Neoadjuvant therapy

新辅助治疗
  • 文章类型: Journal Article
    背景:基于JCOG1109试验,建议多西他赛的组合,顺铂,和5-氟尿嘧啶(DCF)可能成为标准的新辅助化疗方案,除了常规的5-氟尿嘧啶和顺铂(CF)治疗,食道癌.然而,关于新辅助化疗相关的身体成分变化对预后的影响的报道很少。
    目的:本研究旨在探讨不同新辅助化疗方案在治疗过程中对机体成分的影响以及机体成分变化对其预后的影响。
    结果:这是一项对2013年至2019年新辅助化疗后接受手术的215例晚期胸段食管癌患者的回顾性研究。在新辅助化疗前后进行计算机断层扫描以评估身体成分。骨骼肌质量指数(SMI)是通过将第3腰椎水平的总骨骼肌质量除以身高的平方来计算的。而内脏和皮下脂肪量在脐水平测量。男女最低25%的患者分为低内脏脂肪和低皮下脂肪组,分别。在登记的患者中,男性178人,女性37人。其中,91人患有临床II期疾病,124人患有临床III期疾病。此外,146例患者接受新辅助化疗CF,69例接受新辅助化疗DCF。比较DCF和CF组,DCF组由明显年轻的患者组成(p<0.01),男性比例较高(p=0.03),和更多的临床III期病例(p<0.01)。然而,尽管两种方案的SMI和内脏脂肪量的百分比变化没有显着差异,在DCF组中,皮下脂肪量的百分比变化显着。胸段食管癌新辅助化疗后手术患者的主要预后因素为临床III期,过渡到低内脏脂肪,和响应等级(SD/PD),而特定的新辅助化疗方案对结局无显著影响.
    结论:这项研究表明,在整个新辅助化疗过程中,预防向低内脏脂肪转移应能改善患者的预后。
    BACKGROUND: Based on the JCOG1109 trial, it is suggested that the combination of docetaxel, cisplatin, and 5-fluorouracil (DCF) could potentially become a standard neoadjuvant chemotherapy regimen, alongside the conventional 5-fluorouracil and cisplatin (CF) therapy, for esophageal cancer. However, there are few reports on the impact of body composition changes associated with neoadjuvant chemotherapy on prognosis.
    OBJECTIVE: Our study aimed to explore the effect of different neoadjuvant chemotherapy regimens on body composition during treatment and the impacts of body composition changes on their prognosis.
    RESULTS: This is a retrospective study of 215 patients with advanced thoracic esophageal cancer who had surgery after neoadjuvant chemotherapy from 2013 to 2019. Computed tomography scans were performed before and after neoadjuvant chemotherapy to assess body composition. Skeletal muscle mass index (SMI) was calculated by dividing total skeletal muscle mass at the 3rd lumbar level by the square of height, while visceral and subcutaneous fat masses were measured at the level of umbilicus. Patients in the lowest 25% of both sexes were classified into the low visceral fat and low subcutaneous fat groups, respectively. Of the patients enrolled, 178 were male and 37 were female. Among them, 91 had clinical Stage II disease, and 124 had clinical Stage III disease. Additionally, 146 patients received neoadjuvant chemotherapy CF, and 69 received neoadjuvant chemotherapy DCF. Comparing the DCF and CF groups, the DCF group consisted of significantly younger patients (p < .01), a higher proportion of males (p = .03), and a greater number of clinical Stage III cases (p < .01). However, although percent change in SMI and visceral fat mass was not significantly different between two regimens, percent change in subcutaneous fat mass was significant in the DCF group. The major prognostic factors for patients undergoing surgery after neoadjuvant chemotherapy for thoracic esophageal cancer were clinical Stage III, transition to low visceral fat, and response rating (SD/PD), while the specific neoadjuvant chemotherapy regimen did not significantly influence the outcomes.
    CONCLUSIONS: This study suggests that prevention of the shift to low visceral fat throughout the neoadjuvant chemotherapy process should improve patient outcomes.
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  • 文章类型: Journal Article
    基于铂的新辅助化疗(NACT)以及根治性子宫切除术已被提议作为Ib2-IIb期宫颈癌(CC)的替代治疗方法。他们强烈希望接受手术治疗。我们的研究旨在通过使用影像组学和深度学习来开发基于多模态MRI的模型,以预测接受新辅助放化疗(NACRT)治疗的CC患者的治疗反应。2009年8月至2013年6月,在福建省肿瘤医院接受NACRT治疗的Ib2-IIb期(FIGO2008)CC患者纳入本研究。临床信息,对比增强T1加权成像(CE-T1WI),分别收集T2加权成像(T2WI)数据。使用影像组学和深度学习模型从图像中提取影像组学特征和深度抽象特征,分别。然后,使用ElasticNet和SVM-RFE进行特征选择,以构建四个单序列特征集。进行了两个多序列特征集和一个混合特征集的早期融合,其次是使用四个机器学习分类器进行分类预测。随后,通过将患者分为训练集和验证集来评估模型在预测NACRT应答方面的性能.此外,使用Kaplan-Meier存活曲线评估总生存期(OS)和无病生存期(DFS).在四种机器学习模型中,SVM表现出最佳的预测性能(AUC=0.86)。在七个功能集中,混合功能集实现了AUC(0.86)的最高值,ACC(0.75),召回(0.75),精度(0.81),和验证集中的F1分数(0.75),优于其他功能集。此外,模型的预测结局与患者OS和DFS密切相关(p=0.0044;p=0.0039).基于具有来自多个序列和不同方法的特征的MRI图像的模型可以精确地预测CC患者对NACRT的反应。该模型可以帮助临床医生制定个性化的治疗计划并预测患者的生存结果。
    Platinum-based neoadjuvant chemotherapy (NACT) followed by radical hysterectomy has been proposed as an alternative treatment approach for cervical cancer (CC) in stage Ib2-IIb, who had a strong desire to be treated with surgery. Our study aims to develop a model based on multimodal MRI by using radiomics and deep learning to predict the treatment response in CC patients treated with neoadjuvant chemoradiotherapy (NACRT). From August 2009 to June 2013, CC patients in stage Ib2-IIb (FIGO 2008) who received NACRT at Fujian Cancer Hospital were enrolled in our study. Clinical information, contrast-enhanced T1-weighted imaging (CE-T1WI), and T2-weighted imaging (T2WI) data were respectively collected. Radiomic features and deep abstract features were extracted from the images using radiomics and deep learning models, respectively. Then, ElasticNet and SVM-RFE were employed for feature selection to construct four single-sequence feature sets. Early fusion of two multi-sequence feature sets and one hybrid feature set were performed, followed by classification prediction using four machine learning classifiers. Subsequently, the performance of the models in predicting the response to NACRT was evaluated by separating patients into training and validation sets. Additionally, overall survival (OS) and disease-free survival (DFS) were assessed using Kaplan-Meier survival curves. Among the four machine learning models, SVM exhibited the best predictive performance (AUC=0.86). Among the seven feature sets, the hybrid feature set achieved the highest values for AUC (0.86), ACC (0.75), Recall (0.75), Precision (0.81), and F1-score (0.75) in the validation set, outperforming other feature sets. Furthermore, the predicted outcomes of the model were closely associated with patient OS and DFS (p = 0.0044; p = 0.0039). A model based on MRI images with features from multiple sequences and different methods could precisely predict the response to NACRT in CC patients. This model could assist clinicians in devising personalized treatment plans and predicting patient survival outcomes.
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  • 文章类型: Journal Article
    为患有直肠癌的个体患者确定最佳治疗计划是一个复杂的过程。除了与直肠癌手术意图有关的决定外(即,治愈性或姑息性),还必须考虑治疗的可能功能结果,包括维持或恢复正常肠道功能/肛门失禁和保持泌尿生殖系统功能的可能性。特别是对于远端直肠癌患者,在治愈-意向治疗之间找到平衡,同时对生活质量的影响最小可能是一项挑战.此外,与结肠癌患者相比,直肠癌患者的盆腔复发风险更高,局部复发性直肠癌与不良预后相关。建议谨慎选择患者,并在多学科方法后使用测序的多模态疗法。这些NCCN指南见解详细介绍了NCCN直肠癌指南的最新更新,包括增加内镜黏膜下剥离术作为早期直肠癌的一种选择,根据最近临床试验的结果,对总体新辅助治疗方法进行了更新,并为新辅助治疗的临床完全缓解者增加“观察并等待”非手术管理方法。
    The determination of an optimal treatment plan for an individual patient with rectal cancer is a complex process. In addition to decisions relating to the intent of rectal cancer surgery (ie, curative or palliative), consideration must also be given to the likely functional results of treatment, including the probability of maintaining or restoring normal bowel function/anal continence and preserving genitourinary functions. Particularly for patients with distal rectal cancer, finding a balance between curative-intent therapy while having minimal impact on quality of life can be challenging. Furthermore, the risk of pelvic recurrence is higher in patients with rectal cancer compared with those with colon cancer, and locally recurrent rectal cancer is associated with a poor prognosis. Careful patient selection and the use of sequenced multimodality therapy following a multidisciplinary approach is recommended. These NCCN Guidelines Insights detail recent updates to the NCCN Guidelines for Rectal Cancer, including the addition of endoscopic submucosal dissection as an option for early-stage rectal cancer, updates to the total neoadjuvant therapy approach based on the results of recent clinical trials, and the addition of a \"watch-and-wait\" nonoperative management approach for clinical complete responders to neoadjuvant therapy.
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  • 文章类型: Journal Article
    背景:三阴性乳腺癌(TNBC)是一种侵袭性亚型,预后不良。我们旨在确定循环肿瘤DNA(ctDNA)和循环肿瘤细胞(CTC)是否可以预测新辅助化疗(NAC)的疗效和长期结局。
    方法:TNBC患者于2017-2021年在德克萨斯大学MD安德森癌症中心(休斯顿,TX)。在四个时间点收集系列血浆样品:pre-NAC(基线),NAC后12周(NAC中期),NAC后/手术前(NAC后),手术后一年.使用肿瘤知情的ctDNA测定法(SignateraTM,Natera,Inc.)和使用CellSearch的CTC枚举。Wilcoxon和Fisher精确检验用于组间比较,Kaplan-Meier分析用于生存结果。
    结果:总计,37例患者入选。平均年龄为50岁,大多数患者患有浸润性导管癌(34,91.9%),临床T2(25,67.6%)为淋巴结阴性疾病(21,56.8%)。在90%(27/30)的患者中检测到基线ctDNA,其中70.4%(19/27)通过NAC中期实现了ctDNA清除。在中期NAC时ctDNA清除与病理性完全缓解显着相关(p=0.02),而CTC清除率没有(p=0.52)。基线ctDNA和CTC阳性的总生存期(OS)和无复发生存期(RFS)没有差异。然而,NAC中期的ctDNA阳性与OS和RFS恶化显著相关(分别为p=0.0002和p=0.0034).
    结论:ctDNA的早期清除可作为TNBC的预测和预后标志物。NAC期间的个性化ctDNA监测可能有助于预测反应并指导治疗。
    BACKGROUND: Triple negative breast cancer (TNBC) is an aggressive subtype with poor prognosis. We aimed to determine whether circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) could predict response and long-term outcomes to neoadjuvant chemotherapy (NAC).
    METHODS: Patients with TNBC were enrolled between 2017-2021 at The University of Texas MD Anderson Cancer Center (Houston, TX). Serial plasma samples were collected at four timepoints: pre-NAC (baseline), 12-weeks after NAC (mid-NAC), after NAC/prior to surgery (post-NAC), and one-year after surgery. ctDNA was quantified using a tumor-informed ctDNA assay (SignateraTM, Natera, Inc.) and CTC enumeration using CellSearch. Wilcoxon and Fisher\'s exact tests were used for comparisons between groups and Kaplan-Meier analysis used for survival outcomes.
    RESULTS: In total, 37 patients were enrolled. The mean age was 50 and majority of patients had invasive ductal carcinoma (34, 91.9%) with clinical T2, (25, 67.6%) node-negative disease (21, 56.8%). Baseline ctDNA was detected in 90% (27/30) of patients, of whom 70.4% (19/27) achieved ctDNA clearance by mid-NAC. ctDNA clearance at mid-NAC was significantly associated with pathologic complete response (p = 0.02), whereas CTC clearance was not (p = 0.52). There were no differences in overall survival (OS) and recurrence-free survival (RFS) with positive baseline ctDNA and CTC. However, positive ctDNA at mid-NAC was significantly associated with worse OS and RFS (p = 0.0002 and p = 0.0034, respectively).
    CONCLUSIONS: Early clearance of ctDNA served as a predictive and prognostic marker in TNBC. Personalized ctDNA monitoring during NAC may help predict response and guide treatment.
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  • 文章类型: Journal Article
    背景:预后营养指数(PNI)和全身炎症免疫指数(SII)是营养状态和全身炎症反应的特征性指标,分别。然而,这些指标在临床上的联合作用未知。因此,使用SII-PNI评分预测化疗后局部进展期胃癌(LAGC)的预后和肿瘤反应的实用性是本研究的主要重点.
    方法:我们在一项前瞻性研究(NCT01516944)中回顾性分析了181例LAGC患者在新辅助化疗后接受根治性切除术。我们根据肿瘤反应(AJCC/CAP指南)将这些患者分为肿瘤消退等级(TRG)3和非TRG3组。在治疗前评估SII和PNI并确认截止值。SII-PNI值在0到2之间变化,其中2为高SII(≥471.5)和低PNI(≤48.6),高SII或低PNI分别由1表示,并且两者都不由0表示。
    结果:51和130个样品分别具有TRG3和非TRG3肿瘤反应。TRG3患者的SII-PNI评分明显高于无TRG3患者(p<0.0001)。SII-PNI评分较高的患者预后较差(p<0.0001)。在多变量分析中发现SII-PNI评分是总生存期(HR=4.982,95CI:1.890-10.234,p=0.001)和无病生存期(HR=4.763,95CI:1.994-13.903,p=0.001)的独立预测因子。
    结论:基于SII-PNI评分的低成本分层在预测LAGC肿瘤反应和预后方面的临床潜力和准确性令人满意。
    BACKGROUND: The prognosis nutritional index (PNI) and the systemic inflammatory immunological index (SII) are characteristic indicators of the nutritional state and the systemic inflammatory response, respectively. However, there is an unknown combined effect of these indicators in the clinic. Therefore, the practicality of using the SII-PNI score to predict prognosis and tumor response of locally advanced gastric cancer (LAGC) following chemotherapy was the main focus of this investigation.
    METHODS: We retrospectively analyzed 181 patients with LAGC who underwent curative resection after neoadjuvant chemotherapy in a prospective study (NCT01516944). We divided these patients into tumour regression grade(TRG) 3 and non-TRG3 groups based on tumor response (AJCC/CAP guidelines). The SII and PNI were assessed and confirmed the cut-off values before treatment. The SII-PNI values varied from 0 to 2, with 2 being the high SII (≥ 471.5) as well as low PNI (≤ 48.6), a high SII or low PNI is represented by a 1 and neither is represented by a 0, respectively.
    RESULTS: 51 and 130 samples had TRG3 and non-TRG3 tumor responses respectively. Patients with TRG3 had substantially higher SII-PNI scores than those without TRG3 (p < 0.0001). Patients with greater SII-PNI scores had a poorer prognosis (p < 0.0001). The SII-PNI score was found to be an independent predictor of both overall survival (HR = 4.982, 95%CI: 1.890-10.234, p = 0.001) and disease-free survival (HR = 4.763, 95%CI: 1.994-13.903, p = 0.001) in a multivariate analysis.
    CONCLUSIONS: The clinical potential and accuracy of low-cost stratification based on SII-PNI score in forecasting tumor response and prognosis in LAGC is satisfactory.
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  • 文章类型: Journal Article
    背景:新辅助免疫疗法对于具有微卫星不稳定性/错配修复缺陷(MSI/dMMR)的局部结肠癌(CC)患者是一种有希望的策略。这项研究的目的是评估通过术前计算机断层扫描(CT)扫描评估的临床cTN分期与MSI/dMMRCC的pTN分期之间的一致性。
    方法:2013年至2022年在法国两个中心连续诊断为局部MSI/dMMRCC并接受前期手术治疗的患者符合资格。两个独立的放射科医生,对病理结果视而不见,回顾所有术前CT扫描并评估cTN分期,第三位放射科医生正在审查不一致的病例.计算pT4和pN+(N+=N1或N2)的放射学预测诊断准确性。
    结果:纳入了113例患者(右CCs=79%)。pT4的CT扫描诊断性能为灵敏度(Se)=33.3%;特异性(Sp)=94.0%;阳性预测值(PPV)=66.7%;阴性预测值(NPV)=79.6%,pN为Se=70.3%;Sp=59.2%;PPV=45.6%;NPV=80.4%。当pT-pN组合时,37.5%的被鉴定为cT4和/或cN+的肿瘤实际上是pT1-3和pN0,并且23.1%的pT4和pN+群体在放射学上没有被鉴定。
    结论:对于局部MSI/dMMRCC,术前CT扫描预测pT和pN分期的能力有限。需要在该人群中重新评估新辅助治疗策略的获益-风险平衡。
    BACKGROUND: Neoadjuvant immunotherapy emerges as a promising strategy for patients with localized colon cancer (CC) harboring microsatellite instability/mismatch repair deficiency (MSI/dMMR). The aim of this study is to evaluate the concordance between clinical cTN stage assessed by preoperative computed tomography (CT) scan and pTN stage of MSI/dMMR CC.
    METHODS: Consecutive patients diagnosed for localized MSI/dMMR CC and treated with upfront surgery between 2013 and 2022 in two French centers were eligible. Two independent radiologists, blinded to pathological findings, reviewed all preoperative CT scans and assessed cTN stage, with a third radiologist reviewing discordant cases. Radiological predictive diagnostic accuracy for pT4 and pN+ (N+ = N1 or N2) were calculated.
    RESULTS: One hundred and thirteen patients were included (right CCs = 79%). CT scan diagnostic performances for pT4 were sensitivity (Se) = 33.3%; specificity (Sp) = 94.0%; positive predictive value (PPV) = 66.7%; and negative predictive value (NPV) = 79.6% and for pN+ were Se = 70.3%; Sp = 59.2%; PPV = 45.6%; and NPV = 80.4%. When pT-pN were combined, 37.5% of tumors identified as cT4 and/or cN+ were actually pT1-3 and pN0, and 23.1% of the pT4 and pN+ population was not identified as such radiologically.
    CONCLUSIONS: The ability of preoperative CT scan to predict pT and pN stages is limited for localized MSI/dMMR CCs. Reassessing neoadjuvant strategies\' benefit-risk balance in this population is needed.
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  • 文章类型: Journal Article
    前列腺癌(PCa)是男性中最常见的癌症。高危PCa与PCa相关死亡风险增加相关。联合使用雄激素剥夺治疗(ADT)对于改善高危PCa患者的肿瘤预后至关重要。当进行放疗时,相对长期的ADT给药是优选的。同时,前列腺癌根治术(RP)的新辅助治疗是否能改善肿瘤预后仍存在争议.本研究旨在回顾RP在高危PCa中的肿瘤学结果,并强调新辅助治疗的重要性,包括新辅助激素治疗(NHT)和新辅助化学激素治疗(NCHT),然后用RP管理高危PCa。
    我们使用医学主题标题(MeSH)术语搜索了2005年1月1日至2023年3月30日在PubMed和Scopus数据库中发表的文章:前列腺癌,前列腺切除术,放射治疗,新辅助治疗,和治疗结果。
    针对高危PCa的RP前NHT研究发现,NHT与不良病理特征减少有关,如pT3,阳性手术切缘(PSM),淋巴结受累.然而,尽管手术时间较短,手术结果有所改善,NHT并未显著增强生化复发(BCR)或其他肿瘤结局。使用ADT和雄激素受体信号传导抑制剂(ARSI)的联合疗法显示出不同的结果。另一项调查用紫杉烷类药物探索了NCHT,表明在高危PCa患者中可接受的治疗益处和改善的无BCR生存率,证明了这种方法的潜在可行性。正在进行的审判,就像PROTEUS的试验一样,目的进一步评价新辅助治疗对高危PCa的疗效。
    NHT治疗高危PCa无助于改善肿瘤预后,不应轻易用于降期或减少PSM。与单纯RP相比,NHT联合ARSI具有改善高危PCa肿瘤结局的潜在优势,但是目前的结果并不令人满意,并且需要使用几种不同的治疗方法开发个性化治疗策略。
    UNASSIGNED: Prostate cancer (PCa) is the most common cancer in men. High-risk PCa is associated with an increased risk of PCa-related death. The combined use of androgen deprivation therapy (ADT) is essential to improve oncological outcomes in patients with high-risk PCa, and relatively long-term ADT administration is preferred when radiotherapy is performed. Meanwhile, whether neoadjuvant therapy for radical prostatectomy (RP) improves oncological outcomes remains controversial. This study aimed to review the oncological outcomes of RP in high-risk PCa and emphasize the significance of neoadjuvant therapy including neoadjuvant hormonal therapy (NHT) and neoadjuvant chemohormonal therapy (NCHT) followed by RP for managing high-risk PCa.
    UNASSIGNED: We searched for articles published in the PubMed and Scopus databases from January 1, 2005 to March 30, 2023 using the medical subject headings (MeSH) terms: prostate cancer, prostatectomy, radiation therapy, neoadjuvant therapy, and treatment outcome.
    UNASSIGNED: The study on NHT before RP for high-risk PCa found that NHT was associated with reduced adverse pathological features, such as pT3, positive surgical margins (PSM), and lymph node involvement. However, despite shorter operative times and improved surgical outcomes, NHT did not significantly enhance biochemical recurrence (BCR) or other oncological outcomes. The combination therapy using ADT and androgen receptor signaling inhibitors (ARSI) showed varying results. Another investigation explored NCHT with taxane-based agents, indicating acceptable treatment benefits and improved BCR-free survival rates in high-risk PCa patients, demonstrating potential feasibility for this approach. Ongoing trials, like the PROTEUS trial, aim to further evaluate the therapeutic efficacy of neoadjuvant therapy in high-risk PCa.
    UNASSIGNED: NHT for high-risk PCa does not contribute to improved oncological outcome and should not be administered easily for downstaging or PSM reduction. NHT in combination with ARSI has the potential advantage of improving the oncological outcome of high-risk PCa compared to RP alone, but the results are currently unsatisfactory, and the development of individualized treatment strategies using several different therapeutic approaches is needed.
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  • 文章类型: Journal Article
    临界可切除食管鳞状细胞癌(ESCC)患者的预后和一线治疗反应不令人满意。我们正在进行临界可切除食管鳞状细胞癌(BRES-1)研究,以评估卡利单抗联合化疗在临界可切除食管鳞癌患者中的安全性和有效性。
    共有30例临界可切除ESCC患者将纳入BRES-1研究。这些患者将经历三个阶段的治疗:新辅助治疗,手术,和辅助治疗。术前治疗包括camrelizumab,顺铂,和nab-紫杉醇。术前治疗包括camrelizumab,每3周给予一次,共6周,剂量为200mg(基线体重<50kg,3mg/kg),nab-紫杉醇(在21天的一个周期的第1天和第8天为130mg/m2,总共两个周期),和顺铂(在21天的一个周期的第1天75mg/m2,总共两个周期)。患者将在完成新辅助治疗后3-6周接受食管切除术。手术三周后,camrelizumab联合化疗将继续用于两个周期的维持治疗。然后,只有camrelizumab将一整年给药.这项研究的主要终点将是病理完全反应(pCR)。
    BRES-1试验将评估camrelizumab联合化疗对临界可切除ESCC患者的疗效和安全性。转化研究将探讨围手术期并发症和药物相关不良事件(AE)。
    ChiCTR,ChiCTR2200056728。2022年2月11日注册。https://www.chictr.org.cn/index。aspx.
    UNASSIGNED: The prognosis and first-line treatment response of patients with borderline resectable esophageal squamous cell carcinoma (ESCC) are unsatisfactory. We are conducting the borderline resectable esophageal squamous (BRES-1) study to evaluate the safety and efficacy of camrelizumab combined with chemotherapy in patients with borderline resectable ESCC.
    UNASSIGNED: A total of 30 patients with borderline resectable ESCC will be enrolled in the BRES-1 study. These patients will undergo three stages of treatment: neoadjuvant therapy, surgery, and adjuvant therapy. Preoperative therapies will include camrelizumab, cisplatin, and nab-paclitaxel. Preoperative therapies will include camrelizumab, which will be given every 3 weeks for 6 weeks at a dose of 200 mg (baseline weight <50 kg, 3 mg/kg), nab-paclitaxel (130 mg/m2 on days 1 and 8 of one period with 21 days, a total of two cycles), and cisplatin (75 mg/m2 on day 1 of one period with 21 days, a total of two cycles). Patients will undergo esophagectomy 3-6 weeks after completing the neoadjuvant treatment. Three weeks after surgery, camrelizumab combined with chemotherapy will continue to be used for two cycles of maintenance therapy. Then, only camrelizumab will be administered for an entire year. The primary endpoint of this study will be pathological complete response (pCR).
    UNASSIGNED: The BRES-1 trial will evaluate the efficacy and safety of camrelizumab combined with chemotherapy for patients with borderline resectable ESCC. Translational research will explore perioperative complications and drug-related adverse events (AEs).
    UNASSIGNED: ChiCTR, ChiCTR2200056728. Registered 11 February 2022. https://www.chictr.org.cn/index.aspx.
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  • 文章类型: Journal Article
    新辅助治疗已成为局部晚期可切除食管癌的主要治疗手段。这项研究的目的是探讨新辅助免疫疗法联合化疗治疗可手术切除食管鳞状细胞癌(ESCC)的有效性和安全性。
    2016年1月1日至2023年4月1日,我们对南昌大学第一附属医院诊断为可切除食管癌并接受新辅助免疫治疗联合化疗的患者进行了回顾性分析。这项研究的主要终点是病理完全缓解(pCR),主要病理反应(MPR)和无病生存期(DFS)。这项研究的次要终点是总生存期(OS),客观反应率(ORR)和安全性。
    共122例接受新辅助免疫化疗(nICT)的ESCC患者。54例患者达到部分缓解(PR),2例患者达到完全缓解(CR),ORR为45.9%。在106名接受手术的患者中,共有28例患者达到pCR(26.4%),共有37例患者达到MPR(34.9%).26例患者发生3级或以上不良事件(21.3%)。术后最常见的并发症是肺炎(25.5%)。
    新辅助免疫疗法联合化疗治疗局部晚期ESCC疗效满意,与治疗相关的不良事件和术后并发症。
    UNASSIGNED: Neoadjuvant therapy has become a mainstay of treatment for locally advanced resectable esophageal cancer. The objective of this research was to investigate the effectiveness and safety of neoadjuvant immunotherapy combined with chemotherapy in treating surgically removable esophageal squamous cell carcinoma (ESCC).
    UNASSIGNED: From January 1, 2016 to April 1, 2023, we conducted a retrospective analysis of patients diagnosed with resectable esophageal cancer who underwent neoadjuvant immunotherapy combined with chemotherapy at The First Affiliated Hospital of Nanchang University. The primary endpoints of this study were pathologic complete response (pCR), major pathologic response (MPR) and disease-free survival (DFS). The secondary endpoints of this study were overall survival (OS), objective response rate (ORR) and safety.
    UNASSIGNED: A total of 122 patients with ESCC receiving neoadjuvant immune-chemotherapy (nICT) were included. Fifty-four patients achieved partial response (PR) and two patients achieved complete response (CR), with an ORR of 45.9%. Of the 106 patients who underwent surgery, a total of 28 patients achieved pCR (26.4%) and a total of 37 patients achieved MPR (34.9%). Grade 3 or higher adverse events occurred in 26 patients (21.3%). The most common postoperative complication was pneumonitis (25.5%).
    UNASSIGNED: Neoadjuvant immunotherapy combined with chemotherapy demonstrates satisfactory efficacy in the treatment of locally advanced ESCC, with manageable treatment-related adverse events and postoperative complications.
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  • 文章类型: Journal Article
    以前,IIIB期非小细胞肺癌(NSCLC)被认为不能手术治疗.近年来,在多项试验中,新辅助免疫疗法在治疗晚期NSCLC方面显示出令人鼓舞的疗效.然而,新辅助免疫治疗治疗IIIB期非小细胞肺癌的有效性和安全性尚不清楚.因此,我们进行了这项回顾性研究,以检查新辅助免疫疗法联合化疗治疗IIIB期NSCLC后的手术结局.
    对2019年1月至2021年9月仁济医院胸外科收治的30例IIIB期NSCLC患者进行回顾性分析。手术前给予新辅助免疫疗法联合化疗。通过影像学和病理检查评价疗效。
    通过影像学研究评估的新辅助治疗后患者的客观缓解率(ORR)和疾病控制率(DCR)分别为70%和86.7%,分别。在30名患者中,19人(63%)接受了手术切除,其中全部实现了R0完全切除。中位手术时间为168分钟(范围,75-295分钟),术中出血量平均为215.3±258.4mL。术后住院时间中位数为8天(范围,4-59天)。主要病理反应(MPR)率为73.7%(14/19),病理完全缓解率为47.4%(9/19);2/30例(6.7%)患者有术后并发症,包括两名发生支气管胸膜瘘和一名死亡患者,术后肺部感染.治疗相关不良反应主要为1~2级。只有两名患者有3级贫血,未观察到4级不良反应。
    新辅助免疫疗法和化疗联合手术治疗IIIB期非小细胞肺癌是安全可行的。患者预后和新辅助治疗周期的最佳数量需要进一步探索和研究。
    UNASSIGNED: Previously, stage-IIIB non-small cell lung cancer (NSCLC) has been considered inoperable. In recent years, neoadjuvant immunotherapy has shown encouraging efficacy in the treatment of advanced stage NSCLC in several trials. However, the effectiveness and safety of neoadjuvant immunotherapy in treating stage-IIIB NSCLC are still unknown. Therefore, we conducted this retrospective study to examine the outcomes of surgery after neoadjuvant immunotherapy combined with chemotherapy for stage-IIIB NSCLC.
    UNASSIGNED: Thirty patients with stage-IIIB NSCLC who were treated at the Department of Thoracic Surgery of Renji Hospital from January 2019 to September 2021 were analyzed retrospectively. Neoadjuvant immunotherapy combined with chemotherapy was administered prior to surgery. The curative effect was evaluated by imaging and pathological examinations.
    UNASSIGNED: The objective response rate (ORR) and disease control rate (DCR) of the patients after neoadjuvant therapy evaluated by imaging studies were 70% and 86.7%, respectively. Of the 30 patients, 19 (63%) underwent surgical resection, in which all achieved a complete R0 resection. The median operative time was 168 minutes (range, 75-295 minutes), and the average intraoperative blood loss was 215.3±258.4 mL. The median postoperative hospital stay was 8 days (range, 4-59 days). The major pathological response (MPR) rate was 73.7% (14/19), and the pathological complete response rate was 47.4% (9/19); 2/30 patients (6.7%) had postoperative complications, including two who developed bronchopleural fistulas and one mortality, from a postoperative pulmonary infection. The treatment-related adverse reactions were mainly grades 1-2. Only two patients had grade 3 anemia, and no grade 4 adverse reactions were observed.
    UNASSIGNED: Neoadjuvant immunotherapy and chemotherapy combined with surgery in patients with stage-IIIB NSCLC is safe and feasible. The patient outcomes and optimal number of neoadjuvant treatment cycles need to be explored and studied further.
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