A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407)
A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407)
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DOI：
10.1016/j.ejca.2022.12.014
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发表时间：
2023-01-16
影响因子：
8.4
通讯作者：
Furuse, Junji
中科院分区：
文献类型：
--
作者：
Ozaka, Masato;Nakachi, Kohei;Furuse, Junji
目的：我们比较了改良的5-氟尿嘧啶、亚叶酸、伊立替康和奥沙利铂（mFOLFIRINOX）与吉西他滨联合白蛋白结合型紫杉醇（GNP）治疗局部晚期胰腺癌（LAPC.Methods）的疗效。1年总生存期（OS）是主要终点。主要次要终点包括无进展生存期（PFS）、缓解率（RR）、糖链抗原19-9（CA 19 -9）缓解和不良事件。样本量为124例患者，以0.85的最小概率选择更有效的方案，并检验1年OS <53%的无效假设。结果：在29家机构的126例患者中，125例被认为合格。mFOLFIRINOX组和GnP组的1年OS分别为77.4%（95% CI，64.9-86.0）和82.5%（95% CI，70.7-89.9）。mFOLFIRINOX和GnP组的中位PFS分别为11.2个月（95% CI，9.9-15.9）和9.4个月（95% CI，7.4-12.8）。mFOLFIRINOX和GnP组的RR和CA 19 -9缓解率分别为30.9%（95% CI，19.1-44.8）和57.1%（95% CI，41.0-72.3）以及42.1%（95% CI，29.1-55.9）和85.0%（95% CI，70.2-94.3）。3-4级腹泻和厌食症是主要的mFOL-FIRINOX arm.Conclusion：由于其更好的RR，CA 19 -9反应和轻度胃肠道毒性，GNP被认为是随后III期试验的候选者。两种治疗方案的1年生存率均高于吉西他滨单药治疗的历史数据。2022作者（S）由Elsevier Ltd.发布。这是CC BY-NC-ND许可证下的开放获取文章（http：//creativecommons.org/licenses/by-nc-nd/4.0/）。
Aim: We compared the efficacy of modified 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) with that of gemcitabine plus nab-paclitaxel (GnP) for locally advanced pancreatic cancer (LAPC).Methods: Patients with untreated LAPC were randomly assigned (1:1) to receive mFOLFIR-INOX or GnP. One-year overall survival (OS) was the primary endpoint. The major second-ary end-points included progression-free survival (PFS), response rate (RR), carbohydrate antigen 19-9 (CA19-9) response, and adverse events. The sample size was 124 patients to select a more effective regimen with a minimum probability of 0.85 and to examine the null hypoth-esis of the 1-year OS < 53%.Results: Of the 126 patients enrolled from 29 institutions, 125 were deemed eligible. The 1-year OS was 77.4% (95% CI, 64.9-86.0) and 82.5% (95% CI, 70.7-89.9) in the mFOLFIRINOX and GnP arms, respectively. The median PFS was 11.2 (95% CI, 9.9-15.9) and 9.4 months (95% CI, 7.4-12.8) in the mFOLFIRINOX and GnP arms, respectively. The RR and CA19-9 response rate were 30.9% (95% CI, 19.1-44.8) and 57.1% (95% CI, 41.0-72.3) and 42.1% (95% CI 29.1-55.9) and 85.0% (95% CI, 70.2-94.3) in the mFOLFIRINOX and GnP arms, respectively. Grade 3-4 diarrhoea and anorexia were predominant in the mFOL-FIRINOX arm.Conclusion: GnP was considered the candidate for a subsequent phase III trial because of its better RR, CA19-9 response, and mild gastrointestinal toxicities. Both regimens displayed higher efficacy in the 1-year survival than in the historical data of gemcitabine monotherapy. 2022 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).