Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781
Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781
复制标题
DOI：
10.1200/jco.2007.12.9593
复制
发表时间：
2008-03-01
影响因子：
45.3
通讯作者：
Mayer, Robert
中科院分区：
文献类型：
--
作者：
Tepper, Joel;Krasna, Mark J.;Mayer, Robert
目的
食管癌或胃食管交界处癌患者的主要治疗方式一直是手术，尽管同步放化疗的初始放疗也能产生相似的结果。由于两者都有治愈的潜力，人们对三联疗法的应用产生了极大的兴趣。为此，我们比较了三联疗法与单纯食管切除术在非转移性食管癌患者中的生存率、疗效和失败模式。
患者与方法
计划招募475名符合条件的患者。患者被随机分配接受单纯食管切除术加淋巴结清扫，或者在第1周和第5周接受顺铂100mg/m²以及氟尿嘧啶1000mg/m²/天持续4天，同时进行放疗（总剂量50.4Gy：在5.6周内每次1.8Gy），之后再进行食管切除术加淋巴结清扫。
结果
1997年10月至2000年3月期间招募了56名患者，由于招募情况不佳，试验终止。30名患者被随机分配到三联疗法组，26名患者被分配到单纯手术组。两组患者和肿瘤特征相似。治疗的耐受性一般良好。中位随访时间为6年。意向性治疗分析显示，三联疗法组的中位生存期为4.48年，而单纯手术组为1.79年，三联疗法更优（精确分层对数秩检验，P = 0.002）。三联疗法组的5年生存率为39%（95%置信区间，21% - 57%），单纯手术组为16%（95%置信区间，5% - 33%），三联疗法更优。
结论
本试验结果表明，在食管癌治疗中，放化疗后手术具有长期生存优势，并支持将三联疗法作为该病患者的标准治疗方法。
PurposeThe primary treatment modality for patients with carcinoma of the esophagus or gastroesophageal junction has been surgery, although primary radiation therapy with concurrent chemotherapy produces similar results. As both have curative potential, there has been great interest in the use of trimodality therapy. To this end, we compared survival, response, and patterns of failure of trimodality therapy to esophagectomy alone in patients with nonmetastatic esophageal cancer.Patients and MethodsFour hundred seventy-five eligible patients were planned for enrollment. Patients were randomly assigned to either esophagectomy with node dissection alone or cisplatin 100 mg/m(2) and fluorouracil 1,000 mg/m(2)/d for 4 days on weeks 1 and 5 concurrent with radiation therapy (50.4 Gy total: 1.8 Gy/fraction over 5.6 weeks) followed by esophagectomy with node dissection.ResultsFifty-six patients were enrolled between October 1997 and March 2000, when the trial was closed due to poor accrual. Thirty patients were randomly assigned to trimodality therapy and 26 were assigned to surgery alone. Patient and tumor characteristics were similar between groups. Treatment was generally well tolerated. Median follow-up was 6 years. An intent-to-treat analysis showed a median survival of 4.48 v 1.79 years in favor of trimodality therapy (exact stratified log-rank, P=.002). Five-year survival was 39% (95% CI, 21% to 57%) v 16% (95% CI, 5% to 33%) in favor of trimodality therapy.ConclusionThe results from this trial reflect a long-term survival advantage with the use of chemoradiotherapy followed by surgery in the treatment of esophageal cancer, and support trimodality therapy as a standard of care for patients with this disease.