Skip to main content

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).

Publication ,  Conference
Sim, H-W; Barnes, E; Lwin, Z; Rosenthal, M; Wheeler, H; Koh, E-S; Foote, MC; Fisher, L; Leonard, R; Hall, M; Simes, J; Khasraw, M
Published in: Journal of Clinical Oncology
May 20, 2019

2042 Background: The VERTU trial (ANZCTR #ACTRN12615000407594) compared Arm A (standard of care) = RT (60Gy/30 fractions) + TMZ (75mg/m daily) followed by TMZ (150–200mg/m 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/m 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.

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

May 20, 2019

Volume

37

Issue

15_suppl

Start / End Page

2042 / 2042

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Sim, H.-W., Barnes, E., Lwin, Z., Rosenthal, M., Wheeler, H., Koh, E.-S., … Khasraw, M. (2019). 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). In Journal of Clinical Oncology (Vol. 37, pp. 2042–2042). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2019.37.15_suppl.2042
Sim, Hao-Wen, Elizabeth Barnes, Zarnie Lwin, Mark Rosenthal, Helen Wheeler, Eng-Siew Koh, Matthew C. Foote, et al. “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).” In Journal of Clinical Oncology, 37:2042–2042. American Society of Clinical Oncology (ASCO), 2019. https://doi.org/10.1200/jco.2019.37.15_suppl.2042.
Sim H-W, Barnes E, Lwin Z, Rosenthal M, Wheeler H, Koh E-S, et al. 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). In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2019. p. 2042–2042.
Sim, Hao-Wen, et al. “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).Journal of Clinical Oncology, vol. 37, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2019, pp. 2042–2042. Crossref, doi:10.1200/jco.2019.37.15_suppl.2042.
Sim H-W, Barnes E, Lwin Z, Rosenthal M, Wheeler H, Koh E-S, Foote MC, Fisher L, Leonard R, Hall M, Simes J, Khasraw M. 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). Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2019. p. 2042–2042.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

May 20, 2019

Volume

37

Issue

15_suppl

Start / End Page

2042 / 2042

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences