3 research outputs found
Supplementary Material for: 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
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.
ClinicalTrials.gov identifier: NCT0438838
Supplementary Material for: Endocrine Treatment with 2 Years of Tamoxifen versus 2 Years of Exemestane in Postmenopausal Patients with High-Risk Early Breast Cancer and Persisting Circulating Tumor Cells - First Results of the SUCCESS C Endocrine Treatment Sub-Study
<p><b><i>Background:</i></b> Optimal choice and sequence of endocrine
treatment following adjuvant chemotherapy in postmenopausal early breast
cancer patients are still under discussion and treatment stratification
factors are missing. <b><i>Patients and Methods:</i></b> Postmenopausal
women with HER2-negative, hormone receptor-positive tumors and
persisting circulating tumor cells (CTCs; assessed using the
FDA-approved CellSearch® System, Janssen Diagnostics, LLC) after
chemotherapy were randomized to 2 years of tamoxifen followed by 3 years
of exemestane (tamoxifen-exemestane group, n = 54) or 5 years of
exemestane (exemestane-only group, n = 54). CTCs were again assessed
after the first 2 years of endocrine treatment. In addition, safety data
were compared between the 2 groups. <b><i>Results:</i></b> The 2 groups
were well-balanced with regard to baseline characteristics. The CTC
clearance rate after 2 years was 89% in the exemestane-only group and
97% in the tamoxifen-exemestane group (exact Fisher test, p = 0.36). The
safety profile showed good tolerability with few grade 3 or 4 adverse
events in both groups. <b><i>Conclusion:</i></b> The similar CTC
clearance rate after 2 years of endocrine therapy with exemestane or
tamoxifen, and the safety profiles obtained may indicate comparable
efficacy and tolerability of both endocrine treatment regimens. However,
these results have to be confirmed by final survival and safety
analysis.</p