Phase II study of lenalidomide in patients with metastatic renal cell carcinoma
Open accessAbstract
BACKGROUND.: Lenalidomide (LEN) is a structural and functional analogue of thalidomide that has demonstrated enhanced immunomodulatory properties and a more favorable toxicity profile. A Phase II, open‐label study of LEN in patients with metastatic renal cell carcinoma (RCC) was conducted to determine its safety and clinical activity. METHODS.: Patients with metastatic RCC received LEN orally at a dose of 25 mg daily for the first 21 days of a 28‐day cycle. The primary endpoint was the objective response rate. Time to treatment failure, safety, and survival were secondary endpoints. RESULTS.: In total, 28 patients participated in the trial and were included in the current analysis. Three of 28 patients (11%) demonstrated partial responses and continued to be progression‐free for >15 months. Eleven patients (39%) had stable disease that lasted >3 months, including 8 patients who had tumor shrinkage. In total, 6 patients (21%) remained on the trial, and 5 additional patients continued to be followed for survival. The median follow‐up for those 11 patients was 13.5 months (range, 8.3–17.0 months). The median survival had not been reached at the time of the current report. Serious adverse events included fatigue (11%), skin toxicity (11%), and neutropenia (36%). CONCLUSIONS.: LEN demonstrated an antitumor effect in metastatic RCC, as evidenced by durable partial responses. LEN toxicities were manageable. Further studies will be required to assess the overall activity of LEN in patients with metastatic RCC. Cancer 2006. © 2006 American Cancer Society.
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In 2002, a phase I trial of lenalidomide monotherapy revealed promising signs of efficacy in patients with relapsed and/or refractory MM, about 50% of whom had previously received thalidomide.
“In 2002, a phase I trial of lenalidomide monotherapy revealed promising signs of efficacy in patients with relapsed and/or refractory (R/R) MM, about 50% of whom had previously received thalidomide23.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [23]
Lenalidomide doses of up to 50 mg daily were tested and no dose-limiting toxicities were observed, although all patients treated at this dose developed severe myelosuppression after 1-2 cycles and thus 25 mg daily was suggested as the maximum tolerated dose.
“Lenalidomide doses of up to 50 mg daily were tested and no dose-limiting toxicities were observed, although all patients treated at this dose developed severe myelosuppression after 1–2 cycles and thus 25 mg daily was suggested as the maximum tolerated dose23”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [23]
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References 47 · Cited by 54
Research works printed but not linked: 2
- Rini BI. Sorafenib. Expert Opin Pharmacother. 2006;7:453- 461.
- Gordon MS, Manola J, Fairclough D, et al. Low dose inter- feron-alpha 2b (IFN) þ thalidomide (T) in patients (pts) with previously untreated renal cell cancer (RCC): improve- ment in progression-free survival (PFS) but not quality of life (QoL) or overall survival (OS) [abstract 4416]. Proc Am Soc Clin Oncol. 2004;23:384.
- Authors
- Choueiri, T. K., Dreicer, R., Rini, B. I., Elson, P., Garcia, J. A., Thakkar, S. G., Baz, R. C., Mekhail, T. M., Jinks, H. A., & Bukowski, R. M.
- Affiliations
- Cleveland Clinic (US)
- Corresponding author
- Choueiri, Toni K.
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2006-10-30
- Volume
- 107
- Issue
- 11
- Pages
- 2609-2616
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- OpenAlex
- W2032571438
- Cited by
- 54
- References
- 47
- Citations by year
- 2025: 1 · 2024: 1 · 2021: 1 · 2020: 1 · 2018: 1 · 2016: 3 · 2015: 2 · 2014: 2 · 2013: 5 · 2012: 7
- FWCI
- 5.89
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Renal cell carcinoma treatment
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Keywords
- lenalidomide, metastatic renal cell carcinoma, thalidomide analogues, immunomodulation, objective response rate, partial response, stable disease, anticancer activity, drug toxicity, neutropenia, fatigue, skin toxicity
- MeSH terms
- Lenalidomide, Administration, Oral, Adult, Aged, Antineoplastic Agents, Carcinoma, Renal Cell, Female, Humans, Immunologic Factors, Kidney Neoplasms, Male, Middle Aged, Neoplasm Metastasis, Thalidomide, Treatment Outcome
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