Abstract
Objective Anti-PD-1 has dramatically improved the survival of patients with advanced melanoma. However, there is a lack of data on maintenance of the response after treatment discontinuation. We aimed to evaluate the progression-free survival (PFS) of patients with metastatic melanoma after anti-PD-1 interruption for objective response (OR) or limiting toxicity during clinical trials. Methods All patients with advanced melanoma who stopped single-agent anti-PD-1 antibodies for objective response or toxicity were included between April 2014 and January 2019 in our institution (data cut-off, September 10th, 2019). Clinical and biological factors associated with relapse were studied. Results The median follow-up after introduction of treatment was 36.5 months [4.6–62.4], and the median follow-up after discontinuation of treatment was 15.7 months (2.5–45.1). Out of 65 patients, 28 patients stopped immunotherapy for limiting adverse effects (AEs) (43.1%), 25 for complete response (CR) (38.4%), and 12 for partial response (PR) or long-term stable disease (SD) (18.5%). Twelve patients relapsed (18.5%) after a median time of 9 months [1.9–40.9 months]. Seven relapsed after discontinuation for AEs, 3 after discontinuation for CR, and 2 after discontinuation for PR/SD. The median PFS after therapy discontinuation was not reached. No statistical association was found between recurrence and age, sex, increased LDH, BRAF status, presence of brain metastases, previous treatments, radiotherapy, or time on anti-PD-1 treatment. Conclusion This cohort shows a global recurrence rate of 18.5% and confirms a long-lasting response after anti-PD-1 cessation regardless of the cause of discontinuation.
Highlights
Julie Valentin,1 Thomas Ferte,2 Valerie Dorizy-Vuong,1 Lea Dousset,1,3 Sorilla Prey,1,3 Caroline Dutriaux,1,3 Anne Pham-Ledard,1,4 Marie Beylot-Barry,1,4 and Emilie Gerard 1
We aimed to evaluate the progression-free survival (PFS) of patients with metastatic melanoma after anti-programmed cell death-1 (PD-1) interruption for objective response (OR) or limiting toxicity during clinical trials
After a median follow-up after discontinuation of 15.7 months [2.5–45.1], 81.5% of the patients did not experience a relapse (Figure 2). 25% patients who discontinued for adverse effects (AEs) relapsed after 7.1 months [1.9–40.9], while 16.7% from the partial response (PR)/stable disease (SD) subgroup and 12% from the complete response (CR) subgroup relapsed after 11.9 months [10.9–12.9] and 9.3 months [4–11.8], respectively (Figure 3)
Summary
Anti-PD-1 has dramatically improved the survival of patients with advanced melanoma. there is a lack of data on maintenance of the response after treatment discontinuation. We aimed to evaluate the progression-free survival (PFS) of patients with metastatic melanoma after anti-PD-1 interruption for objective response (OR) or limiting toxicity during clinical trials. Ese missing data are crucial in daily practice, as patients often request to cease therapy after objective response Other concerns emerge, such as the immune-related toxicities management and the benefit-risk ratio of a prolonged treatment or the financial. In the KEYNOTE-001 trial, pembrolizumab duration was set for 2 years or discontinuation after complete response (CR) if patients received treatment for at least 6 months and had received at least 2 treatment infusions after the assessment of CR [7]. In the present real-life study, we aimed to assess the PFS in patients with metastatic melanoma after discontinuation of anti-PD-1 antibodies for objective response (OR) (CR or partial response (PR)), durable stable disease (SD), or for limiting adverse events (AEs). We analysed potential predictive factors associated with relapses
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