A prospective feasibility study to evaluate neoadjuvant-synchronous S-1 with radiotherapy for locally advanced rectal cancer: A multicentre phase II trial
A prospective feasibility study to evaluate neoadjuvant-synchronous S-1 with radiotherapy for locally advanced rectal cancer: A multicentre phase II trial
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DOI：
10.3892/mco.2016.767
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发表时间：
2016-04-01
影响因子：
1.2
通讯作者：
Kitano, Seigo
中科院分区：
文献类型：
--
作者：
Inomata, Masafumi;Akagi, Tomonori;Kitano, Seigo
在日本，未经术前放化疗（CRT）的局部晚期直肠癌的治疗结果与西方国家没有差异。术前CRT联合新的抗癌药物可能降低局部复发率，防止远处转移，从而提高生存率。我们进行了一项试验，以评估局部晚期直肠癌患者使用S-1进行新辅助CRT的可行性。2009年4月至2011年8月进行了一项多机构（17个专门中心）干预性II期试验。新辅助CRT前满足以下要求的患者包括：组织学证实的直肠癌;直肠上部或下部肿瘤;癌症分类为T3-4 N 0 -3 M0。采用S-1（80 mg/m2/天，第1-5、8-12、22-26和29-33天）进行新辅助CRT，并进行照射（总计45戈伊/25 fr，1.8戈伊/天，第1-5、8-12、1 - 5 -19、22-26和29-33天）。在新辅助CRT完成后第4周和第8周进行全直肠系膜切除术和D3淋巴结清扫术。主要终点是新辅助CRT的完成率。次要终点为新辅助CRT的应答率、短期临床结局、治愈性切除率和病理学应答（2/3级）。在纳入的37例患者中，86.5%完成了新辅助CRT（95% CI，75.5-97.5%），10.8%（4）发生了不良事件（3/4级）。缓解率（RECIST1.0）为56.8%（95%CI，40.8-72.7%），病理缓解率为48.6%（95%CI，32.5-64.8%）。本研究表明，局部进展期直肠癌的肿瘤同步S-1+放疗在病理反应和不良事件方面是可行的。
Treatment results of locally advanced rectal cancer without preoperative chemoradiotherapy (CRT) in Japan do not differ from those of Western countries. Preoperative CRT with new anticancer agents may decrease local recurrence rate and prevent distant metastases, thus improving survival. We conducted a trial to evaluate feasibility of neoadjuvant CRT using S-1 in patients with locally advanced rectal cancer. A multi-institutional (17 specialized centres), interventional, phase II trial was conducted from April 2009 to August 2011. Patients fulfilling the following requirements before neoadjuvant CRT were included: histo-logically proven rectal carcinoma; tumour in the upper or lower rectum; cancer classified as T3-4 N0-3 M0. Neoadjuvant CRT with S-1 (80 mg/m(2)/day on days 1-5, 8-12, 22-26, and 29-33) and irradiation (total 45 Gy/25 fr, 1.8 Gy/day, on days 1-5, 8-12, 15-19, 22-26, and 29-33) was performed. Total mesorectal excision with D3 lymphadenectomy was performed during weeks 4 and 8 after completion of neoadjuvant CRT. The primary endpoint was completion rate of neoadjuvant CRT. Secondary endpoints were response rate to neoadjuvant CRT, short-term clinical outcomes, curative resection rate, and pathologic response (grade 2/3). Of the 37 patients included, 86.5% completed neoadjuvant CRT (95% CI, 75.5-97.5%), and 10.8% (4) experienced an adverse event (grade 3/4). Response rate (RECIST 1.0) was 56.8% (95% CI, 40.8-72.7%), and pathologic response rate was 48.6% (95% CI, 32.5-64.8%). This study demonstrated that neoadjuvant-synchronous S-1+radiotherapy for locally advanced rectal cancer was feasible in terms of pathologic response and adverse events.