PMID- 38335467
OWN - NLM
STAT- MEDLINE
DCOM- 20240419
LR  - 20240419
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 42
IP  - 12
DP  - 2024 Apr 20
TI  - Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 
      06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]).
PG  - 1344-1349
LID - 10.1200/JCO.23.01428 [doi]
AB  - Clinical trials frequently include multiple end points that mature at different 
      times. The initial report, typically based on the primary end point, may be 
      published when key planned co-primary or secondary analyses are not yet 
      available. Clinical Trial Updates provide an opportunity to disseminate 
      additional results from studies, published in JCO or elsewhere, for which the 
      primary end point has already been reported.The primary joint efficacy analysis 
      of the Anthracyclines in Early Breast Cancer (ABC) trials reported in 2017 failed 
      to demonstrate nonanthracycline adjuvant therapy was noninferior to 
      anthracycline-based regimens in high-risk, early breast cancer. Full analyses of 
      the studies had proceeded when the prespecified futility boundary was crossed at 
      a planned futility analysis for the ability to demonstrate noninferiority of a 
      nonanthracycline regimen with continued follow-up. These results were presented 
      with 3.3 years of median follow-up. This manuscript reports results of the final 
      analyses of the study efficacy end points conducted with 6.9 years of median 
      follow-up. Long-term analysis of invasive disease-free survival (IDFS), the 
      primary end point of the ABC trials, remains consistent with the original 
      results, as noninferiority of the nonanthracycline regimens could not be declared 
      on the basis of the original criteria. The secondary end point of recurrence-free 
      interval, which excluded deaths not due to breast cancer as events, favored 
      anthracycline-based regimens, and tests for heterogeneity were significant for 
      hormone receptor status (P = .02) favoring anthracycline regimens for the hormone 
      receptor-negative cohorts. There was no difference in overall survival, and 
      review of the type of IDFS events in the groups suggested reductions in cancer 
      recurrences achieved with anthracycline regimens were offset by late leukemias 
      and deaths unrelated to breast cancer.
FAU - Geyer, Charles E Jr
AU  - Geyer CE Jr
AUID- ORCID: 0000-0002-2379-5702
AD  - NSABP Foundation/NRG Oncology, Pittsburgh, PA.
AD  - UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, 
      Pittsburgh, PA.
FAU - Blum, Joanne L
AU  - Blum JL
AUID- ORCID: 0000-0002-7951-6645
AD  - Baylor-Sammons Cancer Center, Texas Oncology, US Oncology Research, Dallas, TX.
FAU - Yothers, Greg
AU  - Yothers G
AUID- ORCID: 0000-0002-7965-7333
AD  - NRG Oncology SDMC, Department of Biostatistics, and University of Pittsburgh 
      School of Public Health, Pittsburgh, PA.
FAU - Asmar, Lina
AU  - Asmar L
AD  - USOR, McKesson Specialty Health, The Woodlands, TX.
FAU - Flynn, Patrick J
AU  - Flynn PJ
AUID- ORCID: 0000-0001-6516-8021
AD  - Minnesota Community Oncology Research Consortium (MSORC), Stone Lake, MI.
FAU - Robert, Nicholas J
AU  - Robert NJ
AUID- ORCID: 0000-0002-8491-5392
AD  - Ontada, Irving, TX.
FAU - Hopkins, Judith O
AU  - Hopkins JO
AUID- ORCID: 0000-0002-9829-1242
AD  - Novant Health (Forsyth Medical) Cancer Institute, Southeast Clinical Oncology 
      Research (SCOR) NCORP, Winston Salem, NC.
FAU - O'Shaughnessy, Joyce A
AU  - O'Shaughnessy JA
AD  - Baylor University Medical Center, Texas Oncology, US Oncology Research, Dallas, 
      TX.
FAU - Rastogi, Priya
AU  - Rastogi P
AUID- ORCID: 0000-0002-6179-6407
AD  - NSABP Foundation/NRG Oncology, Pittsburgh, PA.
AD  - UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, 
      Pittsburgh, PA.
AD  - UPMC Magee-Womens Hospital, Pittsburgh, PA.
FAU - Puhalla, Shannon L
AU  - Puhalla SL
AD  - NSABP Foundation/NRG Oncology, Pittsburgh, PA.
AD  - UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, 
      Pittsburgh, PA.
FAU - Hilton, Christie J
AU  - Hilton CJ
AD  - NSABP Foundation/NRG Oncology, Pittsburgh, PA.
AD  - Allegheny Health Network, Pittsburgh, PA.
FAU - Dang, Chau T
AU  - Dang CT
AD  - Memorial Sloan Kettering Cancer Center, West Harrison, NY.
FAU - Gomez, Henry Leonidas
AU  - Gomez HL
AUID- ORCID: 0000-0002-4234-4448
AD  - National Institute of Neoplastic Diseases, Lima, Peru.
FAU - Vukelja, Svetislava J
AU  - Vukelja SJ
AD  - US Oncology Tyler Cancer Center, Tyler, TX.
FAU - Lyss, Alan P
AU  - Lyss AP
AD  - Heartland Cancer Research NCORP-Missouri Baptist Medical Center, St Louis, MO.
FAU - Paul, Devchand
AU  - Paul D
AD  - USOR, McKesson Specialty Health, The Woodlands, TX.
FAU - Brufsky, Adam M
AU  - Brufsky AM
AUID- ORCID: 0000-0001-8080-7960
AD  - UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, 
      Pittsburgh, PA.
AD  - UPMC Magee-Womens Hospital, Pittsburgh, PA.
FAU - Colangelo, Linda H
AU  - Colangelo LH
AD  - NRG Oncology SDMC, Department of Biostatistics, and University of Pittsburgh 
      School of Public Health, Pittsburgh, PA.
FAU - Swain, Sandra M
AU  - Swain SM
AUID- ORCID: 0000-0002-1320-3830
AD  - NSABP Foundation/NRG Oncology, Pittsburgh, PA.
AD  - Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical 
      Center, MedStar Health, Washington, DC.
FAU - Mamounas, Eleftherios P
AU  - Mamounas EP
AUID- ORCID: 0000-0002-9476-2553
AD  - NSABP Foundation/NRG Oncology, Pittsburgh, PA.
AD  - Orlando Health Cancer Institute, Orlando, FL.
FAU - Wolmark, Norman
AU  - Wolmark N
AUID- ORCID: 0000-0001-7156-1110
AD  - NSABP Foundation/NRG Oncology, Pittsburgh, PA.
AD  - UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, 
      Pittsburgh, PA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01547741
SI  - ClinicalTrials.gov/NCT00493870
SI  - ClinicalTrials.gov/NCT00887536
GR  - U10 CA180822/CA/NCI NIH HHS/United States
GR  - U10 CA180868/CA/NCI NIH HHS/United States
GR  - UG1 CA189867/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20240209
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Taxoids)
RN  - 0 (Anthracyclines)
RN  - 0 (Hormones)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Taxoids/therapeutic use
MH  - Follow-Up Studies
MH  - *Breast Neoplasms/drug therapy
MH  - Anthracyclines
MH  - Hormones
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
EDAT- 2024/02/09 18:42
MHDA- 2024/04/19 06:43
CRDT- 2024/02/09 16:03
PHST- 2024/04/19 06:43 [medline]
PHST- 2024/02/09 18:42 [pubmed]
PHST- 2024/02/09 16:03 [entrez]
AID - 10.1200/JCO.23.01428 [doi]
PST - ppublish
SO  - J Clin Oncol. 2024 Apr 20;42(12):1344-1349. doi: 10.1200/JCO.23.01428. Epub 2024 
      Feb 9.