Evidence map›Paper›PMID 34345969›Full record

Trial reportInternational journal of colorectal disease2021

Pre-emptive oral clarithromycin reduces the skin toxicity of panitumumab treatment for metastatic colorectal cancer.

Ken Nakata, Takamichi Komori, Kazuhiro Saso, Hirofumi Ota, Yoshinori Kagawa, Shunji Morita, Shingo Noura, Nobuyasu Hayashi, Mamoru Uemura, Chu Matsuda and 6 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 31% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Risk factor analysis for anti-epidermal growth factor receptor monoclonal antibody-induced skin toxicities in real-world metastatic colorectal cancer treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  6. Review
  7. 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 at 8 institutions in 1 country.

Ken NakataDepartment of Surgery, Sakai City Medical Center, Ebaraji-cho 1-1-1, Nishi-ku, Sakai, Osaka, Japan. nakataken@msn.com.ORCID http://orcid.org/0000-0002-4086-4984
Takamichi KomoriDepartment of Gastroenterological Surgery, Hyogo Prefectural Nishinomiya Hospital, Rokutanji-cho 13-9, Nishinomiya, Hyogo, Japan.
Kazuhiro SasoDepartment of Surgery, Ashiya Municipal Hospital, Asahigaoka-cho 39-1, Ashiya, Hyogo, Japan.
Hirofumi OtaDepartment of Gastroenterological Surgery, Ikeda City Hospital, Jounan 3-1-18, Ikeda, Osaka, Japan.
Yoshinori KagawaDepartment of Gastroenterological Surgery, Osaka General Medical Center, Mandaihigashi 3-1-56, Sumiyoshi-ku, Osaka, Japan.
Shunji MoritaDepartment of Surgery, Itami City Hospital, Koyaike 1-100, Itami, Hyogo, Japan.
Shingo NouraDepartment of Surgery, Toyonaka Municipal Hospital, Shibahara-cho 4-14-1, Toyonaka, Osaka, Japan.
Nobuyasu HayashiDepartment of Surgery, Kinan Hospital, Shinjo-cho 46-70, Tanabe, Wakayama, Japan.
Mamoru UemuraDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Chu MatsudaDepartment of Surgery, Toyonaka Municipal Hospital, Shibahara-cho 4-14-1, Toyonaka, Osaka, Japan.
Taroh SatohDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Tsunekazu MizushimaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Kohei MurataDepartment of Surgery, Itami City Hospital, Koyaike 1-100, Itami, Hyogo, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Hidetoshi EguchiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO)
The University of Osaka · JPItami City Hospital · JPToyonaka Municipal Hospital · JPHyogo Prefectural Nishinomiya Hospital · JPIkeda Municipal Hospital · JPKinan Hospital · JPOsaka Prefectural Medical Center · JPSakai Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeChemotherapy with panitumumab is expected to be well tolerated and improve survival in patients with metastatic colorectal cancer (mCRC). However, skin toxicities are its most common adverse events. The aim of this trial was to evaluate the efficacy and safety of pre-emptive antibiotic treatment with clarithromycin (CAM) to prevent panitumumab skin toxicities.

methodsWe conducted a phase lll, multicenter, open-label, randomized clinical trial on mCRC patients treated with panitumumab. Eligible patients were randomly assigned 1:1 to pre-emptive antibiotic and control groups. In the pre-emptive group, CAM administration (200 mg twice per day) continued daily through the panitumumab treatment period. The control regimen consisted of skin care only. The primary end point was the incidence of grade ≥ 2 skin toxicities during the 6-week skin treatment period.

resultsOf 156 enrolled patients, 78 received pre-emptive antibiotic treatment, and 78 received reactive treatment. The number and incidence of grade ≥ 2 skin toxicities during the 6-week skin treatment period were 16 (21.3%) and 41 (54.7%) for the pre-emptive and control groups, respectively (HR, 0.32; 95% CI, 0.17-0.56). There was almost no difference in the rate of other adverse events between the two groups, but the incidence of grade ≥ 3 diarrhea in the pre-emptive group was high, at 8% vs. 1.3% in the control group. There were no treatment-related deaths.

conclusionProphylactic oral CAM together with relatively simple skin care was found to be effective in suppressing the development of grade ≥ 2 skin toxicities induced by panitumumab. CLINICAL

trial registrationUMIN000011485 DATE OF REGISTRATION: Sep 1st, 2013.

Indexed as

ClarithromycinColorectal NeoplasmsAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsHumansPanitumumabAntibodies, MonoclonalClarithromycinPanitumumabClarithromycinColorectal cancerPanitumumabSkin toxicity

Identifiers

PMID34345969
OpenAlexW3189189286

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.