Evidence map›Paper›PMID 39395258›Full record

Trial reportESMO open2024

A phase II study of daily carboplatin plus irradiation followed by durvalumab therapy for older adults (≥75 years) with unresectable III non-small-cell lung cancer and performance status of 2: NEJ039A.

A Mouri, A Kisohara, R Morita, R Ko, T Nakagawa, T Makiguchi, K Isobe, N Ishikawa, T Kondo, M Akiyama and 8 more

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. 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

18 authors.

A MouriDepartment of Respiratory Medicine, International Medical Center, Saitama Medical University, Saitama, Japan.
A KisoharaDepartment of Respiratory Medicine, Kasukabe Medical Center, Kasukabe, Japan.
R MoritaRespiratory Medicine, Akita Kousei Medical Center, Akita, Japan.
R KoDivision of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
T NakagawaDepartment of Thoracic Surgery, Omagari Kosei Medical Center, Akita, Japan.
T MakiguchiDepartment of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
K IsobeDepartment of Respiratory Medicine, Toho University School of Medicine, Tokyo, Japan.
N IshikawaDepartment of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Japan.
T KondoDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
M AkiyamaDivision of Pulmonary Medicine, Department of Internal Medicine, Iwate Medical University, Iwate, Japan.
A BesshoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
R HondaDepartment of Respiratory Medicine, Asahi General Hospital, Chiba, Japan.
K YoshimuraDepartment of Biostatsitics and Health Data Science, Nagoya City University Graduate School of Medical Science, Nagoya, Japan.
H KagamuDepartment of Respiratory Medicine, International Medical Center, Saitama Medical University, Saitama, Japan.
S KatoDepartment of Radiation Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
K KobayashiDepartment of Respiratory Medicine, International Medical Center, Saitama Medical University, Saitama, Japan.
K KairaDepartment of Respiratory Medicine, International Medical Center, Saitama Medical University, Saitama, Japan. Electronic address: kkaira1970@yahoo.co.jp.
M MaemondoDivision of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStandard care for unresectable locally advanced non-small-cell lung cancer (LA-NSCLC) involves chemoradiotherapy followed by durvalumab. The clinical significance of durvalumab after chemoradiotherapy in patients with LA-NSCLC having a performance status of 2 or aged ≥75 years, however, remains unclear. Therefore, we investigated the clinical benefit of durvalumab after daily carboplatin plus thoracic concurrent radiotherapy. PATIENTS AND

methodsIn this prospective phase II study, daily low-dose carboplatin (30 mg/m

resultsOf 86 patients who underwent chemoradiotherapy with daily carboplatin from September 2019 to October 2021, 61 (70.9%) received durvalumab consolidation. The performance status was 0, 1, and 2 in 28 (45.9%), 26 (42.6%), and 7 (11.5%) patients, respectively. The rate of therapeutic completion for durvalumab was 26.2% (16/61). The PFS rate of 12 months after durvalumab initiation was 51.0%, indicating that the primary endpoint was achieved because the expected value of 35% calculated from previous studies was exceeded. The objective response rate after chemoradiotherapy and durvalumab was 47.0% and 57.4%, respectively. The median PFS and overall survival were 12.3 and 28.1 months, respectively. The most common adverse event in grades 3 or 4 was pneumonitis (8.2%). One patient died because of interstitial pneumonitis.

conclusionsDurvalumab consolidation after daily carboplatin with radiotherapy was effective and tolerable for LA-NSCLC vulnerable patients.

Indexed as

Antibodies, MonoclonalCarboplatinCarcinoma, Non-Small-Cell LungChemoradiotherapyLung NeoplasmsAgedAged, 80 and overFemaleHumansMaleProspective StudiesAntibodies, MonoclonalCarboplatindurvalumabdurvalumablocally advanced NSCLColder adultperformance status 2

Identifiers

PMID39395258
PMCPMC11693428

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.