In the News: FDA Approves Inlyta to Treat Patients with a Type of Advanced Kidney Cancer
Axitinib (Inlyta) is a selective inhibitor of vascular endothelial growth factor (VEGF) that was approved by the Food and Drug Administration in January 2012 as second-line therapy for patients with renal cell carcinoma.
Brian I. Rini, MD, a solid tumor oncologist specializing in genitourinary malignancies at the Taussig Cancer Center, served as principal investigator of the clinical trial that led to the drug's approval. He calls axitinib “a fantastic addition to our armamentarium.”
“Chemically, it is a more potent inhibitor of VEGF than other targeted agents. Against sorafenib, these differences translated into clinical advantages,” he says.
The trial, conducted in 175 sites in 22 countries, was the first to compare a targeted agent with an active comparator. Patients who had failed first-line therapy with sunitinib, bevacizumab plus interferon-alfa, temsirolimus or cytokines were randomized to receive axitinib 5 mg BID or sorafenib 400 mg BID. Median progression-free survival (PFS) was 6.7 months with axitinib, compared with 4.7 months for sorafenib (hazard ratio 0.67).
“At any point in the trial, patients on axitinib were two-thirds as likely to experience cancer progression. This is an excellent advantage,” says Dr. Rini.
The importance of side effects
The primary side effects of axitinib are similar to those of other targeted agents and include hypertension, fatigue and diarrhea. But unlike other agents, axitinib may cause blood pressure to rise very early in the course of therapy.
“Physicians should be aware of this and be prepared to treat it,” says Dr. Rini.
However, the presence of side effects such as high blood pressure is indicative of treatment efficacy.
“We see more on-target side effects when the agent is hitting its target. Patients with high blood pressure have better outcomes,” says Dr. Rini. “If a patient has experienced no side effects after one month, the dose is not therapeutic and needs to be raised,” he says, adding that patients on axitinib were titrated safely to 7 mg BID and 10 mg BID in the clinical trial.
A clinical trial of axitinib in treatment-naive patients is underway, with results expected in 2013.
First Comparative Long Term Look at Least Toxic Prostate Cancer Treatments
Cleveland Clinic researchers released a comprehensive analysis of more than 100,000 prostate cancer patients over a 16-year period that shows brachytherapy or prostatectomy are the least toxic among the three most commonly used methods to treat prostate cancer. The analysis indicates that patients who had brachytherapy or prostatectomy had lower long-term toxicities and treatment-related costs than external beam radiation therapy (EBRT).
“Typically, investigations of prostate cancer toxicity don’t go beyond five years. These results provide valuable insight that may influence future decision-making regarding the use of these treatment options,” said Jay Ciezki, MD, a radiation oncologist in Cleveland Clinic's Taussig Cancer Institute.
Prostate cancer is the most common cancer in men, and the second leading cause of cancer death among men in the U.S. Advancements in the treatment of prostate cancer have increased survival rates, but the toxicity of those treatments has not been well studied beyond five years from treatment.
Dr. Ciezki examined the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to determine which of the three common prostate cancer treatments – brachytherapy, prostatectomy and external beam radiation – had higher long-term toxicities and treatment-related costs. Brachytherapy is the use of a radioactive source placed in the prostate itself, giving a high radiation dose to the tumor while reducing the radiation exposure in the surrounding healthy tissue. Prostatectomy is the surgical removal of the prostate gland.
A total of 137,427 patients who were 65 years or older at the time of a prostate cancer diagnosis and who had prostate cancer as their only cancer diagnosis were retrieved from the SEER-Medicare database. Because the SEER-Medicare database provides information on cancer diagnoses and outcomes, along with individual patient costs, it allowed the investigators to obtain Medicare reimbursement data for both the initial treatment and any subsequent treatments related to the toxicities. Dr. Ciezki and his team of researchers then calculated the total cost per patient-year for each of the three therapies over time.
At the 21012 Genitourinary Cancers Symposium, Dr. Ciezki presented his analysis of the more than 100,000 prostate cancer patients showing that treatment with external beam radiation therapy (EBRT), resulted in higher long-term toxicities and treatment-related costs than prostatectomy and brachytherapy, two other common treatments for the disease. EBRT is the use of beams of radiation aimed at the prostate through various techniques such as IMRT, IGRT, Cyberknife, etc. “We were able to get a good picture of the long-term costs of patient care and were surprised to see such dramatic differences among the three treatment strategies,” Ciezki said. The results provide valuable insight that may influence future decision-making regarding the use of these treatment options.
“Research to date has not given us a clear picture of how each prostate cancer therapy affects men over the long run,” said Ciezki. “Our analysis is one of the first to examine the quality of life and financial costs of these three very common prostate cancer treatment strategies for more than five years after treatment.”
Taussig Cancer Institute Clinical Trials
Taussig Cancer Institute provides world-class care to patients with cancer and is at the forefront of new and emerging clinical, translational and basic cancer research. Taussig annually enrolls over 1300 patients in over 240 clinical trials.
Please read more about our featured trials this month: