Evidence map›Paper›PMID 38607499›Full record

Trial reportBreast cancer (Tokyo, Japan)2024

Acute adverse events of ultra-hypofractionated whole-breast irradiation after breast-conserving surgery for early breast cancer in Japan: an interim analysis of the multi-institutional phase II UPBEAT study.

Peter J K Tokuda, Takamasa Mitsuyoshi, Yuka Ono, Takahiro Kishi, Yoshiharu Negoro, Setsuko Okumura, Itaru Ikeda, Takashi Sakamoto, Yumi Kokubo, Ryo Ashida and 11 more

Open access · hybridAbstract readMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer (Tokyo, Japan), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
1.4field-weighted citation impact, top 19% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Trial
  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

21 authors at 7 institutions in 1 country.

Peter J K TokudaDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
Takamasa MitsuyoshiDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan. mitsu.t@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0001-9983-3106
Yuka OnoDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Kyoto, Japan.
Takahiro KishiDepartment of Radiation Therapy, Osaka Red Cross Hospital, Osaka, Osaka, Japan.
Yoshiharu NegoroDepartment of Radiation Oncology, Japanese Red Cross Wakayama Medical Center, Wakayama, Wakayama, Japan.
Setsuko OkumuraDepartment of Radiation Oncology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Hyogo, Japan.
Itaru IkedaDepartment of Radiation Oncology, Shiga General Hospital, Moriyama, Shiga, Japan.
Takashi SakamotoDepartment of Radiation Oncology, Kyoto-Katsura Hospital, Kyoto, Kyoto, Japan.
Yumi KokuboDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
Ryo AshidaDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
Toshiyuki ImagumbaiDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
Mikiko YamashitaDepartment of Radiological Technology, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Hiroaki TanabeDepartment of Radiological Technology, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Sayaka TakebeDepartment of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Mariko TokiwaDepartment of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Eiji SuzukiDepartment of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Chikako YamauchiDepartment of Radiation Oncology, Shiga General Hospital, Moriyama, Shiga, Japan.
Michio YoshimuraDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Kyoto, Japan.
Takashi MizowakiDepartment of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Kyoto, Japan.
Masaki KokuboDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
Kyoto Radiation Oncology Study Group
Kobe City Medical Center General Hospital · JPKyoto University · JPShiga Medical Center · JPHyogo Prefectural Amagasaki General Medical Center · JPJapanese Red Cross Society Wakayama Medical Center · JPKyoto Katsura Hospital · JPOsaka Red Cross Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe applicability of ultra-hypofractionated (ultra-HF) whole-breast irradiation (WBI) remains unknown in Japanese women. This study aimed to evaluate the safety and efficacy of this approach among Japanese women and report the results of an interim analysis performed to assess acute adverse events (AEs) and determine whether it was safe to continue this study.

methodsWe enrolled Japanese women with invasive breast cancer or ductal carcinoma in situ who had undergone breast-conserving surgery, were aged ≥ 40 years, had pathological stages of Tis-T3 N0-N1, and had negative surgical margins. Ultra-HF-WBI was delivered at 26 Gy in five fractions over one week. When the number of enrolled patients reached 28, patient registration was paused for three months. The endpoint of the interim analysis was the proportion of acute AEs of grade ≥ 2 (Common Terminology Criteria for Adverse Events v5.0) within three months.

resultsOf the 28 patients enrolled from seven institutes, 26 received ultra-HF-WBI, and 2 were excluded due to postoperative infections. No AEs of grade ≥ 3 occurred. One patient (4%) experienced grade 2 radiation dermatitis, and 18 (69%) had grade 1 radiation dermatitis. The other acute grade 1 AEs experienced were skin hyperpigmentation (n = 10, 38%); breast pain (n = 4, 15%); superficial soft tissue fibrosis (n = 3, 12%); and fatigue (n = 1, 4%). No other acute AEs of grade ≥ 2 were detected.

conclusionsAcute AEs following ultra-HF-WBI were within acceptable limits among Japanese women, indicating that the continuation of the study was appropriate.

Indexed as

Breast NeoplasmsMastectomy, SegmentalAdultAgedAged, 80 and overCarcinoma, Intraductal, NoninfiltratingFemaleHumansJapanMiddle AgedRadiation Dose HypofractionationRadiotherapy, AdjuvantBreast cancerInterim analysisPhase II studyUltra-hypofractionated radiation therapyWhole-breast irradiation

Identifiers

PMID38607499
PMCPMC11194189
OpenAlexW4394757737

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.