Journal article
Ipilimumab versus placebo after complete resection of stage III melanoma: Long-term follow-up results the EORTC 18071 double-blind phase 3 randomized trial.
- Eggermont, Alexander M. M. Gustave Roussy Cancer Centre and University Paris-Saclay, Paris, France;
- Chiarion-Sileni, Vanna Veneto Oncology Research Institute, Padua, Italy;
- Grob, Jean Jacques AIX-Marseille University, Marseille, France;
- Dummer, Reinhard Department of Dermatology, University Hospital Zürich Skin Cancer Center, Zürich, Switzerland;
- Wolchok, Jedd D. Memorial Sloan Kettering Cancer Center, New York, NY;
- Schmidt, Henrik Aarhus University Hospital, Aarhus, Denmark;
- Hamid, Omid The Angeles Clinic and Research Institute, Los Angeles, CA;
- Robert, Caroline Paris-Sud University, Gustave Roussy, Villejuif Cedex, France;
- Ascierto, Paolo Antonio Istituto Nazionale dei Tumori IRCCS Fondazione, Naples, Italy;
- Richards, Jon M. Oncology Specialists, SC, Park Ridge, IL;
- Lebbe, Celeste APHP Dermatology and CIC, U976, Université de Paris, Hôpital Saint-Louis, Paris, France;
- Ferraresi, Virginia Regina Elena National Cancer Institute, Rome, Italy;
- Smylie, Michael Cross Cancer Institute, Edmonton, AB, Canada;
- Weber, Jeffrey S. Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY;
- Maio, Michele Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy;
- Hosein, Fareeda Bristol-Myers Squibb, Lawrenceville, NJ;
- de Pril, Veerle Bristol-Myers Squibb, Braine-L'alleud, Belgium;
- Kicinski, Michal EORTC Headquarters, Brussels, Belgium;
- Suciu, Stefan EORTC Headquarters, Brussels, Belgium;
- Testori, Alessandro Formerly at European Institute of Oncology, Milan, Italy;
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2019, vol. 37, no. 15_suppl, p. 2512-2512
English
2512 Background: Since 2015, ipilimumab (Ipi) is an approved treatment for stage III melanoma based on a significantly (P=0.0013) prolonged recurrence-free survival (RFS) (Eggermont et al, Lancet Oncology, 2015). At a median follow-up of 5.3 years, RFS (HR=0.76) and distant metastasis-free survival (DMFS) (HR=0.76), assessed by an IRC, and overall survival (OS) (HR=0.72) were prolonged in the Ipi group as compared to the placebo (Pbo) group (Eggermont et al, NEJM, 2016), despite a 53.3% (Ipi) vs 4.6% (Pbo) treatment discontinuation rate due to adverse events. Methods: In this randomized double-blind trial, eligible patients (pts) included those ≥18 yrs of age who underwent complete resection of stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis). 951 pts were randomized (stratified by stage and region) 1:1 to Ipi 10 mg/kg (n=475) or placebo (Pbo, n=476) q3w for 4 doses, then every 3 mos for up to 3 yrs until completion, disease recurrence, or unacceptable toxicity. Here, we report the comparison between the Ipi and Pbo groups regarding the long-term efficacy outcomes using the local investigator assessments. Results: Overall, 20%/44%/36% of pts had AJCC-7 stage IIIA/IIIB/IIIC, 42% ulcerated primary, and 58% macroscopic lymph node involvement. Median follow-up was 6.9 yrs. The RFS, DMFS and OS benefit observed in the Ipi group was long-lasting (almost 10% difference at 7 years) and consistent across subgroups: no significant predictive factors could be detected. Conclusions: In this phase III trial, Ipi, administered at 10 mg/kg, as adjuvant therapy provided, at a 6.9 yr median follow-up, a sustained improvement in the RFS, DMFS, and OS long-term results in patients with high-risk stage III melanoma. Clinical trial information: NCT00636168. [Table: see text]
- Language
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- English
- Open access status
- closed
- Identifiers
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- DOI 10.1200/jco.2019.37.15_suppl.2512
- ISSN 0732-183X
- Persistent URL
- https://folia.unifr.ch/global/documents/296375
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