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

<ѻý class="mpt-content-deck">– An ASCO Reading Room selection
Masataka Sawaki, MD, PhD; Naruto Taira, MD, PhD; Yukari Uemura, PhD; Tsuyoshi Saito, MD, PhD; Shinichi Baba, MD; Kokoro Kobayashi, MD; Hiroaki Kawashima, MD, PhD; Michiko Tsuneizumi, MD, PhD; Noriko Sagawa, MD, PhD; Hiroko Bando, MD, PhD; Masato Takahashi, MD, PhD; Miki Yamaguchi, MD, PhD; Tsutomu Takashima, MD, PhD; Takahiro Nakayama, MD, PhD; Masahiro Kashiwaba, MD, PhD; Toshiro Mizuno, MD, PhD; Yutaka Yamamoto, MD, PhD; Hiroji Iwata, MD, PhD; Takuya Kawahara, PhD; Yasuo Ohashi, PhD; and Hirofumi Mukai, MD, PhD, for the RESPECT study group
Journal of Clinical Oncology

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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 age 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 = 0.51). 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 =0.53). Common AEs were anorexia (7.4% vs 44.3%; P < 0.0001) and alopecia (2.2% vs 71.7%; P < 0.0001), and grade 3/4 nonhematologic AEs occurred in 11.9% versus 29.8% (P = 0.0003) for trastuzumab monotherapy versus trastuzumab + chemotherapy, respectively. Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy vs 48% for trastuzumab + chemotherapy; P = 0.016) and at 1 year (19% vs 38%; P = 0.009).

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.

Read an interview about the study here and expert commentary about the clinical implications here.

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

Primary Source

Journal of Clinical Oncology

Source Reference:

ASCO Publications Corner

ASCO Publications Corner