Picciocchi A, Coco C, Magistrelli P, Cogliandolo S, Carbone L, Cosimelli M, Impiombato F A, Vecchio F M, De Santis M, Mantini G
Istituto di Patologia Chirurgica, Università Cattolica del S. Cuore, Policlinico A. Gemelli, Roma, Italy.
Rays. 1995 Apr-Jun;20(2):182-9.
Aim of this phase I-II study was to evaluate the efficacy of preoperative concomitant radiochemotherapy in resectable high risk (TNM stage: II and III) rectal tumors, 64 patients entered the study: 37 had low rectal cancer, 27 mid-rectal cancer. 50 patients were clinically staged as stage III (Dukes C) and 14 as stage II (Dukes B). Treatment protocol included bolus mitomycin C at the dose of 10 mg/m2 on day 1 and 5FU continuous infusion at the daily dose of 1000 mg/m2 on day 1, 2, 3, 4. Concomitant external radiotherapy up to a dose of 3780 cGy was delivered at the daily dose of 180 cGy. Surgery was performed 4 to 5 weeks after radiation therapy (RT). Before surgery all patients were clinically restaged to evaluate the response to concomitant radiochemotherapy. Treatment compliance was 97%. Toxicity was 27% prevalently shown as bone marrow depletion and radiodermatitis. In 37 patients (61%) there was 50% reduction (partial response) of neoplastic volume. In 5 patients (8%) no neoplastic cells were evidenced in the surgical specimen on histology (complete response). The distance between the lower margin of the tumor and the internal anal orifice increased in 72% of cases. Postoperative morbidity was 28%. The incidence of anastomotic dehiscences was 8.7% over 46 anterior resections. Postoperative mortality was nil. Definitive staging evidenced 24 patients (39%) stage I or with no evidence of tumor. The incidence of local recurrence was 5% and that of distant metastasis 8%.
这项I-II期研究的目的是评估术前同步放化疗对可切除的高危（TNM分期：II期和III期）直肠肿瘤的疗效。64例患者进入研究：37例为低位直肠癌，27例为中位直肠癌。50例患者临床分期为III期（Dukes C期），14例为II期（Dukes B期）。治疗方案包括第1天静脉推注丝裂霉素C，剂量为10mg/m²，第1、2、3、4天持续静脉输注5-氟尿嘧啶，每日剂量为1000mg/m²。同步进行外照射放疗，总剂量达3780cGy，每日剂量为180cGy。放疗后4至5周进行手术。手术前对所有患者进行临床重新分期，以评估同步放化疗的反应。治疗依从性为97%。毒性反应发生率为27%，主要表现为骨髓抑制和放射性皮炎。37例患者（61%）肿瘤体积缩小50%（部分缓解）。5例患者（8%）手术标本组织学检查未发现肿瘤细胞（完全缓解）。72%的病例中肿瘤下缘与肛门内口之间的距离增加。术后发病率为28%。46例前切除术的吻合口裂开发生率为8.7%。术后死亡率为零。最终分期显示24例患者（39%）为I期或无肿瘤证据。局部复发率为5%，远处转移率为8%。
