Quality-of-life and symptom severity in the PALLAS randomized trial of palbociclib with adjuvant endocrine therapy in early breast cancer (AFT-05, ABCSG-42, BIG-14-03, PrE0109)
Bibliographic record
Abstract
BACKGROUND: The PALLAS phase III, randomized trial investigated whether the addition of 2 years of palbociclib to adjuvant endocrine therapy (ET) improved invasive disease-free survival (iDFS) over adjuvant ET alone. This study reports the patient-reported outcomes (PROs) by treatment arm. PATIENTS AND METHODS: A total of 4688 of 5796 PALLAS patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage II-III breast cancer completed PRO measures. Patients were randomly assigned (1 : 1) to either 2 years of palbociclib (125 mg/day, 3 weeks on 1 week off) plus ongoing provider or patient-choice adjuvant ET (palbociclib + ET) versus ongoing ET alone. Eight PRO endpoints were measured serially (i.e. day 1 of each monthly cycle for the first 3 months, then every 3 months for 2 years, and once at 3 years). These endpoints were the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality-of-life (QoL) score, the Brief Fatigue Inventory (BFI) score, the modified Brief Pain Inventory (mBFI) severity and pain interference scores, the EORTC Core Quality of Life Questionaire-Breast 23 (QLQ-BR23) alopecia score, and the Breast Cancer Prevention Trial (BCPT) hot flash symptoms, vaginal problems, and musculoskeletal pain scores. Treatment with palbociclib stopped after the second interim analysis (May 2020) due to futility, and patients transitioned to follow-up. RESULTS: After adjustment for baseline covariates, on average, no significant differences between arms were observed on any of the eight endpoints over the study period. However, there were differences by treatment regimen in the worsening of symptoms over time, and by race and ethnicity. These findings have important implications for the management of symptoms in HR-positive/HER2-negative breast cancer survivors receiving endocrine and/or other therapies long term. CONCLUSIONS: No clinically significant differences in patient-reported QoL or symptom severity were found by treatment arm. However, the results of the PRO analyses may inform patient-centered communication and adherence efforts regarding treatment toxicity in subgroups of survivors.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 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".