Sexual quality of life assessment in young women with breast cancer during adjuvant endocrine therapy and patient-reported supportive measures

Purpose Sexual quality of life (QoL) is affected during and after breast cancer (BC) treatment. The purpose was to investigate sexual and global QoL and patient-reported measures to address this issue in young women (< 51 years) with BC after the acute treatment phase, during adjuvant endocrine therapy. Methods Three EORTC questionnaires and an additional specific questionnaire, developed for the study, were used to assess sexual and global QoL and patient-reported supportive measures in BC patients who had received their endocrine therapy for at least 24 months. Among the 54 eligible patients, 45 (83%) agreed to participate in the study. Results We showed a deterioration in sexual QoL and poor communication with healthcare professionals. Most patients (88.9%) declared that it was important that sexuality should be discussed with caregivers and that the partner should also be involved. Most patients (60%) had taken at least one action to overcome their sexual problems. Most of these interventions (63%) originated from the patient herself. Conclusions Sexual QoL is a major issue in young BC patients and is poorly addressed by healthcare professionals. Most of the supportive methods used by the patients to overcome these side effects were on their own initiative. Communication and counseling on sexuality by healthcare professionals need to be improved during BC treatment. Patients suggested supportive measures they would find useful and appropriate to develop in the clinic. The final goal is to improve the sexual QoL of BC patients with the appropriate intervention and support.

Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03)

PURPOSE Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor approved for advanced breast cancer. In the adjuvant setting, the potential value of adding palbociclib to endocrine therapy for hormone receptor–positive breast cancer has not been confirmed. PATIENTS AND METHODS In the prospective, randomized, phase III PALLAS trial, patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative early breast cancer were randomly assigned to receive 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle) with adjuvant endocrine therapy or adjuvant endocrine therapy alone (for at least 5 years). The primary end point of the study was invasive disease-free survival (iDFS); secondary end points were invasive breast cancer–free survival, distant recurrence-free survival, locoregional cancer-free survival, and overall survival. RESULTS Among 5,796 patients enrolled at 406 centers in 21 countries worldwide over 3 years, 5,761 were included in the intention-to-treat population. At the final protocol-defined analysis, at a median follow-up of 31 months, iDFS events occurred in 253 of 2,884 (8.8%) patients who received palbociclib plus endocrine therapy and in 263 of 2,877 (9.1%) patients who received endocrine therapy alone, with similar results between the two treatment groups (iDFS at 4 years: 84.2% v 84.5%; hazard ratio, 0.96; CI, 0.81 to 1.14; P = .65). No significant differences were observed for secondary time-to-event end points, and subgroup analyses did not show any differences by subgroup. There were no new safety signals for palbociclib in this trial. CONCLUSION At this final analysis of the PALLAS trial, the addition of adjuvant palbociclib to standard endocrine therapy did not improve outcomes over endocrine therapy alone in patients with early hormone receptor–positive breast cancer.

A Mixed-Methods Study of the Technical Feasibility and Patient Acceptability of a Real-Time Adherence Monitor in Breast Cancer Survivors Taking Adjuvant Endocrine Therapy

Purpose: Oral anti-cancer medications are increasingly common and endocrine therapies represent the most common oral anti-cancer medications in breast cancer. Adjuvant endocrine therapies reduce the likelihood of recurrence and mortality in the approximately 80% of women diagnosed with hormone-receptor positive breast cancer, thus rendering adherence essential. Real-time medication adherence monitors, such as the Wisepill electronic pillbox, transmit adherence data remotely, allowing for early intervention for non-adherence. However, their feasibility and acceptability have yet to be examined among breast cancer survivors taking endocrine therapies.Methods: This study presents quantitative patient-report and technical support data and qualitative patient acceptability data on using Wisepill, a common real-time adherence monitor, among 88 breast cancer survivors prescribed adjuvant endocrine therapy.Results: This mixed-methods study of a common real-time adherence monitor, among the first in breast cancer survivors taking adjuvant endocrine therapy, demonstrates its technical feasibility and patient acceptability.Conclusion: The use of wireless medication monitors that transmit real-time adherence data are uniquely promising for maximizing the benefits of adjuvant endocrine therapy by allowing for continuous tracking, ongoing communication with oncologic or research teams, and early intervention. This study demonstrates the feasibility and patient acceptability of one such real-time adherence monitor.

Copy number heterogeneity identifies ER+ breast cancer patients with adverse outcome after adjuvant endocrine therapy

Background − Endocrine therapy forms the backbone of adjuvant treatment for estrogen-receptor positive (ER+) breast cancer. However, it remains unclear whether adjuvant treatment improves survival rates in low-risk patients . Low intra-tumor heterogeneity (ITH) has been shown to confer low-risk for recurrent disease. Here, it is studied if chromosomal copy number ITH (CNH) can identify low-risk ER+, lymph node-negative breast cancers patients who do not benefit from adjuvant endocrine therapy. Methods − Lymph node-negative ER+ patients from the METABRIC dataset were retrospectively analyzed (n=708). CNH was determined from a single bulk copy number measurement for each patient. Patients were stratified by CNH score as low, medium or high. Overall survival (OS) was compared between patients that did, or did not receive adjuvant endocrine therapy per CNH group with Cox proportional-hazards models, using propensity score weights to correct for confounders. Results − Adjuvant endocrine therapy improved the relapse free survival (RFS) for high-CNH/high-risk patients treatment (Hazard Ratio [HR] = 0.55, 95% Confidence Interval [CI] = 0.35 to 0.87), but not for low CNH/risk patients treatment (HR = 0.88, 95% CI = 0.50 to 1.55). For low-CNH/low-risk patients adjuvant endocrine therapy was associated with impaired OS (HR = 1.62, 95% CI = 1.10 to 2.40). Multivariable Cox analysis identified a significant interaction between CNH and endocrine therapy for OS (HR = 0.77, 95% CI = 0.62 to 0.96). Conclusions − This retrospective study of lymph node-negative, ER+ breast cancer finds that patients identified as low-risk using CNH display reduced OS when treated with adjuvant endocrine therapy.

Level of Combined Estrogen and Progesterone Receptor Expression Determines the Eligibility for Adjuvant Endocrine Therapy in Breast Cancer Patients

Hormone receptor (HR)-positive breast cancer has a heterogeneous pattern according to the level of receptor expression. Patients whose breast cancers express low levels of estrogen receptor (ER) or progesterone receptor (PgR) may be eligible for adjuvant endocrine therapy, but limited data are available to support this notion. We aimed to determine whether HR expression level is related to prognosis. Tumors from 6042 patients with breast cancer were retrospectively analyzed for combined HR levels of ER and PgR. Low expression was defined as ER 1–10% and PgR 1–20%. Four HR groups were identified by combining ER and PgR expression levels. Patients whose tumors expressed high levels of a single receptor showed the worst survival outcomes, and their risk continuously increased even after the 10-year follow-up. Endocrine therapy had a significant benefit for patients whose tumors expressed high HR levels and a favorable tendency for patients with tumors expressing low HR levels. We established the possible benefit of endocrine therapy for patients whose breast tumors expressed low HR levels. Thus, HR level was a prognostic factor and might be a determinant of extended therapy, especially for patients with high expression of a single receptor.

Sexual Quality of Life Assessment in Young Women with Breast Cancer During Adjuvant Endocrine Therapy and Patient-Reported Supportive Measures

Purpose: sexual quality of life (QoL) is affected during and after breast cancer (BC) treatment. The purpose was to investigate sexual and global QoL and patient-reported measures to address this issue in young women (< 51 years) with BC after the acute treatment phase, during adjuvant endocrine therapy. Methods: three EORTC questionnaires and an additional specific questionnaire, developed for the study, were used to assess sexual and global QoL and patient-reported supportive measures in BC patients who had received their endocrine therapy for at least 24 months.Results: We showed a deterioration of the sexual QoL and a poor communication with healthcare professionals. Most patients (88.9%) declared important that sexuality should be discussed with caregivers and that the partner should also be involved. Most patients (60%) had taken at least one action to overcome their sexual problems. Most of these interventions (63%) originated from the patient herself. Conclusions: sexual QoL is a major issue in young BC patients and is poorly addressed by healthcare professionals. Most of the supportive methods used by the patients to overcome these side effects were at their own initiative. Communication and counseling on sexuality from healthcare professionals needs to be improved during BC treatment. Patients suggested supportive measures they would find useful and appropriate to develop in clinic. The final goal being to improve sexual QoL of BC patients with the appropriate intervention and support.NCT 04200001