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The following is issued on behalf of the Hospital Authority:
The spokesperson for the New Territories West Cluster today (May 3) made the following announcement regarding the review of pathological test results involving a group of breast cancer patients:
The New Territories West Cluster provides the Human Epidermal Growth Factor Receptor 2 (HER2) immunohistochemcial stain (IHC) test on breast cancer tissue for patients diagnosed with breast cancer to ascertain the presence of overexpression of the HER2 in the tumour. If the IHC test is strongly positive (indicates that the HER2 is overexpressed), doctors would consider prescribing the targeted therapy drug Trastuzumab in addition to the conventional treatment. The literature and clinical data show that overexpression of HER2 is found in 20 to 25 per cent of all breast cancer patients.
A regular audit conducted early this year by the Cluster Pathology Department revealed that the percentage of "strongly positive" results of the HER2 IHC test conducted in 2012 was higher than the figures of previous years. An investigation was conducted and the Pathology Department found that it was due to the clinical judgement and inclination of a specialist pathologist who interpreted the test results as "strongly positive" during this examination. The Department reviewed the HER2 IHC results of 49 breast cancer patients who have received the Trastuzumab treatment last year, and confirmed that the "breast cancer HER2 status" of 18 patients was not overexpressed (i.e. not reaching the level of "strongly positive") and hence would not be indicated for the targeted therapy as a supplementary treatment.
The Cluster has contacted the patients involved and deployed specialists to follow up on their conditions and adjusted their treatment plans accordingly. Medical examination confirmed that the patients' conditions have not been adversely affected by this incident, and the patients have shown their understanding. The hospital has explained the incident and apologised to the patients. The Cluster has promptly conducted a review of the HER2 test procedures, and enhanced supervision and audits.
The Cluster has notified the Hospital Authority Head Office via the Advanced Incident Reporting System.
Ends/Friday, May 3, 2013
Issued at HKT 18:26
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