114612-132

Progression-free survival (PFS) and health-related quality of life (HRQoL) in AVAglio, a phase III study of bevacizumab (Bv), temozolomide (T), and radiotherapy (RT) in newly diagnosed glioblastoma (GBM).

Subcategory: 
Category: 
Central Nervous System Tumors
Session Type and Session Title: 
Oral Abstract Session, Central Nervous System Tumors
Abstract Number: 

2005^

Citation: 

J Clin Oncol 31, 2013 (suppl; abstr 2005^)

Author(s): 

Roger Henriksson, Andrew Bottomley, Warren Mason, Frank Saran, Wolfgang Wick, Ryo Nishikawa, Timothy Francis Cloughesy, Antoine F Carpentier, Khe Hoang-Xuan, Petr Kavan, Dana Cernea, Alba Ariela Brandes, Magalie Hilton, Ana Maria Abajo Guijarro, Arliene Ravelo, Oliver L. Chinot; Regional Cancer Center Stockholm; Umeå University Hospital, Stockholm/Umeå, Sweden; Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium; Princess Margaret Hospital, Toronto, ON, Canada; The Royal Marsden NHS Foundation Trust, London, United Kingdom; University of Heidelberg Medical Center, Heidelberg, Germany; Saitama Medical University International Medical Center, Saitama, Japan; University of California, Los Angeles, Los Angeles, CA; Department of Neurology, Hôpital Avicenne, AP-HP and Paris 13 University, Assistance Publique-Hopitaux de Paris, Hopital Avicenne, Bobigny and Paris, France; Assistance Publique–Hôpitaux de Paris, UPMC, CRIMC, Paris, France; Department of Oncology, McGill University, Montreal, QC, Canada; Oncology Institute, Cluj-Napoca, Romania; Medical Oncology Department, Bellaria-Maggiore Hospital, Azienda USL of Bologna, Bologna, Italy; F. Hoffmann-La Roche Ltd, Basel, Switzerland; Genentech Inc., South San Francisco, CA; Aix-Marseille University, AP-HM, Service de Neuro-Oncologie, CHU Timone, Marseille, France


Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: GBM has a high disease burden and poor prognosis, and impacts negatively on HRQoL. Symptomatic therapies for GBM, such as corticosteroids (CS), may impact patient status negatively Methods: AVAglio, a randomized, double-blind, placebo (P)-controlled trial in patients (pts) ≥18 yrs with newly diagnosed GBM, evaluated the addition of Bv or P (10mg/kg, q2w) to 6 wks of T (75mg/m2/d) + RT (2Gy, 5d/wk) followed by 28 treatment-free days, then 6 cycles of T (150–200 mg/m2/d, 5d q4w) with Bv or P (10 mg/kg, q2w), and then single-agent Bv or P (15 mg/kg, q3w) until disease progression (PD)/unacceptable toxicity. Co-primary endpoints were investigator-assessed PFS and overall survival. Secondary endpoints included HRQoL (EORTC QLQ-C30 and BN20, with 5 prespecified domains based on relevance in GBM). HRQoL time to definitive deterioration (TDD) was defined as time from randomization to ≥10 point deterioration from baseline with no subsequent improvement, PD, or death. Exploratory endpoints included KPS and CS use. Results: Baseline characteristics were well balanced. Bv significantly prolonged PFS (HR 0.64, 95% CI 0.55–0.74, p<0.0001; median 10.6 vs 6.2 mo) and delayed TDD in HRQoL compared with P (p<0.0001; Table). Functional independence (KPS ≥ 70%) was maintained during PFS in both arms (median Bv vs P: 9 vs 6 mo). Among pts on CS (≥ 2mg) at baseline, discontinuation (≥ 5 consecutive days) was more frequent with Bv than P (66% vs 47%). In pts off CS at baseline (< 2mg), time to CS initiation was significantly longer with Bv than P (HR 0.71, 95% CI 0.57–0.88; median 12.3 vs 3.7 mo). Conclusions: Addition of Bv to RT/T provided a clinically meaningful and statistically significant PFS improvement associated with stable/improved HRQoL and KPS, and reduced CS requirement. Clinical trial information: NCT00943826.

P + RT/T
(n=463
Bv + RT/T
(n=458)
HR (95% CI) P value
KM-estimated median TDD, mo <0.0001
Global health status
3.9 6.4 0.64 (0.56–0.74)
Physical functioning
4.2 6.1 0.70 (0.61–0.81)
Social functioning
4.1 7.4 (0.63 (0.55–0.73)
Motor dysfunction
5.0 8.6 0.67 (0.58–0.78)
Communication deficit
4.2 6.9 0.67 (0.58–0.77)