196P - Short course brachytherapy in locally advanced cervical cancer: Safety and response rate

Background

Short course Brachytherapy in locally advanced cervical cancer; safety and response rateShort course Brachytherapy in locally advanced cervical cancer; safety and response rate Overall treatment time (OTT) is an important index for local control in locally advanced cervical cancer patients who recieve definitive chemoradiation (External Beam Radiation Therapy (EBRT) plus Brachytherapy (BT) plus concomittant chemotherapy). In this study, we examined the efficiency and safety of reducing OTT by reducing duration of the brachytherapy to one week in intervention arm versus three weeks in control arm.

Methods

The study was a non-randomized open-label phase II clinical trial, carried out on 49 cervical cancer patients (26 in intervention group and 23 in control) who received EBRT concomitant with Cisplatin and then brachytherapy in order to deliver 60 Gray equivalent total doses in 2-Gy fractions (EQD2) to Intermediate Risk-Clinical Tumor Volume (IR-CTV) and 85-90 Gy EQD2 to High Risk-Clinical Tumor Volume (HR-CTV). In the intervention group, all brachytherapy sessions were performed in 1 week, while for the control group, it was administrated in 3 consecutive weeks. The participants were followed (Minimum follow up time was 6 month and median follow up time was 10 month) to assess response and toxicity of the treatment.

Results

Overall, more than 95% of study participants had a complete response (according to 3 month post-treatment imaging and physical examination) and more than 4.0% reported partial response, and no treatment failure was observed. The complete response in intervention and control groups was 96.1% and 95.6%, respectively (P value > 0.05). There was no difference in treatment side effects between the two groups.

Conclusions

considering that short course brachytherapy was non inferior to conventional course from point of Response Rate and Side Effects during follow up time; so this strategy can be considered as an option for reducing the OTT which can at least cause decreasing the costs. Studies with larger sample size and phase 3 are recommended.

Clinical trial identification

IRCT20200617047815N1.

Editorial acknowledgement

Legal entity responsible for the study

Tehran University of Medical Sciences.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.