Phase II study of a combination of irinotecan and cisplatin against metastatic gastric cancer
Phase II study of a combination of irinotecan and cisplatin against metastatic gastric cancer
复制标题
DOI：
10.1200/jco.1999.17.1.319
复制
发表时间：
1999-01-01
影响因子：
45.3
通讯作者：
Hyodo, I
中科院分区：
文献类型：
--
作者：
Boku, N;Ohtsu, A;Hyodo, I
目的：顺铂（CDDP）和伊立替康（CPT-11）联合化疗方案的II期研究是为了评估其在转移性胃癌患者中的疗效和可行性。（1）组织学证实的胃癌，具有可测量的转移性病变，（2）体力状态为2或更低，（3）年龄为75岁或更小，（4）既往接受过一次或未接受过化疗，（5）骨髓、肝脏、肾脏和心脏功能良好，以及（6）知情同意书。CPT-11（70 mg/m2）第1天和第15天，CDDP（80 mg/m2）第1天，每4周重复一次。总缓解率为48%（21/44例患者，95%置信区间[CI]，33%-63%），包括1例完全缓解（2%），既往未接受过化疗的患者的缓解率为59%（17/29例患者，95% CI，39%-77%）。所有患者的中位生存期为272天，29例未接受过化疗的患者为322天，25例（57%）患者观察到4级中性粒细胞减少，9例（20%）患者观察到3或4级腹泻，其他不良反应轻微，无治疗相关死亡。这种联合化疗方案是有效的，耐受性良好。它可能是未来III期试验的适当方案。J Clin Oncol 17：319-323，（C）1999，美国临床肿瘤学会。
Purpose: 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.Patients and Methods: 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/m(2)) on day 1 and day 15 and CDDP (80 mg/m(2)) on day 1, repeated every 4 weeks.Results: 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 rare of the patients who had not received prior chemotherapy wets 59% (17 of 29 patients, 95% CI, 39% ta 77%). The median survival time wets 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.Conclusion: This combination chemotherapy regimen is active and well tolerated. It may be an appropriate regimen for future phase III trials.J Clin Oncol 17:319-323, (C) 1999 by American Society of Clinical Oncology.