Trastuzumab deruxtecan (TDXd) demonstrated unprecedented efficacy in patients (pts) with HER2+ metastatic breast cancer after at least a prior anti-HER2 regimen. However, few data are available about its efficacy in routine clinical practice. In this multicenter retrospective study we evaluated effectiveness and safety of TDXd in a real-world (
Clinical and pathological information about pts with HER2+ mBC who received TDXd were collected from 11 italian hospitals. Activity and toxicity were evaluated following RECIST 1.1 and CTCAE v5 criteria. The survival outcomes evaluation included PFS, milestone-PFS and OS.
One hundred forty-three patients were enrolled. Median age was 66 (range 33-84) and 4 men were included. Estrogen receptor (HR) was positive in 108 (75%) pts and negative in 35 (25%). TDXd was administered as first, second, third or subsequent line in 4 (3%), 16 (11%), 42 (29%), and 81 (57%) pts respectively. Among 123 pts with measurable disease, the ORR was 68% and the disease control rate was 91% (9 CRs, 74 PRs, and 30 SD). Nine (7%) pts had primary resistance to TDXd. With a median follow-up of 12 months (range: 1-31), the mPFS was 16 months. PFS was 84%, 59%, and 39% at 6, 12, and 18 months, respectively. A favorable trend in PFS was reported in pts receiving TDXd as I/II line vs further lines, though the difference did not reach statistical significance (17 vs 15 months, 76% vs 56%; p=0.098). OS was 90.8% at 6 months, 74% at 12, and 59% at 18 months, respectively. Median OS was 20 months. 89% of pts who received TDXd as I/II line were alive at 12 months vs 73% of subsequent lines (p=0.39). Any-grade toxicity was registered in 84 patients (59%). The most common toxicities reported were nausea (33%), neutropenia (21%), and asthenia (21%). Liver toxicity and diarrhea were uncommon (5%, and 1% respectively). Severe toxicities were registered in 18% of pts and the most frequent were neutropenia, nausea/vomiting, and interstitial lung disease observed in 15, 2 and 3 pts, respectively. Adverse events led to dose reduction in 37 pts (26%).
The efficacy and safety of TDXd were confirmed in an unselected
Andrea Botticelli.
Has not received any funding.
A. Botticelli: Financial Interests, Personal, Advisory Board: Roche, Novartis, MSD, Lilly, Pfizer, Amgen, BMS, Gilead; Financial Interests, Personal, Invited Speaker: Sofos. S. Pisegna: Financial Interests, Personal, Invited Speaker: Eli Lilly, Novartis, Pfizer, Roche, AstraZeneca. S. Scagnoli: Financial Interests, Personal, Invited Speaker: Novartis, Lilly, MSD, Pfizer, BMS. M. De Laurentiis: Financial Interests, Personal, Speaker’s Bureau: Roche, Celgene, MSD; Financial Interests, Personal, Advisory Board: AstraZeneca, Amgen, Eisai, Exact Science, Gilead, Novartis, Pfizer, Pierre Fabre, Roche; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo, Eli Lilly, Seagen. R. Caputo: Financial Interests, Personal, Invited Speaker: Roche, Eli Lilly, MSD, Gilead, Daiichi; Financial Interests, Personal, Advisory Board: Novartis, Pierre-Fabre. M. Palleschi: Financial Interests, Personal, Advisory Board: Novartis, Lilly. A. Orlandi: Financial Interests, Personal, Invited Speaker: Amgen, Pfizer, Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Lilly, Novartis, Gilead. M. Giampaglia: Financial Interests, Personal, Invited Speaker: Novartis, Eli Lilly. M.A. Fabbri: Financial Interests, Personal, Invited Speaker: Eli Lilly, Novartis, Pfizer; Financial Interests, Personal, Advisory Board: Roche, Gilead. G. D'Auria: Financial Interests, Personal, Advisory Board: Eisai, Amgen, Pfizer, Lilly, Novartis. P. Vici: Financial Interests, Personal, Advisory Board: Novartis, Pfizer; Financial Interests, Personal, Invited Speaker: Eli Lilly, Eisai. P. Marchetti: Financial Interests, Personal, Advisory Role: BMS, Roche, Genentech, MSD, Novartis, Amgen, Merck, Pierre Fabre, Incyte. A. Fabi: Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Gilead, Sophos, Seagen, AstraZeneca, Lilly, Pierre Fabre, Exact Science. All other authors have declared no conflicts of interest.