Axitinib after Sunitinib in Metastatic Renal Cancer: Preliminary Results from Italian "Real-World" SAX Study

Axitinib is an oral angiogenesis inhibitor, currently approved for treatment of metastatic renal cell carcinoma (mRCC) after failure of prior treatment with Sunitinib or cytokine. The present study is an Italian Multi-Institutional Retrospective Analysis that evaluated the outcomes of Axitinib, in second-line treatment of mRCC. The medical records of 62 patients treated with Axitinib, were retrospectively reviewed. The Progression Free Survival (PFS), the Overall Survival (OS), the Objective Response Rate (ORR), the Disease Control Rate (DCR), and the safety profile of axitinib and sunitinib-axitinib sequence, were the primary endpoint. The mPFS was 5.83 months (95% CI 3.93-7.73 months). When patients was stratified by Heng score, mPFS was 5.73, 5.83, 10.03 months according to poor, intermediate, and favorable risk group, respectively. The mOS from the start of axitinib was 13.3 months (95% CI 8.6-17.9 months); the observed ORR and DCR were 25 and 71%, respectively. When stratified patients by subgroups defined by duration of prior therapy with Sunitinib (≤ vs. >median duration), there was a statistically significant difference in mPFS with 8.9 (95% CI 4.39-13.40 months) vs. 5.46 months (95% CI 4.04-6.88 months) for patients with a median duration of Sunitinib >13.2 months. DCR and ORR to previous Sunitinib treatment was associated with longer statistically mPFS, 7.23 (95% CI 3.95-10.51 months, p = 0.01) and 8.67 (95% CI 4.0-13.33 months, p = 0.008) vs. 2.97 (95% CI 0.65-5.27 months, p = 0.01) and 2.97 months (95% CI 0.66-5.28 months, p = 0.01), respectively. Overall Axitinib at standard schedule of 5 mg bid, was well-tolerated. The most common adverse events of all grades were fatig (25.6%), hypertension (22.6%), gastro-intestinal disorders (25.9%), and hypothyroidism (16.1%). The sequence Sunitinib-Axitinib was well-tolerated without worsening in side effects, with a median OS of 34.7 months (95% CI 18.4-51.0 months). Our results are consistent with the available literature; this retrospective analysis confirms that Axitinib is effective and safe in routine clinical practice.

Frontiers in pharmacology. 2016 Sep 28*** epublish ***

Carmine D'Aniello, Maria G Vitale, Azzurra Farnesi, Lorenzo Calvetti, Maria M Laterza, Carla Cavaliere, Chiara Della Pepa, Vincenza Conteduca, Anna Crispo, Ferdinando De Vita, Francesco Grillone, Enrico Ricevuto, Michele De Tursi, Rocco De Vivo, Marilena Di Napoli, Sabrina C Cecere, Gelsomina Iovane, Alfonso Amore, Raffaele Piscitelli, Giuseppe Quarto, Salvatore Pisconti, Gennaro Ciliberto, Piera Maiolino, Paolo Muto, Sisto Perdonà, Massimiliano Berretta, Emanuele Naglieri, Luca Galli, Giacomo Cartenì, Ugo De Giorgi, Sandro Pignata, Gaetano Facchini, Sabrina Rossetti

Oncology Unit, A.O.R.N. dei COLLI "Ospedali Monaldi-Cotugno-CTO," Naples, Italy., UOSC Oncologia Cardarelli Hospital Naples, Italy., Oncology Unit 2, University Hospital of Pisa Pisa, Italy., Ospedale San Bortolo Vicenza, Italy., Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi," Second University of Naples - School of Medicine Naples, Italy., Department of Onco-Hematology Medical Oncology, S.G. Moscati Hospital of Taranto Taranto, Italy., Department of Uro-Gynaecological Oncology, Division of Medical Oncology, Istituto Nazional Tumori IRCCS "Fondazione G. Pascale," Naples, Italy., Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS Meldola, Italy., Unit of Epidemiology, Struttura Complessa di Statistica Medica, Biometria e Bioinformatica, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy., Medical Oncology Unit, Azienda Ospedaliera "Mater Domini," Catanzaro, Italy., Oncology Network ASL1 Abruzzo, Oncology Territorial Care Unit, Division of Medical Oncology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila L'Aquila, Italy., Department of Medical, Oral and Biotechnological Sciences, University "G. D'Annunzio," Chieti, Italy., Hepatobiliary Unit, Division of Abdominal Surgical Oncology, National Cancer Institute "G. Pascale Foundation," IRCCS Naples, Italy., Pharmacy Unit, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy., Division of Urology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy., Scientific Direction, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy., Division of Radiation Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy., Division of Medical Oncology, CRO Aviano, Italy., Division of Medical Oncology, Istituto Oncologico Giovanni Paolo II Bari, Italy.