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【Cancer research】Phase III Study, V-15-32, of Gefitinib V
Purpose: This phase III study (V-15-32) compared gefitinib (250 mg/d) with docetaxel (60 mg/m2) in patients (N = 489) with advanced/metastatic non–small-cell lung cancer (NSCLC) who had failed one or two chemotherapy regimens.
Methods: The primary objective was to compare overall survival to demonstrate noninferiority for gefitinib relative to docetaxel. An unadjusted Cox regression model was used for the primary analysis.
Results: Noninferiority in overall survival was not achieved (hazard ratio [HR], 1.12; 95.24% CI, 0.89 to 1.40) according to the predefined criterion (upper CI limit for HR 1.25); however, no significant difference in overall survival (P = .330) was apparent between treatments. Poststudy, 36% of gefitinib-treated patients received subsequent docetaxel, and 53% of docetaxel-treated patients received subsequent gefitinib. Gefitinib significantly improved objective response rate and quality of life versus docetaxel; progression-free survival, disease control rates, and symptom improvement were similar for the two treatments. Grades 3 to 4 adverse events occurred in 40.6% (gefitinib) and 81.6% (docetaxel) of patients. Incidence of interstitial lung disease was 5.7% (gefitinib) and 2.9% (docetaxel). Four deaths occurred due to adverse events in the gefitinib arm (three deaths as a result of interstitial lung disease, judged to be treatment related; one as a result of pneumonia, not treatment related), and none occurred in the docetaxel arm.
Conclusion: Noninferiority in overall survival between gefitinib and docetaxel was not demonstrated according to predefined criteria; however, there was no statistically significant difference in overall survival. Secondary end points showed similar or superior efficacy for gefitinib compared with docetaxel. Gefitinib remains an effective treatment option for previously treated Japanese patients with NSCLC.
Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.
http://www.mphtimes.com/bbs/redirect.php?tid=3346&goto=lastpost#lastpost
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III期临床实验，V-15-32，治疗失败的日本非小细胞肺癌患者中选用吉非替尼对比多西他赛的对比治疗。
Purpose: This phase III study (V-15-32) compared gefitinib (250 mg/d) with docetaxel (60 mg/m2) in patients (N = 489) with advanced/metastatic non–small-cell lung cancer (NSCLC) who had failed one or two chemotherapy regimens.
目的:该III期(V-15-32)在经过一种或两种化疗方案治疗失败的非小细胞(NSCLC)进展期或转移患者(N = 489)中，对比使用吉非替尼(250 mg/d)和多西他赛(60 mg/m2)的临床实验。
Methods: The primary objective was to compare overall survival to demonstrate noninferiority for gefitinib relative to docetaxel. An unadjusted Cox regression model was used for the primary analysis.
方法：初步目的是通过对比总生存率来显示吉非替尼相对于多西他赛无劣势。未经调整的Cox回归模型用来初步分析。
Results: Noninferiority in overall survival was not achieved (hazard ratio [HR], 1.12; 95.24% CI, 0.89 to 1.40) according to the predefined criterion (upper CI limit for HR 1.25); however, no significant difference in overall survival (P = .330) was apparent between treatments.结果：基于预先制定的标准（HR的CI上限1.25），总生存率非劣势结果没有得到(危险因子 [HR], 1.12; 95.24% CI, 0.89 ~1.40)；然而，在两种研究中，总生存率没有明显差异是很显然的（P = .330）。 Poststudy, 36% of gefitinib-treated patients received subsequent docetaxel, and 53% of docetaxel-treated patients received subsequent gefitinib. 后续的研究，36％的吉非替尼患者接受后续的多西他赛治疗，53％的多西他赛治疗患者接受吉非替尼治疗。Gefitinib significantly improved objective response rate and quality of life versus docetaxel; progression-free survival, disease control rates, and symptom improvement were similar for the two treatments. Grades 3 to 4 adverse events occurred in 40.6% (gefitinib) and 81.6% (docetaxel) of patients. 相对于多西他赛，吉非替尼明显提高目标反应率和生活质量；在无疾病生存时间、疾病控制率和症状提高上，二者相当。3级和4级的不良反应分别为40.6％（吉非替尼）和81.6％（多西他赛）。Incidence of interstitial lung disease was 5.7% (gefitinib) and 2.9% (docetaxel). Four deaths occurred due to adverse events in the gefitinib arm (three deaths as a result of interstitial lung disease, judged to be treatment related; one as a result of pneumonia, not treatment related), and none occurred in the docetaxel arm. 间质性肺病分别为5.7％（吉非替尼）和2.9％（多西他赛）。吉非替尼组因副反应死亡患者4例（3例因治疗相关间质性肺病死亡；1例由于肺炎，非治疗相关），多西他赛组没有死亡病例。
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作者:admin@医学,生命科学 2011-04-07 18:13
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