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Cited by 50Cutaneous Melanoma Detection and ManagementMelanoma and MAPK PathwaysCancer Immunotherapy and Biomarkers

Results of a multicenter, randomized, double‐blind phase 2/3 study of lenalidomide in the treatment of pretreated relapsed or refractory metastatic malignant melanoma

Eisen, Tim, Trefzer, Uwe, Hamilton, Anne, Hersey, Peter, Millward, Michael, Knight, Robert D., Jungnelius, Jarl U., Glaspy, John·2010·Cancer
DOI 10.1002/cncr.24686
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Abstract

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.

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  • Responses to lenalidomide were seen even in patients who had disease progression on prior thalidomide therapy, and the combination of lenalidomide and dexamethasone in patients with one or more prior lines of therapy was FDA approved in 2006.

    “Again, responses were seen even in patients who had disease progression on prior thalidomide therapy and the combination of lenalidomide and dexamethasone in patients with one or more prior lines of therapy was FDA approved in 200624,25.”

    From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [24]

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Authors
Eisen, T., Trefzer, U., Hamilton, A., Hersey, P., Millward, M., Knight, R. D., Jungnelius, J. U., & Glaspy, J.
Affiliations
  • Royal Marsden Hospital (GB)
  • Charité – Universitätsmedizin Berlin (DE)
  • Royal Prince Alfred Hospital (AU)
  • Calvary Mater Newcastle Hospital (AU)
  • Celgene (United States) (US)
  • University of California, Los Angeles (US)
Corresponding author
Eisen, Tim
ORCID
Venue
Cancer
Publisher
Wiley
Published
2009-10-27
Volume
116
Issue
1
Pages
146-154
ISSN
  • 0008-543X (ISSN-L)
  • 1097-0142
DOI
10.1002/cncr.24686
OpenAlex
W2080826905
Cited by
50
References
29
Citations by year
2024: 2 · 2023: 1 · 2022: 1 · 2021: 5 · 2020: 1 · 2019: 2 · 2018: 1 · 2016: 4 · 2015: 3 · 2014: 3 · 2013: 6 · 2012: 9
FWCI
3.50
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Cancer (publishedVersion)
  • PubMed (publishedVersion)
  • UWA Profiles and Research Repository (UWA) (submittedVersion)
  • NOVA (University of Newcastle Australia) (submittedVersion)
Topics
  • Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Keywords
lenalidomide, metastatic melanoma, overall survival, time to progression, tumor response, myelosuppression, treatment-related adverse events, immunomodulators, combination therapy
MeSH terms
Lenalidomide, Antineoplastic Agents, Double-Blind Method, Female, Humans, Male, Melanoma, Middle Aged, Neoplasm Metastasis, Recurrence, Skin Neoplasms, Thalidomide, Disease Progression, Drug Resistance, Neoplasm, Retreatment

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