Frontline anlotinib-containing regimen shows promise in advanced soft-tissue sarcoma

In the treatment of patients with advanced soft-tissue sarcoma, combining anlotinib with anthracyclines and ifosfamide in the first-line setting followed by anlotinib maintenance has demonstrated promising efficacy, with acceptable toxicities, in a phase II study.

The study included 52 patients who received four to six cycles of combination therapy administered every 21 days. The combination regimen consisted of anlotinib 12 mg taken orally daily on days 1–14, anthracyclines (epirubicin 40 mg/m² administered on days 1–2 or liposomal doxorubicin 30 mg/m² on day 1), and ifosfamide 2 g/m² administered on days 1–3. Following induction therapy, patients showing no disease progression continued taking anlotinib in the maintenance phase until progression, unacceptable toxicity, or death.

Objective response rate was the primary endpoint. Secondary endpoints included disease control rate, progression-free survival (PFS), overall survival (OS), and adverse events (AE).

Over a median follow-up of 29.9 months, the objective response rate was 30.8 percent (95 percent confidence interval [CI], 18.7–45.1), and the disease control rate was 82.7 percent (95 percent CI, 69.7–91.8).

The median PFS was 6.2 months (95 percent CI, 2.6–11.2), while the median OS was not reached (95 percent CI, 14.4–not estimable).

In terms of safety, all patients experienced treatment-related AEs, including nausea (100 percent), fatigue (86.5 percent), and hypoalbuminemia (44.2 percent). Frequently reported grade 3–4 AEs were anaemia (23.1 percent), leukopenia (17.3 percent), and thrombocytopenia (9.6 percent). No treatment-related deaths occurred.