دورية أكاديمية

Phase II study of dacarbazine given with modern prophylactic anti-emetics and growth factor support to patients with metastatic, resistant soft tissue, and bone sarcoma

التفاصيل البيبلوغرافية
العنوان: Phase II study of dacarbazine given with modern prophylactic anti-emetics and growth factor support to patients with metastatic, resistant soft tissue, and bone sarcoma
المؤلفون: Van Tine, Brian A, Weiss, Mia C, Hirbe, Angela C, Oppelt, Peter J, Abaricia, Sarah, Trinkaus, Kathryn, Luo, Jingqin, Berry, Shellie, Ruff, Tyler, Callahan, Cheryl, Toensikoetter, Jacqui, Ley, Jessica, Siegel, Marilyn J, Dehdashti, Farrokh, Siegel, Barry A, Adkins, Douglas R
المساهمون: National Cancer Institute
المصدر: Rare Tumors ; volume 13, page 203636132110524 ; ISSN 2036-3613 2036-3613
بيانات النشر: SAGE Publications
سنة النشر: 2021
مصطلحات موضوعية: Oncology, Histology
الوصف: Historically, administration of dacarbazine to sarcoma patients was limited by frequent treat-ment-related nausea/vomiting and neutropenia. These toxicities are now largely preventable with contemporary antiemetics and growth factor support. In this single-arm, phase II study, dacarbazine 850 mg/m 2 was given on day 1 of each 3-week cycle until disease progression or intolerance with prophylactic serotonin-3 receptor, neurokinin-1 antagonists, corticosteroids, and pegfilgrastim. Coprimary endpoints included clinical benefit rate (CBR), and any grade of nausea/vomiting and/or grade 3–4 neutropenia. With a sample size of 80 patients, >24 patients with clinical benefit would indicate that the CBR exceeds the historical (<20%) [Power 0.80; alpha 0.05]. In addition, we hypothesized that the rates of nausea/vomiting would be 27% and grade 3–4 neutropenia would be 1% (historical: 90% and 36%, respectively) [power 0.95; alpha 0.05]. The CBR was 30% (24 patients: PR-2 and stable-22). The rate of nausea/vomiting was 37.5% (31 patients) and grades 3–4 neutropenia was 10% (8 patients). Median time-to-progression was 8.1 weeks (95% CI 8–9.7) and median overall survival was 35.8 weeks (95% CI 26.2–55.4). PET scans demonstrated no association with response. Modern prophylactic anti-emetics and pegfilgrastim given with dacarbazine reduced the rates of treatment related nausea/vomiting and serious neutropenia.
نوع الوثيقة: article in journal/newspaper
اللغة: English
DOI: 10.1177/20363613211052498
الإتاحة: https://doi.org/10.1177/20363613211052498Test
حقوق: https://creativecommons.org/licenses/by-nc/4.0Test/
رقم الانضمام: edsbas.CA6D9C6C
قاعدة البيانات: BASE