Objective Response, Overall Survival
Conditions
Keywords
Epithelioid sarcoma, systemic treatment, objective response, toxicity
Brief summary
Epithelioid sarcoma is a rare soft tissue sarcoma characterized by SMARCB1/INI1 deficiency. Much attention has been paid to the selective EZH2 inhibitor tazemetostat, where other systemic treatments are generally ignored. To explore alternative treatment options, we studied the effects of irinotecan-based chemotherapy in a series of epithelioid sarcoma patients.
Interventions
DRUGVIA combination treatment
a 90-minute intravenous infusion of irinotecan at a dose of 50 mg/m2/d for 5 days every 3 weeks, vincristine given at a dose of 1.4 mg/m2 (maximum 2 mg) on days 1 and 8, and oral administration of Anlotinib once daily on days 1-14 within a 21-day cycle.
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1) Grade 2 or 3 ES confirmed histologically using the American Joint Committee on Cancer (AJCC) system ; * (2) patients presented with measurable lesions using the Response Evaluation Criteria In Solid Tumors (RECIST1.1) and were not amenable to surgical resection or radiotherapy; * (3) primary or secondary metastatic disease; * (4) received more than two courses of the VIA regimen; * (5) no concurrent treatment was given while on the VIA regimen; * (6) follow-up information and evaluation after chemotherapy were available.
Exclusion criteria
* less than 4 cycles of treatment; * medical records were not complete.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 12 weeks | Based on RECIST1.1 criteria, clinical evaluation was done once every 6 weeks |
Countries
China
Outcome results
None listed