Phase II study of concurrent temozolomide and whole brain radiation therapy in patients with brain metastasis
Bibliographic record
Abstract
1540 Background: 30% of patients (pts) with lung cancer develop brain metastases, with XRT representing the conventional treatment of multiple BM. Methods: Pts with lung cancer, Brain metastases (BM) and performance status of 0–2 were enrolled. TMZ (75mg/m2 day 1–14) given on cycle 1 with XRT (3000cGy in 10 fractions) followed by cycles 2–4 TMZ (200mg/m2 day 1–5, q 4 weeks). Pts with active systemic disease received also chemotherapy (cisplatin or docetaxel or paclitaxel) during TMZ cycles 2–4. Primary end points: 1. Radiological response of BM assessed after 4–6 weeks from the end of XRT, 2. Treatment related toxicity, 3.Functional Scale score(FSS)(1 best, 3 worst, based on interaction of WHO performance status, score 0–4, with the neurological status score 1–3). FSS was assessed at baseline, and during the follow up visits. Secondary end points: time to progression and overall survival. Results: 22 patients enrolled, 8 pts received TMZ alone and 14 pts had additional chemotherapy. CR was documented in 2 pts, PR in 6 pts, SD in 5 pts, 4 pts progressed on treatment; 5 pts were not evaluable (death from other causes within 2 months from diagnoses). FSS at baseline was available on 19/22 patients. Of those, thirteen, four and two pts had a FSS of 1, 2 and 3, respectively. Fifteen of the 19 pts maintained their FSS at the end of Tx, with 3 pts exhibiting deterioration, and one patient improved. Post treatment FSS remained stable in 16 patients up to one month prior to death. The median survival (22 pts) from the time of diagnosis of BM was 9 months with average TTP of 3.5 months. Except for moderate nausea and vomiting there was no significant toxicity by combining TMZ with XRT. The addition of single agent chemotherapy to TMZ was well tolerated but two patients who required GCSF support. Conclusion: Adding TMZ to XRT for the treatment of BM from in lung cancer patients showed a response in 13 out of 17 assessable patients with a median survival of 9 months which is above the mean 3 to 6 months survival reported in the literature with XRT alone. More importantly, the majority of patients maintained a stable FSS up to one month prior to death suggesting a quality of life benefit during most of their life span. TMZ can be safely administered concomitantly with either XRT or with other single agent chemotherapy. No significant financial relationships to disclose.
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Non-randomized trial | low |
| gpt | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Other design | high |
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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| 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) | 0.004 | 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, unvalidatedLabeled directly by 2 models reading the full record.
The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.
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".