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
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...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2021-10-01
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| Series: | Rare Tumors |
| Online Access: | https://doi.org/10.1177/20363613211052498 |
| _version_ | 1828946126107049984 |
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| author | Brian A Van Tine Mia C Weiss Angela C Hirbe Peter J Oppelt Sarah Abaricia Kathryn Trinkaus Jingqin Luo Shellie Berry Tyler Ruff Cheryl Callahan Jacqui Toensikoetter Jessica Ley Marilyn J Siegel Farrokh Dehdashti Barry A Siegel Douglas R Adkins |
| author_facet | Brian A Van Tine Mia C Weiss Angela C Hirbe Peter J Oppelt Sarah Abaricia Kathryn Trinkaus Jingqin Luo Shellie Berry Tyler Ruff Cheryl Callahan Jacqui Toensikoetter Jessica Ley Marilyn J Siegel Farrokh Dehdashti Barry A Siegel Douglas R Adkins |
| author_sort | Brian A Van Tine |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T05:03:53Z |
| format | Article |
| id | doaj.art-ef35792130554864b05b1722df7d26bf |
| institution | Directory Open Access Journal |
| issn | 2036-3613 |
| language | English |
| last_indexed | 2024-12-14T05:03:53Z |
| publishDate | 2021-10-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Rare Tumors |
| spelling | doaj.art-ef35792130554864b05b1722df7d26bf2022-12-21T23:16:09ZengSAGE PublishingRare Tumors2036-36132021-10-011310.1177/20363613211052498Phase II study of dacarbazine given with modern prophylactic anti-emetics and growth factor support to patients with metastatic, resistant soft tissue, and bone sarcomaBrian A Van Tine0Mia C Weiss1Angela C Hirbe2Peter J Oppelt3Sarah Abaricia4Kathryn Trinkaus5Jingqin Luo6Shellie Berry7Tyler Ruff8Cheryl Callahan9Jacqui Toensikoetter10Jessica Ley11Marilyn J Siegel12Farrokh Dehdashti13Barry A Siegel14Douglas R Adkins15Siteman Cancer Center, St. Louis, MO, USASiteman Cancer Center, St. Louis, MO, USASiteman Cancer Center, St. Louis, MO, USASiteman Cancer Center, St. Louis, MO, USADivision of Medical Oncology, Washington University in St. Louis, St. Louis, MO, USADepartment of Biostatistics, Washington University in St. Louis, St. Louis, MO, USADepartment of Biostatistics, Washington University in St. Louis, St. Louis, MO, USADivision of Medical Oncology, Washington University in St. Louis, St. Louis, MO, USADivision of Medical Oncology, Washington University in St. Louis, St. Louis, MO, USADivision of Medical Oncology, Washington University in St. Louis, St. Louis, MO, USADivision of Medical Oncology, Washington University in St. Louis, St. Louis, MO, USADivision of Medical Oncology, Washington University in St. Louis, St. Louis, MO, USAMallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, MO, USAMallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, MO, USAMallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, MO, USASiteman Cancer Center, St. Louis, MO, USAHistorically, 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.https://doi.org/10.1177/20363613211052498 |
| spellingShingle | Brian A Van Tine Mia C Weiss Angela C Hirbe Peter J Oppelt Sarah Abaricia Kathryn Trinkaus Jingqin Luo Shellie Berry Tyler Ruff Cheryl Callahan Jacqui Toensikoetter Jessica Ley Marilyn J Siegel Farrokh Dehdashti Barry A Siegel Douglas R Adkins 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 Rare Tumors |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://doi.org/10.1177/20363613211052498 |
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