title: Combination of gemcitabine and oxaliplatin in urothelial cancer patients with severe renal or cardiac comorbidities.
abstract: Clinical trials in urothelial cancer exclude a large population of patients. An observational study evaluated the behavior of frail patients not eligible for cisplatin- or carboplatin-based regimens. Urothelial cancer patients requiring chemotherapy with either chronic renal failure (creatinine clearance <60 ml/min), and/or performance status (PS) > or =2 and/or cardiac dysfunction were prospectively observed. The treatment associated gemcitabine 1200 mg/m and oxaliplatin 85 mg/m, bimonthly (GO). Over 2 years, 31 of 45 (69%) patients with urothelial cancer requiring chemotherapy were not eligible for cisplatin- or carboplatin-based chemotherapy. Sixteen (52%) had a PS > or =2, 23 (74%) had creatinine clearance <60 ml/min, and 20 (65%) had an underlying cardiopathy. A total of 178 cycles of GO were administered (median 6 per patient, range 2-12). No aggravation of renal or cardiac status was noted. Acute grade 3 and 4 neutropenia and thrombocytopenia were observed in 16 and 13% of patients, respectively, with one febrile neutropenia. The median progression-free and overall survival values were 4.2 and 9.5 months, respectively. The majority of urothelial cancer patients have severe renal or cardiac comorbidities, and we conclude that in this subset of patients the combination of gemcitabine and oxaliplatin is well tolerated, and its clinical activity warrants further evaluation.
authors.affiliation: Unité d'Oncologie Médicale, Service de Médecine Interne, Hôpital Cochin, GHU Ouest, Assistance Publique-Hôpitaux de Paris, Paris, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Mir
authors.forename: Jérôme
authors.initials: J
authors.lastname: Alexandre
authors.forename: Stanislas
authors.initials: S
authors.lastname: Ropert
authors.forename: Delphine
authors.initials: D
authors.lastname: Amsellem-Ouazana
authors.forename: Thierry
authors.initials: T
authors.lastname: Flam
authors.forename: Philippe
authors.initials: P
authors.lastname: Beuzeboc
authors.forename: Marc
authors.initials: M
authors.lastname: Zerbib
authors.forename: Bernard
authors.initials: B
authors.lastname: Debré
authors.forename: Loïc
authors.initials: L
authors.lastname: Guillevin
authors.forename: François
authors.initials: F
authors.lastname: Goldwasser
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003404:Creatinine / Q000652:urine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006331:Heart Diseases / Q000150:complications; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D016019:Survival Analysis; D016896:Treatment Outcome; D014571:Urologic Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D003404:Creatinine; D000093542:Gemcitabine