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.

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 (2021) 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. European journal of cancer (Oxford, England : 1990), 147. pp. 1-12. ISSN 1879-0852. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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Official URL: https://www.ejcancer.com/article/S0959-8049(21)000...

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/m, Depatux-M alone, or TMZ or oral lomustine (CCNU) 110 mg/m (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.

Item Type: Article
Additional Information: This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects: QV Pharmacology
QZ Pathology. Oncology
Divisions: Planned IP Care > Oncology and Clinical Haematology
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Depositing User: Mrs Yolande Brookes
Date Deposited: 19 Feb 2021 16:09
Last Modified: 19 Feb 2021 16:09
URI: http://www.repository.uhblibrary.co.uk/id/eprint/3997

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