Hypofractionated 44 Gy in 20 fractions versus conventional chemoradiation in cervical cancer: 2-year results of the randomized HYPOCx-iRex trial with an exploratory pooled analysis of a single-institute EMBRACE-II cohort

Information from the abstract

PURPOSE: To evaluate 2-year late gastrointestinal (GI) toxicity, oncologic outcomes, and cost-effectiveness of hypofractionated concurrent chemoradiation with 44 Gy in 20 fractions (44 Gy/20F; HYPO) versus conventional fractionation (45 Gy/25F; CVRT + EMB) for locally advanced cervical cancer (LACC). METHODS: The primary analysis was the randomized HYPOCx-iRex comparison (HYPO n = 21 vs. CVRT n = 19). A pre-planned pooled analysis additionally incorporated a concurrent, nonrandomized single-institute EMBRACE-II cohort (EMB n = 28; total n = 68). Late GI toxicity was graded by CTCAEv5.0. Dose-toxicity analysis used Cox and Probit regression to identify the effective dose associated with 10% toxicity probability (ED10). The indirect ratio of excess dose volume at 60 Gy EQD2 (iRex60) was evaluated as a brachytherapy (BT) conformity index. Locoregional control (LRC) and overall survival (OS) were estimated by Kaplan-Meier. Incremental cost-effectiveness ratios (ICERs) were calculated from provider and societal perspectives. RESULTS: Median overall treatment time was 39 versus 46 days in HYPO versus CVRT+EMB (p < 0.001). Late GI toxicity was numerically higher in HYPO (2-year Gr ≥2: 23.8% vs. 10.8%, pLR = 0.168; Gr ≥3: 19.1% vs. 5.3%, pLR = 0.066); iRex60 was identified as an independent predictor in multivariable regression (ED10 = 1.6 and 1.85 for Gr ≥2/Gr ≥3; proposed cut-off iRex60

Why this record is monitored

This record has an Impact Signal of 75/100 based on recency, source, collaboration, and bibliographic signals. It prioritizes monitoring and is not a judgment of research quality.

Related topics: Endometrial and Cervical Cancer Treatments · Cervical Cancer and HPV Research · Advanced Radiotherapy Techniques