IXOA regimen, irinotecan (I), capecitabine (X), oxaliplatin (O), and bevacizumab (A), as first-line therapy for advanced unresectable colorectal cancer (aCRC): Preliminary results.
Bibliographic record
Abstract
604 Background: IXO showed acceptable toxicities and promising efficacy in a phase I/II study as 1st-line therapy for aCRC patients (pts). Combination with A might enhance the efficacy of IXO treatment. Methods: The objectives of the study were to evaluate the recommended dose (RD) of IXO regimen when used in combination with A (IXO+A), and to document safety and efficacy of the combination. Starting dose was: I 160mg/m2 IV d1, X 950mg/m2 bid PO d2-15, O 100mg/m2 IV d1, A 7.5 mg/kg iv d1, q3w. IXO regimen dose adjustments were planned in case of therapy-attributed severe toxicities. Results: 23 pts enrolled and evaluable for toxicity, 16M/7F, median age 65 years (range 28-77), PS 0/1/2 in 7/16/0, sites of disease (colon 18/rectum 5) received 288 cycles, median 8 (range 1-40). Gr.4 neutropenia and thromboembolic toxicity in the first 6 pts induced a 15% I and 20% X dose reduction, followed by another 10% I dose reduction in the following 6 pts due to diarrhea and febrile neutropenia. The adjusted regimen with reduced I 25% and X 20% from initial IXO, was considered safe for cohort expansion. Overall Gr.3+ toxicity included: 35% neutropenia, 4% febrile neutropenia, 13% leucopenia, 4% thrombopenia, 7% thromboembolic events, 44% diarrhea, 22% nausea and vomiting, 22% fatigue, 17% dehydration. Two treatment-related deaths (MI and pancolitis) were observed. Among 18 evaluable pts (2 NE, 3 too early for evaluation) response was 12 PR (up to 37 months), 5 SD and one DP. At a median follow-up of 16.5 months, 7 pts have progressed after median 15 months (range 2.5-32.1). Median PFS and OS were not reached. Conclusions: The IXO+A combination required I and X dose adjustment as compared with the initial IXO regimen, with diarrhea, neutropenia and thromboembolic events being the main toxicities. Recruitment continues in an expanded cohort at the newly identified phase II RD: I 125mg/m2, X 750mg/m2, O 100mg/m2, A 7.5 mg/kg. IXO+A shows promising efficacy and acceptable toxicity. Supported by Roche Canada.
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".