An Early Phase II Study of 5-Fluorouracil Combined with Cisplatinum as a Second Line Chemotherapy against Metastatic Gastric Cancer

Twenty-two patients with measurable metastatic gastric cancer, refractory to prior chemotherapy, were treated with a combination chemotherapy of 5-fluorouracil (5FU) and cisdiamminedichroloplatinum (II) (CDDP). 5FU was continuously infused for five consecutive days at a dose of 800 mg/m2/day, and CDDP was given intravenously for five days at a dose of 20 mg/m2/day over 30 mm every four weeks. All patients had received only one regimen of prior chemotherapy, and 10 of the 22 had been pretreated with combination of etoposide, doxorubicin and CDDP (EAP). It was possible to evaluate 20 of the 22 patients treated for response and toxicity. Nine of the 20 patients achieved a partial response, the response rate being 45% (23–67% with 95% confidence limits). The nine patients who responded included three who had been pretreated with EAP, indicating that 5FU + CDDP can be used as a second line chemotherapy against gastric cancer, even when the initial intensive chemotherapy, such as EAP, has failed to obtain or maintain a response. High grade toxicities (WHO grade 3 or 4) of leukocytopenia, thrombocytopenia and stomatitis were seen in 20, 25 and 40%, respectively. No treatment-related death was, however, observed. The above results suggest that 5FU + CDDP could be promising in a phase II trial with a large number of cases.