ASCO 2011 Update June 6

Results of AXIS Trial
(Axitinib versus Sorafenib as second-line therapy for mRCC)

The hall was packed early this morning with attendees eagerly awaiting the presentations of the results of this trial.

723 patients were enrolled in the study that had progressive disease after the use of 1 prior first-line therapy. Sutent was the first-line therapy in 54% of the patients and 35% had previously been on a cytokine therapy.

The patients receiving axitinib had a median progression-free survival (PFS) of 6.7 months while the patients receiving sorafenib had a PFS of 4.7 months.

A partial response or stable disease was achieved in 69.3% of the patients on axitinib and in 63.8% of patients on sorafenib.

The trial was designed so that the patients on axitinib started at a dose of 5 mg. twice a day and the dose was increased to 7 mg twice a day and then to 10 mg. twice a day. One-third of the patients receiving axitinib were able to tolerate the scheduled dose increases.

In the study, axitinib was found to have an acceptable side effect profile. Hypertension and hypothyroidism were more common in the patients receiving axitinib while hand-foot syndrome, rash and hair loss were less common in these patients.

We now await the results of the overall survival analysis!

Patient-Reported Outcomes in the AXIS Trial

Quality of life questionnaires were completed by approximately 90% of patients at various timepoints throughout the trial. The delay in PFS with axitinib was associated with a delay in the worsening of symptoms.

Discussion

Dr. Bruce Redman discussed the morning’s presentation on kidney cancer.
He posed two thought-provoking questions.
1) After disease progression on a good targeted therapy, what is the role of a second good targeted therapy?
2) Do we need more TKIs of mTORs or do we need newer targets?

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