‘‘You have breast cancer.” For a woman sitting in a doctor’s office, receiving that news may have once seemed like a death sentence. In developed economies, particularly in the UK, that news is being delivered with increasing frequency. The incidence of breast cancer is rising, even in younger women, although this may simply be because the screening process is more thorough.

But there is good news: deaths from breast cancer are going down. Early detection not only increases the odds of survival, it also puts more tools in the hands of the patient and her doctor.

It doesn’t seem that long ago that cancer patients had few therapeutic options, none of which could discriminate healthy from cancerous cells. Chemotherapy was developed in the 1940s by the United States Department of Defense after autopsies showed that people exposed to certain chemical warfare agents had suppressed white blood cells. Those same chemicals were administered to people with advanced lymphomas and their health improved, but at a cost. Chemotherapy worked by killing all cells and the hope was that the patient would survive the poisoning, but the tumour would die.

Radiotherapy uses ionised radiation to kill cancer cells, but it too kills healthy cells as well as those of malignant tumours. Surgical treatment meant a radical mastectomy – the complete removal of the breast. In some cases where a family history of breast cancer exists, women may have been encouraged to have radical mastectomies on both sides to reduce the chance of breast cancer.

Thankfully, the intervening years have made treatment more bearable for breast cancer patients. Hormone therapy (also used for men in cases of prostate cancer) can be used to deal with certain types of breast cancers that rely on hormones to grow. The prevalence of a mastectomy as a means of treatment seems to be receding, thanks in part to better diagnoses and knowledge. Of particular interest is the development of a new class of cancer-fighting drug, known as biological therapy.

Rather than trying to poison or remove a large number of cells, in the process damaging healthy cells as well as cancerous cells, biological therapy allow doctors to target and kill cancer cells with much greater accuracy, and less damage to a patient. They also present new options to prevent a recurrence of breast cancer, and for complementing new versions of the original treatments.

“Drug developers are getting smarter at killing cancerous cells specifically,” says Leah Krukowski, Head of European Tandem Oncology Monitor for Synovate Healthcare. “Biological therapies are starting to come into their own since the launch of Herceptin nearly ten years ago.”

Herceptin (generic name: trastuzumab), was developed in 1998 by pharmaceutical firm Genentech, a company now owned by Swiss drug giant Hoffmann-La Roche. The drug works by attaching itself to HER-2, a specific type of protein that is related to cell growth. HER-2 is found to be overproduced in roughly 30% of breast cancer tumours. When Herceptin is ingested, it interferes with the tumours’ cell reproduction, reducing the chance of recurrence. Usually Herceptin is used in tandem with more traditional chemotherapies for greatest effect.

Since Herceptin was introduced to the market, Roche has become the recognised leader in the field of biological therapies for cancer, according to Krukowski. Roche currently has four tumour-fighting biological agents in the market.

Herceptin and other biological therapies have been a big financial success for Roche. Initially only designated for late-stage breast cancer treatment, Herceptin was later given fast-track approval for use on patients with early-stage breast cancer in the UK by the National Institute for Health and Clinical Excellence (NICE), which supplies the UK National Health Service (NHS) with guidance on medicines and usage. After protests by women with breast cancer, the British government agreed that Herceptin should be covered by the NHS – a critical step considering that one year of treatment with Herceptin costs US$40,000.

And while Herceptin has been shown to be effective in preventing the recurrence of breast cancer tumours, there have been some accusations in the media that NICE was pushed too quickly into approving it for use in early stage breast cancer treatment.

However, the potential for financial growth is there. Not only are incidence rates of breast cancer rising in the UK, the incidence of cancer in the EU is expected to rise as the population continues to age. A study conducted for the Annals of Oncology, a medical research journal, showed that the number of new cancer cases in the EU rose from 2.9 million in 2004 to 3.2 million in 2006.  

The promise of a new line of cancer treatments for an ageing population with ready access to state-sponsored health plans must be tempting, and pharmaceutical firms are trying to move into the field. GlaxoSmithkline is putting its own horse in the race with the soon-to-be launched Tykerb, a drug that “promises to be a next generation version of Herceptin,” according to Krukowski.

Tykerb is in last-stage trials now and industry-watchers are expecting big things. One analyst at Collins Stewart, a stockbroker and corporate finance firm, thinks sales of Tykerb could reach nearly US$2 billion per year, primarily due to the requirements of breast cancer patients, according to a report in the Daily Telegraph. Other experts expect sales revenue in the range of $1 billion. On 14 March, the US Food and Drug Administration approved Tykerb, and a decision from European regulators is expected in September.

Another aspect behind the development of high-cost cancer fighting drugs is the fact that many biological therapies that were originally intended for a very specific purpose are being used for other cancers as well. With Herceptin, the original use was to help patients with late-stage breast cancer from having their tumours progress further. That was extended to treat early stage breast cancer. Another biological drug, Avastin, which was intended as a treatment for colorectal cancer, is in clinical trials for use against lung and breast cancer. Approval is expected.

“Extending the use of these drugs to cover other areas of cancer continues to help fund the research and development process,” Krukowski says.

It all adds up to a promising future for cancer patients, and particularly those dealing with breast cancer. The range of options means that treatment for cancer is moving away from the all-or-nothing struggle to beat cancer and towards “maintenance therapy”, as Krukowski describes it. Even chemotherapy, which began with chemical warfare experiments, has been moving towards a quality-of-life focus for patients, with greater care for the side effects.

Certainly there is much that remains to be done, and there will be cost issues down the road – biological therapies are not cheap. But competition plus demand should bring costs down. Which means that in the near future, women who receive the news that they have breast cancer will not automatically think it’s the beginning of the end, but the end of the beginning.

Types of biological therapies
There are several types of drugs that are defined as biological therapy:

• Monoclonal antibodies: These are proteins that are made from a single human antibody. They are designed to identify and kill cancer cells, just as immune system proteins would. Herceptin is an example.
• Cancer vaccines: Still at very early stages of research, cancer vaccines work by causing the body with a cancerous tumour to improve its own defenses, rather than by preventing a cancer from occurring, as happens with a normal vaccine.
• Growth factors: These are natural substances that are produced in a lab and cause the bone marrow to make red, white or stem cells in the blood.
• Cancer growth blockers: This type of drug takes advantage of the substances that cells use to signal one another. These signals control the growth and multiplication of cells, and by blocking those signals these drugs can arrest the growth of tumours. Glivec (US: Gleevec), which is a Novartis drug and designed to stop gastrointestinal tumours, is a cancer growth blocker.
• Anti-angiogenesis treatments: Just like any healthy organism, cancerous tumours need to grow new blood vessels as they increase in size. Anti-angiogenesis treatments (angiogenesis means to grow blood vessels) prevent cancer growth by stopping new blood vessels in tumours from forming.