Abiraterone Risk Higher in Prostate Cancer Patients Who Have CVD


Lessons for Clinical Practice

Preview moderator Elizabeth M. Jaffee, MD, AACR president and deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, noted that clinical trials test new therapies in the healthiest of patients. “This has been rationalized as a safety measure by both investigators and sponsors,” she said.

However, as therapies are getting better and patients are living longer, there is a need to start investigating into real-world scenarios more consistently.

Although the study is retrospective, it provides data to support a prospective collection of information. “This is an approved drug so this is like a phase IV-type study where data are collected post-approval,” she noted.

Nanus, from Weill Cornell, noted that this retrospective analysis spanned a time period when abiraterone acetate was approved in patients with mCRPC regardless of prior chemotherapy exposure.

Although approved in 2011 for mCRPC in patients who had received prior chemotherapy, the approval was expanded in 2012 to all patients with mCRPC regardless of prior chemotherapy exposure, he pointed out. “This study had a mixed population of patients, men who were chemotherapy naïve and those who had received prior chemotherapy,” he observed. (Lu-Yao indicated that approximately 20% of the patients studied had prior chemotherapy use.)

“Who manages these patients may also impact outcomes,” Nanus said. Patients who received abiraterone acetate after chemotherapy are typically treated by medical oncologists, while urologists typically prescribe the drug in chemotherapy-naïve patients, he noted.

“In general, urologists may not be aware of the side effects of treatment and may not manage these as stringently as medical oncologists do,” he said. In his own practice, Nanus noted that patients who have preexisting CVD are monitored carefully and frequently. “We watch patients more closely — their cardiac medications, low potassium and electrolyte imbalance, fluid retention, and blood pressure,” he said.

“Abiraterone acetate is not going away. It is given even earlier [in the disease process] now,” Nanus said.

This study was funded by a Pennsylvania CURE Program award and the National Cancer Institute. Lu-Yao has no direct conflicts except that her spouse, who has no involvement with this study, is an officer of Sun Pharmaceutical Industries Inc.  D’Amico has disclosed no relevant financial relationships. Not related to abiraterone acetate, Nanus reports being on the Data Safety Monitoring Board of Roche/Genentech.


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