohort, 37.6% were classified as extreme users (9% were extreme users of STM and 32.8% were extreme users of radiographic imaging tests), Dr. Accordino and her associates reported.

There was no difference in overall survival between extreme users and the rest of the cohort (HR, 0.93; 95% CI, 0.86-1.02).

A multivariate model showed that women who were older than 80 years (OR, 0.58; 95% CI, 0.45-0.75) and patients who were single (OR, 0.77; 95% CI, 0.63-0.93) were less likely to be extreme users while patients who had more frequent oncology-related doctor’s visits were more likely to be extreme users (OR, 3.14; 95% CI, 2.49-3.96).

A linear regression model revealed that costs of care were significantly higher for patients categorized as extreme users whose mean annual cost of care was 50.6% (95% CI, 40.7-61.1) higher than the mean cost of care for those who weren’t extreme users (P less than .001).

“In addition to cost, frequent disease monitoring can be associated with emotional harm. The prevalence of anxiety and depression among patients with advanced cancers is estimated to be 25%-65%. Previous work has shown that depression and anxiety can increase over time in patients with metastatic solid tumors and has been attributed to multiple factors, including fear of death and fear of disease progression. … In a study that assessed distress in women during the surveillance period, women with more frequent testing had higher levels of anxiety without survival benefit,” the investigators wrote.

The investigators also discussed the potential conflict of interest for physicians who benefit financially from disease-monitoring tests. “A successful strategy may be to change policy for reimbursement,” they wrote.

“In addition, better evidence is needed with regard to the benefits and harms of frequent disease-monitoring testing to inform guidelines,” the investigators wrote. “Future research should determine the most cost-effective strategy to monitor patients with [metastatic breast cancer].”

This study was supported by fellowships and grants from the National Cancer Institute, the ASCO/Breast Cancer Research Foundation, and the Conquer Cancer Foundation. Dr. Accordino reported having no disclosures. One investigator reported having a consulting/advisory role with Pfizer, TEVA Pharmaceutical Industries, Otsuka, United Biosource, and EHE International.

jcraig@frontlinemedcom.com

On Twitter@JessCraig_OP

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“I agree in general with the results and conclusions from this manuscript. It makes sense,” said Dr. Charles Loprinzi, Regis Professor of Breast Cancer Research at the Mayo Clinic, in an interview. “More tests do not necessarily mean more benefit. More frequent testing may help to determine early progression of disease, and then this may lead to earlier treatment changes.”

“There is a spectrum of clinicians who are more frequent testers versus infrequent testers,” Dr. Loprinzi explained. “I am on the side of not getting a lot of tests, as sometimes they provide too much information. For example, if I have a patient with metastatic breast cancer and a lump that I can feel on her chest wall or a pathologically palpable lymph node and also had a couple lung nodules, I would tend to follow this patient primarily by history and physical examination. Other physicians might order imaging tests every 3 months. I am less likely to order frequent imaging tests as long as the patient is feeling well and has responded to their anticancer therapy as per repeat physical examinations,” he said.

Shirley Mertz, president of the Metastatic Breast Cancer Network, a national, independent, nonprofit all-volunteer patient advocacy group, took issue with the generalized conclusions investigators drew. “The title of the article and the paragraph describing [the] purpose of the article infer that the authors studied the community of women living with metastatic breast cancer,” Ms. Mertz said in an interview.

“In reality, the authors looked at data from a very small proportion of women living with metastatic breast cancer – those who received a de novo diagnosis and were 65 and older. The authors then drew a broad conclusion about all elderly women based on their selected small proportion of patients. … How can the authors accurately state, ‘One-third of all elderly patients are extreme users of disease-monitoring tests?’ ”

“The selection by the authors of the word ‘extreme users’ is curious,” Ms. Mertz continued. “ ‘Extreme’ has a negative connotation and implies someone is doing something to excess. So, are readers expected to draw the conclusions of the authors? Did the authors consider a less emotional term such as ‘frequent’ or ‘heavy?’ Or does their choice of extreme help support the conclusions that ‘women with metastatic breast cancer are driving up health care costs?’ ”

When asked about the definition of extreme users, Dr. Loprinzi said, “I don’t think that there is a clinical definition of an extreme user. The authors came up with an innovative study idea and thus had to define an endpoint, which I think it is quite reasonable.”

Ms. Mertz also pointed out that while the investigators reported demographics of the study population, there was no analysis of the demographic of the medical oncologists who wrote the orders for disease-monitoring tests. “Such information is important and could be informative of issues underlying heavy use of diagnostic tests,” Ms. Mertz suggested.

Dr. Loprinzi agreed. “Is the frequent testing doctor driven or patient driven, or are they both? I suspect they are both,” he said. “That would be an interesting topic for an investigator to explore. Potentially, records could demonstrate a pattern for individual practitioners.”

What about the authors’ assertion that frequent testing is associated with emotional harm? “For some patients for whom STMs [serum tumor markers] do reflect their relative burden of metastasis, the STMs in conjunction with imaging can offer some measure of reassurance that a particular treatment is working,” Ms. Mertz said.

“What is needed is more research to develop blood markers that can be used with imaging with confidence in the clinic to monitor metastatic disease and response to treatment. We need to add to or improve upon the oncologists’ diagnostic tools, not curb their use as the authors suggest,” she added.

Dr. Loprinzi and Ms. Mertz made these comments during interviews.

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“I agree in general with the results and conclusions from this manuscript. It makes sense,” said Dr. Charles Loprinzi, Regis Professor of Breast Cancer Research at the Mayo Clinic, in an interview. “More tests do not necessarily mean more benefit. More frequent testing may help to determine early progression of disease, and then this may lead to earlier treatment changes.”

“There is a spectrum of clinicians who are more frequent testers versus infrequent testers,” Dr. Loprinzi explained. “I am on the side of not getting a lot of tests, as sometimes they provide too much information. For example, if I have a patient with metastatic breast cancer and a lump that I can feel on her chest wall or a pathologically palpable lymph node and also had a couple lung nodules, I would tend to follow this patient primarily by history and physical examination. Other physicians might order imaging tests every 3 months. I am less likely to order frequent imaging tests as long as the patient is feeling well and has responded to their anticancer therapy as per repeat physical examinations,” he said.

Shirley Mertz, president of the Metastatic Breast Cancer Network, a national, independent, nonprofit all-volunteer patient advocacy group, took issue with the generalized conclusions investigators drew. “The title of the article and the paragraph describing [the] purpose of the article infer that the authors studied the community of women living with metastatic breast cancer,” Ms. Mertz said in an interview.

“In reality, the authors looked at data from a very small proportion of women living with metastatic breast cancer – those who received a de novo diagnosis and were 65 and older. The authors then drew a broad conclusion about all elderly women based on their selected small proportion of patients. … How can the authors accurately state, ‘One-third of all elderly patients are extreme users of disease-monitoring tests?’ ”

“The selection by the authors of the word ‘extreme users’ is curious,” Ms. Mertz continued. “ ‘Extreme’ has a negative connotation and implies someone is doing something to excess. So, are readers expected to draw the conclusions of the authors? Did the authors consider a less emotional term such as ‘frequent’ or ‘heavy?’ Or does their choice of extreme help support the conclusions that ‘women with metastatic breast cancer are driving up health care costs?’ ”

When asked about the definition of extreme users, Dr. Loprinzi said, “I don’t think that there is a clinical definition of an extreme user. The authors came up with an innovative study idea and thus had to define an endpoint, which I think it is quite reasonable.”

Ms. Mertz also pointed out that while the investigators reported demographics of the study population, there was no analysis of the demographic of the medical oncologists who wrote the orders for disease-monitoring tests. “Such information is important and could be informative of issues underlying heavy use of diagnostic tests,” Ms. Mertz suggested.

Dr. Loprinzi agreed. “Is the frequent testing doctor driven or patient driven, or are they both? I suspect they are both,” he said. “That would be an interesting topic for an investigator to explore. Potentially, records could demonstrate a pattern for individual practitioners.”

What about the authors’ assertion that frequent testing is associated with emotional harm? “For some patients for whom STMs [serum tumor markers] do reflect their relative burden of metastasis, the STMs in conjunction with imaging can offer some measure of reassurance that a particular treatment is working,” Ms. Mertz said.

“What is needed is more research to develop blood markers that can be used with imaging with confidence in the clinic to monitor metastatic disease and response to treatment. We need to add to or improve upon the oncologists’ diagnostic tools, not curb their use as the authors suggest,” she added.

Dr. Loprinzi and Ms. Mertz made these comments during interviews.

Body

“I agree in general with the results and conclusions from this manuscript. It makes sense,” said Dr. Charles Loprinzi, Regis Professor of Breast Cancer Research at the Mayo Clinic, in an interview. “More tests do not necessarily mean more benefit. More frequent testing may help to determine early progression of disease, and then this may lead to earlier treatment changes.”

“There is a spectrum of clinicians who are more frequent testers versus infrequent testers,” Dr. Loprinzi explained. “I am on the side of not getting a lot of tests, as sometimes they provide too much information. For example, if I have a patient with metastatic breast cancer and a lump that I can feel on her chest wall or a pathologically palpable lymph node and also had a couple lung nodules, I would tend to follow this patient primarily by history and physical examination. Other physicians might order imaging tests every 3 months. I am less likely to order frequent imaging tests as long as the patient is feeling well and has responded to their anticancer therapy as per repeat physical examinations,” he said.

Shirley Mertz, president of the Metastatic Breast Cancer Network, a national, independent, nonprofit all-volunteer patient advocacy group, took issue with the generalized conclusions investigators drew. “The title of the article and the paragraph describing [the] purpose of the article infer that the authors studied the community of women living with metastatic breast cancer,” Ms. Mertz said in an interview.

“In reality, the authors looked at data from a very small proportion of women living with metastatic breast cancer – those who received a de novo diagnosis and were 65 and older. The authors then drew a broad conclusion about all elderly women based on their selected small proportion of patients. … How can the authors accurately state, ‘One-third of all elderly patients are extreme users of disease-monitoring tests?’ ”

“The selection by the authors of the word ‘extreme users’ is curious,” Ms. Mertz continued. “ ‘Extreme’ has a negative connotation and implies someone is doing something to excess. So, are readers expected to draw the conclusions of the authors? Did the authors consider a less emotional term such as ‘frequent’ or ‘heavy?’ Or does their choice of extreme help support the conclusions that ‘women with metastatic breast cancer are driving up health care costs?’ ”

When asked about the definition of extreme users, Dr. Loprinzi said, “I don’t think that there is a clinical definition of an extreme user. The authors came up with an innovative study idea and thus had to define an endpoint, which I think it is quite reasonable.”

Ms. Mertz also pointed out that while the investigators reported demographics of the study population, there was no analysis of the demographic of the medical oncologists who wrote the orders for disease-monitoring tests. “Such information is important and could be informative of issues underlying heavy use of diagnostic tests,” Ms. Mertz suggested.

Dr. Loprinzi agreed. “Is the frequent testing doctor driven or patient driven, or are they both? I suspect they are both,” he said. “That would be an interesting topic for an investigator to explore. Potentially, records could demonstrate a pattern for individual practitioners.”

What about the authors’ assertion that frequent testing is associated with emotional harm? “For some patients for whom STMs [serum tumor markers] do reflect their relative burden of metastasis, the STMs in conjunction with imaging can offer some measure of reassurance that a particular treatment is working,” Ms. Mertz said.

“What is needed is more research to develop blood markers that can be used with imaging with confidence in the clinic to monitor metastatic disease and response to treatment. We need to add to or improve upon the oncologists’ diagnostic tools, not curb their use as the authors suggest,” she added.

Dr. Loprinzi and Ms. Mertz made these comments during interviews.

Title
Patient advocate, oncologist weigh in
Patient advocate, oncologist weigh in

Extreme users of disease-monitoring tests do not have significantly improved overall survival, investigators reported.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on 2,460 women older than 65 years of age with advanced breast cancer revealed that 924 patients (37.6%) were extreme users of disease-monitoring tests, defined as having had more than 12 serum-tumor marker (STM) tests and/or more than four radiographic imaging tests in a 1-year time period.

©Thinkstock

“The objectives of this study were to identify patterns and predictors of use and extreme use of disease-monitoring tests among women with [metastatic breast cancer],” reported Dr. Melissa Accordino of Columbia University, New York, and her colleagues (JCO. 2016 May 9. [doi: 10.1200/JCO.2016.66.6313]).

The investigators reviewed SEER Medicare data on women with pathologically confirmed metastatic breast cancer diagnosed from 2002 to 2011. Costs of care were calculated from Medicare reimbursement claims from physician, hospital, outpatient, durable medical equipment, and hospice filings from the date of diagnosis through the date of death or the end of the study period. Per-patient-per-year serum tumor marker testing rate and per-patient-per-year radiographic imaging rates were calculated.

Of the 2,460-person cohort, 37.6% were classified as extreme users (9% were extreme users of STM and 32.8% were extreme users of radiographic imaging tests), Dr. Accordino and her associates reported.

There was no difference in overall survival between extreme users and the rest of the cohort (HR, 0.93; 95% CI, 0.86-1.02).

A multivariate model showed that women who were older than 80 years (OR, 0.58; 95% CI, 0.45-0.75) and patients who were single (OR, 0.77; 95% CI, 0.63-0.93) were less likely to be extreme users while patients who had more frequent oncology-related doctor’s visits were more likely to be extreme users (OR, 3.14; 95% CI, 2.49-3.96).

A linear regression model revealed that costs of care were significantly higher for patients categorized as extreme users whose mean annual cost of care was 50.6% (95% CI, 40.7-61.1) higher than the mean cost of care for those who weren’t extreme users (P less than .001).

“In addition to cost, frequent disease monitoring can be associated with emotional harm. The prevalence of anxiety and depression among patients with advanced cancers is estimated to be 25%-65%. Previous work has shown that depression and anxiety can increase over time in patients with metastatic solid tumors and has been attributed to multiple factors, including fear of death and fear of disease progression. … In a study that assessed distress in women during the surveillance period, women with more frequent testing had higher levels of anxiety without survival benefit,” the investigators wrote.

The investigators also discussed the potential conflict of interest for physicians who benefit financially from disease-monitoring tests. “A successful strategy may be to change policy for reimbursement,” they wrote.

“In addition, better evidence is needed with regard to the benefits and harms of frequent disease-monitoring testing to inform guidelines,” the investigators wrote. “Future research should determine the most cost-effective strategy to monitor patients with [metastatic breast cancer].”

This study was supported by fellowships and grants from the National Cancer Institute, the ASCO/Breast Cancer Research Foundation, and the Conquer Cancer Foundation. Dr. Accordino reported having no disclosures. One investigator reported having a consulting/advisory role with Pfizer, TEVA Pharmaceutical Industries, Otsuka, United Biosource, and EHE International.

jcraig@frontlinemedcom.com

On Twitter@JessCraig_OP

Extreme users of disease-monitoring tests do not have significantly improved overall survival, investigators reported.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on 2,460 women older than 65 years of age with advanced breast cancer revealed that 924 patients (37.6%) were extreme users of disease-monitoring tests, defined as having had more than 12 serum-tumor marker (STM) tests and/or more than four radiographic imaging tests in a 1-year time period.

©Thinkstock

“The objectives of this study were to identify patterns and predictors of use and extreme use of disease-monitoring tests among women with [metastatic breast cancer],” reported Dr. Melissa Accordino of Columbia University, New York, and her colleagues (JCO. 2016 May 9. [doi: 10.1200/JCO.2016.66.6313]).

The investigators reviewed SEER Medicare data on women with pathologically confirmed metastatic breast cancer diagnosed from 2002 to 2011. Costs of care were calculated from Medicare reimbursement claims from physician, hospital, outpatient, durable medical equipment, and hospice filings from the date of diagnosis through the date of death or the end of the study period. Per-patient-per-year serum tumor marker testing rate and per-patient-per-year radiographic imaging rates were calculated.

Of the 2,460-person cohort, 37.6% were classified as extreme users (9% were extreme users of STM and 32.8% were extreme users of radiographic imaging tests), Dr. Accordino and her associates reported.

There was no difference in overall survival between extreme users and the rest of the cohort (HR, 0.93; 95% CI, 0.86-1.02).

A multivariate model showed that women who were older than 80 years (OR, 0.58; 95% CI, 0.45-0.75) and patients who were single (OR, 0.77; 95% CI, 0.63-0.93) were less likely to be extreme users while patients who had more frequent oncology-related doctor’s visits were more likely to be extreme users (OR, 3.14; 95% CI, 2.49-3.96).

A linear regression model revealed that costs of care were significantly higher for patients categorized as extreme users whose mean annual cost of care was 50.6% (95% CI, 40.7-61.1) higher than the mean cost of care for those who weren’t extreme users (P less than .001).

“In addition to cost, frequent disease monitoring can be associated with emotional harm. The prevalence of anxiety and depression among patients with advanced cancers is estimated to be 25%-65%. Previous work has shown that depression and anxiety can increase over time in patients with metastatic solid tumors and has been attributed to multiple factors, including fear of death and fear of disease progression. … In a study that assessed distress in women during the surveillance period, women with more frequent testing had higher levels of anxiety without survival benefit,” the investigators wrote.

The investigators also discussed the potential conflict of interest for physicians who benefit financially from disease-monitoring tests. “A successful strategy may be to change policy for reimbursement,” they wrote.

“In addition, better evidence is needed with regard to the benefits and harms of frequent disease-monitoring testing to inform guidelines,” the investigators wrote. “Future research should determine the most cost-effective strategy to monitor patients with [metastatic breast cancer].”

This study was supported by fellowships and grants from the National Cancer Institute, the ASCO/Breast Cancer Research Foundation, and the Conquer Cancer Foundation. Dr. Accordino reported having no disclosures. One investigator reported having a consulting/advisory role with Pfizer, TEVA Pharmaceutical Industries, Otsuka, United Biosource, and EHE International.

jcraig@frontlinemedcom.com

On Twitter@JessCraig_OP

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‘Extreme’ monitoring fails to boost survival in breast cancer patients
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FROM THE JOURNAL OF CLINICAL ONCOLOGY

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Key clinical point: Extreme use of disease-monitoring tests significantly elevates health care costs and provides no survival benefit.

Major finding: Costs of care were significantly higher for patients categorized as extreme users whose mean annual cost of care was 50.6% (95% CI, 40.7-61.1) higher than the mean cost of care for those who weren’t extreme users (P less than .001). There was also no difference in overall survival between extreme users and the rest of the cohort (HR, 0.93; 95% CI, 0.86-1.02).

Data source: A retrospective study of SEER Medicare data on 2,460 women with breast cancer.

Disclosures: This study was supported by fellowships and grants from the National Cancer Institute, the ASCO/Breast Cancer Research Foundation, and the Conquer Cancer Foundation. Dr. Accordino reported having no disclosures. One investigator reported having a consulting/advisory role with Pfizer, TEVA Pharmeceutical Industries, Otsuka, United Biosource, and EHE International.