Haddad Peiman, Miraie Monir, Farhan Farshid, Fazeli Mohammad-Sadegh, Alikhassi Afsaneh, Maddah-Safaei Afsaneh, Aghili Mahdi, Kalaghchi Bita, Babaei Mohammad
Radiation Oncology Research Centre, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.
Cancer Research Centre & Radiation Oncology Department, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.
Asia Pac J Clin Oncol. 2017 Dec;13(6):416-422. doi: 10.1111/ajco.12675. Epub 2017 May 10.
Clinical trials investigating the effects of addition of oxaliplatin to neoadjuvant radiochemotherapy in locally advanced rectal cancers (LARCs) have brought controversial results for pathologic complete response as an endpoint. This randomized clinical trial investigated downstaging as a short-term surrogate for progression-free survival (PFS).
Patients with magnetic resonance imaging (MRI) defined T3, T4 or N+ histologically proven adenocarcinoma of rectum within 15 cm from anal verge were randomly assigned to receive 50-50.4 Gy external beam radiation in 25-28 fractions and concurrent capecitabine 825 mg/m twice daily 5 days a week with or without oxaliplatin 60 mg/m weekly as neoadjuvant radiochemotherapy (Capox and Cap group, respectively). T downstage was defined as at least one stage regression in pathologic report after surgery comparing to MRI image before the preoperative treatment. Adverse effects of treatment were recorded on a weekly basis according to National Cancer Institute Common Toxicity Criteria, version 4.
Sixty-three patients were randomly assigned to Cap (n = 31) and Capox (n = 32) groups. There was no grade 4 toxicity. The only grade 3 toxicity that occurred more in Capox group was diarrhea (22% vs 0%; P = 0.006). Histopathologic stage of 52 patients (27 patients in Cap and 25 patients in Capox groups) was compared to their preoperative stage defined by MRI. There was a greater rate of T downstage in Capox group (59% vs 42%; P = 0.037). Eleven patients in Capox group (34%) achieved pathologic complete response, comparing to four in Cap group (13%); P = 0.072.
The addition of oxalipatin to neoadjuvant radiochemotherapy in LARC led to higher rate of tumor downstaging. Longer follow-up is needed to evaluate PFS.
关于在局部晚期直肠癌（LARC）新辅助放化疗中添加奥沙利铂的效果的临床试验，以病理完全缓解作为终点得出了有争议的结果。这项随机临床试验研究了肿瘤降期作为无进展生存期（PFS）的短期替代指标。
经磁共振成像（MRI）确定为距肛缘15厘米内的T3、T4或N +组织学证实的直肠腺癌患者，被随机分配接受50 - 50.4 Gy的外照射，分25 - 28次进行，同时联合卡培他滨，每天两次，每次825 mg/m²，每周5天，联合或不联合奥沙利铂60 mg/m²每周一次作为新辅助放化疗（分别为Capox组和Cap组）。T降期定义为与术前治疗前的MRI图像相比，术后病理报告中肿瘤至少降一期。根据美国国立癌症研究所通用毒性标准第4版，每周记录治疗的不良反应。
63例患者被随机分配至Cap组（n = 31）和Capox组（n = 32）。无4级毒性反应。Capox组中唯一发生率更高的3级毒性反应是腹泻（22%对0%；P = 0.006）。比较了52例患者（Cap组27例，Capox组25例）的组织病理学分期与其术前MRI定义的分期。Capox组的T降期率更高（59%对42%；P = 0.037）。Capox组有11例患者（34%）达到病理完全缓解，而Cap组为4例（13%）；P = 0.072。
在LARC新辅助放化疗中添加奥沙利铂可导致更高的肿瘤降期率。需要更长时间的随访来评估PFS。
