Quality of Life in the Trastuzumab for Gastric Cancer Trial

• Published in: The oncologist (Dayton, Ohio) Ohio), 2014-07, Vol.19 (7), p.712-719
• Main Authors: Satoh, Taroh, Bang, Yung‐Jue, Gotovkin, Evgeny A., Hamamoto, Yasuo, Kang, Yoon‐Koo, Moiseyenko, Vladimir M., Ohtsu, Atsushi, Van Cutsem, Eric, Al‐Sakaff, Nedal, Urspruch, Alexa, Hill, Julie, Weber, Harald A., Chung, Hyun‐Cheol
• Format: Article
• Language: English
• Subjects: Antibodies, Monoclonal, Humanized - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Capecitabine; Chemotherapy; Cisplatin - administration & dosage; Cisplatin - adverse effects; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - analogs & derivatives; Gastric cancer; Gastrointestinal Cancer; HER2; Humans; Quality of Life; Receptor, ErbB-2 - metabolism; Stomach Neoplasms - drug therapy; Stomach Neoplasms - enzymology; Surveys and Questionnaires; Trastuzumab
• ISSN: 1083-7159; 1549-490X
• DOI: 10.1634/theoncologist.2014-0058

Background. The Trastuzumab for Gastric Cancer phase III trial demonstrated that combining trastuzumab with chemotherapy significantly improved overall survival compared with chemotherapy alone in HER2‐positive advanced gastric or gastroesophageal junction cancer. We report health‐related quality of life (HRQoL) and quality‐adjusted time without symptoms of disease or toxicity (Q‐TWiST) results from this trial. Patients and Methods. Patients were randomized to receive six cycles of chemotherapy given every 3 weeks (capecitabine or fluorouracil, plus cisplatin) either alone or combined with administration of trastuzumab every 3 weeks until disease progression. At each clinical visit, HRQoL was assessed using two European Organization for Research and Treatment of Cancer quality of life questionnaires, QLQ‐C30 and QLQ‐STO22. Q‐TWiST methodology was applied retrospectively using the clinical data and utility coefficients. Results. Trastuzumab plus chemotherapy prolonged time to 10% definitive deterioration in all QLQ‐C30 and QLQ‐STO22 scores, including QLQ‐C30 global health status versus chemotherapy alone, from 6.4 months to 10.2 months. In addition, trastuzumab plus chemotherapy extended Q‐TWiST by 2.42 months compared with chemotherapy alone. Conclusion. Compared with chemotherapy alone, trastuzumab plus chemotherapy prolongs time to deterioration of HRQoL and increases quality‐adjusted survival in patients with HER2‐positive gastric or gastroesophageal junction cancer. 摘要 背景。使用曲妥珠单抗治疗胃癌的 III 期研究表明，与单纯化疗相比，曲妥珠单抗与化疗药物的联合使用可显著提高 HER2 阳性晚期胃癌或食管胃结合部癌患者的总生存期。本文报告了这项研究的健康相关生存质量 (HRQoL) 及生存质量校正后的无疾病症状无毒性生存期 (Q‐TWiST) 结果。 患者与方法。患者被随机分为两组，分别接受单纯化疗（卡培他滨或氟尿嘧啶，联合顺铂，每 3 周一个周期，共 6 个周期）或化疗联合曲妥珠单抗（每 3 周一次）治疗，直至出现疾病进展。在每次临床就诊时，我们采用欧洲肿瘤研治组织的两份生存质量调查问卷 QLQ‐C30 和 QLQ‐STO22 对受试者进行 HRQoL 评估。Q‐TWiST 的评估则采用回顾性方式依据临床数据和效用系数来进行。 结果。与单纯化疗相比，曲妥珠单抗与化疗药物的联合使用将所有 QLQ‐C30 和 QLQ‐STO22 评估指标的“至 10% 确定性下降时间”从 6.4 个月推迟到了 10.2 个月，其中包括 QLQ‐C30 总体健康状态这一指标。此外，与单纯化疗相比，曲妥珠单抗与化疗的联合使用也将 Q‐TWiST 延长了 2.42 个月。 结论。与单纯化疗相比，曲妥珠单抗与化疗的联合使用推迟了 HRQoL 的至下降时间，提高了 HER2 阳性胃癌或食管胃结合部癌患者的生存质量校正后生存期。 The Oncologist 2014;19:712–719 This paper reports health‐related quality of life (HRQoL) and quality‐adjusted time without symptoms of disease or toxicity results from the ToGA (Trastuzumab for Gastric Cancer) phase III trial. Compared with chemotherapy alone, trastuzumab plus chemotherapy prolongs time to deterioration of HRQoL and increases quality‐adjusted survival in patients with HER2‐positive gastric or gastroesopha