Neoadjuvant Chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER PRODIGE 23): Health-Related Quality of Life longitudinal analysis
Menée dans 35 hôpitaux français auprès de 461 patients atteints d'un cancer du rectum localement avancé, cette étude analyse la qualité de vie après une chimioradiothérapie seule ou associée à une chimiothérapie néoadjuvante avec FOLFIRINOX
Background: Results from the phase 3 PRODIGE 23 study showed that neoadjuvant chemotherapy with mFOLFIRINOX and preoperative chemoradiotherapy improved disease-free survival compared with preoperative chemoradiotherapy in patients with locally advanced rectal cancer. We aimed to assess the health-related quality-of-life (HRQOL) outcomes from this study. Patients and Methods: A total of 461 patients (231 vs 230 patients) from 35 French hospitals were randomly assigned to either neoadjuvant chemotherapy (NAC) with FOLFIRINOX (oxaliplatin 85mg/m2, irinotecan 180mg/m2, leucovorin 400mg/m2, fluorouracil 2400mg/m2 over 46h intravenously every 2 weeks for 6 cycles) followed by preoperative chemoradiotherapy or chemoradiotherapy only. HRQOL was assessed at baseline, during treatments and at 2-year follow-up using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR29 questionnaires. Results: Compared to baseline, HRQOL scores during neoadjuvant chemotherapy were better for tumor symptoms but worse for global health status, functional domains, fatigue, nausea/vomiting and appetite loss. During follow-up, improved emotional functioning was observed, but deterioration of body image, increased urinary incontinence, and lower male sexual function were observed. Linear mixed model exhibited a treatment-by-time interaction effect for nausea/vomiting and insomnia symptoms showing a greater deterioration in the standard-of-care group. Only treatment arm and baseline physical functioning were independent significant favorable prognostic factors. Conclusion: Neoadjuvant chemotherapy improved tumor-related symptoms and transitorily reduced most functional scores. Adding neoadjuvant chemotherapy before chemoradiotherapy and increased physical functioning at baseline were independent significant prognostic factors for longer disease-free survival.