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.
Highlights
Renal Cell Carcinoma (RCC) accounts for 2–3% of all adult malignancies, representing the seventh most common cancer in men and the ninth most common cancer in women (Escudier et al, 2013)
Our results are consistent with the available literature; this retrospective analysis confirms that Axitinib is effective and safe in routine clinical practice
Between Jan 2014 and Jan 2016, 62 patients with metastatic renal cell carcinoma (mRCC) or recurrent RCC were eligible for the final analysis
Summary
Renal Cell Carcinoma (RCC) accounts for 2–3% of all adult malignancies, representing the seventh most common cancer in men and the ninth most common cancer in women (Escudier et al, 2013). Clear cell renal cell carcinoma (ccRCC) is the most common RCC (75–80% of all primary kidney malignancies; Cohen and McGovern, 2005). 25–30% of patients with kidney cancer present metastases at the time of diagnosis and ∼30% develop recurrent or metastatic disease after radical treatment for localized disease (Leung et al, 2014). Recurrent and/or metastatic renal cell carcinoma (mRCC) is associated with a poor 5-years survival, roughly 10%, in the last decade, a series of novel agents have been introduced in clinical practice and the outcomes are slowly improving. Angiogenesis plays a central role in the development, growth, and metastatic progression of RCC via VHL, HIF 1α, VEGF, PDGF, mTOR (PI3K/AKT signaling; Nicol et al, 1997; Dorevicet al., 2009; Kornakiewicz et al, 2013; Dimova et al, 2014). The TTs include the Tyrosine Kinase Inhibitors, TKIs, targeting the Vascular Endothelial Growth Factor Receptors, VEGFRs, the mammalian Target of Rapamycin inhibitors, mTORis, and Bevacizumab, a monoclonal antibody targeting the VEGF ligand
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