Abstract
PURPOSE: Neoadjuvant therapy (NT) given before surgery for gastrointestinal (GI) malignancies can lead to adverse events. Whether patient-reported outcomes (PRO) or quality of life (QOL) during NT is predictive of postoperative complications is unknown. METHODS: A planned secondary analysis of patients with GI cancers undergoing NT utilized a customized mobile-phone application (app) to measure real-time PROs and monthly QOL using FACT-G (Functional Assessment of Cancer Therapy-General). Among surgical patients, the association between QOL and PROs and postoperative Clavien-Dindo grade ≥ 2 complications was analyzed using univariate analyses. RESULTS: Among 104 patients enrolled, 69 (66%) underwent surgery following NT and 20 (28.9%) experienced 30-day complications. There were no differences in baseline demographics, NT duration, or cancer type between Complications and No Complications groups (all p > 0.05). QOL scores at NT start (mean FACT-G Complications 76.1 vs No Complications 75.2), and changes in QOL during NT did not differ between the two cohorts (p > 0.05). PRO entries of those who experienced complications were more likely to report lack of appetite (25.9% vs 14.2%; p < 0.001) and pain (36.6% vs 18.7%; p < 0.001) but less likely to report fatigue (31.9% vs 41.6%; p = 0.009), anxiety (18.1% vs 39.1%; p < 0.001), trouble sleeping (20.8% vs 39.1%; p < 0.001), lack of focus (5.6% vs 18.5%; p < 0.001), depression (0.5% vs 14%; p < 0.001), and frustration (13.9% vs 21.4%; p = 0.01). CONCLUSION: In this prospective cohort study, specific PROs were associated with postoperative complications among those who underwent surgical resection. Further research is needed to assess whether preoperative PROs can guide patient-centered interventions mitigating postoperative complications.