Introduction This study aimed to explore the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-p) combined with carboplatin as a neoadjuvant chemotherapy (NACT) regimen for patients with ovarian cancer (OC).
Methods This is a single-center, open phase Ib/II Clinical Trial (ChiCTR1900026893). We enrolled women with unresectable epithelial OC, FIGO stage III or IV. Patients received 3 cycles of NACT, then interval debulking surgery (IDS), followed by 3–6 cycles of adjuvant chemotherapy. Each 3-week cycle consisted of carboplatin AUC5 plus nab-p 260 mg/m²(Keaili®). In the phase II part, the primary objective was R0 resection rate(figure 1).
Results Phase Ib results showed the NACT was safe and tolerable, so the study proceeded to phase II. A total of 50 patients were included in this analysis, 10 patients in the phase Ib and 40 patients in the phase II. Twenty-nine (58%) patients had stage IV. All patients completed planned NACT and 8 (16%) patients experienced delayed chemotherapy due to adverse events (AE). After NACT, the objective response rate was 81.3% (95%CI: 67.4%-91.1%) in 48 patients who had at least one tumor assessment. Among the 45 patients who underwent IDS, 5 patients (11.1%) had surgery delayed due to AE, all patients achieved optimal debulking and 77.8% (95%CI: 62.9%-88.8%) achieved R0 resection. During NACT, the most common grade 3/4 AEs were hematologic toxicities, including neutropenia (78%), leucopenia (48%) and thrombocytopenia (24%). All AEs returned to normal or acceptable levels after receiving appropriate treatment.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.