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. 2025 Jul 2;56(1):146.
doi: 10.1007/s12029-025-01268-y.

Patient-Reported Outcomes During Neoadjuvant Therapy for Gastrointestinal Cancer and Their Association with Postoperative Complications

Alexander H Shannon  1 , Samantha M Ruff  1 , Marilly Palettas  1 , Angela Sarna  1 , Emily Huang  1 , Peter J Kneuertz  1 , Mary Dillhoff  1 , Aslam Ejaz  2 , Timothy M Pawlik  1 , Jordan M Cloyd  3
Affiliations

Patient-Reported Outcomes During Neoadjuvant Therapy for Gastrointestinal Cancer and Their Association with Postoperative Complications

Alexander H Shannon et al. J Gastrointest Cancer. .

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.

Keywords: Colorectal cancer; Esophageal cancer; Hepatopancreatobiliary surgery; Patient-reported outcome measures; Preoperative therapy Pancreatic cancer.

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Conflict of interest statement

Declarations. Ethics Approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the clinical scientific review committee and institutional review board of The Ohio State University (#2020C0071). Consent to Participate: Informed consent was obtained from all individual participants included in the study. Conflict of interest: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
A Percentage of patients reporting symptoms at least once during NT. B Percentage of entries reporting symptoms during NT. Abbreviations: NT, neoadjuvant therapy
Fig. 2
Fig. 2
Prospective quality of life assessment between Complications and No Complications groups during NT. Abbreviations: NT, neoadjuvant therapy; FACT-G, Functional Assessment of Cancer Therapy-General
See this image and copyright information in PMC

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