Randomized trial of adjuvant equitoxic dose-escalated anthracycline (A)-containing regimen of doxorubicin, cyclophosphamide (AC) versus cyclophosphamide, methotrexate, 5-FU (CMF) for stage I-II breast cancer (BrCa): Can equitoxicity compensate for agent selection?
Bibliographic record
Abstract
818 Background: Our past data (J. Ragaz, etal; ASCO; 1989, 8: 23) showed similar outcome of BrCa cases treated with varied cumulative delivered CMF dose (low, medium, high), providing the doses were equitoxic, as judged by comparable granulocyte nadir. Other published data agree on BrCa outcome benefit of anthracyclines (ANTHR) (i.e. AC) over CMF, with cardiotoxicity the limiting factor of ANTHR in long-term. Objective: The objective of this randomized trial was to confirm if dose escalation of each drug at each visit to reach equitoxicity (as judged by granulocytes) AC and CMF regimens would reach outcome equivalence. Methods: One hundred and four stage I-II BrCa patients (pts) were randomized to four cycles each of AC or CMF (A=60, C=600 mg/m2 q 21 days) versus CMF (C=500, M=40, F=600/m2 i.v. days 1+8 q 28 days). Both groups had dose of each drug escalated to 110% or 120% if granulocytes nadir was >1500, <2000, or >2000 on the day of therapy, resp. Outcome was five year DFS%. The two treatment groups were similar on age, ER, erbB2, and nodal status. Results: No difference between AC versus CMF was seen between ages <50 versus >50 or nodal status (N-ve versus +ve). Conclusions: Our data indicate that if equitoxic, CMF and AC regimens could be equivalent, with no significant differences for subsets based on ER, erbB2, age, or nodal status. Toxicity was acceptable and will be discussed. Further studies aiming for a maximum safe escalation to achieve targeted equitoxicity may be a required prerequisite, in order: 1) To achieve maximum effectiveness within routine guideline-recommended regimens; and 2) To determine the impact of new, more costly, and toxic chemotherapeutic agents and combinations, particularly as many standard regimens may not yet have been used to their maximum potential. No significant financial relationships to disclose.
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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 | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.006 |
| Insufficient payload (model declined to judge) | 0.010 | 0.002 |
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".