• Acta Gastroenterol. Belg. · Mar 2012

    Randomized Controlled Trial

    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.

    • H Bleiberg, A Vandebroek, I Deleu, P Vergauwe, H Rezaei Kalantari, G D'Haens, M Paesmans, M Peeters, A Efira, and Y Humblet.
    • Institut Jules Bordet, Brussels, Belgium. harry.bleiberg@skynet.be
    • Acta Gastroenterol. Belg. 2012 Mar 1; 75 (1): 14-21.

    BackgroundLeucovorin 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 MethodsFifty 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).ResultsResults 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).ConclusionBoth LV/Na and LV/Ca disclosed an ORR > 35% with comparable safety.

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