Department of Medicine, Division of Hematology/Oncology, University of Florida, 1600 SW Archer Road, Gainesville, FL 32610, USA.
Am J Clin Oncol. 2010 Jun;33(3):251-6. doi: 10.1097/COC.0b013e3181a650e8.
Preoperative treatment of rectal cancer with combined chemotherapy and radiation therapy has become a widely accepted strategy. The current challenge is to improve outcomes whereas minimizing morbidity and maximizing the potential for a sphincter sparing procedure. This study sought to evaluate the safety and efficacy of a combination of 2 novel approaches-accelerated, hyperfractionated radiation therapy and twice daily oral capecitabine.
Consenting patients with locally advanced T3-T4, N0-1, M0 rectal adenocarcinoma, located no further than 15 cm from the anal verge, were treated with twice daily fractions of 1.2 Gy M-F to a total of 50.4 Gy for T3 lesions and 55.2 Gy for T4 lesions. Concomitantly, the patients received capecitabine 825 mg/m twice per day 7 days per week. Patients were operated on 4 to 6 weeks after completion of therapy.
Sixteen of 17 enrolled patients were eligible and all 16 completed the full course of treatment including definitive surgery. Eleven patients had a sphincter sparing procedure and 5 had an abdominoperineal resection. Tumor and/or nodal downstaging occurred in 81% of patients, 100% of resections were R0, and the sphincter preservation rate was 68%. There were 18% pathologic complete remissions and 68% of specimens were node negative with an additional 12% Nx owing to transanal excision. The therapy was well tolerated and there were no unexpected toxicities with only diarrhea reaching grade 3 in 4 patients.
This novel approach to preoperative treatment of rectal adenocarcinoma was well tolerated and effective. Comparison with more established approaches appears justified.
直肠癌的术前化疗和放疗联合治疗已成为一种广泛接受的策略。目前的挑战是在最大限度地减少发病率和最大限度地保留括约肌功能的前提下提高疗效。本研究旨在评估两种新方法（加速超分割放疗和每日两次口服卡培他滨）联合应用的安全性和有效性。
征得局部晚期 T3-T4、N0-1、M0 直肠腺癌患者同意，肿瘤距离肛门边缘不超过 15cm，采用 1.2Gy M-F 每日两次分割，总剂量为 50.4Gy 用于 T3 病变，55.2Gy 用于 T4 病变。同时，患者接受卡培他滨 825mg/m2 每日两次，每周 7 天。治疗完成后 4-6 周进行手术。
17 名入组患者中有 16 名符合条件，且所有 16 名患者均完成了完整的治疗过程，包括确定性手术。11 名患者行保肛手术，5 名患者行腹会阴联合切除术。81%的患者肿瘤和/或淋巴结降期，100%的切除标本为 R0，保肛率为 68%。病理完全缓解率为 18%，100%的标本淋巴结阴性，另有 12%的标本因经肛门切除而 Nx。该治疗方法耐受性良好，无意外毒性反应，仅有 4 例患者出现 3 级腹泻。
这种新的术前治疗直肠腺癌的方法耐受性良好且有效。与更成熟的方法相比，这种方法似乎是合理的。
