期刊
JOURNAL OF THORACIC ONCOLOGY
卷 2, 期 11, 页码 1036-1041出版社
ELSEVIER SCIENCE INC
DOI: 10.1097/JTO.0b013e318155a439
关键词
small-cell lung cancer; temsirolimus; CCI-779; phase II study
资金
- NCI NIH HHS [CA66636, CA49957, CA27525, CA11083, CA16116, CA21076, CA21115, CA23318] Funding Source: Medline
Hypothesis: To study the progression-free survival (PFS) and toxicity with 25- or 250-mg doses of temsirolimus (CCI-779) after induction chemotherapy in patients with extensive small-cell lung cancer. Methods: Patients with either stable or responding disease to four to six cycles of cisplatin or carboplatin plus etoposide or irinotecan were randomized between 4 and 8 weeks after completion of induction therapy to receive either 25 or 250 mg of temsirolimus intravenously every week until disease progression. Results: Eighty-seven patients entered between January 2002 and December 2003, of whom 85 were eligible: 44 received 25 mg (arm A), and 41 received 250 mg (arm 13). The overall median follow-up time for all eligible patients was 34.6 months. Median age was 59 years (range, 39-80); 42 (49.4%) were male and 43 (50.6%) female; 12.9% had brain metastases. The overall median and 1-year PFS were 2.2 months (95% confidence interval [CI]: 1.8, 2.9) and 4.7% (95% Cl: 0.2%, 9.2%), respectively. The median PFS (95% CI) for ann A was 1.9 months (1.6, 2.3); for arm B, it was 2.5 months (1.9, 3.4; p = 0.24). The median overall survival from randomization was 8 months (95% Cl: 6.5, 9.5). Among the 86 patients with reported toxicities. 36 (42%) had grade 3 toxicities, the most common of which were thrombocytopenia, hypophosphatemia, and fatigue, and an additional 12 (14%) had grade 4 toxicities, the most common of which was neutropenia. No patients experienced lethal toxicities. Conclusion: Temsirolimus (CCI 779), given at 25 or 250 mg weekly, seemed not to increase the PFS in this patient population.
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