Patient's Anastrozole Compliance to Therapy (PACT) Program: Baseline Data and Patient Characteristics from a Population-Based, Randomized Study Evaluating Compliance to Aromatase Inhibitor Therapy in Postmenopausal Women with Hormone-Sensitive Early Breast Cancer

Abstract

Background: The Patient's Anastrozole Compliance to Therapy (PACT) program is a large randomized study designed to assess whether the provision of educational materials (EM) could improve compliance with aromatase inhibitor therapy in postmenopausal women with early, hormone receptor-positive breast cancer. Patients and Methods: The PACT study presented a large, homogeneous dataset. The baseline analysis included patient demographics and initial treatments and patient perceptions about treatment and quality of life. Results: Overall, 4,923 patients were enrolled at 109 German breast cancer centers/clinics in cooperation with 1,361 office-based gynecologists/oncologists. 4,844 women were randomized 1:1 to standard therapy (n = 2,402) or standard therapy plus EM (n = 2,442). Prior breast-conserving surgery and mastectomy had been received by 76% and 24% of the patients, respectively. Radiotherapy was scheduled for 85% of the patients, adjuvant chemotherapy for 38%. Reflecting the postmenopausal, hormone-sensitive nature of this population, only 285 patients (7%) had received neoadjuvant chemotherapy. Conclusions: A comparison with epidemiological data from the West German Breast Center suggests that the patients in the PACT study are representative of a general postmenopausal early breast cancer population and that the findings may be applicable to ‘real-world' Germany and beyond. Compliance data from PACT are eagerly anticipated.

Evaluation of Therapy Management and Patient Compliance in Postmenopausal Patients with Hormone Receptor-positive Breast Cancer Receiving Letrozole Treatment: The EvaluateTM Study

“…The EvaluateTM study is one of three prospective studies with a large number of patients which have considered the issue of compliance in aromatase inhibitor therapy. The PACT study (Patientʼs Anastrozole Compliance to Therapy) was a prospective randomized study which also included around 5000 patients [24]. In the PACT study, patients were randomized into one of two groups: one group where patients regularly received information about the disease and the anti-hormone treatment during the first year of treatment and one group which did not receive this regular information.…”

“…In the PACT study, patients were randomized into one of two groups: one group where patients regularly received information about the disease and the anti-hormone treatment during the first year of treatment and one group which did not receive this regular information. The study population receiving adjuvant treatment was very similar to that of the Evalua-teTM study [24]. Randomization in the PACT study was analyzed with regard to compliance.…”

A Review of the Literature Evaluating Adherence and Persistence to Adjuvant Endocrine Therapy

“…Research has shown that educational materials and reminders did not increase adherence to ET [29][30][31]. Two randomized trials that compared educational materials about ET with standard care showed no difference in adherence after 1 year [29,32]. Another intervention trial with a small sample compared standard care versus mailings (5 letters year 1 and 3 letters year 2) versus telephone calls (5 calls year 1; 3 calls year 2) to improve adherence to aromatase inhibitors [31].…”

Evaluation des Therapiemanagements und der Therapieadhärenz bei postmenopausalen Patientinnen mit hormonrezeptorpositivem Mammakarzinom, die mit Letrozol behandelt werden – die EvaluateTM-Studie

“…Heruntergeladen [24]. In dieser Studie wurde eine Randomisierung durchgeführt, welche die Patientinnen in eine Gruppe einteilte, die regelmäßig im 1.…”

“…Jahr Informationen über die Erkrankung und die Antihormontherapie erhalten hatte, und eine Gruppe, die diese Informationen nicht regelmäßig erhalten hatte. Diese Studienpopulation in der adjuvanten Situation war der der EvaluateTM-Studie sehr ähnlich [24]. Die Randomisierung wurde in der PACT-Studie im Hinblick auf die Compliance untersucht.…”