Breast (Oct 2021)
Who are the women who enrolled in the POSITIVE trial: A global study to support young hormone receptor positive breast cancer survivors desiring pregnancy
- Ann H. Partridge,
- Samuel M. Niman,
- Monica Ruggeri,
- Fedro A. Peccatori,
- Hatem A. Azim, Jr.,
- Marco Colleoni,
- Cristina Saura,
- Chikako Shimizu,
- Anna Barbro Sætersdal,
- Judith R. Kroep,
- Audrey Mailliez,
- Ellen Warner,
- Virginia F. Borges,
- Frédéric Amant,
- Andrea Gombos,
- Akemi Kataoka,
- Christine Rousset-Jablonski,
- Simona Borstnar,
- Junko Takei,
- Jeong Eon Lee,
- Janice M. Walshe,
- Manuel Ruíz Borrego,
- Halle CF. Moore,
- Christobel Saunders,
- Fatima Cardoso,
- Snezana Susnjar,
- Vesna Bjelic-Radisic,
- Karen L. Smith,
- Martine Piccart,
- Larissa A. Korde,
- Aron Goldhirsch,
- Richard D. Gelber,
- Olivia Pagani
Affiliations
- Ann H. Partridge
- Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA; Corresponding author. Department of Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
- Samuel M. Niman
- International Breast Cancer Study Group Statistical Center, Department of Data Science, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA, USA
- Monica Ruggeri
- International Breast Cancer Study Group, Program for Young Patients, Coordinating Center, Effingerstrasse 40, Bern, 3008, Switzerland
- Fedro A. Peccatori
- Fertility and Procreation Unit, Gynecologic Oncology Program, European Institute of Oncology IRCCS, Via Ripamonti 435, Milan, 20141, Italy
- Hatem A. Azim, Jr.
- Breast Cancer Center, Hospital Zambrano Hellion, School of Medicine, Tecnologico de Monterrey, Av. Batallon de San Patricio 112, San Pedro Garza Garcia, 66278, Mexico
- Marco Colleoni
- International Breast Cancer Study Group, Division of Medical Senology, IEO, European Institute of Oncology, IRCCS, Milan, Italy
- Cristina Saura
- Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Medical Oncology Service, Barcelona, Spain
- Chikako Shimizu
- Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Toyama, Shinjuku-ku, Tokyo, 1-21-1, Japan
- Anna Barbro Sætersdal
- Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway
- Judith R. Kroep
- Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands
- Audrey Mailliez
- Department of Medical Oncology, Centre Oscar Lambret, Lille, France
- Ellen Warner
- Odette Cancer Center, Sunnybrook Health Sciences Center, Toronto, Canada
- Virginia F. Borges
- Division of Medical Oncology, Department of Medicine, University of Colorado Cancer Center, Aurora, CO, USA
- Frédéric Amant
- Department of Oncology, KU Leuven and Leuven Cancer Institute, Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium; Center for Gynecologic Oncology Amsterdam, Antoni van Leeuwenhoek-Netherlands Cancer Institute, Amsterdam University Medical Center, Amsterdam, the Netherlands
- Andrea Gombos
- Institut Jules Bordet and L'Universite Libre de Bruxelles, Brussels, Belgium
- Akemi Kataoka
- Breast Oncology Cancer, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
- Christine Rousset-Jablonski
- Leon Berard Cancer Centre, Centre Léon Bérard, Department of Surgery, Lyon, France
- Simona Borstnar
- Division of Medical Oncology, Institute of Oncology, Ljubljana, Slovenia
- Junko Takei
- St Luke's International Hospital, Breast Center, Tokyo, Japan
- Jeong Eon Lee
- Breast Division, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Clinical Research and Evaluation, SAIHST, Sungkyunkwan University, Seoul, South Korea
- Janice M. Walshe
- Cancer Trials Ireland and Medical Oncology Department, St. Vincent's University Hospital and Tallaght University Hosptial, Dublin, Ireland
- Manuel Ruíz Borrego
- Hospital Virgen del Rocio Sevilla, GEICAM Spanish Breast Cancer Group, Sevilla, Spain
- Halle CF. Moore
- Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA
- Christobel Saunders
- Division of Surgery, Faculty of Health and Medical Sciences, University of Western Australia, Crawley, WA, Australia
- Fatima Cardoso
- Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal
- Snezana Susnjar
- Department of Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia
- Vesna Bjelic-Radisic
- Breast Unit, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal, Germany; Medical University Graz, Department Gynaecology, Graz, Austria
- Karen L. Smith
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA
- Martine Piccart
- Institut Jules Bordet and L'Universite Libre de Bruxelles, Brussels, Belgium
- Larissa A. Korde
- Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA
- Aron Goldhirsch
- International Breast Cancer Study Group, IEO European Institute of Oncology, IRCCS, Milan, Italy
- Richard D. Gelber
- International Breast Cancer Study Group Statistical Center, Department of Data Science, Division of Biostatistics, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard TH Chan School of Public Health and Harvard Medical School, Boston, MA, USA
- Olivia Pagani
- Interdisciplinary Cancer Service Hospital Riviera-Chablais Rennaz, Geneva University Hospitals, Lugano University, Swiss Group for Clinical Cancer Research (SAKK), Vaud, Switzerland; Corresponding author. Riviera-Chablais Hospital, Route du Vieuz Sequoia 20, 1847 Rennaz, Switzerland.
- Journal volume & issue
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Vol. 59
pp. 327 – 338
Abstract
Background: Premenopausal women with early hormone-receptor positive (HR+) breast cancer receive 5–10 years of adjuvant endocrine therapy (ET) during which pregnancy is contraindicated and fertility may wane. The POSITIVE study investigates the impact of temporary ET interruption to allow pregnancy. Methods: POSITIVE enrolled women with stage I-III HR + early breast cancer, ≤42 years, who had received 18–30 months of adjuvant ET and wished to interrupt ET for pregnancy. Treatment interruption for up to 2 years was permitted to allow pregnancy, delivery and breastfeeding, followed by ET resumption to complete the planned duration. Findings: From 12/2014 to 12/2019, 518 women were enrolled at 116 institutions/20 countries/4 continents. At enrolment, the median age was 37 years and 74.9 % were nulliparous. Fertility preservation was used by 51.5 % of women. 93.2 % of patients had stage I/II disease, 66.0 % were node-negative, 54.7 % had breast conserving surgery, 61.9 % had received neo/adjuvant chemotherapy. Tamoxifen alone was the most prescribed ET (41.8 %), followed by tamoxifen + ovarian function suppression (OFS) (35.4 %). A greater proportion of North American women were <35 years at enrolment (42.7 %), had mastectomy (59.0 %) and received tamoxifen alone (59.8 %). More Asian women were nulliparous (81.0 %), had node-negative disease (76.2%) and received tamoxifen + OFS (56.0 %). More European women had received chemotherapy (69.3 %). Interpretation: The characteristics of participants in the POSITIVE study provide insights to which patients and doctors considered it acceptable to interrupt ET to pursue pregnancy. Similarities and variations from a regional, sociodemographic, disease and treatment standpoint suggest specific sociocultural attitudes across the world.
