PMID- 32936713
OWN - NLM
STAT- MEDLINE
DCOM- 20210323
LR  - 20210323
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 38
IP  - 32
DP  - 2020 Nov 10
TI  - Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for 
      HER2-Positive Early Breast Cancer in Older Patients.
PG  - 3743-3752
LID - 10.1200/JCO.20.00184 [doi]
AB  - PURPOSE: Adjuvant trastuzumab monotherapy has not been compared with trastuzumab 
      + chemotherapy. We investigated the relative value of trastuzumab monotherapy for 
      older patients with breast cancer. METHODS: This study was an open-label, 
      randomized controlled study with a treatment selection design in which a 
      noninferiority criterion was predefined. Patients aged 70-80 years with 
      surgically treated human epidermal growth factor receptor 2-positive invasive 
      breast cancer received trastuzumab monotherapy or trastuzumab + chemotherapy. The 
      primary end point was disease-free survival (DFS) with assessment of prespecified 
      hazard ratio (HR), relapse-free survival (RFS), adverse events (AEs), 
      health-related quality of life (HRQoL), and restricted mean survival time (RMST). 
      RESULTS: The study involved 275 patients (mean age, 73.5 years) who were followed 
      up for a mean of 4.1 years (range, 0.3-8.0 years). The percentages of patients by 
      cancer stage were as follows: I (pT > 0.5 cm), 43.6%; IIA, 41.7%; IIB, 13.5%; and 
      IIIA, 1.1%. Three-year DFS was 89.5% with trastuzumab monotherapy versus 93.8% 
      with trastuzumab + chemotherapy (HR, 1.36; 95% CI, 0.72 to 2.58; P = .51). At 3 
      years, RMST differed by -0.39 months between arms (95% CI, -1.71 to 0.93; P = 
      .56). Three-year RFS was 92.4% with trastuzumab monotherapy versus 95.3% with 
      trastuzumab + chemotherapy (HR, 1.33; 95% CI, 0.63 to 2.79; P = .53). Common AEs 
      were anorexia (7.4% v 44.3%; P < .0001) and alopecia (2.2% v 71.7%; P < .0001), 
      and grade 3/4 nonhematologic AEs occurred in 11.9% versus 29.8% (P = .0003) for 
      trastuzumab monotherapy versus trastuzumab + chemotherapy, respectively. 
      Clinically meaningful HRQoL deterioration rate showed significant differences at 
      2 months (31% for trastuzumab monotherapy v 48% for trastuzumab + chemotherapy; P 
      = .016) and at 1 year (19% v 38%; P = .009). CONCLUSION: The primary objective of 
      noninferiority for trastuzumab monotherapy was not met. However, the observed 
      loss of survival without chemotherapy was < 1 month at 3 years. Therefore, and in 
      light of the lower toxicity and more favorable HRQoL profile, trastuzumab 
      monotherapy can be considered an adjuvant therapy option for selected older 
      patients.
FAU - Sawaki, Masataka
AU  - Sawaki M
AD  - Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
FAU - Taira, Naruto
AU  - Taira N
AD  - Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, 
      Japan.
FAU - Uemura, Yukari
AU  - Uemura Y
AD  - Biostatistics Section, Department of Data Science, Center for Clinical Sciences, 
      National Center for Global Health and Medicine, Tokyo, Japan.
FAU - Saito, Tsuyoshi
AU  - Saito T
AD  - Department of Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan.
FAU - Baba, Shinichi
AU  - Baba S
AD  - Department of Surgery, Sagara Hospital, Kagoshima, Japan.
FAU - Kobayashi, Kokoro
AU  - Kobayashi K
AD  - Department of Medical Oncology, the Cancer Institute Hospital of the Japanese 
      Foundation for Cancer Research, Tokyo, Japan.
FAU - Kawashima, Hiroaki
AU  - Kawashima H
AD  - Department of Surgery, Aomori City Hospital, Aomori, Japan.
FAU - Tsuneizumi, Michiko
AU  - Tsuneizumi M
AD  - Department of Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan.
FAU - Sagawa, Noriko
AU  - Sagawa N
AD  - Department of Breast Surgery, Kameda Medical Center, Kamogawa, Japan.
FAU - Bando, Hiroko
AU  - Bando H
AD  - Department of Breast and Endocrine Surgery, Faculty of Medicine, University of 
      Tsukuba, Tsukuba, Japan.
FAU - Takahashi, Masato
AU  - Takahashi M
AD  - Department of Breast Surgery, National Hospital Organization Hokkaido Cancer 
      Center, Sapporo, Japan.
FAU - Yamaguchi, Miki
AU  - Yamaguchi M
AD  - Department of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan.
FAU - Takashima, Tsutomu
AU  - Takashima T
AD  - Department of Breast and Endocrine Surgery, Osaka City University Graduate School 
      of Medicine, Osaka, Japan.
FAU - Nakayama, Takahiro
AU  - Nakayama T
AD  - Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, 
      Osaka Japan.
FAU - Kashiwaba, Masahiro
AU  - Kashiwaba M
AD  - Department of Surgery, Sagara Hospital, Kagoshima, Japan.
FAU - Mizuno, Toshiro
AU  - Mizuno T
AD  - Department of Medical Oncology, Mie University Hospital, Tsu, Japan.
FAU - Yamamoto, Yutaka
AU  - Yamamoto Y
AD  - Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, 
      Kumamoto University, Kumamoto, Japan.
FAU - Iwata, Hiroji
AU  - Iwata H
AD  - Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
FAU - Kawahara, Takuya
AU  - Kawahara T
AD  - Biostatistics Division, Clinical Research Support Center, The University of Tokyo 
      Hospital, Tokyo, Japan.
FAU - Ohashi, Yasuo
AU  - Ohashi Y
AD  - Department of Integrated Science and Engineering for Sustainable Society, Chuo 
      University, Tokyo, Japan.
FAU - Mukai, Hirofumi
AU  - Mukai H
AD  - Department of Breast and Medical Oncology, National Cancer Center Hospital East, 
      Kashiwa, Japan.
CN  - RESPECT study group
LA  - eng
SI  - ClinicalTrials.gov/NCT01104935
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200916
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 15H5577CQD (Docetaxel)
RN  - 3Z8479ZZ5X (Epirubicin)
RN  - 80168379AG (Doxorubicin)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
CIN - J Clin Oncol. 2020 Nov 10;38(32):3727-3730. PMID: 32936714
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/enzymology/pathology
MH  - Cyclophosphamide/administration & dosage
MH  - Disease-Free Survival
MH  - Docetaxel/administration & dosage
MH  - Doxorubicin/administration & dosage
MH  - Epirubicin/administration & dosage
MH  - Female
MH  - Humans
MH  - Neoplasm Staging
MH  - Quality of Life
MH  - Receptor, ErbB-2/*metabolism
MH  - Survival Rate
MH  - Trastuzumab/administration & dosage/*therapeutic use
EDAT- 2020/09/17 06:00
MHDA- 2021/03/24 06:00
CRDT- 2020/09/16 17:11
PHST- 2020/09/17 06:00 [pubmed]
PHST- 2021/03/24 06:00 [medline]
PHST- 2020/09/16 17:11 [entrez]
AID - 10.1200/JCO.20.00184 [doi]
PST - ppublish
SO  - J Clin Oncol. 2020 Nov 10;38(32):3743-3752. doi: 10.1200/JCO.20.00184. Epub 2020 
      Sep 16.