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Jill Anzarut in her Toronto home with her husband, Dan, and their two children, Benjamin, 4, and Laila, 2 on March 7, 2011. Jill has breast cancer but has been told that her tumour is too small to qualify for the drug Herceptin, which dramatically reduces the chances of recurrence and death. In some other provinces, including BC she would be approved for the drug.Peter Power/The Globe and Mail

All the best medical advice could not have prepared a 35-year-old breast cancer patient for this: After finding a lump, Jill Anzarut was told her tumour was "too small" to be treated with a drug that can prevent a recurrence, potentially saving her life.

"I feel like I caught my breast cancer too early," said the Toronto mother of two young children, who learned she does not qualify for Herceptin under her provincial medicare plan. "I followed all the rules, I found it early and the answer is: 'Sorry, not big enough.'"

Had Ms. Anzarut delayed treatment until her tumour had more than doubled in size – to greater than one centimetre – Ontario would have financed the $40,000-a-year treatment. British Columbia, Alberta and Saskatchewan all fund Herceptin for smaller tumours.

When used with chemotherapy, Herceptin has been found to halve rates of recurrence within four years of diagnosis for women who have HER-2 (human epidermal growth factor receptor type 2) breast cancer, which affects 20 to 25 per cent of patients.

"It's a difficult situation for us as oncologists," said Philippe Bedard, an oncologist at Princess Margaret Hospital. "...We know patients in Jill's situation are at some degree of risk even with chemotherapy or hormone therapy alone."

For that reason, Dr. Bedard has filed an exceptional access request to the province, hoping it will approve Herceptin for Ms. Anzarut. He estimates about 100 Ontario women each year will be in the same situation.

The exceptional access program is a patient safety valve, with a 12-member committee of doctors, pharmaceutical experts, health economists and members of the public making a decision, in some cases in as little as 72 hours, said Ontario health ministry spokesman Andrew Morrison.

Cancer Care Ontario's vice-president of clinical programs and quality initiatives, Carol Sawka, said the agency's guidelines are based on high-quality scientific evidence and there is no discretion to go outside them. She said the agency is in discussion with government about having a compassionate access review program.

"We administer the publicly funded program for intravenous cancer drugs and it has been set up with the recognition that resources are finite," Dr. Sawka said. "...There will always be circumstances where patients really just don't quite fit an indication."

At issue is the fact that, of the six large clinical trials done on Herceptin, only one included patients with tumours smaller than one centimetre, and the results of that trial have not yet been published. Ontario's medicare program is saying that this means that the evidence so far warrants use of the drug only in patients with tumours of more than one centimetre.

Karen Gelmon, a Vancouver-based medical oncologist, said the BC Cancer Agency pays for the drug to be given to patients with smaller tumours, and Ms. Anzarut, with a 0.5 cm cancer would qualify due to her risk factors, which include her relatively young age, her HER-2 status and the fact that the tumour has invaded blood vessels. She called it "ridiculous" that such a patient would have to pay.

"I think one of the things that has to be stressed is that despite being small, these tumours have a risk of recurrence," Dr. Gelmon said in a telephone interview from Vancouver. "Everybody has to be looked at in terms of recurrence."

Ellen Warner, a medical oncologist at Sunnybrook Health Sciences Centre in Toronto, said she has seen about four patients in the same predicament; most got the drug through private insurance.

Dr. Warner said there is "absolutely no biological rationale" for thinking Herceptin wouldn't work on smaller tumours, especially in younger women with other risk factors.

Dianne Moore, director of the Canadian Breast Cancer Network, a group of breast cancer survivors, said Ontario should re-examine its policy or give "emergency consideration" to Ms. Anzarut's case.

And Rethink Breast Cancer, an organization for women under 40, is posting a letter to the health minister on its website.

As for Ms. Anzarut, she is tweeting about her case. With her chemotherapy starting on Wednesday, she is wondering how to explain her hair loss to son Benjamin, 4, and daughter Laila, 2, and worries about its effect on them.

"I'm feeling anxious, I'm feeling overwhelmed," she said in an interview after picking up a wig. "I don't want to scare them; I don't want to frighten my children."

Tracking tumours

Trastuzumab, known by the trade name Herceptin, is a monoclonal antibody given to women whose tumours express too much HER-2 protein.

HER-2 is a protein marker of a gene that controls how cells grow, divide and repair themselves. Cells that make too much of this protein behave more aggressively, making the cancer more likely to return.

Unlike chemotherapy, which destroys good and bad cells, Herceptin targets the receptor of HER-2 and stops or slows growth of those cells.

It is given intravenously through a vein or port, typically every three weeks for one year.

It is very costly; about $40,000 to $47,000 for a course of treatment.

Lisa Priest

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