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Cited by 805

The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.

Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma

Open access
Ribas, Antoni, Kefford, Richard, Marshall, Margaret A., Punt, Cornelis J.A., Haanen, John B., Marmol, Maribel, Garbe, Claus, Gogas, Helen, Schachter, Jacob, Linette, Gerald, Lorigan, Paul, Kendra, Kari L., Maio, Michele, Trefzer, Uwe, Smylie, Michael, McArthur, Grant A., Dreno, Brigitte, Nathan, Paul D., Mackiewicz, Jacek, Kirkwood, John M., Gomez-Navarro, Jesus, Huang, Bo, Pavlov, Dmitri, Hauschild, Axel·2013·Journal of Clinical Oncology
DOI 10.1200/jco.2012.44.6112
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Abstract

Purpose: In phase I/II trials, the cytotoxic T lymphocyte–associated antigen-4–blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients and Methods: Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). Results: In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. Conclusion: This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.

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Metadata

Authors
Ribas, A., Kefford, R., Marshall, M. A., Punt, C. J. A., Haanen, J. B., Marmol, M., Garbe, C., Gogas, H., Schachter, J., Linette, G., Lorigan, P., Kendra, K. L., Maio, M., Trefzer, U., Smylie, M., McArthur, G. A., Dreno, B., Nathan, P. D., Mackiewicz, J., Kirkwood, J. M., Gomez-Navarro, J., Huang, B., Pavlov, D., & Hauschild, A.
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2013-02-10
Volume
31
Issue
5
Pages
616-622
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2012.44.6112
OpenAlex
W2136746908
Cited by
805
References
4
FWCI
49.64
Type
journal article
Language
en
Open access
bronze

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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