Evidence map›Paper›PMID 30778794›Full record

Trial reportInternational journal of clinical oncology2019

Biweekly S-1 plus oxaliplatin (SOX) reintroduction in previously treated metastatic colorectal cancer patients (ORION 2 study): a phase II study to evaluate the efficacy and safety.

Hiroaki Tanioka, Michitaka Honda, Chihiro Tanaka, Yoshitaka Morita, Keiichiro Ishibashi, Takeshi Kato, Chu Matsuda, Masato Kataoka, Hironaga Satake, Yoshinori Munemoto and 6 more

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

Trial report in International 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 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  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

16 authors.

Hiroaki TaniokaDepartment of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.
Michitaka HondaDepartment of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University, 1 Hikarigaoka, Fukushima, Fukushima, 960-1295, Japan. mhonda@fukushimamed.com.ORCID http://orcid.org/0000-0003-3492-9881
Chihiro TanakaDepartment of Surgery, Gifu Prefectual General Medical Center, Gifu, Japan.
Yoshitaka MoritaDepartment of Radiology, National Hospital Organization Kobe Medical Center, Kobe, Japan.
Keiichiro IshibashiDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Takeshi KatoDepartment of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Chu MatsudaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Masato KataokaDepartment of Surgery, Naogoya Medical Center, Nagoya, Japan.
Hironaga SatakeDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Yoshinori MunemotoDepartment of Surgery, Fukui Saiseikai Hospital, Fukui, Japan.
Kenji KobayashiDepartment of Surgery, Matsunami General Hospital, Gifu, Japan.
Masazumi TakahashiDepartment of Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Ken NakataDepartment of Surgery, Sakai City Medical Center, Sakai, Japan.
Junichi SakamotoTokai Central Hospital, Kagamigahara, Japan.
Koji ObaDepartment of Biostatistics, The University of Tokyo School of Public Health, Tokyo, Japan.
Hideyuki MishimaCancer Center, Aichi Medical University, Aichi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe reintroduction of oxaliplatin as a third-or-later-line regimen has been a promising option for patients with metastatic colorectal cancer (mCRC) who previously received chemotherapy including oxaliplatin. In this single-arm phase II study, we evaluated the efficacy of biweekly SOX, which is the combination of oxaliplatin reintroduction and S-1, as a third-or-later-line treatment.

methodsPatients with mCRC who had previously received prior chemotherapy including oxaliplatin and irinotecan and were planned to receive the reintroduction of oxaliplatin were enrolled. Oxaliplatin (85 mg/m

resultsA total of 41 patients from 12 institutes were enrolled. The median PFS and OS survival were 3.3 months (95% confidence interval [CI] 2.7-4.2) and 10.1 months (8.3-14.6), and response rate and disease control rate were 10.0% and 65.0%, respectively. Grade 3 AEs included thrombocytopenia (5.0%), anorexia (5.0%), pneumonia (5.0%) and fatigue (5.0%). There were no cases of grade 4 AEs or treatment-related death.

conclusionBiweekly SOX regimen with reintroduction of oxaliplatin could be exploitable as the third- and/or later-line treatments for patients with mCRC.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsDisease-Free SurvivalDrug Administration ScheduleDrug CombinationsFemaleHumansMaleMiddle AgedOxaliplatinOxonic AcidRetreatmentBevacizumabDrug CombinationsOxaliplatinOxonic AcidS 1 (combination)TegafurBiweekly SOXMetastaic colorectal cancerOxaliplatin reintroduction

Identifiers

PMID30778794

What OpenQuestion holds

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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.