Axitinib after Sunitinib in metastatic renal cancer: Preliminary results from Italian "Real-World" SAX Study

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 QuartoSalvatore 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

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Article number331
JournalFrontiers in Pharmacology
Volume7
Issue numberSEP
DOIs
Publication statusPublished - Sep 28 2016

Fingerprint

Kidney Neoplasms
Renal Cell Carcinoma
sunitinib
axitinib
Angiogenesis Inhibitors
Survival
Therapeutics
Hypothyroidism
Treatment Failure
Disease-Free Survival
Medical Records
Appointments and Schedules
Cytokines
Hypertension
Safety

Keywords

  • Axitinib
  • First-line treatment
  • MPFS
  • mRCC
  • Real-life patient

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

D'Aniello, C., Vitale, M. G., Farnesi, A., Calvetti, L., Laterza, M. M., Cavaliere, C., ... Rossetti, S. (2016). Axitinib after Sunitinib in metastatic renal cancer: Preliminary results from Italian "Real-World" SAX Study. Frontiers in Pharmacology, 7(SEP), [331]. https://doi.org/10.3389/fphar.2016.00331

Axitinib after Sunitinib in metastatic renal cancer : Preliminary results from Italian "Real-World" SAX Study. / D'Aniello, Carmine; Vitale, Maria G.; Farnesi, Azzurra; Calvetti, Lorenzo; Laterza, Maria M.; Cavaliere, Carla; Pepa, Chiara Della; Conteduca, Vincenza; Crispo, Anna; De Vita, Ferdinando; Grillone, Francesco; Ricevuto, Enrico; De Tursi, Michele; De Vivo, Rocco; Di Napoli, Marilena; Cecere, Sabrina C.; Iovane, Gelsomina; Amore, Alfonso; Piscitelli, Raffaele; Quarto, Giuseppe; Pisconti, Salvatore; Ciliberto, Gennaro; Maiolino, Piera; Muto, Paolo; Perdonà, Sisto; Berretta, Massimiliano; Naglieri, Emanuele; Galli, Luca; Cartenì, Giacomo; Giorgi, Ugo De; Pignata, Sandro; Facchini, Gaetano; Rossetti, Sabrina.

In: Frontiers in Pharmacology, Vol. 7, No. SEP, 331, 28.09.2016.

Research output: Contribution to journalArticle

D'Aniello, C, Vitale, MG, Farnesi, A, Calvetti, L, Laterza, MM, Cavaliere, C, Pepa, CD, Conteduca, V, Crispo, A, De Vita, F, Grillone, F, Ricevuto, E, De Tursi, M, De Vivo, R, Di Napoli, M, Cecere, SC, Iovane, G, Amore, A, Piscitelli, R, Quarto, G, Pisconti, S, Ciliberto, G, Maiolino, P, Muto, P, Perdonà, S, Berretta, M, Naglieri, E, Galli, L, Cartenì, G, Giorgi, UD, Pignata, S, Facchini, G & Rossetti, S 2016, 'Axitinib after Sunitinib in metastatic renal cancer: Preliminary results from Italian "Real-World" SAX Study', Frontiers in Pharmacology, vol. 7, no. SEP, 331. https://doi.org/10.3389/fphar.2016.00331
D'Aniello, Carmine ; Vitale, Maria G. ; Farnesi, Azzurra ; Calvetti, Lorenzo ; Laterza, Maria M. ; Cavaliere, Carla ; Pepa, Chiara Della ; Conteduca, Vincenza ; Crispo, Anna ; De Vita, Ferdinando ; Grillone, Francesco ; Ricevuto, Enrico ; De Tursi, Michele ; De Vivo, Rocco ; Di Napoli, Marilena ; Cecere, Sabrina C. ; Iovane, Gelsomina ; Amore, Alfonso ; Piscitelli, Raffaele ; Quarto, Giuseppe ; Pisconti, Salvatore ; Ciliberto, Gennaro ; Maiolino, Piera ; Muto, Paolo ; Perdonà, Sisto ; Berretta, Massimiliano ; Naglieri, Emanuele ; Galli, Luca ; Cartenì, Giacomo ; Giorgi, Ugo De ; Pignata, Sandro ; Facchini, Gaetano ; Rossetti, Sabrina. / Axitinib after Sunitinib in metastatic renal cancer : Preliminary results from Italian "Real-World" SAX Study. In: Frontiers in Pharmacology. 2016 ; Vol. 7, No. SEP.
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AU - D'Aniello, Carmine

AU - Vitale, Maria G.

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AU - Calvetti, Lorenzo

AU - Laterza, Maria M.

AU - Cavaliere, Carla

AU - Pepa, Chiara Della

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