Abstract
Cisplatin-based chemotherapy is recommended for use as first-line treatment for patients with advanced transitional cell carcinoma of the bladder. Unfortunately, 30-50 % of patients are ineligible for cisplatin due to renal insufficiency. Oxaliplatin is a less nephrotoxic platin which can be used for patients with impaired renal function. We carried out a phase II study of gemcitabine (1,200 mg/m²) in combination with oxaliplatin (100 mg/m²) given on days 1 and 14 every 28 days (GEMOX) in predominantly cisplatin-'unfit' stage IV transitional cell bladder cancer patients to determine whether this combination exhibited a clinical activity profile similar to cisplatin plus gemcitabine. Eighteen patients with a median GFR of 49 ml/min were enrolled. GEMOX treatment led to a 36 % response rate in assessable patients. Median progression-free survival was 4.9 months, with a median overall survival (OS) of 10.4 months and a one-year survival rate of 44.4 %. GEMOX in bladder cancer patients exhibited a tolerable side effects profile, with thrombocytopenia as the most frequent grade 3/4 toxicity. These findings suggest that GEMOX is an active combination in advanced bladder cancer patients with reduced renal function.
MeSH terms
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Aged
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Aged, 80 and over
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Carcinoma, Transitional Cell / complications
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Carcinoma, Transitional Cell / drug therapy*
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Carcinoma, Transitional Cell / pathology
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Carcinoma, Transitional Cell / physiopathology
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Deoxycytidine / administration & dosage
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Deoxycytidine / adverse effects
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Deoxycytidine / analogs & derivatives
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Deoxycytidine / therapeutic use
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Drug Monitoring
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Female
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Glomerular Filtration Rate
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Humans
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Kidney / drug effects
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Kidney / physiopathology
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Male
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Middle Aged
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Neoplasm Staging
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Organoplatinum Compounds / administration & dosage
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Organoplatinum Compounds / adverse effects
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Organoplatinum Compounds / therapeutic use
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Renal Insufficiency / complications
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Renal Insufficiency / physiopathology
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Severity of Illness Index
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Survival Analysis
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Thrombocytopenia / chemically induced
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Thrombocytopenia / physiopathology
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Urinary Bladder Neoplasms / complications
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Urinary Bladder Neoplasms / drug therapy*
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Urinary Bladder Neoplasms / pathology
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Urinary Bladder Neoplasms / physiopathology
Substances
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Organoplatinum Compounds
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Deoxycytidine
Supplementary concepts
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gemcitabine-oxaliplatin regimen