培美曲塞用于既往接受过治疗的转移性胃癌患者：一项前瞻性II期研究。
Pemetrexed for previously treated patients with metastatic gastric cancer: a prospective phase II study.
作者信息
Zhang D S, Jin Y, Luo H Y, Wang Z Q, Qiu M Z, Wang F H, Li Y H, Xu R H
机构信息
Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
出版信息
Br J Cancer. 2015 Jan 20;112(2):266-70. doi: 10.1038/bjc.2014.607. Epub 2014 Dec 4.
BACKGROUND
Gastric cancer is one of the leading causes of cancer-related death worldwide. There were debates on the value of the second-line and beyond chemotherapy by the time we designed this trial. So we designed this phase II trial to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.
METHODS
Thirty-four patients with pretreated metastatic gastric cancer were enroled in the study. Patients received pemetrexed 500 mg m(-2) every 21 days until the presence of progressive disease (PD) or unacceptable toxicity.
RESULTS
A total of 34 patients were enroled in the study; 34 were eligible for toxicity and 30 for response. The response rate was 13.3%, 13.3% patients achieved a partial response, 50.0% achieved stable disease and 36.7% had a PD as the best response. The median overall survival time and median progression-free survival time was 6.4 months (95% confidence interval (CI) 5.8-9.5 months) and 2.2 months (95% CI 2.0-5.5 months), respectively. Most haematologic and non-haematologic toxicity were grade 1/2. Grade 3/4 toxicity included fatigue, neutropenia, thrombocytopenia, weight loss, anorexia and transaminase elevation.
CONCLUSIONS
The monochemotherapy of pemetrexed is active and well tolerated when used in previously treated patients with metastatic gastric cancer.
背景
胃癌是全球癌症相关死亡的主要原因之一。在我们设计本试验时，对于二线及后续化疗的价值存在争议。因此，我们设计了这项II期试验，以评估培美曲塞在预处理的转移性胃癌患者中的疗效和安全性。
方法
34例预处理的转移性胃癌患者纳入本研究。患者每21天接受500mg/m²培美曲塞治疗，直至出现疾病进展（PD）或不可接受的毒性。
结果
共有34例患者纳入本研究；34例符合毒性评估标准，30例符合疗效评估标准。缓解率为13.3%，13.3%的患者达到部分缓解，50.0%的患者疾病稳定，36.7%的患者以PD为最佳反应。中位总生存时间和中位无进展生存时间分别为6.4个月（95%置信区间（CI）5.8 - 9.5个月）和2.2个月（95%CI 2.0 - 5.5个月）。大多数血液学和非血液学毒性为1/2级。3/4级毒性包括疲劳、中性粒细胞减少、血小板减少、体重减轻、厌食和转氨酶升高。
结论
培美曲塞单药化疗用于既往治疗过的转移性胃癌患者时具有活性且耐受性良好。
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