According to data presented during the 2021 ASCO Quality Care Symposium,¹ 1-month changes in patient-reported outcomes may predict treatment response and survival outcomes in patients with advanced gastrointestinal cancers.

The results of a prospective study of 159 patients with metastatic gastrointestinal cancer showed that changes in quality-of-life assessments, physical symptoms, and psychological symptoms were all associated with clinical benefit at the time of the first scan. Conversely, 1-month data for changes in the tumor marker carcinoembryonic antigen (CEA) were correlated solely with progression-free survival, whereas changes in CA 19-9 levels did not significantly predict treatment response or survival outcomes.

“These findings highlight the potential for early changes in patient-reported outcomes to predict treatment outcomes while underscoring the need to monitor and address patient-reported outcomes in patients with advanced cancer,” said lead study author Joy X. Jarnagin, BA, CRC, Gastrointestinal Clinical Research Coordinator at Massachusetts General Hospital’s Cancer Center.

Joy X. Jarnagin, BA, CRC

As Ms. Jarnagin explained, previous studies have demonstrated that patient-reported outcomes, which assess quality of life and symptoms at a single time point, can frequently correlate with clinical outcomes in patients with cancer. However, efforts to understand how longitudinal changes in patient-reported outcomes can predict treatment responses are lacking. Similarly, in the clinical setting, tumor markers such as CEA and CA 19-9 are often used to monitor patients with gastrointestinal cancer, she added, but data are lacking on the utility of early changes in patient-reported outcomes and tumor markers to monitor patients and predict treatment response and survival.

Study Methods

For this prospective, longitudinal cohort study, Ms. ­Jarnagin and colleagues sought to examine the associations of 1-month changes in patient-reported outcomes and tumor markers with treatment response and survival outcomes, specifically progression-free and overall survival, among patients with advanced gastrointestinal cancers. The investigators consecutively approached and enrolled eligible patients starting a new line of treatment at Massachusetts General Hospital from May 2019 to November 2020.

Baseline and 1-month tumor marker and patient-reported outcomes data were the focus of this analysis, but patients also had circulating tumor DNA (ctDNA) samples drawn and were followed every month on study until disease progression. All participants had CEA levels drawn, whereas only those with pancreatic, biliary, and esophageal gastric cancers had both CEA and CA 19-9 levels drawn.

Investigators used the Edmonton Symptom Assessment System (ESAS) and Patient Health Questionnaire-4 (PHQ-4) to assess physical and psychological symptoms, respectively. The Functional Assessment of Cancer Therapy–General (FACT-G) was used to assess quality of life.

For treatment response, clinical benefit (defined as decreased or stable tumor burden) or progressive disease was analyzed at the time of the first scan. Survival outcomes included progression-free and overall survival. All regression models were adjusted for baseline values of each respective predictor of interest.

Physical Symptoms Linked to Risk of Death

Of the 159 patients who consented to the study, 134 were considered evaluable, meaning they had both baseline and 1-month follow-up data available, including surveys and tumor marker information. The median age of patients enrolled was 64 years, and 36% of participants were female. Most patients had pancreatobiliary cancer and were on their first line of metastatic therapy.

With respect to treatment response, 63.4% of patients had a clinical benefit, whereas 36.6% had progressive disease at the time of the first scan. Of note, the investigators identified a statistically significant association between changes in patient-reported outcomes from baseline to 1 month and treatment response.

“ESAS Total and ESAS Physical were statistically significant, indicating that as physical symptoms decreased for our participants, the odds of clinical benefit increased,” said Ms. Jarnagin. “Conversely, as quality of life increased with the FACT-G, the likelihood of clinical benefit also increased.”

In addition, findings showed a statistically significant association between CEA levels and progression-free survival, with the risk of disease progression increasing along with CEA levels. Similar findings were also seen for physical symptoms and quality-of-life measures.

“As symptom burden for our patients increased, the risk of disease progression increased as well. In addition, as the quality of life for patients decreased on the FACT-G survey, the risk of disease progression increased,” Ms. Jarnagin explained.

Finally, analysis of overall survival data demonstrated a statistically significant association between physical symptom burden and the risk of death, although tumor markers were not found to be significantly correlated.

Ms. Jarnagin and colleagues are looking to obtain Response Evaluation Criteria in Solid Tumors data to assess treatment response. The investigators are also planning to explore the role of ctDNA and body composition measures to predict clinical outcomes as they analyze further longitudinal data. 

DISCLOSURE: Ms. Jarnagin reported no conflict of interests.

REFERENCE

1. Jarnagin JX, Baiev I, van Seventer EE, et al: Changes in patient-reported outcomes and tumor markers to predict treatment response and survival in patients with metastatic gastrointestinal cancer. 2021 ASCO Quality Care Symposium. Abstract 154. Presented September 25, 2021.