13. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong. The reasons for our decision are set out below.
Chemotherapy treatment:
14. Mrs Y says clinicians should have arranged an interpreter for her brother when they were explaining the risks/ benefits of treatment on 5 July to make sure he fully understood, as his first language was not English. She says clinicians did not test Mr B for all DPYD mutations either at the start of treatment or when he started to have a reaction, and they recommended he continue with treatment when he reported having a reaction to it. She also says the oncology team told Mr B to go to A&E at another hospital on 1 August instead of the oncology centre, where he would have received more specialised treatment.
15. The Trust says the clinical team fully considered the decision to start Mr B’s chemotherapy treatment (capecitabine) and they fully consented him and made him aware of the risks. It says the DPYD analysis showed no abnormalities in the four mutations and there was no indication for further screening. It says Mr B was advised to go to A&E on 1 August because of the risk of sepsis.
16. Capecitabine is a chemotherapy drug used for the treatment of different types of cancers. Dihydropyridine dehydrogenase (DYD) is an enzyme that is crucial for breaking down chemotherapy drugs including capecitabine.
17. Before starting treatment, patients should have a blood test to check for the gene mutations (changes) that are most likely to cause low levels of the DPD enzyme. The UK chemotherapy board guidance says, ‘all patients being considered for fluoropyrimidine (i.e. capecitabine, 5-fluorouracil, tegafur) based therapy should undergo pre-treatment pharmacogenomic screening for the four variants of DPYD associated with severe toxicity’. It also states this in the summary of product characteristics. Patients with low DPD enzyme levels can have serious side effects from capecitabine, which can be life threatening.
18. Paragraph 32 of GMC GMP guidance says ‘you must give patients the information they want or need to know in a way they can understand. You should make sure that arrangements are made, wherever possible, to meet patients’ language and communication needs.’
19. The notes show following Mr B’s surgery in May 2022, the hepato-pancreato-biliary (HPB) multidisciplinary team (MDT) discussed Mr B’s care and recommended adjuvant chemotherapy to prevent the risk of recurrence. Adjuvant chemotherapy is given after primary treatment such as surgery.
20. On 5 July 2022, Mr B attended an appointment with the oncology team at the Trust. The oncologist noted they discussed the risks and benefits of chemotherapy with Mr B. They also noted he had good performance status, no issues on the blood tests and was assessed to be suitable for treatment with capecitabine. Mr B signed the consent form agreeing to the treatment. On 12 July 2022, Mr B had a telephone review with an oncologist and the plan was to proceed with treatment. He stared capecitabine on 19 July.
21. We can see clinicians discussed the risks and benefits of this treatment with Mr B before it started. We appreciate Mrs Y says the Trust should have arranged a translator as English was not her brother’s first language. There is no mention in the notes Mr B had any difficulties with either translation or comprehension of the information given, or that he requested any assistance with this. Given this, we cannot say there was any requirement for the Trust to have arranged an interpreter for Mr B and we consider it acted in line with GMC guidance.
22. As noted above, the UK chemotherapy board and the product characteristics says patients should have blood tests for gene changes before starting treatment. Our adviser explains the genetic testing for the four common DYPD mutations is undertaken throughout the NHS as standard procedure and the same testing is carried out throughout the country. We can see the Trust carried out the appropriate tests for Mr B to check for the common DYPD gene mutations before commencing his treatment in line with the guidance. The results came back normal and there was no requirement in the guidance to carry out any further testing. We therefore cannot see an indication the Trust got something wrong here.
23. Individual Trusts have their own protocol for use of chemotherapy agents. The Trust protocol for capecitabine says ‘toxicity due to capecitabine administration may be managed symptomatically and/or modification of the dose (treatment interruption or dose reduction)’. There are different grades of toxicity. Grade zero is where the patient has no symptoms, grade one is mild, grade two is moderate, grade three is severe and grade four is potentially life threatening. When a patient has grade one reaction, the protocol says to maintain the dose.
24. On 27 July 2022, Mr B contacted the acute oncology service (AOS) and advised he had developed a skin rash on his chest and neck, and there were no bowel changes. The clinician recommended antihistamines and cream and to continue with the treatment. Our adviser says this would constitute grade one toxicity (mild). According to the Trust protocol for a grade one toxicity, continuation of treatment would be expected along with symptomatic care, and we cannot see any indication the Trust’s approach was incorrect.
25. Mr B contacted AOS again on 30 July. He reported a low-grade fever and slight increase in bowel frequency but no diarrhoea. The clinician advised to continue treatment and go to A&E if his fever worsened or developed other symptoms. This approach was again in line with the Trust protocol and there was no indication clinicians should have stopped treatment or reduced the dose at this time.
26. On 1 August 2022, Mr B called AOS again and reported worsening diarrhoea, lethargy and a fever. The clinician advised him to stop taking the medication as the reaction was now more serious and to attend A&E urgently. Mr Y attended the A&E department at his local hospital. The local hospital communicated with the AOS and discharged Mr B the following day as his diarrhoea had settled, his temperature was normal and there were no other concerns.
27. Given Mr B’s reported symptoms (including fever) when he called the AOS on 1 August, clinicians were concerned about the risk of sepsis. Sepsis is a life-threatening illness that develops when an existing infection triggers an extreme immune system response in the body, and it is common in immunosuppressed cancer patients receiving treatment, such as Mr B. The national benchmark set out in NICE guideline NG51 is for patients suspected to have sepsis to receive IV antibiotics within one hour of attendance at hospital. Oncology centres typically cover a wide geographic area and therefore the Trust’s advice for Mr B to attend the nearest A&E so he could be seen as quickly as possible was clinically appropriate and in Mr Y’s best interests. We therefore cannot see this is an indication of a failing.
28. We are incredibly sorry Mr B had a rare mutation, and this led to him developing severe toxicity. This was not foreseeable based on the clinical information available to clinicians at the time. We can see clinicians carried out appropriate tests before treatment started and provided appropriate advice when Mr B started to experience a reaction. We cannot see an indication the Trust got something wrong. Our physician adviser tells us if the rare mutation was identified earlier following the commencement of treatment, this would have not made a difference to his management as the mutation cannot be reversed. The treatment would be supportive care, which Mr B received.
Delay with CT scan/ collapse:
29. Mrs Y says the Trust delayed performing a CT scan for her brother following his admission on 4 August and they allowed Mr B to use the toilet unassisted on 8 August and he collapsed.
30. The Trust acknowledge there was a delay in arranging Mr B’s CT scan. It explains one of the hospitals two CT scanners was not in operation at this time. because of technical issues, so only critically unwell patients were being accepted for scans. It says Mr B was clinically stable at this point. It says Mr B was independently mobile and there was no assistance required for mobilising to the toilet.
31. Paragraph 15 of GMC Good Medical Practice Guidance says ‘you must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must:
• adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary.’
32. On 4 August 2022, Mr B attended an appointment at the AOS cancer centre. He reported worsening diarrhoea. The clinical impression was capecitabine induced diarrhoea and clinicians arranged for him to be admitted to specialist oncology ward due to concerns over dehydration. Clinicians referred Mr B for a CT scan on 5 August.
33. On 6 August 2022, the notes show Mr B had diarrhoea, vomiting and persistent hiccups. His stool culture was negative for infection. There was a technical issue with the CT scanner, which meant only critically ill patients were accepted, and clinicians considered Mr B was clinically stable at this time. An X-ray of Mr B’s abdomen on 7 August did not show any definite bowel obstruction.
34. We recognise there was a delay with Mr B having a CT scan. It is difficult for us be critical of the Trust for this, given this was because a piece of equipment had an unplanned fault. Our adviser explains for patients with severe chemotherapy toxicity the management is supportive i.e. fluids and antibiotics ionotropic support if needed. A CT scan result does not alter this fundamental approach. A CT scan can provide useful information that may change subsequent management for example it could identify a bowel perforation. In Mr Y’s case, our adviser says an earlier CT scan would not have made a material difference to the treatment the Trust administered or Mr Y’s sad outcome and the Trust’s prioritisation was appropriate.
35. At around midnight on 8 August 2022, the notes say Mr B got up to use the toilet and became unsteady on his feet. He collapsed, became unresponsive and went into cardiac arrest. CPR was successful and Mr B transferred to the intensive care unit (ICU). A CT scan showed inflammation and dilatation of the bowel and aspiration pneumonia due to vomiting. Our adviser says prior to his sudden unexpected collapse there was no indication from the notes to suggest Mr Y should not have been allowed to use the toilet unassisted on 8 August, given his stable clinical condition at that point. We cannot see Mr B’s collapse was predictable and we do not consider there is any indication clinicians failed to provide appropriate care and treatment to Mr B in line with GMC guidance.
36. Mr B’s condition continued to deteriorate, and he very sadly died at 2:04pm. We are truly sorry to hear about these very sad events. We do not doubt this has been an incredibly upsetting period for Mrs Y and the rest of her family. After considering the available evidence, overall, we cannot see any indication the Trust failed to act in line with the relevant guidance and standards. We hope our decision provides Mrs Y with some reassurance.