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

Autor: Kollmannsberger, C, Quietzsch, D, Haag, C, Lingenfelser, T, Schroeder, M, Hartmann, J T, Baronius, W, Hempel, V, Clemens, M, Kanz, L, Bokemeyer, C
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Zdroj: British Journal of Cancer; 8/15/2000, Vol. 83 Issue 4, p458, 5p
Abstrakt: To evaluate the toxicity and efficacy of combination chemotherapy with paclitaxel, cisplatin and 24 h continuous infusion of 5-FU/folinic acid in patients (pts) with unresectable, locally advanced or metastatic gastric adenocarcinoma. 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[SUP2] was given weekly over 24 h i.v. preceded by folinic acid 500 mg/m[SUP2] as a 2 h infusion. Paclitaxel 175 mg/m[SUP2] was administered as a 3 h-infusion on days 1 and 22 and cisplatin 50 mg/m[SUP2] 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 considered 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 CR and 18 pts (40%) a PR (ORR 51%; 95% Cl: 35.8-66.3%). Responses were achieved 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 have 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-haematologic toxicity. The median progression-free and overall survival times were 9 months (range 1-36+) and 14 months (range 2-36+), respectively. Neutropenia WHO III°/IV° occurred in 7 pts (15%) with only 1 pt having grade IV. Additional non-haematologic WHO III°/IV° toxicities included nausea/vomiting in 5 (11%), alopecia in 22 (49%), and diarrhoea in 1 patient each (2%). Dose reductions or treatment delays were necessary in 8 pts (17%), mainly due to neutropenia. All pts were treated on an outpatient basis. The combination of paclitaxel, cisplatin and continuously infused 5-FU/folinic acid appears to be a highly active regimen for the treatment of pts with advanced gastric cancer. While the overall acceptable toxicity allows its use in the palliative setting... [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index