A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer.

I Chitapanarux, T Chitapanarux, E Tharavichitkul, S Mayurasakorn, P Siriwittayakorn, S Yamada, V Lorvidhaya
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引用次数: 2

Abstract

Objective: To evaluate the activity and safety of adding oxaliplatin to a standard chemoradiotherapy schema, including 5-fluorouracil (5-FU)/folinic acid (FA), in locally-advanced rectal cancer (LARC).

Methods: Two cycles of oxaliplatin 130 mg/m(2) plus FA 20 mg/m(2) bolus for 5 days and 5-FU 350 mg/m(2) continuous infusion for 5 days were given during week 1 and 4 of pelvic radiotherapy 46 Gy. Patients with a T3/4 and/or node-positive rectal tumour were eligible. Surgery was performed 4-6 weeks after radiotherapy. The primary endpoint was to determine the rate of pathological response. Secondary endpoints were to assess the rate of clinical response and the safety profile.

Results: Between March 2005 and January 2009, a total of 35 patients were enrolled. The pathological down-staging rate was 79% with a pathological complete response rate of 17%. The overall clinical response rate (assessed by computed tomography or transrectal ultrasound) was 77%. Grade 3 diarrhoea and Grade 3 neutropaenia were reported in 14% and 11% of the patients, respectively. Eleven patients did not undergo surgery: four of them refused the operation, and seven patients were inoperable due to disease progression. In 24 patients who had surgery, a sphincter-preserving procedure could be performed in 29%. At the median follow-up time of 28.1 months, 25 patients (71%) survived with no evidence of disease.

Conclusion: The promising results in terms of pathological response, and the associated good safety profile of a regimen of oxaliplatin plus 5-FU/FA with concomitant radiotherapy, suggest that the regimen could be used in LARC.

Abstract Image

奥沙利铂联合5-FU/亚叶酸及伴随放疗作为局部晚期直肠癌患者术前治疗的II期研究
目的:评价在5-氟尿嘧啶(5-FU)/亚叶酸(FA)标准放化疗方案中加入奥沙利铂治疗局部晚期直肠癌(LARC)的活性和安全性。方法:在盆腔放疗46 Gy的第1周和第4周给予奥沙利铂130 mg/m(2) + FA 20 mg/m(2)灌注5 d和5- fu 350 mg/m(2)连续输注5 d 2个周期。T3/4和/或结阳性直肠肿瘤患者符合条件。放疗后4 ~ 6周行手术治疗。主要终点是确定病理反应率。次要终点是评估临床反应率和安全性。结果:2005年3月至2009年1月,共纳入35例患者。病理降期率为79%,病理完全缓解率为17%。总体临床缓解率(通过计算机断层扫描或经直肠超声评估)为77%。3级腹泻和3级中性粒细胞减少分别在14%和11%的患者中报告。11例患者未行手术,其中4例拒绝手术,7例因病情进展不能手术。在24名接受手术的患者中,29%的患者可以进行保留括约肌的手术。在28.1个月的中位随访时间中,25例患者(71%)存活,无疾病证据。结论:奥沙利铂+ 5-FU/FA联合放疗方案在病理反应方面的良好结果,以及相关的良好安全性,表明该方案可用于LARC。
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