Department of Gastroenterology and Hepatology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Br J Surg. 2011 Mar;98(3):418-26. doi: 10.1002/bjs.7315. Epub 2010 Nov 17.
Capecitabine is an attractive radiosensitizer. In this study acute toxicity and surgical complications were evaluated in patients with locally advanced rectal cancer following total mesorectal excision (TME) after preoperative chemoradiotherapy (CRT) with capecitabine.
Between 2004 and 2008, consecutive patients with clinical tumour category (cT) 3-4 (with a threatened circumferential resection margin or cT3 within 5 cm of the anal verge) or clinical node category 2 rectal cancer were treated with preoperative CRT (25 × 2 Gy, capecitabine 825 mg/m(2) twice daily, days 1-33). TME followed 6 weeks later. Toxicity was scored according to the Common Terminology Criteria (version 3.0) and Radiation Therapy Oncology Group scoring systems. Treatment-related surgical complications were evaluated for up to 30 days after discharge from hospital using the modified Clavien-Dindo classification.
Some 147 patients were analysed. The mean cumulative dose of capecitabine was 95 per cent and 98·0 per cent of patients received at least 45 Gy. One patient died from sepsis following haematological toxicity. Grade 3-5 toxicity developed in 32 patients (21·8 per cent), especially diarrhoea (10·2 per cent) and radiation dermatitis (11·6 per cent). There were no deaths within 30 days after surgery. Anastomotic leakage and perineal wound complications developed after 13 of 47 low anterior resections and 23 of 62 abdominoperineal resections. Surgical reintervention was required in 30 patients. Twenty-seven patients (19·6 per cent) of 138 patients who had a laparotomy were readmitted within 30 days after initial hospital discharge.
Preoperative CRT with capecitabine is associated with acceptable acute toxicity, significant surgical morbidity but minimal postoperative mortality.
卡培他滨是一种有吸引力的放射增敏剂。在这项研究中，我们评估了接受术前放化疗（CRT）联合卡培他滨（25×2 Gy，卡培他滨 825mg/m²，每天 2 次，第 1-33 天）后行全直肠系膜切除术（TME）的局部晚期直肠癌患者的急性毒性和手术并发症。
2004 年至 2008 年期间，连续入组临床肿瘤分期（cT）为 3-4 期（有环周切缘受侵或 cT3 距肛缘<5cm）或临床淋巴结分期为 2 期的直肠癌患者，行术前 CRT。6 周后行 TME。毒性根据通用术语标准（第 3.0 版）和放射治疗肿瘤学组评分系统进行评分。使用改良 Clavien-Dindo 分级，在出院后 30 天内评估与治疗相关的手术并发症。
共分析了 147 例患者。卡培他滨的平均累积剂量为 95%，98.0%的患者接受了至少 45 Gy 的治疗。1 例患者因血液学毒性导致脓毒症死亡。32 例（21.8%）患者出现 3-5 级毒性，特别是腹泻（10.2%）和放射性皮炎（11.6%）。术后 30 天内无死亡病例。47 例低位前切除术中有 13 例和 62 例腹会阴联合切除术中有 23 例发生吻合口漏和会阴伤口并发症，需要再次手术干预的患者有 30 例。138 例行剖腹手术的患者中，27 例（19.6%）在初始出院后 30 天内再次入院。
术前 CRT 联合卡培他滨具有可接受的急性毒性、显著的手术发病率，但术后死亡率低。
