Evidence map›Paper›PMID 34215931›Full record

ArticleInvestigational new drugs2021

Phase 1b study of ramucirumab in combination with erlotinib or osimertinib for untreated EGFR-mutated non-small cell lung cancer patients with asymptomatic brain metastases.

Hiroyasu Kaneda, Kenji Sawa, Haruko Daga, Asuka Okada, Yuki Nakatani, Shinji Atagi, Kyoichi Okishio, Yoko Tani, Yoshiya Matsumoto, Koichi Ogawa and 4 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 41% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Observational
  3. Review
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 3 institutions in 1 country.

Hiroyasu KanedaDepartment of Clinical Oncology, Graduate School of Medicine, Osaka City University, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan. kaneda.hiroyasu@med.osaka-cu.ac.jp.ORCID 0000-0002-7696-2391
Kenji SawaDepartment of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Haruko DagaDepartment of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Asuka OkadaDepartment of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Yuki NakataniDepartment of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Shinji AtagiDepartment of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.
Kyoichi OkishioDepartment of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.
Yoko TaniDepartment of Clinical Oncology, Graduate School of Medicine, Osaka City University, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.
Yoshiya MatsumotoDepartment of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Koichi OgawaDepartment of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Kenji NakahamaDepartment of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Motohiro IzumiDepartment of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Shigeki MitsuokaDepartment of Clinical Oncology, Graduate School of Medicine, Osaka City University, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.
Tomoya KawaguchiDepartment of Clinical Oncology, Graduate School of Medicine, Osaka City University, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.
Osaka City University · JPOsaka City General Hospital · JPNHO Kinki Chuo Chest Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe study was designed to investigate the safety of ramucirumab administered in combination with erlotinib or osimertinib for patients with untreated EGFR-mutated non-small cell lung cancer (NSCLC) and asymptomatic brain metastases, a patient subgroup in which these regimens have remained untested. MATERIALS AND

methodsThis phase 1b study (RELAY-Brain) consisted of two cohorts with three patients each. Patients with asymptomatic brain metastases received ramucirumab every 2 weeks plus either daily oral erlotinib or osimertinib until disease progression or intolerable toxicity. The primary objective was to assess dose-limiting toxicity (DLT), defined as central nervous system (CNS) hemorrhage of grade ≥ 2.

resultsSix patients were enrolled. Neither DLT nor serious or unexpected adverse events were observed. One treatment-related adverse event of grade ≥ 3 (hypertension of grade 3) was apparent. Common adverse events were generally manageable. The median number of ramucirumab administrations was 18.5 (range, 13 to 31), and there were no detected episodes of CNS hemorrhage. Five of the six patients showed an objective systemic response. Although only one patient had a measurable CNS lesion at baseline, a confirmed intracranial partial response was observed.

conclusionRamucirumab in combination with erlotinib or osimertinib showed safety for EGFR-mutated NSCLC with brain metastases.

Indexed as

AcrylamidesAgedAniline CompoundsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugErbB ReceptorsErlotinib HydrochlorideFemaleHumansIndolesLung NeoplasmsMaleMaximum Tolerated DoseAcrylamidesAniline CompoundsAntibodies, Monoclonal, HumanizedErbB ReceptorsErlotinib HydrochlorideIndolesosimertinibPyrimidinesRamucirumabAntiangiogenic agentBrain metastasisEGFR mutationNon–small cell lung cancerRamucirumabTyrosine kinase inhibitor

Identifiers

PMID34215931
OpenAlexW3164994511

What OpenQuestion holds

Textmetadata
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.