Randomized phase II study of neoadjuvant combined-modality chemoradiation for distal rectal cancer: Radiation Therapy Oncology Group Trial 0012
Randomized phase II study of neoadjuvant combined-modality chemoradiation for distal rectal cancer: Radiation Therapy Oncology Group Trial 0012
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DOI：
10.1200/jco.2005.03.6095
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发表时间：
2006-02-01
影响因子：
45.3
通讯作者：
Willett, C
中科院分区：
文献类型：
--
作者：
Mohiuddin, M;Winter, K;Willett, C
目的：在一项随机II期研究中，评估晚期T3/T4直肠癌的新辅助放化疗的病理完全缓解率和毒性。患者和方法：在一项11期研究中，临床T3/T4直肠癌患者随机分配接受联合新辅助放化疗后手术切除。患者被随机分配接受连续静脉输注（CVI）氟尿嘧啶（FU） 225 mg/m(2)每天，每周7天，加上盆腔超分割放疗55.2至60 Gy / bid 1.2 Gy（第1组）或CVI FU 225 mg/m(2)每天周一至周五，每周120小时加上伊立替康50 mg/m(2)每周一次，持续4周加上盆腔放疗50.4至54 Gy，每天1.8 Gy（第2组）。手术于辅助治疗完成后4 ~ 10周进行。本研究的主要终点是病理完全缓解（pCR）。次要终点包括急性和晚期正常组织发病率。结果共有106例患者进入研究，其中103例可评估反应。总可切除率为93%。中位手术时间为7周。在两组患者中，78%的患者肿瘤分期降低。每组所有可评估患者的pCR率为26%。对于接受手术的患者，两组的pCR率也相同（28%）。急性和晚期毒性也相似。3级和4级急性血液学和非血液学毒性在第1组分别为13%和38%，在第2组分别为12%和45%。结论：尽管两组患者的总体完全缓解率和毒性似乎相似，但这是首次在多机构研究中发现新辅助治疗后的pCR率相对较高（28%）。
Purpose To evaluate the rate of pathologic complete response and toxicity of neoadjuvant chemoradiation for advanced T3/74 distal rectal cancers in a randomized phase II studyPatients and Methods Patients with clinical T3/T4 distal rectal cancers were randomly assigned in a phase 11 study to receive combined neoadjuvant chemoradiotherapy followed by surgical resection. Patients were randomly assigned to receive continuous venous infusion (CVI) fluorouracil (FU) 225 mg/m(2) per day, 7 days per week, plus pelvic hyperfractionated radiation 55.2 to 60 Gy at 1.2 Gy bid (arm 1) or CVI FU 225 mg/m(2) per day Monday to Friday, 120 hours per week plus irinotecan 50 mg/m(2) once weekly for 4 weeks plus pelvic radiation therapy 50.4 to 54 Gy at 1.8 Gy per day (arm 2). Surgery was performed 4 to 10 weeks after completion of necadjuvant therapy. The primary end point of this study was pathologic complete response (pCR). Secondary end points included acute and late normal tissue morbidity.Results A total of 106 patients were entered onto the study, with 103 assessable for response. The overall resectability rate was 93%. The median time to surgery was 7 weeks. Tumor downstaging was observed in 78% of patients in both arms. The pCR rate for all assessable patients was 26% in each arm. For patients who had surgery, the pCR rate was also the same (28%) in both arms. Acute and late toxicity was also similar. Grade 3 and 4 acute hematologic and nonhematologic toxicity occurred in 13% and 38% in arm 1 and 12% and 45% in arm 2, respectively.Conclusion Although the overall complete response rate and toxicity seems similar in both arms, this is the first multi-institutional study to establish a relatively high (28%) pCR rate after neoadjuvant therapy.