Abstract PD8-07: Does resection of cavity shave margins result in lower positive margin and re-excision rates in patients with stage 0-III breast cancer? Results from a prospective multicenter randomized controlled trial

Abstract

Abstract INTRODUCTION: Routine resection of cavity shave margins has been shown in single center studies to result in a significant reduction in positive margin and re-excision rates. In this prospective multicenter randomized controlled trial, we sought to validate these findings across practice settings. METHODS: Nine centers across the United States, varying in practice setting and patient population, participated in this clinical trial of 398 stage 0-III breast cancer patients undergoing partial mastectomy (with or without resection of selective cavity margins). Participants were stratified by clinical stage and randomized 1:1 to either have routine cavity shave margins resected (“shave”) or not (“no shave”). Randomization group was revealed to the surgeon intraoperatively, after they had completed their standard partial mastectomy and were ready to close. Positive margins were defined as “tumor at ink” for invasive cancer or within 2 mm for ductal carcinoma in situ (DCIS). Adverse events were defined as seromas requiring percutaneous drainage, and/or hematomas or abscesses requiring operative intervention. RESULTS: Median patient age was 65 (range; 29-94). 116 patients had invasive disease, 74 had DCIS, 179 had both, and 29 had no residual cancer at the time of partial mastectomy. The median invasive cancer size was 1.2 cm (range; 0.05-8.00 cm); the median extent of DCIS was 0.9 cm (range; 0.05-6.40 cm). The “shave” and “no shave” groups were well matched at baseline for clinicopathologic and demographic factors. FactorShave (n=197)No Shave (n=201)p-valueAge (years); median (range)67 (36-94)64 (29-89)0.585Race 0.062-- White173 (87.8%)164 (81.6%) -- Black20 (10.2%)33 (16.4%) -- Asian2 (1.0%)2 (1.0%) -- Native American0 (0%)2 (1.0%) -- Unknown/Declined2 (1.0%)0 (0%) Hispanic ethnicity28 (14.2%)32 (15.9%)0.806Invasive tumor size (cm); median (range)1.30 (0.09-8.00)1.20 (0.05-7.50)0.282DCIS extent (cm); median (range)0.80 (0.10-6.40)1.00 (0.05-5.50)0.906Invasive histology 0.556-- Ductal177 (89.8%)186 (92.5%) -- Lobular16 (8.1%)13 (6.5%) -- Mucinous3 (1.5%)2 (1.0%) -- Other1 (0.5%)0 (0%) Neoadjuvant therapy15 (7.6%)19 (9.5%)0.592Palpable tumor57 (28.9%)56 (27.9%)0.825Node positive*24 (16.3%)16 (10.6%)0.175*Of the 298 patients who had lymph nodes evaluated Prior to randomization, positive margin rates were similar in the “shave” and “no shave” groups (38.1% vs. 37.3%, respectively, p=0.918). After randomization, however, those in the “shave” group were significantly less likely than those in the “no shave” group to have positive margins (8.6% vs. 37.3%, respectively, p<0.001). They were also less likely to require re-excision or mastectomy for margin clearance (8.6% vs. 23.9%, p<0.001). There were no significant differences between the two groups in terms of adverse events (p=0.280). Rates of seroma (1.5% vs. 0.5%, p=0.368), hematoma (0.5% vs. 0.5%, p=1.000) and abscess (0.3% vs. 0%, p=0.495) were similar between the “shave” and “no shave” groups, respectively. CONCLUSION: Resection of cavity shave margins significantly reduces positive margin and re-excision rates in patients with stage 0-III breast cancer undergoing partial mastectomy. Citation Format: Chagpar AB, Tsangaris T, Garcia-Cantu C, Howard-McNatt M, Chiba A, Berger AC, Levine E, Gass JS, Gallagher K, Lum SS, Martinez RD, Willis AI, Pandya SV, Brown EA, Fenton A, Mendiola A, Murray M, Haddad V, Solomon NL, Senthil M, Bansil H, Ollila D, Snyder SK, Edmonson D, Lazar M, Namm JP, Li F, Butler M, McGowan NE, Herrera ME, Avitan YP, Yoder B, Dupont E. Does resection of cavity shave margins result in lower positive margin and re-excision rates in patients with stage 0-III breast cancer? Results from a prospective multicenter randomized controlled trial [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 PD8-07.