Background: Both immunotherapy (IO) and targeted therapy, specifically dabrafenib + trametinib (DT), are recommended by the NCCN guidelines for the management of BRAF+ cutaneous melanoma in the adjuvant setting. However, data surrounding their use in the real-world setting is scarce. Objective: To examine treatment patterns and outcomes among BRAF+ cutaneous melanoma patients treated with adjuvant IO or DT in the United States. Methods: This was a retrospective cohort study using electronic health records from the Novartis BRAF+ cutaneous meLanoma patients ObsErvational (NOBLE) database. Patients (18+ years) diagnosed with resectable American Joint Committee on Cancer stage IIIA to IIID cutaneous melanoma who received first-line (1L) adjuvant DT or IO (nivolumab or pembrolizumab monotherapy) treatment following successful tumor resection on or after Jan/01/2014 were followed until death, loss of follow-up, metastatic diagnosis, or data cut-off date (Aug/30/2020), whichever occurred earliest. Kaplan–Meier curves were used to analyze recurrence-free survival (RFS) and overall survival (OS). Results: Among the 318 included patients, 215 (68%) received nivolumab, 58 (18%) received DT, and 45 (14%) received pembrolizumab as 1L therapy. The median time from diagnosis to 1L initiation was 93 days, 99 days, and 115 days, respectively. The median treatment duration was 292 days for nivolumab, 115 days for DT, and 147 days for pembrolizumab (p <0.001). In the IO cohort, 7% of nivolumab patients and 9% of pembrolizumab patients discontinued treatment and were started on IO or DT. In the DT cohort, 19% of patients discontinued therapy and started on IO therapy. The median RFS was 34.6 months for pembrolizumab and was not reached for DT or nivolumab (Figure 1). The 1-year and 2-year rate of RFS in DT, nivolumab, pembrolizumab were 87.5%, 80.2%, 86.2%, and 66.2%, 70.7%, 68.6%, respectively. The median OS was 38.1 months for those receiving pembrolizumab and was not reached for patients receiving DT or nivolumab. The 1-year and 2-year rate of OS in DT, nivolumab, pembrolizumab were 99.9%, 94.9%, 80.0%, and 76.6%, 81.1%, 70.0%, respectively. No significant differences were observed in RFS or OS among patients received different treatments (all p >0.05). Conclusions: Patients on DT had a lower median treatment duration compared with those on IO. Outcomes with DT and IO in the adjuvant setting were comparable for patients with resected BRAF-mutated cutaneous melanoma.
Recurrence-free survival with 1L DT or IO as adjuvant therapy for BRAF + melanoma
Citation: Journal of the National Comprehensive Cancer Network 20, 3.5; 10.6004/jnccn.2021.7225
