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PURPOSE: Adjuvant therapy in patients with ductal carcinoma in situ who undergo partial mastectomy remains controversial, particularly for low-risk patients (60 years or older, estrogen-positive, tumor extent < 2.5 cm, grade 1 or 2, and margins ≥ 3 mm). We performed a cost-effectiveness analysis comparing three strategies: no adjuvant treatment after surgery, a five-fraction course of accelerated partial breast irradiation using intensity-modulated radiation therapy (accelerated partial breast irradiation [APBI]–alone), or APBI plus an aromatase inhibitor for 5 years. MATERIALS AND METHODS: Outcomes including local recurrence, distant metastases, and survival as well as toxicity data were modeled by a patient-level Markov microsimulation model, which were validated against trial data. Costs of treatment and possible adverse events were included from the societal perspective over a lifetime horizon, adjusted to 2019 US dollars and extracted from Medicare reimbursement data. Quality-adjusted life-years (QALYs) were calculated based on utilities extracted from the literature. RESULTS: No adjuvant therapy was the least costly approach ($5,744), followed by APBI-alone ($11,070); combined therapy was costliest ($16,052). Adjuvant therapy resulted in slightly higher QALYs (no adjuvant, 11.320; APBI-alone, 11.343; and combination, 11.381). In the base case, no treatment was the cost-effective strategy, with an incremental cost-effectiveness ratio of $239,109/QALY for APBI-alone and $171,718/QALY for combined therapy. The incremental cost-effectiveness ratio for combined therapy compared with APBI-alone was $131,949. Probabilistic sensitivity analyses found that no therapy was cost effective (defined as $100,000/QALY of lower) in 63% of trials, APBI-alone in 19%, and the combination in 18%. CONCLUSION: No adjuvant therapy represents the most cost-effective approach for postmenopausal women 60 years or older who receive partial mastectomy for low-risk ductal carcinoma in situ.

We sought to evaluate time trends and correlates of the use of a radiation tumor bed boost (TBB) after breast-conserving surgery and either conventional or hypofractionated whole-breast irradiation (CWBI or HWBI) for patients with early stage breast cancer.The National Cancer Database was queried for patients diagnosed between 2012 and 2016. We evaluated the utilization of TBB before and after publication of the Society of Surgical Oncology-American Society for Radiation Oncology margin guidelines in relation to sociodemographic variables, treatment facility, tumor characteristics, and whole-breast fractionation.The population included 380,387 patients, of whom 76.7% received a TBB. Utilization of TBB decreased over time (2012-2013: 79.2%; 2014: 76.6%; 2015-2016: 74.7%; P.001); this was seen for most subgroups evaluated. Rates of TBB differed by facility type and region. There was a decrease in TBB use in patients treated with CWBI over time (2012-2013: 84.9%; 2014: 83.5%; 2015-2016: 82.3%; P.001) but an increase among patients treated with HWBI (2012-2013: 55.5%; 2014: 60.7%; 2015-2016: 65.1%; P.001); this was also seen for low-risk patients (age70 years, negative margins). Among patients undergoing HWBI, TBB was more frequently used when 15 fractions were used compared with 16 fractions (76.8% vs 59.1%; P.001).The use of TBB decreased over time, coinciding with the publication of new margin guidelines, for patients receiving CWBI and those with negative margins, but TBB use increased for patients treated with HWBI. Hence, fractionation regimen is a critical variable in analyzing changes over time in the practice patterns of TBB.

The optimal tumor-free margin definition and width following breast-conserving therapy (BCT) for early-stage invasive cancers has been evaluated in previous meta-analyses and guidelines. We performed an updated meta-analysis to assess how improvements in treatment over time have affected the impact of margins on local recurrence (LR) rates over time. A systematic literature review identified 38 eligible studies comprising 54,502 patients treated between 1968 and 2010. Inclusion criteria included patients treated with BCT and minimum follow-up of 50 months, pathologic definitions of margin status explicitly stated, and LR data in relation to margin status. Data were pooled using a Bayesian logistic regression model to evaluate the risk of LR in relation to both margin status and study enrollment periods. Median follow-up was 7.25 years. Absolute LR rates decreased over time for each margin width cohort, with maximum differences between negative margin groups of less than 1% for the most recent enrollment period. However, relative rates of LR between different margin groups remained stable over time. With an additional 22,000 patients compared with the previous meta-analysis, this updated meta-analysis supports the consensus guideline of “no tumor on ink” for the majority of patients. Additionally, while concerns exist regarding a benefit with wider margins from previous studies, the analysis demonstrates the impact of margin width on LR rates has declined substantially over time, with very small differences between the narrowest and widest margin groups in the most recent cohort. Hence, older studies appear to have limited value to inform current management guidelines.

BACKGROUND: Axillary lymph node dissection (ALND) with or without postmastectomy radiation therapy (PMRT) was traditionally the standard of care for patients with a positive sentinel node following mastectomy. However, recent clinical trial data has led to an interest in de-escalating therapy and a debate over optimal axillary management. We sought to assess current practice patterns and the impact of different approaches to managing positive sentinel nodes following mastectomy. METHODS: Using the National Cancer Database (NCDB), patients with clinical T1-2 N0 M0 breast cancer from 2012-2015 treated with a mastectomy who were found to have a single positive sentinel node were analyzed. A logistic regression model stratified by patients’ characteristics in association to the type of axillary treatment received was performed.RESULTS: We identified 12,137 women with a positive sentinel lymph node biopsy (SLNB) at the time of mastectomy. Of these, 4,221 had an ALND; 1,609 received PMRT; 1,565 underwent combination therapy, and 4,742 had no further treatment following SLNB (NFT). Factors associated with an increased likelihood of further axillary treatment included younger age (CONCLUSION: Our study indicates significant practice variation in the axillary management of patients with metastasis limited to a single sentinel node undergoing mastectomy. The clinical variation observed raises the possibility of unnecessary or overtreatment of the axilla. These findings suggest a need to expand the adoption of evidenced-based clinical protocols to improve quality of care.

Background: During the SARS-CoV-2 pandemic in 2020, the use of routine screening mammography (SM) and diagnostic mammography (DM) was limited for several months in order to reduce patient exposure and redeploy medical personnel. Previous studies suggest such delays result in more late-stage breast cancer diagnoses. We hypothesized that this impact would vary between institutions depending on regional variations in shutdown periods and the ability and willingness of patients to resume screening. Methods: Patients diagnosed with invasive breast cancers from 2016-2020 were identified using the Beth Israel Deaconess Medical Center (BIDMC) and the Duke University Medical Center (DUMC) cancer registries. Rates of mammography were ascertained from billing data. Baseline patient characteristics, demographics, and clinical information were gathered and cross-referenced with the electronic medical record. Late-stage was defined as Anatomic Stage III-IV disease (AJCC 8th edition). Chi-squared analysis was used to examine monthly distributions in stage at presentation for diagnosis in 2016-2019 compared to in 2020 at each institution. Results: There were 5907 patients diagnosed with invasive breast cancer between 2016-2019 (1597 at BIDMC and 4310 at DUMC) and 1075 in 2020 (333 and 742, respectively). Mammography was limited from 3/16/20-6/8/20 at BIDMC and from 3/16/20-4/20/20 at DUMC. There were fewer SM at each institution during their respective shutdown periods in 2020 than in the same months in 2019: BIDMC 1713 versus 8566 (80% reduction) and at DUMC 1649 versus 5698 (71% reduction). Following the pandemic shutdown, SM volume increased in July-December 2020 compared to July-December 2019 (108% at BIDMC and 116% at DUMC). The proportion of patients diagnosed with late-stage disease at BIDMC was greater in 2020 than in 2016-2019, at 12.6% and 6.6%, respectively (p < 0.001); 86% of late-stage diagnoses and 68% of all diagnoses in 2020 at BIDMC occurred from July-December following the initial shutdown period. The proportion of patients diagnosed with late-stage disease at DUMC in these two cohorts were 14.3% in 2020 and 16.2%% in 2016-2019 (p = 0.1); 50% of late-stage diagnoses and 51% of all diagnoses in 2020 at DUMC occurred in the period following the initial shutdown from July-December. Conclusion: We identified variation between two large academic medical centers in the impact of the SARS-CoV-2 pandemic shutdown on the proportion of late-stage breast cancer diagnoses. These dissimilar outcomes may be the result of differences in referral patterns as well as regional differences in the approach to SM during the pandemic. In particular, a shorter closure time and substantial increase in SM volume following the initial shutdown period in the Southeast region may have prevented an increase in late-stage diagnoses. Further information and analysis may help suggest additional strategies to minimize adverse effects of reduced cancer screening in future public-health emergencies. Table 1.Proportion of SM in 2020 compared to 2019 and proportion of late disease per month in 2020BIDMC 2020JanFebMarAprMayJunJulAugSepOct NovDecSM, %96109480034104106112105113112Late Disease, n(%)0 (0)2 (10)1 (3)0 (0)0 (0)3 (21)1 (7)9 (21)10 (15)10 (19)5 (12)1 (8)DUMC 2020JanFebMarAprMayJunJulAugSepOctNovDecSM, %565860040123111109127116120119Late Disease, n(%)12 (11)13 (19)14 (19)4 (18)4 (12)6 (11)12 (13)10 (13)6 (10)12 (19)7 (13)5 (13) Citation Format: Sarah J Stephens, Maxwell R Lloyd, Julian C Hong, Tejas Mehta, Ted A James, Rachel Blitzblau, Abram Recht, Daphna Y Spiegel. Multi-institutional perspective on screening mammography and breast cancer stage at diagnosis during the COVID-19 pandemic [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-04-04.

There are few data on the long-term outcomes of patients with phyllodes tumors following breast-conserving surgery with or without radiation therapy (RT). We reviewed 69 patients diagnosed from 2000 to 2015 with surgical specimens available for central pathology assessment for outcome in relation to histopathologic subtype, margin width, and utilization of RT. Median follow-up was 63 months (interquartile range, 35-131 months). Forty-eight patients had benign, 13 borderline, and eight malignant phyllodes tumors, with local recurrence rates of 4%, 0%, and 38%, respectively (P ≤ .04 comparing malignant lesions to both benign and borderline lesions). None of the eight patients who received RT suffered a local recurrence. Two of the 26 (8%) patients with benign phyllodes tumors who did not receive RT with margins that were positive or

Axillary surgery and radiotherapy are important aspects of breast cancer treatment associated with development of lymphedema. Studies demonstrate that Lymphatic Microsurgical Preventive Healing Approach (LYMPHA) may greatly reduce the incidence of lymphedema in high-risk groups. The objective of this study is to summarize the evidence relating lymphedema incidence to axillary lymph node dissection (ALND), regional lymph node radiation (RLNR) therapy, and LYMPHA.We performed a literature search to identify studies involving breast cancer patients undergoing ALND with or without RLNR. Our primary outcome was the development of lymphedema. We analyzed the effect of LYMPHA on lymphedema incidence. We chose the DerSimonian and Laird random-effects meta-analytic model owing to the clinical, methodological, and statistical heterogeneity of studies.Our search strategy yielded 1476 articles. After screening, 19 studies were included. Data were extracted from 3035 patients, 711 of whom had lymphedema. The lymphedema rate was significantly higher when RLNR was administered with ALND compared with ALND alone (P0.001). The pooled cumulative incidence of lymphedema was 14.1% in patients undergoing ALND versus 2.1% in those undergoing LYMPHA and ALND (P = 0.029). The pooled cumulative incidence of lymphedema was 33.4% in those undergoing ALND and RLNR versus 10.3% in those undergoing ALND, RLNR, and LYMPHA (P = 0.004).Axillary lymph node dissection and RLNR are important interventions to obtain regional control for many patients but were found to constitute an increased risk of development of lymphedema. Our findings support that LYMPHA, a preventive surgical technique, may reduce the risk of breast cancer-related lymphedema in high-risk patients.

Objective: Elderly patients with low-risk hormone-positive breast cancer are at risk of over treatment. Avoidance of radiation therapy (RT) in favor of endocrine therapy alone was first heralded as the optimal conservative strategy due to logistical simplicity, low acute sequelae and a reduction of contralateral cancers not seen with RT. However, long-term use of aromatase inhibitors (AI) is not without costs and morbidity, often leading to low compliance and notable late effects. We therefore performed a cost-effectiveness analysis to compare the outcomes and costs between AI for five years without RT versus hypofractionated RT alone without endocrine therapy. Materials and Methods: Using data from available phase III trials and meta-analyses, we constructed a patient-level microsimulation Markov decision model to replicate the comparative outcomes between the strategies above from the societal perspective among 200,000 simulated patients. Five years of anastrozole was compared to a 15-fraction hypofractionated whole breast RT course without boost in a cohort of patients with low-risk disease as defined by CALGB 9343 entry criteria. Noncompliance with AI was modeled from recent population-based data. Relative effectiveness on ipsilateral breast tumor recurrence and contralateral breast cancers were based off the NSABP B-21 trial, adjusted to match the modern outcomes demonstrated in CALGB 9343 and PRIME II with further adjustment for AI over tamoxifen (ATAC, EBCTCG meta-analysis). Indirect costs of travel were accounted for, as were the costs of common and serious side-effects from RT (dermatitis, fibrosis, second malignancy, heart disease) and AI (arthralgia, hot flashes, osteopenia, fracture, thrombosis). A 1-year cycle time and lifetime horizon were used, with all costs adjusted to 2018 US dollars and extracted primarily from Medicare reimbursement data. The primary measure of efficacy was the quality-adjusted life-year (QALY) with age-adjusted utilities extracted from the literature. Half-cycle correction and a 3% discount rate were applied. Probabilistic sensitivity analysis was used to vary all parameters simultaneously. Results: On average, RT was approximately $3,981 more expensive than endocrine therapy over the lifetime horizon. Under a number of assumptions, RT appeared similar in long-term effectiveness to AI therapy, with a difference of less than 0.03 quality-adjusted life years. Given the low value of the denominator in the incremental cost-effectiveness ratio (ICER), RT did not meet the formally defined $100,000/QALY threshold. On one-way sensitivity analysis, the ICER was particularly sensitive to the incidence and impact of salvage strategies for recurrence, treatment of contralateral breast cancers, cardiac events and fracture rates. Conclusions: Modeling with the available evidence suggests it is likely that quality-of-life after RT-alone is nearly identical to an AI-alone strategy but associated with a small increase in cost. These results suggest select patients at risk of noncompliance can safely be treated with RT-alone rather than AI alone. Given the relative pros and cons of each strategy, RT-alone should be considered for select elderly low-risk breast patients. Citation Format: Ward MC, Vicini F, Chadha M, Pierce L, Recht A, Hayman J, Thaker N, Khan A, Keisch M, Shah C. Evaluating the cost of endocrine therapy vs. radiation therapy alone for low risk hormone positive early stage breast cancer in elderly patients [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-15-02.

A comprehensive decision aid (DA) for women ≥70 years with Stage I ER+/HER2-negative breast cancer was developed to support locoregional and systemic treatment decision-making. We aimed to test the acceptability of this novel DA in women newly-diagnosed with breast cancer.Women ≥70 diagnosed with Stage I, ER+/HER2- breast cancer were recruited from three Boston-area hospitals. They underwent baseline interviews after initial surgical consultation, reviewed the DA, and were surveyed2 weeks later to determine DA acceptability (e.g., was it helpful?), changes in decisional conflict, stage of decision-making, and knowledge. Participants could optionally complete a three-month follow-up. Paired t-tests and McNemar's tests were used for statistical comparisons, and thematic analyses were conducted to identify themes in participants' open-ended comments.Thirty-three of 56 eligible patients approached completed the baseline and acceptability surveys, and 25 completed the three-month follow-up. Participants' mean age was 74.7 years (±3.8). Nearly all participants (n = 31, 94%) strongly agreed that the DA was helpful and felt that the DA prepared them for treatment decision-making, with a mean decision preparation score of 4.1 (out of 5.0); 6% (n = 2) found it very anxiety provoking. Knowledge improved with a mean of 9.0 out of 14 questions correct at baseline to 10.6 correct on the acceptability survey (p 0.0001).A DA tailored to women ≥70 with Stage I, ER+, HER2- breast cancer increased knowledge and was perceived to be helpful by older women. A randomized controlled trial is needed to evaluate its efficacy.

We performed a cost-effectiveness analysis of three strategies for the adjuvant treatment of early breast cancer in women age 70 years or older: an aromatase inhibitor (AI-alone) for 5 years, a 5-fraction course of accelerated partial-breast irradiation using intensity-modulated radiation therapy (APBI-alone), or their combination. We constructed a patient-level Markov microsimulation from the societal perspective. Effectiveness data (local recurrence, distant metastases, survival), and toxicity data were obtained from randomized trials when possible. Costs of side effects were included. Costs were adjusted to 2019 US dollars and extracted from Medicare reimbursement data. Quality-adjusted life-years (QALY) were calculated using utilities extracted from the literature. The strategy of AI-alone ($12,637) was cheaper than both APBI-alone ($13,799) and combination therapy ($18,012) in the base case. All approaches resulted in similar QALY outcomes (AI-alone 7.775; APBI-alone 7.768; combination 7.807). In the base case, AI-alone was the cost-effective strategy and dominated APBI-alone, while combined therapy was not cost-effective when compared to AI-alone ($171,451/QALY) or APBI-alone ($107,932/QALY). In probabilistic sensitivity analyses, AI-alone was cost-effective at $100,000/QALY in 50% of trials, APBI-alone in 28% and the combination in 22%. Scenario analysis demonstrated that APBI-alone was more effective than AI-alone when AI compliance was lower than 26% at 5 years. Based on a Markov microsimulation analysis, both AI-alone and APBI-alone are appropriate options for patients 70 years or older with early breast cancer with small cost differences noted. A prospective trial comparing the approaches is warranted.

Purpose Hormone therapy without radiation therapy is considered appropriate for women age 70 or above with low-risk, hormone-positive breast cancer after partial mastectomy. However, some patients may prefer radiation without hormone therapy, for which there is minimal modern data. We modeled the comparative efficacy of aromatase inhibition alone without radiation versus radiation alone without hormone therapy. Methods and Materials We constructed a patient-level Markov model and compared 5 years of anastrozole to a 15-fraction course of radiation without boost or anastrozole. The relative effectiveness between treatments was based on the National Surgical Adjuvant Breast and Bowel Project B-21 trial, which was further adjusted such that the endocrine-alone arm matched the Cancer and Leukemia Group B 9343 and PRIME II trials. Common or severe side effects were considered. Eight survival metrics were assessed and validated against clinical trial data. The cost-efficacy of each strategy was considered using the quality-adjusted life year and incremental cost-effectiveness ratio (ICER). Results The model's predicted outcomes matched those demonstrated by modern trials. Aromatase inhibitors were superior in preventing contralateral cancers, with a small impact on the risk of distant metastatic disease. Radiation was superior in preventing ipsilateral breast tumor recurrence with a small impact on regional failure. No clinically significant differences were seen in the other 4 oncologic endpoints. Differences in quality-adjusted life years were small, but radiation therapy was $3809 more expensive over the average lifetime. The ICER suggested anastrozole was cost-effective in 62% of probabilistic simulations. However, the ICER was unstable owing to a denominator that approached zero. Conclusions Women age 70 or above with low-risk early breast cancer who are reluctant or unable to pursue adjuvant aromatase inhibition can safely pursue adjuvant radiation alone with limited differences in outcome and a modest increase in costs.

Objectives Since women ≥70 years with early stage, estrogen receptor positive (ER+), HER2 negative breast cancer face several preference-sensitive treatment decisions, the investigative team aimed to develop a pamphlet decision aid (DA) for such women. Materials and methods The content of the DA was informed by literature review, international criteria, and expert feedback, and includes information on benefits and risks of lumpectomy versus mastectomy, lymph node surgery, radiotherapy after lumpectomy, and endocrine therapy. It considers women's overall health and was written using low literacy principles. Women from two Boston-based hospitals who were diagnosed in the past 6–24 months were recruited to provide feedback on the DA and its acceptability. The DA was iteratively revised based on their qualitative input. Results Of 48 eligible women contacted, 35 (73%) agreed to participate. Their mean age was 74.3 years; 33 (94%) were non-Hispanic white; and 24 (67%) were college graduates. Overall, 26 (74%) thought the length of the DA was just right, 29 (83%) thought all or most of the information was clear, 32 (91%) found the DA helpful, and 33 (94%) would recommend it. In open ended comments, participants noted that the DA was clear, well-organized, and would help women prepare for and participate in treatment decision-making. Conclusions The investigative team developed a novel breast cancer treatment DA that is acceptable to women ≥70 years with a history of ER+, HER2-, early stage breast cancer. Next, the DA's efficacy needs to be tested with diverse older women newly diagnosed with breast cancer.

528 Background: During the SARS-CoV-2 pandemic, routine screening mammography (SM) was stopped and diagnostic mammography (DM) was limited for several months across the United States in order to reduce patient exposure and redeploy medical personnel. We hypothesized that this delay would result in patients presenting with later-stage disease following the initial shutdown. Methods: Patients diagnosed with invasive breast cancers from 2016-2020 were identified using the Beth Israel Deaconess Medical Center Cancer Registry. Baseline patient characteristics, demographics, and clinical information were gathered and cross-referenced with our electronic medical record. Late-stage disease was defined as initial anatomic stage III-IV disease in the AJCC 8th edition staging system. The control cohort consisted of patients diagnosed from 2016-2019; patients diagnosed in 2020 were the test cohort. Chi-squared analysis was used to compare monthly distributions in stage at diagnosis between the control and test cohorts. Multivariate analysis was performed using a logistic regression model. Results: There were 1597 patients diagnosed with invasive breast cancer between 2016-2019 and 333 in 2020. Median age at diagnosis was 60 years; 99% were female, and 69.1% were white. Mammography was limited from 3/16/20-6/8/20, with 90% reduction in volume during this time. The number of screening studies performed in March, April, May, and June of 2020 were 987, 1, 4, and 721 compared to 2042, 2141, 2241, and 2142 in 2019. The volume of new diagnoses per month decreased substantially during the shutdown (see table). The proportion of patients diagnosed with late-stage disease was 6.6% in the control cohort compared to 12.6% in the 2020 test cohort (p < 0.001); 92.9% of late-stage diagnoses in 2020 occurred from June to December following the shutdown period. On multivariate analysis, year of diagnosis (2020 vs 2016-2019; OR = 4.25 95% CI 0.035-0.095, p < 0.001), lower income (

This retrospective study was aimed at identifying clinicopathologic characteristics associated with an increased risk for ipsilateral local recurrence (LR) in patients with ductal carcinoma in situ (DCIS) treated with wide local excision (WLE) alone without radiotherapy (RT).All patients with DCIS treated with WLE alone at the Beth Israel Deaconess Medical Center, Boston, MA, USA, between the years 2000 and 2010 were identified. We collected data on demographics, parity, personal or family history of breast cancer, exogenous hormone use, tobacco use, comorbidities, genetic mutation carrier status, imaging interval, and tumor-specific characteristics.Overall, 222 patients were included in the study. Median follow-up time was 8 years. LR occurred in 9% of patients, with a recurrence rate of 11.3 per 1000 person-years. The risk of recurrence was lower for patients with nuclear grade (NG) I tumors than for patients with NG II or NG III tumors (3, 8.5, and 19%, respectively; p = 0.01). The median margin width was 1 mm in patients experiencing LR versus 1.8 mm in patients without LR (p = 0.3). Patients who had used exogenous hormones, or patients with a history of tobacco use, had higher rates of LR than those who did not, although the difference did not reach statistical significance.Our data indicate that higher NG, narrower margin width, use of exogenous hormones, and smoking history may be associated with an increased risk of LR. The evaluation of these factors may be helpful when considering whether or not to use adjuvant RT for patients with DCIS.

Purpose The Oncotype DX DCIS Score short form (DCIS Score) estimates the risk of an ipsilateral breast event (IBE) in patients with ductal carcinoma in situ (DCIS) treated with breast-conserving surgery without adjuvant radiation therapy (RT). We determined the cost effectiveness of strategies using this test. Materials and Methods We developed a Markov model simulating 10-year outcomes for 60-year-old women eligible for the Eastern Cooperative Oncology Group E5194 study (cohort 1: low/intermediate-grade DCIS, ≤ 2.5 cm; cohort 2: high-grade DCIS, ≤ 1 cm) with each of five strategies: (1) no testing, no RT; (2) no testing, RT only for cohort 2; (3) no RT for low-grade DCIS, test for intermediate- and high-grade DCIS, RT for intermediate- or high-risk scores; (4) test all, RT for intermediate- or high-risk scores; and (5) no testing, RT for all. We used utilities and costs extracted from the literature and Medicare claims to determine incremental cost-effectiveness ratios and examined the number of women needed to irradiate per IBE prevented. Results No strategy using the DCIS Score was cost effective. The most cost-effective strategy (RT for none or RT for all) was sensitive to small differences between the utilities of receiving or not receiving RT and remaining without recurrence. The numbers needed to irradiate per IBE prevented were 10.5, 9.1, 7.5, and 13.1 for strategies 2 to 5, respectively, relative to strategy 1. Conclusion Strategies using the DCIS Score lowered the proportion of women undergoing RT per IBE prevented. However, no strategy incorporating the DCIS Score was cost effective. The cost effectiveness of RT was exquisitely utility sensitive, highlighting the importance of engaging patient preferences in this decision. Physicians should discuss trade-offs associated with omitting or adding adjuvant RT with each patient to maximize quality-of-life outcomes.

Nodal staging with sentinel node biopsy (SLNB), post-lumpectomy radiotherapy (RT), and endocrine therapy (ET) for estrogen receptor-positive (ER+) tumors is valuable in the treatment of early-stage (stages 1 or 2) breast cancer but used less often for elderly women.This retrospective study investigated women referred for surgical evaluation of biopsy-proven primary early-stage invasive breast cancer from January 2001 to December 2010. Clinicopathologic features, treatment course, and outcomes for women ages 80-89 years and 50-59 years were compared.The study identified 178 eligible women ages 80-89 years and 169 women ages 50-59 years. The elderly women more often had grade 1 or 2 disease (p = 0.003) and ER+ tumors (p = 0.007) and less frequently had undergone adjuvant therapies (all p ≤ 0.001). Lumpectomy was performed more commonly for the elderly (92 vs. 83 %, p = 0.02), and axillary surgery was less commonly performed (46 vs. 96 %; p 0.001). Fewer elderly women had undergone post-lumpectomy RT (42 vs. 89 %; p 0.001) and ET for ER+ tumors (72 vs. 95 %; p 0.001). During the median follow-up period of 56 months for the 80- to 89-year old group and 98 months for the 50- to 59-year-old group, death from breast cancer was similar (4 vs. 5 %; p = 0.5). The two groups respectively experienced 7 versus 6 locoregional recurrences and 11 versus 13 distant recurrences.The octogenarians had disease survivorship similar to that of the younger women despite less frequent use of adjuvant therapies, likely reflecting lower-risk disease features. Whether increased use of axillary surgery, post-lumpectomy RT, and/or ET for ER+ tumors would further improve outcomes is an important area for further study, but treatment should not be deferred solely on the basis of age.

Background: In the management of DCIS clinicians and patients (pts) must choose between the various options for breast conservation treatment based on an assessment of local recurrence (LR) risk. Traditional clinicopathologic (CP) factors such as age, size, grade, margin width or comedo necrosis, provide an average LR risk derived from clinical trials and population studies. The Oncotype DX® 12-gene assay for DCIS gives individual 10-yr LR risk estimates and has now been validated in two studies in a total of 893 pts. We report the 2nd study assessing the impact of the DCIS Score result on XRT recommendations. In addition, surveys assessing pt and physician confidence will provide insight into the overall clinical utility of the DCIS Score result. Baseline characteristics including the pre-assay LR risk and XRT recommendation are described here; final results on change in XRT recommendation from pre- to post-assay and distribution of the score across the CP factors will be presented. Methods: 13 U.S. sites enrolled pts with DCIS from 3/2014-5/2015. Pts with LCIS but no DCIS, invasive BC, or planned mastectomy were excluded. Data were prospectively collected on CP factors, physician estimates of LR risk, DCIS score, and pre/post XRT recommendation. Each pt had a surgeon and radiation oncologist complete study surveys. Pt surveys were also administered pre/post assay for decision conflict and the STAIT anxiety survey. The LR risk estimates and XRT recommendations were analyzed for all physicians as well as by specialty. Descriptive statistics summarized study variables. 95% Clopper-Pearson Exact CIs were calculated for percent change in XRT recommendation. McNemar's test was used to determine if the proportion of pts had a significant change in XRT recommendation post assay. Paired t-tests were used to compare physician estimates of recurrence risk pre/post assay. Results: Of the 121 pts enrolled, median age was 61y (34-83) and 80.2% were postmenopausal. Median size was 8mm and 40% were < 5mm; 22.3% were grade 1, 51.2% grade 2, and 26.4% grade 3. Comedo necrosis was noted in 55.4% and 19% had multiple foci. Median margin width was 3mm and 47.1% had margins 1-3mm. ER and PR by IHC were positive in 88.4% and 75.2% of pts. Among the 242 MD risk assessments, mean 10-yr LR risk was 14.8% (range 4-50%) for any LR; 14.2% for surgeons and 15.3% for radiation oncologists. The pre-assay XRT recommendation was 70.2%; 68.6% for surgeons and 71.9% for radiation oncologists. Conclusions: The role of new molecular tools such as the DCIS Score assay that provide individual risk estimates for LR on treatment decisions is evolving. The DCIS pts enrolled in the study reveal inclusion of baseline features like higher nuclear grade (26%), comedo necrosis (55%) and margin width of 1-3mm (47%) that have historically been associated with XRT use. This represents a continued broadening of the assay use from the predominantly lower risk DCIS cohort in the 1st validation study (E5194). The impact on XRT decisions is critical to establishing the clinical utility of the assay. The decision impact analysis, differences in use of the assay among surgeons and radiation oncologists and the impact on overall confidence with the treatment decision will be presented. Citation Format: Manders JB, Kuerer HM, Smith BD, McCluskey C, Farrar WB, Frazier TG, Li L, Leonard CE, Carter DL, Chawla S, Medeiros LE, Guenther JM, Castellini LE, Buchholz DJ, Mamounas EP, Wapnir IL, Horst KC, Chagpar A, Evans SB, Riker AI, Vali FS, Solin LJ, Jablon L, Recht A, Sharma R, Lu R, Sing AP, Hwang ES, White J. The 12-gene DCIS score assay: Impact on radiation treatment (XRT) recommendations and clinical utility. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-17-03.

Background: There is ongoing debate regarding the added benefit of radiation therapy (RT) for patients with ductal carcinoma in situ (DCIS) believed to be at low risk for recurrence after wide local excision (WLE) alone since RT is costly and can cause significant adverse effects. In this retrospective study we aimed to identify clinicopathological characteristics associated with an increased risk for ipsilateral local recurrence (LR) in patients not undergoing RT. Methods: All patients with DCIS treated with WLE alone at the Beth Israel Deaconess Medical Center, Boston between 2000 and 2010 were identified. We collected data on demographics, parity, personal or family history of breast cancer, exogenous hormone use, tobacco use, comorbidities, genetic mutation carrier status, imaging interval, and tumor-specific characteristics (size, margins, grade, architectural subtype, presence of necrosis, estrogen receptor status). We analyzed their effects on the risk of LR. Results: The study cohort included 281 eligible patients (mean age at diagnosis 59 years, range 33-90). Median follow-up time was 8 years (range 0.11-16.59 years); 59 patients were excluded because they were not followed in our institution after undergoing WLE. LR occurred in 19 of 222 patients (9%), with a recurrence rate of 11.3 per 1000 person-years. The median time from excision to LR was 4.2 years (range, 0.8-11.7). The risk of recurrence was lower for the 64 patients with nuclear grade (NG) I tumors than for the 110 patients with a NG II or 20 patients NG III tumors (3%, 9%, and 20%, respectively, p for trend = 0.01). The mean margin width was 1.8 mm in patients experiencing LR, versus 2.5 mm in patients without LR (p=0.4). Patients who had used hormone replacement therapy or oral contraceptives (n=61) or patients with a history of tobacco use (n=41) had higher rates of LR than those who did not, although these did not reach statistical significance (15% versus 6%, p=0.06; and 17% versus 7%, p=0.07 respectively). There was no significant correlation between the use of tamoxifen or aromatase inhibitors and the risk of LR. Conclusions: Our data indicate that higher nuclear grade, narrower margin width, use of exogenous hormones, and smoking history may be associated with an increased risk of LR. The evaluation of these factors may be helpful when considering whether to use adjuvant RT or not for patients with DCIS. Citation Format: Recht A, Mele A, Mehta P, Brook A, Slanetz P, Sharma R. Breast conserving surgery alone for ductal carcinoma in situ: Factors associated with increased risk of local recurrence. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-17-04.

The American Society for Radiation Oncology produced an evidence-based guideline on whole-breast radiation therapy for patients with early-stage invasive breast cancer and ductal carcinoma in situ. This commentary points out areas where we believe the data are too limited to make definitive recommendations and where alternative approaches are supported by evidence.

Background: The ECOG E5194 study was a prospective trial designed to evaluate surgical excision (lumpectomy) without radiation for selected women with ductal carcinoma in situ (DCIS) of the breast with low risk clinical and pathologic features. Methods: Eligible patients were enrolled on two study cohorts (not randomized): (1) low or intermediate grade DCIS, tumor size < 2.5 cm; or (2) high grade DCIS, tumor size < 1.0 cm. Cohort assignment was based on pathology assessment from the treating institution. Protocol specifications included surgical excision of the DCIS tumor with a minimum negative margin width of at least 3 mm or no tumor on re-excision. Radiation treatment was not allowed. From April 1997 to October 2002, 665 evaluable patients were enrolled through ECOG or NCCTG (561 in Cohort 1; 104 in Cohort 2). Tamoxifen was optional (not randomized) beginning in May 2000, and was given to 30% of the patients. The primary study endpoint was the rate of developing an ipsilateral breast event (IBE), defined as local recurrence of DCIS or invasive carcinoma in the treated breast. The median follow-up was 12.3 years. We have previously reported 7-year results (L. Hughes, J Clin Oncol 27:5319, 2009; median follow-up 6.3 years; 66 IBE’s), and we herein provide 12-year results. Results: Median patient age was 60 years and 58 years for Cohort 1 and Cohort 2, respectively. Tumor size was < 10 mm for 79% and 80% of patients, respectively. The minimum negative margin width was > 5 mm for 64% and 69% of patients, respectively. There were 99 IBE’s, of which 51 (52%) were an invasive IBE. The IBE and invasive IBE rates increased over time in both cohorts (see Table). The 12-year rates of an IBE were 14.4% for Cohort 1 and 24.6% for Cohort 2 (p = 0.003), and for an invasive IBE, 7.5% and 13.4%, respectively (p = 0.08). No difference was seen for the 12-year rates of overall survival (84.0% vs 82.8%; p = .96) or contralateral breast events (6.7% vs 12.0%; p = 0.16). On multivariate analysis, study cohort (hazard ratio = 1.81; p = 0.01) and tumor size (p = 0.01) were statistically significant for an IBE, and study cohort was borderline statistically significant for an invasive IBE (p = 0.08). On central pathology review (75% of cases), neither grade nor comedo necrosis was associated with the risk of an IBE or invasive IBE (all p > 0.15). Salvage treatment at the time of an IBE included mastectomy for 42% (31/74) and 64% (16/25) of the patients, respectively. Conclusions: For these selected patients with favorable DCIS based on clinical and pathologic characteristics treated with surgical excision without radiation, the rates of an IBE and an invasive IBE continued to increase through at least 12 years of follow-up. IBE Rates According To Study Cohort. Cohort 1 (Low or Intermediate Grade)Cohort 2 (High Grade)TimeIBEInvasive IBEIBEInvasive IBEAt 5 years6.0% (4.0%, 8.1%)2.7% (1.3%, 4.1%)15.0% (7.7%, 21.7%)5.3% (0.8%, 9.7%)At 7 years9.5% (7.0%, 12.0%)4.8% (2.9%, 6.6%)18.2% (10.6%, 25.8%)7.6% (2.2%, 13.0%)At 10 years12.5% (9.5%, 15.4%)6.4% (4.2%, 8.6%)24.6% (15.7%, 33.4%)13.4% (5.9%, 20.9%)At 12 years14.4% (11.2%, 17.6%)7.5% (5.1%, 10.0%)24.6% (15.7%, 33.4%)13.4% (5.9%, 20.9%) Citation Format: Lawrence J Solin, Robert Gray, Lorie L Hughes, William C Wood, Mary Ann Lowen, Sunil Badve, Frederick L Baehner, James N Ingle, Edith A Perez, Abram Recht, Joseph Sparano, Kathy Miller, Nancy E Davidson. Local excision without radiation for ductal carcinoma in situ: 12-year results from the ECOG E5194 study [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P6-13-01.

Octogenarians with early-stage breast cancer often have low-risk tumor biology. However, optimal treatment strategies for those with high-risk biology remain unclear. We reviewed the records of women ages 80–89 years with biopsy-proven, Stage I–II invasive breast cancer who were referred for surgical evaluation from January 2001 through December 2010. High-risk was defined as human epidermal growth factor receptor-positive (HER2+), triple-negative (TN), or histologic grade 3 disease. Among 178 patients, 40 (22%) were high-risk: 12 were grade 1–2 (10 HER2 + , 2 TN); 28 were grade 3 (7 HER2+, 6 TN, 15 estrogen receptor-positive (ER+)/HER2−). The high-risk group had larger tumors and more often had ductal histology and lymphovascular invasion than the low-risk group and was more likely to undergo mastectomy (18 vs. 5%, p = 0.02), radiotherapy (55 vs. 36%, p = 0.03), and chemotherapy (10 vs. 0%, p = 0.002). Endocrine therapy use was similar among ER+ patients in both groups. The four patients in the high-risk group given chemotherapy were HER2+ and received trastuzumab-based regimens, without any reported toxicities. At median follow-up of 67 months, 10% of the high-risk group had a recurrence (3 distant-only, 1 simultaneous locoregional and distant in a patient treated with mastectomy without radiotherapy). Tailored locoregional and systemic therapy resulted in low incidence of failure in these octogenarians with high-risk cancers with low morbidity. Modern adjuvant therapies should be considered for elderly women with high-risk cancers in the absence of significant comorbidities.

PurposeToanalyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety.Methods and materialsRecall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions.ResultsThere were 502 ROD recalls and 9534 other classII device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P

Purpose A relationship between mean heart dose (MHD) and acute coronary event (ACE) rate was reported in a study of patients with breast cancer (BC). The main objective of our cohort study was to validate this relationship and investigate if other dose-distribution parameters are better predictors for ACEs than MHD. Patients and Methods The cohort consisted of 910 consecutive female patients with BC treated with radiotherapy (RT) after breast-conserving surgery. The primary end point was cumulative incidence of ACEs within 9 years of follow-up. Both MHD and various dose-distribution parameters of the cardiac substructures were collected from three-dimensional computed tomography planning data. Results The median MHD was 2.37 Gy (range, 0.51 to 15.25 Gy). The median follow-up time was 7.6 years (range, 0.1 to 10.1 years), during which 30 patients experienced an ACE. The cumulative incidence of ACE increased by 16.5% per Gy (95% CI, 0.6 to 35.0; P = .042). Analysis showed that the volume of the left ventricle receiving 5 Gy (LV-V5) was the most important prognostic dose-volume parameter. The most optimal multivariable normal tissue complication probability model for ACEs consisted of LV-V5, age, and weighted ACE risk score per patient (c-statistic, 0.83; 95% CI, 0.75 to 0.91). Conclusion A significant dose-effect relationship was found for ACEs within 9 years after RT. Using MHD, the relative increase per Gy was similar to that reported in the previous study. In addition, LV-V5 seemed to be a better predictor for ACEs than MHD. This study confirms the importance of reducing exposure of the heart to radiation to avoid excess risk of ACEs after radiotherapy for BC.

Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non-radiation oncology devices.MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χThere were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P.001). Device age and time since 510(k) approval were shorter among RODs (P.001).Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer-user training may help mitigate these events.

Purpose To present long-term outcomes of a prospective feasibility trial using either protons or 3-dimensional conformal photon-based (accelerated partial-breast irradiation [APBI]) techniques. Methods and Materials From October 2003 to April 2006, 98 evaluable patients with stage I breast cancer were treated with APBI (32 Gy in 8 fractions given twice daily) on a prospective clinical trial: 19 with proton beam therapy (PBT) and 79 with photons or mixed photons/electrons. Median follow-up was 82.5 months (range, 2-104 months). Toxicity and patient satisfaction evaluations were performed at each visit. Results At 7 years, the physician rating of overall cosmesis was good or excellent for 62% of PBT patients, compared with 94% for photon patients ( P =.03). Skin toxicities were more common for the PBT group: telangiectasia, 69% and 16% ( P =.0013); pigmentation changes, 54% and 22% ( P =.02); and other late skin toxicities, 62% and 18% ( P =.029) for PBT and photons, respectively. There were no significant differences between the groups in the incidences of breast pain, edema, fibrosis, fat necrosis, skin desquamation, and rib pain or fracture. Patient-reported cosmetic outcomes at 7 years were good or excellent for 92% and 96% of PBT and photon patients, respectively ( P =.95). Overall patient satisfaction was 93% for the entire cohort. The 7-year local failure rate for all patients was 6%, with 3 local recurrences in the PBT group (7-year rate, 11%) and 2 in photon-treated patients (4%) ( P =.22). Conclusions Local failure rates of 3-dimensional APBI and PBT were similar in this study. However, PBT, as delivered in this study, led to higher rates of long-term telangiectasia, skin color changes, and skin toxicities. We recommend the use of multiple fields and treatment of all fields per treatment session or the use of scanning techniques to minimize skin toxicity.

A joint panel of the American Society of Clinical Oncology (ASCO), American Society for Radiation Oncology (ASTRO), and Society of Surgical Oncology (SSO) convened in 2015 to develop an update of the prior ASCO guideline (J Clin Oncol 2001;19:1539-1569) concerning the use of postmastectomy radiation therapy (PMRT). This effort focused on common scenarios where there have been substantial controversy. Their conclusions and supporting evidence have been published (J Clin Oncol 2016;34:4431-4442). The Panel unanimously agreed that PMRT reduces the risks of local-regional failure (LRF), any recurrence, and breast cancer mortality for patients with T1-2 breast cancer with 1-3 positive axillary nodes. However, some subsets of these patients are likely to have such a low risk of LRF that the absolute benefit of PMRT is outweighed by its potential toxicities. The Panel however could not find sufficient evidence to recommend a specific formula or method of how to combine clinical, pathologic, and biologic data to calculate the risk of LRF. In addition, the acceptable ratio of benefit to toxicity varies among patients and physicians. Thus, the decision to recommend PMRT or not requires a great deal of clinical judgement. The Panel agreed clinicians making such recommendations for an individual patient should consider factors that may decrease the risk of LRF, attenuate the benefit of reduced breast cancer-specific mortality, and/or increase the risks of complications from PMRT. When clinicians and patients elect to omit axillary dissection after a positive sentinel node biopsy, the Panel recommended that these patients receive PMRT only if there is already sufficient information to justify its use without needing to know that additional axillary nodes are involved. Patients with axillary nodal involvement following neoadjuvant systemic therapy should receive PMRT. The role of PMRT in other patients with clinical Stage I or II breast cancer is uncertain. Finally, the Panel recommended that radiation therapy generally be given to both the internal mammary nodes and the supraclavicular-axillary apical nodes in addition to the chest wall or reconstructed breast when PMRT is used. However, there may be subgroups that will have limited, if any, benefits from treating both these nodal areas compared to treating only one of them or, perhaps, treating only the chest wall or reconstructed breast. There is insufficient evidence at this time to define such subgroups in detail. This lecture will address selected elements of the data leading to the Panel's decisions. Citation Format: Recht A. Guidelines for postmastectomy radiotherapy [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr ES1-2.

Background Despite growing utilization of accelerated partial breast irradiation using brachytherapy (APBI-Brachy) for elderly breast cancer patients, there are limited data from randomized Phase III trials to support its routine use. This study uses population-based data to examine whether APBI-Brachy results in comparable survival rates compared with whole breast irradiation (WBI). Methods A sample of 29,647 female patients diagnosed with nonmetastatic breast cancer in 2002–2007 treated with breast-conserving surgery and radiotherapy was identified in the Surveillance, Epidemiology, and End Results Program-Medicare data set. Log-rank tests, Cox proportional hazards models, instrumental variable analysis, and subgroup analysis were used to study the comparative effectiveness of APBI-Brachy and WBI. Results During a median followup of 3.6 and 4.8 years, 123 (7.7%) and 3438 (13.6%) patients died after APBI-Brachy and WBI, respectively. Recurrence-free survival ( p = 0.9711) and overall survival rates ( p = 0.0551) did not differ significantly between the two radiation modalities. After accounting for tumor characteristics, patient characteristics, community factors, and comorbidities, the recurrence-free survival (hazard ratio, 1.05; 95% confidence interval, 0.90–1.23; p = 0.5125) and overall survival (hazard ratio, 0.87; 95% confidence interval, 0.72–1.04; p = 0.1332) rates were still not significantly different between patients treated with APBI-Brachy and WBI. Conclusion Partial breast brachytherapy and WBI resulted in similar recurrence-free and overall survival rates in this cohort of elderly breast cancer patients, even after adjustment for the more favorable characteristics of patients in the former group. These findings will need to be confirmed by the randomized trials comparing these modalities.

BACKGROUND: Stereotactic body radiotherapy (SBRT) is an alternative to surgery for clinical stage I non–small cell lung cancer (NSCLC), but comparing its effectiveness is difficult because of differences in patient selection and staging. METHODS: Two databases were combined which contained patients treated from 1999 to 2008 by lobectomy (LR, n 5132), sublobar resection (SLR, n 548), and SBRT (n 5137) after negative staging. Univariate and multivariate analysis were performed for survival (OS), total recurrence control (TRC comprises local-regional and distant control), and locoregional control (LRC) in our entire population. A matchedpair analysis was also performed that compared surgery and SBRT results. Median follow-up for the entire study population was 25.8 months. RESULTS: On univariate analysis, OS was significantly worse with SBRT and also correlated with histology, the Charlson comorbidity index, tumor size, and aspirin use; TRC correlated only with histology; and no variable significantly correlated with LRC. OS was significantly poorer for SBRT in the matched-pair analysis than for patients treated with surgery, but TRC and LRC were not significantly different between these groups. Multivariate analyses including propensity score as a covariate (controlling for all factors affecting treatment selection) found that OS correlated only with Charlson comorbidity index, and TRC correlated only with tumor grade. LRC correlated only with tumor size with or without propensity score correction. CONCLUSIONS: This retrospective study has demonstrated similar OS, LRC, and TRC with SBRT or surgery after controlling for prognostic and patient selection factors. Randomized clinical trials are needed to better compare the effectiveness of these treatments. Cancer 2013;119:2683–91. V C 2013 American Cancer Society.

Recent data suggest that axillary lymph node dissection (ALND) may be unnecessary for patients with positive sentinel lymph node biopsy (SLNB) receiving whole-breast irradiation (ACOSOG Z0011). The purpose of this study was to use decision analysis with simulated patients to determine subgroups with positive SLNB who may still benefit from ALND. We performed a decision analysis simulating axillary recurrence (ALR) risk, lymphedema, and quality of life following breast-conserving surgery (BCS) with positive SLNB and either completion ALND and whole-breast radiation (ALND + BRT) or breast radiation (BRT) alone. Simulated patients were divided into two risk groups based on the likelihood of disease in non-sentinel axillary nodes after positive SLNB: those with risk 30-60 % ("high-risk") and those with risk under 30 % ("low-risk," similar to average Z0011 patients). In simulated patients aged 55, BRT alone resulted in 1 month of additional QALE in the low-risk group versus ALND + BRT, while ALND + BRT resulted in 9.7 months of additional QALE in the high-risk group versus BRT alone. Overall survival was similar at 5 years in this simulation with either treatment in both groups, but ALND + BRT was superior to BRT alone at 20 years in the high-risk group (42 vs. 38 %). In the low-risk group, BRT alone is preferable unless ALR risk with BRT is greater than 1.6 % or lymphedema risk with ALND is under 10 %. Patients eligible for Z0011 but at a higher risk of residual nodal disease following BCS and positive SLNB may benefit from ALND + BRT, rather than BRT alone.

Purpose To examine characteristics of medical malpractice claims involving radiation oncologists closed during a 10-year period. Methods and Materials Malpractice claims filed against radiation oncologists from 2003 to 2012 collected by a nationwide liability insurance trade association were analyzed. Outcomes included the nature of claims and indemnity payments, including associated presenting diagnoses, procedures, alleged medical errors, and injury severity. We compared the likelihood of a claim resulting in payment in relation to injury severity categories (death as referent) using binomial logistic regression. Results There were 362 closed claims involving radiation oncology, 102 (28%) of which were paid, resulting in $38 million in indemnity payments. The most common alleged errors included "improper performance" (38% of closed claims, 18% were paid; 29% [$11 million] of total indemnity), "errors in diagnosis" (25% of closed claims, 46% were paid; 44% [$17 million] of total indemnity), and "no medical misadventure" (14% of closed claims, 8% were paid; less than 1% [$148,000] of total indemnity). Another physician was named in 32% of claims, and consent issues/breach of contract were cited in 18%. Claims for injury resulting in death represented 39% of closed claims and 25% of total indemnity. "Improper performance" was the primary alleged error associated with injury resulting in death. Compared with claims involving death, major temporary injury (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.29-5.85, P =.009), significant permanent injury (OR 3.1, 95% CI 1.48-6.46, P =.003), and major permanent injury (OR 5.5, 95% CI 1.89-16.15, P =.002) had a higher likelihood of a claim resulting in indemnity payment. Conclusions Improper performance was the most common alleged malpractice error. Claims involving significant or major injury were more likely to be paid than those involving death. Insights into the nature of liability claims against radiation oncologists may help direct efforts to improve quality of care and minimize the risk of being sued.

The American Society of Clinical Oncology guideline for the use of postmastectomy radiotherapy (PMRT) was published in 2001. This update of that guideline, completed in collaboration with the American Society for Radiation Oncology and the Society of Surgical Oncology, focuses on key areas of ongoing controversy, including the use of PMRT for patients with one to three positive lymph nodes, use of PMRT for patients undergoing neoadjuvant systemic therapy, and selected technical aspects of PMRT, particularly the extent of regional nodal irradiation. The question of whether PMRT is indicated in women with T1-2 tumors and a positive sentinel node biopsy who do not undergo completion axillary lymph node dissection is also discussed.

Purpose A joint American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology panel convened to develop a focused update of the American Society of Clinical Oncology guideline concerning use of postmastectomy radiotherapy (PMRT). Methods A recent systematic literature review by Cancer Care Ontario provided the primary evidentiary basis. The joint panel also reviewed targeted literature searches to identify new, potentially practice-changing data. Recommendations The panel unanimously agreed that available evidence shows that PMRT reduces the risks of locoregional failure (LRF), any recurrence, and breast cancer mortality for patients with T1-2 breast cancer with one to three positive axillary nodes. However, some subsets of these patients are likely to have such a low risk of LRF that the absolute benefit of PMRT is outweighed by its potential toxicities. In addition, the acceptable ratio of benefit to toxicity varies among patients and physicians. Thus, the decision to recommend PMRT requires a great deal of clinical judgment. The panel agreed clinicians making such recommendations for individual patients should consider factors that may decrease the risk of LRF, attenuate the benefit of reduced breast cancer–specific mortality, and/or increase risk of complications resulting from PMRT. When clinicians and patients elect to omit axillary dissection after a positive sentinel node biopsy, the panel recommends that these patients receive PMRT only if there is already sufficient information to justify its use without needing to know additional axillary nodes are involved. Patients with axillary nodal involvement after neoadjuvant systemic therapy should receive PMRT. The panel recommends treatment generally be administered to both the internal mammary nodes and the supraclavicular-axillary apical nodes in addition to the chest wall or reconstructed breast.