Evidence map›Paper›PMID 33447040›Full record

ArticleBreast cancer : basic and clinical research2020

Real-World Outcomes of Treating Advanced Breast Cancer Patients With Palbociclib: A Multicenter Retrospective Cohort Study in Japan-The KBCOG-14 Study.

Nina Odan, Yuichiro Kikawa, Hajime Matsumoto, Junya Minohata, Hirofumi Suwa, Takashi Hashimoto, Toshitaka Okuno, Masaru Miyashita, Masaru Saito, Kazuhiko Yamagami and 1 more

Open access · goldAbstract read
In one paragraph

Article in Breast cancer : basic and clinical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 13% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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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

11 authors at 7 institutions in 1 country.

Nina OdanDepartment of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.ORCID https://orcid.org/0000-0002-6952-3534
Yuichiro KikawaDepartment of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.
Hajime MatsumotoDepartment of Breast Surgery and Oncology, Shinko Hospital, Kobe, Japan.
Junya MinohataDepartment of Breast Surgery, Yodogawa Christian Hospital, Osaka, Japan.
Hirofumi SuwaDepartment of Breast Surgery, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan.
Takashi HashimotoDepartment of Breast Surgery, Hashimoto Clinic, Kobe, Japan.
Toshitaka OkunoDepartment of Breast Surgery, Kobe City Nishi-Kobe Medical Center, Kobe, Japan.
Masaru MiyashitaDepartment of Breast Surgery, Konan Medical Center, Kobe, Japan.ORCID https://orcid.org/0000-0001-9463-4730
Masaru SaitoDepartment of Breast Surgery, Ikawadani Hospital, Kobe, Japan.
Kazuhiko YamagamiDepartment of Breast Surgery and Oncology, Shinko Hospital, Kobe, Japan.
Shintaro TakaoDepartment of Breast Surgery, Hyogo Cancer Center, Akashi, Japan.
Hyogo Prefectural Amagasaki General Medical Center · JPShinko Hospital · JPHashimoto Municipal Hospital · JPHyogo Prefectural Cancer Center · JPKansai Medical University · JPKobe City Nishi-Kobe Medical Center · JPYodogawa Christian Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical studies have shown that palbociclib improves progression-free survival in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) patients with advanced breast cancer (ABC). However, there are insufficient data on its use in a real-world setting in Japan. The aim of this study was to investigate the effectiveness, predictive factors, and safety of palbociclib among Japanese patients in routine clinical practice.

methodsBetween December 1, 2017, and April 30, 2019, we recruited patients from 9 hospitals and retrospectively evaluated the data on HR+/HER2- patients with ABC who received palbociclib for at least 1 week. The correlation between time-to-treatment discontinuation (TTD) and clinical background was investigated via univariate and multivariate analyses using Cox hazards models.

resultsA total of 177 women were available for analysis. Of these patients, 58 (33%) patients were treated with palbociclib with an aromatase inhibitor and 117 (66%) patients were treated with palbociclib and a selective estrogen receptor degrader. Approximately three-fourths of the patients (n = 130, 73%) received palbociclib as third- or later-line therapy. One-third of the patients had 3 or more metastatic sites (n = 59, 33%), and one-third of the patients had liver metastasis (n = 59, 33%). The median follow-up duration at the time of data cutoff was 8.9 months, the median TTD was 6.3 months, and the median overall survival was not reached. Liver metastasis (hazard ratio [HR]: 1.54 [95% confidence interval {CI}: 1.03-2.27]), high serum lactate dehydrogenase (LDH) level (>300 U/L) (HR: 2.58 [95% CI: 1.49-4.26]), and high neutrophil-to-lymphocyte ratio (NLR) (⩾3.0) (HR: 1.76 [95% CI: 1.13-2.69]) were significantly associated with shorter TTD. The most common hematologic adverse event was neutropenia, which occurred in 93% of the patients.

conclusionBased on the results of the pivotal phase 3 trials, the median TTD recorded in this study was shorter than expected. Our results suggest that liver metastasis, serum LDH level, and NLR may be predictive factors for HR+/HER2- ABC treatment outcomes.

Indexed as

Advanced breast cancerlactate dehydrogenaseneutrophil-to-lymphocyte ratiopalbociclib

Identifiers

PMID33447040
PMCPMC7780165
OpenAlexW3116253732

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.