Evidence map›Paper›PMID 29123409›Full record

ArticleOncoTargets and therapy2017

Preventive effect of kampo medicine (hangeshashin-to, TJ-14) plus minocycline against afatinib-induced diarrhea and skin rash in patients with non-small cell lung cancer.

Masao Ichiki, Hiroshi Wataya, Kazuhiko Yamada, Nobuko Tsuruta, Hiroaki Takeoka, Yusuke Okayama, Jun Sasaki, Tomoaki Hoshino

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in OncoTargets and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.6field-weighted citation impact, top 15% 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

14 citing papers in PubMed, 21 citations in OpenAlex.

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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

8 authors at 4 institutions in 2 countries.

Masao IchikiDepartment of Respiratory Medicine, Clinical Research Institute, National Hospital Organization, Kyushu Medical Center.
Hiroshi WatayaDivision of Internal Medicine, Saiseikai Fukuoka General Hospital, Fukuoka City.
Kazuhiko YamadaDivision of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University, Kurume City.
Nobuko TsurutaDepartment of Respiratory Medicine, Hamanomachi Hospital, Fukuoka City, Fukuoka, Japan.
Hiroaki TakeokaDepartment of Respiratory Medicine, Clinical Research Institute, National Hospital Organization, Kyushu Medical Center.
Yusuke OkayamaDepartment of Respiratory Medicine, Clinical Research Institute, National Hospital Organization, Kyushu Medical Center.
Jun SasakiDepartment of Respiratory Medicine, Clinical Research Institute, National Hospital Organization, Kyushu Medical Center.
Tomoaki HoshinoDivision of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University, Kurume City.
National Kyushu Medical Center · JPKurume University · JPHamanomachi Hospital · JPSaiseikai Fukuoka General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDiarrhea and oral mucositis induced by afatinib can cause devastating quality of life issues for patients undergoing afatinib treatment. Several studies have shown that hangeshashin-to (TJ-14) might be useful for chemotherapy-induced diarrhea and oral mucositis. In this study, we investigated the prophylactic effects of TJ-14 for afatinib-induced diarrhea and oral mucositis and minocycline for afatinib-induced skin rash. PATIENTS AND

methodsFirst- and second-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors have become the standard first-line treatment in patients with EGFR-mutated non-small cell lung cancer. The incidence of diarrhea was higher with afatinib than with gefitinib, and we conducted a single-arm Phase II study with afatinib. Patients who had previously undergone treatment with afatinib were ineligible. Both TJ-14 (7.5 g/day) and minocycline (100 mg/day) were administered simultaneously from the start of afatinib administration. The primary end point was the incidence of ≥ grade 3 (G3) diarrhea (increase of ≥7 stools/day over baseline) during the first 4 weeks of treatment. The secondary end points were the incidence of ≥ G3 oral mucositis (severe pain interfering with oral intake) and $ G3 skin toxicity (severe or medically significant but not immediately life-threatening).

resultsA total of 29 patients (nine men and 20 women; median age, 66 years; performance status, 0/1/2: 18/10/1) were enrolled from four centers. Four patients had undergone prior treatment with chemotherapy, including gefitinib or erlotinib. In all, 20 (68.9%) patients and one (3.4%) patient had diarrhea of any grade and ≥ G3, respectively. One (3.4%) patient had ≥ G3 oral mucositis; no patients had ≥ G3 skin rash. A total of 18 (62%) of the 29 patients achieved a partial response.

conclusionThe present study indicated a trend in which TJ-14 reduced the risk of afatinib-induced diarrhea and minocycline reduced the risk of afatinib-induced skin rash.

Indexed as

adverse eventsafatinibepidermal growth factor receptorhangeshashin-to

Identifiers

PMID29123409
PMCPMC5661491
OpenAlexW2767200425

What OpenQuestion holds

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LicenceCC BY-NC
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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.