Cancer Center, Taipei Veterans General Hospital & School of Medicine, National Yang Ming University, Taipei, Taiwan.
J Surg Oncol. 2014 May;109(6):580-5. doi: 10.1002/jso.23538. Epub 2013 Dec 24.
To report the results of a phase II trial combining celecoxib and preoperative chemoradiotherapy (CRT) for locally advanced rectal cancer.
Patients with clinical stage II or III rectal cancer were treated with radiotherapy of 44 Gy in 22 fractions. Concurrent chemotherapy consisted of oral tegafur-uracil and folinate on days 1-30 and 38-65. Celecoxib (400 mg/day) given from days 1 to 65. Surgery was done on day 70. The expression of cyclooxygenase 2 (COX-2) in tumor tissues was evaluated microscopically as a prognostic factor.
From 2008 to 2011, 53 patients completed CRT+ celecoxib therapy and 47 received radical surgery. Grade 3 diarrhea developed in 5 (9%). Grade 4 anemia was seen in 2 (4%). Pathological complete response (pCR) was seen in 6 (13%). T or N downstaging found in 38 (81%). Sphincter preservation was achieved in 77% of low-positioned tumors. Patients with tumors expressing high-level COX-2 after CRT + celecoxib treatment had inferior pelvic control (P = 0.01), disease-free survival (P = 0.04), and overall survival (P = 0.03) than those with low-level expression.
Celecoxib can be safely combined with preoperative CRT for rectal cancer. More intensified adjuvant therapy may be considered for tumors expressing high-level COX-2 after CRT and surgery.
报告塞来昔布联合术前放化疗治疗局部进展期直肠癌的 II 期临床试验结果。
临床 II 期或 III 期直肠癌患者接受 44Gy/22 次放疗。同期化疗采用替加氟-尿嘧啶和亚叶酸 1-30 天、38-65 天口服，塞来昔布（400mg/天）从第 1 天至第 65 天给药。第 70 天行手术。肿瘤组织中环氧化酶 2（COX-2）的表达作为预后因素进行评估。
2008 年至 2011 年，53 例患者完成 CRT+塞来昔布治疗，47 例接受根治性手术。发生 3 级腹泻 5 例（9%）。4 级贫血 2 例（4%）。病理完全缓解（pCR）6 例（13%）。T 或 N 降级 38 例（81%）。低位肿瘤保肛率为 77%。接受 CRT+塞来昔布治疗后 COX-2 高表达的肿瘤患者盆腔局部控制（P=0.01）、无病生存（P=0.04）和总生存（P=0.03）较差。
塞来昔布可与术前放化疗联合安全治疗直肠癌。对于 CRT 和手术后 COX-2 高表达的肿瘤，可能需要考虑更强化的辅助治疗。
