Henning Schäffler, Dorothee Jakob, Sophia Huesmann, Kerstin Pfister, Kristina Veselinovic, Fabienne Schochter, Elena Leinert, Visnja Fink, Brigitte Rack, Alexander Englisch, Lea-Louise Volmer, Tobias Engler, Marie Louise Frevert, Ingolf Juhasz-Böss, Sara Brucker, Sabine Heublein, Wolfgang Janni, Florin-Andrei Taran, Andreas Hartkopf, Dominik Dannehl
{"title":"常规临床实践中用于治疗转移性乳腺癌的新型抗体药物轭合物：依从性、疗效和耐受性--来自德国乳腺中心的真实世界数据。","authors":"Henning Schäffler, Dorothee Jakob, Sophia Huesmann, Kerstin Pfister, Kristina Veselinovic, Fabienne Schochter, Elena Leinert, Visnja Fink, Brigitte Rack, Alexander Englisch, Lea-Louise Volmer, Tobias Engler, Marie Louise Frevert, Ingolf Juhasz-Böss, Sara Brucker, Sabine Heublein, Wolfgang Janni, Florin-Andrei Taran, Andreas Hartkopf, Dominik Dannehl","doi":"10.1055/a-2375-5194","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The third-generation antibody-drug conjugates (ADC), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), recently obtained approval for metastatic breast cancer treatment across various subtypes and therapeutic contexts.</p><p><strong>Materials and methods: </strong>This retrospective, multicentric study evaluated real-world tolerability, feasibility and efficacy in a pre-treated, real-world cohort at three major German breast cancer centers.</p><p><strong>Results: </strong>125 patients treated with T-DXd or SG from November 2020 to June 2023 were included (T-DXd: 77 patients; SG: 48 patients). The median treatment duration was 6.0 months for T-DXd and 3.5 months for SG therapy, with a median follow-up duration of 10.4 months for T-DXd (95% CI: 8.4-11.6) and 11.8 months for SG (95% CI: 8.0-14.4). Severe neutropenia (CTC ≥ III°) occurred in 33.3% during SG therapy, with a numerical reduction observed following primary, prophylactic use of G-CSF. T-DXd-associated pneumonitis occurred in 8 out of 77 patients (10.4 %). Median progression-free survival (mPFS) was 8.6 months (95% CI: 5.8-12.4) with T-DXd (HER2+: 10.8; HER2-low: 4.7) and 4.9 months (95% CI: 2.8-6.3) with SG (TNBC 4.9; HR+/HER2-: not reached). Median overall survival (OS) was 23.8 months (95% CI: 16.1-not estimable) with T-DXd (HER2+: 27.1; HER2-low: not reached), and 12.4 months (95% CI: 8.7-not estimable) with SG therapy (TNBC: 12.4, HR+/HER2-: not reached). 95.7% of the protocol-specified, therapeutic dose was administered for T-DXd and 89.6% for SG.</p><p><strong>Conclusion: </strong>Overall, this indicates good feasibility, tolerability, and effectiveness of ADC therapies in the real-world setting.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 9","pages":"855-865"},"PeriodicalIF":2.4000,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11368468/pdf/","citationCount":"0","resultStr":"{\"title\":\"Novel Antibody-Drug-Conjugates in Routine Clinical Practice for the Treatment of Metastatic Breast Cancer: Adherence, Efficacy and Tolerability - Real-World Data from German Breast Centers.\",\"authors\":\"Henning Schäffler, Dorothee Jakob, Sophia Huesmann, Kerstin Pfister, Kristina Veselinovic, Fabienne Schochter, Elena Leinert, Visnja Fink, Brigitte Rack, Alexander Englisch, Lea-Louise Volmer, Tobias Engler, Marie Louise Frevert, Ingolf Juhasz-Böss, Sara Brucker, Sabine Heublein, Wolfgang Janni, Florin-Andrei Taran, Andreas Hartkopf, Dominik Dannehl\",\"doi\":\"10.1055/a-2375-5194\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The third-generation antibody-drug conjugates (ADC), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), recently obtained approval for metastatic breast cancer treatment across various subtypes and therapeutic contexts.</p><p><strong>Materials and methods: </strong>This retrospective, multicentric study evaluated real-world tolerability, feasibility and efficacy in a pre-treated, real-world cohort at three major German breast cancer centers.</p><p><strong>Results: </strong>125 patients treated with T-DXd or SG from November 2020 to June 2023 were included (T-DXd: 77 patients; SG: 48 patients). The median treatment duration was 6.0 months for T-DXd and 3.5 months for SG therapy, with a median follow-up duration of 10.4 months for T-DXd (95% CI: 8.4-11.6) and 11.8 months for SG (95% CI: 8.0-14.4). Severe neutropenia (CTC ≥ III°) occurred in 33.3% during SG therapy, with a numerical reduction observed following primary, prophylactic use of G-CSF. T-DXd-associated pneumonitis occurred in 8 out of 77 patients (10.4 %). Median progression-free survival (mPFS) was 8.6 months (95% CI: 5.8-12.4) with T-DXd (HER2+: 10.8; HER2-low: 4.7) and 4.9 months (95% CI: 2.8-6.3) with SG (TNBC 4.9; HR+/HER2-: not reached). Median overall survival (OS) was 23.8 months (95% CI: 16.1-not estimable) with T-DXd (HER2+: 27.1; HER2-low: not reached), and 12.4 months (95% CI: 8.7-not estimable) with SG therapy (TNBC: 12.4, HR+/HER2-: not reached). 95.7% of the protocol-specified, therapeutic dose was administered for T-DXd and 89.6% for SG.</p><p><strong>Conclusion: </strong>Overall, this indicates good feasibility, tolerability, and effectiveness of ADC therapies in the real-world setting.</p>\",\"PeriodicalId\":12481,\"journal\":{\"name\":\"Geburtshilfe Und Frauenheilkunde\",\"volume\":\"84 9\",\"pages\":\"855-865\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-09-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11368468/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Geburtshilfe Und Frauenheilkunde\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1055/a-2375-5194\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Geburtshilfe Und Frauenheilkunde","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1055/a-2375-5194","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Novel Antibody-Drug-Conjugates in Routine Clinical Practice for the Treatment of Metastatic Breast Cancer: Adherence, Efficacy and Tolerability - Real-World Data from German Breast Centers.
Introduction: The third-generation antibody-drug conjugates (ADC), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), recently obtained approval for metastatic breast cancer treatment across various subtypes and therapeutic contexts.
Materials and methods: This retrospective, multicentric study evaluated real-world tolerability, feasibility and efficacy in a pre-treated, real-world cohort at three major German breast cancer centers.
Results: 125 patients treated with T-DXd or SG from November 2020 to June 2023 were included (T-DXd: 77 patients; SG: 48 patients). The median treatment duration was 6.0 months for T-DXd and 3.5 months for SG therapy, with a median follow-up duration of 10.4 months for T-DXd (95% CI: 8.4-11.6) and 11.8 months for SG (95% CI: 8.0-14.4). Severe neutropenia (CTC ≥ III°) occurred in 33.3% during SG therapy, with a numerical reduction observed following primary, prophylactic use of G-CSF. T-DXd-associated pneumonitis occurred in 8 out of 77 patients (10.4 %). Median progression-free survival (mPFS) was 8.6 months (95% CI: 5.8-12.4) with T-DXd (HER2+: 10.8; HER2-low: 4.7) and 4.9 months (95% CI: 2.8-6.3) with SG (TNBC 4.9; HR+/HER2-: not reached). Median overall survival (OS) was 23.8 months (95% CI: 16.1-not estimable) with T-DXd (HER2+: 27.1; HER2-low: not reached), and 12.4 months (95% CI: 8.7-not estimable) with SG therapy (TNBC: 12.4, HR+/HER2-: not reached). 95.7% of the protocol-specified, therapeutic dose was administered for T-DXd and 89.6% for SG.
Conclusion: Overall, this indicates good feasibility, tolerability, and effectiveness of ADC therapies in the real-world setting.
期刊介绍：
Geburtshilfe und Frauenheilkunde (GebFra) addresses the whole field of obstetrics and gynecology and is concerned with research as much as with clinical practice. In its scientific section, it publishes original articles, reviews and case reports in all fields of the discipline, namely
gynecological oncology, including oncology of the breast
obstetrics and perinatal medicine,
reproductive medicine,
and urogynecology.
GebFra invites the submission of original articles and review articles.
In addition, the journal publishes guidelines, statements and recommendations in cooperation with the DGGG, SGGG, OEGGG and the Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF, Association of Scientific Medical Societies, www.awmf.org). Apart from the scientific section, Geburtshilfe und Frauenheilkunde has a news and views section that also includes discussions, book reviews and professional information.
Letters to the editors are welcome. If a letter discusses an article that has been published in our journal, the corresponding author of the article will be informed and invited to comment on the letter. The comment will be published along with the letter.
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