One third of ABC pts is currently represented by women aged over 70. However, this population remains under-represented in clinical trials. Recently, T-DXd revolutionized the treatment of HER2 positive ABC, demonstrating its efficacy in DESTINY-Breast trials. Its safety profile was manageable and most adverse events (AEs) were gastrointestinal in nature. Nevertheless, T-DXd was associated with the development of interstitial lung disease (ILD) in 10-15% of pts. Thus, some concerns could raise regarding those outcomes in elderly patients. The aim of this retrospective analysis was to evaluate the safety and efficacy of T-DXd in ABC pts over 70 in a real-life setting.
TREX-Old is an European retrospective registry evaluating the real-life use of T-DXd in ABC pts aged ≥ 70 among 4 centers across Austria, France, Italy and Portugal. Clinical and pathological characteristics, previous treatments and AEs were collected.
Overall, to date, 27 pts were enrolled. Median age was 74 years (range 70-81), with 10 patients over 75 (37%). The ECOG performance status was 0, 1 and ≥ 2 in 22%, 56% and 22% of pts, respectively. Among them, 37% had cardiovascular comorbidities. The median number of lines before T-DXd was 3 (1-13). At treatment initiation, 71% and 29% of pts had a visceral and non-visceral (bone only, skin or lymph nodes) disease, respectively. Eight pts (30%) started with a dose-reduction, and 8 pts (30%) had secondary dose adjustment. Overall, any-grade treatment-related AEs occurred in 19 pts (70%). Among them, nausea was the most common AE (37%), followed by asthenia (18%). Three out 27 pts (11%) developed ILD. Finally, at a median follow-up of 9.5 months (1-29), median PFS was 12 months, considering that only 8 pts progressed at time of current analysis.
With the limit of number and follow-up, our data suggest that T-DXd is not associated with new safety signals in pts ≥ 70 years. ILD occurrence was in line with previously reported data. Therefore, age should not be a criterion to discourage treatment with T-DXd. This registry is ongoing, and updated data will be presented.
The authors.
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G. Buono: Financial Interests, Personal, Invited Speaker: Novartis, Eli Lilly, Pfizer, AstraZeneca, Roche, Daiichi Sankyo, Exact Science, Genetic, Pierre-Fabre. E.V. Klocker: Financial Interests, Personal, Invited Speaker: Novartis, Eli Lilly, Daiichi Sankyo, AstraZeneca, Pierre-Fabre, Gilead, Roche. S. Nardin: Financial Interests, Personal, Other, travel expenses: Daiichi Sankyo. S. Braga: Financial Interests, Personal, Advisory Board: Novartis, AstraZeneca, Daiichi Sankyo, MSD. N. Harbeck: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Seagen, Medscape, Art Tempi, Onkowissen, Gilead, Sanofi, Exact Sciences; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Roche, Sandoz-Hexal, Seagen, Aptitude Health, Gilead, Sanofi; Financial Interests, Personal, Other, Husband: WSG (Husband); Financial Interests, Personal, Ownership Interest: West German Study Group; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Daiichi Sankyo, Lilly, MSD, Novartis, Pierre Fabre, Roche, Palleos, Seagen, TRIO, WSG; Non-Financial Interests, Member, Member German AGO Breast Guideline Committee: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO/ESCO; Other, Founding Editor: BreastCare Journal. V.C. Dieras: Financial Interests, Personal, Advisory Board, National advisory board: Pierre Fabre Oncologie; Financial Interests, Personal, Advisory Board, Steering Committee, consultant, Symposium, travel expenses: Roche Genentech; Financial Interests, Personal, Advisory Board, + Symposia and travel expenses: Novartis; Financial Interests, Personal, Advisory Board, Advisory boards, symposia, travel expenses: Pfizer; Financial Interests, Personal, Advisory Board, Symposia, travel expenses: Lilly, AstraZeneca, MSD; Financial Interests, Personal, Advisory Board, Symposia,travel expenses: Daiichi Sankyo; Financial Interests, Personal, Advisory Board, symposia,travel expenses: Seagen, Gilead; Financial Interests, Personal, Advisory Board, Steering Committee: AbbVie; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Other, IDMC: Sanofi; Financial Interests, Personal and Institutional, Other, IDMC: Sanofi; Financial Interests, Institutional, Invited Speaker: Roche Genentech, AstraZeneca; Financial Interests, Institutional, Invited Speaker, Steering Committee: Lilly; Financial Interests, Institutional, Invited Speaker, + IDMC: Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker, PI: Seagen. All other authors have declared no conflicts of interest.