ATCT-12RESULTS OF NRG ONCOLOGY/RTOG 9813- A PHASE III RANDOMIZED STUDY OF RADIATION THERAPY (RT) AND TEMOZOLOMIDE (TMZ) VERSUS RT AND NITROSOUREA (NU) THERAPY FOR ANAPLASTIC ASTROCYTOMA (AA)
Bibliographic record
Abstract
BACKGROUND: The primary objective of this study was to compare overall survival (OS) of patients with AA treated with RT and either TMZ or NU. Secondary endpoints: time to tumor progression (TTP), toxicities of the regimens and molecular analyses. METHODS: Eligibility criteria: age ≥18 years; central review of AA; KPS ≥60. Patients were randomized 1:1 to RT 59.4 Gy with TMZ versus NU (BCNU or CCNU). An estimated increase from 3 to 4.5 years on the median survival time (MST) would require a sample size of 216 patients per arm (power = 90% with a one-sided alpha = 0.05). RESULTS: Because accrual goals were not met, the trial was closed in 2007. From 2002-2007, 196 eligible patients were randomized, 97 (RT + TMZ) and 99 (RT + NU). Stratification factors were balanced between the 2 arms. 65% of patients have died at the time of this report. Median follow-up time for patients still alive was 9.1 years (1.9-11.6 years). There was no difference in OS between the RT + TMZ and the RT + NU arm (MST 3.9 versus 3.8 years; p-value = 0.37). The differences in PFS and TTP between the 2 arms were not statistically significant. The RT + NU arm had a significantly higher rate of worse overall grade ≥3 toxicity (75.8% versus 47.9%; p-value < .001), related to bone marrow toxicity. Of the 196 patients, 111 were tested for IDH status, 60 (RT + TMZ) and 51 (RT + NU). 54 patients were IDH negative and 49 were IDH positive with a better OS in IDH positive patients (MST 7.9 versus 2.8 years; p-value = 0.006, HR = 0.51; 95% CI: 0.31-0.83). CONCLUSIONS: RT + TMZ did not appear to significantly improve OS or TTP for AA compared with RT+ NU. RT + TMZ was better tolerated. IDH mutation was associated with better survival outcome. Clinical trial information: NCT00004259. Supported by National Cancer Institute grants U10CA21661, U10CA180868, U10CA180822 and U10CA37422 and Merck & Co.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.012 | 0.002 |
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".