Trial reportThe oncologist2019
Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial.
Trial report in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01740427 (A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
A randomized, multicenter, double-blind phase 3 study of pd-0332991 (oral cdk 4/6 inhibitor) plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with er (+), her2 (-) breast cancer who have not received any prior systemic anti cancer treatment for advanced disease
Who cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 93 citations in OpenAlex.
- Association of germlineFrontiers in pharmacology · 2026Pooled it
- Trial
- Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies.Breast cancer research : BCR · 2020Trial
- Crossing the toxicity threshold: a repeated landmark analysis of early toxicities and treatment modification during first-line CDK4/6 inhibitor therapy.Cancer chemotherapy and pharmacology · 2026Article
- Genetic Variation inInternational journal of molecular sciences · 2026Article
- Prediction of dose reductions and impact of reduced starting doses of CDK4/6i on effectiveness in HR-positive/HER2-negative metastatic breast cancer: Real-world data from the OPAL registry.International journal of cancer · 2026Observational
- Predictive Role of Serum Inflammatory Markers in Metastatic Luminal A/B Breast Cancers Receiving CDK-4/6 Inhibitors Therapy.Immunity, inflammation and disease · 2026Article
- Observational
- Comparative safety signal prioritization of CDK4/6 inhibitors in breast cancer: a FAERS pharmacovigilance, machine learning, and clinical contextualization study.Frontiers in pharmacology · 2026Article
- Palbociclib in endocrine-resistant metastatic breast cancer patients: gene polymorphism- based study.Pharmacological reports : PR · 2025Article
- Review
- From controversy to clarity: reimagining the role of CDK4/6 inhibitors in the adjuvant setting- a number needed to treat perspective.Journal of cancer research and clinical oncology · 2025Article
- CDK4/6 inhibitor plus endocrine therapy for advanced breast cancer: results from a web-based survey in Japan.Future oncology (London, England) · 2025Article
- Real-World Outcomes of First-Line Palbociclib Plus Endocrine Therapy for HR+/HER2- Metastatic Breast Cancer in Japan: A Single-Center Retrospective Study.Oncology research · 2025Article
- Timing of Dose Reductions and Survival Outcomes in Metastatic Breast Cancer Patients Treated with Cyclin-Dependent Kinase 4/6 Inhibitors.Current oncology (Toronto, Ont.) · 2024Article
- Overall survival after CDK4/6 inhibitor dose reduction in women with metastatic breast cancer.BJC reports · 2024Article
- Strategy of combining CDK4/6 inhibitors with other therapies and mechanisms of resistance.International journal of clinical and experimental pathology · 2024Review
- Article
- Cyclin-dependent kinase 4/6 inhibitor-associated thromboembolism: a critical evaluation of the current evidence.Journal of thrombosis and haemostasis : JTH · 2023Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPALOMA-2 confirmed that first-line palbociclib + letrozole improved progression-free survival (hazard ratio, 0.58; 95% confidence interval, 0.46-0.72) in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). This analysis evaluated palbociclib-associated hematologic adverse events (AEs) and provides insight on managing these AEs. MATERIALS AND
methodsPostmenopausal women with ER+/HER2- ABC were randomly assigned 2:1 to letrozole (2.5 mg daily continuously) plus oral palbociclib (125 mg daily; 3 weeks on/1 week off) or placebo. Safety assessments were performed at baseline, days 1 and 15 (first two cycles) and day 1 of subsequent cycles, and included white blood cell, platelet, and absolute neutrophil count (ANC).
resultsPALOMA-2 randomized 666 women to palbociclib + letrozole (
conclusionPalbociclib + letrozole was generally well tolerated. Neutropenia, the most frequently reported AE in women with ER+/HER2- ABC, was mostly transient and manageable by dose modifications in patients who experienced grade ≥ 3 neutropenia, without appearing to compromise efficacy. (Pfizer; NCT01740427) IMPLICATIONS FOR PRACTICE: Palbociclib demonstrated an acceptable safety profile in PALOMA-2 in women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) receiving first-line palbociclib + letrozole. Although hematologic adverse events (AEs) are typically expected with anticancer therapies and are often clinically significant, palbociclib-related hematologic AEs, particularly neutropenia (most frequent AE), were transient/manageable by dose reduction, interruption, or cycle delay, which is in contrast to the more profound neutropenia associated with chemotherapy. Palbociclib dose adjustments decreased hematologic AE severity without appearing to compromise efficacy, supporting palbociclib + letrozole as a first-line treatment for ER+/HER2- ABC.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.