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

作者：Bleiberg H^*; Vandebroek A; Deleu I; Vergauwe P; Kalantari H Rezaei; D' Haens G; Paesmans M; Peeters M; Efira A; Humblet Y

来源：Acta Gastro Enterologica Belgica, 2012, 75(1): 14-21.

• colorectal cancer
• chemotherapy
• leucovorin continuous infusion

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. %26lt;br%26gt;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) %26gt;35% (alpha = 5%, beta = 10% in case of true ORR %26gt;55%, 51 evaluable patients planned/arm). %26lt;br%26gt;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 %26gt;= 3 events were 64% and 46% (p = 0.28). %26lt;br%26gt;Conclusion : Both LV/Na and LV/Ca disclosed an ORR %26gt; 35% with comparable safety. (Acta gastroenterol. belg., 2012, 75, 14-21).

• 出版日期2012-3