Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kyushu University, Fukuoka, Japan.
Oncologist. 2019 Nov;24(11):1420-e1010. doi: 10.1634/theoncologist.2019-0513. Epub 2019 Jul 22.
This clinical trial, evaluating the efficacy and safety of a carboplatin plus paclitaxel regimen in a biweekly or weekly schedule instead of the more toxic 3-weekly administration, showed that the weekly regimen was better in efficacy than the biweekly regimen, with mild toxicities, for patients with non-small cell lung cancer (NSCLC).The weekly carboplatin plus paclitaxel regimen could be considered as an alternative to the 3-weekly regimen in Japanese patients with NSCLC.
Combination therapy comprising carboplatin (C) and paclitaxel (P) is the most commonly used regimen for the treatment of advanced non-small cell lung cancer (NSCLC). Common toxicities associated with the regimen, such as neuropathy and myelosuppression, cause its discontinuation. In the present study, we conducted a clinical trial evaluating the efficacy of biweekly (B) and weekly (W) PC therapy to identify the appropriate chemotherapy schedule for Asian patients.
Chemonaive patients with IIIB/IV NSCLC and a performance status of 0-1 were randomly assigned to a biweekly regimen (paclitaxel 135 mg/m with carboplatin area under the curve [AUC] 3 on days 1 and 15 of every 4 weeks) or to a weekly regimen (paclitaxel 90 mg/m on days 1, 8, and 15 with carboplatin AUC 6 on day 1 of every 4 weeks).
A total of 140 patients were enrolled in the study. The objective response rates (ORRs) were 28.1% (B) and 38.0% (W). The most common toxicity was neutropenia, with incidence rates of 62.0% (B) and 57.8% (W). Progression-free survivals (PFSs) were 4.3 months (B) and 5.1 months (W), and overall survival durations were 14.2 months (B) and 13.3 months (W).
The ORR and PFS in the weekly regimen were better than those in the biweekly schedule, although a statistical difference was not observed. The toxicity profile was generally mild for both regimens. The weekly CP regimen was suitable to be considered as an alternative to the current 3-weekly regimen in NSCLC treatment.
这项临床试验评估了卡铂加紫杉醇方案在两周或每周方案中的疗效和安全性，而不是更具毒性的三周方案，结果表明，每周方案的疗效优于两周方案，毒性较小，适用于非小细胞肺癌（NSCLC）患者。对于日本的 NSCLC 患者，每周卡铂加紫杉醇方案可考虑替代三周方案。
卡铂（C）加紫杉醇（P）联合治疗是治疗晚期非小细胞肺癌（NSCLC）最常用的方案。该方案常见的神经病变和骨髓抑制等毒性导致其停药。在本研究中，我们进行了一项临床试验，评估了两周（B）和每周（W）PC 治疗的疗效，以确定适合亚洲患者的化疗方案。
随机分配未经化疗的 IIIB/IV 期 NSCLC 患者和表现状态为 0-1 的患者至两周方案（紫杉醇 135mg/m 加卡铂曲线下面积 [AUC] 3 于每 4 周的第 1 天和第 15 天）或每周方案（紫杉醇 90mg/m 于第 1、8 和 15 天，卡铂 AUC 6 于每 4 周的第 1 天）。
共有 140 名患者入组。客观缓解率（ORR）分别为 28.1%（B）和 38.0%（W）。最常见的毒性是中性粒细胞减少症，发生率分别为 62.0%（B）和 57.8%（W）。无进展生存期（PFS）分别为 4.3 个月（B）和 5.1 个月（W），总生存期分别为 14.2 个月（B）和 13.3 个月（W）。
每周方案的 ORR 和 PFS 优于两周方案，但无统计学差异。两种方案的毒性谱均较轻。每周 CP 方案适合替代 NSCLC 治疗中的现行三周方案。
