Christine Chevreau1, Alain Ravaud2, Bernard Escudier3, Eric Amela4, Remy Delva5, Frederic Rolland6, Diego Tosi7, Stephane Oudard8, Ellen Blanc9, Celine Ferlay9, Sylvie Négrier10. 1. Institut Claudius Regaud, Toulouse, France. Electronic address: chevreau.christine@claudiusregaud.fr. 2. Centre Hospitalier Universitaire Saint André, Bordeaux, France. 3. Institut Gustave Roussy, Villejuif, France. 4. Centre Oscar Lambret, Lille, France. 5. Institut de Cancérologie de l'Ouest, Angers, France. 6. Institut de Cancérologie de l'Ouest, Saint Herblain, France. 7. Institut regional de Cancérologie de Montpellier, Montpellier, France. 8. Hôpital Européen Georges Pompidou, University Paris Descarte, Paris, France. 9. Centre Leon Bérard, Lyon, France. 10. Centre Leon Bérard, Lyon, France; Université Lyon, Lyon, France.
Abstract
BACKGROUND: The expanded access program and anecdotal cases suggested sunitinib is safe in RCC patients with BM and might have worthwhile activity. PATIENTS AND METHODS: In a phase II trial, patients with untreated BM received the standard regimen of sunitinib. The primary end point was objective response (OR) rate in BM after 2 cycles. An OR rate of 35% was prospectively defined as the minimum needed to warrant further investigation. According to Simon's optimal 2-stage design, at least 3 of the initial 15 patients had to have an OR for accrual to continue. RESULTS: Among 16 evaluable patients, 1 had a complete response outside the central nervous system (CNS). CNS disease was stabilized in 5 (31%). However, no BM showed an OR. Therefore, no further accrual took place. Median time to progression was 2.3 months and overall survival was 6.3 months. There was 1 toxic death, from peritonitis with gastric perforation. Three patients experienced at least 1 treatment-related grade 3 or greater toxicity but no neurological adverse events were attributable to sunitinib. CONCLUSION: Although tolerability was acceptable in RCC patients with previously untreated BM, sunitinib has limited efficacy in this setting.
BACKGROUND: The expanded access program and anecdotal cases suggested sunitinib is safe in RCCpatients with BM and might have worthwhile activity. PATIENTS AND METHODS: In a phase II trial, patients with untreated BM received the standard regimen of sunitinib. The primary end point was objective response (OR) rate in BM after 2 cycles. An OR rate of 35% was prospectively defined as the minimum needed to warrant further investigation. According to Simon's optimal 2-stage design, at least 3 of the initial 15 patients had to have an OR for accrual to continue. RESULTS: Among 16 evaluable patients, 1 had a complete response outside the central nervous system (CNS). CNS disease was stabilized in 5 (31%). However, no BM showed an OR. Therefore, no further accrual took place. Median time to progression was 2.3 months and overall survival was 6.3 months. There was 1 toxic death, from peritonitis with gastric perforation. Three patients experienced at least 1 treatment-related grade 3 or greater toxicity but no neurological adverse events were attributable to sunitinib. CONCLUSION: Although tolerability was acceptable in RCCpatients with previously untreated BM, sunitinib has limited efficacy in this setting.
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