Decision to start second line chemotherapy on 13 November 2023 Mr C’s complaint to us:
18. Mr C complains Mrs G was not well enough to start second line chemotherapy. He says she had lost around one stone in weight (6kg) and had eaten very little for three to four weeks. He feels the chemotherapy hastened her death and meant she died in A&E after days of being unwell at home.
19. Mr C has told us a nurse at the Trust weighed Mrs G before starting treatment and confirmed she had lost a stone. He also says Mrs G told the nurse she had been eating very little for several weeks. We cannot see any reference to this in the Trust’s records.
The Trust’s complaint response:
20. The Trust said Mrs G was keen to proceed with second line chemotherapy. It said staff review each patient and their blood results before each chemotherapy cycle to ensure they are fit to proceed. It said Mrs G was deemed fit to proceed in November 2023.
21. The Trust said Mrs G’s notes do not mention weight loss or any concerns about starting treatment. It said the notes say her blood results were reviewed, and doctors gave the go ahead for treatment. It said this indicates there were no indications her blood results showed any cause for concern.
Mrs G’s clinical records:
22. Mrs G was 61.2kg at the start of the first line chemotherapy in October 2022. The Trust then weighed her before each cycle. Her weight fell to 53.6kg in January 2023 before rising to 56.9kg in February 2023. It then ranged between 55.6kg and 57.2kg before rising to 59.9kg in June 2023 and then 64.4kg later that month.
23. We can see no record of Mrs G’s weight after June 2023. The Trust has also been unable to provide us with its ‘Pre Systemic Anti-Cancer Treatment Assessment Form’ for the second line chemotherapy. This document includes a record of the patient’s weight prior to chemotherapy. We have seen this document for the first line chemotherapy.
24. We know from Mr C that district nurses from another NHS Trust were seeing Mrs G at the time, so we requested these records. These say she was 57.1kg in September 2023 (down 7.3kg or 12% since June 2023) and 54.8kg in November 2023 (down 9.6kg or 15% since June 2023). They also say she was eating poorly from August 2023.
25. We can see the notes from A&E in November 2023 say Mrs G looked ‘very fragile’ and ‘emaciated’ (unusually thin or weak usually due to illness or lack of food). Our oncology adviser said it is unlikely she became emaciated within the short time since her appointments earlier that month.
26. Overall, the records we have seen support Mr C’s account to us. These records show Mrs G had lost around 9.6kg (one and a half stone) since the Trust last weighed her in June 2023. This is a loss of 15%. It also appears she had not been eating well since at least August 2023.
What we have found:
27. Our oncology adviser said it is good practice to weigh patients before each cycle. They said a change in weight of 10% or more is a clinical cause for concern. Our chemotherapy adviser also said the Trust should have checked and recorded Mrs G’s weight prior to starting second line chemotherapy. They said a weight loss of 10kg is significant.
28. The local cancer policy says a patient’s weight should be checked and recorded before starting chemotherapy and then checked again at the start of each cycle. Therefore, the lack of a recorded weight for Mrs G prior to starting the second line chemotherapy is not in line with local guidance.
29. Our oncology adviser said, if Mrs G had lost a stone in weight and had eaten very little for three to four weeks, the Trust should have deferred treatment until she was well enough. We have therefore found Mrs G’s treatment should have been delayed due to her poor status at the time.
30. The Trust has also been unable to provide us with a copy of its ‘Oncology Chemotherapy Regimens Request Form’. Again, we have seen this document for the first line chemotherapy. Without this document, we do not have the details of exactly what medication the Trust gave Mrs G in November 2023.
31. However, the notes from the Trust’s later ‘Oncology 30 days Mortality Review Meeting’ in January 2024 say it gave Mrs G an 80% dose of FOLFIRI. Our chemotherapy adviser said an 80% dose could equate to a full dose if it has not been adjusted to account for a patient’s weight loss.
32. Mrs G’s blood tests results show she had a very high C-reactive protein, and a high white blood cell count when the Trust deemed her fit to start treatment in November 2023. Her C-reactive protein was 183 (normal being 0 to 6) and her white blood cell count was 14 (normal being 3.7 to 11.1).
33. These results indicate Mrs G had inflammation in her body. The Trust’s notes say staff reviewed her blood results but there is nothing to suggest they recognised her C-reactive protein and white blood cell count were elevated. This adds to the evidence she was not well enough to start second line chemotherapy.
34. The second line chemotherapy the Trust gave Mrs G is called FOLFIRI. It is a made up of two chemotherapy drugs: fluorouracil and irinotecan. They work together to slow tumour growth.
35. The local chemotherapy policy says irinotecan is not recommended when a patient’s bilirubin is over 51 micromole per litre. Bilirubin is a waste product formed by the breakdown of old red blood cells. High levels usually indicate something is not working as expected in the liver or gallbladder.
36. The EMC’s irinotecan page similarly says patients with bilirubin levels more than three times the upper level of normal (62 micromole per litre), should not be treated with irinotecan.
37. The local chemotherapy policy says to stop or change fluorouracil if bilirubin is over 50 micromole per litre as it may be a sign of disease progression. Both the local chemotherapy policy and the EMC’s fluorouracil page say to reduce the dose of fluorouracil to 50-70% if liver function is impaired.
38. Mrs G’s bilirubin was 67 micromole per litre in November 2023. According to the above guidance, the Trust should not have prescribed irinotecan and gave too high a dose of fluorouracil. Again, the notes say Mrs G’s blood results were reviewed but there is nothing to suggest staff recognised her high bilirubin level.
39. Mrs G’s records show a doctor gave the go ahead for FOLFIRI to start via telephone in November 2023. Our chemotherapy adviser said a doctor should have seen her to decide whether she was well enough to start treatment. We consider this was particularly important in view of Mrs G’s weight loss, poor appetite and blood results.
40. This would have been in line with the NMC professional standards which say nurses must refer matters to colleagues when appropriate. The nurses who saw Mrs G should have asked a doctor to review her. We note the local chemotherapy policy says deteriorating liver function should always be discussed with a consultant.
41. This would also have been in line with the GMC professional standards. These say doctors must adequately assess the patient’s conditions taking into account their history, views and values and, where necessary, examine the patient. They also say doctors must provide or arrange suitable advice, investigations or treatment.
42. The records show the medical team did not plan to see Mrs G again until cycle three of FOLFIRI. Our chemotherapy adviser said this also suggests they were not fully aware of her condition at the time. This supports our thinking that the Trust did not carry out a thorough review of Mrs G’s status before starting treatment.
43. Overall, we recognise Mrs G consented to second line chemotherapy. However, the Trust had a responsibility to ensure she was clinically well enough and provide an appropriate dose. We have found Mrs G was not well enough to start treatment, and the Trust gave her too high a dose based on her blood results at the time. This is a serious failing.
Referral to the palliative care team Mr C’s complaint to us:
44. Mr C says, looking back, there were signs Mrs G was approaching the end of her life. He complains the Trust did not refer her for palliative care and support. He feels her death could have been less painful and distressing had the Trust’s palliative care team been involved.
The Trust’s complaint response:
45. The Trust said an earlier referral would have been challenging as Mr C was not willing to engage in discussions about non-curative treatment. Mr C disputes this. The Trust said its clinical nurse specialists are trained to offer holistic support and refer to palliative care. It said this is based on a needs assessment and when needs increase.
46. The Trust also said training on advanced communication to support managing difficult conversations is due to be provided to staff. It said addressing these conversations at the right time is a must to ensure it manages both the patient’s and family’s anxieties over the diagnosis and treatment plan.
Mrs G’s records:
47. Looking at Mrs G’s records, we can see both her and Mr C initially questioned her cancer diagnosis. She raised concerns with the Trust’s Patient Advice and Laison Service in September 2022. She said the staff who carried out her colonoscopy told her the cancer looked operable, but her consultant then said it was inoperable.
48. The records indicate Mrs G also raised these concerns with her GP. We can see her GP wrote to the Trust about this in September 2022. They also passed on her request for a second opinion. This led the Trust to rediscuss her case in September 2022 and confirm her cancer was inoperable.
49. We cannot see any referral to palliative care or a needs assessment on file. We can see a letter from Mrs G’s consultant to her GP in November 2023. This says the consultant suggested supportive care or second line chemotherapy at the appointment in October 2023. Mr C disputes the consultant offered a referral.
What we have found:
50. Both our advisers said the Trust should have referred Mrs G for palliative care. Our oncology adviser said early input is always advisable and the Trust should have referred her as well as starting chemotherapy. They said it should have ideally done this at the first consultant appointment in September 2022 as they had diagnosed stage four cancer.
51. We agree. Palliative care is a specialised area focused on improving the quality of life of terminally ill patients. It can include addressing emotional, social and spiritual needs as well as helping manage physical symptoms. It is an essential part of patient-centred care and significantly improves the experience of patients and their families.
52. We consider a referral would have been in line with the GMC’s professional standards. This says doctors must refer a patient to another suitably qualified practitioner when this serves their needs. In this case, the Trust had diagnosed Mrs G with an incurable disease, and she therefore needed input from colleagues specialising in palliative care.
53. We also consider it would have been in line with the GMC guidance. This says doctors should consult with other staff who may have relevant knowledge and experience that may help in managing or treating the patient’s condition. It also says doctors must give early consideration to the patient’s palliative care needs.
54. The local cancer policy says the palliative care team provides specialist advice which compliments and does not replace the care provided by the patient’s own clinical team. It also says referrals should be considered for patients and families who are distressed and need specialist support to work through their feelings.
55. We note the Trust says one of the reasons it did not refer Mrs G to its palliative care team was because Mr C did not accept the terminal diagnosis. However, its own policy suggests this is a reason to refer a patient to its palliative care team for more specialist support.
56. Our oncology adviser said a failure to refer patients for palliative care can cause issues particularly as things can move very quickly near the end of a person’s life. They said an early referral also makes the chemotherapy journey easier and allows patients to plan their death ensuring it is more comfortable.
57. The GMC guidance says patients whose death from their current condition is a foreseeable possibility are likely to want the opportunity to decide what arrangements should be made to manage the final stages of their illness. It says these discussions are easier to do in advance than in a time pressured situation.
58. The guidance also says the benefits of advance care planning include ensuring timely access to safe, effective care and continuity in its delivery to meet the patient’s needs. It says misunderstandings and conflict between medical professionals and patients and those close to them can usually be avoided through early, sensitive discussion.
59. Overall, we recognise Mrs G and Mr C did not accept her terminal diagnosis or the Trust’s decision not to operate. However, the Trust failed to refer her for palliative care and support. We have found it should have done this from as early as September 2022. This is a significant failing.
Impact of failings
60. Mr C says the family could have had one more Christmas with Mrs G had the Trust not provided second line chemotherapy. He has also told us Mrs G’s final few weeks could have been more peaceful, and she could have died at home with her loved ones had the Trust referred her to palliative care.
61. Mrs G’s bilirubin was very high prior to starting second line chemotherapy which suggests impaired liver function. The liver clears irinotecan meaning it can build up if the liver is not functioning as it should. This can lead to increased toxicity which can cause life- threatening neutropenia (low neutrophil count), sepsis (a life-threatening condition caused by the body’s extreme response to an infection), severe diarrhoea and multi-organ failure.
62. Our chemotherapy adviser said the blood results from A&E show the Trust gave Mrs G too high a dose. She had a dangerously low white blood cell count of 0.2 (normal being 3.7 to 11.1), a very low neutrophil count (a type of white blood cell) of 0.00 (normal being 1.7 to 7.5), a low platelet count of 54 (normal being 150 to 450) and a high potassium level of 9.4 (normal being 3.5 to 5.3).
63. White blood cells protect the body from infection. A low white blood cell count can indicate a weakened immune system, increasing the risk of infection. Platelets are crucial for blood clotting. A low count can lead to easy bruising and prolonged bleeding. Potassium is an essential mineral. A high level can affect the heart and muscles.
64. We know Mrs G had stage four colorectal cancer with a prognosis of 18-24 months with chemotherapy and less than six months without. This means her deterioration and death were sadly expected and recent scans showed her cancer was progressing. We therefore cannot say her death was avoidable. However, we consider chemo-related toxicity contributed to, or hastened, her death.
65. Looking at the Trust’s records, we can see Mrs G missed appointments due to being unwell with her bowels. Looking at her district nursing records, we can see she felt unwell, had lost weight and was eating poorly during her final weeks. Mr C has also told us how much she struggled with her bowels in the days leading up to her death.
66. We can see Mrs G was taken to the Trust via ambulance in November 2023 after Mr C found her drowsy and unresponsive. She arrived in A&E at 1.36pm and went into cardiac arrest at 2.03pm. A&E staff tried to resuscitate her until they completed a Do Not Attempt Resuscitation (DNAR) at 2.26pm. Mrs G then very sadly died at 2.50pm.
67. We consider the palliative care team could have helped Mrs G manage her ongoing symptoms, discussed what she wanted to happen as her condition deteriorated, and explored putting a DNAR in place. Instead, Mrs G struggled with her symptoms at home and died in A&E with a DNAR being completed while doctors tried to resuscitate her.
68. We consider a referral to palliative care would have more than likely meant Mrs G’s final months could have been more comfortable and less distressing. It is also possible it could have avoided her A&E admission completely. We recognise how distressing the circumstances surrounding Mrs G’s death must have been for her family.