Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials. (January 2019)

• Record Type: Journal Article
• Authors: Chau, Ian; Fuchs, Charles S.; Ohtsu, Atsushi; Barzi, Afsaneh; Liepa, Astra M.; Cui, Zhanglin Lin; Hsu, Yanzhi; Al-Batran, Salah-Eddin
• Is Part Of: European journal of cancer. Volume 107(2019)
• Page Start: 115
• Page End: 123
• Publication Date: 2019-01
• Subjects: Quality of life -- Gastric cancer -- Gastroesophageal junction -- Disease progression -- Palliative care -- Metastasis -- Retrospective studies -- Ramucirumab -- Paclitaxel; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2018.11.013
• Languages: English
• ISSNs: 0959-8049

Abstract

Abstract: Background: Inadequate understanding of interpretation of quality of life (QoL) instruments leads to unsatisfactory data reporting and clinical decision-making, including in gastric cancer care. Materials and methods: Pooled QoL data from two phase III studies of ramucirumab with or without paclitaxel in previously treated patients with gastric or gastroesophageal junction cancer were used to explore associations with clinical attributes, including tumour response, disease measurability and performance status (PS). The European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ)-C30 was used in both studies. Changes in QLQ-C30 scores from baseline to week 6 as a predictor of clinical outcomes and impacts of changes in clinical status on QoL were estimated by multivariate logistic regression and analyses of variance, respectively. Results: Baseline QoL data were available for 989 patients. Fatigue, pain and appetite loss were prominent baseline symptoms. Disease progression resulted in worse QoL in all functional scales (p < 0.0001 to p = 0.0306), global QoL (p = 0.0011) and symptom scales (fatigue, p < 0.0001; nausea/vomiting, p = 0.0007; pain, p = 0.0052; appetite loss, p = 0.0061). Similar trends were seen with deterioration of PS on QoL. A 15- to 20-point change in global QoL and functional scale scores predicted change in tumour status as did change in fatigue, pain and appetite loss scores. Smaller QoL changes (5–15 points) predicted PS change. Results were similar in patients regardless of baseline disease measurability. Conclusions: Our study underscores the importance of disease control for maintaining or improving QoL. These data could improve future trial design and routine clinical care for patients receiving therapy for previously treated gastric cancer. NCT00917384, NCT01170663. Highlights: Quality of life (QoL) data from two ramucirumab phase III gastric cancer trials were analysed. Disease progression resulted in worse QoL in most European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ)-C30 scales. Deterioration of performance status was similarly associated with worse QoL. 15- to 20-point changes in QoL scales predicted change in tumour status. 5- to 15-point changes in QoL scales predicted change in performance status.