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Case Reports
. 2013 May;8(2):110-20.
doi: 10.1159/000350777.

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

Nadia Harbeck  1 , Maria Blettner  2 , Peyman Hadji  3 , Christian Jackisch  4 , Hans-Joachim Lück  5 , Christine Windemuth-Kieselbach  6 , Silke Zaun  7 , Renate Haidinger  8 , Doris Schmitt  9 , Hilde Schulte  10 , Ulrike Nitz  11 , Rolf Kreienberg  12
Affiliations
Case Reports

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

Nadia Harbeck et al. Breast Care (Basel). 2013 May.

Abstract
in English, German

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.

Hintergrund: Das Programm Patienten-Compliance bei Anastrozoltherapie (PACT) ist eine große randomisierte Studie, die evaluieren soll, ob die regelmäßige Bereitstellung von Informationsmaterialien (EM) die Compliance unter einer adjuvanten Aromataseinhibitor-Therapie bei postmenopausalen Patientinnen mit frühem, hormonrezeptor-positivem Mammakarzinom verbessern könnte.

Patientinnen und methoden: PACT stellt ein großes, homogenes Patientinnenkollektiv dar. Die hier dargestellte Baseline-Analyse beschreibt Demographie und Erstbehandlung sowie die Patientinnen-Selbsteinschätzung in Hinsicht auf Therapie und Lebensqualität.

Ergebnisse: Insgesamt wurden 4923 Patientinnen an 109 deutschen Brustzentren und Kliniken in Kooperation mit 1361 niedergelassenen Gynäkologen und Onkologen in die Studie eingeschlossen. 4844 Patientinnen wurden 1:1 zu Standardtherapie (n = 2402) bzw. Standardtherapie mit zusätzlichen EM (n = 2442) randomisiert. 76% der Patientinnen erhielten vor Studieneinschluss eine brusterhaltende Therapie und 24% eine Mastektomie. Eine Strahlentherapie war für 85% der Patientinnen geplant und eine Chemotherapie für 38%. Wie in dieser postmenopausalen Krankenpopulation mit endokrin empfindlichen Tumoren zu erwarten war, erhielten nur 285 Patientinnen (7%) eine neoadjuvante Chemotherapie.

Schlussfolgerungen: Der Vergleich mit den epidemiologischen Daten des Westdeutschen Brustzentrums zeigt, dass die Patientengruppe der PACT-Studie repräsentativ für die allgemeine postmenopausale Patientenpopulation ist. Dies legt nahe, dass die Ergebnisse der PACT-Studie sehr gut auf die reale Behandlungssituation in Deutschland und darüber hinaus übertragbar sein werden. Die Ergebnisse zur Compliance in der PACT-Studie werden daher dringend erwartet.

Keywords: Aromatase inhibitors; Breast cancer; Breast-conserving surgery; Compliance; Mastectomy.

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Figures

Fig. 1
Fig. 1
Study design and information about educational materials. Starter set: letter, brochures ‘Breast cancer and endocrine therapy’ and ‘Social information’, diary/notebook reminder stickers, pill box. Week 1: letter, brochure ‘Side effects of aromatase inhibitors’. Week 3: letter, brochure ‘Self-reflection: a personal experience’, lip balm. Week 5: letter, brochure ‘Early recognition and treatment’, fitness band with exercise suggestions. Week 8: letter, brochure ‘Communication with friends and family, and your caring physician’. Week 12: letter, brochure ‘Coping with fears’, CD with relaxation music. Month 5: letter, brochure ‘Breast cancer and sexuality’. Month 7: letter, brochure ‘Exercise and diet’, sports towel. Month 12: letter, optional registration for a reminder service, handbag mirror.
Fig. 2
Fig. 2
Distribution of PACT study centers (n = 109) throughout Germany.
Fig. 3
Fig. 3
Patient flow in PACT study.
See this image and copyright information in PMC

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