Real-World Experience with Vismodegib on Advanced and Multiple BCCs: Data from the RELIVIS Study.

BACKGROUND: Vismodegib is approved for advanced cases of basal cell carcinomas not amenable to surgery or radiotherapy. Large studies on the use of vismodegib in clinical practice are scarce. OBJECTIVES: The main objective of the study was to analyse the evolution and therapeutic management of relapses and lack of response in patients who had received vismodegib for locally advanced and/or multiple basal cell carcinomas in a real-life multicentre setting. METHODS: This nationwide retrospective study collected data on patients treated with vismodegib in 15 specialized centres. We included patients who first received vismodegib until intolerable toxicity, maximum response, or progressive disease. Exploratory research variables referred to patient and tumour characteristics, vismodegib effectiveness and safety, relapse rate and management, and mortality. A multivariable logistic regression model was used to identify predictors of complete clinical response. RESULTS: 133 patients with advanced BCC were included in the registry. The objective response rate (ORR) was 77.5% and nearly half of the patients (45.9%) achieved complete remission. Long-term information and detailed information of subsequent treatments after a regime of vismodegib was available for 115 patients. Only 34% of the patients in this group were subsequently treated with other therapies or vismodegib rechallenge. Sixty-nine percent of the patients who had shown a complete remission with vismodegib remained free of recurrence while 30.7% relapsed. Almost half of the patients who received additional therapies after the first course of vismodegib achieved complete tumour remission. Three and 2 out of 9 patients who were rechallenged with vismodegib achieved complete and partial responses, respectively, with an ORR of 55.5%. CONCLUSION: Our study confirms efficacy of vismodegib in routine clinical practice. The risk of recurrence after achieving complete response with vismodegib was lower than previous reports. Rechallenge with vismodegib is feasible and most patients responded to re-treatment.

Integra as Firstline Treatment for Scalp Reconstruction in Elderly Patients.

PURPOSE: Large scalp defects pose a reconstructive problem especially in elderly patients. The purpose of the study is to describe our experience of oncologic scalp reconstruction using a dermal matrix (Integra). MATERIAL AND METHODS: We conducted a retrospective cohort study (January 2007 to March 2021) of patients who had undergone scalp tumor excision and reconstruction using Integra and a split-thickness skin graft (STSG). The primary end point was Integra and STSG success (defined by ≥75% percent take) and the secondary end point was postoperative complications. Both end points were assessed by the surgeon during follow-up. Demographic data, tumor characteristics, average defect size, time between stages and full-thickness scalp defects were characterized using descriptive statistics. Univariate and multivariate logistic regression models were used to evaluate the association between variables and end points. RESULTS: The sample included 70 patients with a mean (SD) age of 83.3 (7.0) years, 75.7% men and 92.9% with comorbidities. Mean (SD) defect area was 23 (17.0) cm2 and the mean (SD) first-to-second phase interval was 30.6 (8.4) days. Sixty-four patients (91.4%) underwent outpatient surgery. Integra and STSG success rates were 87.1% (95% CI: 77.69 to 93.74%) and 100%, respectively. The complications rate was 18.6% (95% CI: 9 to 28%). Mean (SD) follow-up was 18 (16.7) months. Univariate and multivariate logistic regression analysis showed no association between variables and the primary and secondary end points. CONCLUSIONS: Reconstruction of oncologic scalp defects using Integra can be performed under sedation and local anesthesia. Integra should be considered as firstline treatment for the reconstruction of scalp defects in elderly patients with comorbidities, given the low postoperative major complications rate and Integra and STSG take success.