Evidence map›Paper›PMID 32385918›Full record

Trial reportThe oncologist2020

Randomized Phase II Study of First-Line Biweekly Gemcitabine and Carboplatin Versus Biweekly Gemcitabine and Carboplatin plus Maintenance Gemcitabine in Elderly Patients with Untreated Non-Small Cell Lung Cancer: LOGIK0801.

Koichi Takayama, Masafumi Takeshita, Koji Inoue, Masao Ichiki, Masaki Fujita, Taishi Harada, Yoshimasa Shiraishi, Hiroshi Wataya, Shoji Tokunaga, Tadaaki Yamada and 2 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 93% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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 9 institutions in 1 country.

Koichi TakayamaDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Masafumi TakeshitaDepartment of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
Koji InoueDepartment of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
Masao IchikiDepartment of Respirology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Masaki FujitaDepartment of Respiratory Medicine, Fukuoka University Hospital, Fukuoka, Japan.
Taishi HaradaDepartment of Respiratory Medicine, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.
Yoshimasa ShiraishiResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Hiroshi WatayaDivision of Internal Medicine, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Shoji TokunagaMedical Information Center, Kyushu University Hospital, Fukuoka, Japan.
Tadaaki YamadaDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Junji UchinoDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kenji SugioDepartment of Thoracic and Breast Surgery, Oita University, Faculty of Medicine, Oita, Japan.
Kitakyushu Municipal Medical Center · JPKyoto Prefectural University of Medicine · JPKyushu University · JPFukuoka University Hospital · JPJapan Community Healthcare Organization · JPKyushu University Hospital · JPNational Kyushu Medical Center · JPOita University · JPSaiseikai Fukuoka General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedThe usefulness of maintenance gemcitabine (GEM) after biweekly carboplatin + GEM in elderly patients with non-small cell lung cancer could not be proved. Superior overall survival was obtained in the group that did not receive maintenance therapy.

backgroundThe primary objective of this randomized phase II study was to assess progression-free survival (PFS) in elderly patients with advanced non-small cell lung cancer (NSCLC) treated with gemcitabine (GEM) maintenance therapy versus best supportive care following first-line GEM plus carboplatin (CBDCA).

methodsElderly chemotherapy-naive patients with stage IIIB or IV NSCLC were randomly assigned 1:1 to the control arm or the study arm. All patients received biweekly combination therapy with GEM and CBDCA (1,000 mg/m

resultsEighty-four patients were enrolled. The objective response rates (ORRs) were 17.5% in the control arm and 14.0% in the study arm. The most common toxicity was neutropenia (control arm: 47.5% and study arm: 69.8%). The median progression-free survivals were 4.99 months (control arm) and 4.44 months (study arm), and the median overall survivals (OSs) were 21.7 months (control arm) and 8.2 months (study arm).

conclusionOur data do not support maintenance GEM after biweekly CBDCA+GEM in elderly patients with NSCLC.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDeoxycytidineGemcitabineHumansTreatment OutcomeCarboplatinDeoxycytidineGemcitabine

Identifiers

PMID32385918
PMCPMC7418367
OpenAlexW3023789067

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.