一项随机对照试验性研究，比较卡培他滨 - 奥沙利铂与5-氟尿嘧啶 - 亚叶酸钙作为局部晚期直肠癌新辅助同步放化疗的疗效。

A randomized controlled pilot study to compare capecitabine-oxaliplatin with 5-FU-leucovorin as neoadjuvant concurrent chemoradiation in locally advanced adenocarcinoma of rectum.

作者信息

Saha Animesh, Ghosh Sajal Kumar, Roy Chhaya, Saha Makhan Lal, Choudhury Krishnangshu Bhanja, Chatterjee Koushik

机构信息

Department of Radiotherapy, Institute of Post Graduate Medical Education and Research, Kolkata, India.

出版信息

J Cancer Res Ther. 2015 Jan-Mar;11(1):88-93. doi: 10.4103/0973-1482.150341.

DOI:10.4103/0973-1482.150341

PMID:25879343

Abstract

CONTEXT

Established as an adjuvant chemotherapy, CapeOX has recently been shown to have radiosensitizer property in a phase I and II studies, with appreciable downstaging and tolerable toxicities.

AIMS

The study was designed to evaluate whether the capecitabine-oxaliplatin combination was superior to 5-fluorouracil (5-FU)-leucovorin as radiosensitizer for neoadjuvant chemoradiation in downstaging locally advanced rectal adenocarcinoma and to compare the toxicities between the two arms.

SETTINGS AND DESIGN

Single institutional, double blinded, prospective, noncrossover, randomized control pilot study.

SUBJECTS AND METHODS

In arm A (n = 21), patients received capecitabine (1,000 mg/m(2) daily) in twice dailydoseon days 1-14 and 25-38 and oxaliplatin (85 mg/m(2)) intravenous ( IV) over 2 h, on D1 and D29. In arm B (n = 21), patients received leucovorin (20 mg/m(2)) and 5-FU (350 mg/m(2)) from D1-5 and D29-33. Patient in both the arms received concurrent radiation (50.4 Gy in 28 #, in conventional fractionation of 1.8 Gy per fraction). Six to eight weeks after concurrent chemoradiation, patients underwent assessment and surgery with total mesorectal resection. Postoperatively, adjuvant chemotherapy with m-FOLFOX 6 of 4 months was given to all patients.

STATISTICAL ANALYSIS USED

Chi-square test was used to compare categorical variables between the groups.

RESULTS

Objective response rate (ORR) in arm A was 80.95% compared to arm B which had 66.66% (P = 0.3055). Pathological complete response (pCR) rate of arm A was comparable to arm B (23.8 vs 14.28%, P value = 0.6944). Surgery with R0 resection was possible in 80.95% cases of arm A compared to 66.66% cases of arm B (P = 0.4827). Grade III toxicities were quite comparable between two treatment arms.

CONCLUSIONS

In terms of ORR, pCR rate, R0 resection, and toxicity profile; both the arms were comparable.

摘要

背景

CapeOX作为一种辅助化疗方案，近期的I期和II期研究表明其具有放射增敏特性，能显著降低肿瘤分期且毒性可耐受。

目的

本研究旨在评估卡培他滨 - 奥沙利铂联合方案作为新辅助放化疗的放射增敏剂，在降低局部晚期直肠腺癌分期方面是否优于5 - 氟尿嘧啶（5 - FU）- 亚叶酸，同时比较两组的毒性。

设置与设计

单机构、双盲、前瞻性、非交叉、随机对照试验研究。

研究对象与方法

A组（n = 21）患者在第1 - 14天和第25 - 38天每日分两次服用卡培他滨（1000 mg/m²），并在第1天和第29天静脉滴注奥沙利铂（85 mg/m²），持续2小时。B组（n = 21）患者在第1 - 5天和第29 - 33天接受亚叶酸（20 mg/m²）和5 - FU（350 mg/m²）治疗。两组患者均接受同步放疗（50.4 Gy，分28次，每次1.8 Gy常规分割）。同步放化疗6至8周后，患者接受评估并进行全直肠系膜切除术。术后，所有患者接受4个月的m - FOLFOX 6辅助化疗。