Yoh Kiyotaka, Kubota Kaoru, Kakinuma Ryutaro, Ohmatsu Hironobu, Goto Koichi, Niho Seiji, Saijo Nagahiro, Nishiwaki Yutaka
Division of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
Lung Cancer. 2007 Oct;58(1):73-9. doi: 10.1016/j.lungcan.2007.04.015. Epub 2007 Jun 4.
The purpose of this phase II trial was to evaluate the efficacy and toxicity of carboplatin plus paclitaxel in the treatment of advanced non-small cell lung cancer (NSCLC) previously treated with chemotherapy. Patients with a performance status (PS) of 0 or 1 who had received one or two previous chemotherapy regimens for advanced NSCLC were eligible. Paclitaxel 200mg/m(2) was infused over 3h and followed by carboplatin (area under the curve 6) infusion over 1h, once every 3 weeks. Thirty patients were enrolled. A complete response was observed in 1 patient and a partial response in 10 patients, for an overall response rate of 36.7%. The median time to progression was 5.3 months. The median survival time was 9.9 months, and the 1-year survival rate was 47%. Hematological toxicity in the form of grade 3/4 neutropenia occurred in 54%, but grade 3 febrile neutropenia developed in only 3%. Non-hematological grade 3 toxicities were less frequent. There were no treatment-related deaths. The combination of carboplatin plus paclitaxel is an active and well-tolerated regimen for the treatment of NSCLC patients who have previously been treated with chemotherapy and have a good PS.
本II期试验的目的是评估卡铂联合紫杉醇治疗先前接受过化疗的晚期非小细胞肺癌（NSCLC）的疗效和毒性。符合条件的患者为既往接受过一或两个晚期NSCLC化疗方案、体能状态（PS）为0或1的患者。紫杉醇200mg/m²静脉滴注3小时，随后卡铂（曲线下面积为6）静脉滴注1小时，每3周一次。共入组30例患者。1例患者达到完全缓解，10例患者达到部分缓解，总缓解率为36.7%。中位疾病进展时间为5.3个月。中位生存时间为9.9个月，1年生存率为47%。3/4级中性粒细胞减少形式的血液学毒性发生率为54%，但3级发热性中性粒细胞减少仅发生3%。非血液学3级毒性较少见。无治疗相关死亡。卡铂联合紫杉醇对先前接受过化疗且PS良好的NSCLC患者是一种有效的且耐受性良好的治疗方案。
