• Gaetano Facchini, Sabrina Rossetti, Massimiliano Berretta, Carla Cavaliere, Sarah Scagliarini, Maria Giuseppa Vitale, Chiara Ciccarese, Giuseppe Di Lorenzo, Erica Palesandro, Vincenza Conteduca, Umberto Basso, Emanuele Naglieri, Azzurra Farnesi, Michele Aieta, Nicolò Borsellino, Leonardo La Torre, Gelsomina Iovane, Lucia Bonomi, Donatello Gasparro, Enrico Ricevuto, Michele De Tursi, Rocco De Vivo, Giovanni Lo Re, Francesco Grillone, Paolo Marchetti, Ferdinando De Vita, Claudio Scavelli, Claudio Sini, Salvatore Pisconti, Anna Crispo, Vittorio Gebbia, Antonio Maestri, Luca Galli, Ugo De Giorgi, Roberto Iacovelli, Carlo Buonerba, Giacomo Cartenì, and Carmine D'Aniello.
• Departmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Via M. Semmola, 80131, Napoli, Italy. g.facchini@istitutotumori.na.it.
• J Transl Med. 2019 Aug 29; 17 (1): 296.

BackgroundThis multi-institutional retrospective real life study was conducted in 22 Italian Oncology Centers and evaluated the role of Axitinib in second line treatment in not selected mRCC patients.Methods148 mRCC patients were evaluated. According to Heng score 15.5%, 60.1% and 24.4% of patients were at poor risk, intermediate and favorable risk, respectively.ResultsPFS, OS, DCR and ORR were 7.14 months, 15.5 months, 70.6% and 16.6%, respectively. The duration of prior sunitinib treatment correlated with a longer significant mPFS, 8.8 vs 6.3 months, respectively. Axitinib therapy was safe, without grade 4 adverse events. The most frequent toxicities of all grades were: fatigue (50%), hypertension (26%), and hypothyroidism (18%). G3 blood pressure elevation significantly correlated with longer mPFS and mOS compared to G1-G2 or no toxicity. Dose titration (DT) to 7 mg and 10 mg bid was feasible in 24% with no statistically significant differences in mPFS and mOS. The sunitinib-axitinib sequence was safe and effective, the mOS was 41.15 months. At multivariate analysis, gender, DCR to axitinib and to previous sunitinib correlated significantly with PFS; whereas DCR to axitinib, nephrectomy and Heng score independently affected overall survival.ConclusionsAxitinib was effective and safe in a not selected real life mRCC population. Trial registration INT - Napoli - 11/16 oss. Registered 20 April 2016. http://www.istitutotumori.na.it.

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