BACKGROUND: Recurrence-free survival (RFS) and overall survival (OS) data for adjuvant nivolumab versus placebo (proxy for routine surveillance) in patients with high-risk, resected melanoma are lacking. This post hoc, indirect treatment comparison (ITC) used pooled data from the phase 3 EORTC 18,071 (ipilimumab vs. placebo) and CheckMate 238 (nivolumab vs. ipilimumab) trials to assess RFS and OS with nivolumab versus placebo and the numbers needed to treat (NNT) over 4 years. METHODS: Patients with resected stage IIIB-C cutaneous melanoma (American Joint Committee on Cancer seventh edition) were included. Inverse probability treatment weighting (IPTW) was used to balance baseline characteristics. RFS NNTs were calculated for nivolumab versus ipilimumab and placebo. OS NNTs were calculated for nivolumab versus placebo. To adjust for different post-recurrence treatments, the difference in post-recurrence survival between the two ipilimumab arms was added to OS of the placebo arm. RESULTS: This ITC included 278, 643, and 365 patients treated with nivolumab, ipilimumab, and placebo, respectively. Following IPTW, nivolumab was associated with improved RFS versus placebo (hazard ratio [HR]: 0.49; 95% confidence interval [CI] 0.39-0.61) and ipilimumab (HR: 0.69; 95% CI 0.56-0.85). RFS NNT was 4.2 for nivolumab versus placebo and 8.9 for nivolumab versus ipilimumab. After post-recurrence survival adjustment, weighted 4-year OS rates were 75.8% for nivolumab and 64.1% for placebo; OS NNT for nivolumab versus placebo was 8.5. CONCLUSIONS: In patients with resected stage IIIB-C cutaneous melanoma in this ITC, nivolumab improved RFS versus placebo and ipilimumab, and OS versus placebo after post-recurrence survival adjustment.
BACKGROUND: Recurrence-free survival (RFS) and overall survival (OS) data for adjuvant nivolumab versus placebo (proxy for routine surveillance) in patients with high-risk, resected melanoma are lacking. This post hoc, indirect treatment comparison (ITC) used pooled data from the phase 3 EORTC 18,071 (ipilimumab vs. placebo) and CheckMate 238 (nivolumab vs. ipilimumab) trials to assess RFS and OS with nivolumab versus placebo and the numbers needed to treat (NNT) over 4 years. METHODS: Patients with resected stage IIIB-C cutaneous melanoma (American Joint Committee on Cancer seventh edition) were included. Inverse probability treatment weighting (IPTW) was used to balance baseline characteristics. RFS NNTs were calculated for nivolumab versus ipilimumab and placebo. OS NNTs were calculated for nivolumab versus placebo. To adjust for different post-recurrence treatments, the difference in post-recurrence survival between the two ipilimumab arms was added to OS of the placebo arm. RESULTS: This ITC included 278, 643, and 365 patients treated with nivolumab, ipilimumab, and placebo, respectively. Following IPTW, nivolumab was associated with improved RFS versus placebo (hazard ratio [HR]: 0.49; 95% confidence interval [CI] 0.39-0.61) and ipilimumab (HR: 0.69; 95% CI 0.56-0.85). RFS NNT was 4.2 for nivolumab versus placebo and 8.9 for nivolumab versus ipilimumab. After post-recurrence survival adjustment, weighted 4-year OS rates were 75.8% for nivolumab and 64.1% for placebo; OS NNT for nivolumab versus placebo was 8.5. CONCLUSIONS: In patients with resected stage IIIB-C cutaneous melanoma in this ITC, nivolumab improved RFS versus placebo and ipilimumab, and OS versus placebo after post-recurrence survival adjustment.
Authors: Alexander M M Eggermont; Vanna Chiarion-Sileni; Jean-Jacques Grob; Reinhard Dummer; Jedd D Wolchok; Henrik Schmidt; Omid Hamid; Caroline Robert; Paolo A Ascierto; Jon M Richards; Céleste Lebbé; Virginia Ferraresi; Michael Smylie; Jeffrey S Weber; Michele Maio; Cyril Konto; Axel Hoos; Veerle de Pril; Ravichandra Karra Gurunath; Gaetan de Schaetzen; Stefan Suciu; Alessandro Testori Journal: Lancet Oncol Date: 2015-03-31 Impact factor: 41.316
Authors: C M Balch; A C Buzaid; S J Soong; M B Atkins; N Cascinelli; D G Coit; I D Fleming; J E Gershenwald; A Houghton; J M Kirkwood; K M McMasters; M F Mihm; D L Morton; D S Reintgen; M I Ross; A Sober; J A Thompson; J F Thompson Journal: J Clin Oncol Date: 2001-08-15 Impact factor: 44.544
Authors: Alexander M M Eggermont; Vanna Chiarion-Sileni; Jean-Jacques Grob; Reinhard Dummer; Jedd D Wolchok; Henrik Schmidt; Omid Hamid; Caroline Robert; Paolo A Ascierto; Jon M Richards; Céleste Lebbé; Virginia Ferraresi; Michael Smylie; Jeffrey S Weber; Michele Maio; Lars Bastholt; Laurent Mortier; Luc Thomas; Saad Tahir; Axel Hauschild; Jessica C Hassel; F Stephen Hodi; Corina Taitt; Veerle de Pril; Gaetan de Schaetzen; Stefan Suciu; Alessandro Testori Journal: N Engl J Med Date: 2016-10-07 Impact factor: 91.245
Authors: Jeffrey Weber; Mario Mandala; Michele Del Vecchio; Helen J Gogas; Ana M Arance; C Lance Cowey; Stéphane Dalle; Michael Schenker; Vanna Chiarion-Sileni; Ivan Marquez-Rodas; Jean-Jacques Grob; Marcus O Butler; Mark R Middleton; Michele Maio; Victoria Atkinson; Paola Queirolo; Rene Gonzalez; Ragini R Kudchadkar; Michael Smylie; Nicolas Meyer; Laurent Mortier; Michael B Atkins; Georgina V Long; Shailender Bhatia; Celeste Lebbé; Piotr Rutkowski; Kenji Yokota; Naoya Yamazaki; Tae M Kim; Veerle de Pril; Javier Sabater; Anila Qureshi; James Larkin; Paolo A Ascierto Journal: N Engl J Med Date: 2017-09-10 Impact factor: 91.245
Authors: Georgina V Long; Axel Hauschild; Mario Santinami; Victoria Atkinson; Mario Mandalà; Vanna Chiarion-Sileni; James Larkin; Marta Nyakas; Caroline Dutriaux; Andrew Haydon; Caroline Robert; Laurent Mortier; Jacob Schachter; Dirk Schadendorf; Thierry Lesimple; Ruth Plummer; Ran Ji; Pingkuan Zhang; Bijoyesh Mookerjee; Jeff Legos; Richard Kefford; Reinhard Dummer; John M Kirkwood Journal: N Engl J Med Date: 2017-09-10 Impact factor: 91.245