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Combination phase II study of weekly paclitaxel and 5'-DFUR for unresectable or recurrent gastric cancer.

BACKGROUND
Paclitaxel and 5'-deoxy-5-fluorouridine (5'-DFUR) have single-agent activity in gastric cancer and have distinct mechanisms of action and no overlap of key toxicities. To evaluate the efficacy and safety of their combination, we conducted a combination phase II study of paclitaxel and 5'-DFUR in patients with unresectable or recurrent gastric cancer who had received up to one prior chemotherapy.


PATIENTS AND METHODS
Treatment included paclitaxel at 70 mg/m(2) i.v. on days 1, 8 and 15 every four weeks, and 5'-DFUR at 600 mg p.o. every day. The primary end-point was the response rate (RR) and secondary end-points were overall survival (OS), progression-free survival (PFS), time-to-treatment failure (TTF) and rate of adverse events.


RESULTS
In 42 eligible patients, the RR was 40.5%. OS, PFS and TTF were 371 days, 170 days, and 147 days, respectively. Adverse events were relatively mild. Commonly observed grade 3/4 adverse events were neutropenia (26.2%), anorexia (4.8%), neuropathy (4.8%) and fatigue (4.8%).


CONCLUSION
The combination of weekly paclitaxel and 5'-DFUR chemotherapy is active and well-tolerated.