Outcomes and Prognostic Factors in Recurrent Glioma Patients Enrolled Onto Phase II Clinical Trials
Abstract
PURPOSE: To determine aggregate outcomes and prognostic covariates in patients with recurrent glioma enrolled onto phase II chemotherapy trials. PATIENTS AND METHODS: Patients from eight consecutive phase II trials included 225 with recurrent glioblastoma multiforme (GBM) and 150 with recurrent anaplastic astrocytoma (AA). Their median age was 45 years (range, 15 to 82 years) and their median Karnofsky performance score was 80 (range, 60 to 100). Prognostic covariates were analyzed with respect to tumor response, progression-free survival (PFS), and overall survival (OS) by multivariate logistic and Cox proportional hazards regression analyses. RESULTS: Overall, 34 (9%) had complete or partial response, whereas 80 (21%) were alive and progression-free at 6 months (APF6). The median PFS was 10 weeks and median OS was 30 weeks. Histology was a robust prognostic factor across all outcomes. GBM patients had significantly poorer outcomes than AA patients. The APF6 proportion was 15% for GBM and 31% for AA, whereas the median PFS was 9 weeks for GBM and 13 weeks for AA. Results were also significantly poorer for patients with more than two prior surgeries or chemotherapy regimens. CONCLUSION: Histology is a dominant factor in determining outcome in patients with recurrent glioma enrolled onto phase II trials. Future trials should be designed with separate histology strata.
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The average historical PFS6 based on the above studies is 15.3 ± 3.8%.
“The average historical PFS6 based on the above studies is 15.3 ± 3.8%”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [10]
The average historical TTP is 9.5 ± 1.6 weeks.
“and the average historical TTP is 9.5 ± 1.6 weeks.”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [10]
The average historical OS is 29.3 ± 6 weeks.
“OS averaged 29.3 ± 6 weeks (see SI Table 2).”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [10]
Efficacy analysis was performed for 10 recurrent GBM patients by comparing TTP, PFS6, and OS in recurrent GBM patients treated with the NovoTTF-100A device with the TTP, PFS6, and OS of recurrent GBM patients in a literature based historical control group.
“Efficacy analysis was performed for 10 recurrent GBM patients by comparing TTP, PFS6, and OS in recurrent GBM patients treated with the NovoTTF-100A device with the TTP, PFS6, and OS of recurrent GBM patients in a literature based historical control group (10, 25–28).”
From Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors (2007) · cites this paper as [10]
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- Authors
- Wong, E. T., Hess, K. R., Gleason, M. J., Jaeckle, K. A., Kyritsis, A. P., Prados, M. D., Levin, V. A., & Yung, W. K. A.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 1999-08
- Volume
- 17
- Issue
- 8
- Pages
- 2572-2572
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W1858161324
- Cited by
- 902
- References
- 24
- Citations by year
- 2026: 7 · 2025: 2 · 2024: 11 · 2023: 24 · 2022: 14 · 2021: 18 · 2020: 17 · 2019: 26 · 2018: 26 · 2017: 31 · 2016: 43 · 2015: 46 · 2014: 49 · 2013: 47 · 2012: 67
- FWCI
- 7.88
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (1r01ca055621-01, 5u01ca062431-04)
- National Cancer Institute (U01CA062412, CA62431, CA62412, CA55621)
- Topics
- Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Keywords
- recurrent glioma, glioblastoma, anaplastic astrocytoma, prognostic factors, histology, progression-free survival, overall survival, tumor response, prior chemotherapy, prior surgery, trial design
- MeSH terms
- Adolescent, Adult, Antineoplastic Combined Chemotherapy Protocols, Astrocytoma, Brain Neoplasms, Glioblastoma, Humans, Middle Aged, Neoplasm Recurrence, Local, Probability, Prognosis, Logistic Models, Proportional Hazards Models, Salvage Therapy, Treatment Outcome, Karnofsky Performance Status
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