Axitinib CAS 319460-85-0 AG013736 for Advanced Kidney Cance

 Axitinib CAS 319460-85-0 AG013736 for Advanced Kidney Cancer

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1.Axitinib is indicated for kidney cancer. Axitinib is a kinase inhibitor shown to inhibit the vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3) implicated in angiogenesis and tumor growth leading to cancer progression.Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

2.The AXIS trial was a phase 3 randomized trial that showed the efficacy of this drug. In this study it was showed that axitinib may increase progression-free survival (PFS) compared to sorafenib in patients with metastatic renal cell carcinoma who previously had failed to first-line therapy with sunitinib, bevacizumab plus interferon-alfa, temsirolimus, or cytokines. 389 patients (54%) had received 1 prior sunitinib-based therapy, 251 patients (35%) had received 1 prior cytokine-based therapy (interleukin-2 or interferon-alfa), 59 patients (8%) had received 1 prior bevacizumab-based therapy, and 24 patients (3%) had received 1 prior temsirolimus-based therapy. The baseline demographic and disease characteristics were similar between the axitinib and sorafenib groups with regard to age (median 61 years), gender (72% male), race (75% white and 21% Asian), and Eastern Cooperative Oncology Group (ECOG) performance status (55% 0, 45% 1), and histology (99% clear cell)

3.In this study they recruited 723 patients (median age 61 years) with metastatic renal cell carcinoma; they were randomized (1:1) without blinding to axitinib 5mg (N = 361) twice daily versus sorafenib 400mg (N = 362) twice daily; allocation concealment was not done. All patients had renal clear-cell carcinoma that progressed despite first-line therapy with sunitinib, bevacizumab plus interferon-alfa, temsirolimus, or cytokines. Increased Axitinib dose was allowed for patients without hypertension or adverse reactions

4.Progression free survival (PFS) was defined as time from randomization to either first documentation of disease progression (per independent blinded radiology review of images) or death due to any cause. The median duration of axitinib therapy was 6.4 months and sorafenib therapy was 5 months. Disease progression or relapse occurred in 160 patients (44%) in axitinib group and 180 patients (50%) in sorafenib group. There was a statistically significant advantage for axitinib over sorafenib for the endpoint of PFS. There was no statistically significant difference between the arms in OS. Comparing axitinib versus sorafenib in intention-to-treat analysis, the PFS was 6.7 months in the axitinib group versus 4.7 months in the sunitinib group; hazard ratio was 0.665 (95% CI 0.544-0.812); one-sided P < 0.0001, and the objective tumor response was 19% versus 9% respectively (P = 0.0001, NNT 10)