Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for HER2-Positive Early Breast Cancer in Older Patients

Author:

Sawaki Masataka1,Taira Naruto2,Uemura Yukari3,Saito Tsuyoshi4,Baba Shinichi5,Kobayashi Kokoro6,Kawashima Hiroaki7,Tsuneizumi Michiko8,Sagawa Noriko9,Bando Hiroko10,Takahashi Masato11,Yamaguchi Miki12,Takashima Tsutomu13,Nakayama Takahiro14,Kashiwaba Masahiro5,Mizuno Toshiro15,Yamamoto Yutaka16,Iwata Hiroji1,Kawahara Takuya17,Ohashi Yasuo18,Mukai Hirofumi19,

Affiliation:

1. Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan

2. Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan

3. Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan

4. Department of Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan

5. Department of Surgery, Sagara Hospital, Kagoshima, Japan

6. Department of Medical Oncology, the Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan

7. Department of Surgery, Aomori City Hospital, Aomori, Japan

8. Department of Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan

9. Department of Breast Surgery, Kameda Medical Center, Kamogawa, Japan

10. Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan

11. Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan

12. Department of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan

13. Department of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan

14. Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka Japan

15. Department of Medical Oncology, Mie University Hospital, Tsu, Japan

16. Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan

17. Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan

18. Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan

19. Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan

Abstract

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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