A prospective randomized controlled study about oral nutrition supplement in local advanced nasopharyngeal carcinoma patients: An update of long-term survival.

Abstract

e18018 Background : Radiotherapy will aggravate malnutrition of nasopharyngeal carcinoma (NPC) patients and influence the prognosis. However, there is no reliable evidence to confirm the value of nutritional intervention on survival. Our study aims to explore whether preventive oral nutritional supplements (ONS) can improve the long-term survival of locally advanced NPC. Methods: Eligible patients were prospectively enrolled and received induction chemotherapy and concurrent chemoradiotherapy (NCT 02948699). Participants were randomly assigned into two groups at a 1:1 ratio. The intervention group was supplemented with preventive ONS in addition to their standard diet, starting from the initiation of radiotherapy, to achieve an energy intake target of 30 kcal/kg/day. The control group maintained a regular diet and only received additional ONS when experiencing severe malnutrition. We collected data on clinical characteristics before and after treatment, as well as long-term survival outcomes, which were monitored over time. Results: From October 2016 to May 2018, 114 patients (male vs female = 83 vs 31) were randomly assigned into an intervention (n=58) and a control group (n=56). The last follow-up was conducted in May 2023, the median OS and PFS were 63.6 and 62.1 months. There were no significant differences in 5-year OS(86.2% vs 83.9%), PFS (75.9% vs 77.2%), DMFS(84.5% vs 89.3%) and LRRFS (82.8% vs 85.7%) between two groups. In our study, the intervention compliance rate was 56.9% and the reactive intervention rate was 19.6% in the control group. Intervention compliance rate, sex, smoking history, overweight and total protein were significant prognostic factors. Subgroup analysis suggested that the reactive intervention group had more significant decrease in body weight and BMI before and after radiotherapy, higher nasal feeding rate and the worst prognosis (P=0.037). The response intervention rate of female patients was significantly higher than male patients, but the prognosis was also significantly better (96.7% vs 83.1%, p=0.014). Among the male group, weight loss before treatment and continuous weight loss 3 months after radiotherapy, overweight/obesity before and after treatment, high triglyceride, and receiving reactive intervention were significant adverse prognostic factors. Conclusions: Current prophylactic ONS interventions do not significantly improve the long-term survival of local advanced NPC patients, which may be related to poor intervention compliance. Precise nutrition interventions based on different gender, different baseline nutritional status and health status may be needed in the future. Clinical trial information: NCT02948699 .