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首页> 外文期刊>Journal of Clinical Oncology >Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: A French intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) study
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Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: A French intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) study

机译：氟尿嘧啶，亚叶酸钙和伊立替康与表柔比星，顺铂和卡培他滨在晚期胃腺癌中的前瞻性，随机，多中心，III期研究：法国的一个研究小组（法国消化道法语国家联盟，法国国家癌症研究中心和法国吕特·孔特尔癌症研究中心，肿瘤学多学科合作者）研究

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Purpose: To compare epirubicin, cisplatin, and capecitabine (ECX) with fluorouracil, leucovorin, and rinotecan (FOLFIRI) as first-line treatments in patients with advanced gastric or esophagogastric junction (EGJ) adenocarcinoma.Patients and Methods: This open, randomized, phase III study was carried out in 71 centers. Patients with locally advanced or metastatic gastric or EGJ cancer were randomly assigned to receive either ECX as first-line treatment (ECX arm) or FOLFIRI (FOLFIRI arm). Second-line treatment was predefined (FOLFIRI for the ECX arm and ECX for the FOLFIRI arm). The primary criterion was time-totreatment failure (TTF) of the first-line therapy. Secondary criteria were progression-free surviva (PFS), overall survival (OS), toxicity, and quality of life.Results: In all, 416 patients were included (median age, 61. 4 years; 74% male). After a median follow-up of 31 months, median TTF was significantly longer with FOLFIRI than with ECX (5. 1 v 4. 2 months; P =. 008). There was no significant difference between the two groups in median PFS (5. 3 v 5. 8 months; P =. 96), median OS (9. 5 v 9. 7 months; P =. 95), or response rate (39. 2% v 37. 8%) First-line FOLFIRI was better tolerated (overall rate of grade 3 to 4 toxicity, 69% v84%; P <. 001; hematologic adverse events [AEs], 38% v64. 5%; P<. 001; nonhematologic AEs: 53% v53. 5%; P =. 81).Conclusion: FOLFIRI as first-line treatment for advanced gastric and EGJ cancer demonstrated significantly better TTF than did ECX. Other outcome results indicate that FOLFIRI is an acceptable first-line regimen in this setting and should be explored as a backbone regimen for targeted agents.
机译：目的：比较表柔比星，顺铂和卡培他滨（ECX）与氟尿嘧啶，亚叶酸钙和利替康（FOLFIRI）作为晚期胃或食管胃交界（EGJ）腺癌患者的一线治疗方法和方法：这种开放，随机， III期研究在71个中心进行。患有局部晚期或转移性胃癌或EGJ癌症的患者被随机分配接受一线治疗ECX（ECX组）或FOLFIRI（FOLFIRI组）。预定义了二线治疗方法（ECX组为FOLFIRI，FOLFIRI组为ECX）。主要标准是一线治疗的治疗失败时间（TTF）。次要标准为无进展生存期（PFS），总生存期（OS），毒性和生活质量。结果：总共纳入416例患者（中位年龄61. 4岁;男性74％）。在中位随访31个月后，FOLFIRI的中位TTF显着长于ECX（5。1 v 4. 2个月; P = .008）。两组之间的中位PFS（5. 3 v 5. 8个月; P =。96），中位OS​​（9. 5 v 9. 7个月; P =。95）或缓解率（（ 39. 2％v 37. 8％）一线FOLFIRI的耐受性更好（3至4级毒性总体发生率，69％v84％; P <.001;血液学不良事件[AEs]，38％v64。5％ ; P <.001;非血液学不良事件：53％v53.5％; P = .81）。结论：FOLFIRI作为晚期胃癌和EGJ癌症的一线治疗药物的TTF明显优于ECX。其他结果结果表明，在这种情况下，FOLFIRI是可接受的一线治疗方案，应作为靶向药物的主要治疗方案进行探讨。

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