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SINGAPORE – A trial for breast cancer patients guiding their treatment options has produced inaccurate positive results at Khoo Teck Puat Hospital (KTPH), causing around 90 patients to receive unnecessary treatments since 2012.
Treatment side effects that affected patients may experience include heart problems, diarrhea, chills, and fever.
KTPH said on Friday (December 11) that it estimates that 180 patients may have obtained incorrect test results. Preliminary research suggests that the cause was an incorrect staining process for the human epidermal growth factor receptor 2 (HER2) test.
The HER2 test is used to determine how aggressive breast cancer can be so that doctors can prescribe the appropriate treatment for patients.
In the test, the patient’s tissue sample is “stained” with antibodies that have a color dye, which binds to HER2 proteins.
Since the problem with the test was discovered, the hospital said it had identified all affected patients and that their samples dating back to 2012 were sent to various outside labs to speed up retesting.
As some of the new test results come back, the hospital has begun to personally reach out 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 internal HER2 testing in its laboratory.
KTPH said it had reported the incident to the National Healthcare Group (NHG) on November 22 and to the Ministry of Health (MOH) on November 24.
Since then, NHG has convened an independent review committee, which includes external experts, to do a comprehensive review of how the incident occurred to improve the process and prevent the recurrence of similar incidents.
Said Ms Chew Kwee Tiang, Executive Director of KTPH: “I would like to convey my deepest apologies to all affected patients, their families and the oncologists treating them. I am very sorry that they have to go through this. We will provide all the support and necessary assistance, and we will do our best to take care of them. “
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