Chemotherapy
16. Mrs E complains the Trust gave Mr E the full dose of chemotherapy medication, instead of 80% as they had agreed with the oncologist on 28 August 2019. She explains she worried that he would be given too much chemotherapy and asked a nurse about this. She said the nurse reassured her that the right dose would be given but this did not happen.
17. The Trust recognised that Mr E was given 100% of the dose of chemotherapy, instead of 80% of the dose as planned. It explained it made an error which meant the pharmacy was not aware the dose had been amended to 80%. The nurses then gave this to Mr E. While the Trust acknowledged there was an error with the dose, it did not agree this would have had any adverse negative impact on Mr E.
18. When Mr E was admitted to hospital on 23 August 2019, the records say he had been vomiting for three weeks. He was taking Levomepromazine which is used to treat nausea in palliative care patients. He was also using a 24hr syringe driver and anti-sickness medication.
19. We asked our adviser what should have happened, to decide whether Mr E should have given chemotherapy at 100% dose on 28 August, and what the impact of this would have been. Our adviser explained that clinicians use a performance status tool to determine physical health and it is an important factor when considering chemotherapy.
20. The ECOG is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. It ranges from zero to five, with zero being fully active and five where a patient has died.
21. Our adviser explained Mr E would have had an ECOG performance status of three at this time because of the infection. This means he would have spent a lot of time in bed or in a chair and would have only limited ability to take care of himself.
22. The NICE guidance says that in cases of locally advanced pancreatic cancer, doctors should offer gemcitabine, a chemotherapy medication, to people who are not well enough to tolerate combination chemotherapy. Combination chemotherapy is the use of more than one medication at a time to treat cancer. The EMC Abraxane (combination chemotherapy) guidance says if a patient’s platelet count is less than 100 the dose should be delayed until they have recovered. If it is less than 50 then the dose needs to be withheld completely.
23. Platelets are small cell fragments in our blood that form clots and stop or prevent bleeding. Mr E’s platelet count was 162 on the 23 August, 90 on the 25 August, 70 on the 26 August, and 78 on the 27 August. Mr E received chemotherapy on 28 August.
24. We can see evidence the Trust treated Mr E for neutropenic sepsis as a side effect of chemotherapy. This is when a person has too few neutrophils, a type of white blood cells, and has a potentially life-threatening infection. The Trust treated him with Tazocin for this.
25. Mr E was taking antibiotics and granulocyte colony-stimulating factor (GCSF) which was used to help him produce white cells to help the infection. This means he was being treated aggressively for an infection.
26. The Trust gave Mr E combination chemotherapy on 28 August. This was not in line with the NICE guidance, which explains Mr E should have received gemcitabine as single dose chemotherapy because he already had an infection.
27. Our adviser also explained that he had gemcitabine, at 1000 mg per metre squared. He should have had 1660mg and he received 1900mg, which we think related to dose banding. If he had 80%, he would have been given 1220mg. This is a significant dose difference for someone who was already unwell.
28. The EMC Abraxane guidance also shows us that Mr E’s platelet count was too low for him to receive combination chemotherapy on 28 August. His platelet count was 78 and it should have been above 100 to receive chemotherapy, in line with the EMC Abraxane. guidance. As a result, his platelet count continued to reduce to a level where he needed a platelet transfusion in the days before he died.
29. Our adviser also explained that as Mr E was so unwell, it is questionable whether he should have received any chemotherapy. We also know he was given a higher dosage of chemotherapy on 28 August. This is not what was agreed with Mr E and should not have happened.
30. It is our view that the Trust should not have given Mr E combination chemotherapy on 28 August. He was clinically unwell, had an infection, and was receiving antibiotics at that time. He took Tazocin on 23 August for four days. He received Piperacillin, used to treat bacterial infections, on 5 September, and then started Tazocin until his death.
31. We have therefore identified failings in the chemotherapy treatment the Trust gave Mr E on 28 August. It did not follow NICE guidance in prescribing chemotherapy treatment. The Trust should have explained that a reduced dose of gemcitabine was available, in line with the NICE guidance.
32. The Trust also did not follow EMC Abraxane guidance as it should have withheld treatment until Mr E’s platelet counts had increased. We checked the medical records and could not find any evidence that the Trust recorded Mr E’s performance status, in line with the ECOG guidance. This is very important when determining if a patient is suitable for chemotherapy treatment. We have considered the impact of the failings we have identified below.
33. The GMC guidance says doctors must work in partnership with patients, sharing with them the information they will need to make decisions about their care.
34. We have also been unable to find documentation of Mr E’s consent to chemotherapy. However, as we have not seen any evidence to indicate Mr E would not have given his consent, we concluded this would not have changed the overall outcome.
Impact
35. We took further advice from our nursing adviser to consider the impact of the failings we have identified.
36. As explained above, we have identified failings in the Trust’s decision to give Mr E combination chemotherapy treatment on 28 August 2019, as he was too unwell to receive this.
37. We considered the likely impact of this. Our adviser explained it is likely Mr E experienced side effects from the chemotherapy and his platelets and white cell count would have decreased. As Mr E already had an underlying infection, this likely worsened, and had the potential for the infection to become life threatening.
38. It is known that combination chemotherapy is more toxic than single agent chemotherapy. Therefore, Mr E would have had more side effects from this rather than having the gemcitabine. Mr E’s platelets dropped to 16 which meant he had a risk of bleeding to death. The Trust gave him a platelet infusion which meant he was in a life-threatening state.
39. We cannot say what Mr E’s ECOG score would have been if he had received gemcitabine alone. We can see his ECOG was already three before he had chemotherapy. If he had been given gemcitabine, then he would likely have still been three, or even four, on the ECOG. However, we can say that his blood count levels and toxicity would have been worse from the combination treatment, compared to single agent gemcitabine.
40. It is very difficult to say how much better Mr E’s condition would have been if he had gemcitabine alone instead of combination chemotherapy. He would have had less blood count toxicity and colitis. This would have meant his overall condition could have been better and he may have been able to go home to attend the family event.
41. We also think it likely that the chemotherapy shortened Mr E’s life. Mr E already had an infection, and treating his cancer so aggressively when he already had an infection likely worsened his condition. We understand that Mr E had terminal cancer so this would not have changed his prognosis.
42. However, we think it is likely he would have lived a little longer. We cannot say how much longer. This means Mr E’s family are left not knowing how much time they lost, and this is an injustice to them. Mr E sadly died 12 days after the chemotherapy.
43. We have therefore seen a profound impact to Mr and Mrs E’s family. We have looked at whether this has been remedied below. Mrs E would like service improvements and a financial remedy. She understands the Trust say they have made service improvements but wants to see evidence of this.
44. We recognise the Trust agrees it should not have given Mr E the 100% dosage of combination chemotherapy on 28 August, and it apologised in its February 2020 complaint response. The Trust also explained it had made some changes to its internal processes to prevent future prescription errors occurring. We are pleased to hear this, as it is in line with our Principles for Remedy.
45. However, the Trust has not recognised that, in line with NICE and EMC Abraxane guidance, Mr E should not have been given combination chemotherapy on 28 August. Therefore, we think the service improvements already made are not enough to prevent future mistakes happening, or to put right the devastating impact to Mr and Mrs E’s family.