Evidence map›Paper›PMID 32654250›Full record

Trial reportThe oncologist2020

Erlotinib for Non-Small Cell Lung Cancer with Leptomeningeal Metastases: A Phase II Study (LOGIK1101).

Kaname Nosaki, Takeharu Yamanaka, Akinobu Hamada, Yoshimasa Shiraishi, Taishi Harada, Daisuke Himeji, Takeshi Kitazaki, Noriyuki Ebi, Takayuki Shimose, Takashi Seto and 2 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.4field-weighted citation impact, top 15% 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

14 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Osimertinib Improves Overall Survival in Patients with Leptomeningeal Metastases Associated withEvidence-based complementary and alternative medicine : eCAM · 2021
    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

12 authors at 9 institutions in 1 country.

Kaname NosakiDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Takeharu YamanakaDepartment of Biostatistics, Yokohama City University, Yokohama, Japan.
Akinobu HamadaDivision of Molecular Pharmacology, National Cancer Center Research Institute, Tokyo, Japan.
Yoshimasa ShiraishiDepartment of Respiratory Disease, National Hospital Organization Fukuoka-Higashi Medical Center, Koga, Japan.
Taishi HaradaDepartment of Respiratory Medicine, Japan Community Health Care Organization (JCHO) Kyushu Hospital, Kitakyushu, Japan.
Daisuke HimejiDepartment of Internal Medicine, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.
Takeshi KitazakiDepartment of Respiratory Disease, Japan Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Noriyuki EbiDepartment of Respiratory Oncology, Iizuka Hospital, Iizuka, Japan.
Takayuki ShimoseClinical Research Support Center Kyushu, Fukuoka, Japan.
Takashi SetoDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Mitsuhiro TakenoyamaDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kenji SugioDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
National Hospital Organization Kyushu Cancer Center · JPAso Iizuka Hospital · JPFukuoka Higashi Medical Center · JPJapanese Red Cross Society, Japan · JPKyushu Economic Research Center · JPKyushu Hospital · JPMiyazaki Prefectural Hospital · JPOita University · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedThis phase II trial evaluated the efficacy of erlotinib for patients with non-small cell lung cancer with leptomeningeal metastasis. The 17 cerebrospinal fluid specimens that were available for epidermal growth factor receptor mutation analysis were all negative for the resistance-conferring T790M mutation. The cytological objective clearance rate was 30.0% (95% confidence interval: 11.9%-54.3%). The median time to progression was 2.2 months. The rate of cerebrospinal fluid penetration among these patients was equivalent to those in previous reports regarding leptomeningeal metastasis.

backgroundLeptomeningeal metastases (LM) occur in approximately 5% of patients with non-small cell lung cancer (NSCLC) and are associated with a poor prognosis. However, no prospective study has identified an active chemotherapeutic drug in this setting.

methodsPatients were considered eligible to receive erlotinib if they had NSCLC with cytologically confirmed LM. The objective cytological clearance rate, time to LM progression (TTP), overall survival (OS), quality of life outcomes, and pharmacokinetics were analyzed. This study was closed because of slow accrual at 21 of the intended 32 patients (66%).

resultsBetween December 2011 and May 2015, 21 patients (17 with activating epidermal growth factor receptor [EGFR] mutations) were enrolled. The 17 cerebrospinal fluid specimens available were all negative for the T790M mutation, which confers erlotinib resistance. The clearance rate was 30.0% (95% confidence interval [CI]: 11.9%-54.3%), the median TTP was 2.2 months, and the median OS was 3.4 months. Significantly longer TTP and OS times were observed in patients with mutant EGFR (p = .0113 and p < .0054, respectively). The mean cerebrospinal fluid penetration rate was 3.31% ± 0.77%. There was a good correlation between plasma and cerebrospinal fluid (CSF) concentrations, although there was no clear correlation between pharmacokinetic parameters and clinical outcome.

conclusionErlotinib was active for LM and may be a treatment option for patients with EGFR-mutated NSCLC and LM.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsErbB ReceptorsErlotinib HydrochlorideHumansMutationProtein Kinase InhibitorsQuality of LifeErbB ReceptorsErlotinib HydrochlorideProtein Kinase Inhibitors

Identifiers

PMID32654250
PMCPMC8108053
OpenAlexW3040695144

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.