- Title
- Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with Carboplatin and Paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma
- Creator
- Hauschild, Axel; Agarwala, Sanjiv S; Peschel, Christian; Schadendorf, Dirk; Garbe, Claus; O'Day, Steven; Daud, Adil; White, J. Michael; Xia, Chenghua; Patel, Kiran; Kirkwood, John M.; Keilholz, Ulrich; Trefzer, Uwe; Hogg, David; Robert, Caroline; Hersey, Peter; Eggermont, Alexander; Grabbe, Stephan; Gonzalez, Rene; Gille, Jens
- Relation
- Journal of Clinical Oncology Vol. 27, Issue 17, p. 2823-2830
- Publisher Link
- http://dx.doi.org/10.1200/jco.2007.15.7636
- Publisher
- American Society of Clinical Oncology
- Resource Type
- journal article
- Date
- 2009
- Description
- Purpose: This phase III, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of sorafenib with carboplatin and paclitaxel (CP) in patients with advanced melanoma who had progressed on a dacarbazine- or temozolomide-containing regimen. Patients and Methods: A total of 270 patients were randomly assigned to receive intravenous paclitaxel 225 mg/m2 plus intravenous carboplatin at area under curve 6 (AUC 6) on day 1 of a 21-day cycle followed by either placebo (n = 135) or oral sorafenib 400 mg (n = 135) twice daily on days 2 to 19. The primary efficacy end point was progression-free survival (PFS); secondary and tertiary end points included overall survival and incidence of best response, respectively. Results: The median PFS was 17.9 weeks for the placebo plus CP arm and 17.4 weeks for the sorafenib plus CP arm (hazard ratio, 0.91; 99% CI, 0.63 to 1.31; two-sided log-rank test P = .49). Response rate was 11% with placebo versus 12% with sorafenib. Dermatologic events, grade 3 thrombocytopenia, diarrhea, and fatigue were more common in patients treated with sorafenib plus CP versus placebo plus CP. Conclusion: In this study, the addition of sorafenib to CP did not improve any of the end points over placebo plus CP and cannot be recommended in the second-line setting for patients with advanced melanoma. Both regimens had clinically acceptable toxicity profiles with no unexpected adverse events. A trial of similar design for the first-line treatment of patients with advanced melanoma (intergroup trial E2603) is currently ongoing.
- Subject
- sorafenib; carboplatin and paclitaxel; melanoma; placebo-controlled studies; dacarbazine; temozolomide
- Identifier
- http://hdl.handle.net/1959.13/916305
- Identifier
- uon:7958
- Identifier
- ISSN:0732-183X
- Language
- eng
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