Health-related quality of life (HRQL) in VERTU: A randomized phase II trial of veliparib (V), radiotherapy (RT), and temozolomide (TMZ) for newly diagnosed MGMT unmethylated (uMGMT) glioblastoma (GBM).

Authors

Hao-Wen Sim

Hao-Wen Sim

The Kinghorn Cancer Centre, St Vincent's Hospital Sydney, Sydney, Australia

Hao-Wen Sim , Elizabeth Barnes , Zarnie Lwin , Mark Rosenthal , Helen Wheeler , Eng-Siew Koh , Matthew C. Foote , Lauren Fisher , Robyn Leonard , Merryn Hall , John Simes , Mustafa Khasraw

Organizations

The Kinghorn Cancer Centre, St Vincent's Hospital Sydney, Sydney, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW, Australia, Department of Medical Oncology, Brisbane, QLD, Australia, The Royal Melbourne Hospital, Parkville, Australia, Royal North Shore Hospital, Department of Oncology, St Leonards, Australia, Liverpool Hospital, Liverpool, Australia, Princess Alexandra Hospital, University of Queensland, Brisbane, Australia, NHMRC Clinical Trials Centre, Sydney, Australia, COGNO Consumer Advisory Panel, Sydney, Australia, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia, Royal North Shore Hospital/ University of Sydney, St Leonards, Australia

Research Funding

Other Foundation
Pharmaceutical/Biotech Company

Background: The VERTU trial (ANZCTR #ACTRN12615000407594) compared Arm A (standard of care) = RT (60Gy/30 fractions) + TMZ (75mg/m2 daily) followed by TMZ (150–200mg/m2 D1–5) every 28 days for 6 cycles vs Arm B (experimental arm) = RT (60Gy/30 fractions) + V (200mg PO BID) followed by TMZ (150–200mg/m2 D1–5) + V (40mg PO BID, D1–7) every 28 days for 6 cycles in pts with newly diagnosed centrally determined uMGMT GBM. To ensure that veliparib was not associated with clinical detriment, serial HRQL assessments were performed for comparison as a secondary objective. Methods: Pts completed the EORTC quality of life core questionnaire (QLQ-C30) and brain cancer module (BN20) every 4 weeks (w) (baseline: w0; concurrent: w4,8; adjuvant: w10,14,18,22,26,30). Based on relevance to GBM patients, 5 HRQL scales (global health [GH], physical functioning [PF], social functioning [SF], motor dysfunction [MD] and communication deficit [CD]) were pre-selected for primary analysis. Maximum change from baseline score (clinically relevant deterioration/improvement defined as ≥10-point change) during the progression-free period, and deterioration-free survival (time to deterioration/progression/death) were evaluated. Results: Patient characteristics were well-matched (Arm A: N = 41, median age = 62, male = 68%, ECOG 0 = 66%, macroscopic resection = 88%; Arm B: N = 84, median age = 60, male = 70%, ECOG 0 = 65%, macroscopic resection = 86%). Almost all completed at least one HRQL assessment (98%). HRQL assessments during the progression-free period were completed in 87% (Arm A) and 90% (Arm B) of cases. For Arm A vs B, the proportion of patients who experienced a deterioration in GH (59% vs 64%, p = 0.69), PF (53% vs 53%, p > 0.99), SF (46% vs 53%, p = 0.56), MD (63% vs 58%, p = 0.70) and CD (45% vs 46%, p > 0.99) were similar. Deterioration-free survival was not statistically different for any HRQL item. Conclusions: The addition of veliparib to standard of care for newly diagnosed uMGMT GBM does not appear to compromise HRQL. This would support the primary efficacy analysis of the VERTU trial. Clinical trial information: ACTRN12615000407594.

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Central Nervous System Tumors

Track

Central Nervous System Tumors

Sub Track

Central Nervous System Tumors

Clinical Trial Registration Number

ACTRN12615000407594

Citation

J Clin Oncol 37, 2019 (suppl; abstr 2042)

DOI

10.1200/JCO.2019.37.15_suppl.2042

Abstract #

2042

Poster Bd #

231

Abstract Disclosures