Efficacy of Gemcitabine in recurrent meningioma: A phase II study.
Bibliographic record
Abstract
e14044 Background: Systemic therapy has a limited role in meningiomas. There is in-vivo and in-vitro data that gemcitabine can potentially be useful in meningiomas. We did a phase II study with the primary objective of studying the 6-month progression-free survival (PFS) of gemcitabine in meningiomas. Methods: This was a single-arm prospective phase II study. Adult patients with recurrent meningiomas who were not eligible for local therapies with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 with normal organ and marrow function were included in this study. Patients who had received any chemotherapy within the last three weeks or on any other investigational agents were excluded. All patients received gemcitabine 1000 mg/m2 administered intravenously over 30 minutes on day 1, day 8 and day 15 every 4 weeks until disease progression or development of intolerable side effects. The response was assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. The adverse events were recorded as per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The primary objective of this study was to assess the 6-months progression-free survival (PFS). The 6-months progression-free survival (PFS) of 50% or more was considered sufficient to warrant further studies. Results: Nine patients were recruited in this study. The median age of the patient was 56 years(24-73). The m: f ratio was 2:3. All patients had undergone previous surgeries and 8 patients had undergone previous radiotherapy. The median number of cycles of gemcitabine was 3. Any grade toxicity was observed in all patients. Grade 3 and above adverse events were not observed. The two commonest adverse events noted were anaemia in 7 (77.8%) patients and vomiting in 2 (22.2) patients. The best response was stable disease (SD) in 3 patients (33.4%) and progressive disease (PD) in 6 (66.6%) patients. At a median follow up of 18.8 months, the 6-months progression-free survival (PFS) was 33.3% (95%CI 7.8-62.3). The 1-year overall survival (OS) was 66.7 % (95%CI 28.2-87.8). Conclusions: Gemcitabine failed to meet the prespecified endpoint of 6-month PFS and does not warrant any further investigation in this setting. Clinical trial information: CTRI/2019/02/017499.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".