Men get breast cancer too. But they don’t always have access to new medicines

Warren Kotler has outlived his prognosis.

Eight years ago, Kotler was told he had three to five years to live. The diagnosis: stage 4 metastatic breast cancer. It is a common disease in women, but rare in men, who make up only one percent of cases.

Kotler, 61, has had a mix of drug treatments and various radiation therapies. His quality of life is excellent, he said: He got married two years ago. He travels frequently. He regularly takes long bike rides.

Still, the Toronto man knows that cancer could eventually outsmart his treatments. The plan he and his medical team developed: “Stay long enough. New drugs are coming and hopefully they’ll work,” Kotler said.

This summer, his oncologist suggested a new drug: capivasertib, sold as Truqap.

Clinical trials suggest the drug, which was approved in Canada in January 2024, can hold back cancer for several months in patients with a type of advanced breast cancer known as HR-positive, HER2-negative. These cancers respond to hormone therapy drugs and do not have abnormal levels of the protein HER2, which can accelerate tumor growth. The drug stops the cancer from growing by blocking AKT, one of the enzymes needed for cell growth.

But Truqap is expensive. Canada’s Drug Agency says it costs about $10,000 for a 28-day supply. And while Kotler can get provincial assistance for some of his other high-priced medications through Ontario’s Trillium Drug Program, Truqap isn’t covered by the program.

Kotler’s medical team has asked the drugmaker to cover the cost of the drug on a compassionate basis through a patient support program the company runs. AstraZeneca said it cannot do that.

The reason? Health Canada has only approved the drug for women.

Too few men in research, says Health Canada

Some other jurisdictions, the United States and the European Union, have approved the use of the drug for both men and women after a clinical trial.

When CBC News asked Health Canada about the decision, the ministry pointed to its Summary of the regulatory decision for the drug, saying that too few men were involved Phase 3 clinical trial: seven of the approximately 700 participants.

In those men, the drug appeared to keep the cancer from getting worse for about two months — compared with about seven months for the overall study population. Health Canada raised concerns about the drug’s toxicity, including side effects such as diarrhea, rash and nausea.

While side effects are a part of many treatments, there is a trade-off between risk and benefit – and whether drugs used in end-stage cancer meaningfully improve survival and quality of life. group of cancer doctors in North America say that drugs with marginal benefits are overused for patients nearing the end of life. They say that ultimately, whether a patient decides whether a drug is worth taking is a very personal choice, and that this is a choice that should only be made after an honest conversation about the reality of what a drug can do.

But the Canadian Medicines Agency, an independent, non-profit organization that provides objective evidence to health care decision-makers, came to a different conclusion than Health Canada in the case of Truqap.

In a refund assessment For Truqap, the expert review committee said the drug should be covered for all adult patients — with conditions. The percentage of men in the study, it said, reflects the rate of breast cancer among men, and because so few men participated in the study, it was impossible to say for sure that the drug would be less effective in male patients.

For Kotler, who is no stranger to the side effects of cancer drugs, it’s about choice.

“In terms of quality of life, I definitely want to make an informed choice,” he said.

“I have no choice with Truqap. It’s not available to me.”

WATCH | Male breast cancer patients struggle with access to medicine:

Access to new treatments for breast cancer is a challenge for some male patients

More than 250 Canadian men are diagnosed with breast cancer each year, but they represent less than one percent of diagnoses and are often left out of clinical trials for new drugs. Now, patients and doctors are calling on Health Canada to update the approval process.

‘It doesn’t make sense,’ says cancer doctor

Dr. Philippe Bedard, Kotler’s oncologist at the Princess Margaret Cancer Centre in Toronto, thinks the drug could be an effective option for some patients like Kotler.

“It’s very frustrating,” he said.

“Historically, men have been excluded from these types of clinical trials that test new drugs. And what we’ve learned is that the disease biology in men and women is really the same.”

Breast cancer is a rare disease among male patients. The Canadian Cancer Society estimates that 290 men will be diagnosed with breast cancer this year and 60 of them will die. By comparison, about 28,000 women in Canada are diagnosed with the disease each year and 5,500 die from the disease.

Because the disease is so rare in men, it can take much longer to collect the same amount of data for male patients as it does for women. In the case of Ibrance, another drug used to treat hormone receptor-positive, HER2-negative breast cancer, Health Canada expanded the drug’s approval for men three years later The drug was approved for women after examining data based on actual use of the drug among male patients.

Dr. Gerald Batist, director of the Segal Cancer Centre at the Jewish General Hospital in Montreal, says regulators should use “common sense and scientific reasoning” in these situations.

“It’s a very unusual cancer in men. But they behave very much like female breast cancer. We treat them very much like female breast cancer. So it doesn’t make sense,” he said.

Batist believes flexibility is warranted in this case, even as Health Canada weighs the risks and benefits.

“There is a lack of data, but I think we have to recognize that there is a small limitation because of the number of incidents of this. We have to look around the world and see other expert panels and regulatory bodies that have approved this drug,” he said.

“They don’t want to expose anyone to unnecessary toxicity. On the other hand, we’re at a point where we want more access to better medicines that help people, and that’s very urgent.”

An urgency that patients like Kotler know all too well.

“I have to keep going. I have a lot to do. I have a long list. I have three children,” he said.