Calvo F A, Serrano F J, Diaz-González J A, Gomez-Espi M, Lozano E, Garcia R, de la Mata D, Arranz J A, García-Alfonso P, Pérez-Manga G, Alvarez E
Department of Oncology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Ann Oncol. 2006 Jul;17(7):1103-10. doi: 10.1093/annonc/mdl085. Epub 2006 May 2.
To compare efficacy in terms of pathologic response in LARC patients treated with preoperative chemoradiation, with or without a short-intense course of induction oxaliplatin.
From 05/98 to 10/02, 114 patients were treated with preoperative chemoradiation (4500-5040 cGy + oral Tegafur 1200 mg/day) for cT(3)-(4)N(+/x)M(0) rectal cancer. Starting 05/01, 52 consecutive patients additionally received induction FOLFOX-4, oxaliplatin (85 mg/m(2) iv d1), 5-FU (400 mg/m(2) iv bolus d1) and 600 mg/m(2) iv continuous infusion in 22 h with leucovorin (200 mg iv) d1 and d2, every 15 days (2 cycles), followed by the previously described Tegafur chemoradiation regime. Surgery was performed in 5-6 weeks. Pathological assessment investigated post-treatment T and N status in the rectal wall and peri-rectal tissues.
Patients, tumor and treatment characteristics were comparable between groups. Incidence of pT(0) specimens was significantly increased by induction FOLFOX-4 (P = 0.006). Total T and N downstaging were 58% versus 75% and 42% versus 40%, respectively (P = ns). T downstaging of > or =2 categories was significantly superior in FOLFOX-4 group (P = 0.029).
Short-intense induction FOLFOX-4 significantly improves pathologic complete response in LARC patients treated with tegafur-sensitized preoperative chemoradiation. The 44% rate of pT(0)-(1) specimens observed in the oxaliplatin group should impulse innovative surgical approaches to promote ano-rectal sphincter conserving protocols.
比较术前放化疗（无论是否联合短疗程强化奥沙利铂诱导化疗）治疗局部晚期直肠癌（LARC）患者的病理反应疗效。
1998年5月至2002年10月，114例cT(3)-(4)N(+/x)M(0)直肠癌患者接受术前放化疗（4500 - 5040 cGy + 口服替加氟1200 mg/天）。从2001年5月起，52例连续患者额外接受FOLFOX - 4诱导化疗，奥沙利铂（85 mg/m²静脉滴注，第1天），5 - 氟尿嘧啶（400 mg/m²静脉推注，第1天）以及600 mg/m²静脉持续输注22小时，亚叶酸钙（200 mg静脉滴注）第1天和第2天，每15天进行一次（2个周期），随后采用上述替加氟放化疗方案。5 - 6周后进行手术。病理评估研究直肠壁和直肠周围组织治疗后的T和N分期情况。
两组患者、肿瘤及治疗特征具有可比性。FOLFOX - 4诱导化疗使pT(0)标本发生率显著增加（P = 0.006）。总的T和N分期降低分别为58%对75%以及42%对40%（P = 无统计学差异）。FOLFOX - 4组T分期降低≥2个级别的情况显著更优（P = 0.029）。
短疗程强化FOLFOX - 4诱导化疗显著提高了接受替加氟增敏术前放化疗的LARC患者的病理完全缓解率。奥沙利铂组观察到的44%的pT(0)-(1)标本发生率应推动创新手术方法以促进保留肛门直肠括约肌方案的实施。
