KEY TAKEAWAYS
- The phase 3 DESTINY-Breast02 trial evaluated the PROs and QoL among patients who had improved PFS and OS with T-DXd over TPC.
- Pts were randomly assigned with HER2+ T-DM1–resistant/refractory mBC in 2:1 to T-DXd or TPC.
- T-DXd treatment maintained overall health and QoL; longer TDD was observed on most QLQ-C30 subscales, reaffirming T-DXd’s benefits for HER2+ mBC.
The DESTINY-Breast02 trial randomly assigned patients (pts) with HER2+ (immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization amplified) T-DM1–resistant/refractory metastatic breast cancer (mBC) in 2:1 to trastuzumab deruxtecan (T-DXd) or treatment of physician’s choice (TPC) (trastuzumab + capecitabine or lapatinib + capecitabine).
PROs were gathered and evaluated at specific timepoints using the European Organization for Research and Treatment of Cancer QoL questionnaires (EORTC QLQ)-C30, the breast-cancer–specific EORTC QLQ-BR45 (scored as EORTC QLQ-BR23), and the EuroQol 5-dimension 5-level (EQ-5D-5L) visual analog scale.Changes from baseline (CFB) and time to definitive deterioration (TDD) was also determined. The study’s primary endpoint was QLQ-C30 global health status (GHS)/QoL score.
The study assigned 406 pts in the T-DXd arm and 202 pts in the TPC arm. The median treatment duration of the safety analysis set was 11.3 and approximately 4.5 months in the T-DXd and TPC arms, respectively. The questionnaire compliance was high throughout the study, with over 92% at baseline and over 76% at cycles 3-29. The mean CFB of global health status/quality of life (GHS/QoL) remained stable (within ±10 points) until cycle 39 for T-DXd and cycle 21 for TPC. However, after this, the number of patients on treatment was not informative as it was less than 10%. The median time to deterioration (TDD) was longer for patients who received T-DXd compared to TPC for GHS/QoL (14.1 vs 5.9 mo; HR, 0.56 [95% CI, 0.44-0.71]). This was also observed across all measured QLQ-C30 subscales, including physical functioning 18.7 vs 6.8 mo; HR, 0.46 [95% CI, 0.36-0.60]) and pain (18.7 vs 5.8 mo; HR, 0.38 [95% CI, 0.29-0.49]), except for nausea/vomiting (5.7 vs 6.1 mo; HR, 1.09 [95% CI, 0.86-1.39]). Additionally, pts experienced prolonged TDD on the QLQ-BR23 arm symptom subscale with T-DXd compared to TPC (18.3 vs 8.8 mo; HR, 0.57 [95% CI, 0.44-0.75]).
The findings from mean CFB in GHS/QoL indicate that the overall health and QoL were sustained in pts who received T-DXd treatment. Moreover, the Total Disease Duration (TDD) was longer on all the QLQ-C30 subscales assessed, except for nausea/vomiting, for those who were administered T-DXd compared to TPC. These outcomes further establish the advantage of T-DXd in pts with T-DM1-resistant HER2+ mBC.
Source: https://oncologypro.esmo.org/meeting-resources/esmo-breast-cancer-congress/patient-reported-outcomes-pros-from-destiny-breast02-a-randomized-phase-3-study-of-trastuzumab-deruxtecan-t-dxd-vs-treatment-of-physician-s-ch
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03523585
Fehm, T.N., Cottone, F., Dunton, K., André, F., Krop, I., Park, Y.H., De Laurentiis, M., Miyoshi, Y., Armstrong, A., Ruiz Borrego, M., Yerushalmi, R., Duhoux, F.P., Takano, T., Lu, W., Livings, C., Egorov, A., Kim, S. Annals of Oncology (2023) 8 (1suppl_4): 101223-101223. 10.1016/esmoop/esmoop101223
