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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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Abstract

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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Acknowledgments

This study was supported in part by Public Health Service Grants (Grant numbers CA23318, CA66636, CA21115, CA49883, and CA16116) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, and by Genentech, Inc. David Cella, Ph.D. consulting honoraria received research funding from Genentech, Inc. Kathy Miller, M.D. consulting honoraria and speaker’s bureau from Genentech, Inc. No other authors have disclosures to report.

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Correspondence to Lynne Wagner.

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This study was conducted for the Eastern Cooperative Oncology Group. Primary analysis of this study was reported in Miller K et al.: New England Journal of Medicine, 2007, 357 (26), 2666–2676.

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Cella, D., Wang, M., Wagner, L. et al. 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). Breast Cancer Res Treat 130, 855–861 (2011). https://doi.org/10.1007/s10549-011-1725-6

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