Evidence map›Paper›PMID 33276755›Full record

Trial reportBMC cancer2020

A single-arm, phase 2 study of adjuvant chemotherapy with oral tegafur-uracil for pathologically lymphovascular invasion positive stage IA non-small cell lung cancer: LOGIK0602 study.

Tomoshi Tsuchiya, Ryotaro Kamohara, Masashi Muraoka, Takeshi Nagayasu, Sho Saeki, Mitsuhiro Takenoyama, Makoto Suzuki, Kazuo Inada, Shoji Tokunaga, Tomayoshi Hayashi and 4 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2020. 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. Article
  4. Article
  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

14 authors.

Tomoshi TsuchiyaDepartment of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan. tomoshi@nagasaki-u.ac.jp.ORCID http://orcid.org/0000-0002-8419-1478
Ryotaro KamoharaDepartment of Thoracic Surgery, Oita Prefectural Hospital, Oita, Japan.
Masashi MuraokaDepartment of Thoracic Surgery, Japan Community Health care Organization Isahaya General Hospital, Isahaya, Japan.
Takeshi NagayasuDepartment of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, 852-8501, Japan.
Sho SaekiDepartment of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, Japan.
Mitsuhiro TakenoyamaDepartment of Respiratory Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Makoto SuzukiDepartment of Thoracic Surgery, Kumamoto University Hospital, Kumamoto, Japan.
Kazuo InadaDepartment of Thoracic Surgery, National Hospital Organization Omuta Hospital, Omuta, Japan.
Shoji TokunagaMedical Information Center, Kyushu University Hospital, Fukuoka, Japan.
Tomayoshi HayashiDepartment of Pathology, Nagasaki Prefecture Shimabara Hospital, Nagasaki, Japan.
Shogo UrabeDepartment of Pathology, Oita Prefectural Hospital, Oita, Japan.
Takaomi KogaDepartment of Pathology, Pathophysiological and Experimental Pathology, Fukuoka, Japan.
Shinji AkamineDepartment of Thoracic Surgery, Oita Prefectural Hospital, Oita, Japan.
Kenji SugioDepartment of Thoracic and Breast Surgery, Oita University, Oita, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLymphovascular invasion (LVI), which includes vascular or lymphatic invasions, is a representative prognostic factor even in patients with resected stage IA non-small cell lung cancer (NSCLC). Because tegafur-uracil is effective on cancers with LVI, we conducted a multi-center single-arm phase II study to estimate the efficacy of adjuvant tegafur-uracil in patients with LVI-positive stage IA NSCLC.

methodsPatients with completely resected LVI-positive stage IA NSCLC were registered. LVI was diagnosed by consensus of two of three pathologists. Adjuvant chemotherapy consisted of 2 years of oral tegafur-uracil at 250 mg/m

resultsAmong the 52 eligible patients, 36 (69.2%) completed the treatment course. There were 39 male and 13 female patients. The observation period was calculated as 562 to 3107 days using the reverse Kaplan-Meier method. The 5-year overall and relapse free survival rates were 94.2 and 88.5% respectively, which were significantly better than that of any other studies conducted on patients with LVI-positive stage IA NSCLC. Notably, the overall survival rate was 15% better than that of our prior retrospective study. The retrospective analysis of stage IA NSCLC patients who had received an operation in the same period revealed that the 5-year overall survival rate of the LVI positive group was 73.6% when adjuvant chemotherapy was not applied. Among 55 safety analysis sets, 4 cases of grade 3 hepatic function disorder (9.1%) and 5 cases of grade 2 anorexia (10.9%) were most frequently observed. No grade 4 adverse effects were encountered.

conclusionA 2-year course of oral tegafur-uracil administration is feasible and might have a significant benefit in the adjuvant treatment of LVI-positive stage IA NSCLC.

trial registrationUMIN identifier: UMIN000005921 ; Date of enrolment of the first participant to the trial: 19 June 2007; Date of registration: 5 July 2011 (retrospectively registered).

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBlood VesselsCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantCombined Modality TherapyDisease-Free SurvivalFemaleGastrointestinal DiseasesHumansKaplan-Meier EstimateLung NeoplasmsLymphatic VesselsMaleMiddle AgedNeoplasm InvasivenessProdrugsTegafurUracilAdjuvant chemotherapyLymphovascular invasionNon-small cell lung cancerPhase II studyTargeted therapyTegafur-uracil

Identifiers

PMID33276755
PMCPMC7718684

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.