Evidence map›Paper›PMID 30938103›Full record

Trial reportAsia-Pacific journal of clinical oncology2019

A phase I/II trial of weekly nab-paclitaxel for pretreated non-small-cell lung cancer patients without epidermal growth factor receptor mutations and anaplastic lymphoma kinase rearrangement.

Daijiro Harada, Toshiyuki Kozuki, Naoyuki Nogami, Akihiro Bessho, Shinobu Hosokawa, Nobuaki Fukamatsu, Katsuyuki Hotta, Kadoaki Ohashi, Toshio Kubo, Hiroshige Yoshioka and 8 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Asia-Pacific journal of clinical oncology, 2019. 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
–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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

18 authors.

Daijiro HaradaDepartment of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.ORCID https://orcid.org/0000-0002-5314-2489
Toshiyuki KozukiDepartment of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Naoyuki NogamiDepartment of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Akihiro BesshoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Shinobu HosokawaDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Nobuaki FukamatsuDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Katsuyuki HottaDepartment of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
Kadoaki OhashiDepartment of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
Toshio KuboDepartment of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
Hiroshige YoshiokaDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
Toshihide YokoyamaDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
Naoyuki SoneDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
Shoichi KuyamaDepartment of Respiratory Medicine, National Hospital Organization Iwakuni Medical Center, Yamaguchi, Japan.
Kenichiro KudoDepartment of Respiratory Medicine, National Hospital Organization Iwakuni Medical Center, Yamaguchi, Japan.
Masayuki YasugiDepartment of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
Nagio TakigawaDepartment of General Internal Medicine 4, Kawasaki Medical School, Okayama, Japan.
Isao OzeDivision of Molecular and Clinical Epidemiology, Aichi Cancer Center Research Institute, Nagoya, Japan.
Katsuyuki KiuraDepartment of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimWe investigated the efficacy, safety and optimal schedule of nanoparticle albumin-bound paclitaxel monotherapy as second- or third-line treatment for non-small-cell lung cancer patients without epidermal growth factor receptor mutation and anaplastic lymphoma kinase rearrangement.

methodsPatients with pretreated advanced non-small-cell lung cancer without epidermal growth factor receptor mutation and anaplastic lymphoma kinase rearrangement were included. The patients were administered 100 mg/m

resultsThe recommended schedule was determined as level -1 in phase I. The characteristics of the 55 patients enrolled in phase II were as follows: median age = 66 years, male/female = 40/15, second/third line = 34/21 and adenocarcinoma/squamous cell carcinoma/large cell carcinoma/others = 34/17/2/2. Objective response rate was 7.3% (95% confidence interval, 2.0-17.6%). Median progression-free survival was 3.4 months. Treatment-related grade 3 or 4 toxicities were neutropenia (36.4%), febrile neutropenia (5.5%) and pulmonary infection (3.6%). Three patients had grade 2 pneumonitis and one treatment-related death occurred due to adult respiratory distress syndrome.

conclusionThis study failed to meet predefined primary endpoints for pretreated patients with advanced non-small-cell lung cancer without epidermal growth factor receptor mutation and anaplastic lymphoma kinase rearrangement.

Indexed as

AgedAlbuminsAnaplastic Lymphoma KinaseCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleHumansLung NeoplasmsMaleMutationPaclitaxel130-nm albumin-bound paclitaxelAlbuminsAnaplastic Lymphoma KinaseErbB ReceptorsPaclitaxelcytotoxic chemotherapynanoparticle albumin-bound paclitaxelnon-small cell lung cancerpretreated NSCLCwild-type

Identifiers

PMID30938103
PMCPMC6849786

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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.