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SINGAPORE: Around 90 breast cancer patients may have received “unnecessary treatment” after a test that classifies a patient’s condition produced inaccurate results, Khoo Teck Puat Hospital (KTPH) said on Friday (December 11) .
Around 180 breast cancer patients are estimated to have been incorrectly classified as HER2 positive and may be reclassified as HER2 negative, KTPH said.
HER2, or human epidermal growth factor receptor 2, is a gene that controls how a healthy cell grows, divides, and repairs itself.
According to the Mayo Clinic, HER2 positive breast cancers tend to be more aggressive than other types of breast cancer.
KTPH began screening patients for HER2 in 2012. The test is done to classify a patient’s condition and guide treatment options; it does not diagnose whether a person has cancer.
The hospital said it was informed by its lab on Nov. 19 that its HER2 immunohistochemical (IHC) tests were producing higher-than-expected rates of positive results.
In an IHC HER2 test, a patient’s tissue sample is “stained” with antibodies that have a color tint. These antibodies will bind to HER2 proteins and a doctor will read the slide under a microscope to classify the sample.
Preliminary laboratory investigations suggested that an “incorrect staining process” for the test had produced inaccurate HER2 results, KTPH said.
The hospital reported the incident to the National Healthcare Group (NHG) on November 22 and to the Ministry of Health on November 24.
SAMPLES AFFECTED TO 2012
KTPH said it has investigated the extent of the problem and identified all affected patients since it was discovered.
According to initial estimates, around 180 breast cancer patients can be reclassified from HER2 positive to HER2 negative.
About half of these patients may have received unnecessary treatment for HER2, usually the drug Herceptin.
Common side effects of Herceptin include diarrhea, chills, and fever. About 3 to 4 percent of those who undergo Herceptin treatment may also experience heart problems.
“The treatment regimen of affected patients will be reviewed by their oncologists,” KTPH said.
The patient samples, which date back to 2012, were sent to various external labs to speed up retesting for HER2, KTPH added.
“As some of the new test results come back, the hospital has begun personally reaching out to patients and their treating oncologists to offer support. This process of contacting patients is still ongoing,” he said.
The lab stopped internal IHC HER2 testing to ensure patient safety, the hospital said.
NHG has also convened an independent review committee, which includes outside experts, to do a comprehensive review of how the incident happened. This is to improve the process and prevent similar incidents from happening again.
“I would like to convey my deepest apologies to all affected patients, their families and their treating oncologists,” said Ms Chew Kwee Tiang, Executive Director of KTPH.
“I am very sorry that they have to go through this. We will provide all necessary support and assistance, and we will do everything possible to take care of them.”
He added that KTPH treats this incident “very seriously” and will take all necessary steps to ensure that it does not happen again.
Patients with related inquiries can contact KTPH at 6602 3333.
