PMID- 33402121 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20210514 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 21 IP - 1 DP - 2021 Jan 5 TI - Comparative efficacy and safety of adjuvant nivolumab versus other treatments in adults with resected melanoma: a systematic literature review and network meta-analysis. PG - 3 LID - 10.1186/s12885-020-07538-1 [doi] LID - 3 AB - BACKGROUND: Immune checkpoint inhibitors and targeted therapies are approved for adjuvant treatment of patients with resected melanoma; however, they have not been compared in randomized controlled trials (RCTs). We compared the efficacy and safety of adjuvant nivolumab with other approved treatments using available evidence from RCTs in a Bayesian network meta-analysis (NMA). METHODS: A systematic literature review was conducted through May 2019 to identify relevant RCTs evaluating approved adjuvant treatments. Outcomes of interest included recurrence-free survival (RFS)/disease-free survival (DFS), distant metastasis-free survival (DMFS), all-cause grade 3/4 adverse events (AEs), discontinuations, and discontinuations due to AEs. Time-to-event outcomes (RFS/DFS and DMFS) were analyzed both assuming that hazard ratios (HRs) are constant over time and that they vary. RESULTS: Of 26 identified RCTs, 19 were included in the NMA following a feasibility assessment. Based on HRs for RFS/DFS, the risk of recurrence with nivolumab was similar to that of pembrolizumab and lower than that of ipilimumab 3 mg/kg, ipilimumab 10 mg/kg, or interferon. Risk of recurrence with nivolumab was similar to that of dabrafenib plus trametinib at 12 months, however, was lower beyond 12 months (HR [95% credible interval] at 24 months, 0.46 [0.27-0.78]; at 36 months, 0.28 [0.14-0.59]). Based on HRs for DMFS, the risk of developing distant metastases was lower with nivolumab than with ipilimumab 10 mg/kg or interferon and was similar to dabrafenib plus trametinib. CONCLUSION: Adjuvant therapy with nivolumab provides an effective treatment option with a promising risk-benefit profile. FAU - Toor, Kabirraaj AU - Toor K AD - Precision HEOR, 1505 West 2nd Avenue, Vancouver, BC, V6H 3Y4, Canada. kabirraaj.toor@precisionvh.com. FAU - Middleton, Mark R AU - Middleton MR AD - University of Oxford, Old Road Campus Research Building, Roosevelt Drive, Oxford, OX3 7DQ, UK. FAU - Chan, Keith AU - Chan K AD - Precision HEOR, 1505 West 2nd Avenue, Vancouver, BC, V6H 3Y4, Canada. FAU - Amadi, Adenike AU - Amadi A AD - Bristol Myers Squibb, Unit 2 Uxbridge Business Park, Uxbridge, UB8 1DH, UK. FAU - Moshyk, Andriy AU - Moshyk A AD - Bristol Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA. FAU - Kotapati, Srividya AU - Kotapati S AD - Bristol Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA. LA - eng GR - Not applicable/Bristol-Myers Squibb Company/ PT - Comparative Study PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20210105 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Imidazoles) RN - 0 (Ipilimumab) RN - 0 (Oximes) RN - 0 (Pyridones) RN - 0 (Pyrimidinones) RN - 31YO63LBSN (Nivolumab) RN - 33E86K87QN (trametinib) RN - DPT0O3T46P (pembrolizumab) RN - QGP4HA4G1B (dabrafenib) SB - IM MH - Antibodies, Monoclonal, Humanized/administration & dosage MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Bayes Theorem MH - Disease-Free Survival MH - Humans MH - Imidazoles/administration & dosage MH - Ipilimumab/administration & dosage MH - Melanoma/*drug therapy MH - Nivolumab/administration & dosage MH - Oximes/administration & dosage MH - Patient Safety MH - Pyridones/administration & dosage MH - Pyrimidinones/administration & dosage PMC - PMC7784366 OTO - NOTNLM OT - Adjuvant treatment OT - Efficacy OT - Network meta-analysis OT - Nivolumab OT - Safety OT - Systematic literature review COIS- KT and KC are employees of Precision HEOR, which received funding from Bristol Myers Squibb for the current work. MRM has served as an advisor to Amgen, Array Biopharma, BiolineRx, Bristol Myers Squibb, GlaxoSmithKline, Immunocore, Kineta, Novartis, Rigontec, Roche, and Silicon Therapeutics; has received institutional research support from Array Biopharma, AstraZeneca, BiolineRx, Bristol Myers Squibb, Eisai, GlaxoSmithKline, Immunocore, Merck, Merck Sharp & Dohme, Millenium, Novartis, Pfizer, Regeneron, Replimune, Rigontec, and Roche; has received travel support from Immunocore, Merck, Merck Sharp & Dohme, and Replimune; and is a member of an independent data safety monitoring committee for Eisai and Merck/Merck Sharp & Dohme. AA and AM are employees of and stockholders in Bristol Myers Squibb. SK is an employee of Bristol Myers Squibb. EDAT- 2021/01/07 06:00 MHDA- 2021/05/15 06:00 PMCR- 2021/01/05 CRDT- 2021/01/06 05:29 PHST- 2020/07/02 00:00 [received] PHST- 2020/10/16 00:00 [accepted] PHST- 2021/01/06 05:29 [entrez] PHST- 2021/01/07 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2021/01/05 00:00 [pmc-release] AID - 10.1186/s12885-020-07538-1 [pii] AID - 7538 [pii] AID - 10.1186/s12885-020-07538-1 [doi] PST - epublish SO - BMC Cancer. 2021 Jan 5;21(1):3. doi: 10.1186/s12885-020-07538-1.