Stéphane Oudard1, Lionnel Geoffrois2, Aline Guillot3, Christine Chevreau4, Jean-Laurent Deville5, Sabrina Falkowski6, Helen Boyle7, Marjorie Baciuchka8, Pierre Gimel9, Brigitte Laguerre10, Mathieu Laramas11, Christian Pfister12, Delphine Topart13, Frédéric Rolland14, Eric Legouffe15, Gwénaël Denechere16, Eric Yaovi Amela17, Sophie Abadie-Lacourtoisie18, Marine Gross-Goupil19. 1. Medical Oncology Department, Hôpital Européen George Pompidou, Paris, France. Electronic address: stephane.oudard@aphp.fr. 2. Oncology Department, Centre Alexis Vautrin, Vandoeuvre Les Nancy, France. 3. Medical Oncology, Institut de Cancérologie Lucien Neuwirth, Saint Priest en Jarez, France. 4. Medical Oncology, Institut Claudius Régaud, Toulouse, France. 5. Oncology Department, CHU de la Thimone, Marseille, France. 6. Medical Oncology, CHU Limoges - Hôpital Dupuytren, Limoges, France. 7. Medical Oncology Department, Centre Léon Bérard, Lyon, France. 8. Multidisciplinary Oncology and Therapeutic Innovations, Hôpital NORD, Marseille, France. 9. Urology Department, Polyclinique St Roch, Cabestany, France. 10. Medical Oncology, Centre Eugène Marquis, Rennes, France. 11. Medical Oncology, CHU de Grenoble, Grenoble, France. 12. Medical Oncology, CHU de Rouen, Rouen, France. 13. Medical Oncology, CHU de Montpellier, Montpellier, France. 14. Institut de Cancérologie de l'Ouest, Saint-Herblain, France. 15. Oncology Department, Polycliniques Ken-Val - Site Valdegour, Nimes, France. 16. Oncology, Pfizer, Paris, France. 17. Medical Oncology, Centre Oscar Lambret, Lille, France. 18. Institut de Cancérologie de la Loire, Angers, France. 19. Medical Oncology, Hôpital Saint-André, CHU Bordeaux, Bordeaux, France.
Abstract
AIM: To assess the efficacy and tolerability of sunitinib rechallenge in the third-line or later setting in patients with metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: This observational study comprised 61 mRCC patients at 19 centres in France who received sunitinib rechallenge between January 2006 and May 2013. Patients received first-line sunitinib, ≥1 different targeted therapies, and then sunitinib rechallenge. Patient/disease characteristics, tolerability, treatment modalities, and outcomes of therapeutic lines were recorded. The primary end-point was progression-free survival (PFS) in sunitinib rechallenge. RESULTS: Analyses included 52 patients; median age was 59 years, 75% were male, and 98% had clear-cell mRCC and prior nephrectomy. At sunitinib rechallenge versus first-line, patients had poorer performance (Karnofsky performance status 90-100: 30% versus 81%) and Memorial Sloan Kettering Cancer Centre prognostic risk (poor risk: 18% versus 3%). Overall, 20%, 65%, 12%, and 4% received sunitinib rechallenge as third-, fourth-, fifth-, and sixth-line therapy, respectively, at 14.6 months (median) after stopping initial treatment. With first-line sunitinib and rechallenge, median PFS was 18.4 and 7.9 months, respectively; objective response rate was 54% and 15%. Two of eight rechallenge responders had not achieved first-line response. Median overall survival was 55.9 months. The sunitinib rechallenge safety profile was as expected, with no new adverse events reported. CONCLUSIONS: Sunitinib rechallenge is a feasible treatment option with potential clinical benefit for mRCC patients. Disease progression with first-line sunitinib may not be associated with complete or irreversible resistance to therapy.
AIM: To assess the efficacy and tolerability of sunitinib rechallenge in the third-line or later setting in patients with metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: This observational study comprised 61 mRCC patients at 19 centres in France who received sunitinib rechallenge between January 2006 and May 2013. Patients received first-line sunitinib, ≥1 different targeted therapies, and then sunitinib rechallenge. Patient/disease characteristics, tolerability, treatment modalities, and outcomes of therapeutic lines were recorded. The primary end-point was progression-free survival (PFS) in sunitinib rechallenge. RESULTS: Analyses included 52 patients; median age was 59 years, 75% were male, and 98% had clear-cell mRCC and prior nephrectomy. At sunitinib rechallenge versus first-line, patients had poorer performance (Karnofsky performance status 90-100: 30% versus 81%) and Memorial Sloan Kettering Cancer Centre prognostic risk (poor risk: 18% versus 3%). Overall, 20%, 65%, 12%, and 4% received sunitinib rechallenge as third-, fourth-, fifth-, and sixth-line therapy, respectively, at 14.6 months (median) after stopping initial treatment. With first-line sunitinib and rechallenge, median PFS was 18.4 and 7.9 months, respectively; objective response rate was 54% and 15%. Two of eight rechallenge responders had not achieved first-line response. Median overall survival was 55.9 months. The sunitinib rechallenge safety profile was as expected, with no new adverse events reported. CONCLUSIONS:Sunitinib rechallenge is a feasible treatment option with potential clinical benefit for mRCC patients. Disease progression with first-line sunitinib may not be associated with complete or irreversible resistance to therapy.