放化疗可改善食管癌预后

5月31日《新英格兰医学杂志》(New England Journal of Medicine)上发表的一项研究显示，术前接受放化疗的食管癌或胃食管交界癌患者的中位总生存期约为单纯接受手术治疗患者的2倍。

荷兰鹿特丹市Erasmus大学医学中心的Pieter van Hagen医生及其同事将年龄18~75岁、肿瘤大小在8 cm×5 cm之内的患者随机分为立即手术组和放化疗后手术组。所有患者符合世界卫生组织(WHO)体能状态评分≤2，且肺、血液、肝脏以及肾功能较好。放化疗组患者在第1、8、15、22和29天接受目标为曲线下面积达到每分钟2 mg/ml静脉卡铂和剂量为每平方米体表面积50 mg的紫杉醇治疗。患者预先接受静脉地塞米松、克立马丁、雷尼替丁和标准止吐治疗。关于放疗部分，患者接受23次放疗，每次的放射剂量为1.8 Gy，总放射剂量为41.4 Gy。从第1个化疗周期的第1天开始，每周进行5次放疗。所有患者接受外照射治疗。

结果显示，在对366例患者的意向治疗分析中，接受放化疗加手术治疗患者的中位总生存期为49个月，单纯手术组为24个月(危险比为0.657；P=0.003)。整个研究期间，放化疗加手术组的总生存率均高于单纯手术组，分别为82% vs. 70%(第1年)、67% vs. 50%(第2年)、 58% vs. 44%(第3年)以及47% vs. 34%(第5年)。放化疗加手术组达到完全切除(定义为切缘1 mm之内无肿瘤)的患者显著多于单纯手术组，分别为92% vs. 69%(P<0.001)。在161例接受放化疗后手术切除的患者中，47例(29%)达到病理学完全应答。两组患者的术后并发症相似，院内死亡率均为4%(N. Engl. J. Med. 2012;366:2074-84)。

研究者总结认为，与单纯手术相比，术前放化疗可延长食管癌及胃食管交界癌患者的生存期。

该研究由荷兰肿瘤基金会资助。van Hagen披露无相关利益冲突。

Median overall survival is approximately twice as long for patients with esophageal or esophagogastric-junction cancer who undergo chemoradiotherapy before surgery than for those treated with surgery alone, investigators reported.

In an intent-to-treat analysis of 366 patients, the median overall survival was 49 months in the chemoradiotherapy plus surgery group, versus 24 months in the surgery group (hazard ratio, 0.657; P = .003). The findings were published May 31 in the New England Journal of Medicine.

The overall survival rates in the chemoradiotherapy plus surgery group were higher than those in the surgery-only group throughout the study: 82% vs. 70% (year 1), 67% vs. 50% (year 2), 58% vs. 44% (year 3), and 47% vs. 34% (year 5).

Significantly more patients in the chemoradiotherapy plus surgery group achieved complete resection (defined as no tumor within 1 mm of the resection margins) compared with the surgery-only group (92% vs. 69%, P less than .001), wrote Dr. Pieter van Hagen of Erasmus University Medical Center, Rotterdam, the Netherlands, and his colleagues.

Of 161 patients who underwent resection after chemoradiotherapy, 47 (29%) had a pathological complete response. Postoperative complications were similar between the two treatment groups, and in-hospital mortality was 4% in both groups (N. Engl. J. Med. 2012;366:2074-84).

Patients aged 18-75 years with tumors no larger than 8 cm in length and 5 cm in width were randomized to immediate surgery or surgery after a regimen of chemoradiotherapy. All patients met the World Health Organization (WHO) performance status score of 2 or lower, and had adequate pulmonary, hematologic, hepatic, and renal function.

Patients in the chemoradiotherapy group received an intravenous dose of carboplatin targeted at an area under the curve of 2 mg/mL per minute and paclitaxel at a dose of 50 mg per square meter of body surface area on days 1, 8, 15, 22, and 29. The patients were premedicated intravenously with dexamethasone, clemastine, ranitidine, and standard antiemetics.

For the radiation part of the treatment, they received a total radiation dose of 41.4 Gy delivered in 23 fractions of 1.8 Gy each. Five fractions were administered per week, starting on the first day of the first chemotherapy cycle. All patients were treated via external-beam radiation.

The study was supported by the Dutch Cancer Foundation. Dr. van Hagen had no relevant financial disclosures.