Abstract
Purpose:
To evaluate the feasibility and efficacy of sorafenib and everolimus in renal cell carcinoma (RCC).
Methods:
Patients with advanced RCC and ≤ 1 previous targeted therapy were treated.
Results:
Maximum tolerated doses were sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly. Dose-limiting toxicity was hand-foot syndrome. The response rate was 13%; median PFS was 5.45 months (95% CI: 3.8-7.6). Skin toxicity, fatigue, hypertension, proteinuria, and mucositis (usually Grade 2) were common.
Conclusions:
Fifty percent doses of sorafenib and everolimus were required when these drugs were combined. No increase in efficacy was suggested; toxicity was modestly increased.
Publication types
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Clinical Trial, Phase I
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Clinical Trial, Phase II
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Multicenter Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Carcinoma, Renal Cell / drug therapy*
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Carcinoma, Renal Cell / secondary
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Disease-Free Survival
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Everolimus
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Female
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Hand-Foot Syndrome / etiology
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Humans
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Kidney Neoplasms / drug therapy*
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Kidney Neoplasms / pathology
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Lung Neoplasms / drug therapy*
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Lung Neoplasms / secondary
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Male
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Maximum Tolerated Dose
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Middle Aged
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Niacinamide / administration & dosage
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Niacinamide / analogs & derivatives
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Phenylurea Compounds / administration & dosage
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Sirolimus / administration & dosage
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Sirolimus / analogs & derivatives
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Sorafenib
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Treatment Outcome
Substances
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Phenylurea Compounds
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Niacinamide
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Everolimus
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Sorafenib
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Sirolimus