title: Axitinib after Sunitinib in Metastatic Renal Cancer: Preliminary Results from Italian "Real-World" SAX Study.
abstract: 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.
authors.affiliation: Oncology Unit, A.O.R.N. dei COLLI "Ospedali Monaldi-Cotugno-CTO," Naples, Italy.
authors.forename: Carmine
authors.initials: C
authors.lastname: D'Aniello
authors.affiliation: UOSC Oncologia Cardarelli Hospital Naples, Italy.
authors.forename: Maria G
authors.initials: MG
authors.lastname: Vitale
authors.affiliation: Oncology Unit 2, University Hospital of Pisa Pisa, Italy.
authors.forename: Azzurra
authors.initials: A
authors.lastname: Farnesi
authors.affiliation: Ospedale San Bortolo Vicenza, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Calvetti
authors.affiliation: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi," Second University of Naples - School of Medicine Naples, Italy.
authors.forename: Maria M
authors.initials: MM
authors.lastname: Laterza
authors.affiliation: Department of Onco-Hematology Medical Oncology, S.G. Moscati Hospital of Taranto Taranto, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Cavaliere
authors.affiliation: Department of Uro-Gynaecological Oncology, Division of Medical Oncology, Istituto Nazional Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Della Pepa
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS Meldola, Italy.
authors.forename: Vincenza
authors.initials: V
authors.lastname: Conteduca
authors.affiliation: Unit of Epidemiology, Struttura Complessa di Statistica Medica, Biometria e Bioinformatica, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Crispo
authors.affiliation: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi," Second University of Naples - School of Medicine Naples, Italy.
authors.forename: Ferdinando
authors.initials: F
authors.lastname: De Vita
authors.affiliation: Medical Oncology Unit, Azienda Ospedaliera "Mater Domini," Catanzaro, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Grillone
authors.affiliation: 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.
authors.forename: Enrico
authors.initials: E
authors.lastname: Ricevuto
authors.affiliation: Department of Medical, Oral and Biotechnological Sciences, University "G. D'Annunzio," Chieti, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: De Tursi
authors.affiliation: Ospedale San Bortolo Vicenza, Italy.
authors.forename: Rocco
authors.initials: R
authors.lastname: De Vivo
authors.affiliation: Department of Uro-Gynaecological Oncology, Division of Medical Oncology, Istituto Nazional Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Marilena
authors.initials: M
authors.lastname: Di Napoli
authors.affiliation: Department of Uro-Gynaecological Oncology, Division of Medical Oncology, Istituto Nazional Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Sabrina C
authors.initials: SC
authors.lastname: Cecere
authors.affiliation: Department of Uro-Gynaecological Oncology, Division of Medical Oncology, Istituto Nazional Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Gelsomina
authors.initials: G
authors.lastname: Iovane
authors.affiliation: Hepatobiliary Unit, Division of Abdominal Surgical Oncology, National Cancer Institute "G. Pascale Foundation," IRCCS Naples, Italy.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Amore
authors.affiliation: Pharmacy Unit, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Piscitelli
authors.affiliation: Division of Urology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Quarto
authors.affiliation: Department of Onco-Hematology Medical Oncology, S.G. Moscati Hospital of Taranto Taranto, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Pisconti
authors.affiliation: Scientific Direction, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Ciliberto
authors.affiliation: Pharmacy Unit, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Piera
authors.initials: P
authors.lastname: Maiolino
authors.affiliation: Division of Radiation Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Muto
authors.affiliation: Division of Urology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Sisto
authors.initials: S
authors.lastname: Perdonà
authors.affiliation: Division of Medical Oncology, CRO Aviano, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Berretta
authors.affiliation: Division of Medical Oncology, Istituto Oncologico Giovanni Paolo II Bari, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Naglieri
authors.affiliation: Oncology Unit 2, University Hospital of Pisa Pisa, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Galli
authors.affiliation: UOSC Oncologia Cardarelli Hospital Naples, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Cartenì
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS Meldola, Italy.
authors.forename: Ugo
authors.initials: U
authors.lastname: De Giorgi
authors.affiliation: Department of Uro-Gynaecological Oncology, Division of Medical Oncology, Istituto Nazional Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Sandro
authors.initials: S
authors.lastname: Pignata
authors.affiliation: Department of Uro-Gynaecological Oncology, Division of Medical Oncology, Istituto Nazional Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Facchini
authors.affiliation: Department of Uro-Gynaecological Oncology, Division of Medical Oncology, Istituto Nazional Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Rossetti
keywords: axitinib; first-line treatment; mPFS; mRCC; real-life patient