Bedenne Laurent, Michel Pierre, Bouché Olivier, Milan Chantal, Mariette Christophe, Conroy Thierry, Pezet Denis, Roullet Bernard, Seitz Jean-François, Herr Jean-Philippe, Paillot Bernard, Arveux Patrick, Bonnetain Franck, Binquet Christine
University Hospital Le Bocage, Dijon, France.
J Clin Oncol. 2007 Apr 1;25(10):1160-8. doi: 10.1200/JCO.2005.04.7118.
Uncontrolled studies suggest that chemoradiation has similar efficacy as surgery for esophageal cancer. Therefore, a randomized trial was carried out to compare, in responders only, chemoradiation alone with chemoradiation followed by surgery in patients with locally advanced tumors.
Eligible patients had operable T3N0-1M0 thoracic esophageal cancer. Patients received two cycles of fluorouracil (FU) and cisplatin (days 1 to 5 and 22 to 26) and either conventional (46 Gy in 4.5 weeks) or split-course (15 Gy, days 1 to 5 and 22 to 26) concomitant radiotherapy. Patients with response and no contraindication to either treatment were randomly assigned to surgery (arm A) or continuation of chemoradiation (arm B; three cycles of FU/cisplatin and either conventional [20 Gy] or split-course [15 Gy] radiotherapy). Chemoradiation was considered equivalent to surgery if the difference in 2-year survival rate was less than 10%.
Of 444 eligible patients, 259 were randomly assigned; 230 patients (88.8%) had epidermoid cancer, and 29 (11.2%) had glandular carcinoma. Two-year survival rate was 34% in arm A versus 40% in arm B (hazard ratio for arm B v arm A = 0.90; adjusted P = .44). Median survival time was 17.7 months in arm A compared with 19.3 months in arm B. Two-year local control rate was 66.4% in arm A compared with 57.0% in arm B, and stents were less required in the surgery arm (5% in arm A v 32% in arm B; P < .001). The 3-month mortality rate was 9.3% in arm A compared with 0.8% in arm B (P = .002). Cumulative hospital stay was 68 days in arm A compared with 52 days in arm B (P = .02).
Our data suggest that, in patients with locally advanced thoracic esophageal cancers, especially epidermoid, who respond to chemoradiation, there is no benefit for the addition of surgery after chemoradiation compared with the continuation of additional chemoradiation.
非对照研究表明，放化疗对食管癌的疗效与手术相似。因此，开展了一项随机试验，仅在有反应的患者中比较单纯放化疗与放化疗后手术治疗局部晚期肿瘤患者的疗效。
符合条件的患者为可手术切除的T3N0-1M0胸段食管癌患者。患者接受两个周期的氟尿嘧啶（FU）和顺铂治疗（第1至5天和第22至26天），并接受常规（4.5周内46 Gy）或分割疗程（15 Gy，第1至5天和第22至26天）同步放疗。有反应且对两种治疗均无禁忌证的患者被随机分配至手术组（A组）或继续放化疗组（B组；三个周期的FU/顺铂和常规[20 Gy]或分割疗程[15 Gy]放疗）。如果两年生存率差异小于10%，则认为放化疗与手术等效。
444例符合条件的患者中，259例被随机分组；230例患者（88.8%）为表皮样癌，29例（11.2%）为腺癌。A组两年生存率为34%，B组为40%（B组与A组的风险比=0.90；校正P=0.44）。A组中位生存时间为17.7个月，B组为19.3个月。A组两年局部控制率为66.4%，B组为57.0%，手术组需要置入支架的患者较少（A组为5%，B组为32%；P<0.001）。A组3个月死亡率为9.3%，B组为0.8%（P=0.002）。A组累计住院天数为68天，B组为52天（P=0.02）。
我们的数据表明，在局部晚期胸段食管癌患者中，尤其是对放化疗有反应的表皮样癌患者，放化疗后加行手术与继续进行额外的放化疗相比并无益处。
