Abstract
Original language | English |
---|---|
Pages (from-to) | 1645-1656 |
Number of pages | 12 |
Journal | New England journal of medicine |
Volume | 388 |
Issue number | 18 |
DOIs | |
Publication status | Published - 2023 |
Keywords
- Breast Cancer
- Complications of Pregnancy
- Hematology/Oncology
- Hematology/Oncology General
- Obstetrics/Gynecology
- Obstetrics/Gynecology General
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In: New England journal of medicine, Vol. 388, No. 18, 2023, p. 1645-1656.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer
AU - Partridge, Ann H.
AU - Niman, Samuel M.
AU - Ruggeri, Monica
AU - Peccatori, Fedro A.
AU - Azim, Hatem A.
AU - Colleoni, Marco
AU - Saura, Cristina
AU - Shimizu, Chikako
AU - Sætersdal, Anna B.
AU - Kroep, Judith R.
AU - Mailliez, Audrey
AU - Warner, Ellen
AU - Borges, Virginia F.
AU - Amant, Frédéric
AU - Gombos, Andrea
AU - Kataoka, Akemi
AU - Rousset-Jablonski, Christine
AU - Borstnar, Simona
AU - Takei, Junko
AU - Lee, Jeong E.
AU - Walshe, Janice M.
AU - Ruíz-Borrego, Manuel
AU - Moore, Halle C. F.
AU - Saunders, Christobel
AU - Bjelic-Radisic, Vesna
AU - Susnjar, Snezana
AU - Cardoso, Fatima
AU - Smith, Karen L.
AU - Ferreiro, Teresa
AU - Ribi, Karin
AU - Ruddy, Kathryn
AU - Kammler, Roswitha
AU - el-Abed, Sarra
AU - Viale, Giuseppe
AU - Piccart, Martine
AU - Korde, Larissa A.
AU - Goldhirsch, Aron
AU - Gelber, Richard D.
AU - Pagani, Olivia
N1 - Funding Information: Supported by the ETOP IBCSG Partners Foundation (globally) and by the Alliance for Clinical Trials in Oncology (in North America), in collaboration with the Breast International Group (BIG), the BIG cooperative groups, and the National Clinical Trials Network of the National Cancer Institute. Globally, the trial receives grant support for central or local trial conduct from the following: the International Breast Cancer Study Group (IBCSG); Frontier Science and Technology Research Foundation, Southern Europe (Frontier Southern Europe), Pink Ribbon Switzerland, Swiss Cancer League (KLS-3361-02), San Salvatore Foundation, Rising Tide Foundation for Clinical Cancer Research (CCR-15-120), Swiss Group for Clinical Cancer Research, Clinical Cancer Research Foundation of Eastern Switzerland, Roche Diagnostics International, Swiss Cancer Foundation, Piajoh Fondazione di Famiglia, Gruppo Giovani Pazienti “Anna dai Capelli Corti,” Verein Bärgüf, and Schweizer Frauenlauf Bern — all in Switzerland; BIG Against Breast Cancer and the Baillet Latour Fund, Belgium; Gateway for Cancer Research (G-15-1900) and Breast Cancer Research Foundation — both in the United States; C & A, Germany; Dutch Cancer Society, the Netherlands; Norwegian Breast Cancer Society and Pink Ribbon — both in Norway; ELGC K.K. and Pink Ring — both in Japan; Korea Breast Cancer Foundation and Mr. Yong Seop Lee — both in South Korea; and other private donors. In North America, the Alliance for Clinical Trials in Oncology receives support from the National Cancer Institute of the National Institutes of Health (NIH) ( Alliance for Clinical Trials in Oncology National Cancer Institute Community Oncology Research Program [NCORP] grant UG1CA189823) and the biorepository resource grant U24CA196171; the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network (ECOG-ACRIN) receives support under ECOG-ACRIN NCORP grants UG1CA189828 and UG1CA233196; Southwest Oncology Group Cancer Research Network receives support under NIH grants UG1CA189974 and U10CA180888; and NRG Oncology receives support under NIH grant U10CA180868 and NCORP grant UG1CA189867. Canadian Cancer Trials Group (CCTG) participation in the trial is supported through its grant from the National Cancer Institute of the NIH (CA180863). Additional programmatic funding support for the CCTG is provided by the Canadian Cancer Society (707213) and the Canada Foundation for Innovation. In addition, the trial receives support from RETHINK Breast Cancer, Canada, and the Gilson Family Foundation, United States. Funding Information: Supported by the ETOP IBCSG Partners Foundation (globally) and by the Alliance for Clinical Trials in Oncology (in North America), in collaboration with the Breast International Group (BIG), the BIG cooperative groups, and the National Clinical Trials Network of the National Cancer Institute. Globally, the trial receives grant support for central or local trial conduct from the following: the International Breast Cancer Study Group (IBCSG); Frontier Science and Technology Research Foundation, Southern Europe (Frontier Southern Europe), Pink Ribbon Switzerland, Swiss Cancer League (KLS-3361-02), San Salvatore Foundation, Rising Tide Foundation for Clinical Cancer Research (CCR-15-120), Swiss Group for Clinical Cancer Research, Clinical Cancer Research Foundation of Eastern Switzerland, Roche Diagnostics International, Swiss Cancer Foundation, Piajoh Fondazione di Famiglia, Gruppo Giovani Pazienti "Anna dai Capelli Corti," Verein Bärgüf, and Schweizer Frauenlauf Bern - all in Switzerland; BIG Against Breast Cancer and the Baillet Latour Fund, Belgium; Gateway for Cancer Research (G-15-1900) and Breast Cancer Research Foundation - both in the United States; C & A, Germany; Dutch Cancer Society, the Netherlands; Norwegian Breast Cancer Society and Pink Ribbon - both in Norway; ELGC K.K. and Pink Ring - both in Japan; Korea Breast Cancer Foundation and Mr. Yong Seop Lee - both in South Korea; and other private donors. In North America, the Alliance for Clinical Trials in Oncology receives support from the National Cancer Institute of the National Institutes of Health (NIH) (Alliance for Clinical Trials in Oncology National Cancer Institute Community Oncology Research Program [NCORP] grant UG1CA189823) and the biorepository resource grant U24CA196171; the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) receives support under ECOG-ACRIN NCORP grants UG1CA189828 and UG1CA233196; Southwest Oncology Group Cancer Research Network receives support under NIH grants UG1CA189974 and U10CA180888; and NRG Oncology receives support under NIH grant U10CA180868 and NCORP grant UG1CA189867. Canadian Cancer Trials Group (CCTG) participation in the trial is supported through its grant from the National Cancer Institute of the NIH (CA180863). Additional programmatic funding support for the CCTG is provided by the Canadian Cancer Society (707213) and the Canada Foundation for Innovation. In addition, the trial receives support from RETHINK Breast Cancer, Canada, and the Gilson Family Foundation, United States. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. Publisher Copyright: © 2023 Massachusetts Medical Society.
PY - 2023
Y1 - 2023
N2 - Background Prospective data on the risk of recurrence among women with hormone receptor-positive early breast cancer who temporarily discontinue endocrine therapy to attempt pregnancy are lacking. Methods We conducted a single-group trial in which we evaluated the temporary interruption of adjuvant endocrine therapy to attempt pregnancy in young women with previous breast cancer. Eligible women were 42 years of age or younger; had had stage I, II, or III disease; had received adjuvant endocrine therapy for 18 to 30 months; and desired pregnancy. The primary end point was the number of breast cancer events (defined as local, regional, or distant recurrence of invasive breast cancer or new contralateral invasive breast cancer) during follow-up. The primary analysis was planned to be performed after 1600 patient-years of follow-up. The prespecified safety threshold was the occurrence of 46 breast cancer events during this period. Breast cancer outcomes in this treatment-interruption group were compared with those in an external control cohort consisting of women who would have met the entry criteria for the current trial. Results Among 516 women, the median age was 37 years, the median time from breast cancer diagnosis to enrollment was 29 months, and 93.4% had stage I or II disease. Among 497 women who were followed for pregnancy status, 368 (74.0%) had at least one pregnancy and 317 (63.8%) had at least one live birth. In total, 365 babies were born. At 1638 patient-years of follow-up (median follow-up, 41 months), 44 patients had a breast cancer event, a result that did not exceed the safety threshold. The 3-year incidence of breast cancer events was 8.9% (95% confidence interval [CI], 6.3 to 11.6) in the treatment-interruption group and 9.2% (95% CI, 7.6 to 10.8) in the control cohort. Conclusions Among select women with previous hormone receptor-positive early breast cancer, temporary interruption of endocrine therapy to attempt pregnancy did not confer a greater short-term risk of breast cancer events, including distant recurrence, than that in the external control cohort. Further follow-up is critical to inform longer-term safety. (Funded by ETOP IBCSG Partners Foundation and others; POSITIVE ClinicalTrials.gov number, NCT02308085.).
AB - Background Prospective data on the risk of recurrence among women with hormone receptor-positive early breast cancer who temporarily discontinue endocrine therapy to attempt pregnancy are lacking. Methods We conducted a single-group trial in which we evaluated the temporary interruption of adjuvant endocrine therapy to attempt pregnancy in young women with previous breast cancer. Eligible women were 42 years of age or younger; had had stage I, II, or III disease; had received adjuvant endocrine therapy for 18 to 30 months; and desired pregnancy. The primary end point was the number of breast cancer events (defined as local, regional, or distant recurrence of invasive breast cancer or new contralateral invasive breast cancer) during follow-up. The primary analysis was planned to be performed after 1600 patient-years of follow-up. The prespecified safety threshold was the occurrence of 46 breast cancer events during this period. Breast cancer outcomes in this treatment-interruption group were compared with those in an external control cohort consisting of women who would have met the entry criteria for the current trial. Results Among 516 women, the median age was 37 years, the median time from breast cancer diagnosis to enrollment was 29 months, and 93.4% had stage I or II disease. Among 497 women who were followed for pregnancy status, 368 (74.0%) had at least one pregnancy and 317 (63.8%) had at least one live birth. In total, 365 babies were born. At 1638 patient-years of follow-up (median follow-up, 41 months), 44 patients had a breast cancer event, a result that did not exceed the safety threshold. The 3-year incidence of breast cancer events was 8.9% (95% confidence interval [CI], 6.3 to 11.6) in the treatment-interruption group and 9.2% (95% CI, 7.6 to 10.8) in the control cohort. Conclusions Among select women with previous hormone receptor-positive early breast cancer, temporary interruption of endocrine therapy to attempt pregnancy did not confer a greater short-term risk of breast cancer events, including distant recurrence, than that in the external control cohort. Further follow-up is critical to inform longer-term safety. (Funded by ETOP IBCSG Partners Foundation and others; POSITIVE ClinicalTrials.gov number, NCT02308085.).
KW - Breast Cancer
KW - Complications of Pregnancy
KW - Hematology/Oncology
KW - Hematology/Oncology General
KW - Obstetrics/Gynecology
KW - Obstetrics/Gynecology General
UR - http://www.scopus.com/inward/record.url?scp=85160235705&partnerID=8YFLogxK
U2 - https://doi.org/10.1056/NEJMoa2212856
DO - https://doi.org/10.1056/NEJMoa2212856
M3 - Article
C2 - 37133584
SN - 0028-4793
VL - 388
SP - 1645
EP - 1656
JO - New England journal of medicine
JF - New England journal of medicine
IS - 18
ER -