In an analysis of patient-reported outcomes (PROs) in the DESTINY-Breast02 trial published in The Lancet Oncology, Tanja Fehm, MD, and colleagues found that general health status/quality of life was maintained over time with fam-trastuzumab deruxtecan-nxki (T-DXd) vs physician’s choice of therapy in patients with HER2-positive unresectable or metastatic breast cancer previously treated with ado-trastuzumab emtansine. Time to deterioration in PROs was also longer with trastuzumab deruxtecan.
Tanja Fehm, MD
Study Details
In the global open-label trial, 608 patients were randomly assigned 2:1 to receive T-DXd (n = 406) or treatment of physician’s choice (n = 202), consisting of either capecitabine/trastuzumab or capecitabine/lapatinib.
Key Findings
Median follow-up was 21.5 months in the T-DXd group and 18.6 months in physician’s choice group. Median treatment duration was 11.3 months vs 4.5 months.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) general health status/quality of life scores were similar in both groups at baseline and remained stable (± 10 points) over time, with no clinically meaningful improvement (≥ 10 points) being observed in either group.
Median time to definitive deterioration in general health status/quality of life was longer in the T-DXd group than in the physician’s choice group (14.1 months vs 5.9 months; hazard ratio [HR] = 0.557, P < .0001). For other PROs, patients receiving T-DXd had longer median times to deterioration in QLQ-C30 physical functioning (18.7 months vs 6.8 months, HR = 0.464, P < .0001) and pain symptom scales (18.7 months vs 5.8 months, HR = 0.378, P < .0001) than patients receiving physician’s choice of treatment. Prolonged median times to deterioration were also observed for EORTC Quality of Life Questionnaire Breast 45 (QLQ-BR45) (HR = 0.416, P < .0001) and arm symptoms scales (HR = 0.574, P < .0001), and EQ-5D-5L visual analog scale (HR = 0.591, P < .0001).
Hospitalization rates were 23% in the T-DXd group vs 20% in the physician’s choice group; median time to hospitalization was 133 days vs 83 days.
The investigators concluded: “Overall, general health status and quality of life were maintained for both treatment groups, with prespecified PRO variables favoring T-DXd over treatment of physician’s choice, suggesting that despite a longer treatment duration, there was no detrimental impact on patient health-related quality of life with T-DXd. When considered with efficacy and safety data from DESTINY-Breast02, these results support the overall benefit of T-DXd for patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab emtansine.”
Dr. Fehm, of University Hospital Düsseldorf, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by Daiichi Sankyo and AstraZeneca. For full disclosures of the study authors, visit thelancet.com.
