Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer

Italian multicenter real world SAX study final results

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 & 18 others 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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number296
JournalJournal of Translational Medicine
Volume17
Issue number1
DOIs
Publication statusPublished - Aug 29 2019

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Renal Cell Carcinoma
Toxicity
Therapeutics
Oncology
Blood pressure
Hypothyroidism
Nephrectomy
Titration
Fatigue
sunitinib
axitinib
Multivariate Analysis
Fatigue of materials
Blood Pressure
Hypertension
Survival
Population

Keywords

  • Axitinib
  • Metastatic
  • Renal cancer
  • Sunitinib
  • Treatment

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer : Italian multicenter real world SAX study final results. / Facchini, Gaetano; Rossetti, Sabrina; Berretta, Massimiliano; Cavaliere, Carla; Scagliarini, Sarah; Vitale, Maria Giuseppa; Ciccarese, Chiara; Di Lorenzo, Giuseppe; Palesandro, Erica; Conteduca, Vincenza; Basso, Umberto; Naglieri, Emanuele; Farnesi, Azzurra; Aieta, Michele; Borsellino, Nicolò; La Torre, Leonardo; Iovane, Gelsomina; Bonomi, Lucia; Gasparro, Donatello; Ricevuto, Enrico; De Tursi, Michele; De Vivo, Rocco; Lo Re, Giovanni; Grillone, Francesco; Marchetti, Paolo; De Vita, Ferdinando; Scavelli, Claudio; Sini, Claudio; Pisconti, Salvatore; Crispo, Anna; Gebbia, Vittorio; Maestri, Antonio; Galli, Luca; De Giorgi, Ugo; Iacovelli, Roberto; Buonerba, Carlo; Cartenì, Giacomo; D'Aniello, Carmine.

In: Journal of Translational Medicine, Vol. 17, No. 1, 296, 29.08.2019.

Research output: Contribution to journalArticle

Facchini, G, Rossetti, S, Berretta, M, Cavaliere, C, Scagliarini, S, Vitale, MG, Ciccarese, C, Di Lorenzo, G, Palesandro, E, Conteduca, V, Basso, U, Naglieri, E, Farnesi, A, Aieta, M, Borsellino, N, La Torre, L, Iovane, G, Bonomi, L, Gasparro, D, Ricevuto, E, De Tursi, M, De Vivo, R, Lo Re, G, Grillone, F, Marchetti, P, De Vita, F, Scavelli, C, Sini, C, Pisconti, S, Crispo, A, Gebbia, V, Maestri, A, Galli, L, De Giorgi, U, Iacovelli, R, Buonerba, C, Cartenì, G & D'Aniello, C 2019, '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, vol. 17, no. 1, 296. https://doi.org/10.1186/s12967-019-2047-4
Facchini, Gaetano ; Rossetti, Sabrina ; Berretta, Massimiliano ; Cavaliere, Carla ; Scagliarini, Sarah ; Vitale, Maria Giuseppa ; Ciccarese, Chiara ; Di Lorenzo, Giuseppe ; Palesandro, Erica ; Conteduca, Vincenza ; Basso, Umberto ; Naglieri, Emanuele ; Farnesi, Azzurra ; Aieta, Michele ; Borsellino, Nicolò ; La Torre, Leonardo ; Iovane, Gelsomina ; Bonomi, Lucia ; Gasparro, Donatello ; Ricevuto, Enrico ; De Tursi, Michele ; De Vivo, Rocco ; Lo Re, Giovanni ; Grillone, Francesco ; Marchetti, Paolo ; De Vita, Ferdinando ; Scavelli, Claudio ; Sini, Claudio ; Pisconti, Salvatore ; Crispo, Anna ; Gebbia, Vittorio ; Maestri, Antonio ; Galli, Luca ; De Giorgi, Ugo ; Iacovelli, Roberto ; Buonerba, Carlo ; Cartenì, Giacomo ; D'Aniello, Carmine. / Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer : Italian multicenter real world SAX study final results. In: Journal of Translational Medicine. 2019 ; Vol. 17, No. 1.
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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.",
keywords = "Axitinib, Metastatic, Renal cancer, Sunitinib, Treatment",
author = "Gaetano Facchini and Sabrina Rossetti and Massimiliano Berretta and Carla Cavaliere and Sarah Scagliarini and Vitale, {Maria Giuseppa} and Chiara Ciccarese and {Di Lorenzo}, Giuseppe and Erica Palesandro and Vincenza Conteduca and Umberto Basso and Emanuele Naglieri and Azzurra Farnesi and Michele Aieta and Nicol{\`o} Borsellino and {La Torre}, Leonardo and Gelsomina Iovane and Lucia Bonomi and Donatello Gasparro and Enrico Ricevuto and {De Tursi}, Michele and {De Vivo}, Rocco and {Lo Re}, Giovanni and Francesco Grillone and Paolo Marchetti and {De Vita}, Ferdinando and Claudio Scavelli and Claudio Sini and Salvatore Pisconti and Anna Crispo and Vittorio Gebbia and Antonio Maestri and Luca Galli and {De Giorgi}, Ugo and Roberto Iacovelli and Carlo Buonerba and Giacomo Carten{\`i} and Carmine D'Aniello",
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T1 - Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer

T2 - Italian multicenter real world SAX study final results

AU - Facchini, Gaetano

AU - Rossetti, Sabrina

AU - Berretta, Massimiliano

AU - Cavaliere, Carla

AU - Scagliarini, Sarah

AU - Vitale, Maria Giuseppa

AU - Ciccarese, Chiara

AU - Di Lorenzo, Giuseppe

AU - Palesandro, Erica

AU - Conteduca, Vincenza

AU - Basso, Umberto

AU - Naglieri, Emanuele

AU - Farnesi, Azzurra

AU - Aieta, Michele

AU - Borsellino, Nicolò

AU - La Torre, Leonardo

AU - Iovane, Gelsomina

AU - Bonomi, Lucia

AU - Gasparro, Donatello

AU - Ricevuto, Enrico

AU - De Tursi, Michele

AU - De Vivo, Rocco

AU - Lo Re, Giovanni

AU - Grillone, Francesco

AU - Marchetti, Paolo

AU - De Vita, Ferdinando

AU - Scavelli, Claudio

AU - Sini, Claudio

AU - Pisconti, Salvatore

AU - Crispo, Anna

AU - Gebbia, Vittorio

AU - Maestri, Antonio

AU - Galli, Luca

AU - De Giorgi, Ugo

AU - Iacovelli, Roberto

AU - Buonerba, Carlo

AU - Cartenì, Giacomo

AU - D'Aniello, Carmine

PY - 2019/8/29

Y1 - 2019/8/29

N2 - 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.

AB - 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.

KW - Axitinib

KW - Metastatic

KW - Renal cancer

KW - Sunitinib

KW - Treatment

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