Aug 25, 2015

Cancer Clinical Trials and the Elderly—an Unlikely Combination


Did you know?
 

Q         What age group is most likely to have Cancer?

A         People older than 65. They represent 13% of the population and more than 60% of all those with cancer.

Q         Who is most likely to die of cancer?
A         Seniors. About 80% of all cancer deaths occur in those older than 65.

Q         What age group is least likely to be represented in cancer clinical trials?
A         Seniors. 

Q         Can seniors respond to cancer medications in a different way than younger patients? (For example, having more toxic side effects.)
A         Yes

Q         So, WHY are seniors with cancer not included more in clinical trials?
A         It’s a long story……

Improving the research base for treating older adults with cancer was a focus of the 2015 ASCO conference. An expert panel presented the problem and possible solutions. The Journal of Clinical Oncology reprinted the complete report and recommendations.

Factors such as meeting eligibility requirements can create hurdles. Many older patients are limited in mobility, have numerous previous treatment regimens, have a more limited predicted lifespan, and take multiple medications (the average is more than 9 for patients over 65). Multiple medications can interfere with trial medications. More than 80% of older patients have a chronic condition (such as diabetes or arthritis) which can complicate cancer treatment. 

Doctors often do not even recommend older patients for inclusion in clinical trials, although Doctor recommendation is the number one predictor of older people choosing to participate in clinical trials.

Many oncologists, such as Stuart Lichtman, MD, Memorial Sloan Kettering Cancer Center in NY, believes that seniors with cancer are being short changed when it comes to cancer treatment because they are under-represented in research.

ASCO makes five recommendations to improve evidence generation in the 65+ population:

(1) Use clinical trials to improve the evidence base for treating older adults (older than 65) with cancer,

(2) Leverage research designs and infrastructure for generating evidence on older adults with cancer (change trial requirements to fit older patients),

(3) Increase US Food and Drug Administration authority to incentivize and require research involving older adults with cancer,

(4) Increase clinicians' recruitment of older adults with cancer to clinical trials (educate doctors to recommend older patients for trials), and

(5) Use journal policies to improve researchers' reporting on the age distribution and health risk profiles of research participants.

Doctors currently have no choice but to use results from clinical trials conducted with people in their 50s to treat people in their 80s.

Research results from clinical trials with older patients could provide a better scientific basis for treating cancer in the elderly. As someone who is elderly and has cancer, this author wholeheartedly supports these recommendations.

Click on the links in this article for a more comprehensive discussion of this issue.
 


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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 13, 2015

Prostate Cancer Research at OHSU--Interview

 Tom's interview with Reggie Aqui at KGW Channel 8 in Portland.


He covered prostate cancer basics, risk, types, and when to get tested.

video


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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 4, 2015

Advances in Prostate Cancer Treatment this Past Year-ASCO 2015


Dr. Tom Beer attended the 2015 ASCO (American Society of Clinical Oncology) Annual Meeting in Chicago. He wrote a paper about some of the  recent discoveries and important advances in prostate cancer treatment. This is a summary of that paper. You can find the original in the Oncology Journal.
  •  A trial called STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) recruited men starting hormone therapy for high-risk, locally advanced prostate cancer. Multiple arms of the study are testing the addition of various agents to standard hormonal therapy. The results of adding docetaxel, zoledronic acid, or both were reported at ASCO. Nearly 3,000 men have participated in the study. The use of docetaxel, with or without zoledronic acid, significantly increased overall survival. The bottom line‑the use of chemotherapy with hormonal therapy in patients with advanced metastatic prostate cancer was supported.

  • In Radiation Therapy Oncology Group study 0521, the early use of chemotherapy was also evaluated, along with radiation and hormonal therapy, in high-risk localized disease.[2] Six hundred twelve patients with localized prostate cancer and features consistent with a high risk of relapse were treated with radiation therapy and 2 years of hormonal therapy with or without 6 cycles of docetaxel. The addition of chemotherapy resulted in an improvement in the 4-year overall survival rate and improvement in 5-year disease free survival. These results support earlier trials which found that using chemotherapy in the initial management of metastatic prostate cancer increased survival time. Additional follow-up is necessary before this becomes standard treatment.

  • A French study, the GETUG-AFU 16 trial, used radiation in men with a PSA rise after a prostatectomy. A six month regimen of hormonal therapy was added for some of the patients. Progression-free survival was significantly improved in those patients receiving the combination therapy.

  • How soon to begin hormonal therapy in men with rising PSA levels was the focus of another study. Men were randomly assigned to a group that started hormonal therapy in two years or four years. The overall survival rate was significantly higher in the men who began therapy at two years. A concern in using hormonal therapy is toxic side effects. Early study results suggest earlier use of hormonal therapy may save lives in spite of side effects. Larger, more definitive studies are needed to test these results.

  •  A comparison of the use of intermittent hormonal therapy versus continual hormone therapy was the focus of a study conducted by the Southwest Oncology Group (SWOG). One group of older men received continual ongoing hormonal therapy and the other group intermittent treatment. Early results suggest the intermittent treatment group had more medical events over the time of the study than those on continual hormonal therapy.

  • Hormonal therapy is routinely combined with radiation for the treatment of high-risk and most intermediate-risk patients. But in intermediate-risk patients, the combination is not as well studied and questions about the need for hormonal therapy have been raised. A randomized trial that involved 600 participants showed that biochemical and disease-free survival with 6 months of hormonal therapy plus radiation were superior even to results with dose-escalated radiation, providing support for the widely practiced approach of combining these two treatment modalities.

 

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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

Jul 19, 2015

A Blog is a Blog is a Blog…


Or is it??? 

This blog was started in 2012 just after our book, Cancer Clinical Trials, was published. Our goal was to provide information about clinical trials, new meds, FDA approvals, how to participate in clinical trials, and other information related to cancer clinical trials. We have tried to be positive, encouraging, and occasionally make you smile. This reflects our outlook on life. Our blog entries are primarily aimed at those with cancer, those thinking about participating in a clinical trial, and the family and friends of those with cancer.

Some have questioned our inclusion of humor. Is there a place for humor in this serious subject? Cancer is not funny, of course, but a positive attitude, sense of humor, and ability to laugh may make life a little easier. This author, Larry, has been living with prostate cancer for 12 years. Being able to laugh at myself, the idiosyncrasies of the medical world, high drug prices, endless forms to fill out, strange side effects, etc. has made my quality of life a little better. We have been pleased to receive positive feedback from many blog followers.

There are literally millions and millions of blogs out there somewhere. There is something for everybody. They run the range of the very scientific, factual and useful information of all sorts, entertainment, political (not necessarily factual), personal diaries, pictures of cute kittens, and probably more than a few X-rated and nefarious ones. The odds are good that you or someone you know has a blog.

Cancer is the topic of a lot of these blogs. Many are dedicated to specific cancers (breast, lung, prostate, skin, and on and on). Then there are the personal information and experience blogs which are not always factual (we hope ours is), and all are infinitely varied. We hope you will follow our blog, but you may find others you prefer. The advantage of having so many choices is that you’ll surely find just what you’re looking for. 

We will continue to provide cutting edge cancer and clinical trial information, a few personal anecdotes, and a bit of humor‑‑often in the form of G-rated cartoons.

 Post Text 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

Jun 29, 2015

A BILLION dollars buys a lot of research

OHSU Press release:

OHSU sets fundraising record by meeting $1 billion challenge from Nike co-founder and wife

06/25/15  Portland, Ore.
$1 billion will create first large-scale program to overhaul early detection of lethal cancers
Fast-track recruitment of 250-300 scientists set to launch


Oregon Health & Science University today announced it met Nike co-founder Phil Knight and his wife Penny’s $1 billion challenge by raising $500 million in less than two years to earn the Knights’ matching gift and set a fundraising record.

The $1 billion will support the first large-scale program dedicated to early detection of lethal cancers — one of the biggest unmet needs in cancer care today.

“While cancer treatment has evolved to become more precise and less toxic, the tests and tools used for cancer detection have not changed in decades. Without better, earlier detection, and a full understanding of cancer’s origins in the body, the promise of precision cancer medicine cannot be realized,” said Brian Druker, M.D., director of the OHSU Knight Cancer Institute.

Meeting the Knights’ $500 million fundraising challenge marks the largest documented challenge pledge to succeed, according to researchers with the Indiana University Lilly Family School of Philanthropy.

“Penny and I have total confidence in Brian Druker and the entire OHSU Knight Cancer Institute team to put a stop to a disease that touches each of our lives,” Phil Knight said. “These last 22 months have shown what is possible when people of vision focus on a single goal. We are more convinced than ever that cancer will meet its match at OHSU, and we are proud to play a role in this history in the making.”

With $1 billion in new funding, the OHSU Knight Cancer Institute will begin fast-track recruitment of about 25 of the world’s top researchers. These recruits will, in turn, hire an additional 225 to 275 scientists and physicians, forming a team focused on the detection of cancer, including the early biological changes in the body that signal a lethal cancer is beginning to develop. Catching the disease in these very early stages will unleash the full potential of precision cancer medicine. It will make it possible to detect cancer when it first starts and treat it when it’s most curable, with the fewest side effects and at the lowest cost.

These scientists will be given substantial financial support, so they can focus on discovery instead of spending time securing grants. With this expansion, OHSU will also move forward with construction of two buildings ― a state-of-the-art cancer research facility designed from the ground up to support a new model of combining scientific disciplines to speed progress and new cancer care clinics for expanded clinical trials that will translate the scientific discoveries made by the team into next-generation detection tests, tools and treatments.

“This is a historic milestone for cancer research, for Oregon and for our institution,” said OHSU President Joe Robertson, M.D., M.B.A. “The support we have received to achieve our ambitious goal ― putting an end to cancer as we know it ― has been nothing short of stunning. We are deeply grateful to the state of Oregon for its leadership and investment at the early stages of our campaign as well as to the thousands of individuals, companies and foundations who joined us along the way.”
In the past few weeks, more than $20 million in donations came in to support the campaign, including significant gifts from Cambia Health Foundation; Pat and Stephanie Kilkenny of San Diego, California; Mark Wolfson and Jasper Ridge Partners; Intel Corporation; Wayne D. Kuni and Joan E. Kuni Foundation; the Blumenfeld family of New York City; the Wendt family of Klamath Falls, Oregon; and Consumer Cellular.
  • The largest gift received since the campaign launched in 2013 was from the state of Oregon, which invested $200 million for the needed research and clinical facilities.
  • The largest gift from an individual ―$100 million — came from Columbia Sportswear Chairman Gert Boyle.
  • In all, more than 10,000 donors participated and, of these, more than half were first-time donors to OHSU.
  • Donations were received from every state in the nation and five countries.
“Our work is just beginning,” added L. Keith Todd, president of the OHSU Foundation. “The Knight Cancer Challenge created an unstoppable movement against cancer. We will continue our efforts to ensure OHSU has all the resources it needs to achieve its vision. Our sense of urgency will not recede until we have fully delivered on the promise of stopping this life-threatening disease.”

The Knights made their challenge pledge in September 2013 after being inspired by the OHSU Knight Cancer Institute’s goal to revolutionize how cancer is detected. The challenge pledge follows their $100 million gift to OHSU in 2008 to support Druker’s work, which helped pioneer the field of precision medicine.

Druker conducted the breakthrough research that led to the development of Gleevec® for chronic myeloid leukemia. This once-a-day cancer pill proved it was possible to kill cancer cells without harming healthy cells. Since he first proved this new type of treatment was possible, many other precision treatments have been developed ― making less toxic, tailored cancer treatment a reality for many patients and launching the field of personalized or precision medicine.

“Today too many patients die or have to suffer through debilitating treatments because their disease is caught too late. Too few physicians and scientists are focused on this problem in a meaningful way and we are committed to filling that gap,” Druker said. “We are thankful to everyone who is making this goal a reality.”

About the Knight Cancer Institute

The Knight Cancer Institute at Oregon Health & Science University is a pioneer in the field of personalized cancer medicine. The institute's director, Brian Druker, M.D., helped prove it was possible to shut down cells that enable cancer to grow without harming healthy cells. This breakthrough has made once-fatal forms of the disease manageable and ushered in a new generation of targeted cancer therapies. The OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle – an honor earned only by the nation's top cancer centers. It offers the latest treatments and technologies as well as hundreds of research studies and clinical trials.

About OHSU

Oregon Health & Science University is a nationally prominent research university and Oregon’s only public academic health center. It serves patients throughout the region with a Level 1 trauma center and nationally recognized Doernbecher Children’s Hospital. OHSU operates dental, medical, nursing and pharmacy schools that rank high both in research funding and in meeting the university’s social mission. OHSU’s Knight Cancer Institute helped pioneer personalized medicine through a discovery that identified how to shut down cells that enable cancer to grow without harming healthy ones. OHSU Brain Institute scientists are nationally recognized for discoveries that have led to a better understanding of Alzheimer’s disease and new treatments for Parkinson’s disease, multiple sclerosis and stroke. OHSU’s Casey Eye Institute is a global leader in ophthalmic imaging, and in clinical trials related to eye disease.


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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

Jun 20, 2015

NCI-MATCH Trials…Something New

In a recent press release, the National Cancer Institute outlined a new cancer clinical trial program, focused on linking targeted cancer drugs to gene abnormalities. MATCH stands for Molecular Analysis for Therapy Choice.

The trial seeks to determine whether targeted therapies for people whose tumors have specific gene mutations will be effective regardless of their cancer type. NCI-MATCH will incorporate more than 20 different study drugs or drug combinations, each targeting a specific gene mutation, in order to match each patient in the trial with a therapy that targets a molecular abnormality in their tumor.
NCI-MATCH is a phase II trial with numerous small substudies (arms) for each treatment being investigated. It will open with approximately 10 substudies, moving to 20 or more within months. 

The NCI-MATCH trial has two enrollment steps. Each patient will initially enroll for screening in which samples of their tumor will be removed (biopsied). The samples will undergo DNA sequencing to detect genetic abnormalities that may be driving tumor growth and might be targeted by one of a wide range of drugs being studied. If a molecular abnormality is detected for which there is a specific substudy available, to be accepted in NCI-MATCH patients will be further evaluated to determine if they meet the specific eligibility requirements within that arm. Once enrolled, patients will be treated with the targeted drug regimen for as long as their tumor shrinks or remains stable. Overall, trial investigators plan to screen about 3,000 patients during the full course of the NCI-MATCH trial to enroll about 1,000 patients in the various treatment arms.

Adults 18 years of age and older with solid tumors or lymphomas that have advanced following at least one line of standard systemic therapy, or with tumors for which there is no standard treatment, will be eligible. Each arm of the trial will enroll up to 35 patients. The trial’s design calls for at least a quarter of the 1,000-patients enrolled to involve people with rare types of cancer. 

For several years now there has been much discussion of using targeted therapies to treat cancer—this will be the first big study to actually do it.

“NCI-MATCH is a unique, ground-breaking trial,” said Doug Lowy, M.D., NCI acting director. "It is the first study in oncology that incorporates all of the tenets of precision medicine. There are no other cancer clinical trials of this size and scope that truly bring the promise of targeted treatment to patients whose cancers have specific genetic abnormalities. It holds the potential to transform cancer care.”
Since many gene mutations in tumors are infrequent or unique, screening for individual mutations is not cost-effective or efficient in clinical trials. Instead, NCI-MATCH will use advanced gene sequencing techniques to screen for many molecular abnormalities at once. Large numbers of patient tumors will need to be screened because most gene mutations occur in 10 percent or less of cancer patients. Most patients are expected to have one, or at most two, treatable mutations in their tumors. By having multiple treatments available for these genetic abnormalities in a single clinical trial, several different study drugs or drug combinations can be evaluated simultaneously.

The cancer treatment drugs being used in NCI-MATCH include both U.S. Food and Drug Administration approved drugs as well as investigational agents that are being contributed by a number of pharmaceutical companies. Most of the arms in the trial will incorporate single-agent drugs that are either commercially available or are still being tested in clinical trials. However, a few arms will contain combinations of drugs for which there are enough safety data and evidence that they might be active against a particular genetic abnormality.

Screening has not started (starts in July 2015) and there is no specific timeline. Participants will continue to take the trial drugs until their cancer no longer responds to the medications. This approach may be the template for future targeted treatments. Specific drugs for specific gene mutations is a step forward. Watch for results—sometime soon, I hope.


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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

May 26, 2015

Clinical Trials--Why Bother?

Editorial Comment

Most clinical trials DO NOT result in a successful drug or treatment being approved by the FDA. Most clinical trials DO NOT provide a benefit for most participants. So why should anybody participate in a clinical trial?

I have participated in several clinical trials. None of them cured me or slowed the progression of my cancer. None of them did any harm, either (so far). I would participate in future clinical trials if they were relevant to my cancer, if I trusted the researchers, and I didn't have to travel too far too often.

Clinical Trials are good at finding out what DOES NOT work. That is an important step. It allows researchers to try something else, go a new direction, or get back to the laboratory and start over. 

I personally hope that there are many more cancer clinical trials in the future. If only one in ten trials is successful, then we need many tens of trials. Every once in a while there is a major breakthrough usually for one type of one cancer. Mine might be next!

Bottom Line
Clinical Trials thrive on numbers. Volunteering to participate helps you, me, everyone else with cancer, and all those who do not yet have cancer. Many trials never get started because not enough of us participate. One of them could have been the breakthrough that would help me--or maybe you.

Larry Axmaker--12 year cancer survivor

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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

Apr 21, 2015

Clinical Trial stopped early for Breast Cancer Drug Ibrance®


Another clinical trial success story
 
Ibrance® (palbociclib) trials were halted early by its creator Pfizer when it met its primary endpoint—a statistically significant improvement in progression-free survival in postmenopausal women with HR+, HER2 metastatic breast cancer. This has been a particularly difficult cancer to treat.

Pfizer announced in an April, 15, 2015 press release:
IBRANCE was approved by the U.S. Food and Drug Administration (FDA) in February 2015 as a first-line treatment for women with advanced or metastatic estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. IBRANCE® (palbociclib), in combination with letrozole, is indicated for the treatment of postmenopausal women with ER+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled. IBRANCE is not approved for the use being investigated in PALOMA-3 or for any indication in any market outside the U.S.

The trials were conducted in more than 150 global sites. Although the FDA has approved Ibrance®, the Phase III studies are ongoing. The combination of Ibrance® plus letrozole extended progression-free survival by about 50% (from 10.2 months with letrozole alone to 20.2 months with the combination) in the Phase II part of the study.

If you or somebody you know might benefit from this drug, talk to your doctors.

The American Cancer Society (ACS) estimates that more than 230,000 American women will be diagnosed the breast cancer and more than 39,000 women will die from breast cancer this year. This new drug is expected to prolong many lives.

This drug is one of the new generation of highly effective and very expensive drugs. The projected cost of Ibrance® will be $9,850 a month. This is not out of line with other recently approved cancer treatment drugs.

For more information on clinical trials, what they are, where they are, and if you might qualify to participate, go to the National Institutes of Health clinical trials site.


Post Text 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