PANCREOX: A Randomized Phase III Study of Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy
PANCREOX: A Randomized Phase III Study of Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy
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DOI：
10.1200/jco.2016.68.5776
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发表时间：
2016-11-10
影响因子：
45.3
通讯作者：
Moore, Malcolm
中科院分区：
文献类型：
--
作者：
Gill, Sharlene;Ko, Yoo-Joung;Moore, Malcolm
目的：晚期胰腺癌患者接受吉西他滨治疗后的二线治疗标准尚不明确。CONKO-003 III期研究报告了使用奥沙利铂、亚叶酸和FU（OFF）方案的二线氟尿嘧啶（FU）和奥沙利铂的生存获益。1 PANCREOX是一项III期多中心试验，以评估FU和奥沙利铂作为改良FOLFOX 6（mFOLFOX 6;输注氟尿嘧啶，leucovorin和奥沙利铂）与输注FU/leucovorin（LV）在此setting.Patients和MethodsPatients确认晚期胰腺癌谁以前接受吉西他滨治疗和东部肿瘤协作组的性能状态为0-2的好处是合格的。共108例患者被随机分配接受每两周一次mFOLFOX 6或输注FU/LV治疗，直至进展。无进展生存期（PFS）是主要的endpoint.ResultsBaseline患者的特征是相似的，在两个武器。PFS无差异（中位数，3.1个月vs 2.9个月; P = 0.99）。分配至mFOLFOX 6组的患者的总生存期（OS）较差（中位数，6.1个月vs 9.9个月; P = 0.02）。在添加奥沙利铂后观察到毒性增加，63%接受mFOLFOX 6的患者和11%接受FU/LV的患者发生3/4级不良事件。mFOLFOX 6组中因不良事件退出研究的患者多于FU/LV组（20% vs 2%），而FU/LV组中使用进展后治疗的患者显著更高（25% vs 7%; P = 0. 015）。没有显着差异，观察到恶化的时间在欧洲组织的研究和治疗癌症的生活质量问卷调查核心30 global health scale.ConclusionNo好处，观察到与奥沙利铂，管理mFOLFOX 6，与输注FU/LV的晚期胰腺癌患者先前与一线吉西他滨治疗。(C)2016年美国临床肿瘤学会
PurposeThe standard of care for second-line therapy in patients with advanced pancreatic cancer after gemcitabine-based therapy is not clearly defined. The CONKO-003 phase III study reported a survival benefit with second-line fluorouracil (FU) and oxaliplatin using the oxaliplatin, folinic acid, and FU (OFF) regimen. 1 PANCREOX was a phase III multicenter trial to evaluate the benefit of FU and oxaliplatin administered as modified FOLFOX6 (mFOLFOX6; infusional fluorouracil, leucovorin, and oxaliplatin) versus infusional FU/leucovorin (LV) in this setting.Patients and MethodsPatients with confirmed advanced pancreatic cancer who were previously treated with gemcitabine therapy and with an Eastern Cooperative Oncology Group performance status of 0-2 were eligible. A total of 108 patients were randomly assigned to receive biweekly mFOLFOX6 or infusional FU/LV until progression. Progression-free survival (PFS) was the primary end point.ResultsBaseline patient characteristics were similar in both arms. No difference was observed in PFS (median, 3.1 months v 2.9 months; P = .99). Overall survival (OS) was inferior in patients assigned to mFOLFOX6 (median, 6.1 months v 9.9 months; P = .02). Increased toxicity was observed with the addition of oxaliplatin, with grade 3/4 adverse events occurring in 63% of patients who received mFOLFOX6 and 11% of those who received FU/LV. More patients in the mFOLFOX6 arm withdrew from study due to adverse events than in the FU/LV arm (20% v 2%), whereas the use of post-progression therapy was significantly higher in the FU/LV arm (25% v 7%; P = .015). No significant differences were observed in time to deterioration on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 global health scale.ConclusionNo benefit was observed with the addition of oxaliplatin, administered as mFOLFOX6, versus infusional FU/LV in patients with advanced pancreatic cancer previously treated with first-line gemcitabine. (C) 2016 by American Society of Clinical Oncology