Gemcitabine and docetaxel combo shows promise in treating synovial sarcoma
The combination of gemcitabine and docetaxel shows promise as a treatment option for patients with advanced, relapsed synovial sarcoma (SS), according to the results of a Phase 2 study.
Although the study had to be closed early due to slow accrual, the therapy demonstrated clinically meaningful outcomes, including a 3-month progression-free rate (PFR) of 45.4% and an overall response rate (ORR) of 4.5%. The treatment also exhibited a manageable toxicity profile, and the quality of life analysis showed stable global health status.
Patients received gemcitabine intravenously at a dose of 900 mg/m2 on days 1 and 8, along with docetaxel at a dose of 75 mg/m2 on day 8, administered every 21 days.
Twenty-two patients were enrolled in the study between March 2020 and September 2021. However, due to slow accrual, the study had to be closed early. Among the participants, 18 (81.8%) had metastatic disease, while 4 (18.2%) had locally advanced, unresectable disease. The most common primary sites of the disease were the extremities in 15 (68%) patients, and the median number of prior therapies received was 1, ranging from 1 to 4.
The primary endpoint of the trial was the 3-month PFR. There was 3-month PFR of 45.4% (95% CI 24.8-66.1) and an ORR of 4.5%. The median progression-free survival (PFS) was 3 months (95% CI 2.3-3.6), and the median overall survival (OS) was 14 months (95% CI 8.9-19.0).
In terms of safety, 7 (31.8%) patients experienced ≥grade 3 toxicities, including anemia (18%), neutropenia (9%), and mucositis (9%). Quality of life analysis demonstrated a significant decline in certain functional and symptom scales, while the financial and global health scales remained stable.
Tansir G, Rastogi S, Kumar A, et al. A phase II study of gemcitabine and docetaxel combination in relapsed metastatic or unresectable locally advanced synovial sarcoma. BMC Cancer. 2023;23(1):639. doi: 10.1186/s12885-023-11099-4. PMID: 37422615.