PMID- 35022029 OWN - NLM STAT- MEDLINE DCOM- 20220228 LR - 20220228 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 22 IP - 1 DP - 2022 Jan 12 TI - Nanoparticle albumin-bound paclitaxel and PD-1 inhibitor (sintilimab) combination therapy for soft tissue sarcoma: a retrospective study. PG - 56 LID - 10.1186/s12885-022-09176-1 [doi] LID - 56 AB - 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. CI - (c) 2022. The Author(s). FAU - Tian, Zhichao AU - Tian Z AD - Department of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Dongming Road, Zhengzhou, 450008, Henan Province, China. tianzhichaoyy@163.com. FAU - Dong, Shuping AU - Dong S AD - Department of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Dongming Road, Zhengzhou, 450008, Henan Province, China. FAU - Yang, Yang AU - Yang Y AD - Huanghe Science and Technology College, Zhengzhou, 450063, Henan Province, China. FAU - Gao, Shilei AU - Gao S AD - Department of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Dongming Road, Zhengzhou, 450008, Henan Province, China. FAU - Yang, Yonghao AU - Yang Y AD - Department of Immunotherapy, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, 450008, Henan Province, China. FAU - Yang, Jinpo AU - Yang J AD - Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, 450008, Henan Province, China. FAU - Zhang, Peng AU - Zhang P AD - Department of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Dongming Road, Zhengzhou, 450008, Henan Province, China. FAU - Wang, Xin AU - Wang X AD - Department of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Dongming Road, Zhengzhou, 450008, Henan Province, China. FAU - Yao, Weitao AU - Yao W AD - Department of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Dongming Road, Zhengzhou, 450008, Henan Province, China. LA - eng PT - Journal Article DEP - 20220112 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Albumin-Bound Paclitaxel) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) RN - 8FU7FQ8UPK (sintilimab) SB - IM MH - Adult MH - Albumin-Bound Paclitaxel/*therapeutic use MH - Antibodies, Monoclonal, Humanized/*therapeutic use MH - Antineoplastic Agents/*therapeutic use MH - Female MH - Humans MH - Male MH - Middle Aged MH - Nanoparticles/therapeutic use MH - Retrospective Studies MH - Sarcoma/*drug therapy/mortality/pathology MH - Soft Tissue Neoplasms/*drug therapy/mortality/pathology PMC - PMC8756702 OTO - NOTNLM OT - Angiosarcoma OT - Nanoparticle albumin-bound paclitaxel OT - PD-1 inhibitor OT - Programmed cell death protein 1 OT - Sintilimab OT - Soft tissue sarcoma COIS- The authors declare they have no competing interests. EDAT- 2022/01/14 06:00 MHDA- 2022/03/01 06:00 PMCR- 2022/01/12 CRDT- 2022/01/13 05:40 PHST- 2021/09/21 00:00 [received] PHST- 2022/01/05 00:00 [accepted] PHST- 2022/01/13 05:40 [entrez] PHST- 2022/01/14 06:00 [pubmed] PHST- 2022/03/01 06:00 [medline] PHST- 2022/01/12 00:00 [pmc-release] AID - 10.1186/s12885-022-09176-1 [pii] AID - 9176 [pii] AID - 10.1186/s12885-022-09176-1 [doi] PST - epublish SO - BMC Cancer. 2022 Jan 12;22(1):56. doi: 10.1186/s12885-022-09176-1.