IMPACT OF RECOMBINANT HUMAN GRANULOCYTE-COLONY-STIMULATING FACTOR ON DOSE INTENSITY AND TOXICITY OF 3 CYCLES OF METHOTREXATE, VINBLASTINE, DOXORUBICIN AND CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED UROTHELIAL BLADDER-CARCINOMA

This single arm, open labeled, nora randomized study was aimed to eval uate the toxicity of 3 cycles of MVAC (methotrexate, vinblastine, doxo rubicin and cisplatin) with rhG-CSF (5 mu g/kg/day from day 3 to day 1 4), on 14 patients with previously untreated infiltrating bladder carc inoma. 42 cycles were administered. Chemotherapy toxicity was very low , with 7 % of neutropenia grade 3 or 4.4 % of thrombocytopenia grade 2 , no mucositis above grade 2 and no-nadir sepsis. Bone pain related to rhG-CSF occured in 14 % of cycles, 88 % of the cycles were given at f ull dose without any delay and mean relative dose intensity was 96.4 % (RDI was 100 % for 9 patients), One patient achieved a complete patho logical response (cystectomy: 1) and 6 clinical responses with negativ e transurethral resection. Addition of rhG-CSF to MVAC chemotherapy al lows a high dose intensity of MVAC with very low toxicity over 3 cycle s. This association should be compared to standard MVAC or intensified regimens to evaluate efficacy, toxicity, and cost effectiveness.