Abstract
Patients: Soft tissue sarcomas are uncommon malignancies with few therapeutic options for recurrent or metastatic disease. Dolastatin-10 (Dol-10) is a pentapeptide anti-microtubule agent that binds to tubulin sites distinct from vinca alkaloids. Based on the novel mechanism of action, limited activity of other anti-microtubular agents, and anti-neoplastic activity in pre-clinical screening of Dol-10, this multi-institutional phase II study was conducted to determine the objective response rate of Dol-10 in recurrent or metastatic soft tissue sarcomas that had not been treated with chemotherapy outside of the adjuvant setting.Methods: Dol-10 was given intravenously at a dose of 400 μg/m2 and repeated every 21 days. Toxicities were assessed using the Common Toxicity Criteria (version 2.0). Radiographic studies and tumor measurements were repeated every two cycles to assess response [Miller AB, et al. Cancer 1981; 47(1): 207].Results: Dol-10 was associated with hematological toxicity and with some vascular toxicities. There was no significant gastrointestinal, hepatic or renal toxicity. There was one death on study due to respiratory failure. There were no objective responses in 12 patients treated with Dol-10.Discussion: Based on this phase II trial, further study of Dol-10 on this schedule is not recommended in advanced or metastatic soft tissue sarcomas.
Highlights
Soft tissue sarcomas (STS) are an uncommon tumor with poor survival
Pretreatment was minimal with only one patient treated with chemotherapy in the adjuvant setting
This study evaluated a new anti-microtubular agent in patients with recurrent or metastatic disease who were chemotherapy naıve with the exception of adjuvant therapy
Summary
Soft tissue sarcomas (STS) are an uncommon tumor with poor survival. Clinical trials of doxorubicin as a single agent or in combined modality therapies have demonstrated response rates in the range of 15–34%, without evidence for a survival benefit.[2,3,4,5] The anti-tumor activity of other chemotherapeutic agents,[6,7,8,9,10] high dose therapy with transplantation,[11,12] and immunological therapies[13,14,15,16] have not been encouraging. Given the limited activity of agents available for the treatment of soft tissue sarcoma, a trial testing a new agent as first line therapy was considered acceptable
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