Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
Oncologist. 2014 Jul;19(7):712-9. doi: 10.1634/theoncologist.2014-0058. Epub 2014 Jun 20.
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 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.
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.
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.
曲妥珠单抗治疗胃癌的 III 期临床试验表明，与单独化疗相比，曲妥珠单抗联合化疗可显著提高 HER2 阳性晚期胃癌或胃食管交界癌患者的总生存期。我们报告了该试验的健康相关生活质量（HRQoL）和无疾病或毒性相关症状的质量调整时间（Q-TWiST）结果。
患者被随机分配接受每 3 周一次的 6 个周期化疗（卡培他滨或氟尿嘧啶加顺铂），单独使用或联合每 3 周一次的曲妥珠单抗治疗，直至疾病进展。在每次临床就诊时，使用欧洲癌症研究和治疗组织（EORTC）的两个生活质量问卷 QLQ-C30 和 QLQ-STO22 评估 HRQoL。使用临床数据和效用系数回顾性地应用 Q-TWiST 方法。
与单独化疗相比，曲妥珠单抗联合化疗可延长所有 QLQ-C30 和 QLQ-STO22 评分中 10%确定性恶化的时间，包括 QLQ-C30 全球健康状况评分，从 6.4 个月延长至 10.2 个月。此外，与单独化疗相比，曲妥珠单抗联合化疗可延长 Q-TWiST 2.42 个月。
与单独化疗相比，曲妥珠单抗联合化疗可延长 HER2 阳性胃癌或胃食管交界癌患者 HRQoL 恶化的时间，并提高质量调整生存。
