A phase II study of anlotinib plus albumin-bound paclitaxel in patients with recurrent, platinum-resistant primary epithelial ovarian or peritoneal carcinomar (A-Plus trial): Updated efficacy and safety.

5557 Background: Initial results of the open-label, single-arm phase II clinical trial, we had demonstrated anlotinib plus albumin-bound paclitaxel treatment activity and favorable tolerance in patients with recurrent, platinum-resistant primary epithelial ovarian or peritoneal carcinoma (SGO 2023. Oral featured poster 549). Here we update the latest efficacy and safety data in enrolled patients. Methods: In this study, 44 patients diagnosed with platinum-resistant or platinum-refractory ovarian cancer were planned to be enrolled. Patients received ab-paclitaxel 260 mg/m2 given by intravenous infusion over 30 min every 3 weeks and anlotinib (10mg, po, qd, for 14 days, every 3 weeks) until disease progression or intolerable toxicity. For efficacy evaluation, the following were required: measurable disease defined by RECIST 1.1, or if there were no measurable lesions but an elevated CA125 with significant symptoms such as abdominal pain, bloating, or pleural effusion/ascites (Rustin criteria). The primary end point were investigator-confirmed objective response rate (ORR). Results: From January 2021 to March 2023, 44 patients were enrolled with a median age of 49 years(range, 40-66). 29 patients had measurable lesions and 15 patients had no measurable lesions but an elevated CA125 evaluated according to Rustin criteria. As of efficacy evaluation, 43 out of 44 patients can be analyzed and one without measurable lesions can not be included due to the absence of a post-treatment data. Among the 29 patients with measurable lesions, 16 (55.2%; 95% CI 0.359-0.730) achieved objective responses, including CR in two patients, PR in fourteen, stable disease in thirteen, and PD in zero. In the group of 14 patients without measurable lesions, 9 (60%; 95% CI 0.328-0.825) achieved responses, including CA 125 responses in nine patients, CA 125 no response in four, and CA125 disease progression in one. Overall responses were observed in 25 out of 44 patients (56.8%; 95% CI 0.411-0.713) in the intention-to-treat population, and in the per-protocol population, the response was seen in 25 out of 43 patients (58.1%; 95% CI 0.422-0.726). The grade 3/4 AEs encompassed leukopenia (31 patients, 70.5%), gum-pain (10 patients, 22.7%), hypertension (10 patients, 22.7%), Hand-foot syndrome (4 patients, 9.1%). Conclusions: Updated results reconfirm a favorable antitumor activity and manageable safety from anlotinib plus albumin-bound paclitaxel in the treatment of recurrent ovarian or peritoneal carcinoma. Further survival results are expected. Clinical trial information: ChiCTR2100054329.