The addition of chemotherapy to trastuzumab as adjuvant therapy among older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer was detrimental to quality of life (QOL) scores at 2 and 12 months but resolved by 36 months, according to an analysis of the RESPECT trial published in the Journal of Clinical Oncology.
“The Early Breast Cancer Trialists’ Collaborative Group did not reach a clear conclusion on the benefit of adjuvant chemotherapy in patients older than 70 years because of limited data,” the authors stated. Given that older patients are at an increased risk for toxicity associated with chemotherapy, the aim of this analysis was to determine the effects of chemotherapy plus trastuzumab on QOL.
The multicenter, open-label, phase 3 RESPECT trial (ClinicalTrials.gov Identifier: NCT 01104935) randomly assigned patients aged 70 to 80 years with stage I to IIIA, HER2-positive breast cancer to trastuzumab alone or chemotherapy plus trastuzumab as adjuvant therapy. All patients underwent curative surgery. The primary endpoint of disease-free survival noninferiority at 1 year was not met. This analysis was of health-related QOL scores from 231 patients.
QOL scores were significantly lower at 2 and 12 months after initiating therapy among patients who received chemotherapy plus trastuzumab compared with patients who received trastuzumab alone. At 2 months, 31% of patients experienced QOL deterioration in the chemotherapy-plus-trastuzumab group compared with 48% in the trastuzumab group (P =. 016). At 12 months, 19% and 38% of patients experienced deterioration in the combination and trastuzumab-alone groups, respectively (P =.009).
Patients who received chemotherapy plus trastuzumab experienced a greater deterioration in scores for morale, anxiety and depression, activity capacity, and chemotherapy-induced peripheral neuropathy. There was no difference in QOL scores between groups at 36 months.
The authors concluded that “These findings may provide relief for patients seeking standard treatment with a combination of chemotherapy and trastuzumab.” They added that for older patients who do receive chemotherapy plus trastuzumab, “Care and social support for at least 1 year are required for older patients with breast cancer who receive adjuvant chemotherapy in addition to anti-HER2 therapy.”
Disclosures: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Taira N, Sawaki M, Uemura Y, et al. Health-related quality of life with trastuzumab monotherapy versus trastuzumab plus standard chemotherapy as adjuvant therapy in older patients with HER2-positive breast cancer. J Clin Oncol. Published online April 9, 2021. doi:10.1200/JCO.20.02751