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

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

Research output: Contribution to journalArticlepeer-review

Abstract

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/m2 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.

Original languageEnglish
JournalRare Tumors
Volume13
DOIs
StatePublished - 2021

Keywords

  • PET
  • Soft tissue sarcoma
  • bone sarcoma
  • dacarbazine
  • nausea
  • vomiting

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