早期非小细胞肺癌辅助化疗中顺铂和培美曲塞与顺铂和长春瑞滨的精细调整的随机 II 期试验的 3 年随访结果（TREAT 研究）。

Three-Year Follow-Up of a Randomized Phase II Trial on Refinement of Early-Stage NSCLC Adjuvant Chemotherapy with Cisplatin and Pemetrexed versus Cisplatin and Vinorelbine (the TREAT Study).

机构信息

Pneumology, Thoraxklinik, University of Heidelberg, Heidelberg, Germany; Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.

Respiratory Oncology Unit (Pneumology Department), University Hospital KU Leuven, Leuven, Belgium.

出版信息

J Thorac Oncol. 2016 Jan;11(1):85-93. doi: 10.1016/j.jtho.2015.09.014.

DOI:10.1016/j.jtho.2015.09.014

PMID:26762743

Abstract

INTRODUCTION

Adjuvant chemotherapy in non-small cell lung cancer (NSCLC) improves survival but is associated with significant toxicity. The Randomized Phase II Trial on Refinement of Early-Stage NSCLC Adjuvant Chemotherapy with Cisplatin and Pemetrexed versus Cisplatin and Vinorelbine (TREAT study) was designed to test the hypothesis that a protocol with reduced toxicity might improve feasibility of postoperative delivery of adjuvant chemotherapy drugs to patients with NSCLC, thereby improving compliance and, potentially, survival.

METHODS

Two adjuvant regimens were evaluated for feasibility in 132 patients with NSCLC: the standard regimen of cisplatin and vinorelbine (CVb) (cisplatin 50 mg/m(2) on day 1 and day 8 and vinorelbine 25 mg/m(2) on days 1, 8, 15, and 22 every 4 weeks) and a regimen consisting of cisplatin and pemetrexed (CPx) (cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 every 3 weeks). The primary end-point analysis showing that CPx is safe and feasible with dose delivery superior to that of CVb has already been published. Here we report the 3-year follow-up results of the secondary efficacy end points-overall, relapse-free, distant metastasis-free, and local relapse-free survival-also with regard to histologic diagnosis.

RESULTS

After a median of 39 months, no significant differences in any of the outcome parameters between CVb and CPx were observed. Also, histologic diagnosis and tumor size in stage IB did not influence survival in the CPx-treated patients. Yet, Cox regression analyses showed that overall survival at 3 years was significantly correlated with feasibility and the occurrence of dose-limiting toxicity.

CONCLUSIONS

Although adjuvant chemotherapy with CPx is safe and characterized by less toxicity and better dose delivery than CVb, overall survival was not influenced by treatment arm in the context of this phase II trial.

摘要

简介

非小细胞肺癌（NSCLC）的辅助化疗可提高生存率，但与显著的毒性相关。顺铂和培美曲塞与顺铂和长春瑞滨用于非小细胞肺癌辅助化疗的随机 II 期试验（TREAT 研究）旨在检验以下假说，即一个毒性降低的方案可能会提高 NSCLC 术后辅助化疗药物给药的可行性，从而提高依从性，并可能提高生存率。

方法

对 132 例 NSCLC 患者评估了两种辅助方案的可行性：顺铂和长春瑞滨（CVb）标准方案（顺铂 50 mg/m2，第 1 天和第 8 天；长春瑞滨 25 mg/m2，第 1、8、15 和 22 天，每 4 周一次）和顺铂和培美曲塞（CPx）方案（顺铂 75 mg/m2 和培美曲塞 500 mg/m2，第 1 天，每 3 周一次）。CPx 安全且可行，剂量给药优于 CVb 的主要终点分析结果已发表。这里我们报告了次要疗效终点（总生存、无复发生存、无远处转移生存和局部无复发生存）的 3 年随访结果，也与组织学诊断有关。