Τίτλος:
Five-year outcomes with nivolumab in patients with wild-type BRAF advanced melanoma
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
PURPOSE The CheckMate 066 trial investigated nivolumab monotherapy as first-line treatment for patients with previously untreated BRAF wild-type advanced melanoma. Five-year results are presented herein. PATIENTS AND METHODS In this multicenter, double-blind, phase III study, 418 patients with previously untreated, unresectable, stage III/IV, wild-type BRAF melanoma were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or dacarbazine 1,000 mg/m2 every 3 weeks. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. RESULTS Patients were followed for a minimum of 60 months from the last patient randomly assigned (median follow-up, 32.0 months for nivolumab and 10.9 months for dacarbazine). Five-year OS rates were 39% with nivolumab and 17% with dacarbazine; PFS rates were 28% and 3%, respectively. Five-year OS was 38% in patients randomly assigned to dacarbazine who had subsequent therapy, including nivolumab (n 5 37). ORR was 42% with nivolumab and 14% with dacarbazine; among patients alive at 5 years, ORR was 81% and 39%, respectively. Of 42 patients treated with nivolumab who had a complete response (20%), 88% (37 of 42) were alive as of the 5-year analysis. Among 75 nivolumab-treated patients alive and evaluable at the 5-year analysis, 83% had not received subsequent therapy; 23% were still on study treatment, and 60% were treatment free. Safety analyses were similar to the 3-year report. CONCLUSION Results from this 5-year analysis confirm the significant benefit of nivolumab over dacarbazine for all end points and add to the growing body of evidence supporting long-term survival with nivolumab monotherapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies. © 2020 by American Society of Clinical Oncology
Συγγραφείς:
Robert, C.
Long, G.V.
Brady, B.
Dutriaux, C.
Di Giacomo, A.M.
Mortier, L.
Rutkowski, P.
Hassel, J.C.
McNeil, C.M.
Kalinka, E.A.
Lebbé, C.
Charles, J.
Hernberg, M.M.
Savage, K.J.
Chiarion-Sileni, V.
Mihalcioiu, C.
Mauch, C.
Arance, A.
Cognetti, F.
Ny, L.
Schmidt, H.
Schadendorf, D.
Gogas, H.
Zoco, J.
Re, S.
Ascierto, P.A.
Atkinson, V.
Περιοδικό:
Journal of Clinical Oncology
Εκδότης:
American Society of Clinical Oncology
Λέξεις-κλειδιά:
amylase; B Raf kinase; dacarbazine; nivolumab; pembrolizumab; placebo; programmed death 1 ligand 1; triacylglycerol lipase; alkylating agent; B Raf kinase; BRAF protein, human; dacarbazine; immunological antineoplastic agent; nivolumab, adult; advanced cancer; adverse event; amylase blood level; Article; cancer immunotherapy; cancer patient; cancer staging; clinical feature; clinical outcome; controlled study; double blind procedure; drug safety; drug withdrawal; fatigue; follow up; human; human tissue; major clinical study; melanoma; monotherapy; multicenter study; overall survival; phase 3 clinical trial; post treatment survival; priority journal; progression free survival; pruritus; randomized controlled trial; treatment duration; treatment response; triacylglycerol lipase blood level; vitiligo; wild type; clinical trial; enzymology; genetics; melanoma; metabolism; survival rate, Antineoplastic Agents, Alkylating; Antineoplastic Agents, Immunological; Dacarbazine; Humans; Melanoma; Nivolumab; Progression-Free Survival; Proto-Oncogene Proteins B-raf; Survival Rate
DOI:
10.1200/JCO.20.00995
