294P - Concurrent chemoradiation with cisplatin every 3 weeks in locally advanced cervical cancer: A single arm phase II clinical trial

Background

We aimed to assess the safety and preliminary efficacy of cisplatin every 3 weeks in concurrent chemoradiation in cervical cancer in the era of modern radiotherapy techniques such as IMRT/VMAT.

Methods

This is a single-arm phase 2 clinical trial which included patients with stage IB3-IVA cervical cancer at Vietnam National Cancer Hospital. Neuroendocrine carcinoma was excluded. Patients were treated with definitive chemoradiotherapy with cisplatin 75mg/m2, day 1, 22 and 43 concurrently with external beam radiotherapy and brachytherapy. Treatment completion rate, response rate and toxicities were assessed.

Results

A total of 38 patients were included, with a mean age of 53.3 years (range 33-71). The mean tumor size was 4.31 ± 0.87 cm. Stage IB3, II and III accounted for 2.6%, 44.7% and 52.6% respectively. Thirty-seven patients (97.3%) completed planned treatment protocol, with the mean total time of radiation therapy of 49.8 ± 5.9 days. At 1 month after treatment, the complete clinical response rate was 84.2% (32/38 patients), partial response was recorded in 4 patients with stage IIIC1 and 2 patients with stage IIB. Among these 6 patients, 4 cases had complete response at 3 months after treatment. Grade 3 toxicity included neutropenia (15.8%) and vomiting (13.2%), no febrile neutropenia or life-threatening toxicities were recorded.

Conclusions

Concurrent chemoradiation with cisplatin every 3 weeks is a safe and feasible therapy for locally advanced cervical cancer and might be suitable for places with shortage of facilities and human resources in chemotherapy infusion unit. A larger randomized controlled trial should be done to confirm the efficacy of the 3-weekly schedule.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.