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Войти в исследования European journal of nuclear medicine and molecular imaging · 2026
Post-hoc analysis of adverse events during the EPOCH trial: reconsidering dosimetry.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Lam Marnix, Kersting David, Harris William, Boucher Eveline, Garin Etienne, Fowers Kirk, Salem Riad
Аннотация
BACKGROUND: EPOCH demonstrated superior progression free survival using yttrium-90 [90Y] glass microspheres radioembolization plus chemotherapy versus chemotherapy in colorectal cancer patients with liver metastases who had progressed following first-line oxaliplatin or irinotecan-based chemotherapy. Exploratory post-hoc analyses and theoretical modeling assessed the potential impact of dosimetry on safety outcomes.
PATIENTS AND METHODS: Liver-related treatment-emergent adverse event (TEAE) frequency and/or severity, and bilirubin increase were explored in participating patients. For hypothesis generation, a theoretical model was constructed to understand EPOCH dosimetry in the absence of multicompartment dosimetry data.
RESULTS: Liver-related TEAEs were reported in 93/186 (50%) patients, TEAEs ≥ grade 3 in 44/186 (24%) patients. A total of 26/186 patients (14%) experienced a bilirubin increase TEAE of any grade, in five of which assessed as related to glass [90Y]Y-radioembolization with a median fractional tumour involvement of 2.3% (range 1.4-4.1%). Under the theoretical assumption of a T/N ratio of 2-10, most patients in EPOCH (62% had a fractional tumour involvement < 10%) received a normal liver absorbed dose of at least 75 Gy. In this model, at < 4.1% fractional tumour involvement, the normal liver absorbed dose approximates 120 Gy at any T/N ratio.
CONCLUSION: When treatment is same-day whole liver at 120 Gy average absorbed dose, the normal liver absorbed dose is dependent on fractional tumour involvement.
TRIAL REGISTRATION: ClinicalTrials.gov NCT01483027.
PATIENTS AND METHODS: Liver-related treatment-emergent adverse event (TEAE) frequency and/or severity, and bilirubin increase were explored in participating patients. For hypothesis generation, a theoretical model was constructed to understand EPOCH dosimetry in the absence of multicompartment dosimetry data.
RESULTS: Liver-related TEAEs were reported in 93/186 (50%) patients, TEAEs ≥ grade 3 in 44/186 (24%) patients. A total of 26/186 patients (14%) experienced a bilirubin increase TEAE of any grade, in five of which assessed as related to glass [90Y]Y-radioembolization with a median fractional tumour involvement of 2.3% (range 1.4-4.1%). Under the theoretical assumption of a T/N ratio of 2-10, most patients in EPOCH (62% had a fractional tumour involvement < 10%) received a normal liver absorbed dose of at least 75 Gy. In this model, at < 4.1% fractional tumour involvement, the normal liver absorbed dose approximates 120 Gy at any T/N ratio.
CONCLUSION: When treatment is same-day whole liver at 120 Gy average absorbed dose, the normal liver absorbed dose is dependent on fractional tumour involvement.
TRIAL REGISTRATION: ClinicalTrials.gov NCT01483027.