Early Changes in PROs Could Predict Response, Survival in Gastrointestinal Cancers

Changes in patient-reported outcomes (PROs) 1 month after starting first-line therapy may predict response and survival in patients with advanced gastrointestinal cancers, according to a study published in JAMA Network Open.

Researchers found that changes in certain PROs from baseline to 1 month were associated with clinical benefit, progression-free survival (PFS), and overall survival (OS).

This study included 134 evaluable patients with advanced gastrointestinal cancer, including pancreaticobiliary (46.3%), colorectal (29.1%), and gastroesophageal (24.6%) cancer.

The researchers collected PROs at baseline and 1 month using several tools, including Functional Assessment of Cancer Therapy General (FACT-G) for quality of life (QOL) and Edmonton Symptom Assessment System (ESAS) for physical symptoms. For psychological symptoms, the researchers used the Patient Health Questionnaire-4 (PHQ4) total, PHQ4-depression, and PHQ4-anxiety. The researchers also measured 2 tumor markers — CEA and CA19-9 — at baseline and 1 month.

Overall, 63.4% of patients had a clinical benefit at the time of their first scan, the median PFS was 11.0 months, and the median OS was 13.5 months.

Several changes in PROs from baseline to 1 month were associated with a greater likelihood of having a clinical benefit at the first scan, including:

• Increases in FACT-G scores (odds ratio [OR], 1.07; 95% CI, 1.03-1.11; P =.001)
• Decreases in ESAS-total scores (OR, 0.97; 95% CI, 0.94-1.00; P =.02)
• Decreases in ESAS-physical scores (OR, 0.96; 95% CI, 0.92-1.00; P =.03)
• Changes in PHQ4-depression scores (OR, 0.67; 95%CI, 0.49-0.92; P =.01).

However, changes in PHQ4-total scores, PHQ4-anxiety scores, CEA, and CA19-9 were not significantly associated with clinical benefit. Likewise, changes in PHQ4-total scores, PHQ4-anxiety scores, and CA19-9 were not significantly associated with PFS or OS.

Increases in FACT-G scores were associated with improved PFS (hazard ratio [HR], 0.97; 95% CI, 0.95-0.99; P =.003) but not OS. Changes in PHQ4-depression scores were associated with worse PFS (HR, 1.22; 95% CI, 1.01-1.48; P =.04) but not OS. And increases in CEA were associated with worse PFS (HR, 1.002; 95% CI, 1.001-1.004; P =.001) but not OS.

Increases in ESAS-total scores were associated with worse PFS (HR, 1.03; 95% CI, 1.01-1.05; P =.004) and OS (HR, 1.03; 95%CI, 1.01-1.06; P =.006). Increases in ESAS-physical scores were associated with worse PFS (HR, 1.03; 95% CI, 1.00-1.05; P =.02) and OS (HR, 1.04; 95%CI, 1.01-1.06; P =.02) as well.

“A more complete understanding of early changes in PROs could be instrumental in identifying patients who may benefit from proactive symptom management, early palliative care, and/or alternate treatment strategies to improve their outcomes,” the researchers wrote. “Our work supports the need for efforts to integrate early monitoring and management of PROs in patients with advanced gastrointestinal cancer.”

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

Reference

Jarnagin JX, Saraf A, Baiev I, et al. Patient-reported outcomes, tumor markers, and survival outcomes in advanced GI cancer. JAMA Netw Open. Published online November 17, 2023. doi:10.1001/jamanetworkopen.2023.43512

This article originally appeared on Cancer Therapy Advisor