Electronic Resource

A Randomized Phase II Study of Anti-CSF1 Monoclonal Antibody Lacnotuzumab (MCS110) Combined with Gemcitabine and Carboplatin in Advanced Triple-Negative Breast Cancer.

التفاصيل البيبلوغرافية
العنوان: A Randomized Phase II Study of Anti-CSF1 Monoclonal Antibody Lacnotuzumab (MCS110) Combined with Gemcitabine and Carboplatin in Advanced Triple-Negative Breast Cancer.
المؤلفون: UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, Kuemmel, Sherko, Campone, Mario, Loirat, Delphine, Lopez, Rafael Lopez, Beck, J Thaddeus, De Laurentiis, Michelino, Im, Seock-Ah, Kim, Sung-Bae, Kwong, Ava, Steger, Guenther G, Adelantado, Esther Zamora, Duhoux, Francois, Greil, Richard, Kuter, Irene, Lu, Yen-Shen, Tibau, Ariadna, Özgüroğlu, Mustafa, Scholz, Christian W, Singer, Christian F, Vega, Estela, Wimberger, Pauline, Zamagni, Claudio, Couillebault, Xuan-Mai, Fan, Liqiong, Guerreiro, Nelson, Mataraza, Jennifer, Sand-Dejmek, Janna, Chan, Arlene
المصدر: Clinical cancer research : an official journal of the American Association for Cancer Research, Vol. 28, no.1, p. 106-115 (2022)
بيانات النشر: 2022
نوع الوثيقة: Electronic Resource
مستخلص: This phase II study determined the efficacy of lacnotuzumab added to gemcitabine plus carboplatin (gem-carbo) in patients with advanced triple-negative breast cancer (TNBC). Female patients with advanced TNBC, with high levels of tumor-associated macrophages not amenable to curative treatment by surgery or radiotherapy were enrolled. Lacnotuzumab was dosed at 10 mg/kg every 3 weeks, ± a dose on cycle 1, day 8. Gemcitabine (1,000 mg/m) and carboplatin (dose in mg calculated by area under the curve [mg/mL/min] × (glomerular filtration rate [mL/min] + 25 [mL/min]) were dosed every 3 weeks. Treatment continued until unacceptable toxicity, disease progression, or discontinuation by physician/patient. Patients received lacnotuzumab + gem-carbo ( = 34) or gem-carbo ( = 15). Enrollment was halted due to recruitment challenges owing to rapid evolution of the therapeutic landscape; formal hypothesis testing of the primary endpoint was therefore not performed. Median progression-free survival was 5.6 months [90% confidence interval (CI), 4.47-8.64] in the lacnotuzumab + gem-carbo arm and 5.5 months (90% CI, 3.45-7.46) in the gem-carbo arm. Hematologic adverse events were common in both treatment arms; however, patients treated with lacnotuzumab experienced more frequent aspartate aminotransferase, alanine aminotransferase, and creatine kinase elevations. Pharmacokinetic results showed that free lacnotuzumab at 10 mg/kg exhibited a typical IgG pharmacokinetic profile and target engagement of circulating colony-stimulating factor 1 ligand. Despite successful target engagement and anticipated pharmacokinetic profile, lacnotuzumab + gem-carbo showed comparable antitumor activity to gem-carbo alone, with slightly poorer tolerability. However, the data presented in this article would be informative for future studies testing agents targeting the CSF1-CSF1 receptor pathway in TNBC.
مصطلحات الفهرس: info:eu-repo/semantics/article
URL: http://hdl.handle.net/2078.1/259553
الاتاحة: Open access content. Open access content
info:eu-repo/semantics/embargoedAccess
ملاحظة: English
Other Numbers: UCDLC oai:dial.uclouvain.be:boreal:259553
boreal:259553
info:doi/10.1158/1078-0432.CCR-20-3955
info:pmid/34615719
urn:EISSN:1557-3265
1328224232
المصدر المساهم: UNIVERSITE CATHOLIQUE DE LOUVAIN
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رقم الانضمام: edsoai.on1328224232
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