Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Bone and Soft Tissue Tumor, Peking University Cancer Hospital & Institute, Beijing, China.
Musculoskeletal Tumor Center, Peking University People's Hospital, Xicheng District, Beijing, China.
Clin Cancer Res. 2022 Aug 15;28(16):3473-3479. doi: 10.1158/1078-0432.CCR-22-0871.
To explore the efficacy and safety of TQB2450 combined with anlotinib in patients with locally advanced or metastatic soft-tissue sarcoma (LA/M STS).
This was a single arm phase II study (TQB2450-Ib-02 study) performed at two hospitals in China to assess the potency of TQB2450 combined with anlotinib in patients with LA/M STS. Patients were previously unresponsive to at least one chemotherapy regimen. Anlotinib (12 mg every day) was administered orally from day 1 to day 14 every 3 weeks. TQB2450 was administered by intravenous infusion at 1,200 mg on day 1 every 3 weeks. The primary endpoint was the objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.
Between January 2019 and June 2020, 30 patients were enrolled. The ORR was 36.67% and the DCR was 76.67%. The median PFS was 7.85 months [95% confidence interval (CI), 2.89-23.06] and the median OS was not reached [95% CI, 10.58-not estimable (NE)]. Among the patients with alveolar soft part sarcoma (ASPS; 12/30, 40%), the ORR was 75% and the median PFS was 23.06 months (95% CI, 8.97-NE). The most common treatment related adverse events were hypothyroidism (76.67%), hypertriglyceridemia (63.33%), hypercholesterolemia (60.00%), and elevated blood lactate dehydrogenase (53.33%).
The study showed the promising activity in patients with ASPS, also indicating the trend of treatment efficacy in other sarcomas. The toxicity was tolerable. More studies with larger sample size and controlled arm were warranted.
探索 TQB2450 联合安罗替尼治疗局部晚期或转移性软组织肉瘤（LA/M STS）的疗效和安全性。
这是一项在中国两家医院进行的单臂 II 期研究（TQB2450-Ib-02 研究），旨在评估 TQB2450 联合安罗替尼在 LA/M STS 患者中的疗效。患者之前对至少一种化疗方案无反应。安罗替尼（每天 12mg）口服，每 3 周 1-14 天给药。TQB2450 静脉输注，每 3 周 1 天 1200mg。主要终点为客观缓解率（ORR）。次要终点包括无进展生存期（PFS）、总生存期（OS）、疾病控制率（DCR）和安全性。
2019 年 1 月至 2020 年 6 月期间，共纳入 30 例患者。ORR 为 36.67%，DCR 为 76.67%。中位 PFS 为 7.85 个月[95%置信区间（CI），2.89-23.06]，中位 OS 未达到[95%CI，10.58-无法估计（NE）]。在 30 例患者中，有 12 例（40%）为腺泡状软组织肉瘤（ASPS），ORR 为 75%，中位 PFS 为 23.06 个月（95%CI，8.97-NE）。最常见的治疗相关不良事件为甲状腺功能减退（76.67%）、高甘油三酯血症（63.33%）、高胆固醇血症（60.00%）和血乳酸脱氢酶升高（53.33%）。
该研究显示 TQB2450 联合安罗替尼在 ASPS 患者中具有良好的疗效，同时也表明该方案在其他肉瘤患者中具有治疗效果的趋势。该方案的毒性是可耐受的。需要更大样本量和对照臂的研究来进一步验证。
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