Quality of life (QOL) among patients (pts) with HER2+ breast cancer (bc) treated with adjuvant lapatinib and/or trastuzumab in the ALTTO study (BIG 2-06, Alliance N063D).
Bibliographic record
Abstract
647 Background: The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO; NCT00490139) study was an international randomized open-label phase III study of 2 targeted therapies for HER2+ bc. Efficacy results will be reported in a separate abstract. Methods: Pts were randomized to 1 of 4 arms with sequential or concurrent chemotherapy: (A) trastuzumab (T) for 52 weeks (w); (B) oral lapatinib (L) for 52w; (C) T for 12w followed by 6w washout followed by L for 34w; or (D) T+L for 52w. Functional Assessment of Cancer Therapy-Breast (FACT-B) and Linear Analogue Self-Assessment (LASA) items measuring overall and 5 QOL domains, fatigue, rash, and diarrhea were administered on paper at baseline, w12, w52, year 3, and year 5 in pts enrolled in ALTTO through the US NCI CTSU. Mean scores were compared using analysis of covariance and paired t-tests. Results: Among 777 pts, 607, 521, and 492 completed booklets at baseline, w12, and w52. At w12, worsening of LASA domains (overall QOL, mental, physical, social wellbeing), FACT-B Trial Outcome Index (TOI), fatigue, rash and diarrhea reached statistical significance within all arms (all p<0.05 except FACT-B TOI for arm C p=0.21). Worsening was similar across arms for these LASA domains and fatigue. Diarrhea worsening was more severe in upfront L-containing (B & D) arms compared to upfront T alone (A & C) arms (B vs A, B vs C, D vs A, D vs C p<0.001). Rash worsening was most severe in B (vs C p=0.02, vs D p=0.007, vs A p=0.10). At w52, LASA domains, fatigue, and FACT-B TOI returned to baseline levels with changes similar across arms (all p>0.05). Rash (C vs A, D vs A p<0.05) and diarrhea (B vs A, C vs A, D vs A, C vs B, D vs B p<0.05) exhibited statistically significant worsening from baseline in L-containing arms relative to A. Conclusions: While L had a larger negative impact than T on diarrhea and rash, QOL did not appear to differ across arms. Patient QOL was negatively impacted similarly across arms at w12 but returned to baseline by the end of the treatment period at w52. These data enhance the understanding of QOL impact of anti-HER2 therapy in pts with early stage bc. Long term QOL collection is ongoing. Clinical trial information: NCT00490139.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".