This was a prospective and multicentric study that included patients from 10 Spanish Institutions to identify biomarkers of response to sunitinib and pazopanib in mRCC patients as a first-line treatment, related to HGF/c-Met signalling and angiogenic/inflammatory TME. The primary endpoint was the association between biomarkers and progression-free survival (PFS) and overall response rate (ORR), according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. The secondary endpoint was the association with overall survival (OS). PFS was defined as the time between treatment initiation and objective progression or death, and OS as the time elapsed between treatment initiation and the date of cancer-related death.

Inclusion criteria were as follows: patients ≥18 years of age, with locally advanced metastatic renal cell carcinoma, histopathologic diagnosis of renal clear-cell carcinoma, measurable disease by CT or MRI, life expectancy higher than 3 months and written informed consent. Patients with any other prior treatment, including cytokines, were excluded. The study was approved by the Ethics Committee at each institution and all participants provided written informed consent.

Patients received either 50 mg sunitinib daily for 4 weeks, followed by 2 weeks off the drug, or 800 mg pazopanib daily. In the case of 5 subjects, treatment of one of the drugs was discontinued at some point during the study (due to toxicity or other non-specified reasons) but patients received the other drug until progression. This group is referred to as sunitinib/pazopanib. All patients received treatment until there was evidence of disease progression, unacceptable toxicity, noncompliance with treatment, withdrawal of the patient’s informed consent or it was decided by the investigator.

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