PD 17 - Breast 4 -Poster Discussion
1144 - Final Results of Phase I Study of Prophylactic Nipple-Areola Complex Radiation Therapy After Nipple Sparing Mastectomy and Immediate Reconstruction for Breast Cancer or DCIS Patients
Wednesday, October 24
1:30 PM - 1:36 PM
Location: Room 217 A/B
Cristiane Takita, MD, MBA
University of Miami Miller School of Medicine: Assistant Professor, Hematology/Oncology Division: Employee, Professor of Clinical Radiation Oncology, Residency Program Director: Employee
University of Miami Miller School of Medicine: Professor,Residency Program Director
Final Results of Phase I Study of Prophylactic Nipple-Areola Complex Radiation Therapy After Nipple Sparing Mastectomy and Immediate Reconstruction for Breast Cancer or DCIS Patients
C. Takita1, I. M. Reis2, D. Yakoub3, Z. Panthaki4, C. Boneti4, W. M. Kassira4, M. Moller3, S. Samuels1, L. M. Freedman5, A. Ahamad6, S. B. Kesmodel3, and E. Avisar3; 1Department of Radiation Oncology, University of Miami / Sylvester Comprehensive Cancer Center, Miami, FL, 2Department of Public Health Sciences, University of Miami/Sylvester C.Cancer Center, Miami, FL, 3Division of Surgical Oncology, University of Miami/Sylvester C. Cancer Center, Miami, FL, 4Division of Plastic Surgery, University of Miami/Sylvester C. Cancer Center, Miami, FL, 5Department of Radiation Oncology, University of Miami /Sylvester C. Cancer Center, Deerfield Satellite, Miami, FL, 6Department of Radiation Oncology, University of Miami/Lennar Medical Foundation, Coral Gables, FL
Purpose/Objective(s): Nipple sparing mastectomy (NSM) has been used in highly selected patients with low risk breast cancer (BC) or DCIS, located at least 2 cm from the nipple, without nipple involvement. NSM is associated with higher patient satisfaction and better psychological outcome compared to skin sparing mastectomy. However, it is still a controversial option for early stage BC due to concerns of its oncological safety. This phase I study assesses safety and feasibility of delayed prophylactic nipple-areola complex (NAC) radiotherapy (RT) after NSM and immediate reconstruction for BC or DCIS patients, expanding the indications of NSM.
Materials/Methods: Study was approved by institutional IRB. Patients were eligible after confirmed biopsy for invasive BC or DCIS, and planned for mastectomy due to multifocal/multicentric disease, unfavorable correlation between breast and tumor size, tumor up to 1 cm from NAC, or patient’s desire for mastectomy. Patients with a negative shave biopsy of tissue behind the nipple at time of mastectomy were eligible for NSM. Type of immediate reconstruction was performed per plastic surgeon’s preference. RT was delivered within 5 to 8 weeks postoperatively. A 3+3 dose-escalation design was used to test RT doses of 25, 30, 35 Gy in 10 fractions, given BID, 6 hours apart with electrons. Dose-limiting toxicity (DLT) was specified as RT-related NAC loss or any grade 4/5 AE up to 1-month from end of RT. AEs, patient/physician cosmesis assessment, patient reported satisfaction were obtained after surgery and RT follow-up visits (1, 3, 6, 12 months, then yearly).
Results: From 2010-2017, 7 screen failures (due to need for postmastectomy RT) and 19 BC/DCIS patients were enrolled. One patient was excluded and did not receive NAC RT, due to bilateral NAC loss 2 weeks postoperatively. 18 patients completed the study, 6 per dose level: 3 pStage 0 (TisN0M0), 14 pStage I (T1N0M0), 1 pStage IIA (T1N1M0); median F/U was 20 months (range: 23-53.6). There was no RT-related DLT or grade 4/5 AEs (G1=73, G2=15, G3=6); 6 Grade 3 AEs in 2 patients, all related to surgery (infection, allergy to tape, pain). RT dermatitis was the most common AE (G1=28). One patient had RT recall grade 2 one month after RT. Patient reported satisfaction with treatment was high, with 94% of patients would choose this option again. Patient's assessment of cosmesis was better than of physician’s at the most recent visit, scoring excellent (67% vs. 39%) and good (28% vs. 61%) respectively. No recurrence was identified.
Conclusion: Prophylactic NAC RT was safe and feasible after NSM with immediate reconstruction in this selected cohort of patients. Most patients would choose this treatment again. Patient's assessment of cosmesis was superior than of physician's. An expansion of the last dose cohort is under way to confirm above findings.
Author Disclosure: C. Takita: Employee; University of Miami Miller School of Medicine. Professor,Residency Program Director; University of Miami Miller School of Medicine. I.M. Reis: None. Z. Panthaki: None. W.M. Kassira: None. S. Samuels: None. L.M. Freedman: None.