局部晚期低位直肠癌术前放化疗的降期效果和加前切除的远期疗效

Down stage and long term results of preoperative chemoradiotherapy for locally advanced lower rectal cancer: a cooperative clinical trial of 6 institutions

目的探讨局部晚期低位直肠癌术前放化疗的降期效果和加前切除与Miles手术的远期疗效的比较。方法将103例直肠癌患者分为术前放化疗+前切除组(A组,53例)和Miles手术组(B组,50例)。原发肿瘤距肛门中位距离6.2cm。临床分期Ⅱ期22例,Ⅲ期81例(TNM,UICC)。放疗采用直线加速器盆腔3～4个野照射,剂量35～45Gy,4～5周完成。化疗以氟尿嘧啶为主联合化疗。结果A、B组5年生存率分别为64.2%、43.7%(P<0.05),5年无瘤生存率分别为52.8%、31.6%(P<0.05),局部复发率分别为15.2%、19.3%(P>0.05),远处转移率分别为25.5%、48.5%(含局部复发加远处转移)(P<0.05)。A组术后病理学完全缓解率为13.2%。随访率为88.3%。结论术前放疗和化疗加前切除手术治疗局部晚期低位直肠癌的方法不但能够保肛,而且可改善5年生存率和无瘤生存率。

Objective To investigate the down stage effect and long-term results of preoperative chemoradiotherapy for locally advanced lower rectal adenocarcinoma. Methods From Jan. 1989 to Jul 1999, 103 patients suffering from lower rectal carcinoma were treated. Criteria entry: 1. Distance between anal verge and centre of tumor 4-8?cm(median 6.2?cm), 2. Uncertainty in decision of preservation of anus before admission, 3. Lesion belonged to locally advanced type, 4. definitive pathology, clinical stage and presence of objective observation of tumor extent, 5. Performance status proposed by Eastern Cooperative Oncology Group 0-2, 6. Age< 75years, 7. Normal blood, heart, renal function and 8. absence of previous anti-cancer therapy. Pathology: tubular adenocarcinoma 69, papillary adenocarcinoma 21, mucinous adenocarcinoma10 and signet-ring cell carcinoma 3. Clinical stage: with the present auxillary examinations, there were TNM stage Ⅱ 22 and stage Ⅲ 81. Decision of treatment: This series of patients was assigned rather than randomized. 53 patients were treated by preoperative chemoradiotherapy(Group A) and 50 patients received Mile's operation (Group B). Preoperative radiotherapy-linear accelerator 6-8?MV X-ray, 35-45?Gy/4-5 wk interposed with chemotherapy; preoperative chemotherapy—5-Fu based chemotherapy (5-Fu 300-400?mg/m2, calcium folinate 200?mg/session, iv, totally 5day). Operation was done 29-58 days(median 38days) after completion of chemoradiotherapy. Surgery: 53 patients received the anal preserving operation of anterior resection; 50 patients were treated by Mile's operation. Postoperation chemotherapy-a total of 34 patients received postoperative chemotherapy and/or radiotherapy for liver or bony metastasis. 88.3% of patients had complete data of follow-up. Results The 5-year survival rate, disease-free survival rate for group A and group B were 64.2% and 43.7%, 52.8% and 31.6% , respectively,(P<0.05). The local failure rate , distant metastasis rate of group A and group B was 15.2% and 19.3% (P>0.05), 25.5% and 48.5% (P<0.05), respectively. The preoperative clinical stages were : T2 10, T3 31 and T4 12. The postoperative pathological stages were: T0N0 7, T1N0 10, T2N0 14, T3N0 13, T4N0 3, T2N1 5 and T3N11. The pathological response rate after surgery in Group A was 13.2%. All patients in Group A were able to retain the sphincter though 29.3% had various degrees of malfunctions in bowel movement and/or urination. The difference incurred by postoperative chemotherapy/or radiotherapy was insignificant. Conclusions Showing obvious down stage effect, the preoperative chemoradiotherapy can improve the 5-year survival and disease-free survival, and offer more chance to preserve the sphincter function in locally advanced lower rectal cancer.