A molecular test that analyzed a piece of Coree Hanczyk's breast tumour told her something no oncologist in the Canadian health-care system could – she didn't require chemotherapy after all.
And she paid for it out of pocket: Ms. Hanczyk had a chunk of tumour couriered from a Toronto hospital to a California laboratory, where the test cost her $3,776 (U.S.). In so doing, she saved medicare an estimated $10,000 in unnecessary treatment and spared herself such gruelling side effects as nausea and hair loss.
The test, whose analysis of 21 genes can help predict whether a cancer is likely to return within the next decade, represents an emerging field of personalized medicine that is moving at such velocity that sluggish health-care bureaucracies can't keep pace.
“I watched my mom die because of the chemotherapy; it completely shut her body down, organ by organ,” said Ms. Hanczyk, a 45-year-old flight attendant who lives outside Toronto. “… This test has been a godsend to me.”
Each year, more than 12,000 Canadian women find themselves in the same medical grey zone: In cases of small, estrogen-receptor positive tumours, with lymph nodes free of cancer, chemotherapy is beneficial to only a few – but determining who they are is often impossible.
Patients face an agonizing choice: undergo chemotherapy, with its possible side effects of leukemia, neurological damage, infertility and premature menopause, or forgo it altogether and risk a recurrence in the next decade.
Funding the Oncotype DX test is a provincial decision, and oncologists say such approvals – if they do occur – are a year away. So far, 130 Canadian women have paid for the test themselves.
“It's crazy that it's not available,” said Ellen Warner, a medical oncologist at Sunnybrook Health Sciences Centre, who has sent patients to pay for it privately and enrolled others in a clinical trial. “…There's a huge gap between research and implementation.”
It's a different story in the United States. There, the test is funded by most health maintenance organizations and Medicare, a program for those aged 65 and older. Francis Collins, director of the U.S. National Institutes of Health, estimated $100-million (U.S.) will be saved this year in chemotherapy and other health-care costs, given that 50,000 breast cancer patients are expected to undergo the test.
“This study is approved … and we are making clinical decisions based on this test,” Dr. Warner said. “So therefore this test must be considered valid. And if it's valid, it should be funded.”
What the test does is remove the medical guesswork on how best to treat breast cancer patients whose tumours look identical under a microscope but who have wildly different outcomes, despite receiving the same treatment.
The test ascribes a score of 0 to 100 – lower is better – which tells patients the risk of their cancer returning within a decade. Those with a higher score are more likely to benefit from chemotherapy, while those with lower scores will have no need for it.
In Canada, there is a large clinical trial in progress at 22 sites, and 703 Canadian breast cancer patients have enrolled to receive the test, according to Ralph Meyer, director of the National Cancer Institute of Canada clinical trials group.
The trial, part of a wider study enrolling 11,000 people in several countries, has divided patients into three groups: Those with low scores receive only hormone therapy; those with intermediate scores are randomly split, with half undergoing hormone therapy alone and the other half receiving hormone therapy and chemotherapy; those with higher scores all get chemotherapy and hormone therapy.
Although the trial is looking at how to best treat patients who have an intermediate score, Dr. Meyer points out that it is also examining how well the test works overall.
“We may be assuming that it's a done deal, that the biomarker separates people who do well from people who are not going to do well,” he said. “This will confirm whether in fact this is true.”
As for Ms. Hanczyk, a low test score of 13 that she received in September meant no chemotherapy. While she saved the province thousands of dollars, her efforts to get the test's cost reimbursed from her private health insurer have so far proved futile, largely because there is no mechanism for compensation.
“It was the best money I spent,” Ms. Hanczyk said. “But I still don't think it's right that I can't get any of it back.”