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Clinical and pathological characteristics of patients who received neratinib through managed access program

Neratinib is approved in the extended adjuvant treatment of early HER2 positive breast cancer after one year of trastuzumab therapy and in the treatment of metastatic HER2 positive breast cancer. An analysis of the clinical and pathological characteristics of patients who recevied neratinib through managed access program was performed at the University Hospital Center (UHC) Zagreb. Methods: From November 2018 to October 2020, a total of 49 patients with HER2- positive breast cancer were treated with neratinib at the Department of Oncology, UHC, Zagreb. Among the analyzed patients, 47 (95.9%) were female and 2 (4.1%) were male with median age of 50 years and range from 30 to 75 years. Result: Extended adjuvant neratinib treatment was performed in 42 patients. Of these, 23 were initially treated by neoadjuvant therapy followed by surgery, while 19 patients initially underwent surgery and subsequently received adjuvant therapy. Positive axillary lymph nodes before neoadjuvant therapy were confirmed in 82.6% (19/23) of patients. Complete pathological response to neoadjuvant therapy was achieved in 39.1% (9/23) and residual disease was present in 60.9% (14/23) of patients. At the time of surgery after neoadjuvant treatment, 60.9% (14/23) of patients had negative and 39.1% (9/23) had positive axillary lymph nodes. Of the primary operated patients, 47.4% (9/19) had negative and 52.6% (10/19) had positive axillary lymph nodes. A total of 7 patients were treated with neratinib for metastatic HER2 positive breast cancer after progression on standard anti-HER2 therapy. Among patients treated with extended adjuvant therapy 88.1% (37/42) and among metastatic breast cancer patients 85.7% (6/7) had hormone receptor positive disease. In patients with metastatic breast cancer, neratinib was administered in the fifth and later treatment lines. Neratinib was discontinued in a total of 19% (8/42) of patients on extended adjuvant therapy due to intolerance. Conclusion: Neratinib has been used in extended adjuvant and in the treatment of metastatic disease in extended adjuvant and as salvage therapy after progression on standard anti-HER2 treatment options. It has generally been tolerated well with acceptable side effects and discontinuation rate.

neratinib ; breast cancer ; extended adjuvant

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