Abstract
BackgroundThere 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.MethodsThe 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.ResultsA 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).ConclusionNab-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.
Highlights
There is increasing evidence that combination therapy with nanoparticle albumin-bound paclitaxel and programmed cell death protein 1 (PD-1) inhibitor is safe and efficacious in treating many types of malignant tumors
The patient eligibility criteria included: 1) histologically proven soft tissue sarcoma (STS), 2) treatment with nab-paclitaxel plus progressive disease (PD)-1 inhibitor, 3) locally unresectable or multiple metastases, 4) measurable lesions according to the response evaluation criteria in solid tumors (RECIST; version 1.1) [28], and 5) complete clinical data and statistical analysis
Evaluation of adverse events (AEs) and tumor responses We firstly reviewed the baseline the demographics and characteristics of STS patients enrolled in this study
Summary
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. Clinical data demonstrating the effect of this treatment combination for patients with metastatic soft tissue sarcoma (STS) are currently limited. Soft tissue sarcomas (STSs) are malignant tumors originating from the mesenchymal tissue. This type of tumor occurs throughout the body and is typically characterized by an asymptomatic mass. 50% of STSs metastasize primarily to the lungs via blood circulation despite surgery [3]. STS incidence is low (approximately 4 per 100,000), there are over 70 subtypes [1, 4]. Despite each subtype of STS having different sensitivity to radiotherapy or chemotherapy, the first- and second-line chemotherapy regimen for advanced STS is doxorubicin and docetaxel plus gemcitabine, respectively [2, 3].
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