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Abstract
Background
Trastuzumab deruxtecan (T-DXd) demonstrated unprecedented efficacy in patients with pretreated HER2+ metastatic breast cancer (mBC). However, few data are available about its efficacy in routine clinical practice. In this multicenter retrospective study, we examined effectiveness and safety of T-DXd in a real-world population.
Methods
Clinico-pathological information about patients with HER2+ mBC who received T-DXd were collected from 12 Italian hospitals. HER2 status was determined locally. Patients who received at least one administration of T-DXd, as any therapy line for advanced disease were included in the analysis. The primary endpoint was real-word PFS (rwPFS).
Results
One hundred and forty-three patients were included. Median age was 66 (range: 37-90), and 4 men were included. Hormone receptor (HR) status was positive in 108 (75%) patients and negative in 35(25%). T-DXd was administered as first, second, third, or subsequent lines in 4 (3%), 16 (11%), 42 (29%), and 81 (57%) patients, respectively. Among 123 patients with measurable disease, the ORR was 68%, and the DCR was 93% (9 CRs, 74 PRs, and 30 SD). Nine (7%) patients had a primary resistance to T-DXd. With a median follow-up of 12 months, the median rwPFS was 16 months. RwPFS was 84%, 59%, and 39% at 6, 12, and 18 months, respectively. A favorable trend in rwPFS was reported in patients receiving T-DXd as I/II line versus further lines (17 vs. 15 months; P = .098). Any-grade toxicity was registered in 84 patients (59%). Most common adverse events (AEs) reported were nausea (33%), neutropenia (21%), and asthenia (21%). Liver toxicity and diarrhea were uncommon (5% and 1%). Severe toxicities was registered in 18% of patients, and the most frequent were neutropenia, nausea/vomiting, and ILD observed in 15, 2, and 3 patients. AEs led to dose reduction in 37 patients (26%). Dose reduction and AEs do not affect patients’ response and survival outcomes.
Conclusions
Efficacy and safety of T-DXd were confirmed in an unselected real-world population of HER2+ mBC. These results are consistent with the results of known findings, and no new safety concerns were reported.
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1 Department of Radiological, Oncological and Pathological Science, Sapienza University of Rome , Rome , Italy
2 Department of Breast and Thoracic Oncology, Division of Breast Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale , Naples , Italy
3 Department of Experimental Medicine, Sapienza University of Rome , Rome , Italy
4 Department of Oncology and Hematology, University of Milan , Milan , Italy
5 Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova , Genova , Italy
6 Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico , Rome , Italy
7 Depatment of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS , Rome , Italy
8 Department of Woman and Child Health, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy
9 Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milan , Italy
10 Medical Oncology Unit, “S. Carlo” Hospital , Italy
11 IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” IRST , Meldola , Italy
12 Clinical Oncology, Università Politecnica delle Marche, AOU Ospedali Riuniti , Ancona , Italy
13 UOSD Centro Oncologico S. Spirito e Nuovo Regina Margherita , Ospedale Santo Spirito in Sassia, Rome , Italy
14 Department of Medical Oncology, Sandro Pertini Hospital , Rome Italy
15 Department of Oncology and Hematology, Medical Oncology and Breast Unit, Central Hospital of Belcolle , Viterbo , Italy
16 Multispeciality Department of Oncology, ASL Latina, “Sapienza” University of Rome , Aprilia , Italy
17 Sapienza Università di Roma - IRCCS Istituto Nazionale Tumori Regina Elena , Rome Italy
18 Department of Medical Physics, IRCCS Azienda Ospedaliero-Universitaria di Bologna , Bologna , Italy
19 Department of Oncology and Dermatological Oncology, Istituto Dermopatico dell’Immacolata IDI IRCCS , Rome , Italy
20 Department of Medico-Surgical Sciences and Biotechnology, Polo Pontino, Sapienza University of Rome , Rome , Italy
21 Precision Medicine in Senology, Scientific Directorate - Department of Women and Child Health, Fondazione Policlinico Universitario “A. Gemelli” IRCCS , Rome , Italy