Evidence map›Paper›PMID 39507035›Full record

ArticleTranslational lung cancer research2024

Phase II study of ramucirumab and docetaxel for previously platinum-treated patients with non-small cell lung cancer and malignant pleural effusion (PLEURAM study).

Shinnosuke Takemoto, Minoru Fukuda, Ryosuke Ogata, Hiroaki Senju, Nanae Sugasaki, Katsumi Nakatomi, Hiromi Tomono, Takayuki Suyama, Eisuke Sasaki, Midori Matsuo and 12 more

Abstract read
In one paragraph

Article in Translational lung cancer research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. 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

22 authors.

Shinnosuke TakemotoDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Minoru FukudaDepartment of Respiratory Medicine, Nagasaki Genbaku Isahaya Hospital, Isahaya, Japan.
Ryosuke OgataDepartment of Respiratory Medicine, Sasebo City General Hospital, Sasebo, Japan.
Hiroaki SenjuDepartment of Internal Medicine, Senju Hospital, Sasebo, Japan.
Nanae SugasakiDepartment of Respiratory Medicine, Nagasaki Prefecture Shimabara Hospital, Shimabara, Japan.
Katsumi NakatomiDepartment of Respiratory Medicine, National Hospital Organization Ureshino Medical Center, Ureshino, Japan.
Hiromi TomonoDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Takayuki SuyamaDepartment of Internal Medicine, National Hospital Organization Nagasaki Hospital, Nagasaki, Japan.
Eisuke SasakiDepartment of Respiratory Medicine, National Hospital Organization Ureshino Medical Center, Ureshino, Japan.
Midori MatsuoDepartment of Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.
Kazumasa AkagiDepartment of Clinical Oncology Center, Nagasaki University Hospital, Nagasaki, Japan.
Fumiko HayashiDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Yosuke DotsuDepartment of Oncological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Sawana OnoDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Noritaka HondaDepartment of Respiratory Medicine, New Tokyo Hospital, Chiba, Japan.
Hirokazu TaniguchiDepartment of Clinical Oncology Center, Nagasaki University Hospital, Nagasaki, Japan.
Hiroshi GyotokuDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Takaya IkedaDepartment of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center, Omura, Japan.
Seiji NagashimaDepartment of Internal Medicine, National Hospital Organization Nagasaki Hospital, Nagasaki, Japan.
Hiroshi SodaDepartment of Respiratory Medicine, Sasebo City General Hospital, Sasebo, Japan.
Akitoshi KinoshitaDepartment of Respiratory Medicine, Nagasaki Prefecture Shimabara Hospital, Shimabara, Japan.
Hiroshi MukaeDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The prognosis of patients with lung cancer and malignant pleural effusion (MPE) caused by carcinomatous pleurisy is poor. Chemical pleurodesis is commonly performed clinically, however, often has a high failure rate. Furthermore, prolonged sustained drainage and delayed introduction of systemic chemotherapy could increase the risk of worsening the Eastern Cooperative Oncology Group Performance Status (ECOG PS) in the treatment of patients with non-small cell lung cancer (NSCLC). Therefore, both systemic and local treatments are crucial to control MPE. Ramucirumab, an antibody targeting vascular endothelial growth factor receptor 2, is expected to be effective for treatment of MPE. However, there are no data supporting this hypothesis. Herein, we performed a prospective phase II study to evaluate the efficacy and safety of ramucirumab plus docetaxel in NSCLC patients with MPE. Methods: A single-arm phase II study was conducted to elucidate the efficacy and safety of ramucirumab plus docetaxel as a combined treatment for patients NSCLC and MPE previously treated with platinum-based chemotherapy. The primary endpoint was the MPE control proportion at eight weeks after protocol treatment initiation. The secondary endpoints of the study were objective response rate (ORR), progression-free survival (PFS), one-year survival rate, overall survival (OS), and toxicity profile. Results: Between September 2019 and March 2022, 15 patients were enrolled. The pleural effusion control proportion at eight weeks was 100% [90% confidence interval (CI): 84.0-100%, and 95% CI: 78.4-100%], and the primary endpoint of this study was met. The ORR was 6.7% (95% CI: 0.2-32.0%), the median PFS was 6.3 months (95% CI: 1.9-6.9), and the median OS was 10.4 months (95% CI: 3.2-16.5). No Grade 5 or unexpected adverse events were observed. Conclusions: Ramucirumab plus docetaxel is a promising and safe treatment option for previously treated patients with NSCLC and MPE, showing a high pleural effusion control rate.

Indexed as

docetaxelmalignant pleural effusion (MPE)Non-small cell lung cancer (NSCLC)ramucirumab

Identifiers

PMID39507035
PMCPMC11535820

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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.