Trial reportBMC cancer2007
Impact of phase II trials with progression-free survival as end-points on survival-based phase III studies in patients with anaplastic gliomas.
Trial report in BMC cancer, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 15 citations in OpenAlex.
- Leukemia-free survival as a surrogate end point for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission.Haematologica · 2011Trial
- Phase II trial of two different irinotecan schedules with pharmacokinetic analysis in patients with recurrent glioma: North Central Cancer Treatment Group results.Journal of neuro-oncology · 2009Trial
- Clinical trial endpoints for patients with gliomas.Neuro-oncology practice · 2017Review
- Prognostic potential of initial CT changes for progression-free survival in gefitinib-treated patients with advanced adenocarcinoma of the lung: a preliminary analysis.European radiology · 2015Article
- Salvage therapy with lomustine for temozolomide refractory recurrent anaplastic astrocytoma: a retrospective study.Journal of neuro-oncology · 2015Article
- Outcomes for patients with anaplastic astrocytoma treated with chemoradiation, radiation therapy alone or radiation therapy followed by chemotherapy: a retrospective review within the era of temozolomide.Journal of neuro-oncology · 2013Article
- Combination of 6-thioguanine, capecitabine, and celecoxib with temozolomide or lomustine for recurrent high-grade glioma.Journal of neuro-oncology · 2011Article
- Article
- Using short-term response information to facilitate adaptive randomization for survival clinical trials.Statistics in medicine · 2009Article
- Suggested response criteria for phase II antitumor drug studies for neurofibromatosis type 2 related vestibular schwannoma.Journal of neuro-oncology · 2009Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo assess progression-free survival (PFS) as the appropriate end-point for phase II trials for anaplastic gliomas (AGs) and to determine the impact of PFS on survival-based phase III trials.
methodsCombined data from 16 phase II studies (N = 529 patients) were analyzed to determine progression-free survival (PFS) at 6, 9, and 12 months and the impact of age, Karnofsky performance score (KPS), number of prior chemotherapies, and response to treatment on PFS.
resultsThe specific chemotherapy used was the major effector of PFS at 6, 9, and 12 months. Age, KPS, treatment response rate, and number of prior chemotherapies did not affect PFS to the same extent. Hierarchical cluster analyses and linear least squares fitting of PFS9 v PFS12 demonstrated the existence of three therapeutic efficacy groups with PFS rates at 6, 9, and 12 months ranging from lowest (A) to highest (C). The PFS6 was 15% in group A and 41% in group C (p < .0001); the PFS12 was 9% in group A and 33% in group C (p < .0001). Further, 80% of patients at recurrence had a 23% likelihood that each chemotherapy would provide > 1 year of additional life.
conclusionBased on PFS rates at 6, 9, and 12 months for AG patients, a differential of 1.5 to 2 years is the norm and could invalidate overall survival as an end-point for phase III studies in patients with AG. PFS is a more reliable end-point because it reflects the true antitumor benefit of the chemotherapy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.