Evidence map›Paper›PMID 26474174›Full record

Trial reportPloS one2015

Randomized Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients with or without Icotinib Consolidation Therapy.

Siyang Feng, Yuanyuan Wang, Kaican Cai, Hua Wu, Gang Xiong, Haofei Wang, Ziliang Zhang

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02430974 (Icotinib as Maintenance Treatment After Chemotherapy for Patients Undergoing Resection of EGRF Mutation-positive Non-small Cell Lung Cancer), which is not on this map. Cited by 26 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 6 pooled it
–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.

NCT02430974 phase2unknown statusnot on this map

Icotinib as Maintenance Treatment After Chemotherapy for Patients Undergoing Resection of EGRF Mutation-positive Non-small Cell Lung Cancer

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2011 to 2018Enrolled50ConditionsCarcinoma, Non-Small-Cell LungArmsIcotinib
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Cancers · 2022
    Review
  14. Postoperative adjuvant EGFR-TKIs for resectedAnnals of translational medicine · 2021
    Article
  15. Review
  16. Neoadjuvant treatment of stage IIIA-N2 inTranslational lung cancer research · 2021
    Review
  17. Review
  18. Article
  19. Article
  20. 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

7 authors.

Siyang FengDepartment of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Yuanyuan WangDepartment of Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Kaican CaiDepartment of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Hua WuDepartment of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Gang XiongDepartment of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Haofei WangDepartment of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Ziliang ZhangDepartment of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEpidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitor (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to ⅢA EGFR-mutated NSCLC.

methodsPatients with surgically resected stage IB (with high risk factors) to ⅢA EGFR-mutated NSCLC were randomly assigned (1:1) to one of two treatment plans. One group received four cycles of platinum-based doublet chemotherapy every three weeks, and the other group received platinum-based chemotherapy supplemented with consolidation therapy of orally administered icotinib (125 mg thrice daily) two weeks after chemotherapy. The icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity. The primary endpoint was disease-free survival (DFS).

results41 patients were enrolled between Feb 9, 2011 and Dec 17, 2012. 21 patients were assigned to the combined chemotherapy plus icotinib treatment group, while 20 patients received chemotherapy only. DFS at 12 months was 100% for icotinib-treated patients and 88.9% for chemotherapy-only patients (p = 0. 122). At 18 months DFS for icotinib-treated vs. chemotherapy-only patients was 95.2% vs. 83.3% (p = 0. 225), respectively, and at 24 months DFS was 90.5% vs. 66.7% (p = 0. 066). The adverse chemotherapy effects predominantly presented as gastrointestinal reactions and marrow suppression, and there was no significant difference between the two treatment groups. Patients in the chemotherapy plus icotinib treatment group showed favorable tolerance to oral icotinib.

conclusionsThe results suggest that chemotherapy plus orally icotinib displayed better DFS compared with chemotherapy only, yet the difference in DFS was not significant. We would think the preliminary result here was promising, and further trials with larger sample sizes might confirm the efficiency of adjuvant TKI in selected patients.

trial registrationClinicalTrials.gov NCT02430974.

Indexed as

MutationAgedCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantConsolidation ChemotherapyCrown EthersErbB ReceptorsFemaleHumansLung NeoplasmsMaleMiddle AgedQuinazolinesCrown EthersEGFR protein, humanErbB ReceptorsicotinibQuinazolines

Identifiers

PMID26474174
PMCPMC4608803

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.