Clinical activity of sunitinib rechallenge in metastatic renal cell carcinoma-Results of the REchallenge with SUnitinib in MEtastatic RCC (RESUME) Study.
Stéphane Oudard, Lionnel Geoffrois, Aline Guillot, Christine Chevreau, Jean-Laurent Deville, Sabrina Falkowski, Helen Boyle, Marjorie Baciuchka, Pierre Gimel, Brigitte Laguerre, Mathieu Laramas, Christian Pfister, Delphine Topart, Frédéric Rolland, Eric Legouffe, Gwénaël Denechere, Eric Yaovi Amela, Sophie Abadie-Lacourtoisie, Marine Gross-Goupil
Author Information
Stéphane Oudard: Medical Oncology Department, Hôpital Européen George Pompidou, Paris, France. Electronic address: stephane.oudard@aphp.fr.
Lionnel Geoffrois: Oncology Department, Centre Alexis Vautrin, Vandoeuvre Les Nancy, France.
Aline Guillot: Medical Oncology, Institut de Cancérologie Lucien Neuwirth, Saint Priest en Jarez, France.
Christine Chevreau: Medical Oncology, Institut Claudius Régaud, Toulouse, France.
Jean-Laurent Deville: Oncology Department, CHU de la Thimone, Marseille, France.
Sabrina Falkowski: Medical Oncology, CHU Limoges - Hôpital Dupuytren, Limoges, France.
Helen Boyle: Medical Oncology Department, Centre Léon Bérard, Lyon, France.
Marjorie Baciuchka: Multidisciplinary Oncology and Therapeutic Innovations, Hôpital NORD, Marseille, France.
Pierre Gimel: Urology Department, Polyclinique St Roch, Cabestany, France.
Brigitte Laguerre: Medical Oncology, Centre Eugène Marquis, Rennes, France.
Mathieu Laramas: Medical Oncology, CHU de Grenoble, Grenoble, France.
Christian Pfister: Medical Oncology, CHU de Rouen, Rouen, France.
Delphine Topart: Medical Oncology, CHU de Montpellier, Montpellier, France.
Frédéric Rolland: Institut de Cancérologie de l'Ouest, Saint-Herblain, France.
Eric Legouffe: Oncology Department, Polycliniques Ken-Val - Site Valdegour, Nimes, France.
Gwénaël Denechere: Oncology, Pfizer, Paris, France.
Eric Yaovi Amela: Medical Oncology, Centre Oscar Lambret, Lille, France.
Sophie Abadie-Lacourtoisie: Institut de Cancérologie de la Loire, Angers, France.
Marine Gross-Goupil: Medical Oncology, Hôpital Saint-André, CHU Bordeaux, Bordeaux, France.
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.
