Evidence map›Paper›PMID 33555359›Full record

Trial reportCancer chemotherapy and pharmacology2021

Phase II study of an oxaliplatin-based regimen for relapsed colon cancer patients treated with oxaliplatin-based adjuvant chemotherapy (INSPIRE study).

Keiichiro Ishibashi, Toru Aoyama, Masahito Kotaka, Hironaga Satake, Yasushi Tsuji, Masato Kataoka, Masato Nakamura, Naoki Nagata, Junichi Sakamoto, Koji Oba and 1 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 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
0.1field-weighted citation impact, top 57% 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, 1 citations in OpenAlex.

  1. Value of MSCT plus MRI in the Detection of Colon Cancer.Evidence-based complementary and alternative medicine : eCAM · 2022
    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

11 authors at 9 institutions in 1 country.

Keiichiro Ishibashi *Department of Digestive Tract and General Surgery Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Toru Aoyama *Department of Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 2360004, Japan. t-aoyama@lilac.plala.or.jp.ORCID http://orcid.org/0000-0001-6803-3800
Masahito KotakaDepartment of Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.
Hironaga SatakeCancer Treatment Center, Kansai Medical University Hospital, Hirakata, Japan.
Yasushi TsujiDepartment of Medical Oncology, KKR Tonan Hospital, Sapporo, Japan.
Masato KataokaDepartment of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Masato NakamuraDepartment of Chemotherapy Comprehensive Cancer Center, Aizawa Hospital, Nagano, Japan.
Naoki NagataKitakyushu General Hospital, Kitakyushu, Japan.
Junichi SakamotoTokai Central Hospital, Kakamigahara, Japan.
Koji ObaDepartment of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Hideyuki MishimaCancer Center, Aichi Medical University, Nagakute, Japan.
Aichi Medical University · JPAizawa Hospital · JPKansai Medical University · JPNational Hospital Organization · JPSocial Insurance Saitama Chuo Hospital · JPThe University of Tokyo · JPTokai Central Hospital · JPTonan Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to evaluate the efficacy and safety of first-line chemotherapy with re-introduction of oxaliplatin (OX) more than 6 months after adjuvant chemotherapy including OX.

methodsStage II/III colon cancer patients with neuropathies of grade ≤ 1 who relapsed more than 6 months after adjuvant chemotherapy including OX were considered eligible. Eligible patients were treated with 5-fluorouracil, l-leucovorin and OX plus molecularly targeted agents or capecitabine and OX plus bevacizumab (BV) or S-1 and OX plus BV. The primary endpoint was the progression-free survival (PFS), and the secondary endpoints were the overall survival (OS), response rate (RR) and toxicity.

resultsA total of 50 patients were enrolled between September 2013 and May 2019. Twelve patients received 5-fluorouracil, l-leucovorin and OX (FOLFOX) plus BV, 21 patients received capecitabine and OX plus BV, 10 patients received S-1 and OX plus BV and 7 patients received FOLFOX plus cetuximab or panitumumab. The median PFS was 11.5 months (95% confidence interval [CI] 8.3-16.0), the median OS was 45.4 months (95% CI 37.4-NA), and the RR was 56.0% (95% CI 42.3-68.8). Adverse events of grade ≥ 3 that occurred in ≥ 5% of cases were neutropenia in 6 patients (12%), peripheral sensory neuropathy in 5 patients (10%), diarrhea in 4 patients (8%), hypertension in 4 patients (8%), anorexia in 3 patients (6%) and allergic reactions in 3 patients (6%).

conclusionsFirst-line chemotherapy with re-introduction of OX more than 6 months after adjuvant chemotherapy including OX can be used safely with expected efficacy for relapsed colon cancer patients.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantColonic NeoplasmsFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalOxaliplatinPatient ComplianceOxaliplatinColon cancerOxaliplatinRe-introduction

Identifiers

PMID33555359
PMCPMC8026470
OpenAlexW3128302658

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.