Herceptin is the amazingly successful breast cancer prescription. However at the height of its renown the drug is being asked some searching questions by the medical community and the answers could have a major impact on the profits of ‘Big Pharma’ and the shareholder earnings. The key question is; just how long should a course of Herceptin be?
The current standard course of Herceptin is 12 months and the results of two eagerly awaited studies seem to say that neither the shorter nor the longer course gives any advantages in terms of cancer returning. Big sighs of relief all round for everyone at Roche, the drug’s manufacturer and patent holder. Profits can keep rolling in and dividends keep rolling out to shareholders because there is unlikely to be any change in the demand for the miracle drug. A shortened course of treatment could have cost the company an estimated billion dollars in reduced revenues. Equally, an elongated prescription course could have given a big windfall to the company.
[box type="note"]In America, Herceptin costs around $55,000 per annum at wholesale prices and has worldwide sales of more than five and a half billion dollars. The drug is prescribed to prevent a cancer relapse, or greatly reduce the chances of it re-growing, in women who have had surgery to remove early stage tumors.[/box]
Roche actually funded one of the new studies. Naturally they were keen to know if a 2 year course of Herceptin would be more efficacious than a 1 year course. Unfortunately for them the outcome was that survival rates were unaffected by such a change. The full conclusions of this study were made public at conference held by the recent European Society for Medical Oncology.
While extending the duration of trastuzumab administration to 2 years did not significantly improve outcome compared with 1 year trastuzumab, ongoing trials are testing whether combining trastuzumab with other anti-HER2 agents (for example pertuzumab or lapatinib) might further benefit patients with HER2-positive early breast cancer.
Simultaneously the French National Cancer Institute researched and experimented on the premise that perhaps a 6 month course of Herceptin would be a better treatment in terms of extended survival rates post-surgery. If this proved to be the case the government health programs and health insurance companies stood to save a great deal of money by not paying it over to Roche. Patients too might gain by reduced impact on their health of side effects from the drug. Heart problems are known to follow treatment with Herceptin.
Unfortunately the outcome of this study showed that women had a greater risk, twenty eight percent greater, of tumors coming back, than women who stayed the course for a full year. In purely statistical terms it could not be said that a 6 month course was not equivalent to a year but the evidence was not strong enough to change the treatment guidelines at this time.
This is by no means the end of the search for the optimum time period for a course of Herceptin. It is always true that every drug effects every patient in slightly different ways, So certain sub groups of breast cancer patients may well respond better to shorter or longer treatment times. As long as Herceptin is so expensive and the side effects so undesirable, the research into variable course durations will continue, according to the European Oncology Society. But for now there is no doubt that Roche have ‘dodged a bullet’.