820P - Sunitinib global expanded-access trial in metastatic renal cell carcinoma (mRCC) - final results

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Cytotoxic agents
Renal Cell Cancer
Biological therapy
Presenter Martin Gore
Authors M.E. Gore1, C. Porta2, S. Bracarda3, G.A. Bjarnason4, S. Oudard5, S. Lee6, L. Crinò7, T.M. Kim8, K. Fly9, C. Szczylik10
  • 1Department Of Medicine, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/UK
  • 2Oncologia Medica, IRCCS San Matteo University Hospital Foundation, Pavia/IT
  • 3Department Of Oncology, Medical Oncology Arezzo, Arezzo/IT
  • 4Division Of Medical Oncology, Sunnybrook Odette Cancer Centre, Toronto/CA
  • 5Medical Oncology Service, Georges Pompidou Hospital and Rene Descartes University, Paris/FR
  • 6Oncology, Seoul National University Hospital, Seoul/KR
  • 7Medical Oncology, S. Maria della Misericordia Hospital, Perugia/IT
  • 8Medical Oncology, Seoul National University Hospital, Seoul/KR
  • 9Oncology, Pfizer Inc., CT 06340 - Groton/US
  • 10Oncology, Military Medical Institute, Warsaw/PL



Sunitinib had a manageable safety profile and encouraging efficacy in a global expanded-access mRCC study (ClinicalTrials.gov, NCT00130897; Pfizer) initiated prior to regulatory approval, in patients (pts) ineligible for other trials (Gore et al, 2009). Here we report final results.


Pts aged ≥18 yrs with treatment-naïve or previously treated mRCC received oral sunitinib on the approved 50 mg/day 4-wk-on/2-wk-off schedule. Safety was assessed regularly and tumor measurements were done as per local standard practice using RECIST-defined response. Analyses included all pts who received ≥1 dose of sunitinib.


4,577 pts were enrolled. From July 2005 to November 2011, 4,543 pts received treatment, including poor prognosis pts with brain metastases (7%), Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 (14%), non-clear cell RCC (12%) and age ≥65 yrs (33%). Median treatment duration was 7.5 mths and median follow-up was 13.6 mths. 4,298 pts (95%) discontinued; reasons included lack of efficacy (37%), death (20%) and adverse events (AEs; 15%). The most common treatment-related AEs of any grade were diarrhea (47%), fatigue (40%), nausea (36%), decreased appetite (31%), mucosal inflammation (29%), stomatitis and vomiting (both 28%), hand–foot syndrome (HFS; 27%), dysgeusia (25%), hypertension (24%), thrombocytopenia (23%) and asthenia (22%). The most common treatment-related grade 3/4 AEs were fatigue (9%), thrombocytopenia (8%), HFS and asthenia (both 7%), hypertension and neutropenia (both 6%) and diarrhea (5%). In 4,219 evaluable pts, the objective response rate (ORR) was 16% (n = 660) with subgroup ORR as follows: baseline brain metastases (30/324 [9%]), ECOG PS ≥2 (32/587 [5%]), non-clear cell RCC (42/505 [8%]), and age ≥65 yrs (195/1,386 [14%]). Overall median progression-free survival was 9.4 mths (95% CI: 8.8, 10.0) and overall survival was 18.7 mths (95% CI: 17.5, 19.5).


Results from this global expanded-access mRCC trial confirm the safety and efficacy of sunitinib in >4,500 pts with wide-ranging disease states in a real-world setting. The sunitinib AE profile in this broad population was manageable and consistent with prior trial results.


M.E. Gore: Advisory relationships with Roche, Pfizer, Bristol Myers, Novartis, GSK, AveoAstellas, Bayer. Honoraria to disclose from Roche, Pfizer, Bristol Myers, Novartis.

C. Porta: Advisory relationship Pfizer Bayer-Schering Hoffman La Roche GSK Novartis Astellas Boehringer Recordati. Honoraria: Pfizer Bayer-Schering Hoffman La Roche GSK Novartis Astellas Boehringer Recordati Research funding Bayer-Schering Novartis.

S. Bracarda: Advisory relationship with Novartis Bayer Schering Pfizer GSK Aveo/Astellas Boheringer-Ingelheim. Honoraria to disclose from Novartis and Pfizer.

G.A. Bjarnason: Advisory relationship with Pfizer. Honoraria to disclose from Pfizer. Research funding to disclose from Pfizer..

S. Oudard: Advisory relationships: Pfizer, Bayer-Schering, Hoffman La Roche, Glaxo SmithKline, Novartis Pharma, Sanofi Aventis Honoraria: Pfizer, Bayer-Schering, Hoffman La Roche, Glaxo SmithKline, Novartis Pharma, Sanofi Aventis.

S. Lee: Advisory relationships with Pfizer, Novartis, Bayer. Honoraria to disclose from Pfizer, Novartis, Bayer.

K. Fly: Employed by Pfizer Inc. as an Oncology Clinician. Hold Pfizer stock as does an immediate family member.

C. Szczylik: Advisory relationship with Pfizer, GSK, Bayer. Honoraria from Pfizer, GSK, Bayer.

All other authors have declared no conflicts of interest.