Reports & Presentations

Recent media coverage and debate over personalized cancer treatment 7.16.11

Letter from Laura Shawver, Ph.D., founder of The Clearity Foundation

July 10, 2011

To Friends of The Clearity Foundation,

On July 8th, The New York Times published an article by healthcare reporter Gina Kolata, “How Bright Promise in Cancer Testing Fell Apart.” As a cancer survivor and advocate of genomic profiling to inform treatment decisions, I’d like to take this opportunity to share my response to it.

Scientific rigor must be applied to all tests used for clinical trials and patient treatment and we should all be outraged at the poor science and ethics exhibited by the Duke investigators described in the Kolata article. However, we should be equally outraged that diagnostic technologies are not used routinely to improve the likelihood of responses and improve patient care.

No two cancers are the same, and patients need to know that there are often several choices of chemotherapy or drug combinations with different mechanisms of action for their particular cancer. This is especially true for cancer that recurs after primary treatment. Tests can be used to select and prioritize the drugs with the best chance of success. Sadly, for every tragic loss of a patient like Juliet Jacobs, there are thousands of other patients who do not receive personalized diagnostic testing. These patients suffer toxic side effects without therapeutic benefit or die because they are treated with drugs that are not effective for their cancer type.

Treating cancer with a one-size-fits-all approach is doomed to failure. We give credence to the stamp of FDA approval as proof that a drug will give us the best chance at a cure, however the reality is that most FDA-approved cancer drugs benefit only 20 to 25% of patients. So, what is the unlucky 75% to do? Indiscriminately select another approved drug that gives a 25% chance, or perhaps utilize a test that can arguably give much better odds?

I’m an ovarian cancer survivor who has faced those grim odds. I’m also a scientist and entrepreneur knowledgeable about the challenges of personalized diagnostics. The research and clinical work being conducted to illuminate opportunities to personalize cancer treatment is not perfect, but in most cases it is a vast improvement over choosing therapeutic options in the dark.

While the Duke research and clinical trial as well as the OvaSure and OvaCheck diagnostic tests were either released prematurely or based on bad science, these cases are not the norm. We must not allow isolated ethical and scientific lapses to reflect broadly on the field of genomic profiling as it would be a disservice to patients to reject an approach that is saving lives and improving quality of life.

There are several examples of the successful use of genomic profiling in cancer treatment. Currently, women with breast cancer aren’t prescribed anti-estrogens or aromatase inhibitors unless they express the estrogen receptor. Similarly, a test measuring HER2 gene amplification can indicate which women are most likely to respond to the drug Herceptin.

The American Society of Clinical Oncology recently issued a provisional clinical opinion supporting testing for EGFR mutations (for which the tests are not FDA cleared) in patients with lung cancer (J Clin Oncol 29(15) May 20, 2011 p 2121 – 2127). In the same issue of the journal, Drs. Bunn and Doebele of the University of Colorado Cancer Center provided an editorial summarizing various lung cancer clinical trials and noted that patients with EGFR activating mutations (about 15% of patients) treated with EGFR inhibitors had “higher response rates, longer progression-free survival periods, less toxicity, improved symptom control, improved quality of life, and greater convenience compared with cytotoxic chemotherapy.”

I am sorry for the loss of Ms. Jacobs, but all cancer patients, especially those with recurrent disease, should enroll in a clinical trial, even if it means going to another institution for care. To stack the cards in our favor, scientists must develop drugs with companion diagnostics to match the drugs with the patient. To expedite development of companion diagnostics, patients must insist on tumor profiling and participate in clinical trials that measure its predictive value. We as cancer patients cannot clamor for more rapid FDA approval of new drugs and tests without being willing to participate in the clinical trials needed to change clinical practice.

To change the cancer treatment paradigm, we need to empower patients with information and advance the clinical research that will lead to tailored cancer treatments. Rather than fear the prospects of truly personalized cancer treatment, we should re-double our collective efforts to provide validated genomic profiling tests to guide cancer therapy so that, as Ms. Kolata points out, we do not waste time with trial and error.

Laura K. Shawver, PhD

Founder

The Clearity Foundation

Ovarian cancer survivor and advocate