Evidence map›Paper›PMID 38935214›Full record

Trial reportBreast cancer research and treatment2024

Comparison of proportions and prognostic impact of pathological complete response between evaluations of representative specimen and total specimen in primary breast cancer after neoadjuvant chemoradiotherapy: an ancillary study of JCOG0306.

Tadahiko Shien, Hitoshi Tsuda, Keita Sasaki, Junki Mizusawa, Futoshi Akiyama, Masafumi Kurosumi, Masataka Sawaki, Nobuko Tamura, Kiyo Tanaka, Takahiro Kogawa and 6 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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.

Tadahiko ShienDepartment of Breast and Endocrine Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 7008558, Japan. tshien@md.okayama-u.ac.jp.
Hitoshi TsudaDepartment of Basic Pathology, National Defense Medical College, Tokorozawa, Japan.
Keita SasakiJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Junki MizusawaJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Futoshi AkiyamaDepartment of Pathology, Cancer Institute Hospital, Tokyo, Japan.
Masafumi KurosumiDepartment of Diagnostic Pathology, Kameda Kyobashi Clinic, Tokyo, Japan.
Masataka SawakiDepartment of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Nobuko TamuraDepartment of Breast Surgery, Toranomon Hospital, Tokyo, Japan.
Kiyo TanakaDepartment of Breast Surgery, Toranomon Hospital, Tokyo, Japan.
Takahiro KogawaDepartment of Breast Medical Oncology, Cancer Institute Hospital, Tokyo, Japan.
Mina TakahashiDepartment of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Naoki HayashiDepartment of Breast Surgery Oncology, St Lukes International Hospital, Tokyo, Japan.
Hirofumi MukaiDepartment of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Norikazu MasudaDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Fumikata HaraDepartment of Breast Medical Oncology, Cancer Institute Hospital, Tokyo, Japan.
Hiroji IwataDepartment of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.

Funding

the National Cancer Center Research and Development Funds 29-A-3, 2020-J-3, 2023-J-03
6 · The paper itself

Abstract

backgroundIn JCOG0306 trial, a phase II study to examine the efficacy of neoadjuvant chemotherapy followed by radiation therapy (NAC-RT) to primary breast cancer, pathological complete response (pCR) was evaluated from specimens of the representative cross-section including the tumor center that had been accurately marked [representative specimen (RS) method]. In this ancillary study, we examined if the RS method was comparable to the conventional total specimen (TS) method, which is widely employed in Japan, to identify the pCR group showing excellent prognosis.

methodsWe obtained long-term follow-up data of 103 patients enrolled in JCOG0306 trial. As histological therapeutic effect, pCR (ypT0 and ypT0/is) and quasi-pCR [QpCR, ypT0/is plus Grade 2b (only a few remaining invasive cancer cells)] were evaluated with RS and TS methods. Concordance of pCR between these two methods and associations of the pCR with prognosis were examined.

resultsypT0, ypT0/is, and QpCR were observed in 28 (27.2%), 39 (37.9%), and 45 (43.7%) patients with RS method, whereas these were 20 (19.4%), 25 (24.3%) and 40 (38.9%) with TS method, respectively. Between RS and TS methods, concordance proportions of ypT0 and ypTis were 92.2% and 86.4%, respectively. Risk of recurrence of ypT0/is group was lower than that of non-ypT0/is group (HR 0.408, 95% CI [0.175-0.946], P = 0.037) and risk of death of ypT0/is group was lower than that of non-ypT0/is group (HR 0.251, 95% CI [0.073-0.857], P = 0.027). The ypT0 and ypT0/is groups with RS method showed excellent prognosis similarly with those with TS method, and RS method was able to differentiate the OS and RFS between pCR and non-pCR than TS method significantly even if pCR was classified ypT0 or ypT0/is. With TS method, QpCR criteria stratified patients into the better and worse prognosis groupsmore clearly than pCR criteria of ypT0 or ypT0/is.

conclusionsRS method was comparable to TS method for the evaluation of pCR in the patients who received NAC-RT to primary breast cancer provided the tumor center was accurately marked. As pCR criteria with RS method, ypT0/is appeared more appropriate than ypT0.

Indexed as

Breast NeoplasmsNeoadjuvant TherapyAdultAgedChemoradiotherapyFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm StagingPrognosisTreatment OutcomeBreast cancerNeoadjuvant chemoradiotherapyPathological therapeutic effectSpecimen sampling method

Identifiers

PMID38935214
PMCPMC11452473

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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.