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Phase I clinical trial of lenalidomide in combination with bevacizumab in patients with advanced cancer.
- Source :
-
Cancer Chemotherapy & Pharmacology . May2016, Vol. 77 Issue 5, p1097-1102. 6p. - Publication Year :
- 2016
-
Abstract
- <bold>Purpose: </bold>Lenalidomide and bevacizumab have antitumor activity in various tumor types. We conducted a phase I study of this combination in patients with advanced cancer.<bold>Patients and Methods: </bold>A "3 + 3" study design was used. Lenalidomide 10 or 20 mg (orally, days 1-21) and bevacizumab 5, 7.5, or 10 mg/kg, (intravenously, every 2 weeks) were given at four escalating dose levels, followed by an expansion phase at the highest maximum tolerated dose (MTD) (1 cycle = 4 weeks). Dose-limiting toxicity (DLT), MTD, adverse events, and clinical outcomes were assessed.<bold>Results: </bold>Thirty-one patients were enrolled (median age, 60 years; men, 52 %). The most common tumor types were colorectal carcinoma (n = 11) and melanoma (n = 5). Overall, 105 cycles (median, 2) were administered. No DLTs were observed. The maximum tested dose (level 4) was used in the expansion phase. The most common toxicities were fatigue (n = 7, 23 %) and skin rash (n = 4, 13 %). One patient developed a transient ischemic attack (3.2 %); prophylactic anticoagulation became mandatory in the subsequent 17 treated patients. Of 31 patients, 27 were evaluable for response. Stable disease (SD) was noted in 10 (37 %) patients, including five patients with SD for ≥6 months (tumor types: clear cell sarcoma, germ cell tumor, colorectal carcinoma, and melanoma). The median progression-free survival and overall survival were 2.8 and 5.5 months, respectively.<bold>Conclusions: </bold>The combination of lenalidomide with bevacizumab in patients with advanced solid tumors was safe. Prolonged stable disease was noted in selected tumor types, warranting further clinical evaluation. [ABSTRACT FROM AUTHOR]
- Subjects :
- *BEVACIZUMAB
*THALIDOMIDE
*CANCER patients
*ANTINEOPLASTIC agents
*CLINICAL trials
*THERAPEUTICS
*COLON tumors
*COMPARATIVE studies
*DRUG administration
*DRUG dosage
*DOSE-effect relationship in pharmacology
*DRUG toxicity
*INTRAVENOUS injections
*RESEARCH methodology
*MEDICAL cooperation
*MELANOMA
*ORAL drug administration
*PROGNOSIS
*RESEARCH
*EVALUATION research
*TREATMENT effectiveness
RECTUM tumors
Subjects
Details
- Language :
- English
- ISSN :
- 03445704
- Volume :
- 77
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- Cancer Chemotherapy & Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 114818153
- Full Text :
- https://doi.org/10.1007/s00280-016-3000-3