Monthly Archives: March 2016

The Truth About Clinical Trials

About-Clinical-Trials

Clinical trials offer a chance to receive investigational medicines or procedures that experts think might improve the treatment of cancer. This important option is not limited to people who have run out of choices. In fact, there may be clinical trials for every stage of disease in dozens of cancer types.

Concern: I don’t want to be a guinea pig for an experimental treatment.
The Truth: Cancer clinical trials are developed with high medical and ethical standards, and participants are treated with care and with respect for their rights.

Concern: I’m afraid I might receive a sugar pill or no treatment at all.
The Truth: Cancer clinical trials rarely use placebo alone if an effective treatment is available; doing so is unethical.

Concern: Cancer clinical trials are only for people with no other treatment options.
The Truth: Trials can study everything from prevention to early- and late-stage treatment, and they may be an option at any point after your diagnosis.

Concern: I’m worried that I won’t receive quality care in a cancer clinical trial.
The Truth: Many procedures are in place to help you receive quality care in a cancer clinical trial.

Concern: People might access private information about me if I participate.
The Truth: In nearly all cancer clinical trials, patients are identified by codes so that their privacy is protected throughout and after the study.

Concern: I’m afraid that my health insurance will not help with the costs of a cancer clinical trial.
The Truth: Many costs are covered by insurance companies and the study sponsor, and financial support is often available to help with other expenses; talk to your doctor to understand what costs you could be responsible for.

Concern: Informed consent only protects researchers and doctors, not patients.
The Truth: Informed consent is a full explanation of the trial that includes a statement that the study involves research and is voluntary, and explanations of the possible risks, the possible benefits, how your medical information may be used, and more. Informed consent does not require you to give up your right to protection if the medical team is negligent or does something wrong.

Concern: I’m afraid that once I join a cancer clinical trial, there’s no way out.
The Truth: You have the right to refuse treatment in a cancer clinical trial or to stop treatment at any time without penalty

Learn more about clinical trials.

 

Think all breast cancers are the same? Think again.

MyLifeLine.org brings you this resource in partnership with Genomic Health.

oncotype-dx

Women facing the difficult decision of whether or not to undergo chemotherapy for their early-stage breast cancer can now make their choice with added confidence, according to new clinical results published in the New England Journal of Medicine.  These results provide strong evidence that the Oncotype DX breast cancer test can be used effectively to help doctors determine a woman’s risk of her breast cancer returning (recurrence), as well as how likely she is to benefit from chemotherapy after breast cancer surgery.

The results were obtained from a unique clinical study, known as TAILORx (Trial Assigning Individualized Options for Treatment (Rx)) in more than 10,000 women with early-stage breast cancer, making it one of the largest-ever trials to look at the impact of breast cancer treatment options following surgery.   Each participant in the study was first tested with the Oncotype DX breast cancer assay, a genomic test that looks at 21 genes in a woman’s individual tumor.  Based on the results of that test, each patient received a personalized Recurrence Score indicating the risk of her breast cancer returning.  Using her Recurrence Score as a guide, each woman was then assigned to receive either hormone therapy alone, or hormone therapy plus chemotherapy.

According to initial TAILORx trial results, 1,626 of the 10,253 study participants had an Oncotype DX Recurrence Score of 10 or less and were assigned to receive hormone therapy alone without chemotherapy.  After five years, 99.3% of these women were free of breast cancer recurrence, providing compelling evidence that future breast cancer patients with a low Recurrence Score may skip chemotherapy and its challenging side effects, and instead choose to receive hormone therapy alone.

The large multi-center TAILORx trial is the first trial of its kind evaluating a multigene test, in which patients with early-stage breast cancer were uniformly treated based on their test results and then followed over time to determine how well the test predicted patient outcomes.  This trial design, known as a prospective study, was developed with the input of patient advocates, among others.

“Any patient who is considering chemotherapy should not make this decision without having the results of this test, because if the Recurrence Score is low, the risk of recurrence is very low,” concluded the lead author of the study, Joseph A. Sparano, M.D., vice chairman of medical oncology at the Montefiore Einstein Center for Cancer Care.

Further confirming that Oncotype DX accurately predicts patient outcomes in early-stage breast cancer are “big data” insights provided through a collaboration with the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI), the premier source of cancer statistics in the U.S. According to a SEER study with more than 44,500 patients, patients with an Oncotype DX Recurrence Score under 18 had excellent breast cancer survival.  The findings show that breast cancer mortality at five years was less than half a percent in patients with node-negative breast cancer and less than one percent in patients with node-positive breast cancer.

The SEER results also revealed significant differences in Oncotype DX testing and outcomes, based on patient age and geographical location. These insights are important, since more than half of the eligible 140,000 patients in the U.S still do not receive an Oncotype DX Recurrence Score when making their critical chemotherapy decision. Additional information from the SEER study is expected later in 2016, as part of Genomic Health’s effort to expand patient access to this valuable test.

Click here to learn more about the TAILORx trial.

Click here to learn more about the Oncotype DX breast cancer test.

After You Hear It’s Cancer: The Unexpected Journey

This is a guest blog post by John Leifer from After You Hear It’s Cancer. Leifer has spent more than 30 years in the health care industry as a senior health care executive, consultant, academician and writer.

after-you-hear-its-cancer

As the spouse of a radiation oncologist, our dinner table conversations often focus on the trials and tribulations of my wife’s patients. Somehow it seems cathartic for Lori to share her patients’ angst – like a long sigh that carries away the collective stress of watching people struggle with their journeys through cancer. Yet, throughout these discussions, rarely did we discuss the possibility that we, too, might be forced to embark on such a journey. Then came Easter 2013, a day that changed our lives.

Easter is a particular sacred and treasured day for my wife who embraces the message that “the worst thing is not the last thing,” and has tremendous faith in the resurrection. That night, three years ago, I had slipped into bed while Lori took a quick shower. Half asleep by the time she joined me, I was suddenly jolted awake by her quiet sobbing. My normally stoic wife was in distress, and I had no clue as to why.

“I found a two-centimeter lesion in my breast. It’s cancer,” Lori said as though reading a pathology report.

I prayed she was wrong.

We awoke numb the next morning, as if fighting off the remnants of a bad dream. But it was no dream, and Lori soon sprang into action — lining up the requisite diagnostic tests to determine our fateful next steps.

After going through a battery of imaging studies, followed by a biopsy, Lori was diagnosed with early-stage breast cancer – and given the option of breast-conserving surgery (a lumpectomy) followed by radiation or a mastectomy.

Though Lori knew that both treatments provided the same statistical probability of cure, she nonetheless struggled with the decision. I realized, then, that if a physician with 25 years of experience treating cancer patients struggled to make the right treatment decision, how extraordinarily difficult it must be for laypeople.

Lori’s lumpectomy appeared to go exactly as planned. After a few hours, the surgeon came out to inform me that he was confident that he’d “gotten it all,” but was careful to advise that cautious optimism was needed until the pathology reports were back. Tears brimmed in my eyes as I heard the news.

The pathologist was shocked when Lori’s tissue samples arrived in her laboratory, for she and Lori were close colleagues. Not wanting Lori to endure the anxiety-ridden wait for results, she worked late into the day to process the slides. Unfortunately, the news was not good.

Not only were the margins (the point at which the surgeon has stopped excising tissue) not clear of tumor cells, but there appeared to be a second type of cancer in Lori’s breast. Lori would need a mastectomy; the only choice was whether it would be bilateral.

Our journey was suddenly more complex, yet Lori came to a decision with relative speed. Because there was lobular cancer in her breast, which is often opaque to diagnostic imaging tests, she did not want to carry the burden of anxiety wondering if another cancer would appear in her other breast.

Recovery from her bilateral mastectomies and reconstruction was a slow and painful process. We were incredibly grateful that her sister, Janet, a nurse at Duke, flew in to aid with her post-surgical care. It would take months, but eventually my energetic, beautiful wife would re-emerge.

There was one, powerful change, however. Though always compassionate, Lori had acquired a new-found empathy for her patients. The arduous nature of the journey was no longer a concept in her mind…it was something she had embarked upon and was surviving.

Our shared journey was a major impetus for writing After You Hear It’s Cancer: A Guide to Surviving the Difficult Journey Ahead. I wanted to do my part to help make this extraordinarily difficult time in patients’ lives, and the lives of their loved ones, a bit easier. Lori served as my clinical consultant on the book.

Our journey does not stop with the book. Today, we are exploring additional ways to help patients and their loved ones understand the twists and turns of the difficult journey through cancer, and how to make truly informed and collaborative decisions with their physicians that incorporate their personal values.

There are no short-cuts on the journey through cancer, but there are ways to make it more tolerable. Our commitment is to help identify them, and share them with those that must follow this life-changing and often unpredictable path.

John LeiferAbout the author: John Leifer, MAPP, has spent more than 30 years in the health care industry as a senior health care executive, consultant, academician and writer. An outspoken advocate for patients’ rights, he has published widely on the need for patients to receive appropriate, safe, effective care.

Lori Lindstrom Leifer, M.D., is a cancer survivor and Assistant Clinical Professor of Radiation at Oncology at the University of Kansas School of Medicine.

For more information, visit: www.afteryouhearitscancer.com or e-mail jleifer@leifer.com