Evidence map›Paper›PMID 37609677›Full record

Trial reportThoracic cancer2023

A randomized phase III study of docetaxel alone versus docetaxel plus S-1 in patients with previously treated non-small cell lung cancer: JMTO LC09-01.

Shinji Atagi, Takashi Daimon, Kyoichi Okishio, Kiyoshi Komuta, Yoshio Okano, Koichi Minato, Young Hak Kim, Ryo Usui, Chiharu Tabata, Atsuhisa Tamura and 1 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thoracic cancer, 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
0.3field-weighted citation impact, top 36% 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, 1 citations in OpenAlex.

  1. Trial
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 10 institutions in 1 country.

Shinji AtagiHealth Management Center, Japan Community Health care Organization Yamatokoriyama Hospital, Yamatokoriyama, Japan.ORCID 0000-0003-1876-7069
Takashi DaimonDepartment of Biostatistics, Hyogo College of Medicine, Nishinomiya, Japan.
Kyoichi OkishioDepartment of Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.
Kiyoshi KomutaInternal Medicine, Osaka Anti-Tuberculosis Association Osaka Fukujuji Hospital, Osaka, Japan.
Yoshio OkanoDepartment of Respiratory Medicine, National Hospital Organization Kochi Hospital, Kochi, Japan.
Koichi MinatoDivision of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan.
Young Hak KimDepartment of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Ryo UsuiDepartment of Respiratory Medicine, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
Chiharu TabataCancer Center, Hyogo College of Medicine, Nishinomiya, Japan.
Atsuhisa TamuraCenter for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital, Tokyo, Japan.
Masaaki KawaharaOperations Office, The Japan-Multinational Trial Organization, Nagoya, Japan.
Hyogo Medical University · JPFukujuji Hospital · JPHyogo Prefectural Cancer Center · JPJapan Community Healthcare Organization · JPKyoto University · JPNational Hospital Organization Kochi National Hospital · JPNHO Kinki Chuo Chest Medical Center · JPThe Japan-Multinational Trial Organization · JPTokyo Metropolitan Bokutoh Hospital · JPTokyo National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the efficacy and safety of the combination chemotherapy of docetaxel plus S-1 in patients with previously treated non-small cell lung cancer (NSCLC) compared to docetaxel alone.

methodsPatients with previously treated NSCLC were randomly assigned to docetaxel alone (arm A) or a combination of docetaxel and S-1 (arm B) for a maximum of four cycles. The primary endpoint was overall survival (OS).

resultsThe study was terminated early because of poor accrual. The number of patients evaluated were 74 and 77 in arm A and arm B, respectively. The median OS was 9.8 months (95% confidence interval [CI]: 6.8-15.2) and 12.3 months (95% CI: 9.2-14.5) in arms A and B, respectively. In arms A and B, the median progression-free survival was 3.5 months (95% CI: 2.7-4.0) and 4.1 months (95% CI: 3.2-4.7), respectively. No statistically significant difference was observed in OS (hazard ratio [HR]: 0.984, 95% CI: 0.682-1.419, p = 0.4569) or progression-free survival (HR: 0.823, 95% CI: 0.528-1.282, p = 0.0953). The major toxicity was myelosuppression. The incidence of grade 3 or more neutropenia was higher in arm A than in arm B (44.6% vs. 35.1%). However, the incidence of grade 3 or more febrile neutropenia and infection with neutropenia (12.2% vs. 22.1%) was more frequently observed in arm B.

conclusionsThe prematurely terminated study did not show the benefit of two cytotoxic agents over single-agent therapy for previously treated NSCLC patients.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsNeutropeniaAntineoplastic Combined Chemotherapy ProtocolsDocetaxelHumansTaxoidsTreatment OutcomeDocetaxelTaxoidsdocetaxelnon-small cell lung cancerpreviously treatedS-1

Identifiers

PMID37609677
PMCPMC10569902
OpenAlexW4386084675

What OpenQuestion holds

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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 OpenQuestion graph.