A phase Ib/II clinical trial has demonstrated promising efficacy and manageable safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin as neoadjuvant chemotherapy for patients with advanced ovarian cancer (OC). The study, published in BMC Medicine, highlights the potential of this regimen to improve outcomes in this challenging patient population.
The trial enrolled 62 patients with advanced epithelial OC, with the majority having high-grade serous carcinoma and FIGO stage III or IV disease. Patients received three cycles of neoadjuvant chemotherapy with nab-paclitaxel and carboplatin, followed by interval debulking surgery (IDS) and postoperative adjuvant chemotherapy. The primary endpoint was overall response rate (ORR) during the neoadjuvant treatment period.
Efficacy Outcomes
The best ORR among all patients was 83.9% (95% CI, 71.7%-92.4%), with 47 patients achieving a partial response (PR). Among the 53 patients who underwent IDS after neoadjuvant chemotherapy, the R0 resection rate was 73.6% (95% CI, 59.7%–84.7%), and the pathological complete response (pCR) rate was 5.7% (95% CI, 1.2%–15.7%).
With a median follow-up of 17.5 months, the median progression-free survival (PFS) was 18.6 months (95% CI, 13.8–23.3 months). The median overall survival (OS) was not reached, with a 1-year OS rate of 89.8% and a 2-year OS rate of 65.7%.
Safety Profile
The most common treatment-related adverse events (TRAEs) of any grade were neutropenia (88.7%) and alopecia (58.1%). Peripheral sensory neuropathy was observed in 21% of patients, with all cases being grade 1 or 2. Grade 3-4 TRAEs, mainly hematologic toxicities, occurred in 79% of patients. No drug-related deaths were reported.
BRCA Status and Treatment Response
Notably, BRCA-positive patients exhibited significantly longer PFS (20.5 months; 95% CI 13.0–28.0%) compared to BRCA-negative patients (12.6 months; 95% CI 7.9–17.2%; p = 0.006). Olaparib was the primary maintenance treatment for BRCA-positive patients, while niraparib was mainly used for BRCA-negative patients.
Implications for Clinical Practice
These findings suggest that nab-paclitaxel plus carboplatin is an effective and well-tolerated neoadjuvant chemotherapy regimen for advanced ovarian cancer. The high ORR and R0 resection rate, coupled with manageable toxicity, support its use in clinical practice. Furthermore, the association between BRCA status and PFS highlights the importance of genetic testing in guiding treatment decisions and maintenance strategies.
Further research is warranted to validate these findings in larger, randomized controlled trials and to explore the potential of combining this regimen with other targeted therapies.
