Evidence map›Paper›PMID 34425776›Full record

Trial reportBMC cancer2021

Randomized phase II study of SOX+B-mab versus SOX+C-mab in patients with previously untreated recurrent advanced colorectal cancer with wild-type KRAS (MCSGO-1107 study).

Yujiro Nishizawa, Naotsugu Haraguchi, Hirotoshi Kim, Yoshihito Ide, Ken Nakata, Shu Okamura, Toshihiro Kudo, Taroh Satoh, Mamoru Uemura, Chu Matsuda and 4 more

Open access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.5field-weighted citation impact, top 32% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. 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

14 authors at 7 institutions in 1 country.

Yujiro Nishizawa *Department of Gastroenterological Surgery, Osaka General Medical Center, 3-1-56 Mandaihigashi Sumiyoshi-ku, Osaka, 558-8558, Japan.
Naotsugu Haraguchi *Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Hirotoshi KimDepartment of Surgery, Rinku General Medical Center, 2-23 Rinku Orai-kita, Izumisano, Osaka, 598-8577, Japan.
Yoshihito IdeDepartment of Surgery, Japan Community Healthcare Organization Osaka Hospital, 4-2-78 Fukushima, Fukushima-ku, Osaka, 553-0003, Japan.
Ken NakataDepartment of Surgery, Sakai City Medical Center, 1-1-1 Ebaraji-cho, Nishi-ku, Sakai, Osaka, 593-8304, Japan.
Shu OkamuraDepartment of Surgery, Suita Municipal Hospital, 5-7 Kishibeshinmachi, Suita, Osaka, 564-8567, Japan.
Toshihiro KudoDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Taroh SatohDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Mamoru UemuraDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Chu MatsudaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Tsunekazu MizushimaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan. tmizushima@gesurg.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0002-0825-6823
Kohei MurataDepartment of Surgery, Kansai Rosai Hospital, 3-1-69 Inabasou, Amagaski-shi, Hyogo, 660-8511, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Hidetoshi EguchiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
The University of Osaka · JPOsaka International Cancer Institute · JPKansai Rosai Hospital · JPOsaka Hospital · JPOsaka Prefectural Medical Center · JPSakai Municipal Hospital · JPSuita Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough chemotherapy for metastatic colorectal cancer (mCRC) has improved, the standard chemotherapy regimens for patients with RAS wild-type mCRC remain debated. This study aimed to compare S-1 and oxaliplatin (SOX) + bevacizumab (B-mab) with SOX + cetuximab (C-mab) in patients with previously untreated recurrent advanced CRC with wild-type KRAS.

methodsThis randomized phase II, open-label, multicenter study compared the efficacy and safety of SOX+B-mab with SOX+C-mab in patients with previously untreated advanced CRC with wild-type KRAS. Between February 2012 and October 2016, 45 patients were enrolled.

resultsOverall response rates were 59.1 and 43.5% (p = 0.29) and disease control rates were 90.9 and 91.3% (p = 0.96) in the SOX+B-mab and SOX+C-mab groups, respectively. Median overall survival (OS) was 25.3 and 15.5 months (HR = 0.607, p = 0.167) and median progression-free survival (PFS) were 11.7 and 5.5 months (HR = 0.558, p = 0.077) in the SOX+B-mab and SOX+C-mab groups, respectively. The OS and PFS of patients with early tumor shrinkage (ETS) were not significantly different in the SOX+B-mab group. However, they were significantly better when ETS was ≥20 in the SOX+C-mab group (p = 0.032 and p = 0.003, respectively).

conclusionsThe efficacy and safety of SOX+B-mab and SOX+C-mab for wild-type KRAS recurrent advanced CRC as first-line chemotherapy were almost the same. Consideration of the treatment strategy based on ETS may improve patient prognosis, especially in patients receiving the SOX+C-mab regimen.

trial registrationUMIN Clinical Trials Registry ( UMIN000006706 ). Date of registration: NOV/11/2011. URL of trial registry record: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007920.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCetuximabColorectal NeoplasmsDrug CombinationsFemaleFollow-Up StudiesHumansMaleMiddle AgedMutationNeoplasm Recurrence, LocalOxaliplatinOxonic AcidBevacizumabCetuximabDrug CombinationsKRAS protein, humanOxaliplatinOxonic AcidProto-Oncogene Proteins p21(ras)S 1 (combination)TegafurCetuximabChemotherapyColorectal cancerEarly tumor shrinkageKRASOxaliplatin

Identifiers

PMID34425776
PMCPMC8381542
OpenAlexW3166652950

What OpenQuestion holds

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LicenceCC BY
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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.