Chemotherapy for Prostate Cancer - Education Video

In an occasional departure from our focus on clinical trials, we thought we would share our latest patient education videos for prostate cancer patients.  Here Dr. Beer discusses chemotherapy for prostate cancer - very much the way it would be discussed in a clinic visit. 


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

What metrics are typically used to determine if the drug is successful?

The ultimate success of a new drug or drug combination is judged by the “safe and effective” standard.  Both of course are examined in context.  Safe often means safe enough – or no less safe than what we have today.  Some cancer treatment have severe side effects – but because their benefits are judged acceptable – they are approved.  Effective means that cancer patients benefit in a meaningful way.  This often involves living longer.  When survival is not impacted, meaningful quality of life improvements are required.  In some situations, cure rates are the measure of success.  Survival benefit, which is the most common measure of success, can take a year to several years to determine.

For more questions and answers about clinical trials, visit the Talk about Health 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

Immunotherapy for prostate cancer - patient education video

In a bit of a temporary departure from our focus on clinical trials, we thought we would share our latest patient education videos for prostate cancer patients.  Here Dr. Beer discusses immunotherapy for prostate cancer - very much the way it would be discussed in a clinic visit.  In the coming weeks, we will share our videos on chemotherapy and hormonal therapy for prostate cancer patients.

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

How to keep track of the latest clinical trials that one may be eligible for

The single most complete resource for clinical trials in cancer is offered through the NCI at www.cancer.gov.  Clinical Trials are listed under the Clinical Trials and the Find a Clinical Trial tab on the www.cancer.gov website.  Detailed instructions on how to use this search tool are available on the website.  We also provide a discussion of that in our book, Cancer Clinical Trials.  Once you set up a search that fits your specific situation, there is an easy way to track the latest trials.  The trial status component of the search form allows you to check the new trials box. This will show you only trials added in the last 30 days. This feature is very helpful if you want to track any new trials that are activated without going through the entire list every time.  A useful strategy is to do a thorough search for clinical trials once and then repeat the same search with the new trials box checked every 30 days.  This way, one can be sure not to miss anything new. 

For more questions and answers about clinical trials, visit the Talk about Health 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

Clinical Trials—a brief history

Over the past few decades clinical trials have been in the news quite frequently. Every time an important new drug has been approved or disapproved you hear about it on TV, read about it on the Internet, or hear about it from your medical team.

But did you know that the first successful clinical trial we know about occurred more than 250 years ago? If you have read our book, Cancer Clinical Trials, of course you do but if you haven’t you may find this interesting.

For hundreds of years, sailing ships explored the world on longer and longer voyages (think Columbus, Cook, Magellan, etc.). While on these long voyages, many sailors became ill with scurvy—a disease that causes severe joint pain, loss of teeth, skin lesions, bleeding ulcers, and even death. Nobody knew for sure what caused this.

In the 1740s a Scottish doctor named James Lind was hired as a ship’s doctor and while on a long voyage observed the devastating effects of scurvy. He believed it was diet-based and devised a plan to test his idea. His hypothesis was that scurvy was diet based and lemons and lemon juice might cure it. The experiment was to give various groups of sailors with scurvy different dietary treatments including lemon juice. After a few weeks the sailors taking lemon juice were cured and the other groups were not. The result was that Dr. Lind had shown scientifically that lemon juice would cure scurvy. We now know that scurvy is caused by a vitamin C deficiency and lemons and limes can prevent or cure it.

It took a long time for Lind’s discovery to be widely accepted, but eventually and to this day citrus fruits and juice are available on nearly all voyages and scurvy is no longer the scourge of the seas.

This is the same process (hypothesis, experiment, result) used to conduct clinical trials today—with a little more sophistication, of course. We owe a debt of gratitude to Dr. Lind.

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

Children and Cancer Clinical Trials

Cancer in children and teenagers is relatively rare, making up only about 1 percent of all cancer cases in the U.S. But according to the National Cancer Institute, that still means more than 12,000 children in the U.S. under the age of 15 will be diagnosed with cancer this year. Cancer is the second leading cause of death for children—after accidental injuries. During the past 20 years, the childhood cancer 5-year survival rate has dramatically increased from 60 percent to more than 80 percent.

                              

Childhood cancers are usually quite different from adult cancers. They often form in parts of the body that are still growing and changing, such as the blood system, brain, nervous system, and kidneys. There is no known cause for most childhood cancers. Leukemias (blood cell cancers) and cancers of the brain and central nervous system account for more than half of all childhood cancers. Pediatric (childhood) cancers tend to be more aggressive than adult cancers.

In stark contrast to adult participation in clinical trials (less than 5 percent) well over half of all children with cancer participate in clinical trials. Improvements in treatment developed in clinical trials account for the rapid improvement in survival rates.  Today, 80% of kids with cancer survive for at least 5 years.  Cancer deaths in kids have been cut in half in the last 3 decades. 

According to ASCO, the American Society of Clinical Oncology, many pediatric clinical trials are focused on new treatments, evaluating whether a new treatment is safe, effective, and possibly better than the current (standard) treatment. These types of studies evaluate new drugs, different combinations of existing treatments, new approaches to radiation therapy or surgery, and new methods of treatment. Researchers also focus on easing symptoms, reducing toxic side effects, and reducing side effects that may occur after treatment has been completed. 

Clinical trials have made a major contribution to the many advances in treating childhood cancer.

To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

Do physicians stand in the way of patient participation in clinical trials?

We've talked a bit about things that keep patients from choosing to participate in cancer clinical trials, but what about their doctors?  Well, there are barriers on the physician side to.  In an article recently published in Oncology Times, I review some of these barriers and offer a bit of a call to arms to the oncology community. 

According to the NCI, physician barriers include: lack of awareness of appropriate clinical trials, unwillingness to “lose control” of a patient’s care, belief that standard therapy is best, belief that referring and/or participating in a clinical trial adds an administrative burden, and concerns about the person’s care or how the person will react to the suggestion of clinical trial participation.  To learn more about it, take a look at the article in Oncology Times.

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

Why don’t THEY (people with cancer) join a clinical trial?

 …so I can get cured

I’m sure (pretty sure) that everyone with cancer wants to be cured. Or at the very least to have their cancer stopped from growing. I sure do.

At the same time, the vast majority of adults with cancer do not to participate in clinical trials—the way new drugs are tested and ultimately approved and made available to you and me.

What’s wrong with this picture? We seem to live in a culture of “let somebody else do it.”

·        If only the government would…

·        THEY should improve education…

·        My doctor should make me feel better…

In the realm of cancer clinical trials, having cancer is usually a prerequisite to participation. There are 12 million of us in the U.S. living with cancer. Yet, many clinical trials are delayed or are never even started because not enough of THEM (people with cancer) volunteer to participate.

Not everyone with cancer is a good candidate for a clinical trial. But many thousands who might be good candidates never hear about clinical trials or may not seriously consider the possibility of volunteering. Fortunately, many thousands do volunteer and many trials are successfully completed.

Where do you stand? Could there be a clinical trial in your future? Should there be?

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

US health care costs: where are we getting our money's worth

A recent article on the PBS website by Jason Kane provides a thorough and thoughtful discussion on US health care costs and how they compare to other countries.  

We spend considerably more on healthcare than everyone else, including other rich countries, and in most areas we do not seem to get our money's worth.  Our health and our longevity are no better than others who spend much less.  In many areas of medicine, we do more procedures and more tests than the rest of the world, but don't seem to get better results.

So are there any areas where we do get some bang for our buck?

Yes there are.  The author points out that cancer outcomes are better in the US than anywhere else and these are important outcomes, like survival!  The other area where we lead the world in is medical research.  There are currently 119,469 clinical trials underway in the United States, far more than any other country.  In addition to that, new drugs and devices get approved faster in the US than most other places.  Yes, you heard that right. 

We need to get better value for the health care dollars that we spend, but it's great to know that there is one area where we appear to get our money's worth and that is cancer care.  

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

Cancer Clinical Trials – minorities and the elderly missing in action

An article in the November 2011 issue of CancerDiscovery, the journal of the American Association for Cancer Research, defines the problems and outlines strategies for recruiting minority groups and seniors for Clinical Trials.

Although about one third of the US population belongs to a minority group, this group accounts for less than 1 percent of adults enrolled in clinical trials. And, while nearly half of those diagnosed with cancer and 65 or older, seniors make up only 25% of clinical trial participants.

Minority groups and the elderly are at higher risk of being diagnosed with cancer than the population as a whole. So when there is low participation in trials from any group of cancer patients, the trial results may not be as applicable to those groups. And the low participation can also delay final approval of beneficial drugs. In order for us to know how to best treat all Americans with cancer, we need all Americans to be represented in clinical trials.

Several groups are now focusing on providing basic clinical trial education using DVDs to these groups—in several languages when appropriate.

Another direction is to provide additional training to nurses and doctors to help them better understand the issues in recruiting and the possibilities of participation in clinical trials for their patients.

And in some locations patient ‘navigators’ are being trained to provide one on one information, answer questions, and help potential participants fill out application materials.

A prostate cancer Dream Team—new hope for men with advanced prostate cancer

 StandUp To Cancer (SU2C) and the Prostate Cancer Foundation have combined resources to fund a Dream Team of Oncologists/Scientists to study personalized treatment for advanced prostate cancer. The three-year project will receive up to 10 million dollars from the sponsoring organizations.

Six doctor/scientists were chosen to work together to identify resistance pathways in advanced prostate cancer and find better treatments. Four campuses of the University of California (San Francisco, Los Angeles, Santa Cruz, and Davis), the University of British Columbia, and the Oregon Health and Science University are involved. This is exciting to me (Larry) as I enter my 10th year with with prostate cancer.

Dr. Tomasz Beer, Deputy Director of the Knight Cancer Institute at OHSU and my oncologist, co-author, and friend, is one of six top scientists picked for the project. Dr. Eric J Small and Dr. Owen N. Witte have been chosen to co-lead the team. The full title of the project is: Targeting Adaptive Pathways in Metastatic Treatment Resistant Prostate Cancer (quite a mouthful). It will concentrate on men who have no reliable treatment options. Current standard treatments to lower testosterone levels often don’t work or stop working in men with advanced prostate cancer.

In the U.S. a man is diagnosed with prostate cancer every 2 minutes and someone dies from prostate cancer every 18 minutes.

According to the Knight Cancer Institute:

Treatment of patients diagnosed with hormone-dependent prostate cancer includes chemical or surgical castration, using drugs or surgery to reduce androgen hormones such as testosterone and dihydrotestosterone. However, as with most hormone-dependent tumors, prostate cancer becomes resistant to this therapy. These resistant tumors are referred to as treatment-resistant prostate cancer or TRPC.

This new Stand Up To Cancer Dream Team will explore the idea that resistance is a result of the prostate cancer cells using common cellular responses, called adaptive pathways, to escape current therapies. The team believes that by identifying these pathways and inhibiting them, they will be able to overcome treatment resistance and profoundly improve survival and quality of life for these patients.

To test their idea, Small, Witte, Beer and their colleagues will systematically subject patient biopsies (fixed, frozen and fresh tissue) and blood samples to a comprehensive molecular assessment and pathway-based analysis to determine the activity level of known and novel pathways. Once the pathways activated in TRPC tumors are identified, the Dream Team will devise co-targeting approaches in the laboratory. After validation they will test novel therapeutic combinations that co-target adaptive pathways associated with resistance. By combining established therapies with new treatments that co-target adaptive pathways, the Dream Team hopes to dramatically improve outcomes for men with advanced prostate cancer.

The long-term goal of the project is to improve outcomes for men with advanced prostate cancer (including me and possibly you). This would include increased length of life, reduced side effects, and a better quality of life. Clinical trials are scheduled to begin in 2013.

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

Some Vaccines Have Been Approved to Prevent Cancer-Causing Infections

Several cancervaccines are currently in use and many, many more are in the experimental stage in clinical trials. Cancer vaccines boost the body’s natural ability to protect itself through the immune system.

The U.S. Food and Drug Administration (FDA) has approved two types of preventive cancer vaccines. One vaccine was designed to prevent Hepatitis B (which can lead to liver cancer) and another to prevent human papillomavirus types 16 and 18 (HPV) infection and effectively prevents about 70 percent of cervical cancer.

And just recently (2010) the FDA approved a vaccine designed to treat (as opposed to prevent) metastatic prostate cancer in men. It has been used successfully to lengthen survival. Named sipuleucel-T (Provenge®), it is individualized to each patient by using immune cells from the patient’s body.

Cancer vaccines may lead to major improvements in cancer treatment in the future. Some studies to date have shown positive results and some have not.

If you are interested in clinical trials for cancer vaccines, check out the list offered on the NCI Factsheet on Cancer Vaccines.

Taking stock - how are we doing on the cancer clinical trials blog

Recently, we got a nice review from the Journal of Clinical Research Best Practices and got selected for their "Bookshelf."  It's not the first nice review, but the first one in a little while after the initial reviews that come at the time of publication. Seeing this review got me thinking that it might be a good time to take stock of how we are doing.   In short, pretty well.  Our blog has been up and running since the beginning of the year and our book was published in May.  The book has been doing well with total sales approaching 10,000 copies.  Several partners have purchased the book in quantity to distribute to cancer patients as an educational resource.  In addition to that, regular folks are buying the books at bookstores at a good clip.  Our hope for the book was not to necessarily sell a lot of copies right away, but to establish the book as the go to resource for folks interested in clinical trials, a resource that will be an enduring one for years to come.  Time will tell, but we are off to a good start.

The blog recently crossed 20,000 page views.  A blip when compared to the giants, but a pretty good showing for us.  The most popular part of the blog...by a mile...Larry's cartoons.

Recently we launched a new effort.  It's a little ways away from being realized, but we are working on a pediatric version of our book.  It won't really be a kids book, but more a book for parents of kids with cancer.  Clinical trials are a part of cancer care for nearly 2/3 of kids diagnosed with the disease.  The principles are similar, but many things are a little different.  Not a lot of kids insured by Medicare, for example...  We are fortunate to have recruited Dr. Stacy Nicholson, Physician-in-chief at the Doernbecher Childrens' Hospital to help us refashion our book for the world of pediatric oncology.
So thank you for visiting our blog, considering our book and being a part of our community, focused on sharing knowledge about cancer clinical trials.


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

Explaining Risk: Know Your Aristotle

To make informed decisions about your healthcare, we absolutely need to understand risk.  Whether you are facing cancer or deciding whether it's worth treating your blood pressure, understanding risk is central to understanding what your choices really mean.  Aristotle can help.  This is a great article everyone should read.  Click here to read it.

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

What are cancer clinical trials about: a webinar for you

Today, Larry and I were joined by Evan Denhart in presenting a webinar about clinical trials.  In the two part discussion we talked about clinical trials, what they are, how they work, and what it is like to participate.  Then we discussed the AFFINITY study, a newly launched phase III clinical trial for advanced prostate cancer.  We took questions and had a great time.  See and hear it all here.  This presentation takes a while, so you can preview it quickly, but you will need to set aside a bit of time to get the most out of it.  Hope you enjoy it.

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

KOIN TV visits about a new drug for prostate cancer

As part of their Stand Up to Cancer programming, KOIN-TV visited with us a bit ago.  This in an inspiring piece with one of our cancer patients.  We are so glad to see stories like this become a reality.


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

An invitation to a reading at Powell's

If you are in Oregon, you surely know Powell's, our signature book store.  The largest independent bookstore in the country, I heard.



Larry and I will be visiting Powell's on Wednesday, September 12 at 7 P.M. for a reading and conversation about clinical trials

This is at the Cedar Hills Crossing Powell's store at 3415 SW Cedar Hills Blvd (not at the downtown store).

Details here

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

Cancer Clinical Trials: what does “significant” mean?

When we hear the words there was a significant treatment effect, you would naturally assume that significant means large, important, or noteworthy. This may be true—but not necessarily. More often than not, significant refers to statistically significant, which means that the difference between the two groups of patients was statistically meaningful and unlikely to be random.

          Statistical significance is an important concept. Without measuring the statistical significance of study results in cancer treatment, it is possible that any effects may not even be real but rather just chance. However, statistical significance is not enough. Another medical term—clinically significant—means “important to patient care.” This is what we are after. If a small effect is statistically significant, it may still not be large enough for us to care much about it. Watch out for the word significant, and assume it’s likely “statistics-speak” and not necessarily the large, important improvement you might think.

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

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

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.

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

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

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 5^th 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

Blind and Double Blind—Sound Ominous?

Those terms certainly sound dangerous. But in the world of cancer clinical trials they refer to methods used to make sure experimental drugs are fairly and accurately tested. Blinded studies are also called randomized studies, although not every randomized study is blinded. Just to clear the air about eye safety, the term “blinded” originated when early participants were actually blindfolded—not likely to happen today.

In many clinical trials two or more drugs are compared in the experimental process. In order to make sure all participants are treated equally, they may not be told which of two or more treatments they are receiving—experimental drug (new), standard drug (the best now available), or maybe even a placebo (see previous entries about placebos) if no standard drug exists. This is a “blind” or “blinded” study. If you participate in a blinded study you will not know and will not be able to choose which treatment you receive. This is common in clinical trials.

It is also common for a blinded study to be a “double blinded” study. This is a second step to insure that all participants and all medical procedures are as fair and equal as possible. In a double blind study not only doesn’t the trial participant know what treatment they are receiving, but the doctors, nurses, and other personnel directly administering the trial do not know either. It is possible to be unblinded and know what one is getting - although this is rare. In general, unblinding happens only if there is a severe side effect and the care of the patient requires knowing what drug he or she is receiving.  Unblinding also happens when the clinical trial is over.

While this may seem frustrating for those involved, blinding increases the chances of determining the actual benefit (if there is one) of the experimental treatment being tested in the trial. 

Ominous? Of course not. It’s all just another part of the clinical trial process.

To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

Does joining one cancer clinical trial disqualify you from joining another trial?

Participating in one clinical trial does not necessarily disqualify you from future trials, as long as you meet the future study criteria. Many people participate in more than one clinical trial over time. Rules for trial participation do take into consideration therapy that you have received prior to joining a trial, and a prior treatment that you have received—either standard or experimental—might make you ineligible. If you already know you might be interested in a specific trial sometime in the future, check with your doctor or clinical trial site to see if the treatment decisions you make today could get in the way later. For the most part, however, many other clinical trials are available, and even if one particular study is off limits to you, another is likely to become available.

Waiting for the new drug to be approved…

Not all clinical trials end with a successful drug or treatment being approved by the FDA. But when the trial is successful we want the new drug to be available today—if not sooner. It seems like it takes forever for the FDA to review and finally approve a drug, especially if it’s one that might benefit us.

In a study recently published by the New England Journal of Medicine, two researchers from the Yale School of Medicine studied the average time from clinical trial to approval by the FDA in the U.S., the European Medical Agency (EMA), and Health Canada between 2001 and 2010.

Although the average approval time still may seem long, the FDA approval time was more than two months faster than the EMA and more than three months faster than Health Canada.

Average drug approval times:

FDA                            322 days

EMA                           366 days

Health Canada         393 days

Approval agencies around the world are always under pressure to approve potentially successful drugs as soon as possible and many approvals are done in less time than the averages shown here. It is worth noting also that a long approval time may mean that the study results are not as clear cut as it seems and the FDA needs to ask more questions. The other side of the coin, of course, is when a drug may be approved too quickly and then have to be recalled because of risks and problems not known at the time of approval.

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

Podcast: Drs. Armstrong and Beer discuss new prostate cancer treatments

Podcast of Dr. Andrew Armstrong and Dr. Tom Beer speaking about new treatments for the most advanced form of prostate cancer.  Listen by clicking on the MP3 icon to the left.  You can also read the text of the interview and listen to the podcast at the Cancer Network website.

To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

Clinical trial phases from the participant's point of view

There are many types of clinical trials.  Most commonly, they are divided into phase I, II, III, and sometimes IV.  The phases refer to the phases of testing of a new drug in humans. Some our previous posts describe the various phases and discuss phase I trials and phase III trials in more detail.  Here we would like to share with you page 47 from our book, where we provide a succinct summary of the advantages and disadvantages of each trial type, from the perspective of trial participants.  The table shown below may not apply to every single trial, but it does give you a quick and straight forward basic guide.

If you would like to download a PDF of this page you can do so here.  Feel free to share it.

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

Dr. Beer interviewed about clinical trials

A few weeks ago, at the 2012 ASCO meeting, I had the privilage of being interviewed about about clinical trials by Andrew Schorr, Founder of Patient Power.


You may also wish to visit the Patient Power website, which is a wonderful resource.


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

Lower income reduces participation in cancer clinical trials

In a carefully documented study, sponsored and funded by the National Cancer Institute and NexCura, researchers found a surprising gap in participation in clinical trials between cancer patients with higher incomes and those with lower incomes. Nearly 5,500 cancer patients were interviewed for the study that concludes:

• Cancer patients with annual incomes under $50,000 were 27% less likely to participate in a clinical trial than those with an annual income of more than $50,000.
• Cancer patients with an annual income under $20,000 (such as many living on Social Security) were 44% less likely to participate in a clinical trial than those with an annual income of more than $50,000. Concern over possible costs was given a major factor in their decision not to participate (including co-pays, time off work, etc.).

Does this matter from a scientific/research point of view?

Researchers say yes.

• Lower participation rates in the lower income groups results in lower overall participation rates and slows the rate of completing trials and ultimately getting FDA approval for new and better treatments.
• With lower participation rates from large segments of the population trial results may not be as reliable, their results may not be fully applicable to all populations.

Does it matter from a patient point of view?

• Clinical trials can provide many benefits to participants, including access to new drugs, excellent medical treatment, and close monitoring of their health status.
• According to the study leader, Dr. Joseph M. Unger, lower income individuals already have more medical conditions and less access to healthcare than their higher income peers. Having less access to cancer clinical trials adds to this treatment gap.

Solutions?

The study recommended:

• Increased and improved education for lower income cancer patients, making sure they knew what the costs were and that costs associated with clinical trials were not significantly different from regular care.
• Increased and improved education for lower income cancer patients about the possible benefits of participating in cancer clinical trials.

Other possibilities…

• Providing transportation or transportation costs for low income participants.
• Providing the trial treatment in the participant’s home (going to them).
• Finding ways to include (more) lower income individuals who do not have health insurance coverage.

In an ideal world, all patients would have equal access to cancer clinical trials. 

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

Our book has made it into the 21st century!

In addition to the print edition, we are now an eBook!  We've had a number of folks ask us if we will be on Kindle and, as of today, we are.  We should be coming to the Nook and the Apple iBookstore soon as well.


If you've been waiting for the electronic version, it's here now!  We are excited about another milestone in our book journey.

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

Video: the personalized medicine revolution in cancer care

Cancer care is changing to become more individualized and personalized.  Detailed biologic analyses of individual cancers are increasingly enabling treatment to be tailored to match each cancer's unique vulnerabilities.  We wrote about this in a  prior blog post.  


Now, you can watch a great show about personalized cancer care from the OHSU Knight Cancer Institute.  Click here to see the show.  Some aspects are specific to the Knight Institute, but most of the program will help you learn about personalized and targeted therapy for cancer.


The call-in lines, by the way, are no longer open.  Folks could call in with questions on the day the show ran on KOIN-TV in Portland.


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

ASCO 2012 Update on advanced prostate cancer treatment

ASCO is the world's largest oncology meeting.  Important new data about abiraterone and MDV-3100 were presented at the meeting.  Both of these drugs have been shown to have a significant benefit for patients with metastatic prostate cancer that is resistant to standard hormonal therapy.


I had the privilege of reviewing the latest developments in treatment of advanced prostate cancer.  The slides for my talk are available here.  It's a large file, so be sure you have a broad band connection to download.  The slides are fairly technical at times, but do include "current status" summary slides that provide a succinct summary of the status of each of the new agents discussed.


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

It’s all about the numbers—or is it?

12 million individual Americans have cancer. That’s a lot. Of course not all cancers are equal. Some grow very slowly, others very quickly. Some are nearly always fatal, some are sometimes fatal, and some are almost never fatal.

There are always new drugs in the clinical trials chain that have the promise of cure (not often enough), prolonging life, or improving quality of life. There are also ongoing controversies about the high costs of trials and drugs, and whether or not regular testing should actually occur (remember the recent discussions about breast cancer and prostate cancer testing). There are published statistics about survival advantage, incontinence, harm vs. benefit, waiting vs. not waiting, and on and on. It never ends--which is probably a good thing in the long run.

But for anyone with incurable cancer it’s a very, very individual thing. For example, I know a lot of guys with long term prostate cancer and no two of us are getting exactly the same treatment (unless we’re in a trial). Individual cancer treatment depends on factors such as age, overall physical condition, speed of cancer growth, resistance to certain drugs, allergies, tolerance of side effects, health insurance coverage, and some other things most of us have probably never heard of.

Regardless of national or international statistics about cancer and cancer treatments, your best interests lie in focusing on your needs, talking and listening to your medical team, and looking for the things that might help you. Whatever the ‘statistics’ and ‘experts’ say, you are not just a number—OK, you’re actually number ONE (remember that)!

Any given drug or treatment will either help (100% effective) or not help (0% effective) you. All those statistics might or might not have anything to do with what’s best for you!

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

Cancer Drug Side effects: Are you getting the whole story?

In a word (or two), maybe yes and maybe no.  Lists of side effects are easy to find.  Every drug has them.  These lists may be so long that they become almost meaningless.  As you leaf through these listing, several questions arise: 

1)    Is the list complete? Are there any side effects missing that I need to know about?

2)    Are all these side effects really caused by the drug?

3)    How do I know which of these side effects may happen to me?

How are side effect reported

We will tackle the first two questions, the third deserves its own blog post.  Researchers who study new cancer drugs are the first to report side effects.  Side effects can also be reported to the FDA after a drug is approved and regularly prescribed. Researchers report every adverse event that happens to their patients who are participating in a clinical trial.  Adverse events are reported together with their grade and “relationship to treatment.”  The grade is a measure of severity and for every imaginable adverse event, there is a table that describes what is mild (grade 1), moderate (grade 2), severe (grade 3), and life threatening (grade 4).  Clinic notes in research centers are filled with these mysterious grades whenever anything untoward happens. 

The relationship to treatment is determined by the research physician’s best judgment about whether the adverse event was caused by the drug or not.  There are shades of grey here:  related, probably, possibly, unlikely, and not related.  The decision is basically a judgment call, an educated guess.  Sometimes it’s obvious: you are feeling great and get the flu along with your entire family.  Pretty unlikely the drug had anything to do with it.  Often it is not so obvious.  People with cancer may also have other medical conditions and take many different drugs.  The illness itself takes a toll. When something untoward happens, there are many possible causes. 

With all this reporting, how could side effects go unnoticed?

Rare side effects can, of course, go unnoticed if they didn’t happen during the study.  Sometimes, the source you are relying on (i.e. research paper) listed only a subset of the