SINGAPORE - About 90 breast cancer patients may have received unnecessary treatment since 2012 due to inaccurate test results, Khoo Teck Puat Hospital (KTPH) said on Friday (Dec 11).
Side effects from the drug given to the affected patients may include diarrhoea, chills and fever. In about 3 per cent to 4 per cent of cases, patients may also experience heart problems.
The Ministry of Health said on Friday that it takes a serious view of the incident and has requested the hospital review other laboratory protocols beyond those for the affected tests as a safety precaution.
It added that KTPH is subject to regulations for private hospitals and medical clinics which ensure its facilities and processes to resolve laboratory issues are in place.
"Appropriate enforcement action will be taken if a breach of protocol is found," said the ministry.
In an earlier statement on Friday, KTPH said it estimated 180 patients may have got the wrong test results. Preliminary investigations suggest an incorrect staining process for the human epidermal growth factor receptor 2 (HER2) test was the cause.
The HER2 test is used to determine how aggressive the breast cancer is likely to be so that medical practitioners can prescribe the right treatment for patients.
Since the issue with the test was discovered, the hospital said it has identified all affected patients, and their samples dating back to 2012 have been sent to various external laboratories to expedite re-testing.
As some of the re-test results return, the hospital has begun reaching out personally to patients and their treating oncologists to offer support. This process of contacting patients is still ongoing.
To ensure patient safety, the hospital has stopped in-house HER2 testing in its laboratory.
KTPH said it reported the incident to National Healthcare Group (NHG) on Nov 22, and to the Health Ministry on Nov 24. Since then, NHG has convened an independent review committee, which includes external experts, to do a thorough review of how the incident occurred to improve the process and prevent a recurrence of similar incidents.
Said Mrs Chew Kwee Tiang, chief executive of KTPH: "I would like to convey my deepest apologies to all the affected patients, their families and their treating oncologists.
"I am very sorry that they have to go through this. We will provide all the necessary support and assistance, and will do our best to take care of them."
Associate Professor Rebecca Dent, who heads the medical oncology division at the National Cancer Centre Singapore, told The Straits Times that the affected patients were "over-treated", but this should not affect their outcomes or prognosis.
She said the side effects of the drug used are temporary and reversible. The patients would have been monitored and any who experienced more severe side effects affecting heart function would have been referred to a cardiologist.
While the affected samples date back to 2012, Prof Dent said no patient would be given HER2-directed therapy for an eight-year period.
She added: "HER2-directed therapy is typically given for a total duration of one year in non-metastatic breast cancer and in certain situations of high-risk disease, patients may be treated with extended HER2-directed therapy for up to two years."
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Additional reporting by Prisca Ang
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