Abstract
BackgroundSunitinib has become mainstay first line treatment for patients with metastatic renal clear cell carcinoma (mRCC). Still, useful predictive markers of response are lacking and urgently needed for clinical decision making.MethodsIn the present study we investigated the predictive value of standard serum markers as well as clinical markers, including C-reactive protein (CRP), Neutrophil to Lymphocyte ratio (NLR) and early hypertension (eHTN) in an unselected prospective patient population treated with sunitinib for mRCC. Forty-six patients were enrolled in a prospective single-arm study of predictive markers for sunitinib response. Response rates according to RECIST 1.1 were used as primary end-point. Secondary objectives were to evaluate prognostic value of the candidate markers with regard to progression free survival (PFS) and overall survival (OS). In addition, toxicity rates and quality of life was recorded.ResultsMedian PFS and OS was 9.1 months and 15.0 months, respectively. Of 38 patients evaluable for response, 1 patient had complete response (CR), 7 had partial response (PR), 18 had stable disease (SD) and 12 had progressive disease (PD). Normal CRP at baseline was significantly associated with objective response (CR + PR) (p = 0.01). Normal CRP was also significantly associated with improved PFS and OS (Log rank, p = 0.05 and <0.01, respectively). Early hypertension, NLR and IMDC risk score were not significantly associated with response rates or survival.ConclusionBaseline CRP was a significant predictive factor of sunitinib response and a prognostic factor of survival. Baseline CRP might be a useful biomarker in the treatment planning of mRCC. Due to the relatively small sample size, our results need to be confirmed in larger studies.
Highlights
Sunitinib has become mainstay first line treatment for patients with metastatic renal clear cell carcinoma
In the present trial we investigated the predictive value of serum markers, including C-reactive protein (CRP) and neutrophil-to-lymphocyte ratio (NLR), in an unselected prospective patient population treated with sunitinib for metastatic renal clear cell carcinoma (mRCC)
In addition to being a potent angiogenic growth factor, vascular endothelial growth factor (VEGF) plays a role in the local immune response in wounds and tumors by inducing accumulation of immature dendritic cells, myeloid-derived suppressor cells, regulatory T cells, as well as by inhibiting the migration of T lymphocytes to the tumor [6]
Summary
Sunitinib has become mainstay first line treatment for patients with metastatic renal clear cell carcinoma (mRCC). Since the reporting of the first positive clinical trial [1], showing an overall survival benefit from a rTKI, sunitinib has become mainstay first line treatment for patients with metastatic renal cell. C-reactive protein (CRP) is an established biomarker for systemic inflammation, available in most clinical datasets, and provides prognostic information in several cancers including RCC [7]. Another biomarker of inflammation, neutrophil-to-lymphocyte ratio (NLR), adds prognostic information in RCC, and was recently suggested as a predictive marker of response to sunitinib in mRCC [8]. We report on toxicity and health related quality of life (HRQoL) data
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