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 Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
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.