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Long-term bresults of radiotherapy combined with nedaplatin and 5-fluorouracil for postoperative loco-regional recurrent esophageal cancer: update on a phase II study

机译:放疗联合奈达铂和5-氟尿嘧啶治疗局部局部复发性食管癌的长期治疗:II期研究的最新进展

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Background In 2006, we reported the effectiveness of chemoradiotherapy for postoperative recurrent esophageal cancer with a median observation period of 18 months. The purpose of the present study was to update the results of radiotherapy combined with nedaplatin and 5-fluorouracil (5-FU) for postoperative loco-regional recurrent esophageal cancer. Methods Between 2000 and 2004, we performed a phase II study on treatment of postoperative loco-regional recurrent esophageal cancer with radiotherapy (60 Gy/30 fractions/6 weeks) combined with chemotherapy consisting of two cycles of nedaplatin (70 mg/m2/2 h) and 5-FU (500 mg/m2/24 h for 5 days). The primary endpoint was overall survival rate, and the secondary endpoints were progression-free survival rate, irradiated-field control rate and chronic toxicity. Results A total of 30 patients were enrolled in this study. The regimen was completed in 76.7% of the patients. The median observation period for survivors was 72.0 months. The 5-year overall survival rate was 27.0% with a median survival period of 21.0 months. The 5-year progression-free survival rate and irradiated-field control rate were 25.1% and 71.5%, respectively. Grade 3 or higher late toxicity was observed in only one patient. Two long-term survivors had gastric tube cancer more than 5 years after chemoradiotherapy. Pretreatment performance status, pattern of recurrence (worse for patients with anastomotic recurrence) and number of recurrent lesions (worse for patients with multiple recurrent lesions) were statistically significant prognostic factors for overall survival. Conclusions Radiotherapy combined with nedaplatin and 5-FU is a safe and effective salvage treatment for postoperative loco-regional recurrent esophageal cancer. However, the prognosis of patients with multiple regional recurrence or anastomotic recurrence is very poor.
机译:背景2006年,我们报道了放化疗在术后复发性食管癌中的有效性,中位观察期为18个月。本研究的目的是更新放疗联合奈达铂和5-氟尿嘧啶(5-FU)治疗局部区域复发性食管癌的结果。方法2000年至2004年间,我们进行了放疗(60 Gy / 30分数/ 6周)联合化疗(由两个周期的奈达铂(70 mg / m 2 / 2 h)和5-FU(500 mg / m 2 / 24 h持续5天)。主要终点为总生存率,次要终点为无进展生存率,照射野控制率和慢性毒性。结果本研究共纳入30例患者。该方案在76.7%的患者中完成。幸存者的中位观察期为72.0个月。 5年总生存率为27.0%,中位生存期为21.0个月。 5年无进展生存率和照射野控制率分别为25.1%和71.5%。仅一名患者观察到3级或更高的晚期毒性。放化疗后5年以上,两名长期幸存者患上了胃管癌。治疗前的治疗状态,复发模式(对吻合口复发患者更糟)和复发性病变数目(对多发性复发性病变患者更糟)是总体生存率的统计学显着预后因素。结论放疗联合奈达铂和5-FU治疗局部区域复发性食管癌是安全有效的方法。但是,多发区域复发或吻合口复发的患者的预后很差。

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