Changes in patient-reported outcomes (PROs) 1 month after treatment initiation can predict response and survival outcomes in patients with metastatic gastrointestinal (GI) cancers, a new study suggests.

The study was presented at the 2021 American Society of Clinical Oncology (ASCO) Quality Care Symposium by Joy X. Jarnagin, a GI clinical research coordinator at Massachusetts General Hospital’s Cancer Center in Boston.

Ms Jarnagin presented data on 134 patients with metastatic GI cancer who were initiating a new line of systemic treatment from May 2019 to November 2020 at Massachusetts General Hospital.

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The patients’ median age was 64 years (range, 28-84 years), 35.8% were women, and 82.8% were White. The most common cancer type was pancreatobiliary (46.3%), followed by colorectal (29.1%) and gastroesophageal (24.6%). Most patients were receiving their first line of treatment at baseline (73.1%).

The researchers evaluated PROs and tumor markers at baseline and 1 month later. Tumor markers included carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9). PROs included:

  • Physical symptoms, assessed via the Edmonton Symptom Assessment System (ESAS)
  • Psychological symptoms, assessed via the Patient Health Questionnaire-4 (PHQ-4)
  • Quality of life, assessed by Functional Assessment of Cancer Therapy General (FACT-G).

The researchers found that treatment response was not associated with changes in the tumor markers, but response was significantly associated with changes in PROs from baseline to 1 month. Specifically, response was associated with improvements in physical symptoms and quality of life, as reflected by:

  • Lower scores on the ESAS-Total (odds ratio [OR], 0.967; 95% CI, 0.939-0.995; P =.022)
  • Lower scores on the ESAS-Physical (OR, 0.959; 95% CI, 0.924-0.995; P =.027)
  • Higher scores on the FACT-G (OR, 1.066; 95% CI, 1.025-1.109; P =.001).

Changes in both CEA and PROs from baseline to 1 month were associated with progression-free survival (PFS). Shorter PFS was significantly associated with:

  • Higher scores on the ESAS-Total (hazard ratio [HR], 1.029; 95% CI, 1.009-1.049; P =.004)
  • Higher scores on the ESAS-Physical (HR, 1.027; 95% CI, 1.004-1.051; P =.021)
  • Lower scores on the FACT-G (HR, 0.970; 95% CI, 0.950-0.990; P =.003)
  • An increase in CEA (HR, 1.002; 95% CI, 1.001-1.004; P =.001).

Shorter overall survival (OS) was also associated with PROs but not the tumor markers. Higher scores on the ESAS-Total (HR, 1.032; 95% CI, 1.009-1.056; P =.006) and the ESAS-Physical (HR, 1.035; 95% CI, 1.007-1.064; P =.015) were significantly associated with shorter OS.

“These findings highlight the potential for early changes in PROs to predict treatment outcomes, while underscoring the need to monitor and address PROs in patients with advanced cancer,” Ms Jarnagin concluded.

Disclosures: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Jarnagin JX, Baiev I, Van Seventer EE, et al. Changes in patient-reported outcomes (PROs) and tumor markers (TMs) to predict treatment response and survival in patients with metastatic gastrointestinal (GI) cancer. J Clin Oncol. 2021;39:(suppl 28; abstr 154). doi:10.1200/JCO.2020.39.28_suppl.154

This article originally appeared on Cancer Therapy Advisor