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.

Conclusion/Implications Nab-p plus carboplatin as a NACT regimen was effective and tolerable for unresectable epithelial OC.

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Abstract EP326/#380 Figure 1

Study design