Biopsy
9. Mrs A says she believed the Trust had taken a biopsy for FGFR2 genomic testing (this can be crucial for diagnosing and managing certain cancers), but she later found out it had not done so.
10. The Trust have acknowledged it did not do this as it was waiting to see if Mr A would respond to chemotherapy before it would carry out the FGFR2 testing. It explained that due to Mr A’s health it unfortunately did not get to the stage of being able to do the testing.
11. We discussed this with our adviser to see if the Trust acted within guidelines when deciding to not send a biopsy to be tested. Our adviser explained this testing is not about diagnosis but to see if the type of cancer Mr A had might respond to certain targeted treatment. The guidelines relating specifically to this testing and treatment did not become available until August 2021. The NICE guidelines were only approved in August 2021 and the guidelines specific to the Cancer Drug Fund only commenced on 24 September 2021. Sadly, the specific guidelines and approval for use only came into existence after Mr A’s death.
12. This means the testing was not available until after Mr A had deteriorated. This means that the Trust are correct that the test could only have been sent if his condition had improved given it was only available from 25 August 2021.
13. We could not find any evidence that the Trust took a biopsy or sent any away for testing. Based on the date the NICE guideline for suitable testing was available, Mr A would not have been a suitable candidate for the testing as his condition had deteriorated too far by the time that testing and treatment had been approved. It must have been very distressing for Mrs A that her husband died before there had been a chance to explore other options.
Clinical trials
14. Mrs A says they were told Mr A might be eligible for clinical trials, however she later found out that no referral was ever made.
15. We discussed this with our adviser to see if we can say if he was a suitable candidate for trials at the time.
16. We can see no explicit evidence that the Trust did referred Mr A for any clinical trials. It is difficult to say what would have happened had this request been made.
17. GMC guidelines says that in providing clinical doctors must:
• prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs • provide effective treatments based on the best available evidence
18. Our adviser said that at this point in 2021 the majority of trials were of targeted therapies predominantly in London. These were available on failure of chemotherapy not as initial therapy. We are unable to say what national trials would have been explicitly available at the time that would have been suitable for Mr A given he had not completed initial therapy before his condition deteriorated.
19. Our adviser said that based on their experience that Mr A would have likely been too unwell to have been a suitable candidate for clinical trials at the time. As this is the case, we believe that, on the balance of probabilities, Mr A would not have been eligible for any clinical trials at the time. Therefore, GMC guidance did not require the Trust to make the referral. This is based on him starting chemotherapy treatment and his health deteriorating meaning he was too unwell for further chemotherapy treatment. Therefore, the Trust did act in line with the GMC guidelines when providing possible treatments and we could not say there is an indication it failed Mr A on this.
20. We are grateful to Mrs A for telling us about what was clearly an incredibly upsetting situation. We are very sorry for her loss.