Abstract PS12-17: Baseline characteristics of women enrolled in the POSITIVE trial (pregnancy outcome and safety of interrupting therapy for women with endocrine responsIVE breast cancer)
Authors: Partridge Ann H , Niman Samuel M , Ruggeri Monica , Peccatori Fedro A , Azim Hatem A , Colleoni Marco , Saura Cristina , Shimizu Chikako , Sætersdal Anna Barbro , Kroep Judith , Warner Ellen , Borges Virginia F , Gombos Andrea , Kataoka Akemi , Rousset-Jablonski Christine , Borstnar Simona , Yamauchi Hideko , Lee Jeong Eon , Walshe Janice M , Borrego Manuel Ruíz , Moore Halle CF , Saunders Christobel , Cardoso Fatima , Susnjar Snezana , Bjelic-Radisic Vesna , Smith Karen L , Piccart Martine , Korde Larissa A , Goldhirsch Aron , Gelber Richard D , Pagani Olivia 
Published: February 2021

Background: Pregnancy is a major concern for young breast cancer (BC) survivors. Conception after BC in women with hormone receptor positive (HR+) disease is affected by the standard 5-10 years of adjuvant endocrine therapy (ET) during which pregnancy is contraindicated and fertility may be waning. The POSITIVE Trial (IBCSG 48-14/BIG 8-13/Alliance A221405/NCT02308085) investigates the impact of temporary ET interruption to allow pregnancy.

Methods: POSITIVE enrolled premenopausal women with stage I-III HR+ early BC, ≤42 years of age, who had received adjuvant ET (SERM alone, ovarian function suppression (OFS) plus SERM or AI) for 18 to 30 months, and wished to interrupt ET to attempt pregnancy. An interruption of ET for up to 2 years was foreseen to allow pregnancy (after a 3-month ET washout period), delivery, and breastfeeding if desired/feasible. Resumption of ET to complete 5-10 years of treatment was planned as soon as pregnancy/breastfeeding was completed or after it was ensured conception was not possible. We report baseline characteristics of participants enrolled in POSITIVE by region of enrollment.

Results: From 12/2014 to 12/2019, 518 participants were enrolled at 116 centers in 20 countries across 4 continents. The table shows the baseline characteristics of the enrolled women.

Several differences were seen across regions: A higher proportion of participants &lt;35 yrs (43%) enrolled in North America than in Europe (33%) or Asia (26%). Eighty-one percent of Asian women had no children at enrollment compared to 75% and 68% of European and North American women, respectively. Consistently, a greater percent of women in Asia (56%) had used fertility preservation measures, compared to Europe (53%) and North America (43%). Stage distribution was also different across continents: a greater percent of Asian participants had stage I, grade 1 and node-negative disease (51%, 29% and 76 %, respectively) compared to European (46%, 14% and 67%) and North American (43%, 16% and 55%) women. Only 19% of Asian women had either 1-3 positive nodes and grade 3 tumors, the proportion increased to 28% and 35% in Europe and to 41% and 38% in North America, respectively. North American women were more likely to have had mastectomy (60% vs. Asian (44%) and European (41%)); European women were more likely to have had chemotherapy (69% vs. North American (56%) and Asian (42%)). ET administration prior to enrollment differed substantially by region: Most North American women had SERM (T) alone (58%), and when OFS was added to oral ET, it was combined with AI in 19% and with T in 8% of participants, respectively. In Asia most women received T + OFS (55%), followed by T alone (36%), and AI + OFS (6%). In Europe, T + OFS was the most frequent treatment (40%), followed by T alone (37%) and AI + OFS (17%). Median duration of ET before enrollment was similar across regions (22-24 months).

Conclusion: Regional variation of baseline characteristics of women enrolled in the POSITIVE trial may provide important insights into different medical and sociocultural attributes and attitudes of the study participants and investigators from those regions.

Affiliation: POSITIVE Investigators, International Breast Cancer Study Group, Alliance for Clinical Trials in Oncology, Breast International Group, North American Breast Cancer Group

CharacteristicRegion: Europe / North America / Asia-Pacific61% / 23% / 16%Median age at enrollment, yrs (IQR)37 (33-39)Caucasian race77%No children prior to enrollment74%Prior fertility preservation measures taken51%Stage I / II46% / 45%0 / 1 positive nodes65% / 21%Grade 2 / 348% / 33%HER2-negative74%Mastectomy46%Chemotherapy61%ET: SERM alone / SERM+OFS / AI+OFS41% / 35% / 16%Median duration of prior ET, mos (IQR)23 (20-27)

Citation Format: 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 Kroep, Ellen Warner, Virginia F Borges, Andrea Gombos, Akemi Kataoka, Christine Rousset-Jablonski, Simona Borstnar, Hideko Yamauchi, 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. Baseline characteristics of women enrolled in the POSITIVE trial (pregnancy outcome and safety of interrupting therapy for women with endocrine responsIVE breast cancer) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS12-17.