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Randomized Controlled Trial
. 2022 Dec:66:245-254.
doi: 10.1016/j.breast.2022.10.017. Epub 2022 Nov 7.

Adjuvant trastuzumab without chemotherapy for treating early HER2-positive breast cancer in older patients: A propensity score-adjusted analysis of a prospective cohort study

Masataka Sawaki  1 , Naruto Taira  2 , Yukari Uemura  3 , Tsuyoshi Saito  4 , Shinichi Baba  5 , Kokoro Kobayashi  6 , Hiroaki Kawashima  7 , Michiko Tsuneizumi  8 , Noriko Sagawa  9 , Hiroko Bando  10 , Masato Takahashi  11 , Miki Yamaguchi  12 , Tsutomu Takashima  13 , Takahiro Nakayama  14 , Masahiro Kashiwaba  15 , Toshiro Mizuno  16 , Yutaka Yamamoto  17 , Hiroji Iwata  18 , Tatsuya Toyama  19 , Koichiro Tsugawa  20 , Takuya Kawahara  21 , Hirofumi Mukai  22 ; RESPECT study group
Affiliations
Randomized Controlled Trial

Adjuvant trastuzumab without chemotherapy for treating early HER2-positive breast cancer in older patients: A propensity score-adjusted analysis of a prospective cohort study

Masataka Sawaki et al. Breast. 2022 Dec.

Abstract

Purpose: To gauge the effects of treatment practices on prognosis for older patients with HER2-positive early breast cancer, particularly to determine whether adjuvant trastuzumab alone can offer benefit over no adjuvant therapy. This is a prospective cohort study which accompanies the RESPECT that is a randomized-controlled trial (RCT).

Methods: Patients who declined the RCT were treated based on the physician's discretion. We studied the 1) trastuzumab-plus-chemotherapy group, 2) trastuzumab-monotherapy group, and 3) non-trastuzumab group (no therapy or anticancer therapy without trastuzumab). The primary endpoint was disease-free survival (DFS), which was compared using the propensity-score method. Relapse-free survival (RFS) and health-related quality of life (HRQoL) were assessed.

Results: We enrolled 123 patients aged over 70 years (median: 74.5). Treatment categories were: trastuzumab-plus-chemotherapy group (n = 36, 30%), trastuzumab-monotherapy group (n = 52, 43%), and non-trastuzumab group (n = 32, 27%). The 3-year DFS was 96.7% in trastuzumab-plus-chemotherapy group, 89.2% in trastuzumab-monotherapy group, and 82.5% in non-trastuzumab group. DFS in non-trastuzumab group was lower than in trastuzumab-plus-chemotherapy and trastuzumab-monotherapy groups (propensity-adjusted hazard ratio; HR: 3.29; 95% CI: 1.15-9.39; P = 0.026). The RFS in non-trastuzumab group was lower than in trastuzumab-plus-chemotherapy and trastuzumab-monotherapy groups (propensity-adjusted HR = 7.80; 95% CI: 2.32-26.2, P < 0.0001). There were no significant intergroup differences in the proportions of patients showing HRQoL deterioration at 36 months (P = 0.717).

Conclusion: Trastuzumab-treated patients had better prognoses than patients not treated with trastuzumab without deterioration of HRQoL. Trastuzumab monotherapy could be considered for older patients who reject chemotherapy.

Keywords: Breast cancer; HER2; Older; Trastuzumab; Without chemotherapy.

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Conflict of interest statement

Declaration of competing interest YU reports honoraria for consulting from Chugai pharmaceutical Co., Ltd. TT reports honoraria for lectures from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Eisai Co., Ltd., Pfizer Japan Inc., Novartis Pharma K·K., AstraZeneca K·K., Takeda Pharmaceutical Co., Ltd., Eli Lilly Japan K·K., and Daiichi Sankyo Co., Ltd. TN reports fees for Non-CME services and honoraria for lectures from Chugai pharmaceutical Co., Ltd., AstraZeneca K·K., Novartis Pharma K·K., Eli Lilly Japan K·K., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, and Eisai Co., Ltd. TM reports fees for non-CME services and honoraria for lectures from AstraZeneca K·K, Chugai pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K·K., Daiichi Sankyo Co., Ltd., Nippon Kayaku Co., Ltd., and Pfizer Japan Inc. HI reports honoraria for lectures from Chugai pharmaceutical Co., Ltd. HM reports honoraria from AstraZeneca K·K, Pfizer Japan Inc, Takeda Pharmaceutical Company Limited, Daiichi Sankyo Co., Ltd and Taiho Pharmaceutical Co., Ltd; and research grants from the Japanese government, Daiichi Sankyo Co., Ltd, Eisai Co., Ltd, Nippon Kayaku Co., Ltd and Pfizer Japan Inc, outside the submitted work.

Figures

Fig. 1
Fig. 1
CONSORT diagram. Patients who met the eligibility criteria but did not agree to participate in the randomized controlled trial were included in the cohort study with written informed consent. The treatment was selected for each patient based on the discretion of the treating physician and the patient's wishes, without intervention.
Fig. 2
Fig. 2
Kaplan–Meier estimates of disease-free survival (DFS). The DFS at 3 years was 96.7% in the trastuzumab-plus-chemotherapy group, 89.2% in the trastuzumab-monotherapy group, and 82.5% in the non-trastuzumab group. The DFS period of the non-trastuzumab group was lower than that of the trastuzumab-plus-chemotherapy and the trastuzumab monotherapy groups (propensity-adjusted HR: 3.29; 95% CI: 1.15–9.39; P = 0.026). The DFS in the non-trastuzumab group also showed a worse prognosis compared with the trastuzumab monotherapy group (propensity-adjusted HR: 2.15; 95% CI: 1.20–3.93; P = 0.012). Tick marks indicate censored data.
Fig. 3
Fig. 3
Kaplan–Meier estimates of relapse-free survival (RFS). The RFS of patients in the non-trastuzumab group was lower than that of patients in the trastuzumab-plus-chemotherapy and trastuzumab monotherapy groups (propensity-adjusted HR = 7.80; 95% CI: 2.32–26.2, P < 0.0001). Tick marks indicate censored data.
Fig. 4
Fig. 4
Means and 95%CI of FACT-G scores at each survey point. Mean value and 95% confidential interval (95%CI) of A) Functional Assessment of Cancer Therapy-general (FACT-G) total, B) physical well-being (PWB), C) social and family well-being (SFWB), D) emotional well-being (EWB) and E) functional well-being (FWB) scores at baseline, and after 36 months in each group.
Fig. A.1
Fig. A.1
Kaplan–Meier estimates of overall survival (OS). The OS of patients in the non-trastuzumab group was marginally lower than that of patients in the trastuzumab-plus-chemotherapy, and trastuzumab monotherapy groups (propensity-adjusted HR = 3.44; 95% CI: 0.75–15.67, P = 0.11). Tick marks indicate censored data.
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References

    1. Sawaki M., Taira N., Uemura Y., Saito T., Baba S., Kobayashi K., et al. Randomized controlled trial of trastuzumab with or without chemotherapy for HER2-positive early breast cancer in older patients. J Clin Oncol. 2020;38:3743–3752. - PubMed
    1. Wolff A.C., Hammond M.E., Schwartz J.N., Hagerty K.L., Allred D.C., Cote R.J., et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007;25:118–145. - PubMed
    1. Cella D.F., Tulsky D.S., Gray G., Sarafian B., Linn E., Bonomi A., et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11:570–579. - PubMed
    1. Eton D.T., Cella D., Yost K.J., Yount S.E., Peterman A.H., Neuberg D.S., et al. A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol. 2004;57:898–910. - PubMed
    1. Piccart-Gebhart M.J., Procter M., Leyland-Jones B., Goldhirsch A., Untch M., Smith I., et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353:1659–1672. - PubMed

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