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Open Access 01-12-2019 | Nephrectomy | Research

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

Authors: 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, Carmine D’Aniello

Published in: Journal of Translational Medicine | Issue 1/2019

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

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Title: Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results
Authors: 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
Carmine D’Aniello
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Nephrectomy
Nephrectomy
Nephrectomy
Axitinib
Sunitinib
Published in: Journal of Translational Medicine / Issue 1/2019
Electronic ISSN: 1479-5876
DOI: https://doi.org/10.1186/s12967-019-2047-4

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