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Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study.

Publication ,  Journal Article
Li, D; McCall, LM; Hahn, OM; Hudis, CA; Cohen, HJ; Muss, HB; Jatoi, A; Lafky, JM; Ballman, KV; Winer, EP; Tripathy, D; Schneider, B; Barry, W ...
Published in: Breast Cancer Res Treat
September 2018

BACKGROUND: In hormone receptor-positive advanced breast cancer, a progression-free survival benefit was reported with addition of bevacizumab to first-line letrozole. However, increased toxicity was observed. We hypothesized that functional age measures could be used to identify patients at risk for toxicity while receiving letrozole plus bevacizumab for hormone receptor-positive advanced breast cancer. METHODS: CALGB 40503 was a phase III trial that enrolled patients with hormone receptor-positive advanced breast cancer randomized to letrozole with or without bevacizumab. Patients randomized to bevacizumab were approached to complete a validated assessment tool evaluating physical function, comorbidity, cognition, psychological state, social support, and nutritional status. The relationship between pretreatment assessment measures and the incidence of grade ≥ 3 (National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0) adverse events was determined. RESULTS: One hundred thirteen (58%) of 195 patients treated with letrozole plus bevacizumab completed the pretreatment assessment questionnaire. One patient was excluded due to missing adverse event data. The median age of patients was 56. Frequently reported grade ≥ 3 adverse events were hypertension (26%), pain (20%), and proteinuria (7%). Two hemorrhagic events (one grade 5) and 1 thrombosis event occurred. Age ≥ 65 years (p < 0.01), decreased vision (p = 0.04), and poorer pretreatment physical function measures (p < 0.05) were found on univariate analysis to be significantly associated with increased incidence of grade ≥ 3 adverse events. Upon multivariate analysis, age ≥ 65 years (p = 0.01) and decreased vision (p = 0.04) remained significant. Univariable and multivariable logistic regression models demonstrated associations between age, vision, the ability to walk up flights of stairs, and grade ≥ 3 adverse events. CONCLUSIONS: Age (≥ 65 years), decreased vision, and impairments in physical function correlated with increased incidence of toxicity in patients receiving first-line letrozole plus bevacizumab. When evaluating therapy likely to increase toxicity, functional assessment measures can identify patients at increased risk for side effects who may benefit from closer monitoring.

Duke Scholars

Published In

Breast Cancer Res Treat

DOI

EISSN

1573-7217

Publication Date

September 2018

Volume

171

Issue

2

Start / End Page

325 / 334

Location

Netherlands

Related Subject Headings

  • Risk Factors
  • Receptors, Progesterone
  • Receptors, Estrogen
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Oncology & Carcinogenesis
  • Odds Ratio
  • Middle Aged
  • Letrozole
  • Incidence
 

Citation

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MLA
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Li, D., McCall, L. M., Hahn, O. M., Hudis, C. A., Cohen, H. J., Muss, H. B., … Hurria, A. (2018). Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study. Breast Cancer Res Treat, 171(2), 325–334. https://doi.org/10.1007/s10549-018-4828-5
Li, Daneng, Linda M. McCall, Olwen M. Hahn, Clifford A. Hudis, Harvey J. Cohen, Hyman B. Muss, Aminah Jatoi, et al. “Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study.Breast Cancer Res Treat 171, no. 2 (September 2018): 325–34. https://doi.org/10.1007/s10549-018-4828-5.
Li, Daneng, et al. “Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study.Breast Cancer Res Treat, vol. 171, no. 2, Sept. 2018, pp. 325–34. Pubmed, doi:10.1007/s10549-018-4828-5.
Li D, McCall LM, Hahn OM, Hudis CA, Cohen HJ, Muss HB, Jatoi A, Lafky JM, Ballman KV, Winer EP, Tripathy D, Schneider B, Barry W, Dickler MN, Hurria A. Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study. Breast Cancer Res Treat. 2018 Sep;171(2):325–334.
Journal cover image

Published In

Breast Cancer Res Treat

DOI

EISSN

1573-7217

Publication Date

September 2018

Volume

171

Issue

2

Start / End Page

325 / 334

Location

Netherlands

Related Subject Headings

  • Risk Factors
  • Receptors, Progesterone
  • Receptors, Estrogen
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Oncology & Carcinogenesis
  • Odds Ratio
  • Middle Aged
  • Letrozole
  • Incidence