Evidence map›Paper›PMID 31125276›Full record

Trial reportJournal of global oncology2019

Palbociclib Plus Letrozole as First-Line Therapy in Postmenopausal Asian Women With Metastatic Breast Cancer: Results From the Phase III, Randomized PALOMA-2 Study.

Seock-Ah Im, Hirofumi Mukai, In Hae Park, Norikazu Masuda, Chikako Shimizu, Sung-Bae Kim, Young-Hyuck Im, Shoichiro Ohtani, Cynthia Huang Bartlett, Dongrui R Lu and 6 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of global oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 7 pooled it
6.8field-weighted citation impact, top 2% 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

51 citing papers in PubMed, 7 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Observational
  13. Observational
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. 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

16 authors at 11 institutions in 4 countries.

Seock-Ah ImSeoul National Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Hirofumi MukaiNational Cancer Center Hospital East, Chiba, Japan.
In Hae ParkNational Cancer Center, Gyeonggi-do, South Korea.
Norikazu MasudaNational Hospital Organization Osaka National Hospital, Osaka, Japan.
Chikako ShimizuNational Center for Global Health and Medicine, Tokyo, Japan.
Sung-Bae KimUniversity of Ulsan College of Medicine, Seoul, South Korea.
Young-Hyuck ImSungkyunkwan University School of Medicine, Seoul, South Korea.
Shoichiro OhtaniHiroshima City Hospital, Hiroshima, Japan.
Cynthia Huang BartlettPfizer, Collegeville, PA.
Dongrui R LuPfizer, La Jolla, CA.
Shrividya IyerPfizer, New York, NY.
Yuko MoriPfizer Japan, Tokyo, Japan.
Ave MoriPfizer Srl, Milan, Italy.
Eric GauthierPfizer, San Francisco, CA.
Richard S FinnDavid Geffen School of Medicine, Los Angeles, CA.
Masakazu ToiKyoto University, Kyoto, Japan.
Pfizer (United States) · USKyoto University · JPNational Cancer Center · KRNational Cancer Center Hospital East · JPNational Center for Global Health and Medicine · JPOsaka National Hospital · JPPfizer (Italy) · ITPfizer (Japan) · JPSeoul National University Hospital · KRSungkyunkwan University · KRUniversity of Ulsan · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn PALOMA-2, palbociclib plus letrozole significantly improved progression-free survival (PFS) as initial treatment of estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. We assessed the benefit of palbociclib plus letrozole in Asians. PATIENTS AND

methodsOf 666 enrolled postmenopausal women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (no prior treatment of advanced disease), 95 were Asian. Patients were randomly assigned 2:1 to receive palbociclib plus letrozole or placebo plus letrozole. The primary end point was investigator-assessed PFS. Secondary end points were overall survival, objective response, patient-reported outcomes, pharmacokinetics, and safety.

resultsMedian PFS was significantly longer in Asian patients who received palbociclib plus letrozole versus placebo plus letrozole (25.7 months [95% CI, 19.2 months to not estimable]

conclusionConsistent with the overall study population, the addition of palbociclib to letrozole significantly improved PFS in Asians. Hematologic toxicities were more frequent in Asians versus non-Asians but manageable with early dose modifications while maintaining QOL.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsFemaleHumansLetrozoleMiddle AgedNeoplasm StagingPiperazinesPostmenopausePrognosisPyridinesTreatment OutcomeLetrozolepalbociclibPiperazinesPyridines

Identifiers

PMID31125276
PMCPMC6550032
OpenAlexW2945156880

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.