Anlotinib combined with carboplatin/paclitaxel and maintenance anlotinib as front-line treatment for newly diagnosed advanced ovarian cancer: A phase II, single-arm, multicenter study (ALTER-GO-010).

5575 Background: Several studies have shown that antiangiogenic drug combined with chemotherapy as first-line treatment, followed by antiangiogenic drug maintenance therapy significantly improve outcomes for patients with ovarian cancer. Anlotinib, a highly effective VEGFRs, FGFRs, PDGFRs and c-kit multi-target tyrosine kinase inhibitor, has been approved for multiple tumor types in China. The aim of this single arm, multicentric, phase II study is to investigate the efficacy and safety of using anlotinib combined with carboplatin/paclitaxel as front-line treatment for advanced ovarian cancer patients. Methods: Eligible patients with FIGO stage III–IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer and ECOG PS 0-1 undergo primary cytoreductive surgery or interval debulking surgery, will receive 6-8 cycles of chemotherapy (paclitaxel 175 mg/m2 + carboplatin area under the curve [AUC] 5 q3w) and anlotinib (12 mg po qd, days 1-14, 21 days per cycle, anlotinib will be omitted from the first treatment cycle to prevent delayed wound healing). After chemotherapy finished, anlotinib continues as maintenance monotherapy until disease progression, unacceptable toxicity, or death. Patients with prior anti-angiogenic therapy or major surgical procedure within 28 days before starting anlotinib therapy will be excluded. The primary endpoint is progression free survival (PFS). Key secondary endpoints include overall response rate, disease control rate per RECIST1.1, overall survival, safety. Results: From 9 Sep 2021 to 30 Jan 2023, 30 pts were enrolled, including 96.7% (29/30) high-grade serous carcinoma (HGSC) and 3.33% (1/30) endometrioid carcinoma (EC). The median age was 56 years old, with 96.7% (29/30) patients in FIGO stage III and 3.33% (1/30) in stage IV Median follow-up was 5.36 (95% CI: 3.68, - 7.98) months. PFS rates at 6 months and 9 months were both 100%. Twenty-nine patients (96.7%) experienced adverse events (AE) of any level. The most common AEs include white blood cell decreased, neutrophil count decreased, anemia, platelet count decreased, lymphocyte count decreased and hypertension. There was no treatment-related death during the study. Conclusions: Preliminary results of anlotinib combined with carboplatin/paclitaxel have shown favorable efficacy and tolerated safety profile in newly diagnosed advanced ovarian cancer patients. Clinical trial information: NCT04807166 .