A Retrospective Multicenter Characterization of Patients with Metastatic Renal Cell Carcinoma: the Sicilian “Real-World” Experience

Background: Over the past 10 years the target of mTOR and VEGF signaling pathways with new oral agents has revolutionized the treatment of metastatic renal cell carcinoma (mRCC) with a clinically significant improvements in median overall survival. In this retrospective study we analyzed the pathological and clinical features, Heng prognostic group, number and sites of metastasis, targeted therapy sequence, treatment-related toxicity and dose reductions, therapeutic responses on CT imaging and the outcome of a Sicilian mRCC patient series treated with new targeted agents. Material and methods: 122 patients (P) with mRCC diagnosis between January 2012 and April 2016 were collected from 11 Sicilian cancer centers. The objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were assessed using Response Evaluation Criteria in Solid Tumor ver. 1.1 criteria and the Kaplan-Meier method with log-rank test. Results: Study population evaluable is composed by 118 P (36 women; 82 man). Histology: clear cell RCC 90 P (76%), other 28 P (24%). Concomitant relevant diseases at diagnosis: hypertension 59 P (50%), Type II diabetes 21 P (18%). Disease stage at diagnosis: stage I 16 P (14%), stage II 21 P (18%), stage III 13 P (11%), stage IV 54 P (46%). Heng risk group in metastatic P at diagnosis: Favorable 4 P (7%), Intermediate 46 P (86%), Poor 4 (7%). I line treatment was completed in 80 P: Pazopanib 29 P (36%), Sunitinib 49 P (61%) and Sorafenib in 2 P (3%). II line treatment was administred in 37 P: Axitinib 4 P (11%), Everolimus 28 P (76%), Sunitinib 3P (8%), Sorafenib 2 P (5%). III line treatment was administered in 8 P: Everolimus 3 P(38%), Sorafenib 3 P(38%), Sunitinib 2 P(24%). Conclusions: Hypertension is confirmed an established risk factor for RCC. The proportion of metastatic disease at diagnosis is almost 50% and intermediate risk is the most frequent risk group. Basing on current data the most used sequence of targeted agents in Sicily for the treatment of mRCC is Sunitinib-Everolimus. Further clinical data, the correlation between PFS and treatment administered, number and sites of metastasis, are under investigation.