Boku N, Ohtsu A, Shimada Y, Shirao K, Seki S, Saito H, Sakata Y, Hyodo I
Department of Gastrointestinal Oncology and Gastroenterology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
J Clin Oncol. 1999 Jan;17(1):319-23. doi: 10.1200/JCO.1999.17.1.319.
A phase II study of a combination chemotherapy regimen of cisplatin (CDDP) and irinotecan (CPT-11) was conducted to assess its efficacy and feasibility in patients with metastatic gastric cancer.
Eligibility criteria included the following: (1) histologically proven gastric cancer with measurable metastatic lesions, (2) performance status of 2 or less, (3) age of 75 years or younger, (4) one or no prior chemotherapy regimens, (5) adequate bone marrow, liver, renal, and cardiac functions, and (6) written informed consent. The treatment consisted of CPT-11 (70 mg/m2) on day 1 and day 15 and CDDP (80 mg/m2) on day 1, repeated every 4 weeks.
Forty-four patients were entered onto the study. The overall response rate was 48% (21 of 44 patients, 95% confidence interval [CI], 33% to 63%) and included one complete remission (2%). The response rate of the patients who had not received prior chemotherapy was 59% (17 of 29 patients, 95% CI, 39% to 77%). The median survival time was 272 days for all patients and 322 days for the 29 patients who had not received prior chemotherapy. Grade 4 neutropenia was observed in 25 patients (57%), and grade 3 or 4 diarrhea was observed in nine patients (20%). Other adverse reactions were mild. No treatment-related deaths occurred.
This combination chemotherapy regimen is active and well tolerated. It may be an appropriate regimen for future phase III trials.
开展一项关于顺铂（CDDP）与伊立替康（CPT-11）联合化疗方案的II期研究，以评估其对转移性胃癌患者的疗效和可行性。
入选标准如下：（1）经组织学证实的胃癌且有可测量的转移病灶；（2）体能状态评分为2分或更低；（3）年龄75岁及以下；（4）接受过一种或未接受过先前的化疗方案；（5）骨髓、肝脏、肾脏和心脏功能良好；（6）签署书面知情同意书。治疗方案为第1天和第15天给予CPT-11（70mg/m²），第1天给予CDDP（80mg/m²），每4周重复一次。
44例患者进入该研究。总缓解率为48%（44例患者中的21例，95%置信区间[CI]，33%至63%），包括1例完全缓解（2%）。未接受过先前化疗的患者缓解率为59%（29例患者中的17例，95%CI，39%至77%）。所有患者的中位生存时间为272天，未接受过先前化疗的29例患者为322天。25例患者（57%）出现4级中性粒细胞减少，9例患者（20%）出现3级或4级腹泻。其他不良反应较轻。未发生与治疗相关的死亡。
该联合化疗方案具有活性且耐受性良好。它可能是未来III期试验的合适方案。
