Evidence map›Paper›PMID 37882974›Full record

ArticleBreast cancer (Tokyo, Japan)2024

Overall survival in Japanese patients with ER+/HER2- advanced breast cancer treated with first-line palbociclib plus letrozole.

Masato Takahashi, Tomofumi Osako, Hiroyuki Yasojima, Kenichi Inoue, Masahiro Kawashima, Hideki Maeda, Akemi Ichikawa, Yasuaki Muramatsu, Norikazu Masuda

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Breast cancer (Tokyo, Japan), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04735367 (Retrospective, Multicenter, Observational Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 20% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04735367 completednot on this map

Retrospective, Multicenter, Observational Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole

TypeobservationalSponsorPfizerRan2021 to 2023Enrolled42ConditionsBreast CancerArmspalbociclib plus letrozole
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 1 country.

Masato TakahashiBreast Surgery, Hokkaido University Hospital, Sapporo, Japan. masato.takahashi0725@gmail.com.
Tomofumi OsakoBreast Center, Kumamoto Shinto General Hospital, Kumamoto, Japan.
Hiroyuki YasojimaDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Kenichi InoueDivision of Breast Oncology, Saitama Cancer Center, Saitama, Japan.
Masahiro KawashimaDepartment of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Hideki MaedaDepartment of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
Akemi IchikawaMedical Affairs, Pfizer Japan Inc., Tokyo, Japan.
Yasuaki MuramatsuMedical Affairs, Pfizer Japan Inc., Tokyo, Japan.
Norikazu MasudaDepartment of Breast and Endocrine Surgery, Graduate School of Medicine, Nagoya University, Nagoya, Japan.
Pfizer (Japan) · JPHokkaido University Hospital · JPKumamoto City Hospital · JPKyoto University · JPNagoya University · JPNational Hospital Organization Hokkaido Medical Center · JPOsaka National Hospital · JPSaitama Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn open-label, single-arm, Japanese phase 2 study (J-Ph2) investigated the efficacy and safety of first-line (1L) palbociclib (PAL) + letrozole (LET) in postmenopausal Japanese women with ER+/HER2- advanced breast cancer (ABC). In the final analysis, median progression-free survival was 35.7 months (95% CI 21.7-46.7); but overall survival (OS) data were immature. Here, we report the findings from a follow-up study of J-Ph2 (NCT04735367) evaluating OS and subsequent therapy in these Japanese women.

methodsPatients (N = 42) who participated in J-Ph2 were enrolled in the OS follow-up study. The primary endpoint was OS and secondary endpoints included type and duration of subsequent therapy.

resultsPatients were a median age of 62.5 years; 48% had visceral metastases. At a median follow-up of 89.7 months, the median OS was 85.4 months (95% CI 64.3-not estimable). Median OS was longer in patients with nonvisceral versus visceral metastases (not reached vs 67.3 months), or with treatment-free interval > 12 months versus ≤ 12 months (85.4 vs 45.4 months), or with treatment duration ≥ 24 months versus < 24 months (not reached vs 47.5 months). Of patients who received a first subsequent therapy (81%), most (67%) continued endocrine-based therapy, while 7% received chemotherapy. The median duration of the first subsequent therapy was 8.3 months (95% CI 3.9-12.2), and the median chemotherapy-free survival was 69.1 months (95% CI 24.2-85.4).

conclusionsIn this population of Japanese women with ER+/HER2- ABC, median OS was over 7 years with 1L PAL + LET, supporting the use of 1L PAL + endocrine therapy. TRIAL NUMBER: NCT04735367.

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansJapanLetrozoleMiddle AgedPiperazinesPyridinesErb-b2 Receptor Tyrosine KinasesLetrozolepalbociclibPiperazinesPyridinesBreast cancerER+/HER2−JapanOverall survivalPalbociclib

Identifiers

PMID37882974
PMCPMC10764519
OpenAlexW4387949651

What OpenQuestion holds

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LicenceCC BY
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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.