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Quality of life in the Trastuzumab for Gastric Cancer Trial
Taroh Satoh, Yung-Jue Bang, Evgeny A. Gotovkin, Yasuo Hamamoto, Yoon-Koo Kang, Vladimir M. Moiseyenko, Atsushi Ohtsu, Eric Van Cutsem, Nedal Al-Sakaff, Alexa Urspruch, Julie Hill, Harald A. Weber, Hyun-Cheol Chung, for the ToGA Trial Investigators
The Oncologist 2014 ; 19 : 712-9
Editors' comments: Dr. Carla Ripamonti
The ToGA trial (ClinicalTrials.gov identifier :NCT01041404) published in The Lancet 2010 by Bang YJ et al. showed that combining trastuzumab with chemotherapy significantly improved overall survival by 2.7 months compared with chemotherapy alone in HER-2 positive patients with advanced gastric or gastroesophageal junction cancer and led to the approval of trastuzumab for this indication. The Quality of life assessment was a secondary objective of the ToGA trial. Health Related QoL assessments were perfomed by patients’ self report of the 1. EORTC QLQ-C30 (version 3.0) quality of life questionnaire , 2. the gastric-cancer-specific QLQ-STO22, 3. the Visual Analog Scale on a 100-mmhorizontal line for pain intensity. The assessments were performed at baseline and then every 3 weeks (on day 1 of each cycle) until PD or withdrawal from the trial. Moreover the quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) was analyzed.
Trastuzumab plus chemotherapy prolonged time to 10% definitive deterioration in all QLQ-C30 and QLQ-STO22 score. The median time to a 10% definitive deterioration in the global health status score of the QLQ-C30 questionnaire was 6.4 months and 10.2 months in the chemotherapy alone and trastuzumab-plus-chemotherapy arms respectively (p < .0001). Moreover trastuzumab plus chemotherapy increased the mean duration of Q-TWiST by 2.42 months compared with chemotherapy alone (p < .001).