Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Impact of BMI in Patients With Early Hormone Receptor-Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Reporting on patient's body mass index (BMI) in recent clinical trials for patients with breast cancer: a systematic review.Breast cancer research : BCR · 2024Pooled it
- Prognostic relation of body mass index on extended aromatase inhibition treatment in postmenopausal patients with estrogen receptor positive breast cancer: A retrospective analysis of the SOLE trial.European journal of cancer (Oxford, England : 1990) · 2025Trial
- Palbociclib in adults aged 70 years and older with advanced breast cancer: A phase 2 multicenter trial (Alliance A171601).Journal of geriatric oncology · 2024Trial
- Regarding: "the impact of body mass index on the efficacy of CDK4/6 inhibitors in patients with metastatic breast cancer".Annals of medicine · 2026Article
- Effect of obesity and endocrine therapy on the prognosis of premenopausal women with HR+HER2-breast cancer: a multi-center retrospective study.Scientific reports · 2026Article
- Association Between Body Mass Index and Clinical Outcomes of CDK4/6 Inhibitors in HR+/HER2- Metastatic Breast Cancer: A Real-World Cohort Study.Journal of clinical medicine · 2026Article
- Assessing the risk of adverse drug events from combining aromatase inhibitors with CDK4/6 inhibitors using the FAERS and JADER databases.Frontiers in medicine · 2026Article
- Prescribing patterns and real-world clinical usage of adjuvant abemaciclib for early-stage, high-risk, hormone receptor-positive breast cancer.JCO oncology advances · 2026Article
- Review
- The impact of body mass index on the efficacy of CDK4/6 inhibitors in patients with metastatic breast cancer.Annals of medicine · 2025Article
- The correlation between obesity and the occurrence and development of breast cancer.European journal of medical research · 2025Review
- Steatotic liver disease in metastatic breast cancer treated with endocrine therapy and CDK4/6 inhibitor.Breast cancer research and treatment · 2025Article
- Evaluation of Dose Reduction Factors and Impact on Progression-Free Survival in Patients Treated with CDK 4/6 Inhibitors.Journal of clinical medicine · 2025Article
- Review
- Low Skeletal Muscle Radiodensity Predicts Response to CDK4/6 Inhibitors Plus Aromatase Inhibitors in Advanced Breast Cancer.Journal of cachexia, sarcopenia and muscle · 2025Article
- Efficacy and Safety of Ciprofol for Anesthesia in Painless Colonoscopy with Varying Body Mass Indices Patients: A Prospective, Single-Center, Observational Study.Drug design, development and therapy · 2025Observational
- Obesity, overweight and breast cancer: new clinical data and implications for practice.Frontiers in oncology · 2025Review
- Article
- Implications of obesity and insulin resistance for the treatment of oestrogen receptor-positive breast cancer.British journal of cancer · 2024Review
- The multifactorial effect of obesity on the effectiveness and outcomes of cancer therapies.Nature reviews. Endocrinology · 2024Review
Corrections and comments
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Authors and funding
52 authors at 20 institutions in 18 countries.
Funding
Abstract
purposeBMI affects breast cancer risk and prognosis. In contrast to cytotoxic chemotherapy, CDK4/6 inhibitors are given at a fixed dose, irrespective of BMI or weight. This preplanned analysis of the global randomized PALLAS trial investigates the impact of BMI on the side-effect profile, treatment adherence, and efficacy of palbociclib.
methodsPatients were categorized at baseline according to WHO BMI categories. Neutropenia rates were assessed with univariable and multivariable logistic regression. Time to early discontinuation of palbociclib was analyzed with Fine and Gray competing risk models. Unstratified Cox models were used to investigate the association between BMI category and time to invasive disease-free survival (iDFS). 95% CIs were derived.
resultsOf 5,698 patients included in this analysis, 68 (1.2%) were underweight, 2,082 (36.5%) normal weight, 1,818 (31.9%) overweight, and 1,730 (30.4%) obese at baseline. In the palbociclib arm, higher BMI was associated with a significant decrease in neutropenia (unadjusted odds ratio for 1-unit change, 0.93; 95% CI, 0.91 to 0.94; adjusted for age, race ethnicity, region, chemotherapy use, and Eastern Cooperative Oncology Group at baseline, 0.93; 95% CI, 0.92 to 0.95). This translated into a significant decrease in treatment discontinuation rate with higher BMI (adjusted hazard ratio [HR] for 10-unit change, 0.75; 95% CI, 0.67 to 0.83). There was no significant improvement in iDFS with the addition of palbociclib to ET in any weight category (normal weight HR, 0.84; 95% CI, 0.63 to 1.12; overweight HR, 1.10; 95% CI, 0.82 to 1.49; and obese HR, 0.95; 95% CI, 0.69 to 1.30) in this analysis early in follow-up (31 months).
conclusionThis preplanned analysis of the PALLAS trial demonstrates a significant impact of BMI on side effects, dose reductions, early treatment discontinuation, and relative dose intensity. Additional long-term follow-up will further evaluate whether BMI ultimately affects outcome.
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