卡培他滨/奥沙利铂联合放疗治疗局部晚期肛门管鳞癌的 II 期研究。

A Phase II Study of Capecitabine/Oxaliplatin With Concurrent Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Anal Canal.

机构信息

Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX.

出版信息

Clin Colorectal Cancer. 2019 Dec;18(4):301-306. doi: 10.1016/j.clcc.2019.06.003. Epub 2019 Jul 2.

DOI:10.1016/j.clcc.2019.06.003

PMID:31350201

Abstract

INTRODUCTION

Squamous cell carcinoma of the anal canal (SCCA) presents a rising incidence in the United States. Standard of care for locally advanced disease is comprised of infusional 5-fluorouracil with mitomycin C or cisplatin concurrent with radiation therapy (RT). We designed this trial to evaluate the efficacy and safety of a more convenient regimen composed of capecitabine and oxaliplatin.

PATIENTS AND METHODS

This was a single-arm, phase II trial, with treatment-naive stage II to IIIB (TX,1-4NxM0) SCCA patients. The regimen was composed of capecitabine (825 mg/m twice per day for 5 days) and oxaliplatin (50 mg/m weekly) during weeks 1 through 6, concurrent with RT (XELOX-XRT; group 1). After the first 11 patients, the study was amended to omit chemotherapy during the third and sixth weeks (group 2). The primary objective was 3-year time to treatment failure (TTF) and safety. Secondary objectives were complete response (CR) rate, locoregional control, colostomy-free survival (CFS), and overall survival (OS).

RESULTS

Twenty patients were enrolled. Seven patients of group 1 (63%) developed Grade 3 toxicity, which reduced to 22% in Group 2. No Grade 4 toxicities were noted. The median RT dose was 55 Gy. CR occurred in 100% of the 19 patients evaluable for response at 12 to 14 weeks. After a median follow-up of 47.6 months, 2 patients had local recurrence and 1 had distant recurrence. Three-year TTF was 90.0%, with similar rates between groups 1 and 2 (respectively, 90.9% vs. 88.8%, P = .984). Three-year CFS was 90.0%. The median OS has not been reached.

CONCLUSION

The XELOX-XRT regimen is safe, with promising efficacy, and should be explored in larger trials for the treatment of locally advanced SCCA.

摘要

介绍

在美国，肛门管鳞癌（SCCA）的发病率呈上升趋势。局部晚期疾病的标准治疗包括氟尿嘧啶持续输注联合丝裂霉素 C 或顺铂，同时进行放射治疗（RT）。我们设计了这项试验来评估更方便的方案（卡培他滨和奥沙利铂）的疗效和安全性。

患者和方法

这是一项单臂、二期试验，纳入了未经治疗的 II 期至 IIIB 期（TX，1-4NxM0）SCCA 患者。方案包括卡培他滨（825mg/m，每日两次，连用 5 天）和奥沙利铂（50mg/m，每周一次），在第 1 周到第 6 周进行，同时进行 RT（XELOX-XRT；第 1 组）。在最初的 11 例患者后，研究修改为在第 3 周和第 6 周省略化疗（第 2 组）。主要目标是 3 年治疗失败时间（TTF）和安全性。次要目标是完全缓解（CR）率、局部区域控制、无结肠造口术生存（CFS）和总生存（OS）。

结果

共纳入 20 例患者。第 1 组 7 例（63%）患者出现 3 级毒性，第 2 组降至 22%。无 4 级毒性。中位 RT 剂量为 55Gy。19 例可评估反应的患者中，12 至 14 周时 100%出现 CR。中位随访 47.6 个月后，2 例患者发生局部复发，1 例发生远处复发。3 年 TTF 为 90.0%，两组之间相似（分别为 90.9%和 88.8%，P=0.984）。3 年 CFS 为 90.0%。中位 OS 尚未达到。