First-Line of Anlotinib Plus Anthracyclines and Ifosfamide Followed by Anlotinib Maintenance in Advanced Soft Tissue Sarcoma: A Phase II Single-Arm Trial
Mené sur 52 patients atteints d'un sarcome des tissus mous (durée médiane de suivi : 29,9 mois), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité d'un traitement de première ligne par anlotinib-anthracyclines-ifosfamide suivi d'un traitement d'entretien par anlotinib
Purpose: This study evaluated the efficacy and safety of first-line anlotinib combined with anthracyclines and ifosfamide, followed by anlotinib maintenance therapy, in patients with advanced soft tissue sarcoma (STS).
Patients and Methods: Patients received 4-6 cycles of combination therapy administered every 21 days, comprising anlotinib (12 mg orally daily on days 1-14), anthracyclines (epirubicin 40 mg/m² daily on days 1-2 or liposomal doxorubicin 30 mg/m² on day 1), and ifosfamide (2 g/m² daily on days 1-3). Following induction therapy, patients without disease progression continued anlotinib maintenance until progression, unacceptable toxicity, or death. The primary endpoint was objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs). The study was registered at Chinese Clinical Trial Registry (ChiCTR2100054711).
Results: A total of 52 patients were enrolled. The ORR was 30.8% (95% confidence interval [CI]: 18.7-45.1%) and DCR was 82.7% (95% CI: 69.7-91.8%). With a median follow-up of 29.9 months (95% CI: 24.6-32.3), the median PFS was 6.2 months (95% CI: 2.6-11.2). The median OS was not reached (95% CI: 14.4-NE). Treatment-related AEs of any grade occurred in all patients. The most frequently reported AEs included fatigue (86.5%), lymphocytopenia (51.9%), and hypoalbuminemia (44.2%). The most common grade 3-4 AEs included anemia (23.1%), leukopenia (17.3%), and thrombocytopenia (9.6%). No treatment-related deaths occurred.
Conclusions: First-line anlotinib combined with anthracyclines and ifosfamide, followed by anlotinib maintenance, demonstrated encouraging efficacy with acceptable toxicities in patients with advanced STS, warranting further investigation in randomized controlled trials.
Clinical Cancer Research , résumé, 2025