Cleveland Clinic Researcher Leads First Head-To-Head Phase 3 Study of Targeted Kidney Cancer Treatments

Today at the 47th Annual American Society of Clinical Oncology (ASCO) meeting, researchers at Cleveland Clinic’s Taussig Cancer Institute reported that cancer progression in patients with previously-treated advanced renal cell carcinoma – the most prevalent form of kidney cancer – was delayed by an average of two months when treated with axitinib versus sorafenib.

This is the first trial to compare these targeted therapies against each other in kidney cancer patients who have relapsed or been unresponsive to their treatments. All prior Phase III studies of the drugs compared their effectiveness against placebo or cytokines.

“Before this study, we had limited proven options for previously-treated patients. Now, we can better understand how to build an effective sequence of treatments for patients with relapsed or refractory kidney cancer,” said Cleveland Clinic oncologist Brian Rini, MD, the principal investigator on the AXIS 1032 international trial and a paid consultant for Pfizer Oncology, makers of axitinib. Axitinib is an investigational agent and has not been approved by regulatory agencies.

Certain subgroups of patients in the study showed even more response to axitinib. For example, in patients who were previously treated with cytokines, axitinib extended median progression-free survival to more than a year.  Complete or partial response to treatment more than doubled in patients treated with axitinib compared to sorafenib, which is made by Bayer.  Axitinib also proved to be generally well-tolerated among study participants.

AXIS 1032 is an international study involving 723 patients with clear-cell advanced kidney cancer. The study population was reflective of the kidney cancer population.

Following Dr. Rini’s presentation at ASCO, researchers from the Robert H. Lurie Comprehensive Cancer Center of Northwestern University shared data showing the progression-free survival benefit demonstrated by axitinib is accompanied by improved quality of life scores for patients compared to those receiving sorafenib.

“Two months may not seem like long, but this extra time has a meaningful impact on patients’ outlook and quality of life,” Dr. Rini said.

Researchers are now conducting a front-line trial of axitinib and sorafenib in a head-to-head study in both previously treated and previously untreated patients with advanced kidney cancer.

“We expect axitinib to be much more active as a first-line therapy since it has shown such good results as a second-line therapy,” Dr. Rini said.

According to the American Cancer Society, about 58,240 new cases of kidney cancer are diagnosed in the U.S. annually, and there are roughly 13,000 deaths from kidney cancer each year. Five-year survival rates for patients with advanced, stage IV kidney cancer are below 10 percent in this country.

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Celebrating its 90th anniversary, Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. It was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. About 2,800 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. Cleveland Clinic Health System includes a main campus near downtown Cleveland, nine community hospitals and 15 Family Health Centers in Northeast Ohio, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and opening in 2013, Cleveland Clinic Abu Dhabi. In 2010, there were 4 million visits throughout the Cleveland Clinic health system and 155,000 hospital admissions. Patients came for treatment from every state and from more than 100 countries. Visit us at Follow us at

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