Phase II trial of oxaliplatin as first-line chemotherapy in metastatic colorectal cancer patients
Phase II trial of oxaliplatin as first-line chemotherapy in metastatic colorectal cancer patients
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DOI：
10.1200/jco.1998.16.8.2739
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发表时间：
1998-08-01
影响因子：
45.3
通讯作者：
Rougier, P
中科院分区：
文献类型：
--
作者：
Bécouarn, Y;Ychou, M;Rougier, P
目的：评估奥沙利铂用于既往未治疗的转移性结直肠癌患者的客观肿瘤反应、罕见性和安全性。患者和方法：共有39例患者进入该II期试验，1例患者因患有第二癌而被排除，因此该研究基于38例患者。患者接受奥沙利铂130 mg/m(2)，第1天输注2小时，每21天一次。每三个疗程评估患者的反应。所有临床和放射学数据由外部专家小组审查，他们的评估被认为是确定的。结果：共观察到9例部分反应（pr），反应率为24.3%，95%可信区间为11.8% ~ 41.2%。中位反应持续时间为216天以上。病情稳定15例（40.5%），病情进展13例（35.2%）。所有患者的中位无进展生存期为126+天（范围21 ~ 447+天），主要毒性为周围感觉神经病变。3级神经毒性（美国国家癌症研究所共同毒性标准[NCI-CTC]）为13%，血液和胃肠道毒性较轻。3级中性粒细胞减少的发生率为5.2%，3级或4级血小板减少的发生率为7.9%，呕吐（3级或4级）发生率为7.9%，3级腹泻发生率为2.6%。结论：这项II期研究为奥沙利铂单药治疗先前未经治疗的转移性结直肠癌患者的安全性和有效性提供了明确的证据。[J]中华临床杂志，16:2739-2744。(C)美国临床肿瘤学会1998。
Purpose: To evaluate the objective tumor response rare and safety profile of oxaliplatin when administered to patients with previously untreated metastatic colorectal adenocarcinoma,Patients and Methods: A total of 39 patients were entered onto this phase II trial, One patient was excluded for having held a second cancer, so the study was based on 38 patients. Patients were treated with oxaliplatin 130 mg/m(2) as a 2-hour infusion on day 1, every 21 days. Patients were assessed for response every three courses. All clinical and radiologic data were reviewed by an external panel of experts, with their assessment being considered definitive.Results: Nine partial responses (PRs) were observed (response rate, 24.3%; 95% confidence interval, 11.8% to 41.2%). The median duration of response was 216+ days. Fifteen patients (40.5%) had stable disease and 13 (35.2%) had progressive disease. The median progression-free survival time for all patients was 126+ days (range, 21 to 447+), The main toxicity was peripheral sensory neuropathy. Grade 3 neurotoxicity (National Cancer Institute common toxicity criteria [NCI-CTC]) was reported in 13%, Hematologic and gastrointestinal toxicities were mild. The incidence of grade 3 neutropenia was 5.2%, while that of grade 3 or 4 thrombopenia was 7.9%, Vomiting (grade 3 or 4) occurred in 7.9% of patients and grade 3 diarrhea in 2.6%,Conclusion: This phase II study provides clear evidence of the safety and efficacy of oxaliplatin monotherapy at this dose and schedule in patients with previously untreated metastatic colorectal carcinoma. J Clin Oncol 16:2739-2744. (C) 1998 by American Society of Clinical Oncology.