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摘要
Background This study was conducted to evaluate the efficacy of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib with pegylated-IFN alpha (PEG-IFN alpha) in patients with advanced renal cell carcinoma. Methods Progression-free survival (PFS) rate at 6 months > 50% was considered promising for further evaluation. Patients with unresectable or metastatic disease, unlimited prior therapies, and adequate performance status and end-organ function were eligible. PEG-IFN alpha was dosed subcutaneously once weekly (initially 6 mu g/kg/week, later reduced to 4 mu g/kg/week) for 12 weeks. Gefitinib was given 250 mg orally once daily until progression or intolerance. Results Twenty-one patients were accrued. Fourteen patients had a prior nephrectomy, and twelve had prior systemic therapy. The 6-month PFS was 29% (95%CI 15-56%). Best responses by RECIST criteria: complete, partial (1, plus 3 unconfirmed) stable (Uhlman et al. Clin Cancer Res 1:913-920, 1995), and progression (Sirotnak et al. Clin Cancer Res 6:4885-4892, 2000). Response duration: complete response (35+ months) and partial response (2, 3, 3, 37 months). Median PFS and overall survival were 5.3 (95%CI 3-10.1) and 13.6 (95%CI 10.3-NA) months, respectively. Most common toxicities included myelosuppression, rash, and nausea. Conclusions Although generally well tolerated, gefitinib plus PEG-IFN alpha did not meet the pre-specified 6-month PFS rate > 50%. Further evaluation of similar regimens would require appropriate molecular selection of subjects most likely to benefit. Thus, preclinical studies to determine candidate predictive markers for this combination are warranted.
- 出版日期2011-10
