Phase I-II study of DalCM-P [daily dalteparin (Dal), cyclophosphamide (C) and prednisone (P) and bi-weekly methotrexate (M)] as therapy for metastatic breast cancer (MBC)
Bibliographic record
Abstract
695 Background: Preclinical and clinical studies indicate that metronomic chemotherapy (dosing at close, regular intervals with no prolonged breaks) inhibits tumour growth through antiangiogenesis. Metronomic C and M have activity in MBC while Dal (‘Fragmin’) and P have anti-angiogenic activity and are synergistic. We designed a two-stage phase I-II study of DalCM-P in MBC (α=5%, β=10%, Po=5% and P1=20%). Methods: Patients with measurable MBC, adequate end-organ function and performance status, and life expectancy >6 months, who had received ≥2 types of chemotherapy for MBC, or were deemed unsuitable for standard 1st or 2nd line chemotherapy were eligible. Treatment was C 50mg and P 5mg by mouth (po) daily, M 2.5mg po twice daily Mon and Tue, and Dal 5000 IU subcutaneously daily, all given continuously. End points were specified as response rate (RR), time to progression (TTP) and overall survival (OS) using standard RECIST criteria. Results: At interim analysis (Sept 2004), 32 patients were accrued. Characteristics were: median age 56 (range 30–84); hormone receptors positive 22 (68.8%); Her-2 negative 18 (56.3%); visceral disease 24 (75.0%); ≥3 sites of metastases 8 (25.0%); disease free survival >1 year 29 (90.6%). Sixteen (50%) had no prior chemotherapy for MBC; 6 (18.8%) had 1 prior regimen; 10 (31.3%) had ≥2 prior regimens. The only ≥ grade 3 toxicities were transient grade 3 transaminitis in 8 patients (25.0%) and grade 3 vomiting in 1 (3.1%). One patient (3.1%) had complete response (CR), 4 (12.5%) had partial response (PR), 2 (6.3%) had prolonged stable disease ≥ 6 mos (PSD) for an overall response rate (CR+PR+PSD) of 7 (21.9%). Of the 16 with no prior chemotherapy for MBC, 1 had CR, 3 PR and 0 PSD (CR+PR+PSD = 4 (25%)). The median TTP was 1.8 mos (range 0.1–9.1+ mos) and median OS 18.3 mos (range 1.1–18.3+ mos). Data will be available on all 41 patients in May, 2005. Conclusions: DalCM-P is safe, well tolerated and demonstrates clinical activity in MBC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis, Biomira, Ortho-Biotech, Pfizer, Pharmacia, Roche, YM Biosciences AstraZeneca, Aventis, Eli Lilly, Novartis, Pfizer, Pharmacia, Roche, Schering AstraZeneca, Aventis
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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) | 0.003 | 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 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 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".