Ian Chau1, Charles S Fuchs2, Atsushi Ohtsu3, Afsaneh Barzi4, Astra M Liepa5, Zhanglin Lin Cui6, Yanzhi Hsu7, Salah-Eddin Al-Batran8. 1. Department of Medicine, Royal Marsden Hospital, Downs Rd., Sutton, Surrey, SM2 5PT, United Kingdom. Electronic address: ian.chau@rmh.nhs.uk. 2. Yale Cancer Center, 333 Cedar St., New Haven, CT, 06510, United States. Electronic address: charles.fuchs@yale.edu. 3. Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. Electronic address: aohts@east.ncc.go.jpe. 4. Division of Oncology, Keck School of Medicine, University of Southern California, 1975 Zonal Ave., Los Angeles, CA 90033, United States. Electronic address: afsaneh.barzi@med.usc.edu. 5. Eli Lilly and Company, 893 S. Delaware St., Indianapolis, IN, 46225, United States. Electronic address: liepa_astra_m@lilly.com. 6. Eli Lilly and Company, 893 S. Delaware St., Indianapolis, IN, 46225, United States. Electronic address: cui_zhanglin@lilly.com. 7. Eli Lilly and Company, 893 S. Delaware St., Indianapolis, IN, 46225, United States. Electronic address: yanzhi.hsu@lilly.com. 8. Institute of Clinical Cancer Research (IKF), University Cancer Center, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany. Electronic address: albatran.salah@khnw.de.
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 paclitaxelin 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.
RCT Entities:
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.
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