Aug 31, 2012

Enzalutamide approved - clinical trials deliver

Enzalutamide (formerly MDV-3100) is a drug for advanced prostate cancer that we have mentioned a number of times.  Today, it is no longer experimental.  It is approved and very soon patients with advanced prostate cancer will have another option for treatment.  This is what clinical trials are all about.

The following is a message from the FDA's Office of Hematology and Oncology Products Director, Dr. Richard Pazdur.

On August 31, 2012, the U. S. Food and Drug Administration approved enzalutamide (XTANDI® Capsules, Medivation, Inc. and Astellas Pharma US, Inc.), for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. 

The approval was based on a single randomized, placebo-controlled, multicenter trial enrolling 1199 patients with metastatic castration-resistant prostate cancer who had received prior docetaxel.  Patients were randomly allocated to receive enzalutamide 160 mg orally once daily (N = 800) or placebo (N = 399).  Study treatment continued until disease progression, initiation of new systemic antineoplastic treatment, unacceptable toxicity, or withdrawal.  Patients were required to continue androgen deprivation therapy and were allowed, but not required, to continue or initiate glucocorticoids during the study period.  Forty-eight percent (48%) of patients on enzalutamide and 46% on placebo received glucocorticoids. 

The primary efficacy endpoint was overall survival (OS).  At the pre-specified interim analysis after 520 events, a statistically significant improvement in OS [HR 0.63 (95% CI: 0.53, 0.75), p < 0.0001, log rank test] was observed.  The median OS was 18.4 and 13.6 months in the enzalutamide and placebo arms, respectively.

The most common (>=5%) grade 1-4 adverse reactions included asthenia or fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension.  Grade 3-4 adverse reactions were reported in 47% of patients treated with enzalutamide and in 53% of those on placebo.

Seizures occurred in 0.9% of patients on enzalutamide.  No patients on the placebo arm experienced seizures.  In the clinical trial, patients experiencing a seizure were permanently discontinued from therapy.  All seizures resolved.  Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizures were excluded from the clinical trial.  The safety of enzalutamide in patients with predisposing factors for seizures is unknown. 

The recommended dose and schedule for enzalutamide is 160 mg orally once daily.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Aug 25, 2012

Our book explained - in a 3 minute video

If you were wondering what our book is really about, this short video will reveal all:


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Aug 19, 2012

Some Clinical Trials Can’t Recruit Enough Participants

Does that surprise you? In fact, participation in cancer clinical trials is very low. The National Cancer Institute (NCI) reports that only about 3 percent of all adult cancer patients ever participate in a clinical trial. And the participation rate of seniors (who have about 2/3 of all diagnosed cancer cases) and ethnic minorities is much lower—only about 1 percent!

Clinical Trials are the process by which new cancer drugs and treatments are tested and finally approved for use by the U.S.Food and Drug Administration.

What happens if there aren’t enough volunteer participants for a clinical trial to be conducted? In that case we will not find out if the untested drug might actually have benefitted those with cancer. This happens frequently.

Why don’t cancer patients participate in clinical trials?
The NCI reports multiple reasons:

·       Lack of awareness—one survey found that 85 percent of cancer patients were not even aware that they might qualify for a clinical trial.
·       Some cancer patients have a distrust of research and those who conduct trials.
·       There is reluctance by some physicians to refer patients to trials.
·       Travel to trial centers and the time required to participate in a trial is cited by some patients.
·       Cost factors—travel to clinic sites and additional medical costs can be deciding factors.

·       On the plus side, a survey of people who had already participated in a cancer clinical trial found that 84 percent said they would participate in another trial if given the chance. And most states now require health insurance providers to cover the ‘routine’ costs of a trial.

Aug 13, 2012

Video: abiraterone and enzalutamide for advanced prostate cancer: results from ASCO 2012 discussed

A video summary of the most important data regarding abiraterone (Zytiga ®) and enzalutamide (MDV-3100) - two of the most important new drugs in prostate cancer.  Recorded at ASCO 2012.


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Aug 7, 2012

Myths and realities in cancer clinical trials: an interview with Dr. Luke


Click to listen


Interview with Dr. Luke about cancer clinical trials.  We touch on some common misconceptions and point the listeners towards resources that they will find helpful.  The original program aired on KFAB 1110AM on Sunday July 5 and is available at Dr. Luke's website.



To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Aug 3, 2012

Dr. Beer's radio interview: clinical trials and advances in prostate cancer


UPDATE:  the interview is now available online as a podcast.  Click here.

Dr. Luke Nordquist, who has quite a following in the heartland of the country, will be interviewing Dr. Beer this weekend.  The show will air Sunday August 5th at 9:30-10 AM CST (7:30 AM PST) on 1110AM KFAB (www.kfab.com).

It can also be heard over the internet on www.iheartradio.com (Omaha, 1110AM KFAB), so you can catch it online even if you are out of the listening area.

We will be talking about cancer clinical trials:  what they are, how they work, and how one might learn more about experimental therapy.  It will be a fun show and all about helping people living with cancer make informed decisions about their cancer care. Tune in if you get a chance or check it out online.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker