P5-19-08: Pooled Analysis of Individual Patient Data from Capecitabine Monotherapy Clinical Trials in Anthracycline-/Taxane-Pretreated Locally Advanced or Metastatic Breast Cancer (LA/MBC).
Bibliographic record
Abstract
Abstract Background Capecitabine (C) has shown efficacy as monotherapy in anthracycline (A)-/taxane (T)-pretreated LA/MBC in phase II/III trials. Since its approval, the treatment landscape in MBC has evolved, and C has served as the combination partner and/or active comparator in trials of novel agents in pretreated MBC. This pooled analysis of clinical trial data, spanning a 12-yr period, assessed the efficacy and safety of C across treatment lines and the impact of disease characteristics on clinical outcomes with C. Methods: Individual patient (pt) data were pooled from 7 clinical trials conducted by Roche/GNE from Feb 1996-Jun 2008 where C monotherapy was the test/control regimen for pts with LA/MBC with/without prior A/T therapy. Analyses were performed on an ITT basis. Univariate and multivariate regression analyses assessed the impact of pt/disease characteristics and prior therapy on outcomes. Results: Data from 805 pts enrolled to intermittent C monotherapy were analyzed: 268 in the 1st-line metastatic setting; 537 in the ≥2nd-line metastatic setting (table). Median age: 55 yrs (range 23–90). Most pts were Caucasian (81%) with ECOG PS of 0 (55%). Baseline demographics were balanced across treatment lines. Data on A/T treatment history were available for 719 pts; 557 pts received prior A/T therapy, 176 were A-refractory, 234 T-refractory and 154 A- and T-refractory. Pooled overall response rate (ORR) was 21.0% (1.7% complete; 19.3% partial). ORR was 25.0% and 19.0% for pts treated in the 1st- and ≥2nd-line settings (OR 0.70, 95% CI: 0.5−1.0; p=0.0486). Median PFS was 126.9 days (95% CI: 119–132) in the pooled analysis, and significantly longer in pts receiving 1st- vs ≥2nd-line C: 150.0 vs 112.0 days (HR 1.45, 95% CI: 1.23−1.71; p<0.0001). Pooled median OS was 482.1 days (95% CI: 438–516). Significantly longer median OS was seen in pts receiving 1st- vs ≥2nd-line C: 666.0 vs 396.0 days (HR 1.98, 95% CI: 1.62−2.41; p<0.0001). 62 pts (8%) withdrew due to C-related AEs, which were severe in 4% of pts and life threatening in 2%. AEs of special interest occurred in 489 pts (63%); these were severe in 24% of pts and life threatening in 2%. Gastrointestinal disorders were most frequent (417 pts [53%]), and were severe or life threatening in 13% and 1% of pts. Conclusions: This pooled analysis of pt data (n=805) revealed significantly longer ORR/survival in pts receiving 1st- vs ≥2nd-line C for A-/T-pretreated MBC. Univariate and multivariate analyses are ongoing; results will be presented. Safety data were in-line with findings from phase III trials of C in MBC. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-19-08.
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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 | 0.027 | 0.026 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.008 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".