816PD - Clinical activity of sunitinib rechallenge in metastatic renal cell carcinoma (mRCC) - Results of the RESUME study

Date 29 September 2014
Event ESMO 2014
Session Genitourinary tumours, non prostate
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Stephane Oudard
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors S. Oudard1, M. Gross Goupil2, L. Geoffrois3, A. Guillot4, C. Chevreau5, J.L. Deville6, S. Falkowski7, H. Boyle8, M. Baciuchka Palmaro9, P. Gimel10, B. Laguerre11, M. Laramas12, C. Pfister13, D. Topard14, F. Rolland15, E. Legouffe16, E. Amela17, S. Abadie-Lacourtoisie18, N. Mahi19
  • 1Medical Oncology Department, Hopital European George Pompidou, 75015 - Paris/FR
  • 2Medical Oncology, Hôpital Saint-André, CHU bordeaux, Bordeaux/FR
  • 3Oncology Departement, Centre Alexis Vautrin, FR-54511 - Vandoeuvre Les Nancy CEDEX/FR
  • 4Medical Oncology, INSTITUT DE CANCÉROLOGIE DE LA LOIRE, 42271 - SAINT PRIEST EN JAREZ CEDEX/FR
  • 5Medical Oncology, Institut Claudius Régaud, 31052 - Toulouse/FR
  • 6Oncology Departement, CHU de la Thimone, MARSEILLE/FR
  • 7Medical Oncology, CHU Limoges - Hopital Dupuytren, Limoges/FR
  • 8Oncology Medicale, Centre Léon Bérard, 69008 - Lyon CEDEX/FR
  • 9Oncology Departement, Hopital Nord, marseille/FR
  • 10Medical Oncology, aaa, aaa/FR
  • 11Medical Oncology, Centre Eugène Marquis, Rennes/FR
  • 12Medical Oncology, CHU de Grenoble, grenoble/FR
  • 13Medical Oncology, CHU de Rouen, ROUEN/FR
  • 14Medical Oncology, CHU de Montpellier, Montpellier/FR
  • 15Oncology, RENE GAUDUCHEAU INSTITUT, SAINT HERBLAIN/FR
  • 16Oncology Department, Polycliniques Ken-Val - Site Valdegour, Nimes/FR
  • 17Medical Oncology, Centre Oscar Lambret, Lille/FR
  • 18-, Institut de Cancérologie de la Loire, Angers/FR
  • 19Oncology, Pfizer, Paris/FR

Abstract

Aim

Sunitinib is a front-line standard of care in mRCC patients. Several studies have shown that a 2nd line with a TKI after sunitinib progression is an effective treatment in mRCC. We assessed the efficacy and tolerability of a sunitinib rechallenge in 3rd line or more after progression with other therapies.

Methods

All mRCC patients (pts) initiating a sunitinib rechallenge in 3rd line or more between January 2006 and May 2013 in the 18 French participating centres were enrolled. Patient characteristics, disease characteristics, tolerability, treatment modalities and outcomes of all therapeutic lines (sunitinib in 1st line, treatment received before rechallenge, sunitinib rechallenge) where retrospectively and/or prospectively recorded. All of these data come from a partial analysis on available data in May 2014 and will be updated with the final analysis (August 2014) at the ESMO congress.

Results

Fifty pts treated with sunitinib rechallenge have been analysed. Seventy four percent of pts were male, mean age at diagnosis was 59.3 years, 98% had a clear cell mRCC, ECOG PS was 0-1 in 92.6% pts and 96% had had a prior radical nephrectomy. Ninety six percent of pts had favourable or intermediate risk per MSKCC criteria in 1st line. Sunitinib was started at 50mg 4/2 in 87.5% and 34.7% pts in 1st line and at rechallenge, respectively and at 37.5mg 4/2 in 10.4% and 53.1%. Sunitinib in 1st line produced an ORR of 52.1%, and a median PFS of 18.4 months [CI95%, 12.4 – 23.7]. Most pts (83.3%) discontinued initial sunitinib for disease progression. Rechallenge began a median of 15 months after discontinuation of initial sunitinib treatment. The majority of pts (63.3%) received sunitinib rechallenge in 4th line and 20.4%, 12.2%, 4.1% received sunitinib in 3rd, 5th, 6th line respectively. Treatments received in between were: 82.6% TKI, 97.8% mTOR and both 80.4%. Upon sunitinib rechallenge, 17.1% of pts achieved a partial response with a median PFS of 7.6 months [95%CI, 4.4-9.7]. The overall survival was 61.9 months [95%CI, 55.5 – 74.5]. Substantial new toxicity or significantly increased severity of prior toxicity was not observed during rechallenge.

Conclusions

These data show that sunitinib rechallenge has potential benefits and is tolerated in mRCC patients. They suggest that disease progression on initial sunitinib is not associated with absolute resistance to therapy.

Disclosure

S. Oudard: Consultant or AdvisoryRole; Entity: Sanofi, Novartis, Roche, Bayer, Keocyt, Amgen, Relationship: Myself, compensation: Compensated, Honoraria, Entity: Sanofi, Novartis, Roche, Bayer, Keocyt, Amgen, Pfizer, Relationship: Myself; L. Geoffrois: consultant or advisory role, entity : Roche, Merck Serono, Novartis, Compenstion : Honoraria; A. Guillot: consultant or advisory board : Sanofi, Janssen, Astellas.

H. Boyle: honoraria: Sanofi, Pfizer, Jansen, Novartis, Pierre Fabre "travel to meetings': Sanofi, Pfizer, Jansen, Novartis; M. Baciuchka Palmaro: Consultant and AdvisoryRole : sanofi, novartis, GSK Compensated honoriara: Sandoz, pierre fabre, novartis, teva, hospira clinical trials (PI or sub investigator) : Pfizer,GSK,Medimmune,Daichi Sankyo,BMS,Roche,Novartis,PUMA Biotechnology,ESAI; B. Laguerre: Honoraira : Sanofi, Astellas, Ipsen, Bayer, GSK, Novartis;

E. Legouffe: Board avec Novartis. Essais cliniques avec Roche, Novartis. Soutiens pour la recherche de la part de Pfizer; N. Mahi: Pfizer employee. All other authors have declared no conflicts of interest.