The World’s Largest Cancer Clinical Trial

The creation of cancer treatment drugs often follows a similar path. Somewhere a researcher or research team independently or as part of a drug company invents a potentially effective drug and a drug company sponsors clinical trials. After many trials at several levels, involving hundreds and maybe thousands of patients, some of the drugs are FDA approved. Conducting clinical trials is expensive and the successful drugs are eventually sold to patients at very high prices. You already know this, of course. But this new clinical trial from the UK has a different twist.

Clinical trials on the cheap

The BBC has reported that Cancer Research UK and NIHR (part of the National Health Service) will be sponsoring a 12-year study of the cancer prevention benefits of ASPIRIN. Yes, common aspirin. It is called the Add-Aspirin Trial. 

There has been some research to suggest that aspirin can delay or slow the growth of some cancers. This trial will help determine if aspirin can be an effective cancer treatment. A proven inexpensive cancer treatment would be a major benefit to millions. 

11,000 people with early stage cancer—the largest number ever in a clinical trial‑‑will be randomly assigned to one of four groups. One group will take a daily placebo and the other three groups will each take aspirin at a different dosage level. This part of the study will last five years. Participants will be monitored for as long as 12 years. Patients with early stage bowel, breast, prostate, stomach, and esophageal cancers will be included in the study. 

Aspirin is one of the cheapest meds on the market. It was originally developed as a painkiller but is now widely used to help reduce the risk of heart attack and stroke. Maybe there is one more chapter in the aspirin story. 

Aspirin has several documented side effects—as do all drugs‑‑ and would not be appropriate for everyone.

Keep an eye on this study. Not all clinical studies have a good outcome but, if successful, this one could be a ‘game changer.’

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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

Cancer Treatment Drugs Approved in 2014 and 2015 by the FDA

Looking  for the latest and greatest medications to treat your cancer? There are a number of drugs approved by the FDA in the past two years and listed by CenterWatch. Never heard of of them? Check them out, talk to your oncologist...

 Drugs Approved in 2015

Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015

Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015

Lenvima (lenvatinib); Eisai; For the treatment of thyroid cancer, Approved February 2015

Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015

Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015

Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015

Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapay, Approved September 2015

Drugs Approved in 2014

Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014

Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014

Blincyto (blinatumomab); Amgen; For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014

Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia, Approved February 2014

Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved September 2014

Lynparza (olaparib); AstraZeneca; For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma, Approved December 2014

Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014

Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014

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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

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

Cancer and Clinical Trials—by the numbers

Every once in a while we find it helpful to take a step back from clinical trial results, experimental drugs, and finding a clinical trial to look at some other cancer information. Today it’s taking a look at the big picture—the numbers, or as close to the facts as we can get. 

In the Wide, Wide World

This year 9,000,000 people worldwide will die from cancer and the number is rising. That is 13% of all deaths. The U.S. ranks 58^th in the rate of world cancer deaths. That means 57 countries have lower rates of cancer deaths than we do. The rates are much higher in Poland and Hungary and much lower in Mexico, Iran and many other countries. 

There are growing numbers of people in the world with cancer. How can this be with all the improvements we have made in diagnosis and treatment? Well, there are more and more older people throughout the world. The number one risk factor in getting cancer is to get older. And, more people are living longer with cancer. Then there are factors like pollution and smoking, which is still very popular around the world.

Close to Home

14.5 million living Americans have or have had cancer. 1.6 million more will be diagnosed this year and 589,000 will die from cancer. And, of all those individuals, only about 3% (42,000) will ever volunteer to participate in a clinical trial. You can help improve that statistic!

In the U.S. the 5-year cancer survival rate for all cancers was 49% in 1977. It is 68% today—and much higher for some cancers such as prostate (99%). Earlier diagnosis, better treatment, and lower smoking rates have helped. The most common cancers in the U.S. are breast, prostate, and lung. Breast and prostate cancer have high survival rates, lung cancer has a very low survival rate‑‑still.

Over a lifetime your chance of getting cancer of any kind is 37% if you are a woman and 43% if you are a man. You can avoid some cancers (stay out of the sun, don’t smoke) but others seem to just happen. 

How About some $ and Sense?

Cancer is expensive. In the U.S., cancer treatment costs exceed $88 billion each year. Half of that is for Doctor and out-patient Hospital costs. 35% is for in-Hospital treatment and 11% is for prescription drugs. That’s a lot of money to help us stay alive. And costs are going to increase.

Summary

Cancer is very common, horrible, expensive, and unpredictable. The numbers in this article won’t cure you, probably didn’t surprise you, and will not likely change any of your behaviors and choices. But you never know…

 

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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