Evaluation of pharmacokinetics and safety of cetuximab with cisplatin/carboplatin in patients with advanced solid tumor: Result from phase II studies
Bibliographic record
Abstract
Abstract The pharmacokinetics and potential drug–drug interactions between cetuximab and cisplatin or carboplatin from two studies (JXBA and JXBB) were evaluated. These studies were multicenter, open‐label phase II trials designed to evaluate the drug–drug interactions between cetuximab (400 mg m −2 initial dose) and cisplatin (JXBA; 100 mg m −2 ) or carboplatin (JXBB; area under the curve [AUC] = 5 mg × min mL −1 ) with or without 5‐fluorouracil (5FU) in patients with advanced solid tumors. Concentrations of cetuximab, cisplatin and carboplatin were determined using analytical methods. The safety and tolerability of cetuximab in combination with cisplatin or carboplatin was also determined in all treated patients. The JXBA study showed that cetuximab serum concentrations were similar when cetuximab was administered alone or in combination with cisplatin. The C max , t max and overall AUC for the cetuximab group (194 µg mL −1 , 2.0 hour, 14 900 µg × h mL −1 ) and the cetuximab and cisplatin combination group (192 µg mL −1 , 1.99 hour, 16 300 µg × h mL −1 ) were similar. The JXBB study showed that mean cetuximab serum concentrations were similar when cetuximab was administered alone or in combination with carboplatin. The C max , t max and overall AUC for the cetuximab group (199 µg mL −1 , 1.15 hour, 17 200 µg × h mL −1 ) and the cetuximab and carboplatin combination group (199 µg mL −1 , 3.17 h, 16 800 µg × h mL −1 ) were similar. Both studies showed that the safety profile was consistent with known side effects of cetuximab, platinum–based therapies and 5‐FU. There was no clinically relevant change in cetuximab pharmacokinetics when it was administered in combination with cisplatin or carboplatin.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".