A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients’ persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer

Yu, Ke; Zhou, Ying; Liu, Guang Yu; Li, Bin; He, Pan; Zhang, Hong Wei; Lou, Li Hua; Wang, Xiao Jia; Wang, Shui; Tang, Jin; Liu, Yin Hua; Wang, Xiang; Jiang, Ze; Wen, Li; Gu, Lin; Cao, Ming; Zhang, Qing Yuan; Wang, Shen Ming; Su, Feng; Zheng, Hong; Li, Hong Yuan; Tang, Li; Sun, Si; Liu, Jin Ping; Shao, Zhi Ming; Shen, Zhen

doi:10.1007/s10549-012-2059-8

Cited by 49 publications

(51 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In relation to the interventions, three of the studies tested the German-based PACT study intervention but in different contexts. 14, 24, 25 In relation to the study design, 80% (n=4) of the papers consisted of randomized controlled trials (RCT; n=4), all included an educational component (100%; n=5), and 60% incorporated reminders (n=3). All interventions were targeted towards patients (100%; n=5).…”

Section: Resultsmentioning

confidence: 99%

“…Similarly, Yu and colleagues' (2012) 25 study tested the efficacy of the PACT education materials and a follow-up reminder service to improve AI medication adherence in ER+ postmenopausal breast cancer patients in China. It is not clear to what extent the PACT materials were changed in order to accommodate the Chinese context however (besides language).…”

Section: Resultsmentioning

confidence: 99%

“…All the studies were randomized except for Yu and colleagues'. 25 Only one study, by Ziller and colleagues, 26 explicitly mentioned blinding of the study staff (interviewers and analysts) although no details were presented regarding how blinding was achieved or whether participants were blinded (see Table 2A, only available as an online appendix, for more specific details about the bias analysis).…”

Section: Resultsmentioning

confidence: 99%

“…Adjuvant hormonal therapy adherence and persistence were expressed as proportions and were either abstracted 14, 24 or calculated 25, 26 based on reported data by two authors (TL and CD). Odds ratios (OR) and its 95% CI comparing adherence and persistence with adjuvant hormonal therapy in the intervention compared to the usual care group were also calculated from study results and are presented in Tables 3 and 4.…”

Section: Methodsmentioning

confidence: 99%

See 3 more Smart Citations

Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review

Hurtado‐de‐Mendoza

Cabling

Lobo

et al. 2016

Clinical Breast Cancer

View full text Add to dashboard Cite

Adjuvant hormonal therapy contributes to reductions in recurrence and mortality for women with hormone receptor positive breast cancer. However, adherence to hormonal therapy is suboptimal. This is the first systematic literature review examining interventions aimed at improving hormonal therapy adherence. Researchers followed the PRISMA guidelines. PubMed-Medline, CINAHL, PsychInfo, Ovid-Medline, and EMBASE were searched for behavioral interventions that aimed to enhance adherence to adjuvant hormonal therapy in breast cancer survivors. There were 376 manuscripts screened for eligibility. Five articles met criteria. All interventions presented adherence outcomes after one-year follow-up. None significantly enhanced adherence compared to the usual care in the primary analysis (OR ranged from 1.03 to 2.06 for adherence and from 1.11 – 1.18 for persistence). All targeted patients and three only included post-menopausal breast cancer patients. Three tested the same intervention consisting of educational materials. Only one was conducted in the US. Only one reported participants' ethnicity. Overall it was unclear whether the studies contained bias. The use of different terminology and operationalization of adherence made comparisons challenging. Interventions to improve adherence to adjuvant hormonal therapy in US breast cancer populations that includes survivors who are ethnically diverse, premenopausal, and taking tamoxifen are necessary to inform future interventions. Adoption of consistent adherence definitions/measurements will provide a clearer framework to consolidate aggregate findings. Given the limited efficacy of tested interventions, it is important to engage oncologists and academics to develop approaches that target different components associated with hormonal therapy adherence, such as doctor-patient communication or social support.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review

Hurtado‐de‐Mendoza

Cabling

Lobo

et al. 2016

Clinical Breast Cancer

View full text Add to dashboard Cite

show abstract

“…Drugs used to treat hormone receptor-positive breast cancer can be divided into two classes (Pickar et al, 2010;Yu et al, 2012): the selective estrogen receptor modulators (SERMs) and the aromatase inhibitors (AIs). Both classes of drugs are designed to interfere with the effects of estrogen, which plays an important role in the development and proliferation of breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Inhibition of Cytochrome P450 Enzymes by the E- and Z-Isomers of Norendoxifen

Liu

Flockhart

et al. 2013

Drug Metab Dispos

View full text Add to dashboard Cite

Aromatase catalyzes the conversion of testosterone to estradiol and is the main source of endogenous estrogen in postmenopausal women. Aromatase inhibitors (AIs) are used to treat postmenopausal women with hormone receptor-positive breast cancer. Norendoxifen [4-(1-(4-(2-aminoethoxy)phenyl)-2-phenylbut-1-en-1-yl)phenol], an active metabolite of the selective estrogen receptor modulator tamoxifen, has been shown to be a potent competitive AI, with an IC 50 of 90 nM. To obtain data relevant to the clinical use of norendoxifen, the primary objective of this study was to investigate norendoxifen's inhibitory capability on enzymes related to drug-drug interactions. We determined the inhibitory ability of norendoxifen against important drug-metabolizing cytochrome P450 enzymes, including CYP1A2, CYP2A6, CYP3A4, CYP3A5, and CYP2C19, to establish the potency of norendoxifen as a potential cause of drug-drug interactions. A second objective was to determine the effects of E-and Z-norendoxifen on the inhibition of these enzymes to further characterize the isomers' selectivity. The inhibitory abilities of E-, mixed, and Z-norendoxifen against recombinant aromatase (CYP19), CYP1A2, CYP3A4, CYP3A5, and CYP2C19 were tested using microsomal incubations. Mixed norendoxifen inhibited these enzymes with K i values of 70 6 9, 76 6 3, 375 6 6, 829 6 62, and 0.56 6 0.02 nM, respectively. E-Norendoxifen had a 9.3-fold-higher inhibitory ability than Z-norendoxifen against CYP19, while E-and Z-norendoxifen had similar potencies against CYP1A2, CYP3A4, CYP3A5, and CYP2C19. These results suggest that norendoxifen is able to act as a potent AI, and that its E-isomer is 9.3-fold more potent than the Z-isomer.

show abstract

Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer

Graetz,

Hu,

Kocak

et al. 2024

JAMA Netw Open

View full text Add to dashboard Cite

ImportanceAdjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor–positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence.ObjectiveTo test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET.Design, Setting, and ParticipantsThis nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year.InterventionsParticipants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team.Main Outcomes and MeasuresThe primary outcome was 1-year, electronic pillbox–captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms.ResultsAmong 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, −3.3%; 95% CI, −11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, −5.7%; 95% CI, −13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, −1.23; 95% CI, −2.03 to −0.43; P = .003), including high-cost encounters (adjusted difference, −0.40; 95% CI, −0.67 to −0.14; P = .003), and office visits (adjusted difference, −0.82; 95% CI, −1.54 to −0.09; P = .03) over the previous 6 months compared with EUC participants.Conclusions and RelevanceThis RCT found that a remote monitoring app with alerts to the patient’s care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life.Trial RegistrationClinicalTrials.gov Identifier: NCT03592771

show abstract

A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients’ persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer

Cited by 49 publications

References 11 publications

Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review

Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review

Inhibition of Cytochrome P450 Enzymes by the E- and Z-Isomers of Norendoxifen

Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer

Contact Info

Product

Resources

About