Axitinib

Brian Rini from the Cleveland Clinic presented the results of a multi-institutional sorafenib (Nexavar) refractory trial of Axitinib (AG-013736), a tyrosine kinase inhibitor (TKI). 62 patients were enrolled, all of whom had previously failed prior sorafenib therapy. Another 14 had also failed sunitinib (Sutent) and 37 failed cytokine therapy (IL-2 or Interferon). The dosage was 5 mg taken twice a day. The most common grade 3/4 side effects were fatigue (11%), hypertension (10%), and hand-foot syndrome (7%).

Axitinib Results


Patients (%)

Partial Response

13 (21%)

Stable Disease

21 (34%)

Progressive Disease

16 (26%)

Progression-Free Survival

7.4 mos.

55% of the patients experienced some degree of tumor shrinkage, but many did not meet the 30% shrinkage requirement for classification as partial responders. Median overall survival has not yet been reached.

Although the above results are not as impressive as those presented by Dr. Rini at ASCO 2005 for Axitinib given to cytokine-refractory patients, which showed a PR of 46%, an SD of 40%, and a PD equal to 8%, this trial did show that Axitinib can be effective when another TKI (sorafenib) has failed. Axitinib looks like a promising drug for renal cell cancer, and Pfizer is now testing it in pancreatic, colorectal, thyroid, and breast cancers. Oncologists to whom we advocates have spoken think the drug is effective and should proceed through further testing.

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