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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

1165 - Updated meta-analysis of randomized controlled trials (RCTs) to determine the CDK 4/6 inhibitors associated venous thromboembolism (VTE) risk in hormone receptor-positive breast cancer (BC) patients

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Supportive Care and Symptom Management

Tumour Site

Breast Cancer

Presenters

Kyaw Thein

Citation

Annals of Oncology (2018) 29 (suppl_8): viii603-viii640. 10.1093/annonc/mdy300

Authors

K.Z. Thein1, S. Ball2, M.H. Zaw3, A.M. Tun4, M. Quirch2, F. Hardwicke1, N. D'Cunha1, L. Tijani1, C. Jones1, T.H. Oo5

Author affiliations

  • 1 Hematology Oncology, Texas Tech University Health Sciences Center, 79430 - Lubbock/US
  • 2 Internal Medicine, Texas Tech University Health Sciences Center, 79430 - Lubbock/US
  • 3 Internal Medicine, The Brooklyn Hospital Center, Brooklyn/US
  • 4 Hematology Oncology, The Brooklyn Hospital Center, Brooklyn/US
  • 5 Benign Hematology, The University of Texas MD Anderson Cancer Center, Houston/US
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Resources

Abstract 1165

Background

Majority of BC express hormone receptors and cyclin dependent kinases especially CDK4/6 have been proven to mediate hormone therapy resistance. Many CDK 4/6 inhibitors have shown survival benefits. Yet, the VTE risk remains considerable. We undertook an updated meta-analysis of RCTs to determine the VTE risk among patients with hormone receptor-positive metastatic BC treated with CDK 4/6 inhibitors.

Methods

MEDLINE, EMBASE databases and meeting abstracts from inception through March 2018 were queried. RCTs that mention VTE as adverse effect were incorporated in the meta-analysis. The primary meta- analytic approach was a fixed effects model using the Mantel-Haenszel (MH) method. It was used to calculate the estimated pooled risk ratio (RR) and risk difference (RD) with 95% confidence interval (CI).

Results

Five phase III studies and one phase II study with a total of 3,159 patients were eligible. The study arms used palbociclib-letrozole, palbociclib-fulvestrant, ribociclib-letrozole, abemaciclib-fulvestrant, abemaciclib-letrozole/anastrozole while the control arms utilized placebo in combination with letrozole or anastrozole or fulvestrant. The I2 statistic for heterogeneity was 16.452, and the heterogeneity X2 (Cochran’s Q) was 5 (P = 0.308), suggesting homogeneity among RCTs. The VTE incidence was 40 (2.03%) in CDK 4/6 inhibitors group vs 5 (0.42%) in control group. The pooled RR for VTE in CDK 4/6 inhibitors group was 3.561 (95% CI: 1. 574 to 8.057, P = 0.002) and the absolute RD was 0.014 (95% CI: 0.002 to 0.027, P = 0.022) according to the fixed effects model. By the random effects model, the pooled RR was 3.072 (95% CI: 1.138 to 8.294, P = 0.027) and RD was 0.015 (95% CI: 0.007 to 0.023, P < 0.0001).

Conclusions

Our meta-analysis showed that the addition of CDK 4/6 inhibitors to letrozole or fulvestrant, contribute to higher incidence of VTE. Patients on CDK 4/6 inhibitors group experienced a significant increase in the VTE risk with a RR of 3.56. VTE remains the second leading cause of death in cancer patients receiving antineoplastic therapy and close monitoring is required.

Clinical trial identification

Legal entity responsible for the study

Kyaw Zin Thein, Texas Tech University Health Sciences Center.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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