Phase II study of irinotecan (CPT-11) alone in patients (pts) with metastatic pancreatic cancer.
Phase II study of irinotecan (CPT-11) alone in patients (pts) with metastatic pancreatic cancer.
复制标题
单独使用伊立替康 (CPT-11) 治疗转移性胰腺癌患者 (pts) 的 II 期研究。
DOI：
10.1200/jco.2004.22.14_suppl.4102
复制
发表时间：
2004
影响因子：
45.3
通讯作者：
S. Saitoh
中科院分区：
文献类型：
--
作者：
A. Funakoshi;T. Okusaka;H. Ishii;A. Sawaki;S. Ohkawa;O. Ishikawa;S. Saitoh
4102目的：本研究的目的是确定CPT-11单药治疗转移性胰腺癌患者的疗效和安全性。还研究了胆汁引流对CPT-11药代动力学的影响。
患者和方法
登记符合以下标准的未经化疗的转移性胰腺癌患者：可测量的转移性疾病、KPS≥50、年龄<75岁、ANC≥2000、Hgb≥10、Plts≥ 100 K、AST和ALT≤ 2.5 X nl、t-bili≤2.0、适当的器官功能和书面知情同意书。CPT-11（100 mg/m2，90分钟输注）在第1、8和15天给药，每4周一次。
结果
2001年8月至2002年11月期间入组了40例患者，37例患者可评价疗效和安全性。其特征为：M/F 25/12;中位年龄59岁（41-74）;中位KPS 90（100-70）; 2例患者有胆管引流。中位疗程数为2（1-10）。使用二维标准，10例患者（27%）显示部分缓解（PR），而使用RECIST标准评估表明29例患者中有8例PR（28%）。中性粒细胞减少、腹泻和呕吐是常见的不良事件，与CPT-11单药治疗的其他研究相同。中位生存期为7.3个月。1例患者因CPT-11诱导的中性粒细胞减少和腹泻而死于脓毒症。其他严重不良事件（SAE）为中性粒细胞减少和血小板减少。阻塞性黄疸、胆红素升高和胃静脉曲张出血也作为与药物无关的SAE发生。7例患者（包括2例胆道引流患者）用于评估药代动力学。有或无胆汁引流的患者之间CPT-11的AUC相似，但有引流的患者中代谢产物（SN-38、APC和SN-38葡萄糖醛酸苷）的AUC较大。
结论
CPT-11单药治疗对转移性胰腺癌有效。无重大财务关系需要披露。
4102 Purpose: The objective of this study was to determine the efficacy and safety of CPT-11 monotherapy in pts with metastatic pancreatic cancer. The influence of biliary drainage on the pharmacokinetics of CPT-11 was also investigated.
PATIENTS AND METHODS
Chemotherapy naive pts with metastatic pancreatic cancer who fulfilled the following criteria were registered: measurable metastatic disease, KPS≥50, age<75, ANC≥2000, Hgb≥10, Plts≥100K, AST&ALT≤2.5X nl, t-bili≤2.0, adequate organ function, and written informed consent. CPT-11 (100 mg/m2 as a 90-minute infusion) was administered on days 1, 8, and 15 every 4 weeks.
RESULTS
Forty pts were enrolled between Aug. 2001 and Nov. 2002, and 37 pts were evaluable for efficacy and safety. Their characteristics were: M/F 25/12; median age 59 years (41-74); median KPS 90 (100-70); and 2 pts with biliary drainage. Median number of courses administered was 2 (1-10). Ten pts (27%) showed a partial response (PR) using bi-dimensional criteria, while assessment using RECIST criteria indicated 8 PRs (28%) in 29 pts. Neutropenia, diarrhea, and vomiting were the common adverse events, as in other studies of CPT-11 monotherapy. The median survival time was 7.3 months. One pt was died of sepsis due to neutropenia and diarrhea induced by CPT-11. Other serious adverse events (SAE) were neutropenia and thrombocytopenia. Obstructive jaundice, elevated bilirubin and gastric variceal bleeding also occurred as drug unrelated SAE. Seven pts (including 2 with biliary drainage) were used to assess pharmacokinetics. The AUC of CPT-11 was similar between pts with or without biliary drainage, but the metabolites (SN-38, APC, and SN-38 glucuronide) showed larger AUCs in the pts with drainage.
CONCLUSIONS
CPT-11 monotherapy is effective for metastatic pancreatic cancer. No significant financial relationships to disclose.