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

2020 ◽  
Vol 38 (19) ◽  
pp. 2122-2129 ◽  
Author(s):  
Dawn L. Hershman ◽  
Joseph M. Unger ◽  
Grace Clarke Hillyer ◽  
Anna Moseley ◽  
Kathryn B. Arnold ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Text Messaging ◽  
Early Stage ◽  
The United States ◽  
Early Stage Breast Cancer ◽  
Sensitivity Analyses ◽  
Rank Test ◽  
Multiple Time

PURPOSE 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. METHODS 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. RESULTS 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. CONCLUSION 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.

Randomized trial of text messaging (TM) to reduce early discontinuation of aromatase inhibitor (AI) therapy in women with breast cancer: SWOG S1105.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6516-6516 ◽  
Author(s):  
Dawn L. Hershman ◽  
Joseph M. Unger ◽  
Hillyer Grace ◽  
Anna Moseley ◽  
Kathryn B Arnold ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Text Messaging ◽  
Behavioral Interventions ◽  
Cox Regression ◽  
Sensitivity Analyses ◽  
Rank Test ◽  
Missed Appointments ◽  
Primary Analysis

6516 Background: Non-adherence to AI’s for breast cancer is common and increases risk of recurrence. Text messaging (TM) has been shown to increase adherence to medications for chronic conditions. We conducted a multicenter randomized trial to evaluate if TM reminders improve AI adherence. Methods: Patients taking an AI for ≥30 days and having ≥36 mos of planned therapy were eligible. Patients were randomly assigned 1:1 to receive either TM or NO-TM twice a week for 36 mos. Randomization was stratified by length of time on prior AI therapy ( < 12 (64%) vs. 12-24 mos (36%)) and AI class (anastrozole, letrozole, exemestane). Content themes of the 36 TMs focused on overcoming barriers to adherence. Patients were assessed for discontinuation of AIs every 3 mos for 36 mos. The primary outcome was time to non-adherence, where non-adherence was defined as urine AI metabolite assay results satisfying the following: < 10 [units], undetectable, or no submitted specimen. A stratified Log-rank test was conducted. Multiple sensitivity analyses were performed using Cox regression. Results: In total, 724 patients were registered between May, 2012 and September, 2013, among whom 696 (338/360 (93.9%) on TM and 338/364 (92.9%) on NO-TM) were eligible and adherent at baseline. Observed (time-independent) adherence at 36 mos was 55.4% for TM and 55.4% for NO-TM. The primary analysis showed no difference in time-to-adherence failure between patients on the TM and NO-TM arms (HR = 0.89, 95% CI:0.76,1.05 p = .18). An analysis of negative urine tests alone resulted in similar non-significant results. With missed appointments not counted as failures, time to self-reported discontinuation (89.6% vs. 89.7%; HR = 1.17, 95% CI:0.69-1.98, p = .57) and site reported discontinuation (78.1% vs. 81.1%; HR = 1.31, 95% CI:0.86-2.01, p = .21) were also similar between the 2 groups. Conclusions: As the first large long-term randomized trial of an intervention directed at improving AI adherence, we found high rates of AI discontinuation. Bi-weekly text reminders did not improve adherence to AIs compared to usual care. Improving long—term adherence will likely require sustained behavioral interventions and support. Clinical trial information: NCT01515800.

Modeling the consequences of recurrences after trastuzumab treatment of HER2+ early-stage breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12032-e12032
Author(s):  
Quan V. Doan ◽  
Miguel Martin ◽  
Deepa Lalla ◽  
Marc Halperin ◽  
Richard Bryce ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Indirect Costs ◽  
The United States ◽  
Nodal Status ◽  
Early Stage Breast Cancer ◽  
Hourly Wage ◽  
Incident Cases ◽  
Over Time

e12032 Background: The study objective was to estimate the long-term consequences of recurrences following treatment with trastuzumab (TRA) among women with HER2+ early stage breast cancer (BC) in the United States (US). Methods: A simulation model was constructed to estimate the following outcomes for each combination of hormone receptor (+/-) and nodal (+/-) status: number of recurrences, direct medical cost and indirect cost attributed to recurrences. The number of women aged ≥18 years with newly diagnosed HER2+ BC between 2018 and 2037 was estimated using SEER incidence rates (assumed constant over time) and from US Census data and accounted for the proportion of women utilizing adjuvant TRA by nodal status and age (assumed constant over time). The recurrence rate to any regional, distant or contralateral site was based on the long-term follow-up of the HERceptin Adjuvant (HERA) trial (expected 20-year recurrence proportions of 27.6% for TRA and 36.7% without TRA). Medical and pharmacy costs due to a recurrence were based on a 3-year study of metastatic BC patients treated with HER2 targeted agents. Beyond year 3, cost increased by 4.5% per year. The indirect costs of recurrences included loss of income from early retirement valued at the mean hourly wage, work absenteeism ($6,960/year), and reduced productivity while at work ($3,456/year). Non-cancer related mortality was estimated using SEER data. Results: We estimated that there would be 411,373 incident cases of early stage BC who would receive adjuvant TRA treatment from 2018 to 2037. Following each annual cohort for 20 years, we estimated that there would be 112,700 recurrences after TRA treatment and 149,674 recurrences without TRA treatment. The 20-year direct medical costs of recurrences were estimated to be $28.2 and $37.5 billion with and without TRA, respectively and the indirect costs were estimated to be $4.1 and $5.6 billion with and without TRA, respectively. Conclusions: Although TRA reduced recurrences by 25% in our 20-year model, there was a substantial number of recurrences. Future research will assess the clinical and economic impact of newer HER2 directed therapies in the adjuvant (pertuzumab, T-DM1) and extended adjuvant (neratinib) setting.

Sequencing of Chemotherapy and Radiation Therapy in Early-Stage Breast Cancer: Updated Results of a Prospective Randomized Trial

2005 ◽  
Vol 23 (9) ◽  
pp. 1934-1940 ◽  
Author(s):  
Jennifer R. Bellon ◽  
Steven E. Come ◽  
Rebecca S. Gelman ◽  
I. Craig Henderson ◽  
Lawrence N. Shulman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Statistical Power ◽  
Early Stage ◽  
Conservative Surgery ◽  
Early Stage Breast Cancer ◽  
Prospective Randomized Trial ◽  
Long Term Results ◽  
Breast Cancer Patients

Purpose The optimal integration of chemotherapy with radiation (RT) for patients with early-stage breast cancer remains uncertain. We present the long-term results of a prospective randomized trial to address this question. Patients and Methods Two hundred forty-four patients were randomly assigned after conservative breast surgery to receive 12 weeks of cyclophosphamide, doxorubicin, methotrexate, fluorouracil, and prednisone (CAMFP) before RT (CT-first) or after RT (RT-first). Median follow-up for surviving patients was 135 months. Results There were no significant differences between the CT-first and RT-first arms in time to any event, distant metastasis, or death. Sites of first failure were also not significantly different. Conclusion Among breast cancer patients treated with conservative surgery, there is no advantage to giving RT before adjuvant chemotherapy. However, this study does not have enough statistical power to rule out a clinically important survival benefit for either sequence.

scholarly journals Neoadjuvant radiotherapy of early-stage breast cancer and long-term disease-free survival

2017 ◽  
Vol 19 (1) ◽  
Author(s):  
Jan Poleszczuk ◽  
Kimberly Luddy ◽  
Lu Chen ◽  
Jae K. Lee ◽  
Louis B. Harrison ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Disease Free Survival ◽  
Early Stage Breast Cancer ◽  
Neoadjuvant Radiotherapy ◽  
Free Survival ◽  
Disease Free
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