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Results of a multicenter, randomized, double‐blind, dose‐evaluating phase 2/3 study of lenalidomide in the treatment of metastatic malignant melanoma
Cancer, 2009-11, Vol.115 (22), p.5228-5236
Glaspy, John
Atkins, Michael B.
Richards, Jon M.
Agarwala, Sanjiv S.
O'Day, Steven
Knight, Robert D.
Jungnelius, J. Ulf
Bedikian, Agop Y.
2009
Details
Autor(en) / Beteiligte
Glaspy, John
Atkins, Michael B.
Richards, Jon M.
Agarwala, Sanjiv S.
O'Day, Steven
Knight, Robert D.
Jungnelius, J. Ulf
Bedikian, Agop Y.
Titel
Results of a multicenter, randomized, double‐blind, dose‐evaluating phase 2/3 study of lenalidomide in the treatment of metastatic malignant melanoma
Ist Teil von
Cancer, 2009-11, Vol.115 (22), p.5228-5236
Ort / Verlag
Hoboken: Wiley Subscription Services, Inc., A Wiley Company
Erscheinungsjahr
2009
Link zum Volltext
Quelle
Electronic Journals Library - Freely accessible e-journals
Beschreibungen/Notizen
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‐α. 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, ∼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. Cancer 2009. © 2009 American Cancer Society. This phase 2/3 study tested the safety and efficacy of lenalidomide for stage IV metastatic melanoma patients with refractory disease. A dose of 25 mg versus 5 mg oral lenalidomide was well tolerated, but it did not confer significant clinical benefits in tumor response, time to progression, or overall survival of these patients.
Sprache
Englisch
Identifikatoren
ISSN: 0008-543X
eISSN: 1097-0142
DOI: 10.1002/cncr.24576
Titel-ID: cdi_crossref_primary_10_1002_cncr_24576
Format
–
Schlagworte
Antineoplastic Agents - administration & dosage
,
Antineoplastic Agents - adverse effects
,
Antineoplastic Agents - therapeutic use
,
Biological and medical sciences
,
Dermatology
,
dose evaluation
,
Double-Blind Method
,
Drug Administration Schedule
,
Female
,
Humans
,
lenalidomide
,
Male
,
Medical sciences
,
Melanoma - drug therapy
,
Melanoma - mortality
,
Melanoma - pathology
,
metastatic malignant melanoma
,
Middle Aged
,
Neoplasm Metastasis
,
phase 2/3
,
Retreatment
,
Skin Neoplasms - drug therapy
,
Skin Neoplasms - pathology
,
Survival Analysis
,
Thalidomide - administration & dosage
,
Thalidomide - adverse effects
,
Thalidomide - analogs & derivatives
,
Thalidomide - therapeutic use
,
Tumors
,
Tumors of the skin and soft tissue. Premalignant lesions
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