Evidence map›Paper›PMID 38594880›Full record

Trial reportJapanese journal of clinical oncology2024

A single arm Phase I/II trial on the combination of carboplatin, nab-paclitaxel and avastin as first-line treatment for advanced non-squamous non-small cell lung cancer (TORG1424/OLCSG1402: CARNAVAL).

Naoyuki Nogami, Toshio Kubo, Akihiro Bessho, Makoto Sakugawa, Satoshi Ikeo, Toshihide Yokoyama, Nobuhiko Seki, Ryosuke Ochiai, Nobukazu Fujimoto, Shuji Murakami and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IMulticenter Study
In one paragraph

Trial report in Japanese journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 38% 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Review
  2. 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 at 13 institutions in 2 countries.

Naoyuki NogamiDepartment of Community Medicine, Pulmonology and Cardiology, Ehime University Graduate School of Medicine, Toon, Japan.
Toshio KuboCenter for Clinical Oncology, Okayama University Hospital, Okayama, Japan.ORCID 0000-0002-2545-3052
Akihiro BesshoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Makoto SakugawaDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Satoshi IkeoDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
Toshihide YokoyamaDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
Nobuhiko SekiDivision of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Ryosuke OchiaiDivision of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Nobukazu FujimotoDepartment of Respiratory Medicine, Okayama Rosai Hospital, Okayama, Japan.
Shuji MurakamiDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.ORCID 0000-0001-5104-5493
Kyoichi KairaDepartment of Allergy and Respiratory Medicine, Gunma University Graduate School of Medicine, Maebashi, Japan.ORCID 0000-0001-5548-7686
Toshiyuki HaradaDepartment of Respiratory Medicine, Japan Community Health Care Organization Hokkaido Hospital, Sapporo, Japan.
Daizo KishinoDepartment of Respiratory Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan.
Yuichi TakiguchiDepartment of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Tsuneo ShimokawaDepartment of Respirology Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Katsuyuki KiuraDepartment of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.ORCID 0000-0002-9172-9379
Natsumi YamashitaClinical Research Center, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Hiroaki OkamotoDepartment of Respirology Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Kurashiki Central Hospital · JPOkayama Red Cross General Hospital · JPOkayama University Hospital · JPTokyo Medical Center · JPYokohama Municipal Citizen's Hospital · JPChiba University · JPGunma University · JPHimeji Red Cross Hospital · JPHokkaido hospital · JPKanagawa Prefectural Hospital Organization · JPOkayama Rosai Hospital · JPPulmonary Associates · USShikoku Cancer Center · JP

Funding

Taiho Pharmaceutical Co, Ltd
6 · The paper itself

Abstract

backgroundBevacizumab with platinum doublet therapy including paclitaxel + carboplatin improves the survival of patients with non-squamous non-small cell lung cancer. However, in a previous trial (CA031), paclitaxel + carboplatin led to Grade > 3 neutropenia in a Japanese population. Nanoparticle albumin-bound paclitaxel exhibits an improved toxicity profile. We evaluated the safety, dosage and response rate of the nanoparticle albumin-bound paclitaxel + carboplatin + bevacizumab combination in a Japanese population.

methodsChemotherapy-naive patients with advanced non-squamous non-small cell lung cancer were included. The dosage schedule was established in the Phase I trial as follows: 4-6 cycles of carboplatin (area under the concentration-time curve = 6 on Day 1) + nanoparticle albumin-bound paclitaxel (100 mg/m2 on Days 1, 8 and 15) + bevacizumab (15 mg/kg on Day 1), followed by maintenance therapy (nanoparticle albumin-bound paclitaxel + bevacizumab). The response rate and presence of adverse effects were evaluated in the Phase II trial.

resultsThe overall response rate was 56.5% (90% confidence interval: 44.5-68.5), and 93% of patients (43/46) showed tumor shrinkage or maintained a stable disease course. The primary endpoint was achieved. At the median follow-up duration of 42 months, the median overall survival was 18.9 (range: 10.5-32.4) months. The most frequently observed Grade ≥ 3 adverse effects were neutropenia (72%), leukopenia (50%) and anemia (30%).

conclusionsAll adverse effects were manageable and none resulted in patient death. In conclusion, the nanoparticle albumin-bound paclitaxel + carboplatin + bevacizumab combination is favorable and well tolerated in Japanese patients as first-line treatment for advanced non-squamous non-small cell lung cancer.

Indexed as

AlbuminsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungLung NeoplasmsPaclitaxelAdultAgedFemaleHumansJapanMaleMiddle Aged130-nm albumin-bound paclitaxelAlbuminsBevacizumabCarboplatinPaclitaxelbevacizumabdosing schemeJapanese populationneutropeniaNSCLC

Identifiers

PMID38594880
PMCPMC11228859
OpenAlexW4394694806

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.