TY - JOUR
T1 - Neratinib as extended adjuvant treatment of HER2-positive/HR-positive early breast cancer patients in Germany, Austria and Switzerland: interim results of the prospective, observational ELEANOR study
AU - Harbeck, N
AU - Wrobel, D
AU - Zaiss, M
AU - Terhaag, J
AU - Guth, D
AU - Distelrath, A
AU - Zahn, MO
AU - Wuerstlein, R
AU - Lorenz, A
AU - Bartsch, R
AU - Breitenstein, U
AU - Schwitter, M
AU - Balic, M
AU - Jackisch, C
AU - Mueller, V
AU - Rinnerthaler, G
AU - Schmidt, M
AU - Zaman, K
AU - Schinköthe, T
AU - Resch, A
AU - Valenti, R
AU - Lüftner, D
N1 - Rinnerthaler: Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg, Austria
PY - 2023/10/5
Y1 - 2023/10/5
N2 - Introduction: Prognosis of patients diagnosed with HER2+ early breast cancer (eBC) has substantially improved, but distant recurrences impacting quality of life and survival still occur. One treatment option for extended adjuvant treatment in patients with HER2+/HR+ eBC is neratinib; available in Europe for patients who completed adjuvant trastuzumab-based therapy within 1 year. The ELEANOR study is investigating the real-world use of neratinib in Germany, Austria and Switzerland. Results from an interim analysis of the first 200 patients observed for >= 3 months are reported.Methods: The primary objective of this prospective, multicentre, observational study is to assess patient adherence to neratinib (defined as percentage of patients taking neratinib on >= 75% prescribed days). Secondary objectives are patient characteristics and treatment outcomes.Results: At cut-off (May 2, 2022), 202 patients had been observed for >= 3 months, with neratinib treatment documented for 187 patients (median age 53.0 years; 67.9% at increased risk of disease recurrence). In total 151 (80.7%) patients had received prior neoadjuvant treatment; of these 82 (54.3%) achieved a pathological complete response. Neratinib was initiated at a median 3.6 months after trastuzumab-based treatment, with 36.4% starting at a dose <240 mg/day. Treatment is ongoing for 46.0% of patients, with median treatment duration of 11.2 (interquartile range 0.9-12.0) months. Diarrhoea was the most common adverse event (78.6% any grade, 20.3% Grade >= 3); pharmacologic prophylaxis was used in 85.6% of patients.Conclusions: The pattern of anti-HER2 pretreatment observed reflected the current treatment for HER2+/HR+ eBC in Germany, Austria and Switzerland. These interim results suggest that neratinib as an extended adjuvant is a feasible option after various anti-HER2 pretreatments, and that its tolerability can be managed and improved with proactive diarrhoea management.
AB - Introduction: Prognosis of patients diagnosed with HER2+ early breast cancer (eBC) has substantially improved, but distant recurrences impacting quality of life and survival still occur. One treatment option for extended adjuvant treatment in patients with HER2+/HR+ eBC is neratinib; available in Europe for patients who completed adjuvant trastuzumab-based therapy within 1 year. The ELEANOR study is investigating the real-world use of neratinib in Germany, Austria and Switzerland. Results from an interim analysis of the first 200 patients observed for >= 3 months are reported.Methods: The primary objective of this prospective, multicentre, observational study is to assess patient adherence to neratinib (defined as percentage of patients taking neratinib on >= 75% prescribed days). Secondary objectives are patient characteristics and treatment outcomes.Results: At cut-off (May 2, 2022), 202 patients had been observed for >= 3 months, with neratinib treatment documented for 187 patients (median age 53.0 years; 67.9% at increased risk of disease recurrence). In total 151 (80.7%) patients had received prior neoadjuvant treatment; of these 82 (54.3%) achieved a pathological complete response. Neratinib was initiated at a median 3.6 months after trastuzumab-based treatment, with 36.4% starting at a dose <240 mg/day. Treatment is ongoing for 46.0% of patients, with median treatment duration of 11.2 (interquartile range 0.9-12.0) months. Diarrhoea was the most common adverse event (78.6% any grade, 20.3% Grade >= 3); pharmacologic prophylaxis was used in 85.6% of patients.Conclusions: The pattern of anti-HER2 pretreatment observed reflected the current treatment for HER2+/HR+ eBC in Germany, Austria and Switzerland. These interim results suggest that neratinib as an extended adjuvant is a feasible option after various anti-HER2 pretreatments, and that its tolerability can be managed and improved with proactive diarrhoea management.
U2 - 10.1159/000533657
DO - 10.1159/000533657
M3 - Original Article
C2 - 38384488
SN - 1661-3791
JO - Breast care (Basel, Switzerland)
JF - Breast care (Basel, Switzerland)
ER -