Effect of palbociclib plus letrozole on patient-reported health-related quality of life: extended follow-up of the PALOMA-2 trial
Bibliographic record
Abstract
BACKGROUND: Metastatic breast cancer (mBC) remains incurable, highlighting the importance of patient-reported outcomes (PROs) in treatment decision making. In the randomized phase III PALOMA-2 trial, health-related quality of life (HRQoL) was maintained in patients receiving first-line palbociclib plus letrozole compared with placebo plus letrozole after a median follow-up of 22.3 months. However, little is known about HRQoL for patients taking palbociclib for an extended period of time. Here, we report the PRO results from the PALOMA-2 trial after a median follow-up time of 90 months. PATIENTS AND METHODS: Women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) mBC were randomly assigned 2 : 1 to receive palbociclib plus letrozole (n = 444) or placebo plus letrozole (n = 222). HRQoL was assessed with the Functional Assessment of Cancer Therapy-Breast (FACT-B) and EuroQoL five-dimensions three-level (EQ-5D-3L) questionnaires, administered on site on day 1 of cycles 1, 2, and 3 and then every other cycle from cycle 5 until study end. Treatment arm comparisons were made for change from baseline in QoL and time to deterioration in FACT-B (definitive definition, TTDD). RESULTS: After a median follow-up of 90 months, no significant differences between treatments were observed for overall change from baseline in FACT-B total, FACT-B subscales, and EQ-5D-3L scores. While TTDD did not differ between treatment arms, TTDD was shorter for patients with disease progression versus those without disease progression (hazard ratio 0.644, P < 0.001). Individual items assessing side-effects and hair loss favored the palbociclib plus letrozole arm versus the letrozole arm; no treatment difference was observed for items assessing pain. CONCLUSIONS: This extended follow-up analysis of PROs in PALOMA-2 shows continued QoL maintenance for patients with ER+/HER2- mBC receiving long-term palbociclib plus letrozole treatment.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".