Institut za onkologiju i radiologiju Srbije / Institute for Oncology and Radiology of Serbia
Published August 3, 2021 | Version v.1
Journal article Open

Who are the women who enrolled in the POSITIVE trial: A global studyto support young hormone receptor positive breast cancer survivorsdesiring pregnancy

Creators

  • 1. Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA
  • 2. International Breast Cancer Study Group Statistical Center, Department of Data Science, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA, USA
  • 3. International Breast Cancer Study Group, Program for Young Patients, Coordinating Center, Effingerstrasse 40, Bern, 3008, Switzerland
  • 4. Fertility and Procreation Unit, Gynecologic Oncology Program, European Institute of Oncology IRCCS, Via Ripamonti 435, Milan, 20141, Italy
  • 5. Breast Cancer Center, Hospital Zambrano Hellion, School of Medicine, Tecnologico de Monterrey, Av. Batallon de San Patricio 112, San Pedro Garza Garcia, 66278, Mexico
  • 6. International Breast Cancer Study Group, Division of Medical Senology, IEO, European Institute of Oncology, IRCCS, Milan, Italy
  • 7. Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Medical Oncology Service, Barcelona, Spain
  • 8. Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Toyama, Shinjuku-ku, Tokyo, 1-21-1, Japan
  • 9. Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway
  • 10. Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands
  • 11. Department of Medical Oncology, Centre Oscar Lambret, Lille, France
  • 12. Odette Cancer Center, Sunnybrook Health Sciences Center, Toronto, Canada
  • 13. Division of Medical Oncology, Department of Medicine, University of Colorado Cancer Center, Aurora, CO, USA
  • 14. 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
  • 15. Institut Jules Bordet and L'Universite Libre de Bruxelles, Brussels, Belgium
  • 16. Breast Oncology Cancer, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
  • 17. Leon Berard Cancer Centre, Centre Léon Bérard, Department of Surgery, Lyon, France
  • 18. Division of Medical Oncology, Institute of Oncology, Ljubljana, Slovenia
  • 19. St Luke's International Hospital, Breast Center, Tokyo, Japan
  • 20. 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
  • 21. Cancer Trials Ireland and Medical Oncology Department, St. Vincent's University Hospital and Tallaght University Hosptial, Dublin, Ireland
  • 22. Hospital Virgen del Rocio Sevilla, GEICAM Spanish Breast Cancer Group, Sevilla, Spain
  • 23. Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA
  • 24. Division of Surgery, Faculty of Health and Medical Sciences, University of Western Australia, Crawley, WA, Australia
  • 25. Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal
  • 26. Department of Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia
  • 27. Breast Unit, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal, Germany ; Medical University Graz, Department Gynaecology, Graz, Austria
  • 28. Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA
  • 29. Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA
  • 30. International Breast Cancer Study Group, IEO European Institute of Oncology, IRCCS, Milan, Italy
  • 31. 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
  • 32. Interdisciplinary Cancer Service Hospital Riviera-Chablais Rennaz, Geneva University Hospitals, Lugano University, Swiss Group for Clinical Cancer Research (SAKK), Vaud, Switzerland

Description

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.

Notes

Authors thank thank the patients who participated in the POSITIVE trial without whom substantial recent progress to improve care for young women with breast cancer would not be possible. We dedicate this paper to the memory of Professor Aron Goldhirsch (1946–2020), medical oncologist and breast cancer specialist, who died on February 26, 2020, and devoted his life to patient care and clinical research. As scientific co-chair of the International Breast Cancer Study Group (IBCSG) and the Breast International Group (BIG), Prof Goldhirsch played a pivotal role to develop and conduct the POSITIVE trial. APPENDIX. POSITIVE Trial Steering Committee, International Breast Cancer Study Group (IBCSG), International Networks, and Participating Centers/Groups and Principal Investigators

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