title: Clinical activity of sunitinib rechallenge in metastatic renal cell carcinoma-Results of the REchallenge with SUnitinib in MEtastatic RCC (RESUME) Study.
abstract: To assess the efficacy and tolerability of sunitinib rechallenge in the third-line or later setting in patients with metastatic renal cell carcinoma (mRCC).
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Medical Oncology Department, Hôpital Européen George Pompidou, Paris, France. Electronic address: stephane.oudard@aphp.fr.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Oudard
authors.affiliation: Oncology Department, Centre Alexis Vautrin, Vandoeuvre Les Nancy, France.
authors.forename: Lionnel
authors.initials: L
authors.lastname: Geoffrois
authors.affiliation: Medical Oncology, Institut de Cancérologie Lucien Neuwirth, Saint Priest en Jarez, France.
authors.forename: Aline
authors.initials: A
authors.lastname: Guillot
authors.affiliation: Medical Oncology, Institut Claudius Régaud, Toulouse, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Chevreau
authors.affiliation: Oncology Department, CHU de la Thimone, Marseille, France.
authors.forename: Jean-Laurent
authors.initials: JL
authors.lastname: Deville
authors.affiliation: Medical Oncology, CHU Limoges - Hôpital Dupuytren, Limoges, France.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Falkowski
authors.affiliation: Medical Oncology Department, Centre Léon Bérard, Lyon, France.
authors.forename: Helen
authors.initials: H
authors.lastname: Boyle
authors.affiliation: Multidisciplinary Oncology and Therapeutic Innovations, Hôpital NORD, Marseille, France.
authors.forename: Marjorie
authors.initials: M
authors.lastname: Baciuchka
authors.affiliation: Urology Department, Polyclinique St Roch, Cabestany, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Gimel
authors.affiliation: Medical Oncology, Centre Eugène Marquis, Rennes, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Laguerre
authors.affiliation: Medical Oncology, CHU de Grenoble, Grenoble, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Laramas
authors.affiliation: Medical Oncology, CHU de Rouen, Rouen, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Pfister
authors.affiliation: Medical Oncology, CHU de Montpellier, Montpellier, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Topart
authors.affiliation: Institut de Cancérologie de l'Ouest, Saint-Herblain, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Rolland
authors.affiliation: Oncology Department, Polycliniques Ken-Val - Site Valdegour, Nimes, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Legouffe
authors.affiliation: Oncology, Pfizer, Paris, France.
authors.forename: Gwénaël
authors.initials: G
authors.lastname: Denechere
authors.affiliation: Medical Oncology, Centre Oscar Lambret, Lille, France.
authors.forename: Eric Yaovi
authors.initials: EY
authors.lastname: Amela
authors.affiliation: Institut de Cancérologie de la Loire, Angers, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Abadie-Lacourtoisie
authors.affiliation: Medical Oncology, Hôpital Saint-André, CHU Bordeaux, Bordeaux, France.
authors.forename: Marine
authors.initials: M
authors.lastname: Gross-Goupil
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D018572:Disease-Free Survival; D005602:France; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000627:therapeutic use*; D019233:Retreatment; D012189:Retrospective Studies; D000077210:Sunitinib; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D042461:Vascular Endothelial Growth Factor A; D000077210:Sunitinib
keywords: First-line; Metastatic renal cell carcinoma; Rechallenge; Resistance; Sunitinib