A phase 2 study of vincristine and irinotecan in metastatic diffuse anaplastic Wilms tumor: Results from the Children’s Oncology Group AREN0321 study.
Bibliographic record
Abstract
10032 Background: Patients with metastatic diffuse anaplastic histology Wilms tumor (DAWT) had an unacceptably low 4-year event-free survival (EFS) and overall survival of 33% on the National Wilms Tumor Study-5. Preclinical and clinical data showed promising antitumor activity of the camptothecins in Wilms tumor. Methods: AREN0321 evaluated the activity of vincristine (Vinc) and irinotecan (Irino) in a phase 2 window in newly-diagnosed patients with Stage IV DAWT. Patients received Vinc (1.5 mg/m2/day) intravenously (IV) on days 1 and 8, and Irino (20 mg/m2/day) IV on days 1-5 and 8-12 of a 21-day cycle. In the absence of progressive disease (PD), a second cycle was administered. Tumor responses after 2 cycles of therapy were centrally reviewed and assessed using the RECIST criteria. Patients with partial response (PR) had Vinc/Irino incorporated into a chemotherapy regimen consisting of Vinc, doxorubicin, cyclophosphamide, carboplatin, and etoposide, plus local and whole lung radiation therapy. Patients with stable disease or PD did not receive additional cycles of Vinc/Irino. A 2-stage design was used with the aim to accrue 10 patients in the first stage and continue accrual if an adequate number of responses was observed. The window study closed after other strata of AREN0321 reached their accrual targets. Results: Twenty-four patients with stage IV DAWT were enrolled from June 2006 to December 2012. Five patients did not have measurable disease and were ineligible for window therapy. Nineteen had measurable disease, 14 of whom elected to participate in the window. Of these 14 patients, 11 (79%) had PR and 3 had PD. Two of the 3 non-responders also did not achieve complete response to the other agents in the chemotherapy regimen. The most common grade 3-4 toxicities during the window were diarrhea (n=3), hypoxia (n=2), elevation of aspartate aminotransferase (n=2), hypoalbuminemia (n=2), and hyperglycemia (n=2). Conclusions: The Vinc/Irino combination was well tolerated and produced a high response rate in patients with metastatic DAWT. Its incorporation into Wilms tumor treatment regimens deserves further evaluation. Clinical trial information: NCT00335556.
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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 | 0.006 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".