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晚期肺鳞癌中卡铂和白蛋白结合型紫杉醇诱导治疗后用 S-1 进行维持治疗的切换。

Switch maintenance therapy with S-1 after induction therapy with carboplatin and nanoparticle albumin-bound paclitaxel in advanced lung squamous cell carcinoma.

机构信息

Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan.

Department of Clinical Oncology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan.

出版信息

Invest New Drugs. 2019 Jun;37(3):531-537. doi: 10.1007/s10637-019-00747-x. Epub 2019 Feb 21.

DOI:10.1007/s10637-019-00747-x
PMID:30790149
Abstract

Background Optimal maintenance therapy for lung squamous cell carcinoma (SCC) has not been established. The aim of this study was to evaluate the efficacy and safety of switch maintenance therapy with S-1, an oral fluoropyrimidine, after induction therapy with carboplatin and nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in chemotherapy-naïve patients with advanced SCC. Methods Chemotherapy-naïve patients with advanced SCC received induction therapy with four cycles of carboplatin (at an area under the curve of 6, day 1 of a 28-day cycle) and nab-paclitaxel (100 mg/kg, days 1, 8, and 15). Patients who achieved disease control after induction therapy received maintenance therapy with S-1 (80 mg/m, days 1-14 of a 21-day cycle) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) from the start of maintenance therapy. Results Seventy-two patients with SCC were enrolled to the study. After four cycles of induction therapy, 35 (48.6%) patients achieved disease control, and 31 (43.1%) of these patients received maintenance therapy. Median PFS from the start of maintenance therapy was 3.0 months (95% confidence interval: 2.1-3.8 months). The most common toxicities of grade 3 or higher during maintenance therapy were nausea (13.3%), neutropenia (10.0%), and diarrhea (6.7%). Conclusions Switch maintenance therapy with S-1 after induction therapy with carboplatin and nab-paclitaxel was associated with moderate efficacy and acceptable safety and may represent a feasible treatment option for patients with advanced SCC.

摘要

背景

尚未确定肺鳞状细胞癌(SCC)的最佳维持治疗方案。本研究旨在评估在初治的晚期 SCC 患者中,卡铂和白蛋白结合型紫杉醇(nab-紫杉醇)诱导治疗后,换用口服氟嘧啶 S-1 进行维持治疗的疗效和安全性。

方法

化疗初治的晚期 SCC 患者接受了 4 个周期的卡铂(曲线下面积 6,每 28 天周期的第 1 天)和 nab-紫杉醇(100mg/kg,第 1、8 和 15 天)诱导治疗。诱导治疗后疾病得到控制的患者接受 S-1(80mg/m,每 21 天周期的第 1-14 天)维持治疗,直至疾病进展或出现不可耐受的毒性。主要终点是从维持治疗开始的无进展生存期(PFS)。

结果

共有 72 例 SCC 患者入组该研究。在 4 个周期的诱导治疗后,35 例(48.6%)患者达到疾病控制,其中 31 例(43.1%)患者接受了维持治疗。从维持治疗开始的中位 PFS 为 3.0 个月(95%置信区间:2.1-3.8 个月)。维持治疗期间最常见的 3 级或以上毒性是恶心(13.3%)、中性粒细胞减少(10.0%)和腹泻(6.7%)。

结论

卡铂和 nab-紫杉醇诱导治疗后换用 S-1 维持治疗具有一定的疗效和可接受的安全性,可能是晚期 SCC 患者的一种可行的治疗选择。

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