Lau D, Ryu J, Gandara D, Morgan R, Doroshow J, Wilder R, Leigh B
University of California, Davis Cancer Center, Sacramento, CA 95817, USA.
Semin Radiat Oncol. 1999 Apr;9(2 Suppl 1):117-20.
Concurrent twice-weekly paclitaxel and thoracic radiation (XRT) for stage III non-small cell lung cancer were studied in a phase I trial. Radiation was delivered in fractions of 1.8 to 2.0 Gy/d to a total dose of 61 Gy. Paclitaxel, at a starting dose of 25 mg/m2/d, was administered intravenously over 1 hour before daily XRT on Mondays and Thursdays for 6 weeks for a total of 12 doses. The paclitaxel dose was escalated by 5 mg/m2/d for each cohort of patients to determine the maximum tolerated dose. The highest dose of paclitaxel reached was 40 mg/m2, which resulted in dose-limiting toxicities of esophagitis and local skin desquamation. For each dose group, the median total number of paclitaxel doses administered was 12 and the median total XRT dose delivered was 61 Gy. The overall response rate was 80%. The overall median survival was 20 months and the 3-year survival rate was 20%. We conclude that the maximum tolerated dose of paclitaxel is 35 mg/m2 given twice weekly for 6 weeks concurrently with XRT. This study provides the basis for using paclitaxel, given twice weekly at 30 mg/m2, with weekly carboplatin and concurrent XRT for stage III non-small cell lung cancer in an ongoing phase II trial.
在一项I期试验中，对III期非小细胞肺癌患者进行了每周两次的紫杉醇与胸部放疗（XRT）联合治疗的研究。放疗采用每天1.8至2.0 Gy的分次剂量，总剂量为61 Gy。紫杉醇起始剂量为25 mg/m²/d，在周一和周四每天进行XRT前1小时静脉滴注1小时，共6周，总计12剂。每一组患者的紫杉醇剂量以5 mg/m²/d的幅度递增，以确定最大耐受剂量。所达到的最高紫杉醇剂量为40 mg/m²，导致食管炎和局部皮肤脱屑等剂量限制性毒性反应。对于每个剂量组，紫杉醇给药的中位总剂量为12剂，XRT的中位总剂量为61 Gy。总体缓解率为80%。总体中位生存期为20个月，3年生存率为20%。我们得出结论，紫杉醇的最大耐受剂量为35 mg/m²，每周两次，共6周，与XRT同时进行。本研究为在一项正在进行的II期试验中，每周两次给予30 mg/m²的紫杉醇，联合每周一次的卡铂和同步XRT用于III期非小细胞肺癌提供了依据。
