LAUSR

Simple Summary More than 80% of global cervical cancer cases and deaths occur in Low-to-Middle-Income Countries. Improving the efficacy of treatments without increasing the costs in these regions is therefore imperative. The aim of our Phase III Randomised Controlled Trial was to investigate the effects of the addition of a mild heating technology, modulated electro-hyperthermia, to chemoradiotherapy protocols for the management of locally advanced cervical cancer patients in a resource-constrained setting. We previously reported on the positive outcomes on local disease control, quality of life, and early toxicity. Our recent results showed a significant improvement in two and three year disease free survival, without any significant changes to the toxicity profile, and with an improvement in quality of life, alongside a cost saving over three years. The effect was most significant in patients with Stage III disease, and a significant systemic effect was observed in patients with distant nodal metastases. Abstract (1) Background: Modulated electro-hyperthermia (mEHT) is a mild to moderate, capacitive-coupled heating technology that uses amplitude modulation to enhance the cell-killing effects of the treatment. We present three year survival results and a cost effectiveness analysis from an ongoing randomised controlled Phase III trial involving 210 participants evaluating chemoradiotherapy (CRT) with/without mEHT, for the management of locally advanced cervical cancer (LACC) in a resource constrained setting (Ethics Approval: M120477/M704133; ClinicalTrials.gov ID: NCT033320690). (2) Methods: We report hazard ratios (HR); odds ratio (OR), and 95% confidence intervals (CI) for overall survival and disease free survival (DFS) at two and three years in the ongoing study. Late toxicity, quality of life (QoL), and a cost effectiveness analysis (CEA) using a Markov model are also reported. (3) Results: Disease recurrence at two and three years was significantly reduced by mEHT (HR: 0.67, 95%CI: 0.48–0.93, p = 0.017; and HR: 0.70, 95%CI: 0.51–0.98, p = 0.035; respectively). There were no significant differences in late toxicity between the groups, and QoL was significantly improved in the mEHT group. In the CEA, mEHT + CRT dominated the model over CRT alone. (4) Conclusions: CRT combined with mEHT improves QoL and DFS rates, and lowers treatment costs, without increasing toxicity in LACC patients, even in resource-constrained settings.