GEMCYTABIN (CYTOGEMr (R)) AND CISPLATIN AS FIRST-LINE THERAPY FOR ADVANCED BLADDER CANCER: RESULTS OF A PROSPECTIVE OPEN-LABELED NON-COMPARATIVE NON-RANDOMIZED STUDY

Purpose. The primary end-points of the study were overall response rate, progressive-free and overall survival in patients received Gemcytabin (Cytogem (R)) and Cisplatin as first-line therapy for transitional-cell bladder cancer. Secondary end-points were toxicity and safety of the regimen. Material. From February 2005 to March 2007 25 patients with morphologically verified inoperable locally advanced and metastatic transitional-cell bladder cancer were recruited. Men-to-women ratio was 3:1. Median age of the patients was 66,5 +/- 6,8 years. All the patients received Cytogem (R) 1000 mg/m(2) days 1, 8, 15, cisplatin 70 mg/m(2) on day 2; every 28 days. No more than 6 cycles were allowed if the evidence of disease progression and unacceptable toxicity were not registered. Median follow-up was 36,2 +/- 12,1 months. Results. Complete response was observed in 2 (8%), partial - in 11 (44%), stabilization - in 10 (40%), progression - in 2 (8%) of 25 patients. Twelve-and 24-month overall survival was - 51,3% and 22,4% (median 13,4 +/- 3,5 (95% CI: 6,6-20,4) months), progressive-free survival - 26% and 13% respectively (median 8,8 +/- 1 (95% CI: 6,6-10,6) months). Toxicity was evaluated in 24 patients and occurred in all cases (grade I-II - 16 (67%), grade III-IV - 8 (33%)). The main regimen-related toxicity was hematological (neutropenia - 16 (67%) (grade I-II - 8 (33%), grade III-IV - 8 (33%)), thrombocytopenia - 14 (58%) (grade I-II - 10 (41,5%), grade III-IV 4 (16,5%)), anemia - 7 (29%) (grade I-II - 5 (21%), grade III-IV - 2 (8%))). Hematological toxicity was not associated with complications in any case. Non-hematological side-effects were nausea and vomiting in 21 (88%) (grade I-II - 67%, grade III - 21%), alopecia - in 11 (44%) patients. The regimen-related toxicity was considerable and reversible. No side-effect demanded blood transfusion, antibiotic and/or growth factors administration, and hospital admission. Conclusion. Gemcytabin (Cytogem (R)) and Cisplatin as first-line therapy for advanced transitional-cell bladder cancer have demonstrated satisfactory efficacy and acceptable toxicity. The regimen can be recommended for the clinical practice.