Any patient with metastatic breast cancer (MBC) will be familiar with the concept of ‘treatment lines’. Unlike primary breast cancer, where you undergo chemotherapy for a fixed time period, after diagnosis with metastatic disease you will usually be offered treatment that will continue indefinitely…until it stops working. This is your first treatment line. You’ll be monitored with regular scans and when they show that the cancer is growing, you’ll be switched to the next treatment line and so on and so on….until you run out of options.
Treatment lines are useful as they guide oncologists treating metastatic breast cancer, but they can be overly restrictive, meaning that patients can run the risk of being denied a treatment on the NHS because of a previous drug they have received, or because their treatments have been in the ‘wrong order’
Take Herceptin (trastuzamab), for example. Herceptin was the first ever targeted therapy for HER2-positive breast cancer and has been approved for over twenty years. It’s safe and effective and extends the life of MBC patients. The NHS does not currently offer Herceptin alongside chemotherapy once patients reach their fifth or later line of treatment for HER2+ MBC. However, there is evidence that continuing to add Herceptin to chemotherapy can be beneficial to patients during later treatment lines, although more data is needed. In the USA in the past 10 years, over 2 million patients have had access to this drug, including on later lines of treatment. Herceptin is widely used as the SOC – Standard of Care – treatment “arm” in clinical trials. So, patients who have had many lines of treatment will be offered Herceptin in clinical trials in combination with various different drugs.
There are also disparities between access for private and NHS patients and across countries: England, Wales, Scotland and Northern Ireland. Private patients are able to access Herceptin at later lines while some UK trusts provide it through local funding arrangements (Robinson 2020).
We need an urgent review by NICE for this unmet need for Herceptin for fifth and subsequent lines. However, the manufacturer of Herceptin, Roche, has no incentive to request a Rapid Review for a now off-patent drug. There is a lack of access to data to request a review by NICE (overwhelming data does exist from several source points from many clinical trials for HER2+ patients). We are told that not enough data exists, but there is a wealth of data from private healthcare, other countries and clinical trials. NICE has not reviewed the data on Herceptin since 2002 and many things have changed with new advances, but the drug is still very relevant in HER2+ MBC patients
Is the NHS here to improve survival for MBC patients? There are many similar issues with other cancers like bowel, lung and prostate. And it’s not just Herceptin. Restrictive treatment lines mean that patients are progressed and pushed through lines of treatment to an earlier death instead of looking at being on a drug that can support survival and outcome (and having surgery or radiotherapy or other treatment in addition to any line of drug.) We need rigid lines of treatment to be quashed. Oncologists are the clinical EXPERTS but need “guidance”.
MBC patients have a median life expectancy of 2-5 years. That’s a death sentence. BUT we know if all these things are applied correctly our lives CAN be extended. It feels in the UK like we are NOT keeping up with new drugs and technologies that are there to extend lives and that should be the primary focus. SMBC is the biggest killer of women from the age of 35 – 64 (ONS nomis data).
We need change for all MBC patients.
Who Really Cares?
Jo Taylor
References
Trastuzumab Beyond Progression in Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: UK Practice now and in the Future
Robinson, T. et al.
Clinical Oncology, Volume 32, Issue 10, 636 – 638
Swain, S.M., Shastry, M. & Hamilton, E. Targeting HER2-positive breast cancer: advances and future directions. Nat Rev Drug Discov 22, 101–126 (2023) https://doi.org/10.1038/s41573-022-00579-0