Alexandre De Moura, Delphine Loirat, Sarah Vaillant, Sinen Korbi, Nicolas Kiavue, Diana Bello Roufai, Laurence Escalup, Romain Desmaris, Pauline Vaflard, Paul Cottu, Jean-Yves Pierga, François-Clément Bidard, Luc Cabel, Alexandre Acramel
{"title":"在居里研究所医院接受治疗的转移性三阴性乳腺癌患者中使用萨妥珠单抗戈维替康：疗效、安全性和脑转移的影响","authors":"Alexandre De Moura, Delphine Loirat, Sarah Vaillant, Sinen Korbi, Nicolas Kiavue, Diana Bello Roufai, Laurence Escalup, Romain Desmaris, Pauline Vaflard, Paul Cottu, Jean-Yves Pierga, François-Clément Bidard, Luc Cabel, Alexandre Acramel","doi":"10.1007/s12282-024-01565-7","DOIUrl":null,"url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Sacituzumab govitecan (SG) has been approved by FDA in April 2021 for pre-treated metastatic triple-negative breast cancer (mTNBC), following the ASCENT trial results.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We set up an ambispective bicentric cohort study to assess the real-world effectiveness and safety of SG in patients with mTNBC treated at Institut Curie Hospitals, with a focus on patients with brain metastases.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>This study included 99 patients treated through the French Early Access Program to SG from May 2021 to January 2023. Median age was 55 years [26–89], <i>N</i> = 8 patients (8%) had <i>BRCA1/2</i> mutation, <i>N</i> = 12 (12%) de novo stage IV disease and <i>N</i> = 31 (31%) brain metastases. Patients had previously received a median of two [1–10] lines of treatment in advanced setting. After a median follow-up of 9.7 months, the median progression-free survival (PFS) and overall survival (OS) were 3.9 months (95%CI[3.4–5.0]) and 8.6 months (95%CI[7.1–11.9]), respectively, while objective response rate was 29% (95%CI[21–39]). Among patients with brain metastases, median PFS and OS were 3.7 months (95%CI[2.6–6.2]) and 6.7 months (95%CI[6.3–NR]), respectively, with intracranial tumor responses. Dose reductions were required in <i>N</i> = 17 patients (17%) within a median of three [2–11] cycles, due to gastrointestinal toxicity (<i>N</i> = 6; 6%), hematological toxicity (<i>N</i> = 9; 9%) including febrile neutropenia (<i>N</i> = 2; 2%), liver enzyme elevation (<i>N</i> = 1; 1%), and physical deterioration (<i>N</i> = 1; 1%). There was no related death to SG.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>The observed response rate and safety of SG are consistent with the results of the ASCENT trial, with efficacy observed in patients with brain metastases, but observed PFS and OS are numerically shorter.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":null,"pages":null},"PeriodicalIF":4.0000,"publicationDate":"2024-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Sacituzumab govitecan in metastatic triple-negative breast cancer patients treated at Institut Curie Hospitals: efficacy, safety, and impact of brain metastases\",\"authors\":\"Alexandre De Moura, Delphine Loirat, Sarah Vaillant, Sinen Korbi, Nicolas Kiavue, Diana Bello Roufai, Laurence Escalup, Romain Desmaris, Pauline Vaflard, Paul Cottu, Jean-Yves Pierga, François-Clément Bidard, Luc Cabel, Alexandre Acramel\",\"doi\":\"10.1007/s12282-024-01565-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Background</h3><p>Sacituzumab govitecan (SG) has been approved by FDA in April 2021 for pre-treated metastatic triple-negative breast cancer (mTNBC), following the ASCENT trial results.</p><h3 data-test=\\\"abstract-sub-heading\\\">Methods</h3><p>We set up an ambispective bicentric cohort study to assess the real-world effectiveness and safety of SG in patients with mTNBC treated at Institut Curie Hospitals, with a focus on patients with brain metastases.</p><h3 data-test=\\\"abstract-sub-heading\\\">Results</h3><p>This study included 99 patients treated through the French Early Access Program to SG from May 2021 to January 2023. Median age was 55 years [26–89], <i>N</i> = 8 patients (8%) had <i>BRCA1/2</i> mutation, <i>N</i> = 12 (12%) de novo stage IV disease and <i>N</i> = 31 (31%) brain metastases. Patients had previously received a median of two [1–10] lines of treatment in advanced setting. After a median follow-up of 9.7 months, the median progression-free survival (PFS) and overall survival (OS) were 3.9 months (95%CI[3.4–5.0]) and 8.6 months (95%CI[7.1–11.9]), respectively, while objective response rate was 29% (95%CI[21–39]). Among patients with brain metastases, median PFS and OS were 3.7 months (95%CI[2.6–6.2]) and 6.7 months (95%CI[6.3–NR]), respectively, with intracranial tumor responses. Dose reductions were required in <i>N</i> = 17 patients (17%) within a median of three [2–11] cycles, due to gastrointestinal toxicity (<i>N</i> = 6; 6%), hematological toxicity (<i>N</i> = 9; 9%) including febrile neutropenia (<i>N</i> = 2; 2%), liver enzyme elevation (<i>N</i> = 1; 1%), and physical deterioration (<i>N</i> = 1; 1%). 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Sacituzumab govitecan in metastatic triple-negative breast cancer patients treated at Institut Curie Hospitals: efficacy, safety, and impact of brain metastases
Background
Sacituzumab govitecan (SG) has been approved by FDA in April 2021 for pre-treated metastatic triple-negative breast cancer (mTNBC), following the ASCENT trial results.
Methods
We set up an ambispective bicentric cohort study to assess the real-world effectiveness and safety of SG in patients with mTNBC treated at Institut Curie Hospitals, with a focus on patients with brain metastases.
Results
This study included 99 patients treated through the French Early Access Program to SG from May 2021 to January 2023. Median age was 55 years [26–89], N = 8 patients (8%) had BRCA1/2 mutation, N = 12 (12%) de novo stage IV disease and N = 31 (31%) brain metastases. Patients had previously received a median of two [1–10] lines of treatment in advanced setting. After a median follow-up of 9.7 months, the median progression-free survival (PFS) and overall survival (OS) were 3.9 months (95%CI[3.4–5.0]) and 8.6 months (95%CI[7.1–11.9]), respectively, while objective response rate was 29% (95%CI[21–39]). Among patients with brain metastases, median PFS and OS were 3.7 months (95%CI[2.6–6.2]) and 6.7 months (95%CI[6.3–NR]), respectively, with intracranial tumor responses. Dose reductions were required in N = 17 patients (17%) within a median of three [2–11] cycles, due to gastrointestinal toxicity (N = 6; 6%), hematological toxicity (N = 9; 9%) including febrile neutropenia (N = 2; 2%), liver enzyme elevation (N = 1; 1%), and physical deterioration (N = 1; 1%). There was no related death to SG.
Conclusions
The observed response rate and safety of SG are consistent with the results of the ASCENT trial, with efficacy observed in patients with brain metastases, but observed PFS and OS are numerically shorter.
期刊介绍：
Breast Cancer, the official journal of the Japanese Breast Cancer Society, publishes articles that contribute to progress in the field, in basic or translational research and also in clinical research, seeking to develop a new focus and new perspectives for all who are concerned with breast cancer. The journal welcomes all original articles describing clinical and epidemiological studies and laboratory investigations regarding breast cancer and related diseases. The journal will consider five types of articles: editorials, review articles, original articles, case reports, and rapid communications. Although editorials and review articles will principally be solicited by the editors, they can also be submitted for peer review, as in the case of original articles. The journal provides the best of up-to-date information on breast cancer, presenting readers with high-impact, original work focusing on pivotal issues.
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