Results of a multicenter, randomized, double-blind, dose-evaluating phase 2/3 study of lenalidomide in the treatment of metastatic malignant melanoma.

Abstract:

BACKGROUND:There are currently no systemic treatments for stage IV melanoma, which have been proven in randomized trials to benefit overall survival (OS). Lenalidomide has efficacy against melanoma in animal models and safety in phase 1 trials. The authors reported the results of a phase 2/3 study comparing the safety and efficacy of 2 doses of lenalidomide in patients with relapsed metastatic melanoma disease refractory to previous treatment with dacarbazine, temozolomide, interleukin-2, or interferon-alpha. METHODS:A total of 294 patients were randomized to oral lenalidomide at 5 mg or 25 mg dose. Tumor response, time to progression, and OS were evaluated. Treatment continued until disease progression or unacceptable adverse events. RESULTS:No significant differences in response rate, OS, or time to progression were observed between lenalidomide 25 mg versus 5 mg (overall response rate: 5.5% vs 3.4%, P = .38; median OS: 6.8 months vs 7.2 months, P = .71; and median time to progression: 2.2 months vs 1.9 months, P = .24). Myelosuppression was observed in 37.0% of patients in the 25 mg group and 13.7% of patients in the 5 mg group. Treatment-related serious adverse events were seen in 39.0% of patients at the 25 mg dose and 35.4% of patients at the 5 mg dose. CONCLUSIONS:Despite the occurrence of treatment-related serious adverse events, approximately 80% of patients continued treatment. The higher dose of lenalidomide did not improve response rate, time to progression, or OS of patients with relapsed/refractory stage IV melanoma. A parallel placebo-controlled study has been conducted to further assess the efficacy of lenalidomide in stage IV melanoma patients.

journal_name

Cancer

journal_title

Cancer

authors

Glaspy J,Atkins MB,Richards JM,Agarwala SS,O'Day S,Knight RD,Jungnelius JU,Bedikian AY

doi

10.1002/cncr.24576

subject

Has Abstract

pub_date

2009-11-15 00:00:00

pages

5228-36

issue

22

eissn

0008-543X

issn

1097-0142

journal_volume

115

pub_type

杂志文章,多中心研究,随机对照试验

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