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A phase II prospective study of gemcitabine and platinum-based combination as first-line chemotherapy for metastatic Bellini duct carcinoma patients. Results of GETUG study

Domenii publicaţii > Ştiinţe medicale + Tipuri publicaţii > Articol în revistã ştiinţificã

Autori: S, Oudard S, Duclos B, Banu E, Priou F, Rousseau F, Langlois D, Banu A, Rolland F

Editorial: Poster discussion. Abstract 4543. J Clin Oncol (supplement) 2005;23(16S):390s., 2005.


Background: Immunotherapy is rarely effective in patients (pts) with Bellini duct carcinoma (BDC), a rare (< 1% off all renal cancers) and aggressive variant of kidney cancer. Gemcitabine (GEM) and platinum salt combination was considered as a potential regimen (Oudard, J Urol. 2003). Methods: We conducted a prospective, multicenter, phase II study to assess the efficacy and safety of GEM-platinum association in metastatic BDC pts. Central pathology review was performed. Treatment consisted of GEM (1250 mg/m2, day 1, 8) and platinum salt (cisplatin 70 mg/m2 or carboplatine AUC 5, day 1, for pts with mild or moderate renal insufficiency), q3w. Overall response rate (WHO criteria) was the primary end point. Additionally, progression-free survival (PFS) and overall survival (OS) was evaluated. Kaplan-Meier and Cox hazard regression methods were used to estimate survival data (PFS, OS) and the relationship with baseline variables. Toxicity was evaluated according CTC-NCI version 2 criteria. Results: Between October 2001 and August 2004, 20 pts were treated in six French centers. Pts characteristics: median age was 62 years [18–73], M/F: 8/12, ECOG performance status (PS) 0/1/2: 5/12/3. Sites of metastases included: lung (65%), bone (20%), lymph nodes (45%), liver (30%) and others (20%), with 80% of pts having > 2 metastatic sites. Four pts (20%) with renal insufficiency at inclusion were treated with carboplatine and other two pts were switched to the same platinum salt for renal toxicity. Pts distribution according to response was: 5 (25%) PR, 8 (40%) SD, 4 (20%) PD and 3 (15%) not yet evaluable. The PFS and OS were 7.9 months (95% CI, 1.8–14 months) and 9.5 months (95% CI, 2.7–16.3 months), respectively. PFS and OS percentages at 1-year were 33% and 48%, respectively. No relationship was demonstrated between survival data and age, PS, sex or baseline hemoglobin. Toxicity was predominantly hematologic, with two severe neutropenia and trombocytopenia. Two mild renal toxicity were registered. Conclusions: This is the first prospective study showing that combination of gemcitabine and platinum salt is an active regimen for pts with metastatic BDC.

Cuvinte cheie: cancer de rinichi, chimioterapie, supravietuire // renal cancer, chemotherapy, survival