BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) general module (QLQ-C30) and disease-specific gastric cancer module (QLQ-STO22) are established and frequently utilized patient-reported outcome measures (PROMs) used to evaluate benefits from cancer treatments (Aaronson et al., 1993). However, they were developed prior to current regulatory guidance regarding patient-based concept elicitation (FDA, 2009). We conducted research to evaluate these PROMs directly in patients with gastric cancer to ascertain: (1) the relevance of the measures to the target patient population and (2) key domains from the patient perspective.
METHODS: Telephone interviews were conducted in a convenience sample of 12 adult patients with advanced gastric cancer in the United States. Eligible participants were recruited by a qualitative research facility and a patient advocacy group and had to self-report unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. Each interview included an open-ended concept elicitation portion followed by a review of the items from both of the EORTC modules.
RESULTS: All participants (n = 12) had stage IV gastric adenocarcinoma, and most were white (n = 11), male (n = 9), had an Eastern Cooperative Oncology Group status of 0 or 1 (n = 10), and were receiving chemotherapy (n = 9). Spontaneously elicited symptoms most commonly reported by participants were pain/cramping (n = 8) usually in the stomach/abdominal area, early satiety (n = 6), constipation (n = 5), fatigue/tiredness (n = 4), diarrhea (n = 4), and problems swallowing (n = 4). Pain/cramping was most often reported as the most bothersome symptom (n = 6). Participants reported that the QLQ-C30 and the QLQ-STO22 were relevant in characterizing their symptoms and also that these measures identified all key symptoms and treatment effects. Frequently reported symptom items of the EORTC modules (selected by ≥ 9 participants) included those from the Pain and Eating Restrictions subscales of the disease-specific QLQ-STO22 module and the Fatigue subscale of the general QLQ-C30 module.
CONCLUSIONS: The symptoms and effects included in two evaluated EORTC PROMs were found to be relevant to this 12-patient sample of adults with gastric cancer. Based on the reported frequency and bother of symptoms, 3 subscales appear particularly salient as targets for assessment of treatment improvement: the Pain and Eating Restrictions subscales from the QLQ-STO22, and the Fatigue subscale from the QLQ-C30.
