Key result
Combination therapy with nab-paclitaxel and sintilimab in patients with advanced soft tissue sarcoma demonstrated an objective response rate of 25% and a median progression-free survival of 2.25 months.
Why the study?
Clinical data demonstrating the effect of combination therapy with nab-paclitaxel and a PD-1 inhibitor for patients with metastatic soft tissue sarcoma were limited.
Does nab-paclitaxel plus sintilimab improve progression-free survival and tumor response in patients with metastatic soft tissue sarcoma?
Cohort (n=28)
No
Does nab-paclitaxel plus sintilimab improve progression-free survival and tumor response in patients with metastatic soft tissue sarcoma?
Answers are grounded in this paper and cite their sources.
Combination therapy with nab-paclitaxel and sintilimab demonstrated a 25% objective response rate and a median progression-free survival of 2.25 months in patients with advanced soft tissue sarcoma, with a manageable safety profile.
BACKGROUND: There is increasing evidence that combination therapy with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and programmed cell death protein 1 (PD-1) inhibitor is safe and efficacious in treating many types of malignant tumors. However, clinical data demonstrating the effect of this treatment combination for patients with metastatic soft tissue sarcoma (STS) are currently limited. METHODS: The clinical data of patients with metastatic STS who received nab-paclitaxel plus PD-1 inhibitor (sintilimab) therapy between January 2019 and February 2021 were retrospectively analyzed. The effectiveness and safety of the combined treatment were evaluated in terms of the median progression-free survival (PFS), estimated using the Kaplan-Meier method. The univariate Cox proportional hazards model was used to analyze the relationship between clinicopathological parameters and PFS. All statistical analyses were two-sided; P < 0.05 was considered statistically significant. RESULTS: A total of 28 patients treated with nab-paclitaxel plus sintilimab were enrolled in this study. The objective response rate was 25%, the disease control rate was 50%, and the median PFS was 2.25 months (95% CI = 1.8-3.0 months). The most common grade 1 or 2 adverse events (AEs) were alopecia (89.3%; 25/28), leukopenia (25.0%; 7/28), fatigue (21.4%; 6/28), anemia (21.4%; 6/28), and nausea (21.4%; 6/28). The most common grade 3 AEs were neutropenia (10.7%; 3/28) and peripheral neuropathy (10.7%; 3/28). No grade 4 AEs were observed. Among the present study cohort, patients with angiosarcoma (n = 5) had significantly longer PFS (P = 0.012) than patients with other pathological subtypes, including undifferentiated pleomorphic sarcoma (n = 7), epithelioid sarcoma (n = 5), fibrosarcoma (n = 4), synovial sarcoma (n = 3), leiomyosarcoma (n = 2), pleomorphic liposarcoma (n = 1), and rhabdomyosarcoma (n = 1); those who experienced three or more AEs had significantly longer median PFS than those who experienced less than three AEs (P = 0.018). CONCLUSION: Nab-paclitaxel plus PD-1 inhibitor is a promising treatment regimen for advanced STS. Randomized controlled clinical trials are required to further demonstrate its efficacy and optimal application scenario.
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Tian et al. (2022) conducted a cohort in Advanced soft tissue sarcoma (n=28). Nab-paclitaxel plus sintilimab was evaluated on Median progression-free survival (PFS) (95% CI 1.8-3.0). Combination therapy with nab-paclitaxel and sintilimab in patients with advanced soft tissue sarcoma demonstrated an objective response rate of 25% and a median progression-free survival of 2.25 months.
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