Early Results of Hypofractionated Chemoradiation in Cervical Cancer with 44 Gy/ 20 F vs 45 Gy/ 25 F: A Phase II, Open-Label, Randomised Controlled Trial (HYPOCx-iRex Trial).

AIMS: To compare the safety and efficacy of hypofractionated chemoradiation (HYPO) regimen with a conventional fractionation (CVRT) for locally advanced cervical cancer (LACC).

MATERIALS AND

METHODS

A single-centre, open-label, randomised controlled trial enrolled patients with LACC to receive either HYPO (44 Gy/20 fractions) or CVRT (45 Gy/25 fractions) with intensity-modulated radiotherapy, image-guided adaptive brachytherapy, and concurrent weekly cisplatin. The primary outcome was the incidence of acute and late gastrointestinal (GI) and genitourinary (GU) toxicity assessed using the Common Terminology Criteria for Adverse Events version 5.0. Secondary outcomes included health-related quality of life (HRQoL), disease control, and survival.

RESULTS

Forty patients with a median follow-up of 19 months were enrolled (HYPO: n=21; CVRT: n=19). The HYPO achieved a significantly shorter overall treatment time (OTT) compared with CVRT (39 vs 47 days, P < .001). GI and GU toxicities were manageable, with a trend towards higher rates in the HYPO compared with CVRT for both acute (grading [Gr]≥3 CTCAE/patient-reported outcome 43%/29% vs 32%/11%, P=.53/0.24) and actuarial 18-month late GI toxicity (Gr≥2/Gr≥3 26.2%/21.2% vs 20.6%/14.4%, P=.537/0.438), although not statistically significant. No Gr≥3 GU toxicity was observed. HRQoL scores during treatment were lower in the HYPO compared with CVRT; however, recovering within the 3-month post-radiotherapy period. A trend toward superior locoregional control was observed in the HYPO. Notably, para-aortic control at 24 months was significantly higher in the HYPO (100% vs 71.2%, P=.003). No significant differences were observed in local control or overall survival at the time of analysis.

CONCLUSION

HYPO with modern techniques is feasible for LACC, significantly reducing OTT. A trend towards higher yet tolerable acute and late GI toxicity warrants further investigation. Encouragingly, HYPO showed promising locoregional control.

REGISTRATION NUMBER: thaiclinicaltrials.org (TCTR20210812003).