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ASCO: lots of results, but what is important for cancer patients?

ASCO: lots of results, but what is important for cancer patients?

Independent clinical research is mandatory to serve the benefit of the cancer patients

ASCO, the annual congress for cancer research in Chicago just finished. For 5 days, scientists presented the results of research in clinical trials. Some of them sometimes worked years on it. Often, there were interesting methods to be seen to fight cancer. Step by step, the secrets of this horrible disease are discovered. But still we don’t see the results with the patient. It’s time something changes in the perception about cancer treatment. We need to put the patient first again.

No survival benefit

Precision oncology, where a targeted medication is used, would cure the disease better. Would, because pharmaceutical giants like Novartis and Roche presented new clinical data for the drugs ribociclib and taselisib and the results show they halted the growth of the tumor for a couple of months, but they didn’t have any overall survival benefit. Moreover, an increase in side effects resulted in early treatment stop (taselisib was 17% versus 2% in placebo). Interesting results, but not useful when the medication kills both cancer and patient.

This week, it also became clear again that existing drugs are not always used in the best way. An older drug, Herceptin (trastuzumab, a biological targeted therapy, monoclonal antibody), for HER2 positive breast cancer patients) has demonstrated increased overall survival but also an in increase in severe cardiac toxicity. But the drug works, so despite the risk it is used as standard of care the treatment of breast cancer.

Treatment time halved, same effect

These days, ESMO, the European Society for Medical Oncology, advises a one-year treatment with Herceptin. The advice is based on pivotal registration studies provided by Roche, the pharmaceutical company that produces the drug. According to basic economic rules pharmaceutical industry will maximize their revenue by opting for the maximal dose and duration. This week Dr. Helena Earl (University of Cambridge) and her team presented their clinical data on ASCO. The UK team of clinicians and researchers started a clinical trial in 2008 with 4000 breast patients eligible for Herceptin treatment. They wanted to examine if a shorter duration of 6 months could reduce toxicities and cost (cost approx €30.000 per patient) whilst providing similar efficacy. This study was funded by the NIHR (National Institute of Health Research) Health Technology Assesment Programme (HTA). In 2016 they could already demonstate significant fewer cardiac events for the 6 months duration and now at ASCO they demonstrated 6 months of treatment as non-inferior to a one-year treatment. This implies that the cost would be significantly lower, which would not be interesting for Roche.

ESMO can adapt the European guidelines for the use of cancer drugs instantly when new clinical data is available, but up until now nothing has changed. The guidelines are drawn up by a group of expert oncologists and are based on consensus among the experts and should be independent of pharmaceutical industry.

Change needed soon

Clearly, things have to change soon. Patient organisations should push harder for their rights. But even more important is that clinical studies in the oncology field can be conducted independently. The quality of treatments can only become better when the financial return of the treatment becomes of a less important role. Time and a budget have to be made available in order to also research the financially less interesting options. Only then optimal solutions can be found.

Government and philantropy: the solution

We can’t expect that the pharmaceutical industry will change its revenue model. The real change has to come from somewhere else.The cost of cancer treatments can only be compensated by collaboration between governmental and philanthropic organisations who should fund independent clinical trials.

Dr. Earl and her team were supported by the British government, but there are also intitiatives on philanthropic level.

In the USA, key opinion leaders in oncology started a new foundation: It is aiming at determining the optimum treatment regimen of cancer drugs for the benefit of the patient.

Also, the Anticancer Fund is supporting an early clinical trial at the University of Cambridge: PIONEER. It is aiming at added therapeutic value for breast cancer patients, by adding a cheap generic drug to an aromatase inhibitor. The advantage of this type of drug? It already has been tested profoundly on side effects, it is cheap and it can be used immediately, so patients can be treated fast.

This week, the new FP9 program for Research in Europe was announced. We hope it will not only aim at economic (marketing building) outcome, but also be supportive for research for the benefit of the patient.

It is a small start in the mindset to do research in which the patient is put first, but wouldn’t it be great if next year at ASCO more clinical data could be presented resulting from independent research that show added therapeutic value for cancer patients?

Gauthier Bouche

Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund. His efforts are dedicated to collaboration with clinicians, researchers and patients groups to initiate clinical trials. He advocates for more pragmatic trials addressing patients' needs and less curiosity-driven trials.