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目的评价术前同步放疗与草酸铂和氟尿嘧啶(5-FU)或甲酰四氢叶酸钙(CF)联合化疗治疗局部晚期直肠癌的耐受性和有效性。方法58例初诊局部晚期直肠癌(T3～T4期)患者进入该研究,疗前获病理类型,腺癌54例,印戒细胞癌4例。放疗为3个野等中心技术,盆腔照射46 Gy分23次4.5周完成。在放疗第1周和第4周同步给予2个周期化疗,草酸铂130 mg/m~2第1天,5-FU 500 mg/m~2第1～3天和CF 200 mg/m~2第1～3天。放疗结束后4～6周进行手术。结果完成术前计划并行手术者55例,手术标本总有效率为58%,其中肿瘤全消(pCR)11例,仅检出少量残存肿瘤细胞21例。3级毒副反应包括中性粒细胞减少1例,腹泻3例,放射性直肠炎4例,肝功能异常1例。结论含草酸铂方案的术前联合放化疗耐受性良好,有效率高,应进一步随访并开展Ⅲ期临床试验,以明确对局部控制率和生存率的影响。
Objective To evaluate the tolerability and efficacy of preoperative synchrotron radiation in the treatment of locally advanced rectal cancer with oxaliplatin combined with 5-fluorouracil (5-FU) or calcium leucovorin (CF). Methods Fifty-eight patients with newly diagnosed locally advanced rectal cancer (stage T3-T4) were enrolled in this study. Fifty-five adenocarcinomas and four signet-ring cell carcinomas were obtained before the procedure. Radiotherapy was performed in 3 field centers and pelvic irradiation at 46 Gy was completed 23 times in 4.5 weeks. Two cycles of chemotherapy were given simultaneously in the first and the fourth week of radiotherapy. The first day of oxaliplatin at 130 mg / m ~ 2, the first day at 500 mg / m ~ (-2) of 5-FU and the second day at CF ~ 200 mg / m ~ The first ~ 3 days. 4 to 6 weeks after radiotherapy surgery. Results 55 cases were scheduled for surgery before surgery, the total effective rate of surgical specimens was 58%. Among them, 11 cases had complete tumor elimination (pCR), and only 21 cases with small residual tumor cells were detected. Grade 3 toxicities include neutropenia in 1 case, diarrhea in 3 cases, radiation proctitis in 4 cases, and liver dysfunction in 1 case. Conclusions The preoperative radiotherapy and chemotherapy combined with oxaliplatin is well tolerated and has high efficiency. It should be further followed up and phase Ⅲ clinical trial should be carried out to clarify the effect on the local control rate and survival rate.