Xin Shelley Wang, MD, MPH, The University of Texas MD Anderson Cancer Center, Houston, discusses results from a real-world study exploring patient-reported outcomes (PROs) of symptom burden and functioning among patients with advanced esophageal, gastroesophageal junction, and gastric cancer undergoing chemotherapy.
These results were presented at the virtual 2021 ASCO Genitourinary Cancers Symposium.
Hello, this is Dr. Xin Shelley Wang. I'm a professor in the Department of Symptom Research in MD Anderson Cancer Center. We appreciate this opportunity to present our study titled "Patient‑Reported Symptom Burden and Functioning in Patients with Advanced Gastroesophageal Junction and Gastric Cancer Undergoing Chemotherapy."
The first issue why we conduct this study in this advanced cancer patient cohort. It's well‑known that patient in the late stage of their disease suffer from great deal of symptom burden and impact on their daily functioning and quality of life. Such symptom burden is driven by both disease and cancer treatment.
Although there are lots of clinical trials reported toxicity and so on, there is no really prospective longitudinal study gathering all of the patient's perspective altogether.
This study, we designed in the real‑world prospective study following the patient for 12 weeks from their starting time of new line of chemotherapy. All of the patients were enrolled in MD Anderson Cancer Center outpatient. We measured patient's symptom burden by validated a tool called MD Anderson Symptom Inventory GI Module.
We have also collected the data clinically and also patient characteristics. Weekly symptom assessment conducted about 12 weeks from their starting the new line of the therapy. The analysis included the longitudinal analysis, trajectory analysis.
We also reviewed the time to deterioration in functioning status that we define if the patient has 2 point on 0‑10 scale increase from the baseline as their symptom interference increasing. Total, we have this intro analysis with 76 patients, and the study is still going on.
We separate patient in several groups, first of all, the treatment-naïve patient. That means when patient come to the clinic and they never receive the cancer therapy, but they newly diagnosed of disease with very late stage.
Another group of the patients received only one line of therapy outside of institution and usually come for further treatment. Another group with more than one line of therapy. Finally, there's still some of the patient very ill at a time to approach our study. They only contributed for baseline pre‑treatment. There's not enough information for being included in this longitudinal analysis. Those 11 patients were excluded in this analysis.
Total, we have 65 patients form this report. 70% of patients are male. Also, we have overwhelming of non‑Hispanic, white patients, about 86% on the sample. However, in the beginning of the study, majority of them had reasonable good performance status.
We found out that, over time, symptom burden are really different by the group who we were just describing. Before the therapy, there are several symptoms that's most are severe. Usually, crossing the group, this symptom burden are consistent. That included a pain, fatigue, disturbed sleep, lack of appetite, and the inability to eat. Those are the most common symptom at the beginning.
Patients, if they received a one‑line therapy, usually would report worsening symptom on pain, fatigue, poor appetite, difficulty swallowing, and reduce the general activity or enjoyment of life. Overtime, increasing symptom burden are significant.
For patients received more than one line of therapy compared those never received therapy, we observe the patient has significantly increased the neuropathy symptom that measured as the item on the numbness and tingling. This is a chemotherapy‑induced toxicity symptom.
The median time we found out to the functioning deterioration increase more than 2 points from the baseline on the general activity is about 7 weeks, that ranged from 5 to 9 weeks, especially much faster in the treatment‑naive patients.
From trajectory analysis, we found that more than half of the patient consistently reported high symptom burden over time. That means, over time, they're in the moderate to severe range, and on the 0-10 is over 4 or greater. That includes a cluster of symptoms of pain, fatigue, disturbed sleep, drowsiness, and moderate to severe symptoms.
Group membership was related to the baseline. If a high symptom burden initial the time of the therapy, usually patient continues to remain in the high symptom burden over time. Conclusion for this observational study from the real‑world data, we observed that a patient with very advanced stage of upper GI cancer undergoing standard therapy, more than half of them suffer from a high symptom burden, persistently.
Those describe the symptom research result. It's really supportive for a well‑targeted cluster of symptoms to be monitored over time during the therapy and to provide patient persist symptom management and also identify the patients in the high‑risk development of high symptom burden. This knowledge we gain from such study may include in the routine patient care in the future.
PRO has been outcome measure in most of the clinical trials. However, in real-world routine patient care has been challenging to be included on the place. Here, we report a study we hope to boost up for those advanced patients for their active, effective symptom management. Thank you.