Real Life Efficacy and Safety of Axitinib (Axi) in Patients with Renal Cell Carcinoma (Rcc): Results from the Spanish Compassionate Use Program

Maroto, Pablo; Laínez, Núria; Esteban, Emilio; Espinosa, Marta; Juan, María José; Etxániz, Olatz; Suárez, Cristina; Sepúlveda, Juan Manuel; Rubio, Gustavo; Arija, José Ángel Arranz; Jiménez, Laura; Sáez, M.I.; Puente, Javier; González, Isabel Chirivella; Gallardo, Enrique; Jurado, J.M.; García-Donás, Jesús; Brea, Marta López; Garrido, María José Molina; Otero, Diego Soto de Prado

doi:10.1093/annonc/mdu337.42

Cited by 2 publications

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“…In our analysis, the mPFS was 5.83 months (95% CI 3.93–7.73 months) with mOS of 13.3 months (95% CI 8.6–17.9 months). These results are similar to the Axis trial and the other real-life experiences (Vogl et al, 2013 ; Basso et al, 2014 ; Maroto et al, 2014 ; Matias et al, 2014 ; Signorovitch et al, 2015 ; Vogelzang et al, 2015 , 2016 ; Guida et al, 2016 ; Hutson et al, 2016 ; Laskey et al, 2016 ; Pal et al, 2016 ; Wagstaff et al, 2016 ). The majority of the evaluated studies are retrospective analysis of indirect comparison between standard second-line treatments (Everolimus vs. Axitinib) and use Axitinib in second or third line with the median duration of therapy as surrogate of mPFS; others are available only in abstract form, therefore not comparable.…”

Section: Discussionsupporting

confidence: 81%

“…Evidences from randomized clinical trials, retrospective studies or single-institution experiences do not provide clear and conclusive information which might guide the clinician in choosing Axitinib rather than Everolimus than Sorafenib, or vice versa, in the second-line setting, hence the decision is made exclusively on the basis of the safety profile and patients medical history. Several “real world” studies have showed the efficacy and safety of Axitinb in unselected populations (Vogl et al, 2013 ; Basso et al, 2014 ; Maroto et al, 2014 ; Matias et al, 2014 ; Signorovitch et al, 2015 ; Vogelzang et al, 2015 , 2016 ; Guida et al, 2016 ; Hutson et al, 2016 ; Laskey et al, 2016 ; Pal et al, 2016 ; Wagstaff et al, 2016 ), we thought to further reinforce such evidences publishing our own experience with the drug.…”

Section: Introductionmentioning

confidence: 99%

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Axitinib after Sunitinib in Metastatic Renal Cancer: Preliminary Results from Italian “Real-World” SAX Study

D’Aniello

Vitale²,

Farnesi

et al. 2016

Front. Pharmacol.

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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.

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Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

Axitinib after Sunitinib in Metastatic Renal Cancer: Preliminary Results from Italian “Real-World” SAX Study

D’Aniello

Vitale²,

Farnesi

et al. 2016

Front. Pharmacol.

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

et al. 2019

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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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Real Life Efficacy and Safety of Axitinib (Axi) in Patients with Renal Cell Carcinoma (Rcc): Results from the Spanish Compassionate Use Program

Cited by 2 publications

References 0 publications

Axitinib after Sunitinib in Metastatic Renal Cancer: Preliminary Results from Italian “Real-World” SAX Study

Axitinib after Sunitinib in Metastatic Renal Cancer: Preliminary Results from Italian “Real-World” SAX Study

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

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