Vincristine, dactinomycin, cyclophosphamide (VAC) versus VAC/V plus irinotecan (VI) for intermediate-risk rhabdomyosarcoma (IRRMS): A report from the Children’s Oncology Group Soft Tissue Sarcoma Committee.
Bibliographic record
Abstract
10004 Background: The long-term event free survival (EFS) for IRRMS is 65%. Since VI had significant activity in metastatic and recurrent RMS, we tested whether adding VI to VAC would improve EFS for IRRMS. Methods: Patients (pts) with alveolar (A)RMS or incompletely resected (Group III) embryonal (E)RMS arising in an unfavorable primary site (Stage 2/3), both without distant metastases, < 50 years, and adequate organ function were eligible to be randomized to 42 weeks of VAC (V=1.5 mg/m2, A=0.045 mg/kg, C=1.2 g/m2 every 3 weeks) vs VAC/VI (I=50 mg/m2/day x 5 days) intravenously; doses were adjusted for children < 3 years; radiation therapy (36-50.4 Gy) was started at week 4, with individualized local control for children < 2 years allowed. The primary study endpoint was EFS. The study was designed with 80% power (5% 1-sided alpha level) to detect an increase in 5 yr EFS from 65% to 76%, a relative risk of 0.64. Results: 481 pts were entered between 12/2006-12/2012, with 461 confirmed eligible. Clinical features included ERMS 53%, ARMS 43%; age < 1 year 6%, 1-9 years 62%, 10+ years 32%; Group III 85%; Stage 3 61%. The most common primary tumor sites were parameningeal (44%), extremity (13%), and bladder/prostate (13%). With median follow up of 2.46 years in surviving pts, EFS and overall survival (OS) with 95% confidence intervals (CI) were similar overall and by histologic subtypes (Table). Grade 3/4 febrile neutropenia, anemia, and thrombocytopenia were less common with VAC/VI, particularly after the first 15 weeks of therapy, while diarrhea was more common with VAC/VI. Conclusions: The addition of VI to VAC did not significantly improve EFS or OS compared to VAC alone for IRRMS. The lower rate of hematologic toxicity and cumulative C dose with VAC/VI (8.4 g/m2 vs 16.8 g/m2) support the use of VAC/VI as the standard arm in future IRRMS trials. Clinical trial information: NCT00354835. Treatment n 2-year EFS (95% CI) 2-year OS (95% CI) VAC 227 64% (56%, 70%) 84% (78%, 89%) VAC/VI 234 64% (56%, 70%) 86% (80%, 90%) ERMS: VAC 118 67% (56%, 76%) 86% (76%, 92%) ERMS: VAC/VI 128 68% (58%, 76%) 89% (81%, 93%) ARMS: VAC 102 58% (48%, 69%) 81% (71%, 88%) ARMS: VAC/VI 95 57% (45%, 67%) 83% (72%, 90%)
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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) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".