KEY TAKEAWAYS
- The study aimed to evaluate the safety of PFS in SERDs in HER+, HER2- aBC pts after progression on ≥ 1 line of ET.
- The results demonstrated that oral SERD offers significant PFS benefits over standard ET in advanced HER+/HER2- breast cancer pts.
Advanced breast cancer (aBC) with human epidermal growth factor receptor-positive (HER+) and human epidermal growth factor receptor 2-negative (HER2-) status often progresses after initial endocrine therapy (ET). New treatment options are needed.
Oral selective estrogen receptor degraders (SERDs) have emerged as a promising new class of drugs for aBC. Their effectiveness, particularly after progression on ≥ 1 line of ET, remains a subject of ongoing debate.
Huang X and other members sought to clarify the value of oral SERDs for HER+ and HER2- aBC patients who had progressed on at least one line of ET. They conducted a meta-analysis of clinical trials to assess the impact of SERDs on progression-free survival (PFS) and safety in this specific patient population.
Researchers systematically and comprehensively searched the Cochrane Library, Embase, PubMed, and conference proceedings from SABCS, ASCO, ESMO, and ESMO Breast. To assess the pooled HRs and 95% CIs for treatment with oral SERDs versus standard of care, random or fixed effects models were employed, depending on the data’s characteristics.
About four studies, including 1,290 patients (pts), were incorporated. The HER for PFS indicated that the oral SERD regimen outperformed standard care in patients with HER+/HER2- aBC following progression on at least one line of ET (HR: 0.75, 95% CI: 0.62-0.91, P=0.004).
In patients harboring ESR1 mutations, the oral SERD regimen yielded better PFS than standard care (HR: 0.58, 95% CI: 0.47-0.71, P<0.00001). For patients experiencing disease progression after prior CDK4/6 inhibitor use, a PFS benefit was observed in the oral SERD treatment arms versus standard care (HR: 0.75, 95% CI: 0.64-0.87, P=0.0002).
The results concluded that the oral SERD regimen significantly improved PFS compared to standard ET in patients with HER+/HER2- aBC who had progressed on at least one line of ET. Oral SERDs were preferred for patients with ESR1 mutations and could potentially replace fulvestrant. The oral SERD regimen also offered a PFS benefit in patients who had experienced disease progression after prior CDK4/6 inhibitor use.
No funding was provided for the study.
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10763362/
Clinical trial: https://www.clinicaltrials.gov/study/NCT03778931
https://clinicaltrials.gov/study/NCT04214288
https://clinicaltrials.gov/study/NCT04059484
https://clinicaltrials.gov/study/NCT04576455
Huang X, Yu Y, Luo S, et al. “The value of oral selective estrogen receptor degraders in patients with HR-positive, HER2-negative advanced breast cancer after progression on ≥ 1 line of endocrine therapy: systematic review and meta-analysis” doi: 10.1186/s12885-023-11722-4.