Saha Animesh, Ghosh Sajal Kumar, Roy Chhaya, Saha Makhan Lal, Choudhury Krishnangshu Bhanja, Chatterjee Koushik
Department of Radiotherapy, Institute of Post Graduate Medical Education and Research, Kolkata, India.
J Cancer Res Ther. 2015 Jan-Mar;11(1):88-93. doi: 10.4103/0973-1482.150341.
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.
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.
Single institutional, double blinded, prospective, noncrossover, randomized control pilot study.
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.
Chi-square test was used to compare categorical variables between the groups.
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.
In terms of ORR, pCR rate, R0 resection, and toxicity profile; both the arms were comparable.
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。
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。
单机构、双盲、前瞻性、非交叉、随机对照试验研究。
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。
采用卡方检验比较两组间的分类变量。
A组的客观缓解率（ORR）为80.95%，B组为66.66%（P = 0.3055）。A组的病理完全缓解（pCR）率与B组相当（23.8%对14.28%，P值 = 0.6944）。A组80.95%的病例可行R0切除手术，B组为66.66%（P = 0.4827）。两组治疗的III级毒性相当。
在ORR、pCR率、R0切除率和毒性方面，两组相当。
