完全切除的非小细胞肺癌患者辅助化疗中每两周使用卡铂加紫杉醇的 II 期试验。
Phase II trial of adjuvant chemotherapy with bi-weekly carboplatin plus paclitaxel in patients with completely resected non-small cell lung cancer.
机构信息
Second Department of Surgery, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan.
出版信息
Anticancer Res. 2010 Jul;30(7):3039-44.
BACKGROUND
Adjuvant chemotherapy improves the prognosis of patients with non-small cell lung cancer (NSCLC) after a complete resection despite unacceptable toxicity and low compliance.
METHODS
A total of 67 patients were enrolled in a multi-institutional study. The patients received chemotherapy with carboplatin (CBDCA) area under the curve of 3 and paclitaxel (PTX) 90 mg/m(2) every 2 weeks for six cycles after surgery.
RESULTS
Fifty patients (74.6%) completed all cycles of therapy. The presence of grade 3 and 4 toxicities of neutropenia were 13.4, and 3.0%, respectively. Non-haematological adverse effects were infrequent and no treatment-related death was registered. The estimated disease-free survival and overall survival at 2 years were 89.0% and 88.8%, respectively.
CONCLUSION
A bi-weekly schedule of CBDCA and PTX as adjuvant chemotherapy showed an acceptable toxicity and favourable feasibility in Japanese NSCLC patients after complete tumor resection. Consequently, it is desirable to validate this regimen in a future randomized clinical trial.
背景
尽管辅助化疗具有不可接受的毒性和低顺应性，但仍能改善完全切除术后非小细胞肺癌（NSCLC）患者的预后。
方法
共有 67 名患者参加了一项多机构研究。患者接受了术后每 2 周用卡铂（CBDCA）曲线下面积 3 和紫杉醇（PTX）90mg/m2 的化疗，共 6 个周期。
结果
50 名患者（74.6%）完成了所有周期的治疗。中性粒细胞减少症的 3 级和 4 级毒性的发生率分别为 13.4%和 3.0%。非血液学不良事件不常见，无治疗相关死亡。2 年时无病生存率和总生存率分别为 89.0%和 88.8%。
结论
在完全肿瘤切除后的日本 NSCLC 患者中，每 2 周一次的 CBDCA 和 PTX 方案作为辅助化疗显示出可接受的毒性和良好的可行性。因此，在未来的随机临床试验中验证该方案是可取的。
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