Evidence map›Paper›PMID 27755796›Full record

Trial reportThoracic cancer2016

Study of efficacy and safety of pulsatile administration of high-dose gefitinib or erlotinib for advanced non-small cell lung cancer patients with secondary drug resistance: A single center, single arm, phase II clinical trial.

Yanzhe Zhu, Yingying Du, Hu Liu, Tai Ma, Yuanyuan Shen, Yueyin Pan

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Thoracic cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Tumor Drug Concentration and Phosphoproteomic Profiles After Two Weeks of Treatment With Sunitinib in Patients with Newly Diagnosed Glioblastoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Article
  2. Article
  3. Article
  4. Article
  5. Data from real world to evaluate the efficacy of osimertinib in non-small cell lung cancer patients with central nervous system metastasis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2019
    Article
  6. Article
  7. Article
  8. Review
  9. 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

6 authors.

Yanzhe ZhuDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Yingying DuDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Hu LiuDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Tai MaDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Yuanyuan ShenDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Yueyin PanDepartment of Oncology, The Affiliated Provincial Hospital of Anhui Medical University, Hefei, China. yueyinpan1965@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe objective of the study was to observe the efficacy and safety of pulsatile administration of high-dose gefitinib or erlotinib in patients with advanced non-small cell lung cancer (NSCLC) with secondary drug resistance to standard doses of tyrosine kinase inhibitor (TKI) treatment. MATERIALS AND

methodsWe recruited 42 NSCLC patients from our hospital, between August 2014 and December 2015, who had experienced drug resistance after one year of conventional treatment with gefitinib or erlotinib. The gefitinib group (29 patients) received one dose of 1000 mg gefitinib every four days. The erlotinib group (13 patients) received one dose of 450 mg erlotinib every three days. Treatments continued until disease progression according to Response Evaluation Criteria In Solid Tumors 1.1 or development of intolerable toxicity.

resultsMedian progression-free survival (PFS) was 30 months (gefitinib vs. erlotinib: 31 vs. 24 months; P > 0.05). After high-dose pulsatile administration, eight patients achieved a partial response (PR), 11 had stable disease (SD), and 23 had progressive disease (PD; relative risk 19.0%; disease control rate 45.2%; median PFS six months). Patients were categorized based on epidermal growth factor receptor gene mutation: exon 19 (no patients achieved complete response [CR], 4 PR, 6 SD, and 17 PD) and exon 21 mutation groups (no patients achieved CR, 4 PR, 5 SD, and 6 PD).

conclusionHigh-dose TKI pulsatile treatment is safe, efficient, and can improve prognoses for certain patients with advanced NSCLC.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmErbB ReceptorsErlotinib HydrochlorideFemaleGefitinibHumansLung NeoplasmsMaleMutationPrognosisQuinazolinesTreatment OutcomeAntineoplastic AgentsEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideGefitinibQuinazolinesDrug resistanceerlotinibgefitinibpulsatile administration

Identifiers

PMID27755796
PMCPMC5093174

What OpenQuestion holds

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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.