A randomized phase II study of S-1 plus oral leucovorin versus S-1 monotherapy in patients with gemcitabine-refractory advanced pancreatic cancer

This is the first phase II trial in which adding oral leucovorin to S-1 (SL) significantly prolonged progression-free survival (PFS) as compared with S-1 monotherapy in patients with gemcitabine-refractory advanced pancreatic cancer (PC). The significantly better PFS and disease control rate with SL than with S-1 monotherapy suggest that the antitumor activity of S-1 is enhanced by leucovorin in advanced PC.

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