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Objective: To examine the efficacy and safety of anlotinib as firstline therapy to treat locally advanced or metastatic soft-tissue sarcoma. Methods: This is a single-arm trial. Treatment-naive patients (≥14 years) with locally advanced or metastatic soft tissue sarcoma were eligible. Each treatment cycle lasted for 3 weeks, and included liposomal doxorubicin (40-50 mg/m2) on day 1 and anlotinib (12 mg) on days 8-21. Starting from the 9th cycle, treatment consisted of only anlotinib. Treatment continued until disease progression or intolerable toxicities. The primary efficacy end point was progression-free survival (PFS). Results: Eight patients were enrolled between July 25, 2019 and January 8, 2020. The median number of treatment cycles was 5.5. Within 5.9 months median follow-up, PFS events occurred in 4 (4/8, 50%) patients. The median PFS was 11.3 months and the 6-month PFS rate was 56%. No patients attained complete response and 2 patients (fibrosarcoma, 1 patient and undifferentiated pleomorphic sarcoma, 1 patient) achieved partial response. Three patients (fibrosarcoma, 2 patients and synovial sarcoma, 1 patient) had stable disease. The objective response rate was 25% (2/8) for the study population, and the disease control rate was 75% (6/8). No new safety concerns emerged. Conclusions: Anlotinib plus liposomal doxorubicin demonstrated antitumor activities in previously untreated locally advanced or metastatic soft tissue sarcomas. Due to the small sample size, further investigations with a larger population should be undertaken to confirm the study findings.
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ABSTRACT Objective: The aim of this study was to describe the real-world experience multikinase inhibitors (MKI) in the treatment advanced differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAIR) therapy. Subjects and methods: We reviewed the records of all patients with MKI-treated DTC from 2010 to 2018. Progression free survival (PFS), response rates (RR) and adverse events (AE) profiles were assessed. Clinical parameters were compared between groups with different outcomes (disease progression and death) to identify possible prognostic factors and benefit from treatment. Results: Forty-four patients received MKI for progressive RAIR DTC. Median PFS was 24 months (10.2-37.7) and median overall survival (OS) was 31 months. Best overall response was complete response in one patient (4.5%), partial response in nine (20.4%), stable disease in twenty-two (50%), and progressive disease (PD) in twelve (27.3%). Seventy-two point 7 percent patients had clinical benefit and AE were mild in most cases (82.7%). Progressive patients were more likely to have FDG positive target lesion than those who did not progress (p = 0.033) and higher maximum SUV on target lesions (p = 0.042). Presence of lung-only metastasis and lower thyroglobulin (Tg) during treatment was associated with stable disease (p = 0.015 and 0,049, respectively). Patients with shorter survival had larger primary tumor size (p = 0.015) and higher maximum SUV on target lesions (p = 0.023). Conclusion: Our findings demonstrate safety and effectiveness of MKI in patients with advanced RAIR DTC. We were able to identify as possible prognostic markers of better outcomes: absence of FDG uptake on target lesions, lower maximum SUV on PET-CT, presence of lung-only metastasis and lower Tg during treatment.