Found 1 Presentation For Request "83P"
83P - Impact of treatment duration of extended adjuvant therapy with neratinib in early stage HER2+ HR+ breast cancer after trastuzumab-based therapy on patient outcomes
- Miguel Martin Jimenez (Madrid, Spain)
- Miguel Martin Jimenez (Madrid, Spain)
- Michael I. Gnant (Vienna, Austria)
- Bent Ejlertsen (Copenhagen, Denmark)
- Janine L. Mansi (London, United Kingdom)
- Manuel Ruiz-Borrego (Sevilla, Spain)
- Erik H. Jakobsen (Vejle, Denmark)
- C. Kent Osborne (Houston, TX, United States of America)
- Ruemu Birhiray (Indianapolis, United States of America)
- Bo Zhang (Los Angeles, United States of America)
- Alvin Wong (Los Angeles, United States of America)
- Beverly Moy (Boston, United States of America)
- Frankie A. Holmes (Fort Worth, TX, United States of America)
Abstract
Background
ExteNET, an international, randomized, placebo-controlled phase III trial, showed that extended adjuvant neratinib given for 12 months after trastuzumab-based adjuvant therapy significantly improved 2-year (HR=0.50, p=0.003) and 5-year (HR=0.58, p=0.002) invasive disease-free survival (iDFS) in early-stage HER2+ and hormone-receptor positive (HR+) breast cancer. We explored the impact of treatment duration on outcomes in the ITT population and in the subgroup of patients (pts) with HR+ disease who started neratinib <1 year after prior trastuzumab (EU label population).
Methods
Pts with early-stage HER2+ breast cancer received oral neratinib 240 mg/day or placebo for 12 months (or until disease recurrence or unacceptable toxicity) after trastuzumab-based adjuvant therapy. Pts who received neratinib for ≤3 or ≥11 months (including those who had recurrence prior to 11 months) were compared with the ITT placebo group. iDFS (primary endpoint) and secondary endpoints (DCIS, DDFS, time to distant recurrence, and 5-year CNS recurrence) were analyzed using Kaplan-Meier methods and Cox proportional-hazards models adjusted for prognostic factors. Data cut-off: March 1, 2017.
Results
There were 2840 pts in the ITT population and 1334 patients who were HR+, <1-year. The table shows iDFS findings for HR+, <1-year pts and stratified by treatment duration (≤3, ≥11 months). Greater benefit was seen in pts who stayed on treatment for ≥11 months when compared to pts who received ≤3 months of treatment. Similar findings were seen for secondary endpoints.
Duration N 5-year iDFS rate, % Neratinib Placebo Neratinib Placebo Difference HR (95% CI) EU label population 670 664 90.8 85.7 + 5.1% 0.58 (0.41-0.82) ≤3 months 201 664 85.9 85.7 + 0.2% 0.88 (0.51-1.42) ≥11 months 402 664 93.1 85.7 + 7.4% 0.44 (0.28-0.68)
Conclusions
These exploratory data suggest that pts who received a longer duration of treatment with neratinib (≥11 months) derived greater benefit compared to those who stopped treatment early (≤3 months). Patients who receive recommended duration of treatment with neratinib of 12 months may have improved outcomes when compared to patients who discontinue early (within 3 months).
Clinical trial identification
NCT00878709.
Legal entity responsible for the study
PUMA Biotechnology.
Funding
PUMA Biotechnology.
Disclosure
M. Martin Jimenez: Advisory/Consultancy: Pierre Fabre. B. Zhang: Full/Part-time employment: PUMA Biotechnology. A. Wong: Full/Part-time employment: PUMA Biotechnology. B. Moy: Research grant/Funding (institution): PUMA Biotechnology. All other authors have declared no conflicts of interest.