Evidence map›Paper›PMID 37822699›Full record

ArticleJTO clinical and research reports2023

Docetaxel Plus Ramucirumab With Primary Prophylactic Pegylated Granulocyte-Colony Stimulating Factor Support for Elderly Patients With Advanced NSCLC: A Multicenter Prospective Single Arm Phase 2 Trial: DRAGON Study (WJOG9416L).

Motoko Tachihara, Akito Hata, Takaaki Tokito, Satoshi Hara, Hideaki Okada, Satoru Miura, Yuki Sato, Eriko Tabata, Hiroshi Watanabe, Yusuke Takayama and 7 more

Open access · goldAbstract read
In one paragraph

Article in JTO clinical and research reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 23% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
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

17 authors at 14 institutions in 1 country.

Motoko TachiharaDivision of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
Akito HataDivision of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan.
Takaaki TokitoDivision of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University, Kurume, Japan.
Satoshi HaraDepartment of Respiratory Medicine, Itami City Hospital, Itami, Japan.
Hideaki OkadaDivision of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan.
Satoru MiuraDepartment of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
Yuki SatoDepartment of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.
Eriko TabataDepartment of Respiratory Medicine, Ikeda City Hospital, Ikeda, Japan.
Hiroshi WatanabeDepartment of Respiratory Medicine, Saka General Hospital, Shiogama, Japan.
Yusuke TakayamaDepartment of Respiratory Medicine, Hiroshima Citizens Hospital, Hiroshima, Japan.
Ryo ToyozawaDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Keiichi OtaResearch Institute for Diseases of the Chest, Kyushu University Hospital, Fukuoka, Japan.
Kazushige WakudaDivision of Thoracic Oncology, Shizuoka Cancer Center, Mishima, Japan.
Atsushi NakamuraDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine Yamaguchi, Ube, Japan.
Nobuyuki YamamotoInternal Medicine III, Wakayama Medical University, Wakayama, Japan.
Kazuhiko NakagawaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
Hiroshima City Asa Citizens Hospital · JPIkeda Municipal Hospital · JPItami City Hospital · JPKindai University · JPKobe City Medical Center General Hospital · JPKobe University · JPKurume University · JPKyushu University Hospital · JPNational Hospital Organization Kyushu Cancer Center · JPNiigata Cancer Center Hospital · JPSendai Kousei Hospital · JPShizuoka Cancer Center · JPWakayama Medical University · JPYamaguchi University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Docetaxel plus ramucirumab could be a promising treatment for chemo-naive elderly patients with NSCLC, but high incidence of febrile neutropenia (FN) is a critical concern. We thus adopted a routine primary prophylactic pegylated-granulocyte-colony stimulating factor (PEG-G-CSF) to reduce FN and maximize the efficacy of docetaxel plus ramucirumab in elderly patients. Methods: This is a single arm phase 2 trial for chemo-naive elderly patients (aged ≥75 y) with advanced NSCLC. Docetaxel (60 mg/m Results: Between February 2018 and January 2021, 54 patients were enrolled. Median age was 78 (range: 75-86). A total of 21 (38.9%) partial response, 22 (40.7%) stable disease, nine (16.7%) progressive disease, and two (3.7%) not assessable were confirmed, resulting in ORR of 38.9% (90% confidence interval [CI]: 27.7%-51.0%) and disease control rate of 79.6%. Median progression-free survival and overall survival were 5.2 (95% CI: 4.2-6.9) and 12.7 (95% CI: 10.2-18.9) months, respectively. There were one (1.9%) FN, two (3.7%) bleeding grade greater than or equal to 3, and one (1.9%) treatment-related death (pneumonitis). Pneumonitis occurred in five patients (9.3%). Main adverse events grade greater than or equal to 3 were observed: four (7%) thrombocytopenia; three (5.6%) neutropenia; six (11.1%) hyposodium; five (9.3%) infection; five (9.3%) hypertension; four (7.4%) anorexia; and three (5.6%) oral mucositis. Conclusions: Docetaxel plus ramucirumab with PEG-G-CSF revealed efficacy and safety for chemo-naive elderly patients with NSCLC. Primary prophylactic PEG-G-CSF highly prevented FN.

Indexed as

DocetaxelelderlyFebrile neutropeniaNon–small cell lung cancerpegylated-granulocyte-colony stimulating factorRamucirumab

Identifiers

PMID37822699
PMCPMC10563050
OpenAlexW4386102280

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.