Cited by 4,496Cancer Immunotherapy and BiomarkersCutaneous Melanoma Detection and ManagementMelanoma and MAPK Pathways

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Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma

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Robert, Caroline, Thomas, Luc, Bondarenko, Igor, O'Day, Steven, Weber, Jeffrey, Garbe, Claus, Lebbe, Celeste, Baurain, Jean-François, Testori, Alessandro, Grob, Jean-Jacques, Davidson, Neville, Richards, Jon, Maio, Michele, Hauschild, Axel, Miller, Wilson H., Gascon, Pere, Lotem, Michal, Harmankaya, Kaan, Ibrahim, Ramy, Francis, Stephen, Chen, Tai-Tsang, Humphrey, Rachel, Hoos, Axel, Wolchok, Jedd D.·2011·New England Journal of Medicine

DOI 10.1056/nejmoa1104621

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Abstract

BACKGROUND: Ipilimumab monotherapy (at a dose of 3 mg per kilogram of body weight), as compared with glycoprotein 100, improved overall survival in a phase 3 study involving patients with previously treated metastatic melanoma. We conducted a phase 3 study of ipilimumab (10 mg per kilogram) plus dacarbazine in patients with previously untreated metastatic melanoma. METHODS: We randomly assigned 502 patients with previously untreated metastatic melanoma, in a 1:1 ratio, to ipilimumab (10 mg per kilogram) plus dacarbazine (850 mg per square meter of body-surface area) or dacarbazine (850 mg per square meter) plus placebo, given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeks through week 22. Patients with stable disease or an objective response and no dose-limiting toxic effects received ipilimumab or placebo every 12 weeks thereafter as maintenance therapy. The primary end point was overall survival. RESULTS: Overall survival was significantly longer in the group receiving ipilimumab plus dacarbazine than in the group receiving dacarbazine plus placebo (11.2 months vs. 9.1 months, with higher survival rates in the ipilimumab-dacarbazine group at 1 year (47.3% vs. 36.3%), 2 years (28.5% vs. 17.9%), and 3 years (20.8% vs. 12.2%) (hazard ratio for death, 0.72; P<0.001). Grade 3 or 4 adverse events occurred in 56.3% of patients treated with ipilimumab plus dacarbazine, as compared with 27.5% treated with dacarbazine and placebo (P<0.001). No drug-related deaths or gastrointestinal perforations occurred in the ipilimumab-dacarbazine group. CONCLUSIONS: Ipilimumab (at a dose of 10 mg per kilogram) in combination with dacarbazine, as compared with dacarbazine plus placebo, improved overall survival in patients with previously untreated metastatic melanoma. The types of adverse events were consistent with those seen in prior studies of ipilimumab; however, the rates of elevated liver-function values were higher and the rates of gastrointestinal events were lower than expected on the basis of prior studies. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00324155.).

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Authors: Robert, C., Thomas, L., Bondarenko, I., O'Day, S., Weber, J., Garbe, C., Lebbe, C., Baurain, J.-F., Testori, A., Grob, J.-J., Davidson, N., Richards, J., Maio, M., Hauschild, A., Miller, W. H., Gascon, P., Lotem, M., Harmankaya, K., Ibrahim, R., Francis, S., Chen, T.-T., Humphrey, R., Hoos, A., & Wolchok, J. D.
Affiliations: Institut Gustave Roussy (FR)
Hôpital Lyon Sud (FR)
Dnipro State Medical University (UA)
Angeles Clinic and Research Institute (US)
Moffitt Cancer Center (US)
Cliniques Universitaires Saint-Luc (BE)
European Institute of Oncology (IT)
Hôpital de la Timone (FR)
Mid Essex Hospital Services NHS Trust (GB)
Oncology Specialists (US)
University of Siena (IT)
Christian-Albrechts-Universität zu Kiel (DE)
Hadassah Medical Center (IL)
Medical University of Vienna (AT)
Bristol-Myers Squibb (United States) (US)
Memorial Sloan Kettering Cancer Center (US)
ORCID: Robert, Caroline
Thomas, Luc
Bondarenko, Igor
O'Day, Steven
Weber, Jeffrey
Garbe, Claus
Baurain, Jean-François
Testori, Alessandro
Grob, Jean-Jacques
Maio, Michele
Hauschild, Axel
Miller, Wilson H.
Lotem, Michal
Ibrahim, Ramy
Chen, Tai-Tsang
Humphrey, Rachel
Hoos, Axel
Wolchok, Jedd D.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2011-06-30
Volume: 364
Issue: 26
Pages: 2517-2526
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1104621
OpenAlex: W2123363005
Cited by: 4,496
References: 29
Citations by year: 2026: 58 · 2025: 99 · 2024: 148 · 2023: 173 · 2022: 213 · 2021: 249 · 2020: 289 · 2019: 283 · 2018: 374 · 2017: 415 · 2016: 466 · 2015: 476 · 2014: 400 · 2013: 392 · 2012: 346
FWCI: 195.50
Type: journal article
Language: en
Open access: green
www.openaccessrepository.it
Licence: other-oa
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Digital Access to Libraries (submittedVersion)
INFM-OAR (INFN Catania) (submittedVersion, other-oa)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
Keywords: ipilimumab, dacarbazine, metastatic melanoma, combination immunotherapy, CTLA-4 blockade, overall survival, adverse events, liver dysfunction, maintenance therapy, immune-related adverse events, immune checkpoint inhibitors, progression-free survival
MeSH terms: Ipilimumab, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Dacarbazine, Double-Blind Method, Female, Humans, Liver Function Tests, Male, Melanoma, Middle Aged, Proportional Hazards Models, Disease Progression, Antineoplastic Agents, Alkylating, Kaplan-Meier Estimate

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Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma

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