Abstract 812P
Background
Nivolumab, pembrolizumab, and dabrafenib plus trametinib are registered as adjuvant melanoma treatments since 2018. Randomized controlled trial results may not fully represent the benefits and risks of treatments in clinical practice. Therefore, the aim of this study was to evaluate real world experience with text-mining software on tolerability, safety and efficacy in patients treated for adjuvant melanoma.
Methods
Adult melanoma patients receiving adjuvant treatment between January 2019 and October 2021 in the Leiden University Medical Center, The Netherlands, were included. We retrospectively identified patients and collected data from electronic health records with text-mining software CTcue.
Results
A total of 122 patients were included: 55 patients treated with nivolumab (N), 48 with pembrolizumab (P), and 20 with dabrafenib plus trametinib (D+T). We found a significant difference in the reason to stop treatment (P-value = 0.0238): 48 (39%) patients completed their scheduled treatment (N: 22 (40%), P: 20 (42%), D+T: 6 (30%)); 20 (16%) patients had treatment-limiting toxicity (N: 9 (16%), P: 3 (6%), D+T: 8 (40%)), and recurrence was treatment-limiting in 28 (23%) patients (N: 15 (27%), P: 12 (25%), D+T: 1 (5%)). Treatment-limiting toxicity from D+T was primarily a combination of adverse events (AEs) including pyrexia and fatigue, which are mainly reversible. Most treatment-limiting AEs from immunotherapy were immune-related. The 1-year recurrence-free survival was 70.3% (95% CI: 58.1–85.0) with nivolumab, 72.4% (95% CI: 60–87.3) with pembrolizumab, and 83.0% (95% CI: 67.1–100) with D+T.
Conclusions
Adjuvant immunotherapy was better tolerated than D+T, comparable to data from clinical trials. Specifically for BRAF+-patients, physicians must weigh the higher risk of reversible treatment-limiting AEs of D+T against the risk of long-term immune-related AEs. For conclusions on efficacy, a longer follow-up period is needed.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Novartis.
Disclosure
S. van Laar: Financial Interests, Institutional, Funding: Novartis. E. Kapiteijn: Financial Interests, Institutional, Advisory Role: Bristol Myers Squibb, Novartis, Merck, Pierre Fabre; Financial Interests, Institutional, Research Grant, not related to this paper: Bristol Myers Squibb, Pierre Fabre. J. Zwaveling: Financial Interests, Institutional, Funding: Novartis. All other authors have declared no conflicts of interest.