Prof Neven comments on the TROPION–Breast01 trial
Prof Patrick Neven, a distinguished gynaecological oncologist affiliated with UZ Leuven in Belgium, provided an account of the TROPION BreastO1 study during the presidential symposium at ESMO 2023. The study, presented by Dr. Aridity Bardia from the Mass General Cancer Center in the United States, aimed to evaluate the efficacy of the monoclonal antibody-drug conjugate Datopotamab deruxtecan (Dato-DXd) in comparison to the physician’s choice of chemotherapy for patients diagnosed with HR+/HER2 metastatic breast cancer. The study encompassed a substantial cohort of over 700 patients and adopted a randomised, phase 3 trial design. The chemotherapy options within the physician’s choice arm included capecitabine, vinorelbine, eribulin, or gemcitabine.
Patients were randomly assigned in a one-to-one ratio, and Prof Neven presented the interim findings of the trial. Significantly, the analysis revealed a marked enhancement in PFS within the group receiving Dato-DXd (6.9 months) as opposed to the group receiving the physician’s choice of chemotherapy (4.9 months), supported by a statistically significant hazard ratio of 0.63. Furthermore, the antibody-drug conjugate group exhibited a more favourable objective response rate.
In terms of the adverse events associated with Dato-DXd, no novel safety concerns were identified. Notably, the treatment was associated with gastrointestinal toxicity, such as stomatitis and nausea. Dry eyes were a specific side effect of interest, while the incidence of interstitial lung disease (ILD) was relatively rare within the TROPION BreastO1 study. At the time of this follow-up report, the study had not yet accrued a sufficient number of events to demonstrate a conclusive OS benefit. However, continuous monitoring is planned to facilitate a more comprehensive evaluation of this critical endpoint. The preliminary hazard ratio for OS was 0.82, although statistical significance had not been reached at this juncture. Prof Neven expressed keen anticipation for further developments in this context.
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