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Safety, efficacy and survival of patients with primary malignant brain tumours (PMBT) in phase I (Ph1) trials: the 12-year Royal Marsden experience.

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Date
2018-08
ICR Author
Banerji, Udai
Tunariu, Nina
De Bono, Johann
Lopez, Juanita
Coleman, Niamh
Turner, Lydia
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Author
Coleman, N
Michalarea, V
Alken, S
Rihawi, K
Lopez, RP
Tunariu, N
Petruckevitch, A
Molife, LR
Banerji, U
De Bono, JS
Welsh, L
Saran, F
Lopez, J
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Type
Journal Article
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Abstract
BACKGROUND:Primary malignant brain tumours (PMBT) constitute less than 2% of all malignancies and carry a dismal prognosis. Treatment options at relapse are limited. First-in-human solid tumour studies have historically excluded patients with PMBT due to the poor prognosis, concomitant drug interactions and concerns regarding toxicities. METHODS:Retrospective data were collected on clinical and tumour characteristics of patients referred for consideration of Ph1 trials in the Royal Marsden Hospital between June 2004 and August 2016. Survival analyses were performed using the Kaplan-Meier method, Cox proportional hazards model. Chi squared test was used to measure bivariate associations between categorical variables. RESULTS:100pts with advanced PMBT were referred. At initial consultation, patients had a median ECOG PS 1, median age 48 years (range 18-70); 69% were men, 76% had glioblastoma; 68% were on AEDs, 63% required steroid therapy; median number of prior treatments was two. Median OS for patients treated on a Ph1 trials was 9.3 months (95% CI 5.9-12.9) versus 5.3 months (95% CI 4.1-6.1) for patients that did not proceed with a Ph1 trial, p = 0.0094. Steroid use, poor PS, neutrophil-to-lymphocyte ratio and treatment on a Ph1 trial were shown to independently influence OS. CONCLUSIONS:We report a survival benefit for patients with PMBT treated on Ph1 trials. Toxicity and efficacy outcomes were comparable to the general Ph1 population. In the absence of an internationally recognized standard second line treatment for patients with recurrent PMBT, more Ph1 trials should allow enrolment of patients with refractory PMBT and Ph1 trial participation should be considered at an earlier stage.
URI
https://repository.icr.ac.uk/handle/internal/1653
DOI
https://doi.org/10.1007/s11060-018-2847-z
Collections
  • Cancer Therapeutics
  • Clinical Studies
Subject
Humans
Glioma
Brain Neoplasms
Antineoplastic Agents
Treatment Outcome
Neurosurgical Procedures
Retrospective Studies
Adolescent
Adult
Aged
Middle Aged
Hospitals
Referral and Consultation
Female
Male
Young Adult
Patient Safety
Research team
Medicine (de Bono Prostate)
Molecular Addictions
Clinical Pharmacology – Adaptive Therapy
Medicine Drug Development Unit (de Bono)
Prostate Cancer Targeted Therapy Group
Language
eng
Date accepted
2018-03-25
License start date
2018-08
Citation
Journal of neuro-oncology, 2018, 139 (1), pp. 107 - 116

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