Nanoparticle polymeric micellar paclitaxel combined with gemcitabine in first-line treatment of patients with metastatic pancreatic cancer: A single-arm, phase II clinical study.

Abstract

e16382 Background: Pancreatic cancer remains one of the most lethal malignancies, characterized by limited therapeutic options. This Phase II clinical trial evaluated the efficacy and safety of nanoparticle polymeric micellar paclitaxel(pm-Pac) combined with gemcitabine as first-line treatment for metastatic pancreatic cancer(mPC). Methods: 21 patients with histologically or cytologically confirmed mPC were enrolled. Patients received pm-Pac intravenously at a dose of 230 mg/m² every 3 weeks and gemcitabine hydrochloride for injection at a dose of 1000 mg/m² on Days 1 and 8 of each 3-week cycle for eight cycles. The primary endpoint was progression-free survival(PFS), and the secondary endpoints included objective response rate (ORR), overall survival (OS), disease control rate (DCR), duration of response (DoR), and the safety of the combination therapy. Results: The median progression-free survival (mPFS) was 7.4 months (95% CI: 5.3-9.5). The ORR was 52.4% (95% CI: 29.1%-75.7%), and the DCR was 95.2% (95% CI: 85.3%-100%). Among patients who achieved a partial response, the median DoR was 5.0 months (95% CI: 3.0-6.9). The time to progression (TTP) was 7.4 months (95% CI: 5.3-9.5). There were no treatment-related deaths reported. Grade 3-4 adverse events (AEs) occurred in 81.0% of patients, with neutropenia (38.1%), neuropathy (14.3%), and anemia (9.5%) being the most frequent. Conclusions: In conclusion, the combination of pm-Pac and gemcitabine, as the first-line therapy for mPC, exhibited favorable tolerability and encouraging clinical efficacy. Larger randomized controlled trials are necessary to validate these preliminary findings. Clinical trial information: ChiCTR2300078861 .