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Survival without common toxicity criteria grade 3/4 toxicity following second-line treatment with pemetrexed for nonsquamous non-small cell lung cancer in Chinese patients

引用

Chinese Medical Journal 2013年第24期126卷 4624-4628页

作者： WU Yi-long SUN Yan ZHOU Cai-cun ZHANG Li YU Shi-ying MA Sheng-lin HAN Ling Lucia ZHANG Xiao-qing Mauro Orlando Guangdong lung cancer Institute Guangdong General Hospital andGuangdong Academy of Medical Sciences Guangzhou Guangdong510080 China cancer Institute and Hospital Chinese Academy of Medical SciencesBeijing 10002 China Department of Oncology Shanghai Pulmonary Hospital School ofMedicine Tongji University Affiliated Cancer Institute Shanghai200433 China Department of Medical Oncology Tumor Hospital Sun Yat-SenUniversity of Medical Sciences Guangzhou Guangdong 510080China Department of Oncology Tongji Hospital Yongji Medical CollegeHuazhong University of Science and Technology Wuhan Hubei430032 China Department of Chemotherapy Center Zhejiang Cancer HospitalHangzhou Zhejiang 310022 China Development Center of Excellence-Asia Pacific Eli Lilly andCompany Shanghai 200021 China Oncology Eli Lilly Asia Shanghai 200021 China Oncology Emerging Markets Eli Lilly Interam6rica Inc. BuenosAires 1430 Argentina

Background The efficacy of pemetrexed in the second-line treatment of Chinese patients with advanced non-small cell lung cancer （NSCLC） has been shown to be similar to that of docetaxel in a recent study; additionally, pemetrexed was associated with much better safety and toxicity profiles. Here, the survival without common toxicity criteria grade 3/4 toxicity （SWT） data from a post hoc analysis of this recent prospective NSCLC study in Chinese patients is reported. This post hoc analysis differs from the main study; it focuses on the nonsquamous population to align with the current approval for pemetrexed in China. Methods A total of 154 patients with nonsquamous NSCLC received either pemetrexed （500 mg/m2 intravenously （IV）） or docetaxel （75 mg/m2 IV） on day 1 of 21-day cycles. SWT was analyzed using Kaplan-Meier and univariate Cox methods. Results Patients treated with pemetrexed had a longer median SWT than patients treated with docetaxel （7.4 months versus 1.2 months; unadjusted hazard ratio =0.59, 95% confidence interval CCI}： 0.41-0.84; P=0.003）. At 12 and 18months, the SWT event-free probability for pemetrexed patients （18 months： 24.5%, 95%C/ 13.9%-36.6%, vs. 12.3%, 95% CI 4.8%-23.6%） was greater than that for docexatel patients （12 months： 37.3%, 95% CI 26.5%- 48.0%, vs. 23.3%, 95% CI 14.4-33.4）. The progression- free survival without common toxicity criteria grade 3/4 toxicity （PFS-WT） was also statistically significantly longer for patients treated with pemetrexed than patients treated with docetaxel （1.9 months vs. 1.1 months, P=0.002）. Conclusions Chinese patients with nonsquamous NSCLC disease treated with pemetrexed had improved SWT beyond 6 months than those receiving docetaxel. This analysis supports a benefit-to-risk profile that favors pemetrexed over docetaxel in the second-line treatment of Chinese nonsquamous NSCLC patients.

关键词： non-small cell lung cancer, pemetrexed survival without toxicity, Chinese patient

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