Creighton University School of Medicine at St. Joseph's Hospital and Medical Center, Department of Obstetrics and Gynecologic Oncology, 500 W. Thomas Road, Suite 600, Phoenix, AZ 85013, USA.
Gynecol Oncol. 2013 Mar;128(3):573-8. doi: 10.1016/j.ygyno.2012.11.038. Epub 2012 Dec 4.
To analyze quality of life (QOL) in a randomized, placebo-controlled phase III trial concluding that the addition of concurrent and maintenance bevacizumab (Arm 3) to carboplatin and paclitaxel prolongs progression-free survival in front-line treatment of advanced ovarian cancer compared to chemotherapy alone (Arm 1) or chemotherapy with bevacizumab in cycles 2-6 only (Arm 2).
The Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) was used to assess QOL before cycles 1, 4, 7, 13, and 21; and 6months after completing study therapy. Differences in QOL scores were assessed using a linear mixed model, adjusting for baseline score, and age. The significance level was set at 0.0167 to account for multiple comparisons.
1693 patients were queried. Arm 2 (p<0.001) and Arm 3 (p<0.001) reported lower QOL scores than those in Arm 1. The treatment differences were observed mainly at cycle 4, when the patients receiving bevacizumab (Arm 2 and Arm 3) reported 2.72 points (98.3% CI: 0.88-4.57; effect size=0.18) and 2.96 points (98.3% CI: 1.13-4.78; effect size=0.20) lower QOL respectively, than those in Arm 1. The difference in QOL scores between Arm 1 and Arm 3 remained statistically significant up to cycle 7. The percentage of patients who reported abdominal discomfort dropped over time, without significant differences among study arms.
The small QOL difference observed during chemotherapy did not persist during maintenance bevacizumab.
分析一项随机、安慰剂对照的 III 期临床试验的生活质量（QOL）结果，该试验表明，与单独化疗（Arm 1）或仅在第 2-6 周期化疗中添加贝伐单抗（Arm 2）相比，卡铂联合紫杉醇联合贝伐单抗（Arm 3）作为一线治疗晚期卵巢癌可延长无进展生存期。
采用癌症治疗功能评估卵巢量表（FACT-O TOI）的试验结局指数，在第 1、4、7、13 和 21 周期以及完成研究治疗后 6 个月评估 QOL。采用线性混合模型调整基线评分和年龄评估 QOL 评分的差异。设定显著性水平为 0.0167，以校正多重比较。
共查询了 1693 名患者。Arm 2（p<0.001）和 Arm 3（p<0.001）报告的 QOL 评分均低于 Arm 1。在第 4 周期观察到治疗差异，接受贝伐单抗的患者（Arm 2 和 Arm 3）报告的 QOL 评分分别低 2.72 分（98.3%CI：0.88-4.57；效应量=0.18）和 2.96 分（98.3%CI：1.13-4.78；效应量=0.20），与 Arm 1 相比。Arm 1 和 Arm 3 的 QOL 评分差异在第 7 周期仍具有统计学意义。报告腹部不适的患者比例随时间下降，但各研究组之间无显著差异。
化疗期间观察到的 QOL 微小差异在维持贝伐单抗治疗期间并未持续存在。
