In an analysis from the Japanese RESPECT trial reported in the Journal of Clinical Oncology, Taira et al found that adjuvant trastuzumab monotherapy was associated with better health-related quality of life (QoL) vs trastuzumab plus standard chemotherapy for at least 12 months in women aged 70 to 80 with HER2-positive breast cancer, with no difference being observed at 36 months.
The previously reported results of the trial did not establish noninferiority of trastuzumab vs trastuzumab plus chemotherapy with respect to disease-free survival.
Study Details
The QoL analysis included 231 (84%) of the 275 patients in the parent study (average age = 74 years). QoL instruments included the Functional Assessment of Cancer Therapy–General (FACT-G; scores range from 0 to 108, with higher scores indicating better QoL), Philadelphia Geriatric Center Morale Scale, Patient Neurotoxicity Questionnaire, Hospital Anxiety and Depression Scale, and Tokyo Metropolitan Institute of Gerontology Index of Competence. These instruments were used at baseline and after 2, 12, and 36 months.
Key Findings
At baseline and at 2, 12, and 36 months, mean FACT-G scores for the trastuzumab group vs the trastuzumab/chemotherapy group were 78.9 vs 79.5, 80.4 vs 74.5, 82.7 vs 78.4, and 79.1 vs 78.5.
For the trastuzumab group vs the trastuzumab/chemotherapy group, proportions showing deterioration on the FACT-G (≥ 5-point decrease from baseline) were 31% vs 48% (P = .016) at 2 months, 19% vs 38% (P = .009) at 12 months, and 31% vs 36% (P = .613) at 36 months. Proportions showing improvement (≥ 5-point increase from baseline) were 38% vs 15% (P < .001) at 2 months, 43% vs 25% (P = .021) at 12 months, and 37% vs 36% (P = .870) at 36 months.
Additional significant improvements in QoL measures for the trastuzumab group vs the trastuzumab/chemotherapy group were improved score on the Hospital Anxiety and Depression Scale (P = .003) and lower proportion of patients with severe sensory peripheral neuropathy (P = .001) at 2 months, as well as better Philadelphia Geriatric Center Morale Scale score (P = .024) and Tokyo Metropolitan Institute of Gerontology Index of Competence score (P = .042) at 12 months.
At 36 months, no significant differences between groups were observed in any QoL measure.
The investigators concluded: “Detrimental effects of adjuvant chemotherapy on global QoL, morale, and activity capacity lasted for at least 12 months but were not observed at 36 months.”
Naruto Taira, MD, PhD, of the Department of Breast and Endocrine Surgery, Okayama University Hospital, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Comprehensive Support Project for Oncology Research of the Public Health Research Foundation, Japan. For full disclosures of the study authors, visit ascopubs.org.
