Trial reportInternational journal of clinical oncology2019
Palbociclib in combination with letrozole in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients.
Trial report in International journal of clinical oncology, 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 32 papers, 2 of them syntheses 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
32 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Association of germlineFrontiers in pharmacology · 2026Pooled it
- CDK4/6 inhibitors plus endocrine therapy vs. placebo plus endocrine therapy for HR+/HER2- advanced breast cancer: a phase III RCTs based meta-analysis.BMC cancer · 2024Pooled it
- Phase I/II trial of palbociclib, pembrolizumab and letrozole in patients with hormone receptor-positive metastatic breast cancer.European journal of cancer (Oxford, England : 1990) · 2021Trial
- Palbociclib-letrozole as first-line treatment for advanced breast cancer: Updated results from a Japanese phase 2 study.Cancer medicine · 2020Trial
- Subgroup analysis of Japanese patients in a Phase 3 study of atezolizumab in advanced triple-negative breast cancer (IMpassion130).Japanese journal of clinical oncology · 2019Trial
- Neutropenia management with palbociclib in Japanese patients with advanced breast cancer.Breast cancer (Tokyo, Japan) · 2019Trial
- Real-world data for a CDK4/6 inhibitor, palbociclib, as 1st- or 2nd-line therapy in HR+/HER2- metastatic breast cancer: a multicenter prospective cohort study.Breast cancer research : BCR · 2026Observational
- Palbociclib in Combination with Endocrine Therapy in Patients with Metastatic Breast Cancer in a Real-World Population: Impact of Dose-Intensity, Dose Reductions and Cycle Delays on Efficacy.Current oncology (Toronto, Ont.) · 2026Article
- Pathological Complete Response after Robot-Assisted Pulmonary Resection Following CDK4/6 Inhibitor-Combined Endocrine Therapy for Endobronchial Oligometastatic Breast Cancer: A Case Report.Surgical case reports · 2026Article
- Health-related quality of life and physical activity collected via mobile application and wearable device in patients with HR +/HER2 - advanced breast cancer treated with palbociclib plus endocrine therapy or endocrine therapy alone: 6-month longitudinal study (JBCRG-26).Breast cancer (Tokyo, Japan) · 2025Observational
- Overall survival of palbociclib plus endocrine therapy in Japanese patients with HR+/HER2- advanced breast cancer in the first-or second-line setting: a multicenter observational study (P-BRIDGE study).Breast cancer (Tokyo, Japan) · 2025Observational
- 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 progression-free survival and overall survival of palbociclib plus endocrine therapy (ET) in Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in the first-line or second-line setting: an observational study.Breast cancer (Tokyo, Japan) · 2024Observational
- Clinical and Genotypic Insights Into Higher Prevalence of Palbociclib Associated Neutropenia in Asian Patients.The oncologist · 2024Article
- Association of Neutrophil-to-Lymphocyte Ratio and Absolute Lymphocyte Count With Clinical Outcomes in Advanced Breast Cancer in the MONARCH 2 Trial.The oncologist · 2024Article
- Overall survival in Japanese patients with ER+/HER2- advanced breast cancer treated with first-line palbociclib plus letrozole.Breast cancer (Tokyo, Japan) · 2024Article
- Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2-metastatic breast cancer patients: a multicenter study (YOUNGBC-28).Therapeutic advances in medical oncology · 2024Article
- Detection of high-risk patients resistant to CDK4/6 inhibitors with hormone receptor-positive HER2-negative advanced and metastatic breast cancer in Japan (KBCSG-TR-1316).Breast cancer (Tokyo, Japan) · 2023Article
- Patient characteristics, treatment patterns, and outcomes of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer patients prescribed cyclin-dependent kinase 4 and 6 inhibitors: large-scale data analysis using a Japanese claims database.Breast cancer research and treatment · 2023Observational
- Prospective Cohort Study of Palbociclib Treatment in Postmenopausal Patients With Unresectable and Metastatic Hormone Receptor-Positive Breast Cancer: Study Protocol for a CSPOR-BC Palbociclib Cohort Trial.World journal of oncology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
backgroundIn PALOMA-2, palbociclib-letrozole significantly improved progression-free survival (PFS) vs placebo-letrozole in women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer (ABC) in the first-line setting. We evaluated the efficacy, safety, and pharmacokinetics of palbociclib in Japanese women in PALOMA-2.
methodsIn this phase 3 study, 666 postmenopausal women with ER+/HER2- ABC were randomized 2:1 to palbociclib (125 mg/day [3 weeks on/1 week off]) plus letrozole (2.5 mg daily) or placebo plus letrozole. A prespecified, exploratory, subgroup analysis of Japanese patients (n = 46) was conducted to compare results with those of the overall population.
resultsAt the February 26, 2016 cutoff, median PFS among the 46 Japanese patients was 22.2 months (95%CI, 13.6‒not estimable) with palbociclib-letrozole vs 13.8 months (5.6‒22.2) with placebo-letrozole (hazard ratio, 0.59 [95%CI, 0.26-1.34]). The most common adverse events (AEs) were hematologic and more frequent among Japanese patients than the overall population (neutropenia: 93.8% [87.5% grade 3/4] vs 79.5% [66.4%]; leukopenia: 62.5% [43.8%] vs 39.0% [24.8%]); no Japanese patients had febrile neutropenia. Palbociclib dose reductions due to toxicity (mainly neutropenia) were more common in Japanese patients (62.5% vs 36.0%); few permanently discontinued due to AEs. Although mean palbociclib trough concentration was higher in Japanese patients vs non-Asians (95.4 vs 61.7 ng/mL), the range of individual values of the Japanese patients was within that of non-Asians.
conclusionsThese results from PALOMA-2 suggest that palbociclib-letrozole merits consideration as a first-line treatment option for postmenopausal Japanese patients with ER+/HER2‒ ABC. ClinicalTrials.gov: NCT01740427.
Indexed as
Identifiers
What OpenQuestion holds
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.