OBJECTIVES: To assess and measure the signs and symptoms of advanced/metastatic gastric (GA) or gastroesophageal junction (GEJ) cancer experienced by recently diagnosed patients, how disease and treatment(s) impact patients’ lives, and assess content validity of PRO instruments (EORTC QLQ-OG25; EORTC QLQ-C30).

METHODS: The most frequently experienced symptoms or impacts of advanced/metastatic GA/GEJ, and their degree of disturbance, were identified in qualitative interviews with recently diagnosed patients. Disturbance by symptoms or impacts was rated on a scale of 0 (not at all) to 10 (extremely). Frequency of prompted vs. unprompted responses and mean disturbance ratings were tabulated. Patients were asked cognitive interview questions to assess their comprehension of the QLQ-OG25 and QLQ-C30.

RESULTS: Nine patients (n=3 GA; n=6 GEJ), on or off treatment, were interviewed. The majority of patients reported multiple disease-specific symptoms with moderate mean disturbance, including difficulty eating (89%; disturbance=6.5), difficulty swallowing (78%; disturbance=6.4), and abdominal pain (78%; disturbance=7.4). Weakness (100%; disturbance=5.4), anxiety (89%; disturbance=5.9), inability to work (67%; disturbance=7.5), and interference with daily activities (67%; disturbance=7.0) were also reported. Additional symptom burden experienced by patients (e.g., loss of appetite, nausea, fatigue) was attributed to previous or ongoing treatments, particularly chemotherapy. Patients indicated the majority of items in the QLQ-OG25 and QLQ-C30 were easily understood and relevant to their experience with GA/GEJ. PRO instrument length was not a concern; patients thought completing these questionnaires, or instruments of similar length, would be easily done with important information collected.

CONCLUSIONS: Patients with recently diagnosed advanced/metastatic GA/GEJ reported a variety of symptoms and impacts attributed to their underlying disease and/or treatments. The most important and relevant symptoms and impacts identified in the interviews can be assessed by the QLQ-OG25 and QLQ-C30. Our data provide evidence that PRO instruments are appropriate to measure symptoms and impacts in this population.