Yasuo Ohashi1, Yasuhiro Hagiwara2, Masataka Sawaki3, Yukari Uemura4, Takuya Kawahara5, Kojiro Shimozuma6, Masato Takahashi7, Tsuyoshi Saito8, Shinichi Baba9, Kokoro Kobayashi10, Hirofumi Mukai11, Naruto Taira12. 1. Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan. 2. Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. hagiwara@epistat.m.u-tokyo.ac.jp. 3. Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. 4. Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan. 5. Biostatistics Division, Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan. 6. Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Kusatsu, Japan. 7. Department of Breast Surgery, NHO Hokkaido Cancer Center, Sapporo, Japan. 8. Department of Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan. 9. Department of Surgery, Sagara Hospital, Kagoshima, Japan. 10. Department of Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. 11. Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 12. Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.
Abstract
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).
RCT Entities:
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).