Questioning the accuracy of breast cancer guidelines.

I was diagnosed with breast cancer November 2018. As a scientist active in cancer research for almost 10 years, the reality of statistics entering my personal life hit hard. Pursuing the Anticancer Fund’s mission offering more, and better treatment options is a daily motivator. Confronted with the disease myself, my belief in the need of our organization’s work is stronger than ever.

As an optimist, I also take learnings with me from my hospital trips. The importance of emotional and practical support after a diagnosis is not to be underestimated. I am very grateful for all colleague cancer organizations that focus on this aspect of cancer care. Thank you for your amazing work!

In our own area of expertise, I was confronted with the issue of guidelines, an essential part of evidence-based medicine and a corner stone of the Anticancer Fund's view on treating cancer. As strong guideline-believers, we are also aware of questions around their pace of change. With fast development in oncology, are existing guidelines always reflecting the most recent evidence? Or are they lagging behind? Critics say they do. Is it a matter of speeding up the process or do commercial incentives influence the agenda of guidelines review? Today I say: treatment guidelines do lag behind, as the best treatment for my cancer is a treatment that is not (yet) in the guidelines.

According to the current guidelines, a patient like me with a HER2–positive breast cancer could receive a regimen that contains anthracyclines. Those regimens are effective but known for tolerability risks like hair loss and nausea, heart problems and in some rare cases even leukaemia. Data presented at major meetings over the last 2 years (ASCO, SABCS) demonstrate that for a subgroup of HER2-positive breast cancer patients (those with negative lymph nodes and tumours limited to 2-3 cm), a paclitaxel (Taxol®) – trastuzumab (Herceptin®) regimen, not preceded by anthracyclines, shows a low risk of recurrence and most importantly reduced toxic effects. Leading clinicians suggest this regimen should become the preferred option.

Why is this not happening? Treatment guidelines are determined by experts who have to come to a consensus and apparently this option is not on the table of these groups yet:

• ESMO guidelines (2015): no mention.
• NCCN guidelines: listed as one of the options, particularly interesting in patients who may not be able to tolerate other options.
• St Gallen recommendations (2017): listed as the possible ‘de-escalation’ option but say standard regimen remains the recommended option.

Some experts will argue that a prospective, randomised, de-escalation trial is required for ultimate proof. Obviously such a trial will not be supported by pharma and investigators will need public money and quite some perseverance to execute such a trial because patients and their providers may be unlikely to enrol given the accumulating evidence.

Backed by personal access to the latest data in oncology, I was lucky with my oncologist, aware of the data, supporting the paclitaxel (Taxol®) - trastuzumab (Herceptin®) regimen. Making the best risk/benefit call for every individual patient is of the highest importance. Unfortunately, women with breast cancer like me are in a heavy anthracycline treatment today because guidelines are not up to date. I think this is unfair and it makes me angry.

I am positive about the future. But being treated for cancer is not a walk in the park. It sucks. And therefore, I would like to raise the attention to the crack in the guideline system. The slow updating of evidence not pushed by pharma in treatment guidelines is a knowledge leak and a waste of opportunities to treat patients better. If additional evidence is required to prove patient benefit, public money should be invested in trials. We should look for solutions to keep guidelines truly multidisciplinary, au courant and free from commercial incentives. All cancer professionals should join efforts, keep patients first and discuss and personalise the most relevant treatment for everyone.

This is our moral duty.