Xiong Henry Q, Varadhachary Gauri R, Blais Joan C, Hess Kenneth R, Abbruzzese James L, Wolff Robert A
Center for Cancer and Blood Disorders, Fort Worth, Texas, USA.
Cancer. 2008 Oct 15;113(8):2046-52. doi: 10.1002/cncr.23810.
To the authors' knowledge, there is no established second-line chemotherapy for patients with pancreatic cancer who have received gemcitabine-based therapy. A phase 2 trial was conducted to explore the efficacy of capecitabine and oxaliplatin (XELOX) in patients with advanced pancreatic cancer previously who were treated with gemcitabine.
Patients aged < or = 65 years who had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 received oxaliplatin at a dose of 130 mg/m(2) given on Day 1 and capecitabine at a dose of 1000 mg/m(2) twice daily for 14 days. For patients aged >65 years or with an ECOG PS of 2, the oxaliplatin dose was 110 mg/m(2) on Day 1 and the capecitabine dose was 750 mg/m(2) twice daily for 14 days. The treatment was repeated every 3 weeks. Tumor measurements were performed every 9 weeks and the primary study objective was 6-month overall survival.
The study enrolled 41 patients. Of the 39 evaluable patients, 1 patient had a partial response and 10 patients demonstrated stable disease. The Kaplan-Meier estimate of the overall median survival was 23 weeks (95% confidence interval [95% CI], 17.0-31.0 weeks). Progression-free survival was 9.9 weeks (95% CI, 9.6-14.5 weeks). The 6-month and 1-year survival rates were 44% (95% CI, 31%-62%) and 21% (95% CI, 11%-38%), respectively. The most common grade 3-4 nonhematologic toxicity was fatigue (toxicity was graded using the National Cancer Institute Common Toxicity Criteria [version 2.0]).
The combination of capecitabine and oxaliplatin is active in gemcitabine-pretreated patients with advanced pancreatic cancer, especially in patients with a good PS and those who have responded to first-line chemotherapy.
据作者所知，对于接受过以吉西他滨为基础治疗的胰腺癌患者，尚无既定的二线化疗方案。开展了一项2期试验，以探究卡培他滨联合奥沙利铂（XELOX方案）对先前接受过吉西他滨治疗的晚期胰腺癌患者的疗效。
年龄≤65岁、东部肿瘤协作组（ECOG）体能状态（PS）为0至1的患者，第1天接受剂量为130 mg/m²的奥沙利铂，卡培他滨剂量为1000 mg/m²，每日两次，共14天。对于年龄＞65岁或ECOG PS为2的患者，第1天奥沙利铂剂量为110 mg/m²，卡培他滨剂量为750 mg/m²，每日两次，共14天。每3周重复一次治疗。每9周进行肿瘤测量，主要研究目标为6个月总生存期。
该研究纳入41例患者。在39例可评估患者中，1例部分缓解，10例病情稳定。总体中位生存期的Kaplan-Meier估计值为23周（95%置信区间[95%CI]，17.0 - 31.0周）。无进展生存期为9.9周（95%CI，9.6 - 14.5周）。6个月和1年生存率分别为44%（95%CI，31% - 62%）和21%（95%CI，11% - 38%）。最常见的3 - 4级非血液学毒性为疲劳（毒性分级采用美国国立癌症研究所通用毒性标准[第2.0版]）。
卡培他滨联合奥沙利铂对接受过吉西他滨预处理的晚期胰腺癌患者有效，尤其是PS良好以及对一线化疗有反应的患者。
