© 2007 European Society for Medical Oncology
urogenital tumors |
Gemcitabine and oxaliplatin combination: a multicenter phase II trial in unfit patients with locally advanced or metastatic urothelial cancer
1 Medical Oncology Department, Hospital Universitario del Mar, Barcelona
2 Medical Oncology Department, Hospital Central de Asturias, Oviedo
3 Medical Oncology Department, Instituto Valenciano de Oncología, Valencia
4 Medical Oncology Department, Hospital Germans Trias i Pujol, Badalona
5 Medical Oncology Department, Hospital Clinico San Carlos, Madrid
6 Medical Oncology Department, Hospital General Universitario, Valencia to Hospital General Universitario, Valencia
7 Medical Department, Eli Lilly and Company, Alcobendas
8 Medical Department, Sanofi-Aventis, Barcelona, Spain
* Corresponding author: Dr J. Carles, Department of Oncology, Hospital Universitari del Mar, Passeig Maritim, 25-29, 08003 Barcelona, Catalonia, Spain. Tel: +34-93-248-31-37; Fax: +34-93-248-33-66; E-mail: jcarles{at}imas.imim.es
Background: Up to 50% of patients with bladder cancer cannot be treated with cisplatin because they are considered unfit due to poor renal function. Gemcitabine and oxaliplatin are active, nonnephrotoxic therapies with nonoverlapping toxicity profiles that provide an alternative therapy for this group of patients.
Patients and methods: In a multicenter study, patients received gemcitabine 1200 mg/m2 on days 1 and 8 and oxaliplatin 100 mg/m2 on day 8 every 21 days. Eligible criteria were creatinine clearance >30 ml/min and/or Eastern Cooperative Oncology Group (ECOG) performance status of two or less.
Results: Forty-six patients were assessable for response and toxicity. Median age was 69 years (range 52–85), median ECOG two (range 0–2). Median number of metastatic sites was 2 (range 1–6). Median creatinine clearance was 50.73 ml/min (range 30–87). A total of 187 cycles were given with a median of 5 (range 1–6). Hematological toxicity was mild with grade 3–4 peripherical neuropathy occurring in 4% of patients. Overall response rate was 48% (three complete response, 19 partial response, seven stable disease and 17 progressive disease). Median time to disease progression was 5 months.
Conclusion: Gemcitabine–oxaliplatin is an active and tolerable combination with response rate that merits further study in patients with impaired renal function but good performance status.
Key words: bladder cancer, gemcitabine, oxaliplatin, unfit patients
Received for publication January 29, 2007. Revision received March 29, 2007. Accepted for publication March 29, 2007.