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Adjuvant Chemoradiotherapy With Epirubicin, Cisplatin, and Fluorouracil Compared With Adjuvant Chemoradiotherapy With Fluorouracil and Leucovorin After Curative Resection of Gastric Cancer: Results From CALGB 80101 (Alliance)
Journal of Clinical Oncology ( IF 45.3 ) Pub Date : 2017-11-10 , DOI: 10.1200/jco.2017.74.2130
Charles S. Fuchs 1 , Donna Niedzwiecki 1 , Harvey J. Mamon 1 , Joel E. Tepper 1 , Xing Ye 1 , Richard S. Swanson 1 , Peter C. Enzinger 1 , Daniel G. Haller 1 , Tomislav Dragovich 1 , Steven R. Alberts 1 , Georg A. Bjarnason 1 , Christopher G. Willett 1 , Leonard L. Gunderson 1 , Richard M. Goldberg 1 , Alan P. Venook 1 , David Ilson 1 , Eileen O’Reilly 1 , Kristen Ciombor 1 , David J. Berg 1 , Jeffrey Meyerhardt 1 , Robert J. Mayer 1
Affiliation  

Purpose

After curative resection of gastric or gastroesophageal junction adenocarcinoma, Intergroup Trial 0116 (Phase III trial of postoperative adjuvant radiochemotherapy for high risk gastric and gastroesophageal junction adenocarcinoma: Demonstrated superior survival for patients who received postoperative chemoradiotherapy with bolus fluorouracil (FU) and leucovorin (LV) compared with surgery alone. CALGB 80101 (Alliance; Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma) assessed whether a postoperative chemoradiotherapy regimen that replaced FU plus LV with a potentially more active systemic therapy could further improve overall survival.

Patients and Methods

Between April 2002 and May 2009, 546 patients who had undergone a curative resection of stage IB through IV (M0) gastric or gastroesophageal junction adenocarcinoma were randomly assigned to receive either postoperative FU plus LV before and after combined FU and radiotherapy (FU plus LV arm) or postoperative epirubicin, cisplatin, and infusional FU (ECF) before and after combined FU and radiotherapy (ECF arm).

Results

With a median follow-up duration of 6.5 years, 5-year overall survival rates were 44% in the FU plus LV arm and 44% in the ECF arm (Plogrank = .69; multivariable hazard ratio, 0.98; 95% CI, 0.78 to 1.24 comparing ECF with FU plus LV). Five-year disease-free survival rates were 39% in the FU plus LV arm and 37% in the ECF arm (Plogrank = .94; multivariable hazard ratio, 0.96; 95% CI, 0.77 to 1.20). In post hoc analyses, the effect of treatment seemed to be similar across all examined patient subgroups.

Conclusion

After a curative resection of gastric or gastroesophageal junction adenocarcinoma, postoperative chemoradiotherapy using a multiagent regimen of ECF before and after radiotherapy does not improve survival compared with standard FU and LV before and after radiotherapy.



中文翻译:

胃癌根治性切除后表柔比星,顺铂和氟尿嘧啶的辅助化学放疗与氟尿嘧啶和白细胞素的辅助化学放疗相比:CALGB 80101(联盟)的结果

目的

胃或胃食管交界处腺癌的根治性切除后,小组间试验0116(高风险胃和胃食管交界处腺癌术后辅助放化疗的III期试验:证实了接受氟尿嘧啶(FU)和亚叶酸佛罗汀(LV)化学放化疗的患者的生存率更高CALGB 80101(联盟;胃癌或胃食管腺癌切除术后辅助放化疗的III期组间试验)评估了术后放化疗方案是否可以用更积极的全身疗法替代FU加LV来进一步改善总体生存率。

患者和方法

在2002年4月至2009年5月之间,对546例行IB期至IV期(M0)胃或胃食管交界处腺癌根治性切除的患者,随机分配接受FU加LV联合放疗前后的FU加LV术后(FU加LV臂) )或术后联合应用FU和放疗(ECF组)前后的表柔比星,顺铂和输注FU(ECF)。

结果

中位随访时间为6.5年,FU加LV组的5年总生存率分别为44%和ECF组的44%(P logrank = .69;多变量危险比,0.98; 95%CI,将ECF与FU加LV进行比较,结果为0.78至1.24)。FU加LV组的五年无病生存率分别为39%和ECF组的37%(P logrank = 0.94;多变量风险比为0.96; 95%CI为0.77至1.20)。在事后分析中,在所有检查过的患者亚组中,治疗效果似乎相似。

结论

根治性切除胃或胃食管交界处的腺癌后,放疗前后使用ECF多药治疗方案的放化疗后放疗与放疗前后的标准FU和LV相比,不能提高生存率。

更新日期:2017-11-10
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