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Evaluation of epothilone B analog in advanced soft tissue sarcoma: a phase II study of the phase II consortium
Scott Okuno1, William J Maples, Michelle R Mahoney
1Mayo Clinic College of Medicine, 200 First St, Southwest, Medical Oncology, Rochester, MN 55905, USA. okuno.scott@mayo.edu
Purpose:
Epothilones are a new class of nontaxane tubulin polymerization agents that have activity in taxane-resistant tumors. Epothilone B (BMS-247550) is a semisynthetic analog of the natural product epothilone B. This study was performed to determine the activity of BMS-247550 in patients with soft tissue sarcomas (STSs) who had not received prior chemotherapy for metastatic disease.
Patients And Methods:
Patients with measurable, advanced, or metastatic STS with no prior chemotherapy for metastatic disease were treated with BMS-2457550 50 mg/m(2) intravenously during 1 hour every 21 days. All responses were confirmed 4 weeks later.
Results:
Thirty-one patients (median age, 54 years; range, 19 to 78 years; 48% female) were entered onto the trial and were assessable for response. All but one patient had an Eastern Cooperative Oncology Group performance score of 0% or 1%, and 39% had received prior adjuvant chemotherapy. Mean follow-up was 22 months, with a confirmed response rate of 6% (95% CI, 0% to 17%). Median time to progression was 4.5 months (95% CI, 1.9 to 8.3 months), and 1 year progression-free survival was 17% (95% CI, 8% to 38%). Median survival was 16.4 months, with a 1-year survival of 61% (95% CI, 46% to 81%). Toxicity was mainly hematologic, with eight of 31 (26%) patients experiencing grade 3 to 4 leukopenia; 15 of 31 patients (48%) experienced grade 3 to 4 neutropenia. The grade 3 to 4 nonhematologic toxicities included neuropathies (26%), myalgia (13%), and fatigue (10%).
Conclusion:
BMS-247550 has limited activity against STSs when given in this dose and schedule. The clinical toxicity is similar to that of taxanes.
Insights
Epothilone B (BMS-247550) showed limited activity in patients with soft tissue sarcomas (STSs). The drug
Area of Science:
- Oncology
- Pharmacology
- Cancer Therapeutics
Background:
- Epothilones represent a novel class of non-taxane tubulin polymerization agents.
- These agents demonstrate efficacy in tumors resistant to taxanes.
- Epothilone B (BMS-247550) is a semi-synthetic analog of epothilone B.
Purpose of the Study:
- To evaluate the activity of Epothilone B (BMS-247550) in patients with soft tissue sarcomas (STSs).
- To assess efficacy in patients with metastatic STSs who have not received prior chemotherapy.
Main Methods:
- Patients with measurable, advanced, or metastatic STS received BMS-247550 at 50 mg/m² intravenously every 21 days.
- Responses were confirmed after 4 weeks.
- Thirty-one patients were assessable for response.
Main Results:
- A confirmed response rate of 6% was observed (95% CI, 0% to 17%).
- Median time to progression was 4.5 months; 1-year progression-free survival was 17%.
- Grade 3-4 hematologic toxicities included leukopenia (26%) and neutropenia (48%); nonhematologic toxicities included neuropathies (26%).
Conclusions:
- BMS-247550 demonstrated limited activity against STSs at the tested dose and schedule.
- The observed clinical toxicity profile is comparable to that of taxanes.
