Department of Thoracic and Cardiovascular Surgery, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1967-72. doi: 10.1016/j.ijrobp.2011.01.043. Epub 2011 Apr 18.
The strategy of definitive chemoradiation with selective surgical salvage in locoregionally advanced esophageal cancer was evaluated in a Phase II trial in Radiation Therapy Oncology Group (RTOG)-affiliated sites.
The study was designed to detect an improvement in 1-year survival from 60% to 77.5% (α = 0.05; power = 80%). Definitive chemoradiation involved induction chemotherapy with 5-fluorouracil (5-FU) (650 mg/mg(2)/day), cisplatin (15 mg/mg(2)/day), and paclitaxel (200 mg/mg(2)/day) for two cycles, followed by concurrent chemoradiation with 50.4 Gy (1.8 Gy/fraction) and daily 5-FU (300 mg/mg(2)/day) with cisplatin (15 mg/mg(2)/day) over the first 5 days. Salvage surgical resection was considered for patients with residual or recurrent esophageal cancer who did not have systemic disease.
Forty-three patients with nonmetastatic resectable esophageal cancer were entered from Sept 2003 to March 2006. Forty-one patients were eligible for analysis. Clinical stage was ≥T3 in 31 patients (76%) and N1 in 29 patients (71%), with adenocarcinoma histology in 30 patients (73%). Thirty-seven patients (90%) completed induction chemotherapy followed by concurrent chemoradiation. Twenty-eight patients (68%) experienced Grade 3+ nonhematologic toxicity. Four treatment-related deaths were noted. Twenty-one patients underwent surgery following definitive chemoradiation because of residual (17 patients) or recurrent (3 patients) esophageal cancer,and 1 patient because of choice. Median follow-up of live patients was 22 months, with an estimated 1-year survival of 71%.
In this Phase II trial (RTOG 0246) evaluating selective surgical salvage after definitive chemoradiation in locoregionally advanced esophageal cancer, the hypothesized 1-year RTOG survival rate (77.5%) was not achieved (1 year, 71%; 95% confidence interval< 54%-82%).
在放射治疗肿瘤学组（RTOG）附属机构进行的 II 期试验中，评估了局部晚期食管癌明确放化疗联合选择性手术挽救的策略。
该研究旨在检测 1 年生存率从 60%提高到 77.5%（α=0.05；功率=80%）的改善。明确放化疗包括两个周期的顺铂（15mg/mg(2)/day）、紫杉醇（200mg/mg(2)/day）和顺铂（15mg/mg(2)/day）联合顺铂（15mg/mg(2)/day）50.4Gy（1.8Gy/fraction）和每天 5-FU（300mg/mg(2)/day）的同期放化疗。对于没有全身疾病的残留或复发性食管癌患者，考虑进行挽救性手术切除。
2003 年 9 月至 2006 年 3 月期间，43 例非转移性可切除食管癌患者入组。41 例患者符合分析条件。31 例患者（76%）临床分期≥T3，29 例患者（71%）N1，30 例患者（73%）为腺癌组织学。37 例患者（90%）完成了诱导化疗，随后接受了同期放化疗。28 例患者（68%）发生 3 级以上非血液学毒性。有 4 例治疗相关死亡。21 例患者在明确放化疗后因残留（17 例）或复发性（3 例）食管癌行手术治疗，1 例因选择而行手术治疗。存活患者的中位随访时间为 22 个月，估计 1 年生存率为 71%。
在这项评估局部晚期食管癌明确放化疗后选择性手术挽救的 II 期试验（RTOG 0246）中，假设的 RTOG 1 年生存率（77.5%）未达到（1 年，71%；95%置信区间<54%-82%）。
