Evidence map›Paper›PMID 34076966›Full record

Trial reportThoracic cancer2021

Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401).

Hisashi Tanaka, Yukihiro Hasegawa, Yuka Fujita, Atsushi Nakamura, Eiki Kikuchi, Yasutaka Kawai, Toshiyuki Harada, Naomi Watanabe, Hiroshi Yokouchi, Kazuhiro Usui and 10 more

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

Trial report in Thoracic cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Review
  3. 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

20 authors at 17 institutions in 2 countries.

Hisashi TanakaDepartment of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.ORCID 0000-0003-2009-0210
Yukihiro HasegawaDepartment of Respiratory Medicine, Aomori Prefectural Central Hospital, Aomori, Japan.
Yuka FujitaDepartment of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.
Atsushi NakamuraDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Eiki KikuchiFirst Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.
Yasutaka KawaiDepartment of Respiratory Medicine, Oji General Hospital, Tomakomai, Japan.
Toshiyuki HaradaDepartment of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan.
Naomi WatanabeDepartment of Respiratory Medicine, Sunagawa City Medical Center, Sunagawa, Japan.
Hiroshi YokouchiDepartment of Pulmonary Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.
Kazuhiro UsuiDivision of Respirology, NTT Medical Center Tokyo, Tokyo, Japan.
Ryota SaitoDepartment of Respiratory Medicine, Tohoku University School of Medicine, Sendai, Japan.
Hiroshi WatanabeDepartment of Respiratory Medicine, Saka General Hospital, Shiogama, Japan.
Tomomi MasudaDepartment of Respiratory Medicine, Gunma University, Maebashi, Japan.
Tatsuro FukuharaDepartment of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.
Keita KudoDepartment of Medical Oncology and Respiratory Medicine, National Hospital Organization Osaka Minami Medical Center, Osaka, Japan.
Ryoichi HondaDepartment of Respiratory Medicine, Asahi General Hospital, Chiba, Japan.
Satoshi OizimiFirst Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.
Makoto MaemondoDivision of Pulmonary Medicine, Allergy, and Rheumatology, Iwate Medical University Faculty of Medicine Graduate School of Medicine Morioka, Iwate, Japan.
Akira InoueDepartment of Palliative Medicine, Tohoku University School of Medicine, Sendai, Japan.
Naoto MorikawaDivision of Pulmonary Medicine, Allergy, and Rheumatology, Iwate Medical University Faculty of Medicine Graduate School of Medicine Morioka, Iwate, Japan.
Hokkaido University · JPIwate Medical University · JPTohoku University · JPAomori Prefectural Central Hospital · JPAsahi General Hospital · JPAsahikawa Medical University · JPFukushima Medical University · JPGeneral Hospital of Drama · GRGunma University · JPHirosaki University · JPHokkaido hospital · JPMiyagi Prefectural Hospital Organization · JPNTT Medical Center · JPOji General Hospital · JPOsaka Minami Medical Center · JPSendai Kousei Hospital · JPSunagawa City Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA cisplatin plus irinotecan (CPT-11) regimen is used for patients with extensive disease small cell lung cancer (ED-SCLC). Amrubicin (AMR) is primarily used for relapsed SCLC. The HOT1401/NJLCG1401 trial, an open-label randomized phase II trial, was designed to assess the benefit of maintenance therapy in patients with ED-SCLC who responded to induction therapy.

methodsPatients with histologically- or cytologically-confirmed ED-SCLC were included and were treated with an induction therapy of four cycles of cisplatin (60 mg/m

resultsA total of 34 patients were enrolled; 20 patients had progressive disease or received incomplete induction chemotherapy. Finally, 14 patients were randomly assigned to receive CPT-11 (n = 7) or AMR (n = 7). This study was terminated prematurely because of low patient accrual. The overall objective response rate was 73%, the median PFS was 5.7 months (95% confidence interval [CI]: 3.6-11.8), and the median overall survival was 20.1 months (95% CI: 13.7-not reached). No statistically significant difference in progression-free survival (PFS) were noted between patients treated with CPT-11 and those treated with AMR. There were no treatment-related deaths in this study.

conclusionsMaintenance therapy with CPT-11 or AMR after induction therapy might be effective in some patients.

Indexed as

Induction ChemotherapyAdultAgedAnthracyclinesAntineoplastic AgentsCisplatinDrug Therapy, CombinationFemaleHumansIrinotecanLung NeoplasmsMaleMiddle AgedProspective StudiesSmall Cell Lung CarcinomaTopoisomerase I InhibitorsamrubicinAnthracyclinesAntineoplastic AgentsCisplatinIrinotecanTopoisomerase I Inhibitorsamrubicincisplatinirinotecanmaintenancesmall-cell lung cancer

Identifiers

PMID34076966
PMCPMC8287008
OpenAlexW3164812996

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.