A retrospective multicenter study of MSKCC poor-prognosis patients with metastatic renal cell carcinoma (mRCC) treated with sunitinib

Abstract

16057 Background: Sunitinib is currently a standard of care for the treatment of mRCC. Due to the inclusion criteria and selection bias inherent to clinical trials, only 6% of patients enrolled in the pivotal phase III sunitinib vs interferon trial had poor-prognosis MSKCC criteria and thus further investigation of the effect of sunitinib in this population is required. Methods: Provincial registries and/or clinical databases were used to identify all patients with mRCC treated with sunitinib in British Columbia, Calgary, Edmonton, and the Cleveland Clinic. Medical records were searched to identify only those patients with MSKCC poor prognosis criteria (3 or more of the following criteria: Karnofsky Performance Status (KPS) <80, diagnosis to treatment interval <1 year, LDH >1.5 times upper limit of normal (ULN), serum corrected calcium >10mg/dL, and hemoglobin below the lower limit of normal (LLN)). Baseline characteristics, overall survival (OS) and progression-free survival (PFS) were collected. Results: 61 poor-prognosis patients met inclusion criteria and were treated with sunitinib (50 mg/d 4/2 wks). Median age of these patients was 60 years (range 23–83) and 43% had prior treatment. 79%, 18% and 3% had 3, 4, and 5 adverse prognosis factors, respectively. 41% had prior nephrectomy, 75% had diagnosis to treatment intervals <1 year, 91% had KPS scores of <80, 70% had >1 metastatic site, 90% had hemoglobin<LLN, 44% had elevated serum corrected calcium, and 26% had LDH elevated 1.5 times ULN. The estimated median PFS and OS of this cohort were 3.9 months and 6.4 months, respectively. There was no difference in outcome according to having prior treatment (PFS p=0.58, OS p=0.72) or prior nephrectomy (PFS p=0.60, OS p=0.91). A KPS score of ≤60 and 70 was associated with a median PFS of 2.9 and 5.1 months, respectively while the median PFS for patients with KPS ≥80 has not been reached (trend test p=0.04). Conclusion: Patients with poor-prognosis MSKCC criteria treated with sunitinib have a PFS that is comparable to clinical trial subsets of similar patients. This remains true despite many of these patients having prior treatment and many being treated outside the context of a clinical trial. The post-progression overall survival of these patients is short. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bayer, Genentech™ BioOncology, Novartis, Pfizer Oncology, Wyeth Bayer, Celgene, Genentech™ BioOncology, Novartis, Pfizer Oncology, Wyeth Bayer, Bristol-Myers Squibb, Celgene, Genentech™ BioOncology, Novartis, Pfizer Oncology, Wyeth