Abstract A28: C-reactive protein as a predictive marker of response to sunitinib treatment in metastatic clear cell renal carcinoma

Abstract

Abstract Background: Antiangiogenic treatment, is currently first line therapy in metastatic renal cell carcinoma (RCC). Due to high drug costs and potentially serious side effects there is an urgent need for clinically useful predictive markers. We conducted a single center phase II clinical trial with sunitinib treatment for metastatic RCC. Study Design: Forty-five patients with metastatic or non-resectable clear cell RCC were included. Sunitinib was given in cycles of six weeks (four weeks of treatment, two weeks pause). Follow up was every six week. Primary endpoint was response rates (RECIST 1.1). Secondary endpoints were time to progression (TTP) and overall survival (OS). Toxicity and quality of life were recorded. Results: Twenty five (55 %) cases showed clinical benefit with complete response (CR): 1, partial response (PR): 6, stable disease (SD)>6months: 18. Twelve patients showed progressive disease (PD). Eight patients stopped treatment or were still under treatment prior to the first radiologic evaluation, and were recorded as non-evaluable. The following parameters were recorded at baseline; gender, age, ECOG-, WHO- and Karnofsky's performance status, Heng- and Motzer prognostic criteria, blood pressure, hemoglobin, white blood count, neutrophil count, platelets, sodium, potassium, creatinine, corrected calcium, C-reactive protein(CRP), albumin, lactate dehydrogenase, thyroid-stimulating hormone, thyroid hormones and D dimer, body mass index, use of antihypertensive medication, location of metastasis and tumor load. Of these, CRP ≤ 10 mg/L at baseline (vs CRP > 10 mg/L), was significantly associated with objective response (CR+PR) (Fisher's Exact test, p=0,030). Good performance status showed a significant association with clinical benefit (Fisher's Exact test, p=0,049). Toxicity data and quality of life data will be presented. Conclusion: Of the clinical markers under investigation, only CRP at baseline as well as performance status were found to be possible predictive markers of response to sunitinib in metastatic RCC. Our patient population is comparable to those in already reported studies and might be useful to further investigations of angiogenesis related predictive markers of response. Citation Format: Martin Pilskog, Christian Beisland, Oddbjørn Straume. C-reactive protein as a predictive marker of response to sunitinib treatment in metastatic clear cell renal carcinoma. [abstract]. In: Proceedings of the AACR Special Conference: Tumor Angiogenesis and Vascular Normalization: Bench to Bedside to Biomarkers; Mar 5-8, 2015; Orlando, FL. Philadelphia (PA): AACR; Mol Cancer Ther 2015;14(12 Suppl):Abstract nr A28.