Mohiuddin Mohammed, Winter Kathryn, Mitchell Edith, Hanna Nader, Yuen Albert, Nichols Charles, Shane Robert, Hayostek Cherie, Willett Christopher
Geisinger Cancer Institute, Wilkes-Barre, PA 18711, USA.
J Clin Oncol. 2006 Feb 1;24(4):650-5. doi: 10.1200/JCO.2005.03.6095.
To evaluate the rate of pathologic complete response and toxicity of neoadjuvant chemoradiation for advanced T3/T4 distal rectal cancers in a randomized phase II study
Patients with clinical T3/T4 distal rectal cancers were randomly assigned in a phase II study to receive combined neoadjuvant chemoradiotherapy followed by surgical resection. Patients were randomly assigned to receive continuous venous infusion (CVI) fluorouracil (FU) 225 mg/m2 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/m2 per day Monday to Friday, 120 hours per week plus irinotecan 50 mg/m2 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 neoadjuvant therapy. The primary end point of this study was pathologic complete response (pCR). Secondary end points included acute and late normal tissue morbidity.
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.
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.
在一项随机II期研究中评估新辅助放化疗对晚期T3/T4期低位直肠癌的病理完全缓解率及毒性。
临床T3/T4期低位直肠癌患者在一项II期研究中被随机分配，接受新辅助放化疗联合手术切除。患者被随机分配接受持续静脉输注（CVI）氟尿嘧啶（FU）225mg/m²/天，每周7天，加盆腔超分割放疗55.2至60Gy，每次1.2Gy，每日2次（1组）；或CVI FU 225mg/m²/天，周一至周五，每周120小时，加伊立替康50mg/m²，每周1次，共4周，加盆腔放疗50.4至54Gy，每次1.8Gy/天（2组）。新辅助治疗完成后4至10周进行手术。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并发症。
共有106例患者进入研究，其中103例可评估疗效。总体可切除率为93%。手术的中位时间为7周。两组中78%的患者观察到肿瘤降期。两组中所有可评估患者的pCR率均为26%。接受手术的患者中，两组的pCR率也相同（28%）。急性和晚期毒性也相似。1组3/4级急性血液学和非血液学毒性发生率分别为13%和38%，2组分别为12%和45%。
虽然两组的总体完全缓解率和毒性似乎相似，但这是第一项多机构研究，证实新辅助治疗后有相对较高（28%）的pCR率。
