There is a significant unmet medical need in stage II and III HR+ early breast cancer (eBC)—too many patients remain at risk of recurrence despite current treatment options, underscoring a gap in the treatment landscape.
Too many patients with HR+ eBC remain at risk of both early and late recurrence, even after endocrine therapy1-4
Patients with stage II or III disease face a considerable risk of recurrence, regardless of nodal involvement. This risk persists despite adjuvant endocrine therapy and remains a significant concern for decades.
The 3-year and 20-year data are not from a longitudinal study.
3-year risk is based on the iDFS outcomes of patients with HR+/HER2- eBC who received endocrine therapy alone in select CDK4/6 inhibitor clinical trials.1,2
20-year risk of distant recurrence is from a meta-analysis of 78 randomized trials in the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) database of 74,194 women with ER+ breast cancer who had 5 years of scheduled endocrine therapy.3
Assessing risk is complicated—consider these factors
Evaluating risk and prognosis is complex, and many criteria are involved5:
Tumor size
Nodal status
Histologic grade
ER, PR, and HER2 status
Genomic profile scores (eg, Oncotype DX®)
Circulating tumor cells and disseminated tumor cells
Ki-67
Age
Menopausal status
Comorbidities
In HR+/HER2- eBC, recently approved adjuvant treatments are limited to patients at the highest risk of recurrence6,7
Adjuvant endocrine therapy has been the standard of care for patients with HR+ eBC for over 3 decades. Though targeted adjuvant treatments have recently been introduced, their limited indications highlight a gap in the treatment landscape.6-11
Calculation based on targeted therapy approval for stage II or III node-positive HR+/HER2- disease and prevalence of BRCA1 and BRCA2 germline mutations in ER+ breast cancer.6,7,10,11
Patients need treatments that can help them live their fullest lives12-19
It is important that patients can adhere to therapy in order to effectively reduce their risk of recurrence. Many patients will need to be on therapy for years, so their ability to tolerate treatment is paramount. Symptomatic adverse reactions contribute to poor tolerability and are commonly associated with12-19:
Expert perspective
A medical expert discusses the treatment gap in HR+/HER2- eBC
Looking forward
Are your patients with stage II or III HR+/HER2- eBC falling into the treatment gap?
UNACCEPTABLE RISK OF RECURRENCE
Too many patients with stage II or III HR+ eBC remain at risk of recurrence, despite adjuvant endocrine therapy—a risk that persists across their lifetime, regardless of nodal involvement1-4
LIMITED TREATMENT OPTIONS
Recently approved targeted treatments are each only approved for use in <15% of patients with eBC—leaving many lost in the treatment gap6,7,10,11
TOLERABILITY CHALLENGES
Nonadherence and discontinuation are associated with an increased risk of recurrence. Treatments with improved tolerability are needed12-14