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Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug Class: | CDK4 inhibitor + CDK6 inhibitor |
| Direction: | Sensitive |
Evidence:
Source:
Title:
ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer†
Excerpt:
Recommendations...First-line treatment...A CDK4/6 inhibitor combined with ET is the standard-of-care first-line
therapy for patients with ER-positive, HER2-negative MBC...
Secondary therapy:
Hormone Therapy
DOI:
https://doi.org/10.1016/j.annonc.2021.09.019.
Source:
Title:
Systematic review and meta-analysis of post-progression outcomes in ER+/HER2- metastatic breast cancer after CDK4/6 inhibitors within randomized clinical trials
Published date:
12/01/2021
Excerpt:
We conducted a systematic literature search of randomized clinical trials with CDK4/6 inhibitors and ET reporting PFS2 or TTC of HR+/HER2− pre- or postmenopausal metastatic breast cancer….A benefit in terms of PFS (pooled HR = 0.55, 95% CI = 0.51-0.59, I2 = 0%) and overall survival (pooled HR = 0.76, 95% CI = 0.69-0.84, I2 = 0%) was also observed. CDK4/6 inhibitors plus ET compared with ET alone improve PFS2 and TTC.
DOI:
https://doi.org/10.1016/j.esmoop.2021.100332
Source:
Title:
457P - Disparities in receipt of CDK4/6 inhibitors with endocrine therapy as therapy for hormone receptor-positive, HER2-negative metastatic breast cancer in the real-world setting
Published date:
10/16/2023
Excerpt:
After IPW adjustment, CDK4/6i+ET treatment was associated with significantly longer median PFS compared to ET alone (27 vs 17 months; hazard ratio [HR]=0.61, p<0.001). Median OS was 52 months in the CDK4/6i+ET group and was 42 months with ET alone (HR=0.74, p<0.001)....RWE confirms the added PFS and OS benefit of adding CDK4/6i to endocrine therapy in patients with ER+, HER2-negative MBC.
Secondary therapy:
Hormone Therapy
Source:
Title:
Outcomes of CDK4/6 Inhibitors vs Weekly Paclitaxel in the Treatment of Patients With ER+/HER2− Advanced Breast Cancer With Impending or Established Visceral Crisis
Published date:
09/17/2023
Excerpt:
Median time to treatment failure (TTF), progression-free survival (PFS) and overall survival (OS) were significantly longer in the CDK4/6i compared to paclitaxel cohort: TTF 17.3 vs. 3.5 months (HR 0.33, 95%CI 0.17-0.61, p = 0.0002), PFS 17.8 vs. 4.5 months (HR 0.38, 95%CI 0.21-0.67, p = 0.002), OS 24.6 vs. 6.7 months (HR 0.37, 95%CI 0.20-0.68, p = 0.002)....In this retrospective study, patients with ER+/HER2- ABC and IVC/VC treated with CDK4/6i had a significantly better survival compared to those treated with weekly paclitaxel.
Source:
Title:
CDK4/6 inhibitors versus weekly paclitaxel for treatment of ER+/HER2- advanced breast cancer with impending or established visceral crisis
Published date:
08/16/2023
Excerpt:
Median time to treatment failure (TTF), progression-free survival (PFS) and overall survival (OS) were significantly longer in the CDK4/6i compared to paclitaxel cohort: TTF 17.3 vs. 3.5 months (HR 0.33, 95%CI 0.17-0.61, p = 0.0002), PFS 17.8 vs. 4.5 months (HR 0.38, 95%CI 0.21-0.67, p = 0.002), OS 24.6 vs. 6.7 months (HR 0.37, 95%CI 0.20-0.68, p = 0.002)....In multivariate analysis, treatment with CDK4/6i was independently associated with a longer PFS compared to paclitaxel (HR 0.31, 95%CI 0.12-0.78, p = 0.015)....In this retrospective study, patients with ER+/HER2- ABC and IVC/VC treated with CDK4/6i had a significantly better survival compared to those treated with weekly paclitaxel.
DOI:
10.1007/s10549-023-07035-6
Source:
Title:
Real-world outcomes from the systemic use of CDK 4/6 inhibitors (CDKIs) in the management of ER positive (+) HER2 negative (-) metastatic breast cancer (mBC).
Published date:
05/19/2021
Excerpt:
272 patients with a median age of 65 years (30-90 years) were treated with CDKIs...in combination with endocrine therapies (letrozole, anastrozole, exemestane and, fulvestrant). Median overall survival was 49.5 months. Treatment with first-line CDKIs (69.8%; n=190) resulted in superior PFS when compared to CDKIs in a ≥ second-line setting...This analysis confirms the PFS benefit from CDKIs demonstrated in clinical trials is mirrored in the real-world setting.
Secondary therapy:
exemestane; letrozole; anastrozole; fulvestrant
DOI:
10.1200/JCO.2021.39.15_suppl.e13031
