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首页> 外文期刊>Acta gastro-enterologica Belgica >A phase II randomized study of combined infusional leucovorin sodium and 5-FU versus the leucovorin calcium followed by 5-FU both in combination with irinotecan or oxaliplatin in patients with metastatic colorectal cancer
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A phase II randomized study of combined infusional leucovorin sodium and 5-FU versus the leucovorin calcium followed by 5-FU both in combination with irinotecan or oxaliplatin in patients with metastatic colorectal cancer

机译：转移性结直肠癌患者联合输注亚叶酸钙钠和5-FU与亚叶酸钙联合5-FU联合伊立替康或奥沙利铂的II期随机研究

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摘要

Background: Leucovorin Sodium (LV/Na) has a high solubility, and is stable when given with continuous infusion of 5-FU. It could maintain significant plasma concentration of 5, 10-meTHF during the whole 5-FU perfusion with the potential of increasing 5-FU cytotoxicity. We conducted a randomized phase II clinical trial on leucovorin calcium (LV/Ca) and LV/Na in metastatic colorectal cancer patients (mCRC). Main objectives were to assess efficacy and safety. Patients and methods: Fifty seven patients with mCRC and no previous chemotherapy for metastatic disease were randomized to receive LV/Na or LV/Ca with irinotecan or oxaliplatine combined with infusional 5-FU. LV/Na was defined as warranting further evaluation in phase III if true overall response rate (ORR) > 35% (α = 5%, β = 10% in case of true ORR > 55%, 51 evaluable patients planned/arm). Results: Results for LV/Ca and LV/Na arm respectively were: observed ORR, 55% (significantly higher than 35%, p = 0.02) and 61% (p = 0.004). Median overall survival durations were 11.9 months and 22.9 months (p = 0.02) and PFS 8.0 vs. 11.5 months (ns). Grade ≥ 3 events were 64% and 46% (p = 0.28). Conclusion: Both LV/Na and LV/Ca disclosed an ORR > 35% with comparable safety.
机译：背景：白叶素钠（LV / Na）具有高溶解度，并且在连续输注5-FU时稳定。在整个5-FU灌注过程中，它可以维持明显的5、10-meTHF血浆浓度，并可能增加5-FU的细胞毒性。我们对转移性结直肠癌患者（mCRC）的亚叶酸钙（LV / Ca）和LV / Na进行了随机的II期临床试验。主要目标是评估疗效和安全性。患者和方法：57例既往未曾接受过转移性疾病化疗的mCRC患者被随机分配接受伊立替康或奥沙利铂联合5-FU输注的LV / Na或LV / Ca。 LV / Na被定义为如果真实总缓解率（ORR）> 35％（如果真实ORR> 55％，则α= 5％，β= 10％，计划/治疗51位可评估患者），需要在第三阶段进行进一步评估。结果：LV / Ca和LV / Na组的结果分别为：观察到的ORR，55％（显着高于35％，p = 0.02）和61％（p = 0.004）。中位总生存期分别为11.9个月和22.9个月（p = 0.02）和PFS 8.0与11.5个月（ns）。 ≥3级事件分别为64％和46％（p = 0.28）。结论：LV / Na和LV / Ca均显示ORR> 35％，具有相当的安全性。

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