Evidence map›Paper›PMID 29043496›Full record

Trial reportDrug safety2018

Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results.

Terufumi Kato, Takashi Seto, Makoto Nishio, Koichi Goto, Noboru Yamamoto, Isamu Okamoto, Liang Tao, Wei Yu, Tarik Khaznadar, Kosei Tajima and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 8 pooled it
4.7field-weighted citation impact, top 4% 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

28 citing papers in PubMed, 8 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. The discovery of Bevacizumab. An historical reappraisal.Clinical and experimental medicine · 2025
    Review
  13. Review
  14. Review
  15. Safety Profile of Mutant EGFR-TK Inhibitors in Advanced Non-Small Cell Lung Cancer: A Meta-analysis.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2022
    Review
  16. Article
  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

13 authors at 8 institutions in 3 countries.

Terufumi KatoDepartment of Respiratory Medicine, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, 241-8515, Japan. terufumikato@gmail.com.
Takashi SetoNational Kyushu Cancer Center, Fukuoka, Japan.
Makoto NishioThe Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Koichi GotoNational Cancer Center Hospital East, Chiba, Japan.
Noboru YamamotoNational Cancer Center Hospital, Tokyo, Japan.
Isamu OkamotoResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Liang TaoRoche (China) Holding Ltd, Building 11, 1100 Longdong Avenue, Shanghai, 201203, China.
Wei YuGenentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Tarik KhaznadarF. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, Basel, 4070, Switzerland.
Kosei TajimaChugai Pharmaceutical Co. Ltd, Tokyo, Japan.
Masahiko ShibataChugai Pharmaceutical Co. Ltd, Tokyo, Japan.
Akihiro SekiChugai Pharmaceutical Co. Ltd, Tokyo, Japan.
Nobuyuki YamamotoWakayama Medical University, Wakayama, Japan.
Tokyo National Hospital · JPJapanese Foundation For Cancer Research · JPKanagawa Prefectural Hospital Organization · JPKyushu University · JPNational Cancer Center Hospital East · JPNational Hospital Organization Kyushu Cancer Center · JPRoche (China) · CNRoche (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe phase II JO25567 study compared the efficacy and safety of erlotinib plus bevacizumab vs. erlotinib alone as first-line therapy for advanced epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).

objectiveOur objective is to provide updated analyses of safety and the assessment of manageability of specific adverse events.

methodsPatients with stage IIIB/IV or recurrent, non-squamous, EGFR mutation-positive NSCLC were randomized to receive erlotinib plus bevacizumab or erlotinib. The primary endpoint was progression-free survival. Adverse event frequency rates, predictability and manageability, reasons for discontinuation, time to onset, and outcomes of specific adverse events were analyzed.

resultsThe safety analysis population comprised 152 randomized patients (75 erlotinib plus bevacizumab; 77 erlotinib) who received at least one dose of study drug between February 2011 and March 2012. There was no difference in overall incidence of serious adverse events between arms, but more grade 3 or higher adverse events were reported with erlotinib plus bevacizumab (90.7%) than with erlotinib (53.2%), primarily due to grade 3 hypertension. Hypertension was controllable with antihypertensive medications in most cases. Proteinuria and bleeding were also more frequently reported with erlotinib plus bevacizumab than with erlotinib but were manageable and did not lead to early discontinuations.

conclusionsThe addition of bevacizumab to erlotinib prolonged progression-free survival in EGFR mutation-positive NSCLC. Follow-up safety data were consistent with the known safety profiles of both erlotinib and bevacizumab in NSCLC; this combination appeared to be manageable, and treatment was well tolerated. JapicCTI-111390.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsErbB ReceptorsErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleProtein Kinase InhibitorsTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedBevacizumabErbB ReceptorsErlotinib HydrochlorideProtein Kinase Inhibitors

Identifiers

PMID29043496
PMCPMC5808045
OpenAlexW2766812598

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.