A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

To evaluate the toxicity and efficacy of combination chemotherapy with pacl itaxel, cisplatin and 24 h continuous infusion of 5-FU/folinic acid in pati ents (pts) with unresectable, locally advanced or metastatic gastric adenoc arcinoma. Forty-five chemotherapy-naive pts (28 male and 17 female) with a median age of 60 years (range 35-74) were enrolled. 5-FU 2 g/m(2) was given weekly over 24 h i.v. preceded by folinic acid 500 mg/m(2) as a 2 h infusi on. Paclitaxel 175 mg/m(2) was administered as a 3 h-infusion on days 1 and 22 and cisplatin 50 mg/m(2) as 1 h infusion on days 8 and 29. Six weeks of therapy (days 1, 8, 15, 22, 29, 36) followed by 2 weeks rest were consider ed one cycle. A median of 3 cycles (range 1-4) were administered to 45 pts assessable for response, survival and toxicity, Five pts (11%) obtained a C R and 18 pts (40%) a PR (ORR 51%, 95% CI: 35.8-66.3%). Responses were achie ved in the liver, lymph nodes, lungs and at the site of the primary tumour. Nine pts (20%) had stable disease. Thirteen pts (29%) were considered to h ave failed treatment, 8 pts (18%) due to progressive disease and 5 pts (11% ) who did not receive one complete cycle of therapy due to acute non-haemat ologic toxicity. The median progression-free and overall survival times wer e 9 months (range 1-36+) and 14 months (range 2-36+), respectively. Neutrop enia WHO III degrees/IV degrees occurred in 7 pts (15%) with only 1 pt havi ng grade IV. Additional non-haematologic WHO III degrees/IV degrees toxicit ies included nausea/vomiting in 5 (11%), alopecia in 22 (49%), and diarrhoe a in 1 patient each (2%). Dose reductions or treatment delays were necessar y in 8 pts (17%), mainly due to neutropenia. All pts were treated on an out patient basis. The combination of paclitaxel, cisplatin and continuously in fused 5-FU/folinic acid appears to be a highly active regimen for the treat ment of pts with advanced gastric cancer. While the overall acceptable toxi city allows its use in the palliative setting, it may also be an attractive option to be tested for neoadjuvant or adjuvant treatment. (C) 2000 Cancer Research Campaign.