1. Impact of depatuxizumab mafodotin on health-related quality of life and neurological functioning in the phase II EORTC 1410/INTELLANCE 2 trial for EGFR-amplified recurrent glioblastoma.
- Author
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UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Clement, Paul M J, Dirven, Linda, Eoli, Marica, Sepulveda-Sanchez, Juan M, Walenkamp, Annemiek M E, Frenel, Jean S, Franceschi, Enrico, Weller, Michael, Chinot, Olivier, De Vos, Filip Y F L, Whenham, Nicolas, Sanghera, Paul, Looman, Jim, Kundu, Madan G, Peter de Geus, Jan, Nuyens, Sarah, Spruyt, Maarten, Gorlia, Thierry, Coens, Corneel, Golfinopoulos, Vassilis, Reijneveld, Jaap C, van den Bent, Martin J, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Clement, Paul M J, Dirven, Linda, Eoli, Marica, Sepulveda-Sanchez, Juan M, Walenkamp, Annemiek M E, Frenel, Jean S, Franceschi, Enrico, Weller, Michael, Chinot, Olivier, De Vos, Filip Y F L, Whenham, Nicolas, Sanghera, Paul, Looman, Jim, Kundu, Madan G, Peter de Geus, Jan, Nuyens, Sarah, Spruyt, Maarten, Gorlia, Thierry, Coens, Corneel, Golfinopoulos, Vassilis, Reijneveld, Jaap C, and van den Bent, Martin J
- Abstract
BACKGROUND: In the EORTC 1410/INTELLANCE 2 randomised, phase II study (NCT02343406), with the antibody-drug conjugate depatuxizumab mafodotin (Depatux-M, ABT-414) in patients with recurrent EGFR-amplified glioblastoma, the primary end-point (overall survival) was not met, and the drug had ocular dose-limiting toxicity. This study reports results from the prespecified health-related quality of life (HRQoL) and neurological deterioration-free survival (NDFS) exploratory analysis. PATIENTS AND METHODS: Patients (n = 260) were randomised 1:1:1 to receive either Depatux-M 1.25 mg/kg or 1.0 mg/kg intravenously every 2 weeks with oral temozolomide (TMZ) 150 mg/m2, Depatux-M alone, or TMZ or oral lomustine (CCNU) 110 mg/m2 (TMZ/CCNU). HRQoL outcomes were recorded using the EORTC core Quality of Life QLQ-C30, and brain cancer-specific QLQ-BN20 questionnaires. Questionnaires were completed at baseline, weeks 8 and 16, and month 6, and changes from baseline to each time point were calculated. NDFS was defined as time to first deterioration in World Health Organisation performance status. RESULTS: Compliance with HRQoL was 88.1% at baseline and decreased to 37.9% at month 6. Differences from baseline between Depatux-M arms and TMZ/CCNU in global health/QoL status throughout treatment did not reach clinical relevance (≥10 points). Self-reported visual disorders deteriorated to a clinically relevant extent with Depatux-M arms versus TMZ/CCNU at all timepoints (mean differences range: 24.6-35.1 points). Changes from baseline for other HRQoL scales and NDFS were generally similar between treatment arms. CONCLUSIONS: Depatux-M had no impact on HRQoL and NDFS in patients with EGFR-amplified recurrent glioblastoma, except for more visual disorders, an expected side-effect of the study drug. CLINICAL TRIAL REGISTRATION: NCT02343406.
- Published
- 2021