TY - JOUR
T1 - Impact of chemotherapy on cognitive functioning in older patients with HER2-positive breast cancer
T2 - a sub-study in the RESPECT trial
AU - Hagiwara, Yasuhiro
AU - Sawaki, Masataka
AU - Uemura, Yukari
AU - Kawahara, Takuya
AU - Shimozuma, Kojiro
AU - Ohashi, Yasuo
AU - Takahashi, Masato
AU - Saito, Tsuyoshi
AU - Baba, Shinichi
AU - Kobayashi, Kokoro
AU - Mukai, Hirofumi
AU - Taira, Naruto
N1 - Funding Information:
The RESPECT trial was funded by the Comprehensive Support Project for Oncology Research (CSPOR) of the Public Health Research Foundation. We thank all patients who participated in the RESPECT trial and investigators, medical staff, and data managers who were dedicated to this trial. We are grateful for support from the Comprehensive Support Project for Health Outcomes Research (CSP-HOR).
Funding Information:
YU reports honoraria from Chugai Pharma and Teijin Pharma; consulting and advisory role for Pfizer, Ono Pharmaceutical, Zeria Pharmaceutical, and Daiichi Sankyo; speakers' bureaus for Pfizer; and travel support from Pfizer and Chugai Pharma. YO reports compensated leadership for Statcom; stock ownership of Statcom; honoraria from Chugai Pharma, Daiichi Sankyo, Sanofi, Eisai, and Shionogi; and grants from Medical Member System. MT reports honoraria from AstraZeneca, Eli Lilly, Eisai, and Pfizer; and grants paid to the institution from Eisai, Kyowa Kirin, and Taiho Pharmaceutical. HM reports honoraria from Pfizer, Daiichi Sankyo, Taiho Pharmaceutical, and Takeda; and grants paid to the institution from Daiichi Sankyo. All remaining authors have declared no conflicts of interest.
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2021/8
Y1 - 2021/8
N2 - Purpose: To investigate whether postoperative adjuvant trastuzumab plus chemotherapy negatively affected cognitive functioning during the post-chemotherapy period compared with trastuzumab monotherapy in older patients with HER2-positive breast cancer. Methods: In the randomized RESPECT trial, women aged between 70 and 80 years with HER2-positive, stage I to IIIA invasive breast cancer who underwent curative operation were randomly assigned to receive either 1-year trastuzumab monotherapy or 1-year trastuzumab plus chemotherapy. Cognitive functioning was assessed using the Mini-Mental State Examination (MMSE) test at enrollment and 1 and 3 years after initiation of the protocol treatment. The primary outcome was change in the MMSE total score from baseline. Secondary outcomes included prevalence of suspected mild cognitive impairment (MMSE total score < 28) and suspected dementia (MMSE total score < 24). Results: The analytical population consisted of 29 and 26 patients in the trastuzumab monotherapy and trastuzumab plus chemotherapy groups, respectively. The group differences in mean changes of the MMSE total score were 0.6 (95% confidence interval [CI] − 0.3 to 1.6) at 1 year and 0.9 (95% CI − 1.0 to 2.8) at 3 years (P = 0.136 for the group difference pooling the two visits). The prevalence of suspected mild cognitive impairment at 3 years was 41.7% in the trastuzumab monotherapy group and 28.6% in the trastuzumab plus chemotherapy group (P = 0.548). Conclusion: This randomized sub-study did not show worse cognitive functioning during the post-chemotherapy period with trastuzumab plus chemotherapy than with trastuzumab monotherapy in older patients with HER2-positive breast cancer. Trial registration number: NCT01104935 (first posted April 16, 2010).
AB - Purpose: To investigate whether postoperative adjuvant trastuzumab plus chemotherapy negatively affected cognitive functioning during the post-chemotherapy period compared with trastuzumab monotherapy in older patients with HER2-positive breast cancer. Methods: In the randomized RESPECT trial, women aged between 70 and 80 years with HER2-positive, stage I to IIIA invasive breast cancer who underwent curative operation were randomly assigned to receive either 1-year trastuzumab monotherapy or 1-year trastuzumab plus chemotherapy. Cognitive functioning was assessed using the Mini-Mental State Examination (MMSE) test at enrollment and 1 and 3 years after initiation of the protocol treatment. The primary outcome was change in the MMSE total score from baseline. Secondary outcomes included prevalence of suspected mild cognitive impairment (MMSE total score < 28) and suspected dementia (MMSE total score < 24). Results: The analytical population consisted of 29 and 26 patients in the trastuzumab monotherapy and trastuzumab plus chemotherapy groups, respectively. The group differences in mean changes of the MMSE total score were 0.6 (95% confidence interval [CI] − 0.3 to 1.6) at 1 year and 0.9 (95% CI − 1.0 to 2.8) at 3 years (P = 0.136 for the group difference pooling the two visits). The prevalence of suspected mild cognitive impairment at 3 years was 41.7% in the trastuzumab monotherapy group and 28.6% in the trastuzumab plus chemotherapy group (P = 0.548). Conclusion: This randomized sub-study did not show worse cognitive functioning during the post-chemotherapy period with trastuzumab plus chemotherapy than with trastuzumab monotherapy in older patients with HER2-positive breast cancer. Trial registration number: NCT01104935 (first posted April 16, 2010).
KW - Adjuvant chemotherapy
KW - Adjuvant trastuzumab
KW - Cognitive functioning
KW - HER2-positive breast cancer
KW - Older patients
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U2 - 10.1007/s10549-021-06253-0
DO - 10.1007/s10549-021-06253-0
M3 - Article
AN - SCOPUS:85107035179
VL - 188
SP - 675
EP - 683
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
SN - 0167-6806
IS - 3
ER -
