A phase II study of neoadjuvant irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) for resectable liver metastases from colorectal cancer
Bibliographic record
Abstract
3662 Background: Perioperative chemotherapy may potentially improve survival in patients undergoing resection of colorectal liver metastases. Neoadjuvant chemotherapy has several potential advantages: it provides in vivo chemosensitivity data; it may help select patients with occult extrahepatic disease (averting unnecessary metastasectomy); and it expedites systemic therapy for micrometastases. Methods: We have initiated a phase II trial in which patients with resectable liver metastases receive CPT-11 (180 mg/m2, on day 1) with 5-FU (400 mg/m2 bolus + 600 mg/m2 by 22 hour infusion) and LV (200 mg/m2) on days 1 and 2, every two weeks for 6 cycles. Hepatic metastasectomy was performed unless extrahepatic disease appeared. Postoperatively, patients with stable or responsive disease receive the same regimen for 12 cycles. Patients with progressive disease receive either second-line chemotherapy or best supportive care. The primary endpoint is survival; secondary endpoints include response, safety, feasibility and quality of life. Results: Since January 2002, 29 patients have been accrued. Median age is 57 years (range 44 - 69); median number of metastases is 2 (range 1 - 10); 16 patients (55%) presented with synchronous metastases. The neoadjuvant phase has been completed in 27 patients. The preoperative response rates are: 1 CR (4%), 10 PR (37%), 10 SD (37%), and 5 PD (19%). During preoperative chemotherapy, 6 patients (22%) had grade 3/4 toxicities. Resection was not possible in 5 patients, due to the appearance of extrahepatic disease (3), clinical deterioration (1), or refusal (1). One patient died of arrhythmia following surgery, and 1 patient had liver failure. Postoperative CPT-11, 5-FU and LV has been given to 13 patients so far. During this treatment phase, 5 patients (38%) had grade 3/4 toxicities; 9 patients (69%) received all prescribed cycles. Conclusions: A 3 month course of chemotherapy prior to hepatic metastasectomy is safe and well tolerated. Response can consequently be assessed and postoperative treatment can be directed. Further accrual and follow-up will be necessary to assess the overall safety of this regimen, as well as impact on survival. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Pfizer Canada Pfizer 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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| 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".