Evidence map›Paper›PMID 35562327›Full record

Trial reportThoracic cancer2022

A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non-small cell lung cancer harboring EGFR mutations (JMTO LC12-01).

Kazuhiro Asami, Masahiko Ando, Takashi Nishimura, Takashi Yokoi, Atsuhisa Tamura, Koichi Minato, Masahide Mori, Fumitaka Ogushi, Akiyoshi Yamamoto, Hiroshige Yoshioka and 2 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Thoracic cancer, 2022. 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
0.6field-weighted citation impact, top 32% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

12 authors at 12 institutions in 1 country.

Kazuhiro AsamiAsami Naika Clinic, Tokyo, Japan.ORCID 0000-0002-5077-0826
Masahiko AndoDepartment of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.
Takashi NishimuraDepartment of Respiratory Medicine, Kyoto Katsura Hospital, Kyoto, Japan.
Takashi YokoiDepartment of Thoracic Oncology, Hyogo College of Medicine, Hyogo, Japan.
Atsuhisa TamuraDepartment of Center for Pulmonary Diseases, Tokyo National Hospital, Tokyo, Japan.
Koichi MinatoDepartment of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma, Japan.
Masahide MoriDepartment of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan.
Fumitaka OgushiDepartment of Respiratory Medicine, Kochi National Hospital, Kochi, Japan.ORCID 0000-0003-3525-3457
Akiyoshi YamamotoDepartment of Respiratory Medicine, Takamatsu Red Cross Hospital, Kagawa, Japan.
Hiroshige YoshiokaDepartment of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan.
Masaaki KawaharaDepartment of Respiratory Medicine, KKR Otemae Hospital, Osaka, Japan.
Shinji AtagiDepartment of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
Gunma Prefectural Cardiovascular Center · JPHyogo Medical University · JPKansai Medical University · JPKyoto Katsura Hospital · JPMinamiaoyama Eye Clinic · JPNagoya University Hospital · JPNational Hospital Organization Kochi National Hospital · JPNHO Kinki Chuo Chest Medical Center · JPOtemae Hospital · JPTakamatsu Red Cross Hospital · JPTokyo National Hospital · JPToneyama National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGefitinib (G) is a recommended molecular-targeted agent for elderly patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). Docetaxel (Doc) and pemetrexed (Pem) have similar efficacies, and either is often used as the sole agent during treatment. The efficacy of continuing G after progressive disease (PD) develops has been reported. It remains unclear whether the continuation of G in combination with a single cytotoxic agent beyond PD is beneficial for elderly patients. Here, we conducted a randomized phase II study to assess the efficacy and safety of cytotoxic chemotherapy with G for elderly patients with progressive EGFR-mutant NSCLC.

methodsElderly patients with EGFR-mutant NSCLC with PD previously treated with G were enrolled. Patients received Pem 500 mg/m or Doc 60 mg/m every 21 days and were randomly assigned to receive chemotherapy with 250 mg G (G+ Doc/Pem arm) or without G (Doc/Pem arm) until further disease progression or unacceptable toxicity.

resultsThis trial was terminated early owing to slow accrual. A group of 22 patients underwent analysis. The primary endpoint, progression-free survival (PFS), was significantly longer in the G + Doc/Pem arm (median: 1.6 months vs. 5.6 months, hazard ratio = 0.40, 95% CI: 0.16-0.99, p = 0.0391). Adverse events ≥ grade 3 were more frequent in the G + Doc/Pem arm (45.5% vs. 90.9%, p = 0.032).

conclusionsPatients on G and Pem or Doc beyond PD showed a longer PFS than those on single-agent chemotherapy; however, it was associated with increased toxicity.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungLung NeoplasmsAgedDisease ProgressionDocetaxelErbB ReceptorsGefitinibHumansMutationPemetrexedDocetaxelEGFR protein, humanErbB ReceptorsGefitinibPemetrexedchemotherapyelderlyepidermal growth factor receptor mutationgefitinibnon-small cell lung cancer

Identifiers

PMID35562327
PMCPMC9200881
OpenAlexW4280571102

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Registered trials

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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.