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Cleveland Clinic Taussig Cancer Institute researchers report that cancer progression in patients with previously treated advanced renal cell carcinoma was delayed by an average of two months when treated with axitnib versus sorafenib.
The global, randomized, Phase III trial of axitnib versus sorafenib as a second-line therapy for mRCC, led by Brian Rini, MD, found that axitinib was superior to sorafenib in the primary endpoint of median progression-free survival (PFS). Axitinib was also superior when considering patient-reported quality of life measures.
This Phase III trial, also called AXIS 1032, was an international study involving 723 patients with clear-cell advanced kidney cancer who had disease progression on one prior standard regimen (cytokines, sunitinib, bevacizumab or temsirolimus). Patients were randomized to receive axitinib 5 mg twice daily or sorafenib 400 mg twice daily. Patient questionnaires (Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index [FKSI-15]) and its disease-related symptoms subscale [FKSI-DRS] were administered at several points during the study.
The results showed a median PFS of 6.7 months with axitinib compared to 4.7 months for sorafenib, with benefit maintained in all patient subgroups. Complete or partial response to treatment more than doubled in patients treated with axitinib (19 percent versus nine percent) compared to sorafenib.
This was the first trial to compare targeted therapies against each other in kidney cancer patients. All prior phase III studies of targeted drugs compared their effectiveness against either placebo or cytokines. Given that axitinib is biochemically more potent against the VEGF receptor, this trial supports that biochemical potency translates into clinical efficacy in this setting.
A Phase III trial has also accrued of front-line trial axitinib vs sorafenib with results expected in the next one to two years.
To refer a kidney cancer patient to Taussig, call 216.444.HOPE (4673) or 866.223.8100.
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