Referral to Oncology:
18. Mr E says the Trust delayed referring his wife to the oncology team. He says the consultant urologist said he would refer his wife to oncology on 14 July, but there was a delay in actioning this.
19. The Trust says the consultant urologist sent a referral to the oncology team based at the Freeman Hospital in Newcastle to ask them to consider systemic anti-cancer therapy. It says this appointment was cancelled, and the referral was redirected to the melanoma team after the biopsy results had unexpectedly shown metastatic melanoma (spread of skin cancer).
20. Paragraph 15 of GMC Good Medical Practice says; ‘you must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must …refer a patient to another practitioner when this serves the patient’s needs’.
21. After speaking with Mrs E on 1 July and communicating her cancer diagnosis, the notes show the doctor sent an internal urgent cancer referral to the urology team. Clinicians assumed it was most likely a recurrence of metastatic kidney cancer because of Mrs E’s history. The renal multidisciplinary team (MDT) discussed Mrs E’s case on 4 July and planned to biopsy an area of the cancer to confirm the diagnosis.
22. On 14 July, Mrs E attended an outpatient appointment with the consultant urologist, and he advised he would refer her to uro-oncology. There was a delay of two weeks for this referral letter to be typed and sent. Our adviser tells us although there are no formal standards for the turnaround time for urgent letters (such as referrals for a new diagnosis of cancer) it is generally accepted that urgent letters should be typed up and sent out within one to two working days. We can see this did not happen.
23. Mrs E’s biopsy results were available on 2 August. Whilst there was a delay in sending the initial referral letter, our adviser explains an appointment with the uro-oncologist could not have taken place until the results of the biopsy were available in any event. We therefore cannot see any impact because of this initial delay.
24. The urology MDT reviewed Mrs E’s biopsy report on 8 August and because the results unexpectedly showed it was metastatic melanoma and not a recurrence of kidney cancer, they recommended a referral to the melanoma team instead.
25. The Trust sent the referral to the melanoma team at Newcastle on 22 August. The more significant delay of nearly three weeks, was therefore between 2 August when the biopsy result was first available, and 22 August when the referral to the melanoma team was sent. The Trust explain the requesting consultant was on annual leave and away from the hospital when the biopsy results came in. Our adviser tells us there should have been a mechanism in place for urgent results to be reviewed and acted upon during this absence. We consider this is not in line GMC guidance on providing good clinical care.
26. Our adviser explains Mrs E’s admission to hospital between 4 and 6 August was also an opportunity for the Trust to review her liver biopsy results and could have been used to highlight that she was deteriorating rapidly and needed an urgent review by the melanoma oncologists before she became unfit for active treatment. Ultimately the referral to the correct oncology team did not happen until 22 August, despite review of the pathology in the urology MDT on 8 August.
27. We consider the Trust’s delay in actioning Mrs E’s referral to the melanoma team following the results of the biopsy is a failing. We have considered the impact of this delay below.
Impact:
28. Our adviser tells us when the biopsy results were first available, Mrs E was of borderline fitness for active treatment. She may not have agreed to go ahead but it was still an option. When the Trust made the referral, she was no longer fit for active treatment.
29. The notes show clinicians discussed potential treatment options with Mrs E during her hospital admission in August 2022. On 5 August, Mrs E said she would be ‘happy to explore potential palliative options with oncology (such as radiotherapy for pain management) but is not keen to pursue chemotherapy’. Clinicians recorded Mrs E said she would be ‘content to see oncologist to discuss possibility and options of palliative chemotherapy or immunotherapy, as previously very fit - however [Mrs E] is not sure whether she actually wants this or not’.
30. Mrs E had a new diagnosis of metastatic melanoma. Additional genetic testing of the cancer showed no evidence of a BRAF mutation. BRAF mutations are DNA changes in some cancer cells that can be treated with newer targeted therapies. In the absence of a BRAF mutation and with widespread metastatic disease, our adviser explains the only active treatment option for Mrs E would have been immunotherapy.
31. Immunotherapy uses the body’s own immune system to actively seek out and destroy cancer cells. It can be given as a single agent using drugs such as pembrolizumab or nivolumab or as a combination of ipilimumab with nivolumab. In the checkmate 067 clinical trial, about half of the patients treated with ipilimumab and nivolumab remained alive and cancer free at 10 years after diagnosis. However, our adviser explains immunotherapy can also work slowly, and it can take at least three to six months to see any evidence of response. In patients whose disease is rapidly progressing, there may be no clinical benefit from starting it.
32. Immunotherapy also has a high chance of causing treatment-related toxicity (harmful effects) due to over-activation of the immune system, damaging normal organ systems (auto-immune toxicity). There is a 20- 50% chance of a patient experiencing auto-immune toxicity which can potentially cause permanent damage and be life-threatening. Our adviser tells us patients therefore need to have a reasonable performance status prior to starting treatment.
33. Performance status is typically measured by a World Health Organisation (WHO) scale with zero being the most fit and active, and four being patients who are predominantly bed bound due to ill health. To start immunotherapy, patients must be of ‘sufficient performance status’ which usually means between zero and two. On review of Mrs E’s notes, our adviser says she was likely to have had a good enough performance status for immunotherapy in June/July, but this appears to have changed following the first hospital admission for symptom control in August and her performance status was lower.
34. If the Trust had sent the referral to the melanoma team when the biopsy results were first available on 2 August and Mrs E had agreed to start immunotherapy, our adviser says she had a 50-60% chance of responding to it, based on the clinical trial evidence. At best, she may have gone into a prolonged and durable remission with good quality of life. However, given her rapid loss of performance status due to the aggressively progressing disease it is possible she would have continued to deteriorate and not benefitted from it at all. Patients with poor performance status are also more at risk of dying if they develop treatment related auto-immune toxicity.
35. We acknowledge Mrs E was borderline fitness for treatment when the referral ought to have been made following the biopsy results on 2 August. We do not know if Mrs E would have agreed to have the treatment if offered, although the notes suggest she was open to discussing the options. We cannot say with any degree of certainty what the clinical outcome would have been had she chosen to proceed with immunotherapy. As noted above, there were considerable risks, so we cannot say it was more likely than not her outcome would have been better.
36. We consider the delayed referral to oncology was a missed opportunity for Mrs E to make an informed decision about her treatment, while she was still borderline fitness for immunotherapy. The delay also meant Mrs E did not get the opportunity to speak to an oncologist to ask further questions about her condition and prognosis and there was lack of clarity for her and her family about what would happen next. We recognise this caused additional distress to Mr and Mrs E at an already incredibly difficult time. We therefore partly uphold this part of Mr E’s complaint.
Pain relief:
37. Mr E says the Trust did not appropriately treat his wife’s pain when she was in hospital from 4 to 6 August 2022. The Trust say it is sorry if more could have been done to provide Mrs E with appropriate pain relief medication while she waited in the reception area of A&E on 4 August. It says following her admission, clinicians initially prescribed morphine before it was changed to oxycodone because of her renal function. It says the palliative care team were due to review Mrs E again, but she self-discharged from hospital.
38. Paragraph 16 of GMC good medical practice says ‘in providing clinical care you 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 • take all possible steps to alleviate pain and distress whether or not a cure may be possible’
39. The notes show Mrs E attended A&E at approximately 11pm on 4 August. A nurse triaged her at 11:18pm and noted she reported a pain score of 10. A doctor assessed Mrs E at 3:48am and noted she reported increasing right sided abdominal pain, despite taking oxycodone at home. Oxycodone is an opioid drug used to treat severe pain. It can either be prescribed as modified release or immediate release. Modified release medications break down slowly to release the drug content over a long period of time, whereas immediate release medications work quickly over a short period of time. The notes show before this attendance, Mrs E had been taking 5mg modified release oxycodone twice daily at home, with 2.5 - 5mg of immediate release oxycodone as required. This dosage had been insufficient to manage her pain, which is why she went to A&E.
40. Clinicians decided to admit Mrs E to hospital for further review from the pain team. Clinicians gave Mrs E a 3mg dose of morphine at 4:40am. Our adviser explains 5mg of oral oxycodone is equivalent to 5mg morphine. Given 5mg Oxycodone had not been effective in managing Mrs E’s pain at home, this morphine dose is unlikely to have been sufficient to control her pain.
41. We can see clinicians stopped Mrs E’s modified release oxycodone but there was no clear reason for this documented in the notes. Clinicians restarted the immediate oxycodone after the single dose of IV morphine on 4 August. This was only at the same dose as she had been on prior to the admission, which as noted above, had not been enough to manage her pain.
42. Our adviser explains where a dose level is not adequately controlling pain, it is usual to increase both the modified and immediate release medications to improve control. The BNF suggests ‘the initial oral dose is based on previous medication use, pain severity, and other factors (such as the presence of renal or hepatic impairment, increasing age, or frailty).……regular pain management reviews should be undertaken, particularly in the titration phase, and the patient’s dose adjusted until a good balance exists between acceptable pain control and side-effects’.
43. When Mrs E left hospital on 6 August, she was effectively on less pain relief than prior to admission and taking it in a less effective way as she was relying on top up immediate release doses rather than having continuous background pain relief. We note Mrs E chose to self-discharge on 6 August. Our adviser says ideally, Mrs E would have stayed in hospital longer to effectively titrate her pain control and convert her 24-hour overall use into a twice daily modified release dose. As she wished to go home sooner, clinicians should have arranged with either Mrs E’s GP or the community palliative care team to review her dose and adjust accordingly.
44. We consider there are failings in how the Trust managed Mrs E’s pain from 4 to 6 August. The Trust discharged Mrs E on the same level of immediate release oxycodone as when she was admitted with no modified release background pain control and no plan to review pain control in the community. This is not in line with BNF guidance or GMC guidance on providing good clinical care as et out above. Our adviser says this likely led to ongoing sub-optimal pain control for Mrs E. This is likely to have continued up until 8 August, when Mrs E’s daughter contacted the hospital palliative care team and her GP for further advice.
45. Our adviser says it is unlikely the issues around pain control contributed significantly to Mrs E’s clinical deterioration and loss of fitness for active treatment. We appreciate it would have caused Mr E upset and distress to see his wife in so much pain during this time. We therefore partly uphold this part of his complaint.