Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
J Formos Med Assoc. 2013 Sep;112(9):518-26. doi: 10.1016/j.jfma.2012.02.030. Epub 2013 Sep 21.
BACKGROUND/PURPOSE: Although global and Asian studies on second-line pemetrexed for the treatment of advanced nonsmall cell lung cancer have confirmed its efficacy and safety, a pivotal postcommitment study to consolidate the evidence regarding the Taiwanese population was warranted. This open-label single-arm study assessed the objective response rate to a tailored dose of single-agent pemetrexed in Taiwanese patients with advanced nonsmall cell lung cancer who had received prior chemotherapy.
Patients with stage IIIB/IV disease were treated with pemetrexed on day 1 of each 21-day cycle. A 500 mg/m(2) dose was administered in cycle 1. For cycle 2, the dose was increased to 1000 mg/m(2) (if there was no toxicity above predefined levels) or decreased to 375 mg/m(2). All patients received standard supplemental therapy. Patient follow-up continued until 18 months after the last patient was enrolled in this study or death. All patients were included in all analyses.
Of the 33 patients who were enrolled, 25 (75.8%) received the 1000 mg/m(2) dose during cycle 2; 18 patients were dropped from the study, including 17 (51.5%) who had died by the time of analysis. The objective response and disease control rates were 18.2% (95% confidence limits [CI]: 7.0-35.5) and 54.5% (95% CI: 36.4-71.9), respectively. No patients exhibited a complete response. There were two serious drug-related adverse events (neutropenia and leukopenia) and two drug-related adverse events that resulted in removal from the study. Decreased neutrophil/granulocyte counts were the most frequently observed drug-related grade 3/4 events (9 patients, 24 treatment cycles).
The objective response rate, disease control rate, and safety and tolerability profile in this population of Taiwanese patients were consistent with the published findings that were conducted using Asian and Western populations. These findings support the use of single-agent, second-line pemetrexed for the treatment of advanced nonsmall cell lung cancer in Taiwanese patients.
背景/目的：虽然全球和亚洲的研究已经证实培美曲塞二线治疗晚期非小细胞肺癌的疗效和安全性，但仍需要一项关键性的后续承诺研究来巩固台湾人群的数据。这项开放标签的单臂研究评估了既往接受过化疗的台湾晚期非小细胞肺癌患者接受培美曲塞单药治疗的客观缓解率。
IIIb/IV 期疾病患者在每个 21 天周期的第 1 天接受培美曲塞治疗。第 1 周期给予 500mg/m2 剂量。对于第 2 周期，如果没有达到预先设定水平的毒性，则将剂量增加至 1000mg/m2（如果没有达到预先设定水平的毒性），或者降低至 375mg/m2。所有患者均接受标准辅助治疗。患者随访持续至最后 1 例患者入组后 18 个月或死亡。所有患者均纳入所有分析。
33 例患者中，25 例（75.8%）在第 2 周期接受了 1000mg/m2 剂量；18 例患者退出研究，其中 17 例（51.5%）在分析时已死亡。客观缓解率和疾病控制率分别为 18.2%（95%置信区间[CI]：7.0-35.5）和 54.5%（95%CI：36.4-71.9）。无患者出现完全缓解。有 2 例严重的药物相关不良事件（中性粒细胞减少和白细胞减少）和 2 例导致退出研究的药物相关不良事件。减少中性粒细胞/粒细胞计数是最常见的药物相关 3/4 级事件（9 例患者，24 个治疗周期）。
在台湾患者人群中，客观缓解率、疾病控制率以及安全性和耐受性特征与亚洲和西方人群开展的已发表研究结果一致。这些发现支持在台湾患者中使用培美曲塞单药二线治疗晚期非小细胞肺癌。
