Sep 28

QP 14 - Modernizing Definitive Therapy in Cervical Cancer: From Systemic Intensification to Adaptive Radiation

LBA 22 - Nab-Paclitaxel and Cisplatin with Image Guided Volumetric Modulated Arc Therapy for Locally Advanced Cervical Cancer: A Multicenter, Single-Arm Phase II Trial

05:20pm - 05:25pm ET

Room 204

Presenter(s)

Shuhua Wei, PhD - Peking University Third Hospital, Beijing, Beijing

S. Wei¹, X. Deng¹, A. Qu¹, W. Jiang¹, Q. Han¹, F. Guo¹, B. Sun², J. Wang¹, and P. Jiang¹; ¹Department of Radiation Oncology, Peking University Third Hospital, Beijing, China, ²Department of Radiotherapy, Tumor Hospital of Jilin Province, Changchun, Jinlin, China

Purpose/Objective(s):

Building upon our earlier phase I dose-escalation study, which established recommended dose of nab-paclitaxel, this Phase II trial aims to evaluate the clinical efficacy of nab-paclitaxel plus cisplatin concurrent with image-guided volumetric modulated arc therapy (IG-VMAT) in locally advanced cervical cancer (LACC).

Materials/Methods:

This study is a multicenter, open-label, prospective phase II trial. Newly diagnosed, treatment-naïve patients aged 18–75 years with histologically confirmed, LACC (FIGO 2018 stage IB3–IVA) were enrolled from two oncology centers in China. External beam radiotherapy was delivered using IG-VMAT, prescribing 50.4 Gy in 28 fractions to the whole pelvis with a simultaneous integrated boost of 59.4 Gy to involved pelvic/para-aortic lymph nodes, followed by high-dose-rate intracavitary brachytherapy (30.0–36.0 Gy in 5–6 fractions, twice weekly). Concurrent chemotherapy consisted of weekly cisplatin (40 mg/m²) plus weekly nab-paclitaxel (33 mg/m²). The primary endpoint was objective response rate (ORR). Secondary endpoints included adverse event (AE) and progression-free survival (PFS). The trial is registered at ClinicalTrials.gov (NCT06426056).

Results:

From June 24, 2024, to April 20, 2026, 64 patients were enrolled. As of June 30, 2026, the median follow-up was 11.2 months (IQR, 5.7–17.8). The median treatment duration was 51 days (IQR, 48–55), with a median of 6 chemotherapy cycles administered (IQR, 5–6). Before brachytherapy initiation, the ORR was 81.3% (95% CI, 70.0%–88.9%), including 26.6% (95% CI, 17.3%–38.5%) with complete response (CR) and 54.7% (95% CI, 42.6%–66.3%) with partial response (PR). At 1 month after treatment completion, the ORR increased to 100% (95% CI, 94.4%–100.0%), with 87.5% (95% CI, 77.2%–93.5%) achieving CR and 12.5% (95% CI, 6.5%–22.8%) achieving PR. The most common treatment-related adverse events (TRAEs) were hematologic and gastrointestinal. Leukopenia occurred in all patients (100%), with anemia in 61 (95.3%), neutropenia in 59 (92.2%), and nausea in 53 (82.8%). Grade =3 AEs were observed in 46 (71.9%) for leukopenia, 18 (28.1%) for neutropenia, and 11 (17.2%) for anemia. The 1-year PFS rate was 97.92% (95% CI, 93.88%–100.00%) and the 2-year PFS rate was 91.39% (95% CI, 81.87%–100.00%); the median PFS was not reached.

Conclusion:

Nab-paclitaxel and cisplatin concurrent with IG-VMAT is a safe and effective regimen for LACC, demonstrating promising early response and a manageable toxicity profile. These results support further evaluation in a phase III randomized trial.