Unnecessary treatment for breast cancer patients at KTPH due to inaccurate test results

Logo of Khoo Teck Puat Hospital. (Yahoo News Singapore file photo)
Logo of Khoo Teck Puat Hospital. (Yahoo News Singapore file photo)

SINGAPORE — An estimated 180 patients may have been affected by inaccurate results produced by a test for breast cancer patients at Khoo Teck Puat Hospital (KTPH) since 2012, which may have resulted in half of them receiving unnecessary treatment.

The hospital on Friday (11 December) said it was informed by its laboratory on 19 November that its immunohistochemistry (IHC) human epidermal growth factor receptor 2 (HER2) tests were producing higher-than-expected rates of positive results.

Preliminary investigations by the laboratory suggested that the incorrect staining process for the test had produced inaccurate HER2 results.

The IHC HER2 test is conducted on breast cancer patients to help guide treatment and does not diagnose whether a person has cancer.

The tissue sample from the patient is “stained” with antibodies that have a coloured dye, which attach themselves to HER2 proteins.

Re-classified from HER2 positive to HER2 negative

Based on initial estimates, about 180 breast cancer patients may be re-classified from HER2 positive to HER2 negative, said the hospital. Of this, about half of these patients may have received unnecessary treatment for HER2, usually the drug Herceptin (Trastuzumab).

Its common side-effects include diarrhoea, chills and fever. About three to four per cent of those who undergo the treatment may also experience heart problems.

The treatment regime of affected patients will be reviewed by their oncologists, said the KTPH.

“Since the issue was discovered, the hospital has investigated the extent of the issue and identified all the affected patients. Their samples, dating back to 2012 when HER2 testing first started in KTPH, have all been sent to various external laboratories to expedite re-testing for HER2,” it added.

As some of the re-test results return, the hospital has begun reaching out personally to patients and their treating oncologists to offer support. The process of contacting patients is still ongoing.

CEO conveys ‘deepest apologies’

To ensure patient safety, the hospital’s laboratory has ceased in-house IHC HER2 testing.

The hospital said that it reported the incident to the National Healthcare Group (NHG) on 22 November, and to the Ministry of Health (MOH) two days later.

The 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 recurrence of similar incidents.

“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,” said KTPH chief executive officer Chew Kwee Tiang.

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