Evidence map›Paper›PMID 33085058›Full record

Trial reportInternational journal of clinical oncology2021

Safety and efficacy of S-1 plus oxaliplatin 130 mg/m

Tomomi Kashiwada, Katsunori Shinozaki, Shohei Ueno, Hirofumi Kawanaka, Futoshi Uno, Yoshihiro Okita, Masaru Fukahori, Hidenobu Matsushita, Yasunori Emi, Mototsugu Shimokawa and 7 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Trial
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

17 authors at 14 institutions in 1 country.

Tomomi KashiwadaDivision Hematology, Respiratory Medical and Oncology, Department of Medical Oncology, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan.
Katsunori ShinozakiDivision of Clinical Oncology, Hirosima Prefectural Hospital, Hirosima, Japan.
Shohei UenoDepartment of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.
Hirofumi KawanakaClinical Research Institute and Department of Surgery, National Hospital Organization, Beppu Medical Center, Beppu, Japan.
Futoshi UnoDepartment of Surgery, Okayama Rosai Hospital, Okayama, Japan.
Yoshihiro OkitaKagawa University Hospital Cancer Center, Takamatsu, Japan.
Masaru FukahoriMultidisciplinary Treatment Cancer Center, Kurume University Hospital, Kurume, Japan.
Hidenobu MatsushitaDepartment of Surgery, Tosei General Hospital, Seto, Japan.
Yasunori EmiDepartment of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Cancer Biostatistics Laboratory, Yamaguchi University Graduate School of Medicine, Clinical Research Institute, Yamaguchi, Japan.
Akitaka MakiyamaDepartment of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.
Hiroshi SaekiDepartment of General Surgical Science, Graduate School of Medicine, Gunma University, Maebashi, Japan.
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. okieiji@surg2.med.kyushu-u.ac.jp.ORCID http://orcid.org/0000-0002-9763-9366
Yoshihiko MaeharaDepartment of Surgery, Kyushu Central Hospital of the Mutual Aid Association of PublicSchool Teachers, Fukuoka, Japan.
Masaki MoriDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Eishi BabaDepartment of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kyushu Study Group of Clinical Cancer (KSCC)
Kyushu University · JPBeppu Medical Center · JPGifu University Hospital · JPGunma University · JPHiroshima Prefectural Hospital · JPKagawa University Hospital · JPKurume University Hospital · JPKyushu Central Hospital of the Mutual Aid Association of Public School Teachers · JPKyushu Hospital · JPOkayama Rosai Hospital · JPSaga University · JPSaiseikai Fukuoka General Hospital · JPTosei General Hospital · JPYamaguchi University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn a randomized pivotal global phase III study, S-1 and oxaliplatin 100 mg/m

methodsPatients with HER2-negative AGC received 80 mg/m

resultsSeventy-one patients were enrolled from June 2015 to November 2016, but eight were excluded for ineligibility. Therefore, all final analyses were conducted with 63 patients. The confirmed RR was 46.0% (90% confidence interval [CI]: 36.1-56.3), and the disease control rate was 77.8% (90% CI: 68.1-85.1). The median PFS and OS were 4.9 (95% CI: 4.2-7.1) and 14.8 (95% CI: 11.1-18.9) months, respectively. Incidences of grade 3-4 AEs > 10% were anorexia (19.0%), peripheral neuropathy (12.7%), nausea (11.1%), and thrombocytopenia (11.1%).

conclusionsThis study represents the first evaluation of SOX130 in patients with HER2-negative AGC. SOX130 showed an acceptable safety profile, but the prespecified statistical efficacy targets were not achieved.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEsophagogastric JunctionNeoplasm Recurrence, LocalStomach NeoplasmsDrug CombinationsErb-b2 Receptor Tyrosine KinasesHumansOxaliplatinOxonic AcidTegafurDrug CombinationsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesOxaliplatinOxonic AcidS 1 (combination)TegafurFirst-line chemotherapyGastric cancerOxaliplatinS-1SOX

Identifiers

PMID33085058
OpenAlexW3094525062

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.