Evidence map›Paper›PMID 32420697›Full record

Trial reportCancer medicine2020

Palbociclib-letrozole as first-line treatment for advanced breast cancer: Updated results from a Japanese phase 2 study.

Masato Takahashi, Norikazu Masuda, Reiki Nishimura, Kenichi Inoue, Shinji Ohno, Hiroji Iwata, Satoshi Hashigaki, Yasuaki Muramatsu, Yoshiko Umeyama, Masakazu Toi

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
1.1field-weighted citation impact, top 19% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Observational
  8. Targeting collagen to optimize cancer immunotherapy.Experimental hematology & oncology · 2025
    Review
  9. Article
  10. Palbociclib as an Antitumor Drug: A License to Kill.Molecules (Basel, Switzerland) · 2024
    Review
  11. Observational
  12. Article
  13. Observational
  14. Cyclin-dependent kinase (CDK) inhibitors in solid tumors: a review of clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
    Review
  15. Review
  16. Review
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

10 authors at 7 institutions in 1 country.

Masato TakahashiNational Hospital Organization Hokkaido Cancer Center, Hokkaido, Japan.
Norikazu MasudaNational Hospital Organization Osaka National Hospital, Osaka, Japan.ORCID 0000-0002-7302-0278
Reiki NishimuraKumamoto Shinto General Hospital, Kumamoto, Japan.
Kenichi InoueSaitama Cancer Center, Saitama, Japan.
Shinji OhnoThe Cancer Institute Hospital of JFCR, Tokyo, Japan.
Hiroji IwataAichi Cancer Center Hospital, Aichi, Japan.
Satoshi HashigakiPfizer R&D Japan, Tokyo, Japan.
Yasuaki MuramatsuPfizer Japan Inc, Tokyo, Japan.
Yoshiko UmeyamaPfizer R&D Japan, Tokyo, Japan.ORCID 0000-0003-4967-0382
Masakazu ToiKyoto University Graduate School of Medicine, Kyoto, Japan.
Pfizer (Japan) · JPAichi Cancer Center · JPKyoto University · JPNational Hospital Organization Hokkaido Medical Center · JPOsaka National Hospital · JPSaitama Cancer Center · JPThe Cancer Institute Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Palbociclib is a highly selective, reversible, oral inhibitor of cyclin-dependent kinases 4 and 6 that is approved to treat hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. An open-label, single-arm, Japanese phase 2 study was conducted to investigate the efficacy and safety of palbociclib plus letrozole as first-line treatment in 42 postmenopausal patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. The probability of progression-free survival originally reported at 1 year was 75.0% (90% confidence interval, 61.3-84.4), but median progression-free survival was not attained at the primary analysis. In this report, updated efficacy and safety results with a longer follow-up period are presented. The median duration of treatment in the updated analysis was 33.0 months (range, 1.8-49.2). The probability of progression-free survival at 1 year was 75.6% (90% confidence interval, 62.4-84.7). Median progression-free survival was 35.7 months (95% confidence interval, 21.7-46.7). Objective response rate and disease control rate were 47.6% (95% confidence interval, 32.0-63.6) and 85.7% (95% confidence interval, 71.5-94.6), respectively. Common treatment-related adverse events (all grades; grade 3/4) were neutropenia (100%; 93%), leukopenia (83%; 60%), and stomatitis (76%; 0%). Treatment-related febrile neutropenia was reported in one patient. In general, no clinically meaningful deterioration in health-related quality of life was observed. Palbociclib plus letrozole remained effective and tolerable in Japanese postmenopausal patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in this updated analysis.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsFemaleHumansJapanLetrozoleMiddle AgedPiperazinesPyridinesAntineoplastic AgentsLetrozolepalbociclibPiperazinesPyridinesadvanced breast cancercyclin-dependent kinaseJapaneseletrozolepalbociclib

Identifiers

PMID32420697
PMCPMC7367628
OpenAlexW3026119116

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.