Stark Dan P, Cook Adrian, Brown Julia M, Brundage Michael D, Embleton Andrew C, Kaplan Richard S, Raja Fharat A, Swart Ann Marie W, Velikova Galina, Qian Wendi, Ledermann Jonathan A
St. James's Institute of Oncology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, United Kingdom.
Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Cancer. 2017 Jul 15;123(14):2752-2761. doi: 10.1002/cncr.30657. Epub 2017 Mar 24.
The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment.
Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group.
The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, -2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea.
The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer. Cancer 2017;123:2752-61. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
ICON6试验表明，口服血管内皮生长因子受体1、2和3抑制剂西地尼布与化疗联合使用并持续作为维持治疗时，可改善铂敏感复发性卵巢癌患者的临床结局。本研究描述了治疗第一年期间的健康相关生活质量（QOL）。
456名女性被随机分配接受单纯标准化疗、化疗联合西地尼布或化疗联合西地尼布并持续作为维持治疗。患者在化疗期间每3周完成一次QOL问卷，直至疾病进展，然后每6周完成一次，持续至1年。疾病进展后仍存活的患者在随机分组1年后完成一份QOL表格。主要QOL终点是1年后欧洲癌症研究与治疗组织生活质量问卷核心30（Quality of Life Questionnaire Core 30）的总体评分，将标准化疗组与西地尼布联合维持治疗组进行比较。
问卷依从率在基线时为90%，在1年时为76%，三组相似。标准化疗组1年时的平均总体QOL评分为62.6分，联合维持治疗组为68.7分（+4.5；95%置信区间，-2.0至11.0；P = 0.18）。敏感性分析表明，这一发现对缺失数据的影响具有稳健性，在对自我报告的腹泻进行调整后，改善具有统计学意义。
国际卵巢肿瘤协作组（ICON6）的第6项研究表明，西地尼布作为联合和维持治疗可显著改善无进展生存期。开始治疗1年后未发现西地尼布对QOL有损害。生活质量的维持以及癌症控制的延长表明西地尼布在复发性卵巢癌治疗中具有重要作用。《癌症》2017年；123:2752 - 61。© 2017作者。《癌症》由威利期刊公司代表美国癌症协会出版。这是一篇根据知识共享署名许可协议条款的开放获取文章，允许在任何媒介中使用、分发和复制，前提是正确引用原始作品。
