Breast Cancer

In women with breast cancer undergoing breast-conserving surgery, accelerated partial breast irradiation (APBI) using multicatheter brachytherapy does not negatively affect quality of life, compared with standard whole breast irradiation, investigators have reported.

Patients reported similar quality of life scores for multicatheter brachytherapy–based APBI and whole breast irradiation in the study by the Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).

Moreover, breast symptom scores were significantly worse for whole-breast radiation, Rebekka Schäfer, MD, of the department of radiation oncology at the University Hospital Würzburg (Germany) and colleagues reported in Lancet Oncology.

“This trial provides further clinical evidence that APBI with interstitial brachytherapy can be considered as an alternative treatment option after breast-conserving surgery for patients with low-risk breast cancer,” Dr. Schäfer and coauthors wrote.

In several previous studies, APBI has been shown to have clinical outcomes equivalent to those of whole breast irradiation in terms of disease recurrence, survival, and treatment side effects, they added.

The quality of life findings in the present report come from long-term follow-up of a randomized, controlled, phase 3 trial conducted at 16 European centers. This study included 1,184 women with early breast cancer randomly who, after receiving breast-conserving surgery, were assigned either to APBI that used multicatheter brachytherapy or to whole breast irradiation.

Women in the study completed validated quality of life questionnaires right before and right after radiotherapy, as well as during follow-up.

A little more than half of the women in each group completed the quality of life questionnaires after the treatment and again at follow-up, investigators said.

Global health status was stable over time in both groups, investigators reported. In the APBI group, global health status score on a scale of 0-100 was 65.6 right after the procedure and 66.2 at 5 years; similarly, scores in the whole breast irradiation group were 64.6 after radiotherapy and 66.0 at 5 years.

The only quality of life difference between arms that investigators characterized as moderately clinically relevant was in breast symptom scores, which were significantly worse in the whole breast radiation group right after radiotherapy (difference of means, 13.6; 95% CI, 9.7-17.5; P less than .0001) and at 3-month follow-up (difference of means, 12.7; 95% CI, 9.8-15.6; P less than .0001).

Emotional functioning, fatigue, and financial difficulty scores in the APBI group were “slightly better” than in the whole breast radiation group right after radiotherapy and at a 3-month follow-up, investigators reported; however, at 5 year follow-up, there were no significant differences between arms in those measures.

“Our findings show that APBI using multicatheter interstitial brachytherapy does not result in clinically significant deterioration of overall quality of life and that the different domains of quality of life after APBI were not worse in comparison with whole breast irradiation in terms of clinically relevant differences,” Dr. Schäfer and colleagues concluded in their report.

Dr. Schäfer reported no conflicts of interest. Coauthors reported disclosures outside of the submitted work including Nucletron Operations BV, Elekta Company, Merck Serono, Novocure, AstraZeneca, and Bristol-Myers Squibb, among others.

SOURCE: Schäfer R et al. Lancet Oncol. 2018 Apr 22. doi: 10.1016/S1470-2045(18)30195-5.

In women with breast cancer undergoing breast-conserving surgery, accelerated partial breast irradiation (APBI) using multicatheter brachytherapy does not negatively affect quality of life, compared with standard whole breast irradiation, investigators have reported.

Patients reported similar quality of life scores for multicatheter brachytherapy–based APBI and whole breast irradiation in the study by the Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).

Moreover, breast symptom scores were significantly worse for whole-breast radiation, Rebekka Schäfer, MD, of the department of radiation oncology at the University Hospital Würzburg (Germany) and colleagues reported in Lancet Oncology.

“This trial provides further clinical evidence that APBI with interstitial brachytherapy can be considered as an alternative treatment option after breast-conserving surgery for patients with low-risk breast cancer,” Dr. Schäfer and coauthors wrote.

In several previous studies, APBI has been shown to have clinical outcomes equivalent to those of whole breast irradiation in terms of disease recurrence, survival, and treatment side effects, they added.

The quality of life findings in the present report come from long-term follow-up of a randomized, controlled, phase 3 trial conducted at 16 European centers. This study included 1,184 women with early breast cancer randomly who, after receiving breast-conserving surgery, were assigned either to APBI that used multicatheter brachytherapy or to whole breast irradiation.

Women in the study completed validated quality of life questionnaires right before and right after radiotherapy, as well as during follow-up.

A little more than half of the women in each group completed the quality of life questionnaires after the treatment and again at follow-up, investigators said.

Global health status was stable over time in both groups, investigators reported. In the APBI group, global health status score on a scale of 0-100 was 65.6 right after the procedure and 66.2 at 5 years; similarly, scores in the whole breast irradiation group were 64.6 after radiotherapy and 66.0 at 5 years.

The only quality of life difference between arms that investigators characterized as moderately clinically relevant was in breast symptom scores, which were significantly worse in the whole breast radiation group right after radiotherapy (difference of means, 13.6; 95% CI, 9.7-17.5; P less than .0001) and at 3-month follow-up (difference of means, 12.7; 95% CI, 9.8-15.6; P less than .0001).

Emotional functioning, fatigue, and financial difficulty scores in the APBI group were “slightly better” than in the whole breast radiation group right after radiotherapy and at a 3-month follow-up, investigators reported; however, at 5 year follow-up, there were no significant differences between arms in those measures.

“Our findings show that APBI using multicatheter interstitial brachytherapy does not result in clinically significant deterioration of overall quality of life and that the different domains of quality of life after APBI were not worse in comparison with whole breast irradiation in terms of clinically relevant differences,” Dr. Schäfer and colleagues concluded in their report.

Dr. Schäfer reported no conflicts of interest. Coauthors reported disclosures outside of the submitted work including Nucletron Operations BV, Elekta Company, Merck Serono, Novocure, AstraZeneca, and Bristol-Myers Squibb, among others.

SOURCE: Schäfer R et al. Lancet Oncol. 2018 Apr 22. doi: 10.1016/S1470-2045(18)30195-5.

In women with breast cancer undergoing breast-conserving surgery, accelerated partial breast irradiation (APBI) using multicatheter brachytherapy does not negatively affect quality of life, compared with standard whole breast irradiation, investigators have reported.

Patients reported similar quality of life scores for multicatheter brachytherapy–based APBI and whole breast irradiation in the study by the Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).

Moreover, breast symptom scores were significantly worse for whole-breast radiation, Rebekka Schäfer, MD, of the department of radiation oncology at the University Hospital Würzburg (Germany) and colleagues reported in Lancet Oncology.

“This trial provides further clinical evidence that APBI with interstitial brachytherapy can be considered as an alternative treatment option after breast-conserving surgery for patients with low-risk breast cancer,” Dr. Schäfer and coauthors wrote.

In several previous studies, APBI has been shown to have clinical outcomes equivalent to those of whole breast irradiation in terms of disease recurrence, survival, and treatment side effects, they added.

The quality of life findings in the present report come from long-term follow-up of a randomized, controlled, phase 3 trial conducted at 16 European centers. This study included 1,184 women with early breast cancer randomly who, after receiving breast-conserving surgery, were assigned either to APBI that used multicatheter brachytherapy or to whole breast irradiation.

Women in the study completed validated quality of life questionnaires right before and right after radiotherapy, as well as during follow-up.

A little more than half of the women in each group completed the quality of life questionnaires after the treatment and again at follow-up, investigators said.

Global health status was stable over time in both groups, investigators reported. In the APBI group, global health status score on a scale of 0-100 was 65.6 right after the procedure and 66.2 at 5 years; similarly, scores in the whole breast irradiation group were 64.6 after radiotherapy and 66.0 at 5 years.

The only quality of life difference between arms that investigators characterized as moderately clinically relevant was in breast symptom scores, which were significantly worse in the whole breast radiation group right after radiotherapy (difference of means, 13.6; 95% CI, 9.7-17.5; P less than .0001) and at 3-month follow-up (difference of means, 12.7; 95% CI, 9.8-15.6; P less than .0001).

Emotional functioning, fatigue, and financial difficulty scores in the APBI group were “slightly better” than in the whole breast radiation group right after radiotherapy and at a 3-month follow-up, investigators reported; however, at 5 year follow-up, there were no significant differences between arms in those measures.

“Our findings show that APBI using multicatheter interstitial brachytherapy does not result in clinically significant deterioration of overall quality of life and that the different domains of quality of life after APBI were not worse in comparison with whole breast irradiation in terms of clinically relevant differences,” Dr. Schäfer and colleagues concluded in their report.

Dr. Schäfer reported no conflicts of interest. Coauthors reported disclosures outside of the submitted work including Nucletron Operations BV, Elekta Company, Merck Serono, Novocure, AstraZeneca, and Bristol-Myers Squibb, among others.

SOURCE: Schäfer R et al. Lancet Oncol. 2018 Apr 22. doi: 10.1016/S1470-2045(18)30195-5.

Hormone therapy for breast cancer more than doubles a woman’s risk for developing type 2 diabetes, results of a case-cohort study suggest.

Hormone therapy with tamoxifen was associated with a more than twofold increase in risk of diabetes, and aromatase inhibitors were associated with a more than fourfold increase, reported Hatem Hamood, MD, of Leumit Health Services in Karmiel, Israel, and colleagues.

Among 2,246 women with breast cancer and no diabetes at baseline, followed for a mean of 5.9 years (longest follow-up 13 years), the crude cumulative lifetime incidence rate of diabetes was 20.9%, the investigators wrote. The report was published in the Journal of Clinical Oncology.

“[Hormone therapy] is a significant risk factor of diabetes among breast cancer survivors. The underlying mechanism is unclear, and additional research is warranted. Although cessation of treatment is not recommended and progression of breast cancer often is inevitable, devised strategies aimed at lifestyle modifications in patients at high risk of diabetes could at least preserve the natural history of breast cancer,” they wrote.

Diabetes has previously been identified as a possible risk factor for breast cancer, but the potential for breast cancer therapy as a precipitating factor for diabetes is uncertain, the authors said.

“Given the detrimental impact of diabetes on breast cancer survival, additional exploration of the role of breast cancer treatment in the development of diabetes is important not only because it would add valuable information on the etiology of diabetes but also because it would help to identify high-risk patients in need of accentuated clinical care,” they wrote.

To explore the possible association between hormone therapy and diabetes risk, the investigators performed a retrospective case-cohort study of 2,246 women who had been diagnosed with primary nonmetastatic breast cancer treated with hormone therapy from 2002 through 2012.

They examined data on a randomly selected cohort of 448 breast cancer survivors and all patients in the parent (no diabetes at baseline) cohort who developed diabetes during the study period (324 patients).

They found that the prevalence of diabetes among their source population of 2,644 breast cancer survivors (including those with baseline diabetes) increased “drastically” from 6% in 2002 to 28% in 2015. The prevalence exceeded Israeli national norms from 2010 through 2013, with standardized prevalence ratios of 1.61 to 1.81 (P less than .001).

As noted, in the population without baseline diabetes, the crude cumulative incidence rate of diabetes in the presence of death as a competing risk factor was 20.9%.

In multivariate analyses controlling for demographic and socioeconomic factors, and for chemotherapy type, hypertension, outpatient visits, use of corticosteroids, thiazide diuretics, beta-blockers, statins, and year of breast cancer diagnosis, factors significantly associated with diabetes risk were use of hormone therapy (adjusted hazard ratio [HR] 2.40, P = .008), tamoxifen (aHR 2.25, P = .013), aromatase inhibitors (aHR 4.27, P = .013), therapy duration more than 1 year (aHR 2.36, P = .009), and 1 year or less (aHR 6.48, P = .004).

The investigators noted that although other reports have found no association between aromatase inhibitors and diabetes risk, those studies had small samples or offered no explanation of the lack of association.

In contrast, a 2016 joint ACS/ASCO breast cancer survivorship-care guideline notes that aromatase inhibitors may raise the risk of diabetes, the investigators noted.

The study was supported by grants from the Israeli Council for Higher Education. The investigators reported no conflicts of interest.

SOURCE: Hamood H et al. J Clin Oncol. 2018 Apr 24. doi: 10.1200/JCO.2017.76.3524.

Hormone therapy for breast cancer more than doubles a woman’s risk for developing type 2 diabetes, results of a case-cohort study suggest.

Hormone therapy with tamoxifen was associated with a more than twofold increase in risk of diabetes, and aromatase inhibitors were associated with a more than fourfold increase, reported Hatem Hamood, MD, of Leumit Health Services in Karmiel, Israel, and colleagues.

Among 2,246 women with breast cancer and no diabetes at baseline, followed for a mean of 5.9 years (longest follow-up 13 years), the crude cumulative lifetime incidence rate of diabetes was 20.9%, the investigators wrote. The report was published in the Journal of Clinical Oncology.

“[Hormone therapy] is a significant risk factor of diabetes among breast cancer survivors. The underlying mechanism is unclear, and additional research is warranted. Although cessation of treatment is not recommended and progression of breast cancer often is inevitable, devised strategies aimed at lifestyle modifications in patients at high risk of diabetes could at least preserve the natural history of breast cancer,” they wrote.

Diabetes has previously been identified as a possible risk factor for breast cancer, but the potential for breast cancer therapy as a precipitating factor for diabetes is uncertain, the authors said.

“Given the detrimental impact of diabetes on breast cancer survival, additional exploration of the role of breast cancer treatment in the development of diabetes is important not only because it would add valuable information on the etiology of diabetes but also because it would help to identify high-risk patients in need of accentuated clinical care,” they wrote.

To explore the possible association between hormone therapy and diabetes risk, the investigators performed a retrospective case-cohort study of 2,246 women who had been diagnosed with primary nonmetastatic breast cancer treated with hormone therapy from 2002 through 2012.

They examined data on a randomly selected cohort of 448 breast cancer survivors and all patients in the parent (no diabetes at baseline) cohort who developed diabetes during the study period (324 patients).

They found that the prevalence of diabetes among their source population of 2,644 breast cancer survivors (including those with baseline diabetes) increased “drastically” from 6% in 2002 to 28% in 2015. The prevalence exceeded Israeli national norms from 2010 through 2013, with standardized prevalence ratios of 1.61 to 1.81 (P less than .001).

As noted, in the population without baseline diabetes, the crude cumulative incidence rate of diabetes in the presence of death as a competing risk factor was 20.9%.

In multivariate analyses controlling for demographic and socioeconomic factors, and for chemotherapy type, hypertension, outpatient visits, use of corticosteroids, thiazide diuretics, beta-blockers, statins, and year of breast cancer diagnosis, factors significantly associated with diabetes risk were use of hormone therapy (adjusted hazard ratio [HR] 2.40, P = .008), tamoxifen (aHR 2.25, P = .013), aromatase inhibitors (aHR 4.27, P = .013), therapy duration more than 1 year (aHR 2.36, P = .009), and 1 year or less (aHR 6.48, P = .004).

The investigators noted that although other reports have found no association between aromatase inhibitors and diabetes risk, those studies had small samples or offered no explanation of the lack of association.

In contrast, a 2016 joint ACS/ASCO breast cancer survivorship-care guideline notes that aromatase inhibitors may raise the risk of diabetes, the investigators noted.

The study was supported by grants from the Israeli Council for Higher Education. The investigators reported no conflicts of interest.

SOURCE: Hamood H et al. J Clin Oncol. 2018 Apr 24. doi: 10.1200/JCO.2017.76.3524.

Hormone therapy for breast cancer more than doubles a woman’s risk for developing type 2 diabetes, results of a case-cohort study suggest.

Hormone therapy with tamoxifen was associated with a more than twofold increase in risk of diabetes, and aromatase inhibitors were associated with a more than fourfold increase, reported Hatem Hamood, MD, of Leumit Health Services in Karmiel, Israel, and colleagues.

Among 2,246 women with breast cancer and no diabetes at baseline, followed for a mean of 5.9 years (longest follow-up 13 years), the crude cumulative lifetime incidence rate of diabetes was 20.9%, the investigators wrote. The report was published in the Journal of Clinical Oncology.

“[Hormone therapy] is a significant risk factor of diabetes among breast cancer survivors. The underlying mechanism is unclear, and additional research is warranted. Although cessation of treatment is not recommended and progression of breast cancer often is inevitable, devised strategies aimed at lifestyle modifications in patients at high risk of diabetes could at least preserve the natural history of breast cancer,” they wrote.

Diabetes has previously been identified as a possible risk factor for breast cancer, but the potential for breast cancer therapy as a precipitating factor for diabetes is uncertain, the authors said.

“Given the detrimental impact of diabetes on breast cancer survival, additional exploration of the role of breast cancer treatment in the development of diabetes is important not only because it would add valuable information on the etiology of diabetes but also because it would help to identify high-risk patients in need of accentuated clinical care,” they wrote.

To explore the possible association between hormone therapy and diabetes risk, the investigators performed a retrospective case-cohort study of 2,246 women who had been diagnosed with primary nonmetastatic breast cancer treated with hormone therapy from 2002 through 2012.

They examined data on a randomly selected cohort of 448 breast cancer survivors and all patients in the parent (no diabetes at baseline) cohort who developed diabetes during the study period (324 patients).

They found that the prevalence of diabetes among their source population of 2,644 breast cancer survivors (including those with baseline diabetes) increased “drastically” from 6% in 2002 to 28% in 2015. The prevalence exceeded Israeli national norms from 2010 through 2013, with standardized prevalence ratios of 1.61 to 1.81 (P less than .001).

As noted, in the population without baseline diabetes, the crude cumulative incidence rate of diabetes in the presence of death as a competing risk factor was 20.9%.

In multivariate analyses controlling for demographic and socioeconomic factors, and for chemotherapy type, hypertension, outpatient visits, use of corticosteroids, thiazide diuretics, beta-blockers, statins, and year of breast cancer diagnosis, factors significantly associated with diabetes risk were use of hormone therapy (adjusted hazard ratio [HR] 2.40, P = .008), tamoxifen (aHR 2.25, P = .013), aromatase inhibitors (aHR 4.27, P = .013), therapy duration more than 1 year (aHR 2.36, P = .009), and 1 year or less (aHR 6.48, P = .004).

The investigators noted that although other reports have found no association between aromatase inhibitors and diabetes risk, those studies had small samples or offered no explanation of the lack of association.

In contrast, a 2016 joint ACS/ASCO breast cancer survivorship-care guideline notes that aromatase inhibitors may raise the risk of diabetes, the investigators noted.

The study was supported by grants from the Israeli Council for Higher Education. The investigators reported no conflicts of interest.

SOURCE: Hamood H et al. J Clin Oncol. 2018 Apr 24. doi: 10.1200/JCO.2017.76.3524.

CHICAGO – Median overall survival (OS) in patients with HER2-negative metastatic breast cancer (mBC) and germline BRCA mutation (gBRCAm), although not statistically significant, was 2.2 months longer with olaparib versus physician’s choice chemotherapy (TPC), according to the final analysis of the OlympiAD study.

The results suggested the possibility of greater benefit among chemotherapy naive patients for metastatic breast cancer, with no cumulative toxicity reported with extended exposure, Mark E. Robson, MD, said at the annual meeting of the American Association for Cancer Research.

OlympiAD was a randomized, controlled, open-label, multicenter, phase 3 study of olaparib tablet monotherapy (300 mg, twice daily) compared with predeclared TPC monotherapy (capecitabine, vinorelbine, or eribulin). Patients were stratified by prior chemotherapy, prior platinum, and receptor status (ER+ and/or PR+ vs. TNBC). Of 302 randomized patients, 205 received olaparib and 91 received TPC (6 TPC patients declined treatment). Eligible patients had HER2-negative mBC and a germline BRCA mutation. In addition, patients should have received less than or equal to two chemotherapy lines in the metastatic setting, with prior anthracycline and taxane treatment either as (neo)adjuvant therapy or in the metastatic setting.

The data presented at AACR was a follow-up on the primary progression-free survival (PFS) analysis, which demonstrated significant benefit in olaparib over standard chemotherapy TPC (7.0 vs 4.2 months, HR 0.58, 95% confidence interval, 0.43-0.80, P less than .001). Overall response rate (ORR) in the olaparib arm was double of that observed on the TPC arm in measurable disease patients (59.9% vs. 28.8%).

SOURCE: Robson ME et al. AACR Annual Meeting Abstract CT038.

CHICAGO – Median overall survival (OS) in patients with HER2-negative metastatic breast cancer (mBC) and germline BRCA mutation (gBRCAm), although not statistically significant, was 2.2 months longer with olaparib versus physician’s choice chemotherapy (TPC), according to the final analysis of the OlympiAD study.

The results suggested the possibility of greater benefit among chemotherapy naive patients for metastatic breast cancer, with no cumulative toxicity reported with extended exposure, Mark E. Robson, MD, said at the annual meeting of the American Association for Cancer Research.

OlympiAD was a randomized, controlled, open-label, multicenter, phase 3 study of olaparib tablet monotherapy (300 mg, twice daily) compared with predeclared TPC monotherapy (capecitabine, vinorelbine, or eribulin). Patients were stratified by prior chemotherapy, prior platinum, and receptor status (ER+ and/or PR+ vs. TNBC). Of 302 randomized patients, 205 received olaparib and 91 received TPC (6 TPC patients declined treatment). Eligible patients had HER2-negative mBC and a germline BRCA mutation. In addition, patients should have received less than or equal to two chemotherapy lines in the metastatic setting, with prior anthracycline and taxane treatment either as (neo)adjuvant therapy or in the metastatic setting.

The data presented at AACR was a follow-up on the primary progression-free survival (PFS) analysis, which demonstrated significant benefit in olaparib over standard chemotherapy TPC (7.0 vs 4.2 months, HR 0.58, 95% confidence interval, 0.43-0.80, P less than .001). Overall response rate (ORR) in the olaparib arm was double of that observed on the TPC arm in measurable disease patients (59.9% vs. 28.8%).

SOURCE: Robson ME et al. AACR Annual Meeting Abstract CT038.

CHICAGO – Median overall survival (OS) in patients with HER2-negative metastatic breast cancer (mBC) and germline BRCA mutation (gBRCAm), although not statistically significant, was 2.2 months longer with olaparib versus physician’s choice chemotherapy (TPC), according to the final analysis of the OlympiAD study.

The results suggested the possibility of greater benefit among chemotherapy naive patients for metastatic breast cancer, with no cumulative toxicity reported with extended exposure, Mark E. Robson, MD, said at the annual meeting of the American Association for Cancer Research.

OlympiAD was a randomized, controlled, open-label, multicenter, phase 3 study of olaparib tablet monotherapy (300 mg, twice daily) compared with predeclared TPC monotherapy (capecitabine, vinorelbine, or eribulin). Patients were stratified by prior chemotherapy, prior platinum, and receptor status (ER+ and/or PR+ vs. TNBC). Of 302 randomized patients, 205 received olaparib and 91 received TPC (6 TPC patients declined treatment). Eligible patients had HER2-negative mBC and a germline BRCA mutation. In addition, patients should have received less than or equal to two chemotherapy lines in the metastatic setting, with prior anthracycline and taxane treatment either as (neo)adjuvant therapy or in the metastatic setting.

The data presented at AACR was a follow-up on the primary progression-free survival (PFS) analysis, which demonstrated significant benefit in olaparib over standard chemotherapy TPC (7.0 vs 4.2 months, HR 0.58, 95% confidence interval, 0.43-0.80, P less than .001). Overall response rate (ORR) in the olaparib arm was double of that observed on the TPC arm in measurable disease patients (59.9% vs. 28.8%).

SOURCE: Robson ME et al. AACR Annual Meeting Abstract CT038.

CHICAGO – Patients with clinically node-negative HER2-positive or triple-negative breast cancer (TNBC) who achieve a pathological complete response in the breast after neoadjuvant chemotherapy could benefit from clinical trials to evaluate the option of omitting axillary node surgery in this population, according to a retrospective analysis of more than 22,000 cases in the National Cancer Database reported at the Society of Surgical Oncology Annual Cancer Symposium.

SOURCE: Barron AU et al. Society of Surgical Oncology Annual Cancer Symposium, Abstract 48.

CHICAGO – Patients with clinically node-negative HER2-positive or triple-negative breast cancer (TNBC) who achieve a pathological complete response in the breast after neoadjuvant chemotherapy could benefit from clinical trials to evaluate the option of omitting axillary node surgery in this population, according to a retrospective analysis of more than 22,000 cases in the National Cancer Database reported at the Society of Surgical Oncology Annual Cancer Symposium.

SOURCE: Barron AU et al. Society of Surgical Oncology Annual Cancer Symposium, Abstract 48.

CHICAGO – Patients with clinically node-negative HER2-positive or triple-negative breast cancer (TNBC) who achieve a pathological complete response in the breast after neoadjuvant chemotherapy could benefit from clinical trials to evaluate the option of omitting axillary node surgery in this population, according to a retrospective analysis of more than 22,000 cases in the National Cancer Database reported at the Society of Surgical Oncology Annual Cancer Symposium.

SOURCE: Barron AU et al. Society of Surgical Oncology Annual Cancer Symposium, Abstract 48.

Bone metastases are a common cause of pain in patients with advanced cancer, with about three-quarters of patients with bone metastases experiencing pain as the dominant symptom.¹ Inadequately treated cancer pain impairs patient quality of life, and is associated with higher rates of depression, anxiety, and fatigue. Palliative radiotherapy (RT) is effective in alleviating pain from bone metastases.⁴ Local field external beam radiotherapy can provide some pain relief at the site of treated metastasis in 80%-90% of cases, with complete pain relief in 50%-60% of cases.^5,6 However, maximal pain relief from RT is delayed, in some cases taking days to up to multiple weeks to attain.^7,8 Therefore, optimal management of bone metastases pain may require the use of analgesics until RT takes adequate effect.

National Comprehensive Cancer Network (NCCN) Guidelines for Adult Cancer Pain (v. 2.2015) recommend that pain intensity rating (PIR; range, 0-10, where 0 denotes no pain and 10, worst pain imaginable) be used to quantify pain for all symptomatic patients. These guidelines also recommend the pain medication regimen be assessed for all symptomatic patients. For patients with moderate or severe pain (PIR of ≥4), NCCN guidelines recommend that analgesic regimen be intervened upon by alteration of the analgesic regimen (initiating, rotating, or titrating analgesic) or consideration of referral to pain/symptom management specialty.

Previous findings have demonstrated inadequate analgesic management for cancer pain,^2,9 including within the radiation oncology (RO) clinic, suggesting that patients seen in consultation for palliative RT may experience uncontrolled pain for days to weeks before the onset of relief from RT. Possible reasons for inadequate acute pain intervention in the RO clinic may be provider discomfort with analgesic management and infrequent formal integration of palliative care within RO.¹⁰

Limited single-institution data from the few institutions with dedicated palliative RO services have suggested that these services improve the quality of palliative care delivery, as demonstrated by providers perceptions’ of the clinical impact of a dedicated service¹¹ and the implementation of expedited palliative RT delivery for acute cancer pain.^12,13 To our knowledge, the impact of a dedicated palliative RO service on analgesic management for cancer pain has not been assessed.

Here, we report how often patients with symptomatic bone metastases had assessments of existing analgesic regimens and interventions at RO consultation at 2 cancer centers. Center 1 had implemented a dedicated palliative RO service in 2011, consisting of rotating attending physicians and residents as well as dedicated palliative care trained nurse practitioners and a fellow, with the service structured around daily rounds,¹¹ whereas Center 2 had not yet implemented a dedicated service. Using data from both centers, we assessed the impact of a palliative RO service on analgesic assessment and management in patients with bone metastases.
 

Methods

We searched our institutional databases for patients seen in RO consultation for bone metastases using ICD-9 code 198.5, and retrospectively reviewed consultation notes for those patients during June-July 2008, January-February 2010, January-February 2013, and June-July 2014. Those time periods were chosen as evenly spaced representative samples before and after implementation of a dedicated palliative RO service in 2011 at Center 1. Center 2 did not implement a dedicated palliative RO service in these time periods.

Within consultation notes, we recorded the following data from the History of the Present Illness section: symptoms from bone metastases (symptomatic was defined as any pain present); PIR (range, 0-10); and whether or not the preconsultation analgesic regimen was reported for symptomatic patients (including analgesic type, dosing, effectiveness, and adherence).

Documentation of the analgesic regimen in the history section of the notes was considered the proxy for analgesic regimen assessment at time of RO consultation. Analgesics within the Medications list, which were autopopulated in the consultation note by the electronic medical record, were recorded.

Whether or not pain was addressed with initiation or titration of analgesics for patients with a PIR of ≥4 was recorded from the Assessment and Plan portion of the notes, and that metric was considered the proxy for pain intervention. In addition, the case was coded as having had pain intervention if there was documentation of the patient declining recommended analgesic intervention, or the patient had been referred to a symptom management service for intervention (eg, referral to a specialty palliative care clinic), or there was recommendation for the patient to discuss uncontrolled pain with the original prescriber. A PIR of 4 was chosen as the threshold for analgesic intervention because at that level, NCCN guidelines for cancer pain state that the analgesic regimen should be titrated, whereas for a PIR of 3 or less, the guidelines recommend only consideration of titrating the analgesic. Only patients with a documented PIR were included in the pain intervention analysis.

Frequencies of analgesic assessment and analgesic intervention were compared using t tests (Wizard Pro, v1.8.5; Evan Miller, Chicago IL).
 

Results

A total of 271 patients with RO consultation notes were identified at the 2 centers within the 4 time periods (Table 1).

Among symptomatic patients, any component of the preconsultation analgesic regimen (including analgesic type, dosing, pain response, and adherence) was documented for 37.9% of the entire cohort at RO consultation (Table 3). At Centers 1 and 2, the frequencies of analgesic regimen assessment were documented for 41.3% and 28.1%, respectively (P = .06). Among symptomatic patients, 81.5% had an opioid or nonopioid analgesic listed in the Medications section in the electronic medical record at time of consultation.

Discussion

Multiple studies demonstrate the undertreatment of cancer pain in the outpatient setting.^2,9,14,15 At 2 cancer centers, we found that about half of patients who present for consideration of palliative RT for bone metastases had a PIR of ≥4, yet only 17% of them had documentation of analgesic intervention as recommended by NCCN guidelines for cancer pain. Underlying this low rate of appropriate intervention may be the assumption of rapid pain relief by RT. However, RT often does not begin at time of consultation,¹⁶ and maximal pain relief may take days to weeks after commencement of RT.¹⁷ It is estimated that a quarter of all patients with cancer develop bone metastases during the course of their disease,¹² and most of those patients suffer from pain. Thus, inherent delay in pain relief before, during, and after RT results in significant morbidity for the cancer patient population if adequate analgesic management is not provided.

The low rate of appropriate analgesic intervention at the time of RO consultation may also be related to the low incidence of proper analgesic assessment. In our cohort, 80% of symptomatic patients had an opioid or nonopioid analgesic listed in their medications within the electronic medical record at time of consultation, but only 38% had the analgesic regimen and/or its effectiveness described in the History of the Present Illness section of the record. Inattentiveness to analgesic type, dosing, and effectiveness during consultation may result in any inadequacies of the analgesic regimen going unnoticed. Consistent with this notion, we found that the rate of appropriate intervention for patients with a PIR of ≥4 was higher among patients who had analgesic regimen reported in the consultation note. Thus, interventions to implement routine review and documentation of the analgesic regimen, for example within the electronic medical record, may be one way to improve pain management.

Another possible reason for low rates of acute pain management within the RO clinic is low provider confidence in regard to analgesic management. In a recent national survey, 96% of radiation oncologists stated they were at least moderately confident with assessment of pain, yet only 77% were at least moderately confident with titrating opioids, and just 56% were at least moderately confident with rotating opioids.¹⁰ Educational interventions that improve providers’ facility with analgesic management may increase the frequency of pain management in the RO clinic.

Patients seen on the dedicated palliative RO service had significantly higher rates of documented analgesic regimen assessment and appropriate intervention during RO consultation, compared with patients seen at Center 2 and those not seen on the dedicated palliative RO service at Center 1. The improvements we observed in analgesic assessment and intervention at Center 1 for patients seen on the palliative RO service are likely owing to involvement of palliative RO and not to secular trends, because there were not similar improvements for patients at Center 1 who were not seen by the palliative RO service and those at Center 2, where there was no service.

At Center 1, the dedicated palliative RO service was created to provide specialized care to patients with metastatic disease undergoing palliative radiation. Within its structure, topics within palliative RO, such as technical aspects of palliative RT, symptom management, and communication are taught and reinforced in a case-based approach. Such palliative care awareness, integration, and education within RO achieved by the palliative RO service likely contribute to the improved rates of analgesic management we found in our study. We do note that rate of analgesic intervention in the palliative RO cohort, though higher than in the nonpalliative RO group, was still low, with only a third of patients receiving proper analgesic management. These findings highlight the importance of continued effort in increasing providers’ awareness of the need to assess pain and raise comfort with analgesic initiation and titration and of having dedicated palliative care clinicians embedded within the RO setting.

Since the data for this study was acquired, Center 2 has implemented a short palliative RO didactic course for residents, which improved their comfort levels in assessing analgesic effectiveness and intervening for uncontrolled pain.¹⁸ The impact of this intervention on clinical care will need to be evaluated, but the improved provider comfort levels may translate into better-quality care.
 

Limitations

An important limitation of this retrospective study is the reliance on the documentation provided in the consultation note for determining frequencies of analgesic regimen assessment and intervention. The actual rates of analgesic management that occurred in clinic may have been higher than reported in the documentation. However, such discrepancy in documentation of analgesic management would also be an area for quality improvement. Inadequate documentation limits the ability for proper follow-up of cancer pain as recommended by a joint guidance statement from the American Society of Clinical Oncology and the American Academy of Hospice and Palliative Medicine.^19,20 The results of our study may also partly reflect a positive impact in documentation of analgesic management by a dedicated palliative RO service.

Given the multi-institutional nature of this study, it may be that general practice differences confound the impact of the dedicated palliative RO service at Center 1. However, with excluding Center 2, the dedicated service was still strongly associated with a higher rate of analgesic assessment within Center 1 and was almost significantly associated with appropriate analgesic intervention within Center 1.

We used a PIR of ≥4 as a threshold for appropriate analgesic regimen intervention because it is what is recommended by the NCCN guidelines. However, close attention should be paid to the impact that any amount of pain has on an individual patient. The functional, spiritual, and existential impact of pain is unique to each patient’s experience, and optimal symptom management should take those elements into account.

Conclusion

In conclusion, this study indicates that advanced cancer patient pain assessment and intervention according to NCCN cancer pain management guidelines is not common in the RO setting, and it is an area that should be targeted for quality improvement because of the positive implications for patient well-being. Pain assessment and intervention were greater in the setting of a dedicated structure for palliative care within RO, suggesting that the integration of palliative care within RO is a promising means of improving quality of pain management.
 

This work was presented at the 2016 ASCO Palliative Care in Oncology Symposium (September 9-10, 2016), where this work received a Conquer Cancer Foundation Merit Award.

Bone metastases are a common cause of pain in patients with advanced cancer, with about three-quarters of patients with bone metastases experiencing pain as the dominant symptom.¹ Inadequately treated cancer pain impairs patient quality of life, and is associated with higher rates of depression, anxiety, and fatigue. Palliative radiotherapy (RT) is effective in alleviating pain from bone metastases.⁴ Local field external beam radiotherapy can provide some pain relief at the site of treated metastasis in 80%-90% of cases, with complete pain relief in 50%-60% of cases.^5,6 However, maximal pain relief from RT is delayed, in some cases taking days to up to multiple weeks to attain.^7,8 Therefore, optimal management of bone metastases pain may require the use of analgesics until RT takes adequate effect.

National Comprehensive Cancer Network (NCCN) Guidelines for Adult Cancer Pain (v. 2.2015) recommend that pain intensity rating (PIR; range, 0-10, where 0 denotes no pain and 10, worst pain imaginable) be used to quantify pain for all symptomatic patients. These guidelines also recommend the pain medication regimen be assessed for all symptomatic patients. For patients with moderate or severe pain (PIR of ≥4), NCCN guidelines recommend that analgesic regimen be intervened upon by alteration of the analgesic regimen (initiating, rotating, or titrating analgesic) or consideration of referral to pain/symptom management specialty.

Previous findings have demonstrated inadequate analgesic management for cancer pain,^2,9 including within the radiation oncology (RO) clinic, suggesting that patients seen in consultation for palliative RT may experience uncontrolled pain for days to weeks before the onset of relief from RT. Possible reasons for inadequate acute pain intervention in the RO clinic may be provider discomfort with analgesic management and infrequent formal integration of palliative care within RO.¹⁰

Limited single-institution data from the few institutions with dedicated palliative RO services have suggested that these services improve the quality of palliative care delivery, as demonstrated by providers perceptions’ of the clinical impact of a dedicated service¹¹ and the implementation of expedited palliative RT delivery for acute cancer pain.^12,13 To our knowledge, the impact of a dedicated palliative RO service on analgesic management for cancer pain has not been assessed.

Here, we report how often patients with symptomatic bone metastases had assessments of existing analgesic regimens and interventions at RO consultation at 2 cancer centers. Center 1 had implemented a dedicated palliative RO service in 2011, consisting of rotating attending physicians and residents as well as dedicated palliative care trained nurse practitioners and a fellow, with the service structured around daily rounds,¹¹ whereas Center 2 had not yet implemented a dedicated service. Using data from both centers, we assessed the impact of a palliative RO service on analgesic assessment and management in patients with bone metastases.
 

Methods

We searched our institutional databases for patients seen in RO consultation for bone metastases using ICD-9 code 198.5, and retrospectively reviewed consultation notes for those patients during June-July 2008, January-February 2010, January-February 2013, and June-July 2014. Those time periods were chosen as evenly spaced representative samples before and after implementation of a dedicated palliative RO service in 2011 at Center 1. Center 2 did not implement a dedicated palliative RO service in these time periods.

Within consultation notes, we recorded the following data from the History of the Present Illness section: symptoms from bone metastases (symptomatic was defined as any pain present); PIR (range, 0-10); and whether or not the preconsultation analgesic regimen was reported for symptomatic patients (including analgesic type, dosing, effectiveness, and adherence).

Documentation of the analgesic regimen in the history section of the notes was considered the proxy for analgesic regimen assessment at time of RO consultation. Analgesics within the Medications list, which were autopopulated in the consultation note by the electronic medical record, were recorded.

Whether or not pain was addressed with initiation or titration of analgesics for patients with a PIR of ≥4 was recorded from the Assessment and Plan portion of the notes, and that metric was considered the proxy for pain intervention. In addition, the case was coded as having had pain intervention if there was documentation of the patient declining recommended analgesic intervention, or the patient had been referred to a symptom management service for intervention (eg, referral to a specialty palliative care clinic), or there was recommendation for the patient to discuss uncontrolled pain with the original prescriber. A PIR of 4 was chosen as the threshold for analgesic intervention because at that level, NCCN guidelines for cancer pain state that the analgesic regimen should be titrated, whereas for a PIR of 3 or less, the guidelines recommend only consideration of titrating the analgesic. Only patients with a documented PIR were included in the pain intervention analysis.

Frequencies of analgesic assessment and analgesic intervention were compared using t tests (Wizard Pro, v1.8.5; Evan Miller, Chicago IL).
 

Results

A total of 271 patients with RO consultation notes were identified at the 2 centers within the 4 time periods (Table 1).

Among symptomatic patients, any component of the preconsultation analgesic regimen (including analgesic type, dosing, pain response, and adherence) was documented for 37.9% of the entire cohort at RO consultation (Table 3). At Centers 1 and 2, the frequencies of analgesic regimen assessment were documented for 41.3% and 28.1%, respectively (P = .06). Among symptomatic patients, 81.5% had an opioid or nonopioid analgesic listed in the Medications section in the electronic medical record at time of consultation.

Discussion

Multiple studies demonstrate the undertreatment of cancer pain in the outpatient setting.^2,9,14,15 At 2 cancer centers, we found that about half of patients who present for consideration of palliative RT for bone metastases had a PIR of ≥4, yet only 17% of them had documentation of analgesic intervention as recommended by NCCN guidelines for cancer pain. Underlying this low rate of appropriate intervention may be the assumption of rapid pain relief by RT. However, RT often does not begin at time of consultation,¹⁶ and maximal pain relief may take days to weeks after commencement of RT.¹⁷ It is estimated that a quarter of all patients with cancer develop bone metastases during the course of their disease,¹² and most of those patients suffer from pain. Thus, inherent delay in pain relief before, during, and after RT results in significant morbidity for the cancer patient population if adequate analgesic management is not provided.

The low rate of appropriate analgesic intervention at the time of RO consultation may also be related to the low incidence of proper analgesic assessment. In our cohort, 80% of symptomatic patients had an opioid or nonopioid analgesic listed in their medications within the electronic medical record at time of consultation, but only 38% had the analgesic regimen and/or its effectiveness described in the History of the Present Illness section of the record. Inattentiveness to analgesic type, dosing, and effectiveness during consultation may result in any inadequacies of the analgesic regimen going unnoticed. Consistent with this notion, we found that the rate of appropriate intervention for patients with a PIR of ≥4 was higher among patients who had analgesic regimen reported in the consultation note. Thus, interventions to implement routine review and documentation of the analgesic regimen, for example within the electronic medical record, may be one way to improve pain management.

Another possible reason for low rates of acute pain management within the RO clinic is low provider confidence in regard to analgesic management. In a recent national survey, 96% of radiation oncologists stated they were at least moderately confident with assessment of pain, yet only 77% were at least moderately confident with titrating opioids, and just 56% were at least moderately confident with rotating opioids.¹⁰ Educational interventions that improve providers’ facility with analgesic management may increase the frequency of pain management in the RO clinic.

Patients seen on the dedicated palliative RO service had significantly higher rates of documented analgesic regimen assessment and appropriate intervention during RO consultation, compared with patients seen at Center 2 and those not seen on the dedicated palliative RO service at Center 1. The improvements we observed in analgesic assessment and intervention at Center 1 for patients seen on the palliative RO service are likely owing to involvement of palliative RO and not to secular trends, because there were not similar improvements for patients at Center 1 who were not seen by the palliative RO service and those at Center 2, where there was no service.

At Center 1, the dedicated palliative RO service was created to provide specialized care to patients with metastatic disease undergoing palliative radiation. Within its structure, topics within palliative RO, such as technical aspects of palliative RT, symptom management, and communication are taught and reinforced in a case-based approach. Such palliative care awareness, integration, and education within RO achieved by the palliative RO service likely contribute to the improved rates of analgesic management we found in our study. We do note that rate of analgesic intervention in the palliative RO cohort, though higher than in the nonpalliative RO group, was still low, with only a third of patients receiving proper analgesic management. These findings highlight the importance of continued effort in increasing providers’ awareness of the need to assess pain and raise comfort with analgesic initiation and titration and of having dedicated palliative care clinicians embedded within the RO setting.

Since the data for this study was acquired, Center 2 has implemented a short palliative RO didactic course for residents, which improved their comfort levels in assessing analgesic effectiveness and intervening for uncontrolled pain.¹⁸ The impact of this intervention on clinical care will need to be evaluated, but the improved provider comfort levels may translate into better-quality care.
 

Limitations

An important limitation of this retrospective study is the reliance on the documentation provided in the consultation note for determining frequencies of analgesic regimen assessment and intervention. The actual rates of analgesic management that occurred in clinic may have been higher than reported in the documentation. However, such discrepancy in documentation of analgesic management would also be an area for quality improvement. Inadequate documentation limits the ability for proper follow-up of cancer pain as recommended by a joint guidance statement from the American Society of Clinical Oncology and the American Academy of Hospice and Palliative Medicine.^19,20 The results of our study may also partly reflect a positive impact in documentation of analgesic management by a dedicated palliative RO service.

Given the multi-institutional nature of this study, it may be that general practice differences confound the impact of the dedicated palliative RO service at Center 1. However, with excluding Center 2, the dedicated service was still strongly associated with a higher rate of analgesic assessment within Center 1 and was almost significantly associated with appropriate analgesic intervention within Center 1.

We used a PIR of ≥4 as a threshold for appropriate analgesic regimen intervention because it is what is recommended by the NCCN guidelines. However, close attention should be paid to the impact that any amount of pain has on an individual patient. The functional, spiritual, and existential impact of pain is unique to each patient’s experience, and optimal symptom management should take those elements into account.

Conclusion

In conclusion, this study indicates that advanced cancer patient pain assessment and intervention according to NCCN cancer pain management guidelines is not common in the RO setting, and it is an area that should be targeted for quality improvement because of the positive implications for patient well-being. Pain assessment and intervention were greater in the setting of a dedicated structure for palliative care within RO, suggesting that the integration of palliative care within RO is a promising means of improving quality of pain management.
 

This work was presented at the 2016 ASCO Palliative Care in Oncology Symposium (September 9-10, 2016), where this work received a Conquer Cancer Foundation Merit Award.

Bone metastases are a common cause of pain in patients with advanced cancer, with about three-quarters of patients with bone metastases experiencing pain as the dominant symptom.¹ Inadequately treated cancer pain impairs patient quality of life, and is associated with higher rates of depression, anxiety, and fatigue. Palliative radiotherapy (RT) is effective in alleviating pain from bone metastases.⁴ Local field external beam radiotherapy can provide some pain relief at the site of treated metastasis in 80%-90% of cases, with complete pain relief in 50%-60% of cases.^5,6 However, maximal pain relief from RT is delayed, in some cases taking days to up to multiple weeks to attain.^7,8 Therefore, optimal management of bone metastases pain may require the use of analgesics until RT takes adequate effect.

National Comprehensive Cancer Network (NCCN) Guidelines for Adult Cancer Pain (v. 2.2015) recommend that pain intensity rating (PIR; range, 0-10, where 0 denotes no pain and 10, worst pain imaginable) be used to quantify pain for all symptomatic patients. These guidelines also recommend the pain medication regimen be assessed for all symptomatic patients. For patients with moderate or severe pain (PIR of ≥4), NCCN guidelines recommend that analgesic regimen be intervened upon by alteration of the analgesic regimen (initiating, rotating, or titrating analgesic) or consideration of referral to pain/symptom management specialty.

Previous findings have demonstrated inadequate analgesic management for cancer pain,^2,9 including within the radiation oncology (RO) clinic, suggesting that patients seen in consultation for palliative RT may experience uncontrolled pain for days to weeks before the onset of relief from RT. Possible reasons for inadequate acute pain intervention in the RO clinic may be provider discomfort with analgesic management and infrequent formal integration of palliative care within RO.¹⁰

Limited single-institution data from the few institutions with dedicated palliative RO services have suggested that these services improve the quality of palliative care delivery, as demonstrated by providers perceptions’ of the clinical impact of a dedicated service¹¹ and the implementation of expedited palliative RT delivery for acute cancer pain.^12,13 To our knowledge, the impact of a dedicated palliative RO service on analgesic management for cancer pain has not been assessed.

Here, we report how often patients with symptomatic bone metastases had assessments of existing analgesic regimens and interventions at RO consultation at 2 cancer centers. Center 1 had implemented a dedicated palliative RO service in 2011, consisting of rotating attending physicians and residents as well as dedicated palliative care trained nurse practitioners and a fellow, with the service structured around daily rounds,¹¹ whereas Center 2 had not yet implemented a dedicated service. Using data from both centers, we assessed the impact of a palliative RO service on analgesic assessment and management in patients with bone metastases.
 

Methods

We searched our institutional databases for patients seen in RO consultation for bone metastases using ICD-9 code 198.5, and retrospectively reviewed consultation notes for those patients during June-July 2008, January-February 2010, January-February 2013, and June-July 2014. Those time periods were chosen as evenly spaced representative samples before and after implementation of a dedicated palliative RO service in 2011 at Center 1. Center 2 did not implement a dedicated palliative RO service in these time periods.

Within consultation notes, we recorded the following data from the History of the Present Illness section: symptoms from bone metastases (symptomatic was defined as any pain present); PIR (range, 0-10); and whether or not the preconsultation analgesic regimen was reported for symptomatic patients (including analgesic type, dosing, effectiveness, and adherence).

Documentation of the analgesic regimen in the history section of the notes was considered the proxy for analgesic regimen assessment at time of RO consultation. Analgesics within the Medications list, which were autopopulated in the consultation note by the electronic medical record, were recorded.

Whether or not pain was addressed with initiation or titration of analgesics for patients with a PIR of ≥4 was recorded from the Assessment and Plan portion of the notes, and that metric was considered the proxy for pain intervention. In addition, the case was coded as having had pain intervention if there was documentation of the patient declining recommended analgesic intervention, or the patient had been referred to a symptom management service for intervention (eg, referral to a specialty palliative care clinic), or there was recommendation for the patient to discuss uncontrolled pain with the original prescriber. A PIR of 4 was chosen as the threshold for analgesic intervention because at that level, NCCN guidelines for cancer pain state that the analgesic regimen should be titrated, whereas for a PIR of 3 or less, the guidelines recommend only consideration of titrating the analgesic. Only patients with a documented PIR were included in the pain intervention analysis.

Frequencies of analgesic assessment and analgesic intervention were compared using t tests (Wizard Pro, v1.8.5; Evan Miller, Chicago IL).
 

Results

A total of 271 patients with RO consultation notes were identified at the 2 centers within the 4 time periods (Table 1).

Among symptomatic patients, any component of the preconsultation analgesic regimen (including analgesic type, dosing, pain response, and adherence) was documented for 37.9% of the entire cohort at RO consultation (Table 3). At Centers 1 and 2, the frequencies of analgesic regimen assessment were documented for 41.3% and 28.1%, respectively (P = .06). Among symptomatic patients, 81.5% had an opioid or nonopioid analgesic listed in the Medications section in the electronic medical record at time of consultation.

Discussion

Multiple studies demonstrate the undertreatment of cancer pain in the outpatient setting.^2,9,14,15 At 2 cancer centers, we found that about half of patients who present for consideration of palliative RT for bone metastases had a PIR of ≥4, yet only 17% of them had documentation of analgesic intervention as recommended by NCCN guidelines for cancer pain. Underlying this low rate of appropriate intervention may be the assumption of rapid pain relief by RT. However, RT often does not begin at time of consultation,¹⁶ and maximal pain relief may take days to weeks after commencement of RT.¹⁷ It is estimated that a quarter of all patients with cancer develop bone metastases during the course of their disease,¹² and most of those patients suffer from pain. Thus, inherent delay in pain relief before, during, and after RT results in significant morbidity for the cancer patient population if adequate analgesic management is not provided.

The low rate of appropriate analgesic intervention at the time of RO consultation may also be related to the low incidence of proper analgesic assessment. In our cohort, 80% of symptomatic patients had an opioid or nonopioid analgesic listed in their medications within the electronic medical record at time of consultation, but only 38% had the analgesic regimen and/or its effectiveness described in the History of the Present Illness section of the record. Inattentiveness to analgesic type, dosing, and effectiveness during consultation may result in any inadequacies of the analgesic regimen going unnoticed. Consistent with this notion, we found that the rate of appropriate intervention for patients with a PIR of ≥4 was higher among patients who had analgesic regimen reported in the consultation note. Thus, interventions to implement routine review and documentation of the analgesic regimen, for example within the electronic medical record, may be one way to improve pain management.

Another possible reason for low rates of acute pain management within the RO clinic is low provider confidence in regard to analgesic management. In a recent national survey, 96% of radiation oncologists stated they were at least moderately confident with assessment of pain, yet only 77% were at least moderately confident with titrating opioids, and just 56% were at least moderately confident with rotating opioids.¹⁰ Educational interventions that improve providers’ facility with analgesic management may increase the frequency of pain management in the RO clinic.

Patients seen on the dedicated palliative RO service had significantly higher rates of documented analgesic regimen assessment and appropriate intervention during RO consultation, compared with patients seen at Center 2 and those not seen on the dedicated palliative RO service at Center 1. The improvements we observed in analgesic assessment and intervention at Center 1 for patients seen on the palliative RO service are likely owing to involvement of palliative RO and not to secular trends, because there were not similar improvements for patients at Center 1 who were not seen by the palliative RO service and those at Center 2, where there was no service.

At Center 1, the dedicated palliative RO service was created to provide specialized care to patients with metastatic disease undergoing palliative radiation. Within its structure, topics within palliative RO, such as technical aspects of palliative RT, symptom management, and communication are taught and reinforced in a case-based approach. Such palliative care awareness, integration, and education within RO achieved by the palliative RO service likely contribute to the improved rates of analgesic management we found in our study. We do note that rate of analgesic intervention in the palliative RO cohort, though higher than in the nonpalliative RO group, was still low, with only a third of patients receiving proper analgesic management. These findings highlight the importance of continued effort in increasing providers’ awareness of the need to assess pain and raise comfort with analgesic initiation and titration and of having dedicated palliative care clinicians embedded within the RO setting.

Since the data for this study was acquired, Center 2 has implemented a short palliative RO didactic course for residents, which improved their comfort levels in assessing analgesic effectiveness and intervening for uncontrolled pain.¹⁸ The impact of this intervention on clinical care will need to be evaluated, but the improved provider comfort levels may translate into better-quality care.
 

Limitations

An important limitation of this retrospective study is the reliance on the documentation provided in the consultation note for determining frequencies of analgesic regimen assessment and intervention. The actual rates of analgesic management that occurred in clinic may have been higher than reported in the documentation. However, such discrepancy in documentation of analgesic management would also be an area for quality improvement. Inadequate documentation limits the ability for proper follow-up of cancer pain as recommended by a joint guidance statement from the American Society of Clinical Oncology and the American Academy of Hospice and Palliative Medicine.^19,20 The results of our study may also partly reflect a positive impact in documentation of analgesic management by a dedicated palliative RO service.

Given the multi-institutional nature of this study, it may be that general practice differences confound the impact of the dedicated palliative RO service at Center 1. However, with excluding Center 2, the dedicated service was still strongly associated with a higher rate of analgesic assessment within Center 1 and was almost significantly associated with appropriate analgesic intervention within Center 1.

We used a PIR of ≥4 as a threshold for appropriate analgesic regimen intervention because it is what is recommended by the NCCN guidelines. However, close attention should be paid to the impact that any amount of pain has on an individual patient. The functional, spiritual, and existential impact of pain is unique to each patient’s experience, and optimal symptom management should take those elements into account.

Conclusion

In conclusion, this study indicates that advanced cancer patient pain assessment and intervention according to NCCN cancer pain management guidelines is not common in the RO setting, and it is an area that should be targeted for quality improvement because of the positive implications for patient well-being. Pain assessment and intervention were greater in the setting of a dedicated structure for palliative care within RO, suggesting that the integration of palliative care within RO is a promising means of improving quality of pain management.
 

This work was presented at the 2016 ASCO Palliative Care in Oncology Symposium (September 9-10, 2016), where this work received a Conquer Cancer Foundation Merit Award.

Among women with nonmetastatic breast cancer, low muscle mass and excess body fat are significantly associated with worse survival, investigators report.

An observational study of 3,241 women diagnosed with stage II or III breast cancer showed that low muscle mass (sarcopenia) was independently associated with a 41% increase in risk for overall mortality, and that total adipose tissue (TAT) measures were associated with a 35% increase in overall mortality.

Women with sarcopenia and high total TAT scores had a nearly twofold higher risk for death, reported Bette J. Caan, DrPH, of Kaiser Permanente in Oakland, Calif., and her colleagues.

Although low muscle mass was found to be a significant risk factor for death, neither poor muscle quality, measured by radiodensity, nor body mass index (BMI) were significantly associated with overall mortality, the investigators reported in a study published online in JAMA Oncology.

“Both muscle and adiposity represent modifiable risk factors in patients with breast cancer. In addition to weight loss, we should also consider interventions to improve muscle mass, such as resistance training or protein supplementation. In the era of precision medicine, the direct measurement of muscle and adiposity will help to guide treatment plans and interventions to optimize survival outcomes,” they wrote.

Although moderate to severe obesity measured by high BMI has been associated with worse outcomes for patients with breast cancer and other malignancies, the evidence is mixed for those who are merely overweight or have borderline obesity, the authors noted.

The article did not report a funding source for the study. The investigators reported having no conflicts of interest to disclose.

[email protected]

SOURCE: Cann BJ et al. JAMA Oncol. 2018 Apr 5. doi: 10.1001/jamaoncol.2018.0137.

Among women with nonmetastatic breast cancer, low muscle mass and excess body fat are significantly associated with worse survival, investigators report.

An observational study of 3,241 women diagnosed with stage II or III breast cancer showed that low muscle mass (sarcopenia) was independently associated with a 41% increase in risk for overall mortality, and that total adipose tissue (TAT) measures were associated with a 35% increase in overall mortality.

Women with sarcopenia and high total TAT scores had a nearly twofold higher risk for death, reported Bette J. Caan, DrPH, of Kaiser Permanente in Oakland, Calif., and her colleagues.

Although low muscle mass was found to be a significant risk factor for death, neither poor muscle quality, measured by radiodensity, nor body mass index (BMI) were significantly associated with overall mortality, the investigators reported in a study published online in JAMA Oncology.

“Both muscle and adiposity represent modifiable risk factors in patients with breast cancer. In addition to weight loss, we should also consider interventions to improve muscle mass, such as resistance training or protein supplementation. In the era of precision medicine, the direct measurement of muscle and adiposity will help to guide treatment plans and interventions to optimize survival outcomes,” they wrote.

Although moderate to severe obesity measured by high BMI has been associated with worse outcomes for patients with breast cancer and other malignancies, the evidence is mixed for those who are merely overweight or have borderline obesity, the authors noted.

The article did not report a funding source for the study. The investigators reported having no conflicts of interest to disclose.

[email protected]

SOURCE: Cann BJ et al. JAMA Oncol. 2018 Apr 5. doi: 10.1001/jamaoncol.2018.0137.

Among women with nonmetastatic breast cancer, low muscle mass and excess body fat are significantly associated with worse survival, investigators report.

An observational study of 3,241 women diagnosed with stage II or III breast cancer showed that low muscle mass (sarcopenia) was independently associated with a 41% increase in risk for overall mortality, and that total adipose tissue (TAT) measures were associated with a 35% increase in overall mortality.

Women with sarcopenia and high total TAT scores had a nearly twofold higher risk for death, reported Bette J. Caan, DrPH, of Kaiser Permanente in Oakland, Calif., and her colleagues.

Although low muscle mass was found to be a significant risk factor for death, neither poor muscle quality, measured by radiodensity, nor body mass index (BMI) were significantly associated with overall mortality, the investigators reported in a study published online in JAMA Oncology.

“Both muscle and adiposity represent modifiable risk factors in patients with breast cancer. In addition to weight loss, we should also consider interventions to improve muscle mass, such as resistance training or protein supplementation. In the era of precision medicine, the direct measurement of muscle and adiposity will help to guide treatment plans and interventions to optimize survival outcomes,” they wrote.

Although moderate to severe obesity measured by high BMI has been associated with worse outcomes for patients with breast cancer and other malignancies, the evidence is mixed for those who are merely overweight or have borderline obesity, the authors noted.

The article did not report a funding source for the study. The investigators reported having no conflicts of interest to disclose.

[email protected]

SOURCE: Cann BJ et al. JAMA Oncol. 2018 Apr 5. doi: 10.1001/jamaoncol.2018.0137.

A study of the molecular and genomic features of breast cancer in men, compared with those in women, highlights the prognostic value of a 21-gene breast recurrence score in both sexes, investigators say.

Men and women with estrogen receptor (ER)–positive breast cancer who had recurrence scores (RS) of 0 to 30 on the 21-gene assay (Oncotype DX) had excellent breast cancer–specific survival rates, which suggests that such patients could be spared from more aggressive treatments, such as chemotherapy, according to Suleiman Alfred Massarweh, MD, of Stanford (Calif.) University and his colleagues.

“Future adjuvant trials in ER-positive breast cancer may need to focus on targeting endocrine resistance in those patients with RS greater than 31 and may need to consider the weight of competing mortality risk when investigating the value of any additional treatment beyond endocrine therapy,” they wrote in the Journal of Clinical Oncology.

In 2016, an estimated 2,600 men were diagnosed with breast cancer in the United States.

“Approximately 95% of breast cancers diagnosed in men express the estrogen receptor and progesterone receptor (PR), which is a higher percentage than in women and suggests a key role for ER in the biology of breast cancer in men,” the investigators noted.

Although treatment of men with breast cancer has traditionally been extrapolated from treatment of women with breast cancer, genomic studies have suggested some key differences, the investigators noted, citing a study of the genomic landscape of male breast cancers presented at the 2014 San Antonio Breast Cancer Symposium.

In that study, investigators from the Memorial Sloan Kettering Cancer Center in New York and other institutions found that all male breast cancers in their sample of 64 patients were ER+ and human epidermal growth factor receptor 2 (HER2)–negative, predominantly of the luminal B subtype, and that the genetic alterations seen in male breast cancers frequently target DNA-repair fibroblast growth factor pathways. However, the pathways that are known to drive luminal cancers when mutated in women are seen less often among men, said Salvatore Piscuoglio, PhD, then a research fellow at MSKCC.

SOURCE: Massarweh SA et al. 2018 Mar 27. doi: 10.1200/JCO.2017.76.8861.

A study of the molecular and genomic features of breast cancer in men, compared with those in women, highlights the prognostic value of a 21-gene breast recurrence score in both sexes, investigators say.

Men and women with estrogen receptor (ER)–positive breast cancer who had recurrence scores (RS) of 0 to 30 on the 21-gene assay (Oncotype DX) had excellent breast cancer–specific survival rates, which suggests that such patients could be spared from more aggressive treatments, such as chemotherapy, according to Suleiman Alfred Massarweh, MD, of Stanford (Calif.) University and his colleagues.

“Future adjuvant trials in ER-positive breast cancer may need to focus on targeting endocrine resistance in those patients with RS greater than 31 and may need to consider the weight of competing mortality risk when investigating the value of any additional treatment beyond endocrine therapy,” they wrote in the Journal of Clinical Oncology.

In 2016, an estimated 2,600 men were diagnosed with breast cancer in the United States.

“Approximately 95% of breast cancers diagnosed in men express the estrogen receptor and progesterone receptor (PR), which is a higher percentage than in women and suggests a key role for ER in the biology of breast cancer in men,” the investigators noted.

Although treatment of men with breast cancer has traditionally been extrapolated from treatment of women with breast cancer, genomic studies have suggested some key differences, the investigators noted, citing a study of the genomic landscape of male breast cancers presented at the 2014 San Antonio Breast Cancer Symposium.

In that study, investigators from the Memorial Sloan Kettering Cancer Center in New York and other institutions found that all male breast cancers in their sample of 64 patients were ER+ and human epidermal growth factor receptor 2 (HER2)–negative, predominantly of the luminal B subtype, and that the genetic alterations seen in male breast cancers frequently target DNA-repair fibroblast growth factor pathways. However, the pathways that are known to drive luminal cancers when mutated in women are seen less often among men, said Salvatore Piscuoglio, PhD, then a research fellow at MSKCC.

SOURCE: Massarweh SA et al. 2018 Mar 27. doi: 10.1200/JCO.2017.76.8861.

A study of the molecular and genomic features of breast cancer in men, compared with those in women, highlights the prognostic value of a 21-gene breast recurrence score in both sexes, investigators say.

Men and women with estrogen receptor (ER)–positive breast cancer who had recurrence scores (RS) of 0 to 30 on the 21-gene assay (Oncotype DX) had excellent breast cancer–specific survival rates, which suggests that such patients could be spared from more aggressive treatments, such as chemotherapy, according to Suleiman Alfred Massarweh, MD, of Stanford (Calif.) University and his colleagues.

“Future adjuvant trials in ER-positive breast cancer may need to focus on targeting endocrine resistance in those patients with RS greater than 31 and may need to consider the weight of competing mortality risk when investigating the value of any additional treatment beyond endocrine therapy,” they wrote in the Journal of Clinical Oncology.

In 2016, an estimated 2,600 men were diagnosed with breast cancer in the United States.

“Approximately 95% of breast cancers diagnosed in men express the estrogen receptor and progesterone receptor (PR), which is a higher percentage than in women and suggests a key role for ER in the biology of breast cancer in men,” the investigators noted.

Although treatment of men with breast cancer has traditionally been extrapolated from treatment of women with breast cancer, genomic studies have suggested some key differences, the investigators noted, citing a study of the genomic landscape of male breast cancers presented at the 2014 San Antonio Breast Cancer Symposium.

In that study, investigators from the Memorial Sloan Kettering Cancer Center in New York and other institutions found that all male breast cancers in their sample of 64 patients were ER+ and human epidermal growth factor receptor 2 (HER2)–negative, predominantly of the luminal B subtype, and that the genetic alterations seen in male breast cancers frequently target DNA-repair fibroblast growth factor pathways. However, the pathways that are known to drive luminal cancers when mutated in women are seen less often among men, said Salvatore Piscuoglio, PhD, then a research fellow at MSKCC.

SOURCE: Massarweh SA et al. 2018 Mar 27. doi: 10.1200/JCO.2017.76.8861.

CHICAGO – Both transgender men and transgender women had an increased risk of breast cancer compared with a male, but not a female, reference population, said Christel de Blok, MD, sharing results of a Dutch national study.

The study included 3,078 transgender people (2,064 transgender women) who began hormone therapy (HT) at age 18 years or older. The mean age at which transgender women began HT was 33 years; for transgender men, the mean age was 25 years. In all, transgender women in the study had a total of 30,699 person-years of exposure to HT; for transgender men, the figure was 13,155 person-years.

[email protected]
 

SOURCE: de Blok C, et al. ENDO 2018, abstract OR 25-6.

CHICAGO – Both transgender men and transgender women had an increased risk of breast cancer compared with a male, but not a female, reference population, said Christel de Blok, MD, sharing results of a Dutch national study.

The study included 3,078 transgender people (2,064 transgender women) who began hormone therapy (HT) at age 18 years or older. The mean age at which transgender women began HT was 33 years; for transgender men, the mean age was 25 years. In all, transgender women in the study had a total of 30,699 person-years of exposure to HT; for transgender men, the figure was 13,155 person-years.

[email protected]
 

SOURCE: de Blok C, et al. ENDO 2018, abstract OR 25-6.

CHICAGO – Both transgender men and transgender women had an increased risk of breast cancer compared with a male, but not a female, reference population, said Christel de Blok, MD, sharing results of a Dutch national study.

The study included 3,078 transgender people (2,064 transgender women) who began hormone therapy (HT) at age 18 years or older. The mean age at which transgender women began HT was 33 years; for transgender men, the mean age was 25 years. In all, transgender women in the study had a total of 30,699 person-years of exposure to HT; for transgender men, the figure was 13,155 person-years.

[email protected]
 

SOURCE: de Blok C, et al. ENDO 2018, abstract OR 25-6.

CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.

“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.

Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.

Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.

Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”

She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.

Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.

Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.

The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.

Dr. Greenup and her study coauthors reported having no financial disclosures.

[email protected]

SOURCE: Greenup RA. SSO 2018, Abstract No. 24.

CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.

“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.

Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.

Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.

Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”

She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.

Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.

Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.

The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.

Dr. Greenup and her study coauthors reported having no financial disclosures.

[email protected]

SOURCE: Greenup RA. SSO 2018, Abstract No. 24.

CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.

“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.

Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.

Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.

Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”

She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.

Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.

Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.

The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.

Dr. Greenup and her study coauthors reported having no financial disclosures.

[email protected]

SOURCE: Greenup RA. SSO 2018, Abstract No. 24.

ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.

Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.

Sharon Worcester/MDedge News

“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”

There may be other mechanisms for this activity as well, she noted.

The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.

“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.

Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.

These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.

The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.

However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.

Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.

This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures

[email protected]

SOURCE: Connolly RM et al. NCCN, Poster 3.

ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.

Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.

Sharon Worcester/MDedge News

“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”

There may be other mechanisms for this activity as well, she noted.

The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.

“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.

Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.

These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.

The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.

However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.

Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.

This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures

[email protected]

SOURCE: Connolly RM et al. NCCN, Poster 3.

ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.

Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.

Sharon Worcester/MDedge News

“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”

There may be other mechanisms for this activity as well, she noted.

The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.

“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.

Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.

These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.

The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.

However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.

Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.

This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures

[email protected]

SOURCE: Connolly RM et al. NCCN, Poster 3.