Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results

Journal of Translational Medicine

Donatello Gasparro¹  Giuseppe Di Lorenzo²  Carlo Buonerba²  Massimiliano Berretta³  Ugo De Giorgi⁴  Vincenza Conteduca⁴  Anna Crispo⁵  Sabrina Rossetti⁵  Gaetano Facchini⁵  Gelsomina Iovane⁵  Carmine D’Aniello⁶  Maria Giuseppa Vitale⁷  Erica Palesandro⁸  Emanuele Naglieri⁹  Ferdinando De Vita^1,10  Giacomo Cartenì^1,11  Sarah Scagliarini^1,11  Michele Aieta^1,12  Leonardo La Torre^1,13  Antonio Maestri^1,13  Umberto Basso^1,14  Francesco Grillone^1,15  Vittorio Gebbia^1,16  Salvatore Pisconti^1,17  Nicolò Borsellino^1,18  Claudio Scavelli^1,19  Roberto Iacovelli^2,20  Chiara Ciccarese^2,20  Giovanni Lo Re^2,21  Claudio Sini^2,22  Lucia Bonomi^2,23  Michele De Tursi^2,24  Rocco De Vivo^2,25  Paolo Marchetti^2,26  Enrico Ricevuto^2,27  Carla Cavaliere^2,28  Azzurra Farnesi^2,29  Luca Galli^2,29 

[1] Civil Hospital;Department of Clinical Medicine and Surgery, Università degli Studi di Napoli Federico II;Department of Medical Oncology, Centro di Riferimento Oncologico, Istituto Nazionale Tumori CRO;Department of Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.);Departmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori–IRCCS-Fondazione G. Pascale;Division of Medical Oncology, AORN Dei Colli “Ospedali Monaldi-Cotugno-CTO”;Division of Medical Oncology, Azienda Ospedaliera Universitaria Policlinico di Modena;Division of Medical Oncology, Candiolo Cancer Institute-FPO, IRCCS;Division of Medical Oncology, Istituto Oncologico Giovanni Paolo II;Division of Medical Oncology, University of Campania “L. Vanvitelli”;Division of Oncology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli;Medical Oncology Department, National Institute of Cancer;Medical Oncology Department, “Santa Maria della Scaletta” Hospital AUSL;Medical Oncology Unit 1, Istituto Oncologico Veneto IOV IRCCS;Medical Oncology Unit Azienda Ospedaliera “Mater Domini”;Medical Oncology Unit, La Maddalena Clinic for Cancer, University of Palermo;Medical Oncology Unit, POC SS Annunziata;Medical Oncology Unit, “Buccheri-La Ferla” Hospital;Medical Oncology Unit, “S. Cuore di Gesù” Hospital;Medical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona;NCI Aviano, Oncology Pordenone-S.Vito;Oncologia Medica ASL 2;Oncology Department, Ospedale Papa Giovanni XXIII;Oncology and Experimental Medicine, “G. D’Annunzio” University;Ospedale San Bortolo di Vicenza;Ospedale Sant’ Andrea Oncology;S. Salvatore Hospital, ASL1 Abruzzo, University of L’Aquila;UOC of Medical Oncology ASL NA 3 SUD Ospedali Riuniti Area Nolana;University Hospital of Pisa;

关键词: Axitinib;    Sunitinib;    Metastatic;    Renal cancer;    Treatment;   

DOI  :  10.1186/s12967-019-2047-4

来源: DOAJ

【 摘 要 】

Abstract Background This 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. Methods 148 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. Results PFS, 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. Conclusions Axitinib 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

【 授权许可】

Unknown