Evidence map›Paper›PMID 37060430›Full record

Trial reportTargeted oncology2023

A Multicenter, Phase II Trial of Schedule Modification for Nab-Paclitaxel in Combination with Ramucirumab for Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer: The B-RAX Trial (JACCRO GC-09).

Ryohei Kawabata, Naoki Izawa, Takahisa Suzuki, Yoshio Nagahisa, Kazuhiro Nishikawa, Masazumi Takahashi, Masato Nakamura, Atsushi Ishiguro, Hiroo Katsuya, Jun Hihara and 11 more

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

Trial report in Targeted oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. 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

21 authors at 20 institutions in 1 country.

Ryohei Kawabata *Department of Surgery, Osaka Rosai Hospital, Osaka, Japan.
Naoki Izawa *Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
Takahisa SuzukiDepartment of Surgery, National Hospital Organization Kure Medical Center, Kure, Japan.
Yoshio NagahisaDepartment of Surgery, Kurashiki Central Hospital, Kurashiki, Japan.
Kazuhiro NishikawaDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Masazumi TakahashiDivision of Gastroenterological Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Masato NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Atsushi IshiguroDepartment of Medical Oncology, Teine Keijinkai Hospital, Sapporo, Japan.
Hiroo KatsuyaDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Jun HiharaDepartment of Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan.
Dai ManakaDepartment of Surgery, Gastro-Intestinal Center, Kyoto Katsura Hospital, Kyoto, Japan.
Yuji NegoroDepartment of Oncological Medicine, Kochi Health Sciences Center, Kochi, Japan.
Akihito TsujiDepartment of Clinical Oncology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
Takao TakahashiDepartment of Gastroenterological Surgery/Pediatric Surgery, Gifu University, Graduate School of Medicine, Gifu, Japan.
Mitsugu KochiDepartment of Gastrointestinal Surgery, International University of Health and Welfare Ichikawa Hospital, Ichikawa, Japan.
Mizutomo AzumaDepartment of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan.
Shigenori KadowakiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Hirofumi MichimaeDepartment of Clinical Medicine (Biostatistics), School of Pharmacy, Kitasato University, Tokyo, Japan.
Yu SunakawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan. y.sunakawa@marianna-u.ac.jp.ORCID 0000-0002-0163-7543
Wataru IchikawaDivision of Medical Oncology, Showa University Fujigaoka Hospital, Yokohama, Japan.
Masashi FujiiDepartment of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
St. Marianna University School of Medicine · JPAichi Cancer Center · JPAizawa Hospital · JPGifu University · JPHiroshima City Asa Citizens Hospital · JPInternational University of Health and Welfare · JPKagawa University · JPKitasato University · JPKitasato University Hospital · JPKurashiki Central Hospital · JPKyoto Katsura Hospital · JPNational Hospital Organization · JPNihon University · JPOsaka National Hospital · JPOsaka Rosai Hospital · JPSaga University · JPShowa University Fujigaoka Hospital · JPTeine Keijinkai Hospital · JPUniversity of Kochi · JPYokohama Municipal Citizen's Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study investigated whether schedule modification of bi-weekly nanoparticle albumin-bound paclitaxel (nab-PTX) plus ramucirumab (RAM) is efficacious against gastric cancer (GC) or gastroesophageal junction cancer (GJC). PATIENTS AND

methodsPatients with unresectable GC or GJC who were previously treated with fluoropyrimidine-containing regimens received nab-PTX (100 mg/m

resultsOf the 81 patients enrolled, 47 patients (58%) were assigned to bi-weekly therapy. Patient characteristics were Eastern Cooperative Oncology Group performance status of 1 (19%) and diffuse type (45%). Median PFS was 4.7 months (95% confidence interval [CI] 3.7-5.6 months) and overall response rate was 25% (95% CI 11-39%). Severe AEs of grade 3 or worse were mainly neutropenia (83%) and hypertension (23%). EQ-5D scores were maintained during the treatment. In patients who continued standard-schedule therapy, median PFS was 2.7 months (95% CI 1.8-4.0 months).

conclusionsThe primary endpoint for PFS was statistically not met, but modification of nab-PTX plus RAM to a bi-weekly schedule might be a feasible treatment option as second-line treatment for advanced GC/GJC patients, especially elderly patients, with severe AEs during the first cycle.

Indexed as

Esophageal NeoplasmsStomach NeoplasmsAgedAlbuminsAntineoplastic Combined Chemotherapy ProtocolsEsophagogastric JunctionEye ProteinsHomeodomain ProteinsHumansPaclitaxelRamucirumabTranscription FactorsTreatment Outcome130-nm albumin-bound paclitaxelAlbuminsEye ProteinsHomeodomain ProteinsPaclitaxelRamucirumabRAX protein, humanTranscription Factors

Identifiers

PMID37060430
OpenAlexW4365810745

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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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.