IMPORTANCEThe outcomes of vismodegib treatment in a relatively large cohort of study participants with periocular locally advanced basal cell carcinoma (POLA-BCC) may guide physicians when considering this treatment.OBJECTIVE To report the outcomes of vismodegib treatment in patients with POLA-BCC in the Safety Events in Vismodegib (STEVIE) study. DESIGN, SETTING, AND PARTICIPANTSThis post hoc subgroup analysis from the STEVIE single-arm, multicenter, open-label cohort study screened all 1215 participants for ocular or periocular involvement and identified 244 participants with POLA-BCC or metastatic BCC. Data for the first STEVIE trial were collected from 167 treatment locations in 36 countries from June 30, 2011, to June 14, 2017. This post hoc analysis was performed from April 1 to August 31, 2019. MAIN OUTCOMES AND MEASURESResponse to treatment and adverse events. RESULTS Ocular or periocular involvement was found in 244 of 1215 STEVIE participants (20.1%), who constituted the analytic sample. The median age of the study participants was 72.0 (interquartile range [IQR], 60.0-82.0]) years, and they included 143 men (58.6%). Locally advanced BCC was diagnosed in 238 of the 244 participants (97.5%) and metastatic BCC, in 6 (2.5%). The median duration of exposure to vismodegib was 40.0 (IQR, 20.0-78.0) weeks, specifically 39.7 (IQR, 19.9-76.0) weeks for POLA-BCC and 92.4 (IQR, 53.2-163.0) weeks for metastatic BCC. Sixty-nine participants (28.3%) sustained serious adverse events (alopecia, muscle spasms, dysgeusia, weight loss, decreased appetite, asthenia, ageusia, nausea, fatigue, and diarrhea). Two hundred thirty-two study participants (95.1%) sustained more than 1 adverse effect. The overall mean (SD) number of drug-related adverse effects per study participant by first adverse event, regardless of the severity, was 5.48 (3.84). Discontinuation of vismodegib treatment owing to an adverse event was recorded in 58 participants (23.8%). During the study, 22 participants (9.0%) died, 70 (28.7%) achieved complete response, and 94 (38.5%) achieved partial response. CONCLUSIONS AND RELEVANCEVismodegib was well tolerated by the study participants with POLA-BCC. The safety of vismodegib treatment according to the STEVIE trial findings is consistent with that reported in previous studies. These data may be helpful when considering vismodegib for patients with POLA-BCC.

Background: Implant-based breast reconstruction is commonly avoided in the setting of radiation therapy, mainly because of risks of capsular contracture. Nevertheless, as breast reconstruction is becoming more available, more patients undergo both implant-based breast reconstruction and radiotherapy. The dilemma is how to manage capsular contracture if it does occur. The goal of this study was to examine the outcome of patients with implant-based breast reconstruction who developed postirradiation capsular contracture and were treated with capsulotomy or capsulectomy, with or without fat grafting. Methods: The authors reviewed charts of patients who developed capsular contracture following alloplastic breast reconstruction followed by radiation therapy, between 2008 and 2018. The surgical treatment methods for capsular contracture were evaluated along with their outcomes. A follow-up of at least 1 year was required. Results: Forty-eight breasts with postirradiation capsular contracture underwent surgical implant exchange with capsular release, of which 15 had combined fat grafting and 33 did not. Overall, 35 breasts (72.9 percent) showed long-term resolution of capsular contracture; 24 underwent a single procedure and 11 required an additional fat grafting procedure. Some patients [six breasts (12.5 percent)] were offered a consecutive round of fat grafting, and some [seven breasts (14.5 percent)] were offered autologous reconstruction because of lack of improvement. Fat grafting increased the success rate by more than 30 percent when it was initially and consecutively used. Conclusions: Postirradiation capsular contracture may be treated successfully by secondary procedures, sustaining implant-based breast reconstruction in over 70 percent of breasts. Fat grafting may elevate resolution rates even further, to 86 percent. Larger prospective studies are required to validate these findings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.