Aromatase Inhibitor Therapy In Women Research Articles

Simulation modeling of breast cancer endocrine therapy duration by patient and tumor characteristics

BackgroundExtending endocrine therapy from 5 to 10 years is recommended for women with invasive estrogen receptor (ER)‐positive breast cancers. We evaluated the benefits and harms of the five additional years of therapy.MethodsAn established Cancer Intervention and Surveillance Network (CISNET) model used a lifetime horizon with national and clinical trial data on treatment efficacy and adverse events and other‐cause mortality among multiple birth cohorts of U.S. women ages 25–79 newly diagnosed with ER+, non‐metastatic breast cancer. We assumed 100% use of therapy. Outcomes included life years (LYs), quality‐adjusted life years (QALYs), and breast cancer mortality. Results were discounted at 3%. Sensitivity analyses tested a 15‐year time horizon and alternative assumptions.ResultsExtending tamoxifen therapy duration among women ages 25–49 reduced the lifetime probability of breast cancer death from 11.9% to 9.3% (absolute difference 2.6%). This translates to a gain of 0.77 LYs (281 days)/woman (undiscounted). Adverse events reduce this gain to 0.44 QALYs and after discounting, gains are 0.20 QALYs (73 days)/woman. Extended aromatase inhibitor therapy in women 50–79 had small absolute benefits and gains were offset by adverse events (loss of 0.06 discounted QALYs). There were greater gains with extended endocrine therapy for women with node‐positive versus negative cancers, but only women ages 25–49 and 50–59 had a net QALY gain. All gains were reduced with less than 100% treatment completion.ConclusionThe extension of endocrine therapy from 5 to 10 years modestly improved lifetime breast cancer outcomes, but in some women, treatment‐related adverse events may outweigh benefits.

Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105.

Nonadherence to aromatase inhibitors (AIs) for breast cancer is common and increases the risk of recurrence. Text messaging increases adherence to medications for chronic conditions. We conducted a randomized clinical trial of text messaging (TM) versus no text messaging (No-TM) at 40 sites in the United States. Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months. Test messages were sent twice a week over 36 months. Content themes focused on overcoming barriers to medication adherence and included cues to action, statements related to medication efficacy, and reinforcements of the recommendation to take AIs. Both groups were assessed every 3 months. The primary outcome was time to adherence failure (AF), where AF was defined as urine AI metabolite assay results satisfying one of the following: < 10 ng/mL, undetectable, or no submitted specimen. A stratified log-rank test was conducted. Multiple sensitivity analyses were performed. In total, 724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline. Observed adherence at 36 months was 55.5% for TM and 55.4% for No-TM. The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18). Multiple time to AF sensitivity analyses showed similar nonsignificant results. Three-year self-reported time to AF (10.4% v 10.3%; HR, 1.16 [95% CI, 0.69 to 1.98]; P = .57) and site-reported time to AF (21.9% v 18.9%; HR, 1.31 [95% CI, 0.86 to 2.01]; P = .21) also did not differ by arm. To our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions.

Risk of ovarian function recovery should be considered when switching from treatment with adjuvant tamoxifen to aromatase inhibitor therapy in women with chemotherapy-induced amenorrhea.

Key Points In this study, the risk of a return to menses and/or premenopausal estradiol/follicle‐stimulating hormone levels by 30 months after a switch from adjuvant tamoxifen to aromatase inhibitor therapy in women with postmenopausal estradiol levels at the time of the switch was 15.2% (38 of 250 patients) for women who had chemotherapy‐induced amenorrhea and were aged younger than 50 years at the time of breast cancer diagnosis. The risk was 1.2% (1 in 79 women) for women who were aged 50 to 54 years but still were premenopausal at the time of breast cancer diagnosis.

Acupuncture for Treatment of Arthralgia Secondary to Aromatase Inhibitor Therapy in Women with Early Breast Cancer: Pilot Study

Aromatase inhibitors (AIs) are recommended as adjuvant hormone treatment for postmenopausal women with early breast cancer. A substantial proportion of women taking AIs experience joint pain and stiffness. Studies have suggested that acupuncture may be effective in treating joint pain. A pilot study was conducted to evaluate the feasibility, safety and efficacy of using acupuncture to treat AI-induced arthralgia. A total of 32 patients were randomised to receive either sham or real electroacupuncture (EA) twice weekly for 6 weeks. Outcomes of joint pain, stiffness and physical function were measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), overall pain severity and interference with the BPI-SF and quality of life (QOL) with the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. Hand strength was assessed by a grip test, and a serum marker of inflammation (C reactive protein (CRP)) was also measured. All assessments were performed at baseline, 6 weeks and 12 weeks, except for blood samples at baseline and 6 weeks only. No serious adverse events were reported during or after acupuncture treatments. There were no significant differences in outcome measures. However, positive trends were observed in stiffness and physical function at week 12 in favour of real EA. Findings suggest that acupuncture is feasible and safe in patients with breast cancer with joint pain caused by AI. A larger study with adequately powered to confirm these results and detect clinically relevant effects is needed.

Sexual outcomes of aromatase inhibitor therapy in women with breast cancer

Sexual outcomes of aromatase inhibitor therapy in women with breast cancer

Abstract S6-4: Association between Prescription Co-Payment Amount and Compliance with Adjuvant Aromatase Inhibitor Therapy in Women with Early Stage Breast Cancer

Abstract Background: Non-adherence to adjuvant hormonal therapy among women with breast cancer is common, but little is known about how financial factors influence it. We investigated the relationship between prescription co-payment amount and compliance with adjuvant aromatase inhibitors (AI) therapy. Patients and Methods: Using de-identified, integrated pharmacy and medical claim database at Medco Health Solutions, Inc. women &amp;gt;50 years old on AIs for early breast cancer with at least 2 mail order prescription refills between 1/1/07 and 12/31/08 were identified. All data were pooled prior to the analysis. Variables that were evaluated included medical and demographic information, household income, number of other prescriptions, diagnostic codes, prescription refill dates, provider type and co-payment amounts. Age was classified as &amp;lt;63 or ≥63 to distinguish patients ever covered by Medicare. Copayment amount was categorized as &amp;lt;$30, between $30 and $89.99, and ≥$90. Non-persistence was defined as prescription supply gap of 45 days with no subsequent refill. Non-adherence was defined as a medication possession ratio ≥80% of eligible days. Logistic regressions and Cox proportional hazards modeling were used. Results: Of 8110 women age 50-62 years (mean=59.1), 1721(21.2%) were non-persistent and of those who continued, 863(10.3%) were non-adherent over the 2 year period. Among 14,050 women ≥63 years (mean=74.9), 3476(24.7%) were non-persistent and of those who continued, 1248(8.9%) were non-adherent. Ninety day co-payments ranged from $0 to $893.49. In a multivariate analysis, non-persistence (ever/never) in both age groups was associated with older age, having a primary care physician write the prescription, and higher number of co-prescriptions. Similar results were seen with non-adherence. Compared to a copayment of &amp;lt;$30, a 90 day copayment of $30-$89.99 was associated with time to non-persistence in women ≥63 (HR 1.34, 95%CI 1.24-1.46) but not among women &amp;lt;63, while a copayment ≥$90 was associated with time to non-persistence both in women &amp;lt;63 (HR 1.26, 95%CI 1.09–1.38) and women ≥63 (HR 1.33, 95%CI 1.22–1.46). Conclusions: We found that a higher prescription co-payment was associated with both early discontinuation and non-adherence to AIs. This relationship was stronger for older women. Because hormone therapy non-compliance is associated with worse survival outcomes, future public policy efforts should be directed towards reducing financial constraints as a means of increasing the use of these life-saving medications. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr S6-4.