A phase II evaluation of trabectedin in the treatment of advanced, persistent, or recurrent uterine leiomyosarcoma: A gynecologic oncology group study
| Autor: | James J. Burke, Bradley J. Monk, Carolyn Y. Muller, Daron Street, John A. Blessing, Martee L. Hensley |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Leiomyosarcoma medicine.medical_specialty Dioxoles Gynecologic oncology Neutropenia Gastroenterology Disease-Free Survival Drug Administration Schedule Article Uterine cancer Tetrahydroisoquinolines Internal medicine medicine Humans Prospective Studies Infusions Intravenous Prospective cohort study Antineoplastic Agents Alkylating Survival rate Trabectedin Aged Aged 80 and over business.industry Obstetrics and Gynecology Middle Aged medicine.disease Confidence interval Surgery Survival Rate Oncology Uterine Neoplasms Female Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | Gynecologic Oncology. 124:48-52 |
| ISSN: | 0090-8258 |
| Popis: | Objective To estimate activity and safety of trabectedin 1.5mg/m2 IV over 24hours every 3weeks (1 cycle) in uterine leiomyosarcoma. Methods Patients with chemotherapy naive, advanced, persistent or recurrent uterine leiomyosarcoma, acceptable organ function and PS≤2 were eligible. A two-stage design was utilized. Three responses were required in the first stage to initiate the second stage; the target sample size was 40 for the combined stages. If the true response rate was 10%, the study design provided a 95% chance of correctly classifying the treatment as "inactive." Conversely, if the true response rate was 30%, then the average probability of correctly classifying the treatment as active would be 90%. Results Twenty patients were eligible and evaluable. The median number of cycles was 10 (123 total cycles, range 2–29). The number of patients with partial responses was 2 (10%; 95% confidence interval of 1.2%–31.7%). Response durations were 3.3 and 5.7months. Ten patients had stable disease (50%). The median progression-free survival (PFS) and overall survival were 5.8months and greater than 26.1months (median not reached), respectively. Observed grade 3/4 toxicity included: neutropenia 16/20 (1 infection); thrombocytopenia 3/20; metabolic 3/20; anemia, gastrointestinal and vascular 1/20 each. There were no treatment related deaths nor cases of liver failure. Conclusions Although a second stage of accrual was not indicated based on the overall response rate, the drug was well tolerated. |
| Databáze: | OpenAIRE |
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