correlation between emotional-and physical-QOL domains except for correlation between anxiety and saliva at 36 months (r Z 0.665, PZ.018). Conclusion: In our cohort of patients, emotional health improved over time despite decline in physical function. Physical and emotional health are most strongly associated immediately before and after RT but not at later time points. Therefore, resources addressing emotional health should be allocated at earlier time points in the course of treatment.

Background: BCS has been historically associated with a high re-excision rate, driven in part by lack of consensus on what constitutes an adequate negative margin. The SSO-ASTRO consensus guideline on invasive margins defined a negative margin as no ink on tumor based on evidence suggesting that more widely clear margins do not further decrease the risk of recurrence, potentially reducing the need for re-excision. In a large nationwide cohort of breast cancer patients undergoing BCS for invasive breast cancer we evaluate the rates of re-excision following BCS before and after the SSO-ASTRO consensus guidelines were disseminated. Methods: Breast cancer patients undergoing BCS for invasive breast cancer between January 2012 and December 2015 were identified among female beneficiaries in the MarketScan database. Patients receiving chemotherapy before surgery were excluded. Based upon presentation of the guideline recommendations in October 2013, the pre-guideline period was defined from January 2012 to September 2013. On-line publication of the guideline in February 2014 led to definition of the post-guideline period from March 2014 onwards. The peri-guideline period was defined as the time between the pre and post-guideline intervals. Any re-excision or mastectomy within 3 months of initial BCS was identified using ICD-9 or CPT codes. Overall re-excision rates and 95% CI were calculated; groups were compared using X2test. We used a regression model to evaluate the association between pre-peri-post guideline period and re-excision while adjusting for important covariates. Results are expressed as risk ratios (RRs) and 95%CI. Results: A total of 38,573 patients were included (20,159 in the pre-guideline, 4,607 peri-guideline and 13,807 post-guideline). The overall re-excision rate was 23.9% (95%CI 23.4-24.3). The pre-guideline re-excision rate was 25.3% (95%CI 24.7-29.9) compared to 21.6% (95%CI 20.9-22.3] in the post-guideline period. (p<0.001). The rate of mastectomy as the final surgical procedure was 20.2% in the pre-guideline period and 19.1% in the post-guideline (p=0.15). We observed significant geographic variability by state in the decrease of the re-excision rates. No change in re-excision rates was seen in Mississippi, Vermont, Georgia, Oregon, West Virginia, Arkansas, Oklahoma and Tennessee. An absolute decrease greater than 10% in the re-excision rate was observed in Indiana, Nebraska, Alabama, Maine and Nevada. In the multivariable analysis, patients undergoing BCS in the post-guideline period had a statistically significant decrease in the risk of re-excision compared to patients undergoing surgery in the pre-guideline period (RR=0.87; 95%CI 0.84-0.91; p<0.001). Conclusions: There has been a statistically significant decrease in the re-excision rate after BCS associated with the time of the dissemination of the SSO-ASTRO consensus guideline on invasive margins. The wide geographical variation observed suggests differences in the adoption rates. Our study confirms the impact that guidelines have modifying patterns of practice, reducing the frequency of unnecessary surgical interventions. Citation Format: Chavez-MacGregor M, Lei X, Morrow M, Giordano SH. Impact of the SSO-ASTRO consensus guidelines on invasive margins on the re-excision rate among patients undergoing breast conserving surgery (BCS) [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 P2-12-03.

BACKGROUND: Through the International Male Breast Cancer Program, a prospective registry for male BC was created with the goals of evaluating 1) the clinical and biological features of this disease and 2) assessing feasibility of a prospective therapeutic clinical trial. METHODS: All men, with any stage histologically proven invasive breast cancer, age 3 18 years, and newly presenting at the participating institutions (within 3 months prior) were eligible. Patients were enrolled for 30 months after activation of the first center, through February 2017. Per the study design, if <100 men enrolled, the study would be considered a failure and therapeutic trials would not be pursued through this network. Epidemiologic data, staging, pathologic features, and BRCA status were collected. Treatment and outcome data collection is ongoing. Optional collection of FFPE tumor samples, blood, and QOL were performed in the US, the Netherlands, and Latin America. Clinical database lock for this report was May 30, 2017. We currently report patient and disease characteristics and will update with patterns of treatment for the presentation. Outcomes and biological samples will be analyzed in the future. RESULTS: 557 patients were enrolled: 75% in Europe, 20% in United States, 5% in other countries. 6.3% of patients had missing forms. Median age was 67 years (range 26-92). 93% were diagnosed 2010-2017. Among patients with complete data, 79% presented with a breast mass. 88% were M0 and 12% M1. Among M0 patients: 47%, 39%, 2%, and 11% had T1, T2, T3, and T4 disease respectively; 52% were N0. Overall, 98% had ER+ disease and 11% had HER2+ cancer. 14% had grade 1, 56% had grade 2, and 30% had grade 3 tumors. Among 112 men who underwent BRCA1 testing, 1 was positive. Among 118 men who had BRCA2 testing, 18 (15%) were positive. 21% of men had prior or concurrent malignancies, with the following most common sites: prostate, non-melanoma skin, colorectal, and melanoma. The prevalence of previously identified possible risk factors for male breast cancer were: overweight/obesity (72%), former/current smoker (51%), current alcohol 31 drink daily (41%), family history of breast cancer (35%), gynecomastia (16%), history radiation exposure (8%), use of anti-androgens (1%), and use of estrogens (1%). CONCLUSION: Through an international collaborative effort, we were able to prospectively accrue 557 patients to a male breast cancer registry. These results demonstrate feasibility of pursuing a therapeutic clinical trial in men with breast cancer. In addition, this study shows the relatively low uptake of BRCA testing, high rates of concurrent/prior malignancy, and the rates of potentially modifiable risk factors in this patient population. Funding from Breast Cancer Research Foundation, Susan G. Komen, Dutch Pink Ribbon Foundation, Swedish Breast Cancer Association (BRO) and EBCC Council. Citation Format: Giordano SH, Schröder CP, Poncet C, van Leeuwen-Stok E, Linderholm B, Abreu MH, Rubio I, Van Poznak C, Morganstern D, Cameron D, Vleugel MM, Smilde TJ, Bozovic-Spasojevic I, Korde L, Russell NS, den Hoed IDM, Honkoop AH, van der Velden AWG, van 't Riet M, Dijkstra N, Bogler O, Goulioti T, Hilsenbeck S, Ruddy KJ, Wolff A, van Deurzen CHM, Martens J, Bartlett JMS, Aalders K, Tryfonidis K, Cardoso F. Clinical and biological characterization of male breast cancer (BC) EORTC 10085/TBCRC 029/BOOG 2013-02/BIG 2-07: Baseline results from the prospective registry [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 P5-23-01.

Background: Accelerated partial breast brachytherapy (APBI-brachy) is an increasingly popular radiation treatment for older patients diagnosed with early stage breast cancer. Despite growing utilization, there is a lack of population-based cohort studies as well as randomized phase III data to compare its effectiveness and toxicity profile with standard whole breast irradiation (WBI). The purpose of this study was to provide the first nationally comprehensive comparison of effectiveness and toxicity outcomes in older Medicare patients treated with APBI-brachy versus WBI. Methods: Medicare billing claims identified beneficiaries age>66 with incident invasive breast cancers diagnosed between 2000 and 2007 and treated with conservative surgery followed by APBI-brachy alone versus WBI. Cumulative incidence of subsequent mastectomy (a validated surrogate for local failure) was compared between the two treatment groups using the log-rank test. Adjusted risk of subsequent mastectomy was determined using a multivariate Cox proportional hazards model including demographic, socioeconomic, and clinical covariates. Risks of acute complications (hospitalization or infection within 120 days of radiation), were compared using the chi-square test. Adjusted odds of acute complications were determined using multivariate logistic models including covariates. Cumulative incidences of long-term toxicities (rib fracture, fat necrosis, breast pain, and pneumonitis) were compared using the log-rank test. Results: In 130,535 women, use of APBI-brachy increased over time from <1% of patients treated in 2000 to 13% of patients in 2007 (P<0.001 for trend). Patients treated with APBI-brachy were less likely to have axillary lymph node involvement or to have received chemotherapy, and were more likely to be older, White, and have comorbid illness. At 5 years, the cumulative incidence of subsequent mastectomy was significantly higher in patients treated with APBI-brachy (4.0% in APBI-brachy vs. 2.2% in WBI, P<0.001). On multivariate analysis, there was a two-fold increased risk for subsequent mastectomy in patients treated with APBI-brachy (HR= 2.14; 95% CI 1.83−2.52, P<0.001). APBI-brachy was also associated with more acute complications, including a higher risk of hospitalization (9.6% vs. 5.7%; P<0.001) (Adjusted OR= 1.71; 1.58−1.86); and infection (8.1% vs. 4.5%; P<0.001) (Adjusted OR=1.85; 1.69−2.02; P<0.001). APBI-brachy was also associated with higher 5-year cumulative incidence of rib fracture (4.2% vs. 3.6% in WBI), fat necrosis (9.1% vs. 3.7%), and breast pain (14.9% vs. 11.7%) (P<0.001 for all comparisons), but a lower incidence of pneumonitis (0.1% vs. 0.8%, P<0.001). Discussion: APBI-brachy was associated with inferior effectiveness as well as increased acute and late toxicities compared with WBI in this cohort of older breast cancer patients. These data underscore the importance of awaiting mature results of randomized trials designed to prospectively compare these treatments before employing widespread adoption of APBI-brachy as an alternative to WBI in select patients. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr S2-1.