1079 - Nab-Paclitaxel plus Cisplatin Concurrent with Image Guided Volumetric Modulated Arc Therapy for Locally Advanced Cervical Cancer: Five-Year Follow-Up Results of a Single-Arm, Prospective Study

Purpose/Objective(s):

A prior dose-escalation trial established the recommended dose of nanoparticle albumin-bound (nab)-paclitaxel in this setting, however, long-term follow-up data from that study have not been reported. This study aims to present the 5-year follow-up results of nab-paclitaxel plus cisplatin concurrent with radiotherapy for locally advanced cervical cancer (LACC).

Materials/Methods:

Newly diagnosed, treatment-naive patients aged 18-75 years with an ECOG performance status 0-2 and histologically confirmed LACC (FIGO 2018 IB3-IVA) were included. The radiotherapy regimen consisted of image-guided volumetric modulated arc therapy delivering pelvic external beam radiotherapy (59.4 Gy in 28 fractions) with a simultaneous integrated boost to involved pelvic or para-aortic lymph nodes, followed by high-dose-rate intracavitary brachytherapy (30 Gy in 5 fractions). Concurrent chemotherapy comprised weekly cisplatin (40 mg/m²) plus nab-paclitaxel, administered at dose levels of 10, 20, 33, 50, and 70 mg/m². For this long-term follow-up analysis, the primary endpoint was 5-year progression-free survival (PFS). Secondary endpoints included 5-year overall survival (OS) and late adverse event (AE). The trial is registered at clinicaltrials.gov (NCT04017377).

Results:

Between Sep 2019 and Aug 2021, twenty-two patients were enrolled. The best overall response rate was 100% (95% CI, 84.6–100.0), with all patients achieving a complete response (CR). Grade 3 or higher AEs included leukopenia in 14 patients (63.6%), anemia in 2 (9.1%), thrombocytopenia in 1 (4.5%), subcutaneous edema in 1 (4.5%), thrombophlebitis in 2 (9.1%), and hypokalemia in 1 (4.5%). As of the data cutoff date (Feb 10, 2026), the median follow-up was 68.1 months (IQR, 59.0–74.7). The local control rate was 95.5% (95% CI, 77.2–99.9). The 5-year PFS and OS rates were both 95.5% (95% CI, 86.8–100.0). Four patients (18.2%) developed late radiation-related AEs (Grade 2 radiation proctitis in two [9.1%] and Grade 2 radiation urethritis in two [9.1%]), all of which resolved with symptomatic management.

Conclusion:

Nab-paclitaxel and cisplatin combined with concurrent radiotherapy is a safe and effective treatment regimen for LACC. The long-term follow-up data from this study provide robust evidence to support future phase II and III clinical trials.