Evidence map›Paper›PMID 33413212›Full record

Trial reportBMC cancer2021

Secondary endpoints analysis in patients with estrogen receptor-positive metastatic breast cancer treated with everolimus and exemestane enrolled in Oral Care-BC.

Katsuhiko Nakatsukasa, Naoki Niikura, Kosuke Kashiwabara, Takeshi Amemiya, Ken-Ichi Watanabe, Hironobu Hata, Yuichiro Kikawa, Naoki Taniike, Takashi Yamanaka, Sachiyo Mitsunaga and 10 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
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. It is linked to trial NCT02376985 (Evaluation of Oral Care to Prevent Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated With Everolimus), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 39% 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.

NCT02376985 phase3completednot on this map

Evaluation of Oral Care to Prevent Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated With Everolimus: Phase III Randomized Control Trial

TypeinterventionalSponsorComprehensive Support Project for Oncology ResearchRan2015 to 2018Enrolled174ConditionsBreast CancerArmsOral management, Everolimus
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. 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

20 authors at 12 institutions in 1 country.

Katsuhiko NakatsukasaDepartment of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto City, 602-8566, Japan. kacchan@koto.kpu-m.ac.jp.ORCID http://orcid.org/0000-0002-1411-1436
Naoki NiikuraDepartment of Breast and Endocrine Surgery, Tokai University School of Medicine, Tokyo, Japan.
Kosuke KashiwabaraDepartment of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.
Takeshi AmemiyaDepartment of Dentistry and Oral and Maxillofacial Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Ken-Ichi WatanabeDepartment of Breast Surgery, Hokkaido Cancer Center, Sapporo, Japan.
Hironobu HataDepartment of Dentistry, Hokkaido Cancer Center, Sapporo, Japan.
Yuichiro KikawaDepartment of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.
Naoki TaniikeDepartment of Dentistry and Oral and Maxillofacial Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.
Takashi YamanakaDepartment of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Sachiyo MitsunagaDepartment of Dentistry and Oral and Maxillofacial Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Kazuhiko NakagamiDepartment of Breast and Endocrine Surgery, Shizuoka General Hospital, Shizuoka, Japan.
Moriyasu AdachiDepartment of Oral and Maxillofacial Surgery, Shizuoka General Hospital, Shizuoka, Japan.
Naoto KondoDepartment of Breast and Endocrine Surgery, Nagoya City University Hospital, Nagoya, Japan.
Yasuyuki ShibuyaDepartment of Dentistry and Oral and Maxillofacial Surgery, Nagoya City University Hospital, Nagoya, Japan.
Naoki HayashiDepartment of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan.
Mariko NaitoDepartment of Oral Epidemiology, Graduate School of Biomedical and Health Sciences Hiroshima University, Hiroshima, Japan.
Toshinari YamashitaDepartment of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Masahiro UmedaDepartment of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Hirofumi MukaiDepartment of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Yoshihide OtaDepartment of Dentistry and Oral and Maxillofacial Surgery, Tokai University School of Medicine, Tokyo, Japan.
Kanagawa Prefectural Hospital Organization · JPKobe City Medical Center General Hospital · JPKyoto Prefectural University of Medicine · JPNagoya City University Hospital · JPShizuoka General Hospital · JPTokai University · JPHiroshima University · JPHokkaido University Hospital · JPNagasaki University · JPNational Cancer Center Hospital East · JPSt. Luke's International Hospital · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients who received POC to those who had not, and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE.

methodsBetween May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated for both the groups over 8 weeks by an oncologist. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months.

resultsThere were no significant differences in PFS between the POC and Control Groups (P = 0.801). A BMI <  25 mg/m

conclusionsPOC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI <  25 mg/m

trial registrationThe study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov ( NCT02376985 ).

Indexed as

AndrostadienesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCase-Control StudiesErb-b2 Receptor Tyrosine KinasesEverolimusFemaleFollow-Up StudiesHumansJapanMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalOral HealthPrognosisReceptors, EstrogenAndrostadienesErb-b2 Receptor Tyrosine KinasesEverolimusexemestaneReceptors, EstrogenReceptors, ProgesteroneBreast cancerEverolimusOral careOral care-BCProgression-free survival

Identifiers

PMID33413212
PMCPMC7791872
OpenAlexW3120460469

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Registered trials

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.