820P - Sunitinib Global Expanded-Access Trial in Metastatic Renal Cell Carcinoma (MRCC) – Final Results

Abstract

ABSTRACT Background 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. Methods Pts aged ≥18 yrs with treatment-naive 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. Results 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). Conclusions 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. Disclosure M.E. Gore: Advisory relationships with Roche, Pfizer, Bristol Myers, Novartis, GSK, Aveo\\Astellas, 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.