Melanoma

Oncologist reprimanded over patient’s death from inappropriate immunotherapy


A senior oncologist has been found guilty of professional misconduct for inappropriate use of ipilimumab to treat a patient with melanoma, which a tribunal found ultimately led to their early death from colitis.

Based in Queensland, the oncologist was also criticised for failing to seek an opinion from a gastroenterologist in relation to the patient’s refractory colitis as well as for not requesting  endooscopy.

The specialist had been in practice some three decades when they were investigated by the Medical Board of Australia over their treatment of the patient, commencing in late 2017.

Referred to as PB by the Queensland Civil and Administrative Tribunal, the 76-year old patient first attended the oncologist after having a lesion excised from his scalp by a plastic surgeon, although no sentinel lymph node biopsy was performed.

The tribunal heard that due to the absence of an epidermal deposit, it was unclear whether the excised lesion was a nodular melanoma or a metastatic deposit to the skin.

But as PET and CT scans revealed no radiological evidence of metastatic disease, the patient’s melanoma could be staged as either stage IIB or stage IVa, the tribunal heard.

Nevertheless, the oncologist diagnosed the patient with metastatic melanoma and began immunotherapy treatment with ipilimumab, with PB receiving four doses at a rate of 3mg/kg at 21 day intervals.

Expert witnesses told the hearing that in the face of a clear PET scan, standard practice where there was doubt about the true stage of the excised lesion would have been observation, ie, “watch and wait”.

Asked about this by board investigators, the oncologist said his decision reflected the uncertainty in the histopathology reporting and high-risk features of the lesion and subsequent metastasis, combined with the absence of sentinel lymph node biopsy or primary resection.

He said this gave rise to concerns for the potential of nodal involvement and/or micrometastatic disease.

Therefore, out of an “abundance of caution”, he proceeded at the time on the basis that PB’s presentation represented an in-transit metastasis.

The expert witnesses also told the hearing that adjuvant therapy with ipilimumab was inappropriate because there was no evidence it was of any benefit in a stage IIB melanoma or a resected stage IVa melanoma.

They said if the melanoma was a stage IVa, where adjuvant therapy may assist, single agent nivolumab was superior to single agent ipilimumab and had a better adverse event profile and would have been an accepted standard of care.

Colitis

The tribunal heard that towards the end of his immunotherapy treatment, PB began to experience severe bloody diarrhoea and, while the PET scan following the last of the four ipilimumab doses showed no sign of metastatic disease, it “did indicate colitis”.

In response, the oncologist immediately commenced PB on high-dose oral steroids.

But with no improvement in the diarrhoea after a month later and having 22 bowel movements per day, the oncologist had PB admitted to the private hospital where he was a consultant for treatment with intravenous steroids and fluids.

Discharged 15 days later with continuing loose bowel motions, the patient was unable to walk unaided and had to be taken home by ambulance. He presented to his local public hospital the following month, where he was diagnosed with a perforated viscus and sigmoid colitis.

After being transferred to Princess Alexandra Hospital, PB underwent an exploratory laparotomy, and a sub-total colectomy with formation of a ileostomy on the same day and was then transferred to ICU. He then developed tachycardia and tachypnoea, while his renal function also deteriorated. PB developed Streptococcus constellatus and died on 25 May 2018.

Multiple failures

In a decision handed down last week (link here), QCAT member John Robertson said the oncologist was guilty of “multiple failures”, particularly his decision to initiate immunotherapy.

“Ipilimumab was not the appropriate treatment for the patient given the patient’s melanoma was either a stage IIB or stage IVa; has known side effects due to its high toxicity, including colitis and diarrhoea,” Mr Robertson said.

“The appropriate approach to the patient’s condition was to ‘wait and see’.”

The oncologist admitted to professional misconduct and had already surrendered his medical registration, saying he had no intention of ever returning to practise.

He also accepted his decision-making had been deficient, including by failing to seek other specialist opinions or keep adequate records.

Princess Alexandra Hospital oncologist Associate Professor Victoria Atkinson and executive director of medical services Dr Brian Bell appeared before the tribunal as expert witnesses, as did Dr Benjamin Brady from the Peter MacCallum Centre in Melbourne.

All three said the choice of ipilimumab was not clinically inappropriate, with Dr Brady adding he disagreed with the diagnosis of metastatic melanoma.

He also rejected the proposition that PB had an in-transit metastasis.

Associate Professor Atkinson, an author of the current melanoma therapeutic guidelines, said that ipilimumab was not standard care for a resected stage IIB or stage IVa melanoma.

She noted that the patient’s wife and son related that the respondent had described ipilimumab therapy (when proposed) as being recommended to “mop up any circulating tumour cells”.

Dr Bell added: “We would have expected that he should have had infliximab to prevent progression of colitis. This did not occur and this resulted in the patient having a perforated colon.”

The oncologist’s failure to seek an opinion from a general surgeon or gastroenterologist was also criticised by the expert witnesses, with Dr Brady noting a sigmoidoscopy or colonoscopy was indicated during the patient’s two-week admission for colitis.

Similarly, he noted the oncologist’s clinical notes and discharge letter were at odds with the patient’s condition of ongoing severe colitis and need for ambulance transport.

He said PB’s death was “avoidable and unnecessary”, an opinion shared by Professor Atkinson who said the patient “had at worst, a completely resected stage IVa melanoma and had a very high likelihood that he would be cured from his cancer”.

PB’s death could have been prevented if he had been managed in accordance with the appropriate standards of care for melanoma and colitis, Professor Atkinson concluded.

The tribunal noted the oncologist had engaged with the investigation and already expressed his contrition and deep regret for PB’s death,  and was now permanently retired having voluntarily surrendered his registration. It therefore found no specific deterrence was necessary.

“The parties agree that but for his voluntary cessation of practice in 2019, the seriousness of the conduct would ordinarily warrant the respondent be disqualified from practice for a lengthy period to send an appropriate message of denunciation to the medical profession and the community at large”, the tribunal said.

Nevertheless, the oncologist received a reprimand and would be required to convince the board of his fitness to practice if he ever chose to reapply for registration, according to the judgement.

 

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