Survival-adjusted health-related quality of life (HRQL) among patients with metastatic breast cancer receiving paclitaxel plus bevacizumab versus paclitaxel alone: results from Eastern Cooperative Oncology Group Study 2100 (E2100).

Survival-adjusted health-related quality of life (HRQL) among patients with metastatic breast cancer receiving paclitaxel plus bevacizumab versus paclitaxel alone: results from Eastern Cooperative Oncology Group Study 2100 (E2100).
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DOI:
10.1007/s10549-011-1725-6
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发表时间:
2011-12
影响因子:
3.8
通讯作者:
Miller, Kathy
Miller, Kathy
中科院分区:
医学2区
文献类型:
--
作者:
Cella, David;Wang, Molin;Wagner, Lynne;Miller, Kathy

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本研究旨在检查接受紫杉醇或紫杉醇+贝伐珠单抗E2100治疗的转移性乳腺癌女性患者的健康相关生活质量(HRQL)。试验参与者(N = 670)在治疗前以及治疗4个周期和8个周期后完成了癌症治疗功能评估-乳腺(FACT-B),以评估HRQL和乳腺癌特异性问题。在仅接受紫杉醇治疗的患者中观察到FACT-B评估缺失的比例显著更高,原因是至死亡时间更快。为了解释这种缺失数据的不可验证模式,我们使用两阶段模型联合建模纵向HRQL结局和至不可验证脱落的时间,进行了生存调整HRQL分析。在4个和8个治疗周期后,评估HRQL的FACT评分没有差异;然而,在接受紫杉醇+贝伐珠单抗治疗的患者中,在4个和8个治疗周期后,9项乳腺癌量表的平均评分显著更高。治疗组间FACT-B总分无差异。从患者的角度来看,添加贝伐珠单抗与额外的副作用负担无关,并且与乳腺癌特异性问题的更大减少相关。未发现其他差异。
The purpose of this study was to examine health-related quality of life (HRQL) among women with metastatic breast cancer treated on E2100 with paclitaxel or paclitaxel plus bevacizumab. Trial participants (N = 670) completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) pre-treatment and following 4 and 8 cycles of treatment to assess HRQL and breast cancer-specific concerns. A significantly higher proportion of missing FACT-B assessments was observed among patients receiving paclitaxel only, due to faster time to death. To account for this non-ignorable pattern of missing data, we conducted a survival-adjusted HRQL analysis by jointly modeling the longitudinal HRQL outcome and time to non-ignorable dropout using a two-stage model. FACT scores assessing HRQL did not differ following 4 and 8 cycles of treatment; however mean scores on the 9-item Breast Cancer Scale were significantly higher after 4 and 8 cycles of treatment among patients receiving paclitaxel plus bevacizumab. No differences were observed between treatment arms on FACT-B total scores. The addition of bevacizumab was not associated with additional side effect burden from the patient perspective and was associated with a greater reduction in breast cancer-specific concerns. No other differences were noted.
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