Premium
Results of a multicenter, randomized, double‐blind phase 2/3 study of lenalidomide in the treatment of pretreated relapsed or refractory metastatic malignant melanoma
Author(s) -
Eisen Tim,
Trefzer Uwe,
Hamilton Anne,
Hersey Peter,
Millward Michael,
Knight Robert D.,
Jungnelius Jarl U.,
Glaspy John
Publication year - 2009
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.24686
Subject(s) - medicine , lenalidomide , placebo , refractory (planetary science) , multiple myeloma , adverse effect , oncology , phases of clinical research , gastroenterology , surgery , clinical trial , pathology , physics , alternative medicine , astrobiology
BACKGROUND: The results of an international, multicenter, randomized, double‐blind, controlled study assessing the efficacy and safety of lenalidomide treatment in patients with refractory stage IV metastatic malignant melanoma are reported. METHODS: The study compared treatment with lenalidomide (25 mg/d on Days 1‐21 of a 28‐day cycle) to placebo in 306 patients with metastatic malignant melanoma. Treatment was continued until progression of disease or unacceptable toxicity. RESULTS: There were no significant differences between lenalidomide and placebo in overall survival (median 5.9 months vs 7.4 months, respectively; P = .32), time to progression (median 3.0 months vs 2.1 months; P = .19), or Response Evaluation Criteria in Solid Tumors tumor response (5.3% vs 5.8%; P = .82). None of the patients given placebo discontinued treatment because of treatment‐related adverse events, compared with 4.6% of those treated with lenalidomide. Treatment‐related myelosuppression was observed in 2.0% of patients treated with placebo and 7.3% of patients treated with lenalidomide. CONCLUSIONS: This study showed that treatment with lenalidomide (25 mg/d) has a manageable safety profile in patients with previously treated metastatic malignant melanoma but no benefit in tumor response, time to progression, or overall survival in these patients. Future trials for treatment of metastatic malignant melanoma with lenalidomide should focus on its use in combination therapies. Cancer 2010. © 2010 American Cancer Society.