Patient-Reported Outcomes from a Phase 3 Trial in Premenopausal Patients with ER-Positive, HER2-Negative, Lymph Node–Positive Breast Cancer

Although neoadjuvant endocrine therapy (NET) is not yet considered a standard of care in premenopausal women and should be studied in the context of a clinical trial, the therapy could be an alternative treatment option because the adverse effects and negative impact on quality of life associated with endocrine therapy are relatively mild when compared with those associated with chemotherapy.

In a prospective phase 3 clinical trial, individuals with hormone status–positive, lymph node–positive, premenopausal breast cancer were compared with NET versus conventional neoadjuvant chemotherapy (NCT).¹ Patients were randomly assigned to either NCT with doxorubicin plus cyclophosphamide followed by taxane for 24 weeks or NET with gonadotropin-releasing hormone agonist and tamoxifen for 24 weeks.¹

The breast cancer module of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 23 was used to assess patient-reported outcomes (PROs) on the first day of the trial (day 1, baseline) and at the end of treatment.¹ A total of 174 patients completed 24 weeks of neoadjuvant treatment (N = 87 in each group) after being randomly assigned to chemotherapy (N = 95) or endocrine therapy (N = 92). The baseline scores were similar between groups.¹

The function scales, including body image, sexual functioning, and sexual enjoyment, showed no statistically significant differences between the groups after treatment, although the endocrine treatment group showed a significant improvement in the future perspective. The symptom measures, which included unpleasant effects of systemic medication, breast symptoms, arm symptoms, and upset about hair loss, showed no statistically significant differences between the groups. Overall, the PROs in both treatment groups were identical, with the exception of “future view,” which was much better in the NET group than in the NCT group.¹

There were no statistically significant differences between baseline and posttreatment scores in the total PROs, including functional scales and symptom scales.¹

In a separate study, NET achieved T and N downstaging as well as pathologic complete response, despite increased response rates after NCT. For individuals who cannot endure NCT or for whom chemotherapy may not be beneficial based on genetic testing, NET can be utilized to de-escalate surgery.² A third separate study also showed better clinical responses were observed in premenopausal patients after 24 weeks of NCT compared with those observed after NET.³

References

1. Gwark S, Ahn SH, Noh WC, et al. Patient-reported outcomes from phase III neoadjuvant systemic trial comparing neoadjuvant chemotherapy with neoadjuvant endocrine therapy in pre-menopausal patients with estrogen receptor-positive and HER2-negative, lymph node-positive breast cancer. Front Oncol. 2021;11:608207.
2. Cao L, Sugumar, K, Keller E, et al. Neoadjuvant endocrine therapy as an alternative to neoadjuvant chemotherapy among hormone receptor-positive breast cancer patients: pathologic and surgical outcomes. Ann Surg Oncol. 2021;28;5730-5741.
3. Kim, HJ, Noh WC, Lee ES, et al. Efficacy of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy in pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer. Breast Cancer Res. 2020;22:54.