Immunotherapy treatment
17. Mrs H complains the Trust did not offer Mr H immunotherapy treatment when his chemotherapy ended.
18. Mr H was diagnosed with grade three transitional cell carcinoma in January 2023. Transitional cell carcinoma is cancer that starts in the bladder, kidney or the tubes that connect the kidney to the bladder. Stage three means the cancer has spread into or through the muscle layer of the bladder. It is also known as muscle invasive bladder cancer.
19. The NICE bladder cancer guidance says adults with newly diagnosed muscle invasive bladder cancer should be offered neoadjuvant chemotherapy before cystectomy. Neoadjuvant chemotherapy is treatment given as a first step to shrink a tumour before the main treatment, usually surgery, is given.
20. A consultant oncologist wrote to Mr H’s GP on 15 February after they met Mr H the previous day. They said they explained he could have a cystectomy, and neoadjuvant chemotherapy had been shown to slightly increase overall survival rate. Mr H was happy to proceed with chemotherapy before a cystectomy.
21. Mr H completed four rounds of chemotherapy; the final round was on 28 March. He met with the consultant oncologist on 24 May, and they wrote to Mr H’s consultant urologist, who would be performing the cystectomy, on 31 May. They said they anticipated seeing Mr H after the operation to discuss immunotherapy.
22. Immunotherapy works by blocking a protein that stops the immune system from working properly and attacking cancer cells. The NICE bladder cancer guidance recommends nivolumab, an immunotherapy drug, as an option for adjuvant treatment (which is treatment given after primary treatments, such as surgery, which aims to reduce the risk of the cancer returning). For patients with muscle-invasive bladder cancer at high risk of recurrence after radical resection, nivolumab is recommended only in adults who have a marker called PD-L1 at a level of 1% or more.
23. Mr H’s bladder was removed in an operation on 2 August.
24. Tumour, Nodes, Metastasis (TNM) is a system for classifying cancer. The system is based on assessing the tumour (T), regional lymph nodes (N), and distant metastasis (M), which is when the tumour spreads beyond regional lymph nodes. A 0 indicates no presence of cancer. We can see from the Trust’s records that Mr H’s pathology results (from samples taken during his surgery) were T0,N0,M0. This means there was no detectable cancer.
25. We looked at this with the help of our oncology adviser. We understand because there was no residual tumour after surgery, there was no tissue to test for PD-L1. In turn this means Mr H was ineligible for immunotherapy because he did not meet the criteria in NICE bladder cancer guidance we have referred to.
26. We cannot see evidence in the Trust’s records that it told Mr H he did not meet the criteria for immunotherapy treatment. However, when Mrs H complained to the Trust on 3 December 2024, she said she had raised the matter at an appointment she attended with Mr H in August or September 2023. She was told Mr H was not suitable for immunotherapy.
27. In its complaint response of 13 May 2025, the Trust said suitability for adjuvant treatment such as immunotherapy post operatively is dependent on what the result of excised cancer tissue sample from surgery is. In Mr H’s case it showed no tumour was present in the bladder or lymph nodes. Eligibility for immunotherapy requires the presence of residual muscle invasive bladder cancer or positive lymph nodes. Mr H had neither of these findings in his tissue sample and therefore did not meet the eligibility criteria for further treatment.
28. We can understand Mrs H’s concerns that Mr H might have missed an opportunity for immunotherapy treatment, which might have prevented his cancer from returning. We hope we can put her mind at rest that he was not offered this treatment because, as the Trust explained in its complaint response, he did not meet the criteria. We can see no indication of a failing by the Trust when it did not offer immunotherapy treatment to Mr H and it acted in line with NICE bladder cancer guidance. For this reason, we will not be looking at this part of Mrs H’s complaint further.
Investigation of symptoms between September 2023 and January 2024
29. Mrs H complains the Trust did not investigate Mr H’s symptoms for recurrence of his cancer between September 2023 and January 2024.
30. We looked at section 15 of the GMP guidance when considering this part of Mrs H’s complaint. It says doctors must: • adequately assess the patient’s conditions • where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary.
31. Mr H had a post-surgery review with the consultant urologist on 19 October. Mr H told them he was feeling: • generally unwell and fairly lousy • considerably more tired than expected • very lethargic with considerable general aches and pains as well as bony pain.
32. The consultant urologist examined Mr H and made a referral for blood samples to be taken and a CT scan to be done to rule out any possible concerns of early cancer reoccurrence. They said they would review him in four weeks with the results of the scan and blood tests.
33. Our oncology adviser explains that the NICE bladder cancer guidance says consideration should be given to monitoring for cancer recurrence six, 12 and 24 months after a cystectomy, by doing a computed tomography (CT) scan.
34. A CT scan was done on 24 October and was forwarded to a urology multi-disciplinary team (MDT) to review. An MDT is a group of healthcare professionals from different specialties who collaborate to discuss and plan a patient's care. The MDT meeting was scheduled for 17 November.
35. With the help of our oncology adviser, we think this is in line with the GMP guidance. We can see the urologist examined Mr H and arranged suitable investigations. We can see no indications of failings by the Trust.
36. Mr H went to the ED on 14 November presenting with symptoms of constipation and overflow diarrhoea for the past six days. Mr H was examined by a doctor who noted Mr H had recently had a CT scan and had not had the results yet. The doctor requested an X-ray and blood tests. The X-ray showed an SBO.
37. The BMJ guidance says SBOs typically present with the combined symptoms of abdominal pain, bloating, vomiting, and failure to pass wind or stool. Diagnosis is generally based upon clinical features and confirmed with a CT scan. Initial treatment is conservative and involves a combination of nasogastric (NG) decompression, where a tube through the nose to the stomach removes air and fluid, and intravenous fluids.
38. The doctor made a referral for a CT scan of Mr H’s abdomen and pelvis in line with this guidance. The CT scan was done the same day and reviewed by a consultant radiologist. They recorded there were features of an SBO at the site of Mr H’s previous surgery.
39. Mr H was admitted to a gastroenterology ward. He was nil by mouth and treated with IV fluids, although it was noted that attempts to insert an NG tube failed. He was discharged home on 17 November after his symptoms resolved.
40. We looked at this admission with the help of our gastroenterology adviser. They explain that SBO is a known complication of cystectomy surgery, caused by adhesions (scar tissue). We think the Trust followed the GMP guidance we have referred to earlier and assessed and examined Mr H and arranged suitable investigations and treatment. It also followed the BMJ guidance to diagnose and treat Mr H’s SBO. We understand from our oncology adviser the CT scan did not show any signs that would have warranted further investigation for cancer.
41. We can see no indications of failings by the Trust in the way it investigated Mr H’s symptoms during this admission.
42. The urology MDT reviewed Mr H’s case on 17 November. It recorded the CT scan of 19 October demonstrated no areas of concern and there was no evidence of disease reoccurrence. The scan demonstrated likely adhesion related SBO.
43. Mr H had now had two CT scans since his surgery. With the help of our oncologist adviser, we think neither raised concerns that Mr H’s cancer had recurred.
44. On 23 November Mr H attended a post operative review with the consultant urologist. They noted Mr H was ‘still struggling to some degree’ although he was opening his bowels and was not vomiting. They told Mr H the latest CT scan did not show any evidence of disease reoccurrence, and it was normal for people to have altered bowel habit for a considerable period after a cystectomy, and to feel very lethargic. This would hopefully settle in time. They would review Mr H again in six months with a repeat CT scan. We can see this review date is in line with the NICE bladder cancer guidance timeframes we referred to earlier.
45. Our gastroenterology adviser explains that altered bowel function is a common short-term and potential long-term consequence of a cystectomy, primarily because a section of the bowel is used to create a urinary diversion, and acts as a channel to divert urine from the kidneys out of the body.
46. Mr H went to the ED on 3 December complaining of worsening nausea, vomiting and constipation. A doctor examined him and recorded his probable diagnosis was an unresolving SBO. The doctor planned to treat Mr H conservatively, specifically nil by mouth, NG tube and with intravenous fluids. They also made a referral for a CT scan, carried out the same day.
47. The CT scan was reviewed by a consultant radiologist on 4 December. Their impression was Mr H had an SBO likely secondary to adhesions.
48. Mr H was admitted to a gastroenterology ward. We can see from the Trust’s records, it treated him for a non-resolving SBO in line with the BMJ guidance we referred to earlier, and Total Parenteral Nutrition (TPN), a method of delivering all essential nutrients directly into the bloodstream via an intravenous line, was started on 14 December.
49. With the help of our gastroenterology adviser, we can see Mr H’s ongoing symptoms, nausea, vomiting and constipation, were in line with his SBO diagnosis.
50. The Trust’s records show Mr H was examined regularly, had regular blood tests, and investigations also included CT scans on 11 and 28 January. The scan on 11 January was requested by the surgical team to look for any mass causing the SBO. A consultant radiologist reviewed the scan and reported it showed an ongoing SBO as demonstrated on the CT scan on 4 December. The scan on 28 January was requested by the colorectal team to rule out any intraabdominal pathology, which means any disease, condition, or abnormality located inside the abdomen. A consultant radiologist reviewed the scan and reported there was an ongoing SBO.
51. Because Mr H’s condition was not improving, a referral was made for a whole-body PET scan to rule out any underlying malignancy. A PET scan highlights areas of high cell activity which can indicate cancer.
52. The PET scan was done on 31 January and reviewed by a consultant radiologist the next day. They recorded the overall appearance was concerning for multifocal tumour deposits in his abdominal wall. This refers to the presence of multiple, separate clusters of cancer cells within the same area.
53. A biopsy of Mr H’s abdominal wall was done on 2 February and on 12 February it was confirmed cancer had spread into Mr H’s abdomen. Specifically, he had metastatic transitional cell carcinoma. This is also known as stage 4 bladder cancer and means the cancer has spread from the urinary tract to other organs.
54. Unfortunately, Mr H was not well enough for any treatment. He sadly died on 24 March.
55. We have explained that between September and January Mr H presented with symptoms of an SBO. We can see the Trust followed the BMJ SBO guidance when it diagnosed and treated him. Our gastroenterology adviser explains that all the CT scans indicated the underlying reason for Mr H’s symptoms was an SBO due to adhesions from his surgery in August.
56. We also discussed this matter in more detail with our oncology adviser. We can see it was reasonable to conclude, given the CT scans, that Mr H’s symptoms between September and January were due to post operative changes. We can see the Trust did four CT scans during that period, which exceeds the amount in the NICE bladder cancer guidance, and none showed any indication of cancer. We can also see the World Journal of Urology study shows the median overall survival rate for stage 4 bladder cancer is around three to six months. Our oncology adviser explains that even if Mr H’s cancer had been diagnosed as early as October any treatment would have been unlikely to change this prognosis.
57. We understand Mrs H’s strength of feeling that the Trust could have investigated and diagnosed Mr H’s symptoms for cancer recurrence earlier. We understand why she thinks this might have meant he could have treatment and his life been extended. We hope we have explained why this is not the case.
58. We think the Trust investigated Mr H’s symptoms in line with GMP, NICE bladder cancer guidance and BMJ guidance and his cancer was identified as early as possible. We cannot see any indications of failings, and we will therefore not look at this matter further. We were very sorry to read of the circumstances of Mrs H’s complaint and the loss of her husband. We hope our explanations have provided some reassurance for her.