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Early Changes in PROs Are Linked With Treatment Response, Survival in Gastrointestinal Cancer


A cohort study found that early changes in patient-reported outcomes (PROs) were associated with treatment response and survival outcomes in patients with advanced gastrointestinal cancer, supporting the need for more routine implementation of PRO monitoring in cancer care spaces.

Early changes in patient-reported outcomes (PROs), such as measurements for quality of life (QOL) and symptoms, were associated with clinical outcomes among patients with gastrointestinal cancer, suggesting that PROs could be a potential biomarker for cancer-specific survival outcomes, according to a study published in JAMA Network Open.

digestive tract | Image credit: sdecoret - stock.adobe.com

Image credit: sdecoret - stock.adobe.com

The findings highlighted the potential for use of PRO monitoring to improve clinical outcomes. The study also underscored the need to address QOL concerns and symptom burden of patients with advanced cancer. It is the first analysis to report that early longitudinal changes in PROs have an association with treatment response and survival in patients with advanced cancer.

Investigators enrolled patients with advanced gastrointestinal cancer from the Massachusetts General Hospital Cancer Center who had at least 1 month follow-up from May 2019 to December 2020. The patients were all beginning to receive first-line systemic therapy, were 18 years or older, and received diagnoses for either metastatic pancreaticobiliary, colorectal, or gastroesophageal cancer. Data was assessed from January 2021 to January 2022.

PROs, including QOL, physical symptoms, psychological symptoms, and serum tumor markers (TM) were collected at time of chemotherapy initiation and the 1-month mark. QOL was measured using the Functional Assessment of Cancer Therapy General (FACT-G) test; physical symptoms were measured with the Edmonton Symptom Assessment System (ESAS); and psychological symptoms were analyzed using the Patient Health Questionnaire-4 (PHQ4) total, PHQ4-depression, and PHQ4-anxiety tests. TM was evaluated with carcinoembryonic antigen (CEA) and CA 19-9 tests.

The primary outcomes were associations of 1-month changes in PROs and TM with treatment response (clinical benefit vs disease progression) at first scan, progression-free survival (PFS) rates, and overall survival (OS) rates. Regression models were used for all outcomes to adjust for baseline values.

Overall, 159 patients were enrolled, of whom 134 had baseline and follow-up data. The median (range) age was 64.0 (28.0-84.0), with a median follow-up time of 13.5 (1.5-32.5) months. A majority of the cohort was male (64.2%) and White (82.8). By cancer type, 62 (46.3%) patients had pancreaticobiliary cancer, 39 (29.1%) had colorectal cancer, and 33 (24.6%) had gastroesophageal cancer. The median PFS was 11.0 (1.0-189.0) months and median OS was 13.5 (2.0-269.0) months.

The results showed that 1-month PRO changes for QOL (OR, 1.07; 95% CI, 1.03-1.11; P = .001), physical symptoms (ESAS-total: OR, 0.97; 95% CI, 0.94-1.00; P = .02; ESAS-physical: OR, 0.96; 95% CI, 0.92-1.00; P = .03), and depression (OR, 0.67; 95% CI, 0.49-0.92; P = .01) were significantly associated with treatment response. However, TM and PHQ4-total were not.

Furthermore, changes in FACT-G (HR, 0.97; 95% CI, 0.95-0.99; P = .003), ESAS-total (HR, 1.03; 95% CI, 1.01-1.05; P = .004), ESAS-physical (HR, 1.03; 95% CI, 1.00-1.05; P = .02), PHQ4-depression (HR, 1.22; 95% CI, 1.01-1.48; P = .04) and CEA measurements (HR, 1.00; 95% CI, 1.001-1.004; P = .001) were associated with PFS, but changes in PHQ4-total and overall TMs were not. OS was associated with alterations in ESAS-total (HR, 1.03, 95% CI, 1.01-1.06; P = .006) and ESAS-physical (HR, 1.04, 95% CI, 1.01-1.06; P = .015), but changes in TM were not.

The study had some limitations, including the single-center design, lack of sociodemographic diversity/generalizability of the study, the small sample size, and the limited number of gastrointestinal diseases that were assessed. Additionally, although PROs such as coping, self-efficacy, and health literacy may impact patient clinical outcomes, they were not included in the present analysis.


Jarnagin JX, Saraf A, Baiev I, et al. Patient-reported outcomes, tumor markers, and survival outcomes in advanced GI cancer. JAMA Netw Open. 2023;6(11):e2343512. doi:10.1001/jamanetworkopen.2023.43512

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