Evidence map›Paper›PMID 27274999›Full record

Trial reportJournal of immunology research2016

Randomized Phase II Study of Docetaxel plus Personalized Peptide Vaccination versus Docetaxel plus Placebo for Patients with Previously Treated Advanced Wild Type EGFR Non-Small-Cell Lung Cancer.

Koichi Takayama, Shunichi Sugawara, Yasuo Saijo, Makoto Maemondo, Atsushi Sato, Shinzo Takamori, Taishi Harada, Tetsuro Sasada, Tatsuyuki Kakuma, Junji Kishimoto and 4 more

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

Trial report in Journal of immunology research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 21% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Therapeutic vaccines for advanced non-small cell lung cancer.The Cochrane database of systematic reviews · 2024
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  8. Tumor neoantigens and tumor immunotherapies.Aging medicine (Milton (N.S.W)) · 2024
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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 at 8 institutions in 1 country.

Koichi TakayamaDepartment of Respirology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Shunichi SugawaraSendai Kousei Hospital, Sendai, Japan.
Yasuo SaijoDepartment of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Makoto MaemondoDepartment of Respiratory Medicine, Miyagi Cancer Center, Miyagi, Japan.
Atsushi SatoDepartment of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Shinzo TakamoriDepartment of Surgery, Kurume University School of Medicine, Kurume, Japan.
Taishi HaradaResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tetsuro SasadaKanagawa Cancer Center Research Institute, Yokohama, Japan.
Tatsuyuki KakumaBiostatistics Center, School of Medicine, Kurume University, Kurume, Japan.
Junji KishimotoCenter for Clinical and Translational Research, Kyushu University, Fukuoka, Japan.
Akira YamadaCancer Vaccine Development Division, Kurume University Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan.
Masanori NoguchiDivision of Clinical Research, Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan.
Kyogo ItohCancer Vaccine Center, Kurume University School of Medicine, Kurume, Japan.
Yoichi NakanishiResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kurume University · JPKyushu University · JPHirosaki University · JPKanagawa Prefectural Hospital Organization · JPKyoto Prefectural University of Medicine · JPMiyagi Prefectural Hospital Organization · JPNiigata University · JPSendai Kousei Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives. To evaluate the efficacy and safety of personalized peptide vaccination (PPV) combined with chemotherapy for patients with previously treated advanced non-small-cell lung cancer (NSCLC). Patients and Methods. Previously treated PS0-1 patients with IIIB/IV EGFR (epidermal growth factor receptor) wild genotype NSCLC were randomly assigned to docetaxel (60 mg/m(2) on Day 1) plus PPV based on preexisting host immunity or docetaxel plus placebo. Docetaxel administration was repeated every 3 weeks until disease progression. Personalized peptides or placebo was injected subcutaneously weekly in the first 8 weeks and biweekly in subsequent 16 weeks. The primary efficacy endpoint was progression-free survival (PFS). Results. PPV related toxicity was grade 2 or less skin reaction. The median PFS for placebo arm and PPV arm was 52 days and 59 days, respectively. There was no significant difference between two arms by log-rank test (p = 0.42). Interestingly, PFS and overall survival (OS) in humoral immunological responder were significantly longer than those in nonresponder. Conclusion. PPV did not improve the survival in combination with docetaxel for previously treated advanced NSCLC. However, PPV may be efficacious for the humoral immunological responders and a further clinical investigation is needed.

Indexed as

AdultAgedAntineoplastic AgentsBiomarkersCancer VaccinesCarcinoma, Non-Small-Cell LungDocetaxelErbB ReceptorsFemaleFollow-Up StudiesHumansImmunity, CellularImmunity, HumoralLung NeoplasmsMaleMiddle AgedAntineoplastic AgentsBiomarkersCancer VaccinesDocetaxelErbB ReceptorsTaxoidsVaccines, Subunit

Identifiers

PMID27274999
PMCPMC4870343
OpenAlexW2347043395

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.