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 ◽  
...  

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.

2020 ◽  
Vol 38 (19) ◽  
pp. 2122-2129 ◽  
Author(s):  
Dawn L. Hershman ◽  
Joseph M. Unger ◽  
Grace Clarke Hillyer ◽  
Anna Moseley ◽  
Kathryn B. Arnold ◽  
...  

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.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Yang Li ◽  
Su Lu ◽  
Yuhan Zhang ◽  
Shuaibing Wang ◽  
Hong Liu

Abstract Background The number of young patients diagnosed with breast cancer is on the rise. We studied the rate trend of local recurrence (LR) and regional recurrence (RR) in young breast cancer (YBC) patients and outcomes among these patients based on molecular subtypes. Methods A retrospective cohort study was conducted based on data from Tianjin Medical University Cancer Institute and Hospital for patients ≤ 35 years of age with pathologically confirmed primary invasive breast cancer surgically treated between 2006 and 2014. Patients were categorized according to molecular subtypes on the basis of hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status. The 5-year rates for LR, RR, and distant metastases (DM) were estimated by Kaplan-Meir statistics. Nelson-Aalen cumulative-hazard plots were used to describe local recurrence- and distant metastasis-free intervals. Results We identified 25,284 patients with a median follow-up of 82 months, of whom 1099 (4.3%) were YBC patients ≤ 35 years of age. The overall 5-year LR, RR, and DM rates in YBC patients were 6.7%, 5.1%, and 16.6%, respectively. The LR and RR rates demonstrated a decreasing trend over time (P = 0.028 and P = 0.015, respectively). We found that early-stage breast cancer and less lymph node metastases increased over time (P = 0.004 and P = 0.007, respectively). Patients with HR−/HER2+ status had a significantly higher LR (HR 20.4; 95% CI, 11.8–35.4) and DM (HR 37.2; 95% CI, 24.6–56.3) at 10 years. Breast-conserving surgery (BCS) or mastectomy did not influence rates of LR and RR. In the overall population, the 5-year survival of YBC patients exceeded 90%. Conclusions The rates of LR and RR with YBC patients demonstrated a downward trend and the proportion of early-stage breast cancer increased between 2006 and 2014. We report the highest LR rates in this young population were associated with HR−/HER2+ tumors.


Author(s):  
Daphne H. M. Jacobs ◽  
Ramona K. Charaghvandi ◽  
Nanda Horeweg ◽  
John H. Maduro ◽  
Gabrielle Speijer ◽  
...  

Abstract Purpose To evaluate and compare health-related quality of life (HRQL) of women with early-stage breast cancer (BC) treated with different radiotherapy (RT) regimens. Methods Data were collected from five prospective cohorts of BC patients treated with breast-conserving surgery and different RT regimens: intraoperative RT (IORT, 1 × 23.3 Gy; n = 267), external beam accelerated partial breast irradiation (EB-APBI, 10 × 3.85 Gy; n = 206), hypofractionated whole breast irradiation(hypo-WBI, 16 × 2.67 Gy; n = 375), hypo-WBI + boost(hypo-WBI-B, 21–26 × 2.67 Gy; n = 189), and simultaneous WBI + boost(WBI-B, 28 × 2.3 Gy; n = 475). Women ≥ 60 years with invasive/in situ carcinoma ≤ 30 mm, cN0 and pN0-1a were included. Validated EORTC QLQ-C30/BR23 questionnaires were used to asses HRQL. Multivariable linear regression models adjusted for confounding (age, comorbidity, pT, locoregional treatment, systemic therapy) were used to compare the impact of the RT regimens on HRQL at 12 and 24 months. Differences in HRQL over time (3–24 months) were evaluated using linear mixed models. Results There were no significant differences in HRQL at 12 months between groups except for breast symptoms which were better after IORT and EB-APBI compared to hypo-WBI at 12 months (p < 0.001). Over time, breast symptoms, fatigue, global health status and role functioning were significantly better after IORT and EB-APBI than hypo-WBI. At 24 months, HRQL was comparable in all groups. Conclusion In women with early-stage breast cancer, the radiotherapy regimen did not substantially influence long-term HRQL with the exception of breast symptoms. Breast symptoms are more common after WBI than after IORT or EB-APBI and improve slowly until no significant difference remains at 2 years posttreatment.


2017 ◽  
Vol 19 (1) ◽  
Author(s):  
Jan Poleszczuk ◽  
Kimberly Luddy ◽  
Lu Chen ◽  
Jae K. Lee ◽  
Louis B. Harrison ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document