Gemcitabine and oxaliplatin combination: A multicenter phase II trial in unfit patients with locally advanced or metastatic urothelial cancer

• DOI: 10.1200/jco.2004.22.90140.4544
• Publication Date: 2017-04-05T03:17:42Z
• Authors: A. Font; E. Esteban; J. Carles; M. A. Climent; J. L. Gonzalez-La...; A. Berrocal; J. Bellmunt; I. Garcia-Ribas; X. Marfa; X. Fabregat
• Keywords: Nephrotoxicity; Performance status; Mucositis

4544 Background: Although cisplatin is considered the cornerstone for treatment of advanced bladder cancer, up to 50% patients (pts) cannot receive it because they are unfit mainly due poor renal function. New non nephrotoxic regimens needed. Gemcitabine and oxaliplatin active, non-nephrotoxic with non-overlapping toxicity therefore being attractive be studied in combination cancer patients. Methods: Thirty-six pts (mainly function,creatinine clearance < 60 mL/min) standard cisplatin-based were included this multicentric phase II. We describe here first 27 give response data from 12 evaluable pts. Median age was 69 years (range 60–81), 24 male 3 female, median ECOG 1 0–2). Three had received previous adjuvant chemotherapy 2 previously treated radiotherapy. Fifteen one or two metastatic sites more than sites. Calculated creatinine 48 mL/min 30–76). Patients gemcitabine 1200 mg/m2 d 8 100 on day every 21 days. Results: number cycles 1–6). A total 74 toxicity. Grade 3–4 hematological mild. anemia reported 19% thrombopenia 11.5% neutropenia 4.6% cycles. Hospitalization fever required So far efficacy an overall rate (6 partial responses, 5 stabilizations progression).Conclusion: Gemcitabine-oxaliplatin active tolerable locally urothelial cancer. Author Disclosure Employment Leadership Consultant Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly & Co.; Sanofi-Synthelabo