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Multicenter Study
. 2024 May;13(9):e7168.
doi: 10.1002/cam4.7168.

Trastuzumab deruxtecan in previously treated HER2-positive metastatic or unresectable breast cancer: Real-life data from the temporary use authorization program in France

Thierry Petit  1 , Nawale Hajjaji  2 , Eric-Charles Antoine  3 , Marc-Antoine Benderra  4 , Michel Gozy  5 , Cyril Foa  6 , Jean-Loup Mouysset  7 , Julien Grenier  8 , Mireille Mousseau  9 , Audrey Mailliez  2 , Mahasti Saghatchian  10 , Emma Lachaier  11 , Isabelle Desmoulins  12 , Audrey Hennequin  12 , Patricia Maes  13 , Delphine Loirat  14 , Francesco Ricci  14 , Véronique Diéras  15 , Dominique Berton  16 , Florence Lai Tiong  17 , Luis Teixeira  18 , Nadine Dohollou  19 , Christelle Lévy  20 , Thomas Bachelot  21 , Jean-Yves Pierga  14   22
Affiliations
Multicenter Study

Trastuzumab deruxtecan in previously treated HER2-positive metastatic or unresectable breast cancer: Real-life data from the temporary use authorization program in France

Thierry Petit et al. Cancer Med. 2024 May.

Abstract

Background: Early access program (formerly cohort Temporary Authorization for Use) was granted for trastuzumab deruxtecan (T-DXd) in France based on DESTINY-Breast01 trial which demonstrated its efficacy and safety in HER2-positive metastatic/unresectable breast cancer after ≥2 anti-HER2-based regimens received at metastatic stage.

Methods: This multicenter real-world early access program included HER2-positive metastatic/unresectable breast patients pretreated with at least two lines of anti-HER2 regimens who received T-DXd 5.4 mg/kg intravenously in monotherapy every 3 weeks.

Results: Four hundred and fifty-nine patients (median age, 58 years; hormone receptor-positive, 67%; brain metastases, 28.1%) received T-DXd. Before inclusion, 81.7% of patients had radiation therapy and 76.5% had undergone surgery. Median number of prior metastatic treatment lines was four (range, 2-22); 99.8% patients had received trastuzumab, 94.8% trastuzumab emtansine and 79.3% pertuzumab. Follow-up was performed from September 30, 2020 to March 30, 2021; when the early access program stopped, the median duration of T-DXd treatment was 3.4 (range, 0-7.8) months. In 160 patients with available tumor assessment, objective response rate was 56.7% and 12.1% had progression. In 57 patients with available brain tumor assessment, complete or partial intracranial response was reported for 35.7% patients and 5.4% had progression. A total of 17 (3.7%) patients with interstitial lung disease (ILD) was reported with no cases of ILD-related death.

Conclusions: In this early access program in patients with heavily pretreated HER2-positive metastatic/unresectable breast cancer, T-DXd had antitumor activity with a similar response to that reported in previous clinical studies. T-DXd was well tolerated and no new safety signals were observed.

Keywords: HER2‐positive; breast cancer; early‐access program; metastatic cancer; trastuzumab deruxtecan.

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Conflict of interest statement

Nawale Hajjaji reports competing interests with Pfizer, Novartis, Lilly, Daiichi Sankyo, Gilead, AstraZeneca (consulting fees), Novartis, Pfizer (research grant to institution), and Daiichi Sankyo, AstraZeneca (travel expenses); Marc‐Antoine Benderra reports competing interest with Daiichi Sankyo support for attending meetings and/or travel; participation on a Data Safety Monitoring Board or Advisory Board; Cyril Foa reports competing interests with Roche, MSD, AstraZeneca, Novartis; Julien Grenier reports competing interest for Daiichi Sankyo (congress) and AstraZeneca/Daiichi Sankyo (board); Mahasti Saghatchian reports competing interests with AstraZeneca (consulting/expert, speaker/conferences, research grants/clinical trials), BMS (research grants/clinical trials), Daiichi Sankyo (consulting/expert, speaker/conferences, research grants/clinical trials, conference travel), Eisai (consulting/expert, speaker/conferences), Myriad Genetics (consulting/expert, speaker/conferences, research grants/clinical trials), Seagen (consulting/expert, speaker/conferences, research grants/clinical trials, conference travel), MSD (consulting/expert, research grants/clinical trials, conference travel), Novartis (consulting/expert, speaker/conferences, research grants/clinical trials, conference travel), Pfizer (consulting/expert, speaker/conferences, research grants/clinical trials, conference travel), Viatris (consulting/expert, speaker/conferences), Roche (consulting/expert, speaker/conferences, research grants/clinical trials, conference travel), Menarini‐Stemline (consulting/expert); Véronique Diéras reports competing interest with Roche, Novartis, Pfizer, Lilly, AstraZeneca, Daiichi Sankyo, Seagen, Gilead, MSD (travel expenses), Roche/Genentech, Novartis, Lilly, Pfizer, AstraZeneca, AbbVie, MSD, Daiichi Sankyo, Seagen, Gilead, Eisai, Pierre Fabre Oncologie, Medac GmbH, Menarini (honoraria for consulting), Roche, Novartis, Pfizer, Lilly, Astra Zeneca, Daiichi Sankyo, Seagen, Gilead (honoraria for symposia); Luis Teixeira reports competing interest with Roche, Novartis, AZD, Daiichi‐Sankyo (consulting or advisory role); Nadine Dohollou reports competing interests with AstraZeneca, BMS, Boehringer Ingelheim, Genomic Health, Lilly, MSD, Novartis, Pfizer, Roche (research grants for clinical trials), Daiichi, Lilly, Roche, Seagen (consulting/expert and conferences/trainings); Thomas Bachelot reports personal fees (Seagen), grants to institution (Seagen), personal fees (Pfizer), grants to institution (Pfizer), personal fees (AstraZeneca/Daiichi), grants to institution (AstraZeneca/Daiichi), personal fees (Novartis), grants to institution (Novartis), personal fees (Lilly), non‐financial support (Pfizer). The other authors did not report competing interests.

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