PMID- 38236702
OWN - NLM
STAT- Publisher
LR  - 20240425
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Linking)
DP  - 2024 Jan 18
TI  - Adjuvant platinum versus capecitabine for residual, invasive, triple-negative 
      breast cancer: Patient-reported outcomes in ECOG-ACRIN EA1131.
LID - 10.1002/cncr.35187 [doi]
AB  - BACKGROUND: Patient-reported outcomes (PROs) are a better tool for evaluating the 
      experiences of patients who have symptomatic, treatment-associated adverse events 
      (AEs) compared with clinician-rated AEs. The authors present PROs assessing 
      health-related quality of life (HRQoL) and treatment-related neurotoxicity for 
      adjuvant capecitabine versus platinum on the Eastern Cooperative Oncology 
      Group-American College of Radiology Imaging Network (ECOG-ACRIN) EA1131 trial 
      (ClinicalTrials.gov identifier NCT02445391). METHODS: Participants completed the 
      National Comprehensive Cancer Network Functional Assessment of Cancer 
      Therapy-Breast Cancer Symptom Index (NFBSI-16) and the Functional Assessment of 
      Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale (platinum arm 
      only) at baseline, cycle 3 day 1 (C3D1), 6 months, and 15 months. Because of 
      early termination, power was insufficient to test the hypothesis that HRQoL, as 
      assessed by the NFBSI-16 treatment side-effect (TSE) subscale, would be better at 
      6 and 15 months in the capecitabine arm; all analyses were exploratory. Means 
      were compared by using t-tests or the Wilcoxon rank-sum test, and proportions 
      were compared by using the chi(2) test. RESULTS: Two hundred ninety-six of 330 
      eligible patients provided PROs. The mean NFBSI-16 TSE subscale score was lower 
      for the platinum arm at baseline (p = .02; absolute difference, 0.6 points) and 
      for the capecitabine arm at C3D1 (p = .04; absolute difference, 0.5 points), but 
      it did not differ at other times. The mean change in TSE subscale scores differed 
      between the arms from baseline to C3D1 (platinum arm, 0.15; capecitabine arm, 
      -0.72; p = .03), but not from baseline to later time points. The mean decline in 
      Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity 
      subscale scores exceeded the minimal meaningful change (1.38 points) from 
      baseline to each subsequent time point (all p < .05). CONCLUSIONS: Despite the 
      similar frequency of clinician-rated AEs, PROs identified greater on-treatment 
      symptom burden with capecitabine and complemented clinician-rated AEs by 
      characterizing patients' experiences during chemotherapy.
CI  - (c) 2024 American Cancer Society.
FAU - Smith, Karen L
AU  - Smith KL
AD  - Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, 
      Maryland, USA.
AD  - Sibley Memorial Hospital, Washington, District of Columbia, USA.
FAU - Zhao, Fengmin
AU  - Zhao F
AD  - Dana Farber Cancer Institute, Eastern Cooperative Oncology Group-American College 
      of Radiology Imaging Network Biostatistics Center, Boston, Massachusetts, USA.
FAU - Mayer, Ingrid A
AU  - Mayer IA
AD  - Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, 
      Tennessee, USA.
FAU - Tevaarwerk, Amye J
AU  - Tevaarwerk AJ
AUID- ORCID: 0000-0002-8087-5119
AD  - Mayo Clinic Comprehensive Cancer Center, Rochester, Minnesota, USA.
FAU - Garcia, Sofia F
AU  - Garcia SF
AUID- ORCID: 0000-0003-3300-385X
AD  - Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
FAU - Arteaga, Carlos L
AU  - Arteaga CL
AD  - University of Texas Southwestern Simmons Cancer Center, Dallas, Texas, USA.
FAU - Symmans, William F
AU  - Symmans WF
AD  - The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
FAU - Park, Ben H
AU  - Park BH
AD  - Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, 
      Tennessee, USA.
FAU - Burnette, Brian L
AU  - Burnette BL
AD  - Cancer Research of Wisconsin and Northern Michigan (CROWN) NCORP, Green Bay, 
      Wisconsin, USA.
FAU - Makower, Della F
AU  - Makower DF
AD  - Montefiore Medical Center, Bronx, New York, USA.
FAU - Block, Margaret
AU  - Block M
AD  - Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, USA.
FAU - Morley, Kimberly A
AU  - Morley KA
AD  - St Joseph Mercy Hospital, Ann Arbor, Michigan, USA.
FAU - Jani, Chirag R
AU  - Jani CR
AD  - Phoebe Putney Memorial Hospital, Albany, Georgia, USA.
FAU - Mescher, Craig
AU  - Mescher C
AD  - Metro-Minnesota Community Oncology Research Consortium, St Louis Park, Minnesota, 
      USA.
FAU - Dewani, Shabana J
AU  - Dewani SJ
AD  - Columbus Oncology and Hematology Associates Inc., Columbus, Ohio, USA.
FAU - Brown-Glaberman, Ursa
AU  - Brown-Glaberman U
AD  - University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, 
      USA.
FAU - Flaum, Lisa E
AU  - Flaum LE
AD  - Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
FAU - Mayer, Erica L
AU  - Mayer EL
AD  - Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
FAU - Sikov, William M
AU  - Sikov WM
AD  - Women and Infants Hospital of Rhode Island, Providence, Rhode Island, USA.
FAU - Rodler, Eve T
AU  - Rodler ET
AD  - University of California, Davis, Davis, California, USA.
FAU - DeMichele, Angela M
AU  - DeMichele AM
AD  - University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, 
      USA.
FAU - Sparano, Joseph A
AU  - Sparano JA
AUID- ORCID: 0000-0002-9031-2010
AD  - Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, New 
      York, USA.
FAU - Wolff, Antonio C
AU  - Wolff AC
AD  - Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, 
      Maryland, USA.
FAU - Miller, Kathy D
AU  - Miller KD
AD  - Indiana University Melvin and Bren Simon Comprehensive Cancer Center, 
      Indianapolis, Indiana, USA.
FAU - Wagner, Lynne I
AU  - Wagner LI
AUID- ORCID: 0000-0001-9685-4796
AD  - Wake Forest University Health Sciences, Winston-Salem, North Carolina, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02445391
GR  - U10 CA180868/CA/NCI NIH HHS/United States
GR  - UG1 CA233320/CA/NCI NIH HHS/United States
GR  - UG1 CA233329/CA/NCI NIH HHS/United States
GR  - UG1 CA189828/CA/NCI NIH HHS/United States
GR  - UG1 CA189863/CA/NCI NIH HHS/United States
GR  - UG1 CA233340/CA/NCI NIH HHS/United States
GR  - U10 CA180820/CA/NCI NIH HHS/United States
GR  - U10 CA180794/CA/NCI NIH HHS/United States
GR  - U10 CA180821/CA/NCI NIH HHS/United States
GR  - UG1 CA233277/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20240118
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
SB  - IM
OTO - NOTNLM
OT  - adjuvant therapy
OT  - capecitabine
OT  - neuropathy
OT  - patient-reported outcomes
OT  - platinum
OT  - quality of life
OT  - triple-negative breast cancer
EDAT- 2024/01/18 18:42
MHDA- 2024/01/18 18:42
CRDT- 2024/01/18 12:42
PHST- 2023/10/19 00:00 [revised]
PHST- 2023/08/07 00:00 [received]
PHST- 2023/11/20 00:00 [accepted]
PHST- 2024/01/18 18:42 [medline]
PHST- 2024/01/18 18:42 [pubmed]
PHST- 2024/01/18 12:42 [entrez]
AID - 10.1002/cncr.35187 [doi]
PST - aheadofprint
SO  - Cancer. 2024 Jan 18. doi: 10.1002/cncr.35187.