Premedication with dexamethasone for preventing interstitial lung disease in patients with breast cancer treated with trastuzumab deruxtecan

Breast Cancer

Cumulative incidence of patients who experience an ILD > G1 on high-resolution thorax CT scan during the treatment with T-DXd at 12 months from randomization by local Investigator’s judgement according to CTCAE, version 6.0. Discontinuation of T-DXd treatment for any reason other than ILD >G1 will be considered as a competing event.

· Cumulative incidence of patients who experienced an ILD > G1 on HR thorax CT scan at 3, 6 and 9 months from randomization, · Cumulative incidence of patients who experienced an any grade ILD on HR thorax CT scan at 3, 6, 9 and 12 months from randomization., · Proportion of patients diagnosed with ILD > G1 by central retrospective review of HR thoracic CT scans and clinical history within 12 months from randomization, according to CTCAE v6.0 and multidisciplinary team assessment, with timing of ILD development during treatment documented, · Proportion of patients with specific radiological ILD patterns identified through centralized multidisciplinary discussion (radiologists, pneumologists, radiotherapists, thoracic surgeons, oncologists), · Cumulative incidence of patients who experienced nausea or vomiting (any grade and >G2) at 3, 6, 9 and 12 months from randomization, · Cumulative incidence of patients who experienced AST/ALT liver enzyme elevation (any grade and >G2) at 3, 6, 9 and 12 months from randomization, · Cumulative incidence of permanent T-DXd discontinuation due to drug-related AEs at 3, 6, 9 and 12 months from randomization, · Proportion of patients requiring a dose reduction due to T-Dxd-related AEs., · Cumulative incidence of patients who experienced cough (any grade and >G2) according to cough symptom score (CSS) at 3, 6, 9 and 12 months from randomization., · Cumulative incidence of patients who experienced dyspnea (any grade and >G2) according to Modified Medical Research Council (mMRC) Dyspnea Scale at 3, 6, 9 and 12 months from randomization., · Changes in SpO2, FVC and DLCO at 3, 6, 9 and 12 months from randomization., • Worst AE and adverse drug reaction (ADR) grade for each AE type, according to NCI-CTCAE v. 6.0, • Proportion of patients experiencing grade 3-4-5 AEs/ADRs for each AE/ADR type, • Type, frequency, nature, and number of patients with serious AEs (SAEs), serious adverse drug reactions (SADRs) and suspected unexpected serious adverse reactions (SUSARs), · Change from baseline in each single scale of the EORTC QLQ-FA12 questionnaire assessed at planned timepoints (see Study Procedures), · Change from baseline in EQ-5D-5L health state profile, utility score (for QALY calculations), and EQ-VAS score using the EQ-5D-5L questionnaire assessed at planned timepoints (see Study Procedures), · Cumulative incidence of patients who experienced ILD stratified by history of radiotherapy to breast and/or thorax (including palliative radiotherapy to vertebral/costal sites)

No related papers found yet.