Study findings suggest that 1-month changes in patient-reported outcomes (PROs) can predict treatment responses and survival outcomes among patients with metastatic gastrointestinal (GI) cancer, however, tumor markers do not.

These findings were presented by Joy Jarnagin, BA, CRC, Massachusetts General Hospital, Boston, MA, lead author of this study, at the 2021 ASCO Quality Care Symposium.

Ms Jarnagin and colleagues aimed to examine associations of 1-month changes in PROs and tumor markers with treatment response and survival outcomes among patients with advanced GI cancer.

Patients diagnosed with metastatic GI cancer between May 2019, and December 2020 were enrolled for this study. Enrollment began before patients initiated chemotherapy at Massachusetts General Hospital.

Patient-reported outcomes and tumor markers were collected at the start of treatment (baseline) and 1 month into treatment. Regression models were used to assess associations of 1-month changes in PROs and tumor markers with treatment response and survival outcomes.

PROs measures included QOL (Functional Assessment of Cancer Therapy General [FACT-G]), physical symptoms (Edmonton Symptom Assessment System [ESAS]), and psychological symptoms (Patient Health Questionnaire-4 [PHQ-4]).

Of the 159 patients enrolled in this study, 134 had 1-month follow-up data (median age was 64 years, 64.2% male, 46.3% pancreaticobiliary cancer). Results showed that 63.4% of these patients experienced clinical benefit and 36.6% experienced progressive disease at the time of first scan (median time to first scan was 2.01 months). 

Changes in PROs (ESAS-Total: OR = .97, P = .022; ESAS-Physical: OR = 0.96, P = .027; PHQ-4 depression: OR = 0.67, P = .014; FACT-G: OR = 1.07, P = .001) were associated with clinical benefit at the time of first scan, however, changes in tumor markers were not (CEA: OR = 1, P = .836 and CA19-9: OR = 1, P = .796). 

Predictors of PFS were Changes in ESAS-Total (HR = 1.03, P = .004), ESAS-Physical (HR = 1.03, P = .021), PHQ-4 depression (HR = 1.22, P = .042), FACT-G (HR = 0.97, P = .003), and CEA (HR = 1, P = .001).

Predictors of OS were changes in ESAS-Total (HR = 1.03, P = .006) and ESAS-Physical (HR = 1.04, P = .015). Changes in tumor markers at the 1-month mark (CEA: HR = 1, P = .377 and CA19-9: HR = 1, P = .367) did not significantly predict for OS.

Findings reveal that 1-month changes in PROs can predict treatment responses and survival outcomes among patients with metastatic GI cancer.

“Notably, 1-month changes in CEA only correlated with PFS, while changes in CA19-9 did not significantly predict treatment response or survival outcomes,” concluded Ms Jarnagin and colleagues, adding, “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.”

Jarnagin J, Baiev I, Van Seventer E, 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. Presented at: the 2021 ASCO Quality Care Symposium; September 25-26, 2021; Boston, MA, and virtual; Abstract 154.