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Acute toxicity of hypofractionated radiotherapy for Japanese breast cancer patients after surgery: a single center prospective observational study (HyPORT-BC). 日本乳腺癌患者术后低分次放疗的急性毒性:单中心前瞻性观察研究(HyPORT-BC)。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-11-01 Epub Date: 2024-08-08 DOI: 10.1007/s12282-024-01626-x
Masaki Nakamura, Takeshi Fujisawa, Hidekazu Oyoshi, Yuzheng Zhou, Keiko Fukushi, Hidenari Hirata, Kento Tomizawa, Atsushi Motegi, Hidehiro Hojo, Masashi Wakabayashi, Kazuto Kano, Risa Ohno, Azusa Nakamura, Masayuki Yamaguchi, Sadamoto Zenda

Background: This single center prospective observational study was conducted to evaluate the acute toxicity of hypo-fractionated radiotherapy for Japanese breast cancer patients after surgery.

Methods: This study recruited patients who were scheduled for moderately hypo-fractionated radiotherapy including supraclavicular lymph node area (Cohort M) or ultra-hypo-fractionated radiotherapy for the conserved breast (Cohort U) as postoperative treatment for breast cancer. Radiotherapy plans were generated using automated planning system. Irradiation of 42.5 Gy/16 fractions (Cohort M) or 26 Gy/5 fractions (Cohort U) was delivered, and boost irradiation of 10 Gy/5 fractions was added as needed. The primary endpoint was the proportion of grade ≥ 2 acute adverse events within 90 days. The toxicities were evaluated using CTCAE ver 5.0.

Results: Between January 2023 and December 2023, 123 patients (81 in Cohort M and 42 in Cohort U) were enrolled. All the included patients were Japanese and completed their planned radiotherapy and were also able to be evaluated for acute adverse events. Grade 1/2/3-5 acute adverse events were observed in 67/12/0 for Cohort M and 31/4/0 for Cohort U. The proportion of grade ≥ 2 acute adverse events within 90 days was 15% (95% confidence interval 8-24%) for Cohort M and 10% (95% confidence interval 3-23%) for Cohort U.

Conclusions: The proportion of acute toxicity of hypo-fractionated radiotherapy for Japanese breast cancer patients after surgery was shown to be acceptable in this study.

背景:这是一项单中心前瞻性观察研究:这项单中心前瞻性观察研究旨在评估日本乳腺癌患者术后低分次放疗的急性毒性:本研究招募了计划接受中度低分次放疗(包括锁骨上淋巴结区)(队列 M)或保留乳房超低分次放疗(队列 U)的乳腺癌术后患者。放疗计划由自动计划系统生成。放疗剂量为42.5 Gy/16次(M组)或26 Gy/5次(U组),并根据需要增加10 Gy/5次的增强照射。主要终点是90天内发生≥2级急性不良事件的比例。毒性采用 CTCAE 5.0 版进行评估:2023 年 1 月至 2023 年 12 月期间,共有 123 名患者入组(M 组 81 人,U 组 42 人)。所有入组患者均为日本人,完成了计划的放疗,并接受了急性不良事件评估。M队列中有67/12/0人观察到1/2/3-5级急性不良事件,U队列中有31/4/0人观察到1/2/3-5级急性不良事件。90天内发生≥2级急性不良事件的比例,M队列为15%(95%置信区间为8-24%),U队列为10%(95%置信区间为3-23%):本研究显示,日本乳腺癌患者术后接受低分次放疗的急性毒性比例是可以接受的。
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引用次数: 0
Increasing survivors of anthracycline-related cardiomyopathy with breast cancer in trastuzumab era: thirty-one-year trends in a Japanese Community. 曲妥珠单抗时代乳腺癌蒽环类相关心肌病存活者的增加:一个日本社区的 31 年趋势。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-11-01 Epub Date: 2024-08-13 DOI: 10.1007/s12282-024-01623-0
Mitsuhiro Watanabe, Shinya Fujiki, Yuji Okura, Chie Toshikawa, Mayuko Ikarashi, Chizuko Kanbayashi, Koji Kaneko, Akira Kikuchi, Eiko Sakata, Keiichi Tsuchida, Kazuyuki Ozaki, Kazuki Moro, Naoki Kubota, Takeshi Kashimura, Masato Moriyama, Nobuaki Sato, Naohito Tanabe, Yu Koyama, Toshifumi Wakai, Yasuo Saijo, Takayuki Inomata

Background: Trastuzumab has improved breast cancer (BC) prognosis and reduced anthracycline use. However, the characteristic changes of anthracycline-related cardiomyopathy (ARCM) in patients with BC remain unclear. We aimed to update our understanding of ARCM in the trastuzumab era.

Methods: This retrospective observational cohort study included 2959 patients with BC treated with anthracyclines at three regional cancer centers in Niigata City between 1990 and 2020. Seventy-five patients (2.5%) developed ARCM and were categorized into two groups: pre- 2007 (early phase) and post-2007 (late phase), corresponding to before and during the trastuzumab era in Japan.

Results: ARCM incidence peaked at 6% in the 1990s, then decreased and stabilized at 2% until the 2010s. Survivors of anthracycline-treated BC increased more rapidly in the late phase, with four times as many patients with ARCM compared to the end of the early phase (26 and six, respectively). Although the rate of change in accumulation from the early phase to the late phase was slight in the anthracycline-treated BC group, it was more pronounced in the ARCM group (P < 0.001). Mean anthracycline use in the late phase was significantly lower than in the early phase (307 vs. 525 mg/m2, P < 0.001). Five-year survival rates in the late phase tended to be higher than early phase (45% and 28%, respectively. P = 0.058). Human epidermal growth factor receptor type 2 (HER2) positivity with trastuzumab therapy in the late phase was an independent predictor for mortality within 10 years (hazard ratio = 0.24, 95% confidence interval: 0.10-0.56; P = 0.001).

Conclusions: HER2-positive patients with ARCM receiving trastuzumab therapy had a better prognosis than HER2-positive and HER2-negative patients with ARCM not receiving trastuzumab therapy, and this trend has been increasing in the trastuzumab era. These findings highlight the importance of HER2-targeted treatments in improving prognosis for BC patients with ARCM.

背景:曲妥珠单抗改善了乳腺癌(BC)的预后并减少了蒽环类药物的使用。然而,蒽环类药物相关心肌病(ARCM)在乳腺癌患者中的特征性变化仍不清楚。我们旨在更新我们对曲妥珠单抗时代蒽环类药物相关心肌病的认识:这项回顾性观察队列研究纳入了 1990 年至 2020 年期间在新潟市三个地区癌症中心接受蒽环类药物治疗的 2959 例 BC 患者。75名患者(2.5%)发生了ARCM,并被分为两组:2007年以前(早期阶段)和2007年以后(晚期阶段),分别对应于日本曲妥珠单抗时代之前和期间:结果:ARCM发病率在20世纪90年代达到6%的峰值,随后下降并稳定在2%,直到2010年代。蒽环类药物治疗 BC 的存活者在晚期增加得更快,与早期末期相比,ARCM 患者人数增加了四倍(分别为 26 人和 6 人)。虽然蒽环类药物治疗的 BC 组从早期到晚期的蓄积变化率很小,但 ARCM 组的变化率更为明显(P 2,P 结论):接受曲妥珠单抗治疗的HER2阳性ARCM患者的预后优于未接受曲妥珠单抗治疗的HER2阳性和HER2阴性ARCM患者,而且这一趋势在曲妥珠单抗时代不断增强。这些发现凸显了HER2靶向治疗在改善ARCM BC患者预后方面的重要性。
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引用次数: 0
Survival in patients with rheumatoid arthritis and early breast cancer treated with tumor necrosis factor inhibitors. 使用肿瘤坏死因子抑制剂治疗类风湿性关节炎和早期乳腺癌患者的生存率。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-11-01 Epub Date: 2024-08-08 DOI: 10.1007/s12282-024-01618-x
Juan I Ruiz, Xiudong Lei, Wu Chi-Fang, Sharon H Giordano, Hui Zhao, Suja S Rajan, Heather Lin, Maria E Suarez-Almazor

Background: There have been concerns about the use of tumor necrosis factor inhibitors (TNFi) for autoimmune disease in patients with recently diagnosed cancer. We assessed the survival of patients with rheumatoid arthritis (RA) and newly diagnosed early breast cancer (BC) treated with TNFi in the first two years after BC diagnosis.

Methods: We identified patients in two datasets: (1) Optum's de-identified Clinformatics® Data Mart Database (CDM), (2) Surveillance, Epidemiology, and End Results program (SEER) and Texas Cancer Registry (TCR) Medicare-linked cohort. We grouped patients according to whether they received TNFi, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) only, or no DMARDs within 2 years after BC. Outcomes were overall survival (OS) and BC-specific survival (BCSS). We conducted landmark analyses at years 1 and 2, with multivariable Cox regressions using propensity scores for adjustment.

Results: In the first year after BC, 165/970 (17.0%) and 201/1246 (16.1%) patients received TNFi in CDM and SEER/TCR-Medicare respectively. In the 1 year landmark, no significant differences in OS were observed between patients treated with TNFi and patients treated with csDMARDs only in CDM (hazard ratio [HR] = 0.77, 95% confidence interval [CI] 0.42-1.40) or SEER/TCR-Medicare (HR = 0.84, 95% CI 0.54-1.31). BCSS (SEER/TCR-Medicare) was better in patients receiving TNFi than in those receiving csDMARDs only (HR = 0.28, 95% CI 0.08-0.98). In CDM, glucocorticoid therapy had worse OS than those without glucocorticoids (HR = 2.18, 95% CI 1.13-4.18). This was also observed in SEER/TCR-Medicare (not statistically significant). Similar results were observed for the 2 year landmark.

Conclusions: TNFi treatment during the first two years after early BC was not associated with worse survival.

背景:肿瘤坏死因子抑制剂(TNFi)用于治疗新确诊癌症患者的自身免疫性疾病一直备受关注。我们评估了类风湿性关节炎(RA)患者和新确诊的早期乳腺癌(BC)患者在BC确诊后两年内接受TNFi治疗的生存情况:我们在两个数据集中识别了患者:(1) Optum 的去标识化 Clinformatics® Data Mart 数据库 (CDM);(2) 监测、流行病学和最终结果计划 (SEER) 和德克萨斯州癌症登记处 (TCR) 医保关联队列。我们根据患者在 BC 后 2 年内是否接受 TNFi 治疗、仅接受传统合成改良抗风湿药 (csDMARDs) 治疗或未接受 DMARDs 治疗进行分组。结果为总生存期(OS)和BC特异性生存期(BCSS)。我们在第1年和第2年进行了地标分析,并使用倾向评分进行多变量Cox回归调整:在 BC 后的第一年,CDM 和 SEER/TCR-Medicare 分别有 165/970 (17.0%) 和 201/1246 (16.1%) 例患者接受了 TNFi 治疗。在CDM(危险比[HR] = 0.77,95%置信区间[CI] 0.42-1.40)或SEER/TCR-Medicare(HR = 0.84,95%置信区间[CI] 0.54-1.31)中,接受TNFi治疗的患者与仅接受csDMARDs治疗的患者在1年的OS方面没有观察到显著差异。接受TNFi治疗的患者的BCSS(SEER/TCR-Medicare)优于仅接受csDMARDs治疗的患者(HR = 0.28,95% CI 0.08-0.98)。在CDM中,接受糖皮质激素治疗的患者的OS比未接受糖皮质激素治疗的患者差(HR = 2.18,95% CI 1.13-4.18)。在 SEER/TCR-Medicare 中也观察到这种情况(无统计学意义)。结论:TNFi治疗的头两年也会出现类似的结果:结论:早期 BC 后头两年的 TNFi 治疗与生存率下降无关。
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引用次数: 0
Acknowledgments to reviewers 2024. 鸣谢审稿人 2024.
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-27 DOI: 10.1007/s12282-024-01631-0
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引用次数: 0
Non-irradiated area of intraoperative radiotherapy with electron technique: outcomes and pattern of failure in early-stage breast cancer from a single-center, registry study 采用电子技术进行术中放疗的非照射区:一项单中心登记研究得出的早期乳腺癌疗效和失败模式
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-10 DOI: 10.1007/s12282-024-01624-z
Tanun Jitwatcharakomol, Jiraporn Setakornnukul, Suebwong Chuthatisith, Adune Ratanawichitrasin, Janjira Petsuksiri, Naponwan Sirima, Kullathorn Thephamongkhol

Introduction

Intraoperative radiotherapy (IORT) with electrons has revealed to have higher rates of ipsilateral breast tumor recurrence (IBTR) than external beam radiotherapy in updated large-scale, randomized controlled trials in 2021. This study details the oncological outcomes of IORT with electron beams using our strict IORT policies. We have found new and important observations regarding the location of recurrence.

Methods and materials

This is a single institution registry of early-stage breast cancer patients who underwent lumpectomy and electron beam IORT with appropriate cone size. All patients met our pre-excision requirements. The primary endpoint was 5-year IBTR rate, with secondary endpoints being 5-year locoregional failure rate, 5-year distant metastasis rate, 5-year overall survival and, importantly, the failure patterns.

Results

Between January 2011 and December 2022, 124 patients were recruited. The median follow-up was 6.7 years. The 5-year IBTR rate was 1.87% (95% CI 0.47–7.29%), which is much lower than the ELIOT trial and comparable with other accelerated partial breast irradiation (APBI) techniques. The 5-year locoregional failure rate was 3.68% (95% CI 1.40–9.52%), and the 5-year distant metastasis rate was 0.88% (95% CI 0.13–6.12%), while the 5-year overall survival rate was 97.52% (95% CI 92.44–99.19%). Six patients experienced IBTR. All recurrences were in surgical area, occurring superficial to the tumor bed and within 1 cm of the skin dermis. This failure pattern is very unique and might be explained by our hypothesis of the non-irradiated area beneath the skin.

Conclusions

IORT with electron beams with strict patient selection criteria and strict large cone size is still an acceptable treatment for select patients with early-stage breast cancer. However, our new findings support extreme caution in the non-irradiated area beneath the skin around the tumor cavity. Given the constraints of our sample size, these findings should be interpreted cautiously and warrant further investigation in larger, more comprehensive studies.

导言在2021年更新的大规模随机对照试验中发现,使用电子束的术中放疗(IORT)的同侧乳腺肿瘤复发率(IBTR)高于外照射放疗。本研究详细介绍了使用电子束进行IORT的肿瘤学结果,并采用了我们严格的IORT政策。我们发现了关于复发位置的新的重要观察结果。方法和材料这是一项单机构登记,对象是接受肿块切除术和适当锥体大小的电子束 IORT 的早期乳腺癌患者。所有患者均符合切除术前要求。主要终点是 5 年 IBTR 率,次要终点是 5 年局部失败率、5 年远处转移率、5 年总生存率,以及重要的失败模式。中位随访时间为 6.7 年。5年IBTR率为1.87%(95% CI 0.47-7.29%),远低于ELIOT试验,与其他加速乳腺部分照射(APBI)技术相当。5年局部失败率为3.68%(95% CI 1.40-9.52%),5年远处转移率为0.88%(95% CI 0.13-6.12%),5年总生存率为97.52%(95% CI 92.44-99.19%)。6名患者出现了IBTR。所有复发均发生在手术区域,位于肿瘤床表层,距离皮肤真皮层不到 1 厘米。这种失败模式非常独特,也许可以用我们关于皮下非照射区的假设来解释。然而,我们的新研究结果表明,对肿瘤腔周围皮下非照射区的治疗要格外谨慎。鉴于我们的样本量有限,这些发现应谨慎解读,并值得在更大规模、更全面的研究中进一步探讨。
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引用次数: 0
Contrast-enhanced mammography in the management of breast architectural distortions and avoidance of unnecessary biopsies. 对比增强乳腺 X 射线照相术在处理乳房结构变形和避免不必要的活组织检查中的应用。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-29 DOI: 10.1007/s12282-024-01599-x
Chiara Bellini, Francesca Pugliese, Giulia Bicchierai, Francesco Amato, Diego De Benedetto, Federica Di Naro, Cecilia Boeri, Ermanno Vanzi, Giuliano Migliaro, Ludovica Incardona, Cinzia Tommasi, Lorenzo Orzalesi, Vittorio Miele, Jacopo Nori

Background: To assess contrast-enhanced mammography (CEM) in the management of BI-RADS3 breast architectural distortions (AD) in digital breast tomosynthesis (DBT).

Methods: We retrospectively reviewed 328 women with 332 ADs detected on DBT between 2017 and 2021 and selected those classified as BI-RADS3 receiving CEM as problem-solving. In CEM recombined images, we evaluated AD's contrast enhancement (CE) according to its presence/absence, type, and size. AD with enhancement underwent imaging-guided biopsy while AD without enhancement follow-up or biopsy if detected in high/intermediate-risk women.

Results: AD with enhancement were 174 (52.4%): 72 (41.4%) were malignant lesions, 102 (59.6%) false positive results: 28 (16%) B3 lesions, and 74 (42.5%) benign lesions. AD without enhancement were 158 (47.6%): 26 (16.5%) were subjected to biopsy (1 malignant and 25 benign) while the other 132 cases were sent to imaging follow-up, still negative after two years. CEM's sensitivity, specificity, positive (PPV) and negative predictive values (NPV), and accuracy were 98.63%, 60.62%, 41.38%, 99.37%, and 68.98%. The AUC determined by ROC was 0.796 (95% CI, 0.749-0.844).

Conclusion: CEM has high sensitivity and NPV in evaluating BI-RADS3 AD and can be a complementary tool in assessing AD, avoiding unnecessary biopsies without compromising cancer detection.

背景:评估对比增强乳腺X线摄影(CEM)在数字乳腺断层合成术(DBT)中处理BI-RADS3乳腺结构变形(AD)的效果:目的:评估造影剂增强乳腺摄影(CEM)在数字乳腺断层合成术(DBT)中处理BI-RADS3乳腺结构变形(AD)的情况:我们回顾性地查看了2017年至2021年间328名女性在DBT中检测到的332个AD,并选择被归类为BI-RADS3的女性接受CEM作为问题解决方案。在CEM重组图像中,我们根据AD的有/无、类型和大小评估其对比度增强(CE)。如果在高危/中危妇女中发现有增强的 AD,则在成像引导下进行活检;如果发现无增强的 AD,则进行随访或活检:结果:有增强的 AD 为 174 例(52.4%):72例(41.4%)为恶性病变,102例(59.6%)为假阳性结果:28例(16%)为B3病变,74例(42.5%)为良性病变。无强化的 AD 为 158 例(47.6%):26 例(16.5%)进行了活检(1 例为恶性,25 例为良性),其他 132 例进行了影像学随访,两年后仍为阴性。CEM的敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)以及准确性分别为98.63%、60.62%、41.38%、99.37%和68.98%。ROC得出的AUC为0.796(95% CI,0.749-0.844):CEM在评估BI-RADS3 AD方面具有较高的灵敏度和NPV,可作为评估AD的辅助工具,在不影响癌症检测的情况下避免不必要的活检。
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引用次数: 0
Resilience's impact on quality of life and post-traumatic growth in breast cancer patients during treatment. 复原力对乳腺癌患者在治疗期间的生活质量和创伤后成长的影响。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-17 DOI: 10.1007/s12282-024-01594-2
Songül Duran, Umut Varol, Özlem Tekir, Ahmet Hakan Soytürk

Background: This article aims to examine how psychological resilience influences the interplay between quality of life and post-traumatic growth among breast cancer patients receiving follow-up care and treatment in Türkiye.

Methods: The study involved 119 female individuals diagnosed with breast cancer who visited the Oncology outpatient clinic at a state hospital in Türkiye from January to September 2023. Data were gathered through the administration of a survey form and the utilization of several assessment tools, including the Adult Life Quality Scale in Cancer Survivors (QLACS), the Brief Resilience Scale (BRS), and the Post-traumatic Growth Inventory (PTGI). Data analysis was carried out using SPSS 25 software.

Results: The participants demonstrated an inverse correlation between Post-Traumatic Growth (PTG) and two QLACS sub-dimensions, namely recurrence and family concern. Conversely, a positive association was identified between PTG and the advantages of dealing with cancer. Furthermore, a statistically significant positive association was established between BRS and all QLACS sub-dimensions, except for family concern and appearance. However, it was determined that psychological resilience did not act as a moderator in the relationship between PTG and QLACS.

Conclusion: It is important to enhance psychological resilience in women who have survived cancer at all stages of the cancer journey, including the years after treatment, to have a positive impact on post-traumatic growth and quality of life.

研究背景本文旨在研究在土耳其接受后续护理和治疗的乳腺癌患者中,心理复原力如何影响生活质量和创伤后成长之间的相互作用:本研究涉及 119 名确诊为乳腺癌的女性患者,她们于 2023 年 1 月至 9 月期间在土耳其一家国立医院的肿瘤科门诊就诊。通过发放调查表和使用多种评估工具收集数据,包括癌症幸存者成人生活质量量表(QLACS)、简易复原力量表(BRS)和创伤后成长量表(PTGI)。数据分析采用 SPSS 25 软件进行:结果:受试者的创伤后成长(PTG)与 QLACS 的两个子维度(即复发和家庭关注)呈反向相关。相反,创伤后成长与应对癌症的优势之间存在正相关。此外,除家庭关注和外表外,BRS 与所有 QLACS 子维度之间均存在统计学意义上的显著正相关。然而,研究结果表明,在 PTG 与 QLACS 的关系中,心理复原力并没有起到调节作用:结论:在癌症治疗过程的各个阶段,包括治疗后的数年,增强癌症女性患者的心理复原力对创伤后成长和生活质量具有积极影响,这一点非常重要。
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引用次数: 0
Mesenchymal-like immune-altered is the fourth robust triple-negative breast cancer molecular subtype. 间质样免疫改变是第四个强大的三阴性乳腺癌分子亚型。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-22 DOI: 10.1007/s12282-024-01597-z
Pascal Jézéquel, Hamza Lasla, Wilfried Gouraud, Agnès Basseville, Bertrand Michel, Jean-Sébastien Frenel, Philippe P Juin, Fadoua Ben Azzouz, Mario Campone

Background: Robust molecular subtyping of triple-negative breast cancer (TNBC) is a prerequisite for the success of precision medicine. Today, there is a clear consensus on three TNBC molecular subtypes: luminal androgen receptor (LAR), basal-like immune-activated (BLIA), and basal-like immune-suppressed (BLIS). However, the debate about the robustness of other subtypes is still open.

Methods: An unprecedented number (n = 1942) of TNBC patient data was collected. Microarray- and RNAseq-based cohorts were independently investigated. Unsupervised analyses were conducted using k-means consensus clustering. Clusters of patients were then functionally annotated using different approaches. Prediction of response to chemotherapy and targeted therapies, immune checkpoint blockade, and radiotherapy were also screened for each TNBC subtype.

Results: Four TNBC subtypes were identified in the cohort: LAR (19.36%); mesenchymal stem-like (MSL/MES) (17.35%); BLIA (31.06%); and BLIS (32.23%). Regarding the MSL/MES subtype, we suggest renaming it to mesenchymal-like immune-altered (MLIA) to emphasize its specific histological background and nature of immune response. Treatment response prediction results show, among other things, that despite immune activation, immune checkpoint blockade is probably less or completely ineffective in MLIA, possibly caused by mesenchymal background and/or an enrichment in dysfunctional cytotoxic T lymphocytes. TNBC subtyping results were included in the bc-GenExMiner v5.0 webtool ( http://bcgenex.ico.unicancer.fr ).

Conclusion: The mesenchymal TNBC subtype is characterized by an exhausted and altered immune response, and resistance to immune checkpoint inhibitors. Consensus for molecular classification of TNBC subtyping and prediction of cancer treatment responses helps usher in the era of precision medicine for TNBC patients.

背景:对三阴性乳腺癌(TNBC)进行可靠的分子亚型鉴定是精准医疗取得成功的先决条件。如今,人们已就三种 TNBC 分子亚型达成明确共识:腔内雄激素受体 (LAR)、基底样免疫激活 (BLIA) 和基底样免疫抑制 (BLIS)。然而,关于其他亚型的稳健性仍有争议:方法:收集了数量空前(n = 1942)的 TNBC 患者数据。对基于芯片和 RNAseq 的队列进行了独立调查。使用 k-means 共识聚类法进行了无监督分析。然后使用不同的方法对患者群进行功能注释。还对每种 TNBC 亚型的化疗和靶向治疗、免疫检查点阻断和放疗反应进行了预测:结果:队列中发现了四种TNBC亚型:LAR(19.36%)、间充质干样(MSL/MES)(17.35%)、BLIA(31.06%)和BLIS(32.23%)。关于 MSL/MES 亚型,我们建议将其更名为间充质样免疫改变(MLIA),以强调其特殊的组织学背景和免疫反应性质。治疗反应预测结果显示,尽管存在免疫激活,但免疫检查点阻断在MLIA中可能效果较差或完全无效,这可能是间质背景和/或功能失调的细胞毒性T淋巴细胞富集所致。TNBC亚型结果已纳入bc-GenExMiner v5.0网络工具(http://bcgenex.ico.unicancer.fr ):间质 TNBC 亚型的特点是免疫反应衰竭和改变,以及对免疫检查点抑制剂的耐药性。TNBC 亚型分子分类和癌症治疗反应预测的共识有助于 TNBC 患者进入精准医疗时代。
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引用次数: 0
Cost-effectiveness of adjuvant endocrine treatment with tamoxifen for male breast cancer. 使用他莫昔芬辅助内分泌治疗男性乳腺癌的成本效益。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-06-15 DOI: 10.1007/s12282-024-01605-2
Yaping Huang, Chengjie Ke, Jiaqin Cai, Xiaoxia Wei, Maohua Chen, Hong Sun

Background: Tamoxifen (TAM) is recommended as the first-line strategy for men with estrogen receptor (ER)-positive early breast cancer who are candidates for adjuvant endocrine therapy in ASCO guideline. Our study aims to analyze the cost-effectiveness of receiving adjuvant endocrine therapy with TAM compared to no TAM, and to assess the cost-effectiveness of using TAM with high adherence over low adherence for ER-positive early male breast cancer in the USA.

Methods: Two Markov models comprising three mutually exclusive health states were constructed: (1) the first Markov model compared the cost-effectiveness of adding TAM with not using TAM (TAM versus Not-TAM); (2) the second model compared the cost-effectiveness of receiving TAM with high adherence and low adherence (High-adherence-TAM versus Low-adherence-TAM). The simulation time horizon for both models was the lifetime of patients. The efficacy and safety data of two models were elicited from the real-world studies. Model inputs were derived from the US website and published literature. The main outcomes of two models both included the total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).

Results: In the first model, TAM yielded an ICER of $5707.29 per QALY compared to Not-TAM, which was substantially below the WTP threshold of $50,000.00 per QALY in the USA. Probabilistic sensitivity analysis results demonstrated a 100.00% probability of cost-effectiveness for this strategy. In the second model, High-adherence-TAM was dominated absolutely compared to Low-adherence-TAM. The High-adherence-TAM was cost-effective with a 99.70% probability over Low-adherence-TAM when WTP was set as $50,000.00/QALY. All of these parameters within their plausible ranges did not reversely change the results of our models.

Conclusions: Our study will offer valuable guidance for physicians or patients when making treatment decisions and provide an effective reference for decision-making to consider the appropriate allocation of funds to this special group.

背景:ASCO指南推荐他莫昔芬(TAM)作为雌激素受体(ER)阳性早期乳腺癌男性患者辅助内分泌治疗的一线策略。我们的研究旨在分析与不使用 TAM 相比,使用 TAM 接受辅助内分泌治疗的成本效益,并评估美国 ER 阳性早期男性乳腺癌患者使用高依从性 TAM 而非低依从性 TAM 的成本效益:方法:构建了两个马尔可夫模型,包括三种相互排斥的健康状态:(1)第一个马尔可夫模型比较了添加 TAM 与不使用 TAM 的成本效益(TAM 与 Not-TAM);(2)第二个模型比较了接受高依从性 TAM 与低依从性 TAM 的成本效益(High-adherence-TAM 与 Low-adherence-TAM)。两个模型的模拟时间范围均为患者的终生。两个模型的疗效和安全性数据均来自真实世界的研究。模型输入数据来自美国网站和公开发表的文献。两个模型的主要结果均包括总成本、质量调整生命年(QALYs)和增量成本效益比(ICERs):在第一个模型中,TAM 与非 TAM 相比,每 QALY 的 ICER 为 5707.29 美元,大大低于美国每 QALY 50,000.00 美元的 WTP 临界值。概率敏感性分析结果表明,该策略的成本效益概率为 100.00%。在第二个模型中,与低依从性-TAM 相比,高依从性-TAM 占绝对优势。当 WTP 设为 50,000.00 美元/QALY 时,高依从性-TAM 的成本效益概率为 99.70%,而低依从性-TAM 的成本效益概率为 99.70%。所有这些参数在其合理范围内都不会反向改变我们的模型结果:我们的研究将为医生或患者做出治疗决定提供有价值的指导,并为考虑向这一特殊群体适当分配资金提供有效的决策参考。
{"title":"Cost-effectiveness of adjuvant endocrine treatment with tamoxifen for male breast cancer.","authors":"Yaping Huang, Chengjie Ke, Jiaqin Cai, Xiaoxia Wei, Maohua Chen, Hong Sun","doi":"10.1007/s12282-024-01605-2","DOIUrl":"10.1007/s12282-024-01605-2","url":null,"abstract":"<p><strong>Background: </strong>Tamoxifen (TAM) is recommended as the first-line strategy for men with estrogen receptor (ER)-positive early breast cancer who are candidates for adjuvant endocrine therapy in ASCO guideline. Our study aims to analyze the cost-effectiveness of receiving adjuvant endocrine therapy with TAM compared to no TAM, and to assess the cost-effectiveness of using TAM with high adherence over low adherence for ER-positive early male breast cancer in the USA.</p><p><strong>Methods: </strong>Two Markov models comprising three mutually exclusive health states were constructed: (1) the first Markov model compared the cost-effectiveness of adding TAM with not using TAM (TAM versus Not-TAM); (2) the second model compared the cost-effectiveness of receiving TAM with high adherence and low adherence (High-adherence-TAM versus Low-adherence-TAM). The simulation time horizon for both models was the lifetime of patients. The efficacy and safety data of two models were elicited from the real-world studies. Model inputs were derived from the US website and published literature. The main outcomes of two models both included the total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).</p><p><strong>Results: </strong>In the first model, TAM yielded an ICER of $5707.29 per QALY compared to Not-TAM, which was substantially below the WTP threshold of $50,000.00 per QALY in the USA. Probabilistic sensitivity analysis results demonstrated a 100.00% probability of cost-effectiveness for this strategy. In the second model, High-adherence-TAM was dominated absolutely compared to Low-adherence-TAM. The High-adherence-TAM was cost-effective with a 99.70% probability over Low-adherence-TAM when WTP was set as $50,000.00/QALY. All of these parameters within their plausible ranges did not reversely change the results of our models.</p><p><strong>Conclusions: </strong>Our study will offer valuable guidance for physicians or patients when making treatment decisions and provide an effective reference for decision-making to consider the appropriate allocation of funds to this special group.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":"917-925"},"PeriodicalIF":4.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141328190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The effect of exercise and educational programs for breast cancer patients on the development of breast cancer-related lymphoedema: secondary endpoint from a randomized controlled trial in the Setouchi Breast Project-10. 乳腺癌患者运动和教育计划对乳腺癌相关淋巴水肿发展的影响:濑户内乳腺项目-10随机对照试验的次要终点。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-09 DOI: 10.1007/s12282-024-01610-5
Shogo Nakamoto, Takayuki Iwamoto, Naruto Taira, Yukiko Kajiwara, Kengo Kawada, Daisuke Takabatake, Yuichiro Miyoshi, Shinichiro Kubo, Yoko Suzuki, Mari Yamamoto, Yutaka Ogasawara, Minami Hatono, Seiji Yoshitomi, Kyoko Hara, Asako Sasahara, Shozo Ohsumi, Masahiko Ikeda, Hiroyoshi Doihara, Yuri Mizota, Seiichiro Yamamoto, Tadahiko Shien, Shinichi Toyooka

Background: Although the association between higher physical activity and preventive effect on breast-cancer-related lymphoedema (BCRL) has been reported, it is unclear what intervention is optimal. We aimed to investigate the effect of exercise and educational programs on BCRL development.

Methods: This study was a secondary endpoint analysis from a prospective randomized controlled trial. We enrolled patients with stage 0-III breast cancer from March 2016 to March 2020 and randomly assigned them to the control (n = 111), education (n = 115), or exercise (n = 104) group. As secondary endpoint, we assessed the incidence of and preventive effect on BCRL at 12 months post-intervention.

Results: There were no significant differences in the incidence of BCRL at 12 months post-intervention between the exercise and control groups (9.8% and 10.8%, P = 0.83) and the education and control groups (11.6% and 10.8%, P = 1.00). There were no significant differences in time to BCRL onset from the day of surgery between the exercise and control groups (event rate at 12 months: 20.7% and 17.2%, log-rank, P = 0.54) and the education and control groups (18.8% and 17.2%, log-rank, P = 0.57). The multivariable analyses indicated that axillary dissection and obesity significantly increased the risk of BCRL [hazard ratio (HR): 2.36, 95% confidence interval (CI) 1.52-3.67 and HR: 1.68, 95% CI 1.07-2.63, respectively].

Conclusions: The intervention did not decrease the risk of BCRL, and axillary dissection and obesity were the risk factors of BCRL.

Trial registration number: UMIN000020595 at UMIN Clinical Trial Registry.

背景:尽管有报道称增加体育锻炼与预防乳腺癌相关淋巴水肿(BCRL)之间存在关联,但目前尚不清楚哪种干预措施是最佳的。我们旨在研究运动和教育项目对乳腺癌相关淋巴水肿发展的影响:本研究是一项前瞻性随机对照试验的次要终点分析。我们在2016年3月至2020年3月期间招募了0-III期乳腺癌患者,并将他们随机分配到对照组(n = 111)、教育组(n = 115)或运动组(n = 104)。作为次要终点,我们评估了干预后 12 个月 BCRL 的发生率和预防效果:结果:干预后 12 个月,运动组和对照组(9.8% 和 10.8%,P = 0.83)以及教育组和对照组(11.6% 和 10.8%,P = 1.00)的 BCRL 发生率无明显差异。运动组和对照组(12 个月时的事件发生率分别为 20.7% 和 17.2%,对数秩和,P = 0.54)以及教育组和对照组(18.8% 和 17.2%,对数秩和,P = 0.57)在从手术当天到 BCRL 发病的时间上没有明显差异。多变量分析表明,腋窝解剖和肥胖会显著增加 BCRL 的风险[危险比(HR):2.36,95% 置信区间(CI)分别为 1.52-3.67 和 HR:1.68,95% CI 1.07-2.63]:干预并没有降低 BCRL 的风险,腋窝解剖和肥胖是 BCRL 的风险因素:UMIN000020595 at UMIN Clinical Trial Registry.
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引用次数: 0
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Breast Cancer
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