1. Combination therapy with gemcitabine and docetaxel for patients with metastatic or locally advanced synovial sarcoma met the primary endpoint of 3-month progression-free survival.
Evidence Rating Level: 3 (Average)
Synovial sarcoma (SS) accounts for 5-10% of all soft tissue sarcomas. SS carries a high risk for local recurrence and metastasis. The median 5-year overall survival of metastatic SS is only 10%. Anthracyclines are the standard of first-line care advanced SS. Combination therapy with gemcitabine and docetaxel has not been prospectively studied. Researchers aimed to assess the efficacy, tolerability, and quality of life of this combination therapy for patients with metastatic or unresectable locally advanced SS. Twenty-two participants between the ages of 15 and 60 (median age 32) were enrolled for a single-arm, two-stage, phase II study. 18 participants had metastatic disease, and 4 had locally advanced, unresectable disease. All participants had previously attempted treatment with one line of medical therapy. The chemotherapy regimen for this study included IV gemcitabine 900 mg/m2 on days 1 and 8 and IV docetaxel 75 mg/m2 on day 8 every 21 days. Participants underwent 2-6 cycles, with a median of 4 cycles. The median progression-free survival (PFS) was 3 months (95% CI, 2.3–3.6). 10 patients were progression-free at the end of the study period. Median overall survival was 14 months (95% CI, 8.9–19.0). Between weeks 0 and 12 of the study, participants reported significantly worsened quality of life on both functional and symptom scales. 7 patients developed severe toxicities, including anemia (18%), neutropenia (9%), and mucositis (9%). This study is limited by the single-arm approach. As well, researchers experienced poor participant accrual, leading to a small sample size. Overall, this study demonstrates the potential for combination therapy with Gemcitabine and Docetaxel for patients with metastatic or locally advanced SS, though further research is needed to study this regimen in a larger cohort.
Click to read the study in BMC Cancer
Image: PD
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