新辅助化放疗后原发性乳腺癌代表性标本和总标本病理完全反应比例及预后影响的比较:JCOG0306 的辅助研究。

IF 3 3区 医学 Q2 ONCOLOGY Breast Cancer Research and Treatment Pub Date : 2024-11-01 Epub Date: 2024-06-27 DOI:10.1007/s10549-024-07408-5
Tadahiko Shien, Hitoshi Tsuda, Keita Sasaki, Junki Mizusawa, Futoshi Akiyama, Masafumi Kurosumi, Masataka Sawaki, Nobuko Tamura, Kiyo Tanaka, Takahiro Kogawa, Mina Takahashi, Naoki Hayashi, Hirofumi Mukai, Norikazu Masuda, Fumikata Hara, Hiroji Iwata
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引用次数: 0

摘要

研究背景JCOG0306试验是一项旨在研究新辅助化疗后放疗(NAC-RT)对原发性乳腺癌疗效的II期研究,在该试验中,病理完全反应(pCR)是通过包括肿瘤中心在内的准确标记的代表性横截面标本(代表性标本(RS)法)进行评估的。在这项辅助研究中,我们考察了 RS 法与日本广泛采用的传统的总标本法(TS)在确定预后良好的 pCR 组别方面是否具有可比性:方法:我们获得了参加 JCOG0306 试验的 103 例患者的长期随访数据。作为组织学治疗效果,我们用 RS 和 TS 方法评估了 pCR(ypT0 和 ypT0/is)和准 pCR [QpCR,ypT0/is 加 2b 级(仅存少量侵袭性癌细胞)]。结果:采用 RS 方法观察到 ypT0、ypT0/is 和 QpCR 的患者分别为 28 人(27.2%)、39 人(37.9%)和 45 人(43.7%),而采用 TS 方法则分别为 20 人(19.4%)、25 人(24.3%)和 40 人(38.9%)。在 RS 和 TS 方法中,ypT0 和 ypTis 的一致性比例分别为 92.2% 和 86.4%。ypT0/is 组的复发风险低于非 ypT0/is 组(HR 0.408,95% CI [0.175-0.946],P = 0.037),ypT0/is 组的死亡风险低于非 ypT0/is 组(HR 0.251,95% CI [0.073-0.857],P = 0.027)。采用RS方法的ypT0和ypT0/is组与采用TS方法的ypT0和ypT0/is组显示出相似的良好预后,即使pCR被归类为ypT0或ypT0/is,RS方法也能比TS方法显著区分pCR和非pCR的OS和RFS。在TS方法中,QpCR标准比pCR标准(ypT0或ypT0/is)更明确地将患者分为预后较好和预后较差的两组:结论:在对接受 NAC-RT 治疗的原发性乳腺癌患者进行 pCR 评估时,如果肿瘤中心标记准确,RS 法与 TS 法具有可比性。作为 RS 法的 pCR 标准,ypT0/is 似乎比 ypT0 更合适。
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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.

Background: In 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.

Methods: We 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.

Results: ypT0, 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.

Conclusions: RS 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.

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来源期刊
CiteScore
6.80
自引率
2.60%
发文量
342
审稿时长
1 months
期刊介绍: Breast Cancer Research and Treatment provides the surgeon, radiotherapist, medical oncologist, endocrinologist, epidemiologist, immunologist or cell biologist investigating problems in breast cancer a single forum for communication. The journal creates a "market place" for breast cancer topics which cuts across all the usual lines of disciplines, providing a site for presenting pertinent investigations, and for discussing critical questions relevant to the entire field. It seeks to develop a new focus and new perspectives for all those concerned with breast cancer.
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