Schuette Wolfgang, Blankenburg Thomas, Guschall Wolf, Dittrich Ina, Schroeder Michael, Schweisfurth Hans, Chemaissani Assaad, Schumann Christian, Dickgreber Nikolas, Appel Tabea, Ukena Dieter
City Hospital Martha-Maria Halle-Doelau, Germany.
Clin Lung Cancer. 2006 Mar;7(5):338-43. doi: 10.3816/clc.2006.n.016.
The combination of paclitaxel with carboplatin is effective in advanced-stage non-small cell lung cancer (NSCLC). This phase III study was designed to compare the efficacy and tolerability of a weekly versus an every-3-week schedule in the first-line treatment of advanced-stage NSCLC.
Chemotherapy-naive patients were randomized to receive paclitaxel 100 mg/m2 and carboplatin at an area under the curve of 2 once weekly for 6-8 weeks (arm A) or paclitaxel 200 mg/m2 and carboplatin at an area under the curve of 6 on day 1 every 21 days (arm B).
A total of 883 patients received >or= 1 chemotherapy cycle and were included in the results. The objective response rates observed (complete response plus partial response) were 38% for arm A and 33% for arm B. Median times to progression and median survival times were 6.1 months and 8.9 months in arm A and 7.2 months and 9.5 months in arm B, respectively. There were no significant differences between treatment arms. The chemotherapy was well tolerated in both schedules. However, grade 3/4 sensory neuropathy occurred more frequently with the every-3-week schedule (9.1% vs. 4.4%), whereas grade 3/4 diarrhea occurred more frequently with the weekly schedule (4.2% vs. 1.1%).
In terms of response and survival, paclitaxel/carboplatin administered once weekly is comparable with the every-3-week schedule. Toxicity differences should be considered when choosing the appropriate schedule for the individual.
紫杉醇与卡铂联合用药对晚期非小细胞肺癌（NSCLC）有效。本III期研究旨在比较晚期NSCLC一线治疗中每周给药方案与每3周给药方案的疗效和耐受性。
未接受过化疗的患者被随机分为两组，一组接受紫杉醇100mg/m²和卡铂曲线下面积为2，每周1次，共6 - 8周（A组）；另一组接受紫杉醇200mg/m²和卡铂曲线下面积为6，每21天第1天给药1次（B组）。
共有883例患者接受了≥1个化疗周期，并纳入结果分析。观察到的客观缓解率（完全缓解加部分缓解）A组为38%，B组为33%。A组的中位进展时间和中位生存时间分别为6.1个月和8.9个月，B组分别为7.2个月和9.5个月。两组治疗方案之间无显著差异。两种给药方案的化疗耐受性均良好。然而，每3周给药方案中3/4级感觉神经病变的发生率更高（9.1%对4.4%），而每周给药方案中3/4级腹泻的发生率更高（4.2%对1.1%）。
就缓解率和生存率而言，每周1次给予紫杉醇/卡铂与每3周给药方案相当。为个体选择合适的给药方案时应考虑毒性差异。
