Systemic chemotherapy

全身化疗
  • 文章类型: Journal Article
    背景:局部晚期结肠癌是肿瘤复发的高危疾病,生存率低。目前的治疗是手术,然后是基于氟嘧啶和奥沙利铂的辅助化疗。这种方法改善了该人群的肿瘤学结果,然而,粘液性疾病尚未得到深入研究,尽管证据不足,它被认为对全身化疗的反应较差。CHEMUCCA研究旨在回答这个问题。
    目的:评估辅助全身化疗对II期和III期黏液性结肠癌患者的无病生存期的有效性单独手术。
    方法:回顾性分析研究,包括被诊断为高危II期和III期结肠癌的患者,2010年至2021年期间接受治疗,至少随访3年。分析了人口统计学变量和肿瘤特征。主要终点是无病生存期。使用对数秩检验和Cox回归。
    结果:在1134例高风险II期和III期结肠癌患者中,206(18,17%)具有粘液组织学,928(81,83%)具有非粘液组织学。708名接受辅助化疗的患者,粘液性组129例(62,62%),非粘液性组579例(62,39%)。II期和III期粘液性结肠癌的辅助全身化疗改善了DFS(HR=0.58[95%CI0.37-0.91];p=0.017)。然而,在分层分析中,高危II期粘液性结肠癌患者采用该方法无获益(HR=0.4541[95%CI0.19~1.03];p=0.06).
    结论:已证明辅助化疗对局部晚期黏液性结直肠癌有效,可改善肿瘤预后。然而,在高危II期粘液性结肠癌患者中,这种获益可能会减弱.对该患者亚组的辅助化疗的给药必须根据风险与获益来平衡。
    BACKGROUND: Locally advanced colon cancer is a high-risk condition for tumour recurrence with poor survival. The current treatment is surgery followed by adjuvant chemotherapy based on fluoropyrimidines and oxaliplatin. This approach has improved the oncological outcomes on this population, however the mucinous condition has not been studied in depth and although the evidence is weak, it is thought to have a worse response to systemic chemotherapy. The CHEMUCCA study aims to answer this question.
    OBJECTIVE: To evaluate the effectiveness of adjuvant systemic chemotherapy using the disease-free survival for stage II and III mucinous colon cancer who underwent surgical resection plus systemic adjuvant chemotherapy vs. surgery alone.
    METHODS: Retrospective analytical study including patients diagnosed with high-risk stage II and stage III colon cancer, treated between 2010 and 2021, with a minimum follow-up of 3 years. Demographic variables and tumour features were analysed. The primary endpoint was disease-free survival. Log rank test and Cox regression were used.
    RESULTS: Of 1134 patients with high-risk stage II and III colon cancer disease, 206 (18,17 %) had mucinous histology and 928 (81,83 %) had non-mucinous histology. 708 patients who received adjuvant chemotherapy, 129 (62,62 %) in mucinous group and 579 (62,39 %) in the non-mucinous group. Adjuvant systemic chemotherapy in stage II and III mucinous colon cancer improved the DFS (HR = 0.58 [95 % CI 0.37-0.91]; p = 0,017). However, in a stratified analysis, patients with high-risk stage II mucinous colon cancer showed no benefit with this approach (HR = 0.4541 [95 % CI 0.19-1.03]; p = 0.06).
    CONCLUSIONS: Adjuvant chemotherapy has demonstrated to be effective in locally advanced mucinous colorectal cancer improving the oncological outcomes. However, this benefit could be diminished in high-risk stage II mucinous colon cancer patients. The administration of adjuvant chemotherapy on this patient\'s sub-group must be balanced according to risk versus benefits.
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  • 文章类型: Journal Article
    不可切除,转移性,晚期尿路上皮癌(aUC)是一种侵袭性疾病,采用含铂一线化疗治疗,其次是免疫检查点抑制剂和抗体-药物偶联物。对一线化疗的反应是序贯治疗策略中至关重要的优先事项,因为对一线化疗的更好反应与对后续治疗的更好反应相关。对于顺铂不合格的患者,通常推荐吉西他滨加卡铂化疗。这个多中心,单臂前瞻性试验将调查剂量密集的甲氨蝶呤,长春碱,阿霉素,卡铂(DD-MVACarbo)化疗在铂类药物疗效方面优于吉西他滨联合卡铂化疗,顺铂不合格的aUC患者。经过筛选和登记,共有46例患者将接受这种新型化疗方案的治疗.主要终点是客观反应率。次要终点包括疾病控制率,患者报告的结果,和不良事件。截至2024年7月,尚无这种新颖干预措施的证据。结果有望改变护理标准并改善aUC患者的管理。
    Unresectable, metastatic, advanced urothelial carcinoma (aUC) is an aggressive disease and is treated with platinum-containing first-line chemotherapy, followed by immune checkpoint inhibitors and antibody-drug conjugates. Response to first-line chemotherapy is a vital priority in sequential treatment strategies because a better response to first-line chemotherapy is associated with a better response to subsequent therapies. Gemcitabine plus carboplatin chemotherapy is conventionally recommended for cisplatin-ineligible patients. This multicenter, single-arm prospective trial will investigate whether dose-dense methotrexate, vinblastine, doxorubicin, and carboplatin (DD-MVACarbo) chemotherapy is superior to gemcitabine plus carboplatin chemotherapy in terms of efficacy in platinum-naïve, cisplatin-ineligible patients with aUC. After screening and registration, a total of 46 patients will be treated with this novel chemotherapy regimen. The primary endpoint is the objective response rate. The secondary endpoints include disease control rate, patient-reported outcomes, and adverse events. No evidence of this novel intervention is available as of July 2024. The results are expected to change the standard of care and improve the management of patients with aUC.
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  • 文章类型: Journal Article
    背景:自2016年以来,分期腹腔镜已在胃癌患者的诊断检查中实施。分期腹腔镜检查旨在检测无法治愈的疾病(腹膜转移和无法切除的肿瘤)并防止徒劳的腹腔镜手术。
    方法:在这项基于人群的全国性研究中,我们寻找与进行分期腹腔镜检查相关的患者和肿瘤特征.此外,我们分析了同时性腹膜转移的患病率,分期腹腔镜检查的结果及其对治疗决策的临床影响。纳入了2016年至2021年荷兰癌症登记处诊断为非贲门胃癌的所有患者。
    结果:除了肿瘤特征,患者特征,如年龄较小,没有合并症和较低的WHO表现状态与进行分期腹腔镜检查相关.在学习期间,观察到接受分期腹腔镜检查的患者比例增加,从2016年的19.6%到2021年的32.3%(p值<0.001)。在同一时期,同步腹膜转移的患病率从25%增加到31%.在37.6%的患者谁有他们的分期腹腔镜结果报告,在分期腹腔镜检查期间诊断出不治之症。与分期腹腔镜检查阴性的患者相比,接受三联疗法治疗的患者明显少(18.5vs.76.3%;p值<0.001)。
    结论:在胃癌患者中实施分期腹腔镜检查与不治之症的诊断增加和在这些患者中应用三联疗法的减少平行。
    BACKGROUND: Since 2016, staging laparoscopy has been implemented in the diagnostic workup of patients with gastric cancer. Staging laparoscopy aims to detect incurable disease (peritoneal metastases and irresectable tumors) and to prevent futile laparotomies.
    METHODS: In this population-based nationwide study, we sought patient- and tumor characteristics associated with undergoing a staging laparoscopy. Additionally, we analyzed the prevalence of synchronous peritoneal metastases, the outcome of the staging laparoscopy and its clinical impact on treatment decisions. All patients diagnosed with non-cardia gastric cancer from the Netherlands Cancer Registry between 2016 and 2021 were included.
    RESULTS: Alongside tumor characteristics, patient characteristics such as younger age, absence of comorbidities and lower WHO performance status were associated with performing a staging laparoscopy. In the study period, an increase in the proportion of patients who underwent a staging laparoscopy was observed, from 19.6% in 2016 to 32.3% in 2021 (p-value<0.001). In the same period, the prevalence of synchronous peritoneal metastases increased from 25% to 31%. In 37.6% of the patients who had the outcome of their staging laparoscopy reported, had incurable disease diagnosed during staging laparoscopy. Significantly less of these patients were treated with triplet regimens as compared to patients with a negative staging laparoscopy (18.5 vs. 76.3%; p-value<0.001).
    CONCLUSIONS: The implementation of staging laparoscopy in gastric cancer patients paralleled the increase in diagnosis of incurable disease and a decrease in the application of triplet systemic therapies in these patients.
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  • 文章类型: Journal Article
    原发性骨平滑肌肉瘤(LMSoB)极为罕见,仅包含<0.7%的原发性恶性骨肿瘤,因此被认为是一种非常罕见的肿瘤。目前,对于治疗策略是否应基于软组织平滑肌肉瘤的生物学特征或原发性肿瘤在骨骼中的定位,目前尚无共识。围手术期化疗的使用及其在这种罕见肿瘤实体中的有效性尚不清楚。我们旨在评估不同治疗方法在多中心环境中的影响,共纳入35例患者。5年总生存率(OS)为74%。与未接受手术治疗的患者相比,接受手术的局限性疾病患者的5年OS明显更高(82%vs.0%,p=0.0015)。轴向肿瘤定位与更差的无事件生存率(EFS)概率(p<0.001)和OS(p=0.0082)相关。我们的患者中有很大一部分发生了继发性转移。此外,应用于我们患者的围手术期化疗方案与EFS或OS改善无关.因此,LMSoB围手术期化疗的益处需要进一步研究,而代理人的选择仍需明确。
    Primary leiomyosarcoma of bone (LMSoB) is extremely rare, comprising only <0.7% of primary malignant bone tumors, and is therefore considered an ultra-rare tumor entity. There is currently no consensus as to whether therapeutic strategies should be based on the biological characteristics of soft tissue leiomyosarcoma or on primary tumor localization in the bone. The use of perioperative chemotherapy and its effectiveness in this rare tumor entity remains unclear. We aimed to evaluate the impact of different treatment approaches in a multicenter setting with a total of 35 patients included. The 5-year overall survival (OS) was 74%. Patients with localized disease undergoing surgery had a significantly higher 5-year OS compared to patients who did not undergo surgical treatment (82% vs. 0%, p = 0.0015). Axial tumor localization was associated with worse event-free survival (EFS) probability (p < 0.001) and OS (p = 0.0082). A high proportion of our patients developed secondary metastases. Furthermore, the perioperative chemotherapy protocols applied to our patients were not associated with an improved EFS or OS. Therefore, the benefit of perioperative chemotherapy in LMSoB needs to be further investigated, and the choice of agents still needs to be clarified.
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  • 文章类型: Multicenter Study
    目的:全身化疗(SYS)是不可切除的肝内胆管癌(ICC)的一线治疗方法。然而,SYS的生存优势仍然有限。这项研究比较了经肝动脉化疗栓塞(TACE)加SYS与单独SYS治疗的不可切除ICC患者的疗效和安全性。
    方法:多中心回顾性队列研究纳入年龄≥18岁且病理诊断为ICC的患者。患有无法测量的病变的患者,未接受SYS处理,Child-PughC级,东部肿瘤协作组表现状态得3分或更高,先前的肝切除术,不完整的医疗信息,或首次SYS治疗的终止被排除.数据收集主要来自医院系统,并通过随访获得患者的生存结局。使用Kaplan-Meier方法估计总生存期(OS),并使用对数秩检验进行比较。使用最近邻匹配算法以1:1的比率进行倾向评分匹配,以减少TACE加SYS和SYS单独组之间的选择偏差。Cox比例风险模型用于确定与OS相关的预后因素并估计其风险比。使用实体肿瘤标准中的修改的反应评估标准来评估肿瘤对治疗的反应。
    结果:在2016年6月至2023年2月之间,本研究纳入了来自三家医院的118名不可切除的ICC患者。其中,TACE加SYS组37例,SYS单独组81例。联合组的中位OS为11.3个月,比单独SYS组的6.4个月长(P=0.011)。联合组的客观反应率(ORR)和疾病控制率(DCR)比单独SYS组(ORR,48.65vs.6.17%,P<0.001;DCR,89.19vs.62.96%,P=0.004)。配对后每组16例,并且匹配的结果在OS和肿瘤反应方面保持一致。匹配后两组不良事件(AE)相似。
    结论:与单独的SYS相比,在改进操作系统方面,TACE加SYS的组合处理比单一SYS更有效,ORR,和DCR,AE没有任何显著增加。TACE加SYS可能是不可切除ICC患者的可行治疗选择。
    OBJECTIVE: Systemic chemotherapy (SYS) is the first-line treatment of unresectable intrahepatic cholangiocarcinoma (ICC). However, the survival benefit of SYS is still limited. This study compared the efficacy and safety of patients with unresectable ICC treated with transarterial chemoembolization (TACE) plus SYS to SYS alone.
    METHODS: The multicenter retrospective cohort study included patients aged ≥ 18 years old with pathologically diagnosed ICC. Patients with unmeasurable lesions, not receiving SYS treatment, Child-Pugh grade C, Eastern Cooperative Oncology Group performance status score of 3 or higher, prior liver resection, incomplete medical information, or discontinuation of the first SYS treatment were excluded. Data collection was mainly from the hospital system, and the survival outcome of patients was obtained through follow-up. Overall survival (OS) was estimated using the Kaplan-Meier method and compared using the log-rank test. Propensity score matching at a 1:1 ratio using the nearest neighbor matching algorithm was performed to reduce selection bias between the TACE plus SYS and SYS alone groups. The Cox proportional hazards model was used to identify prognostic factors associated with OS and to estimate their hazard ratios. Modified Response Evaluation Criteria in Solid Tumors criteria were utilized to evaluate the response of tumors to therapy.
    RESULTS: Between June 2016 and February 2023, 118 unresectable ICC patients from three hospitals were included in this study. Of them, 37 were in the TACE plus SYS group and 81 were in the SYS alone group. The median OS in the combination group was 11.3 months, longer than the 6.4 months in the SYS alone group (P = 0.011). A greater objective response rate (ORR) and disease control rate (DCR) were observed in the combination group than in the SYS alone group (ORR, 48.65 vs. 6.17%, P < 0.001; DCR, 89.19 vs. 62.96%, P = 0.004). There were 16 patients in each group after matching, and the matched results remained consistent regarding OS and tumor response. Adverse events (AEs) were similar in the two groups after matching.
    CONCLUSIONS: Compared to SYS alone, the combination treatment of TACE plus SYS was more effective than SYS alone in improving OS, ORR, and DCR without any significant increase in AEs. TACE plus SYS may be a viable treatment option for patients with unresectable ICC.
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  • 文章类型: Randomized Controlled Trial
    目的:这项随机对照试验(RCT)的目的是探讨在接受系统治疗的门诊患者中,与接受标准治疗的对照组相比,在前三个治疗周期中,社区护理干预是否减少了计划外的住院情况并改善了身体和社会心理健康结果。
    方法:获得了170名干预组和176名开始门诊化疗的实体瘤成年患者的计划外表现的数量和原因。使用泊松回归比较干预组和对照组之间的演示次数。患者自行完成医院焦虑和抑郁量表,在前四个周期开始时,癌症行为清单和欧洲癌症研究与治疗组织生活质量问卷核心30(EORTCQLQ-C30)。线性回归技术用于比较生活质量结果。
    结果:干预组相对于对照组的计划外表现减少了12%(95%CI,-25%,37%;P=0.48)。在第4周期开始时,焦虑没有差异(差异=0.47(95%CI,-0.28,1.22;P=0.22)),抑郁(差异=0.57(95%CI,-0.18,1.31;P=0.13))或EORTCQLQ-C30汇总评分(差异=0.16(95%CI,-2.67,3.00;P=0.91))。通过癌症行为量表测量的自我效能评分在干预组中较高(差异=4.3(95%CI,0.7,7.9;P=0.02))。
    结论:该RCT未显示出减少意外住院的益处。该试验确定了接受干预的患者基于癌症的自我效能的改善。
    背景:在澳大利亚和新西兰临床试验注册中心注册:ACTRN12614001113640,注册21/10/2014。
    OBJECTIVE: The aim of this randomised controlled trial (RCT) was to explore whether a community nursing intervention for outpatients receiving systemic therapy reduced unplanned hospital presentations and improved physical and psychosocial health outcomes over the first three cycles of treatment compared to a control group receiving standard care.
    METHODS: The number of and reasons for unplanned presentations were obtained for 170 intervention and 176 control group adult patients with solid tumours starting outpatient chemotherapy. Poisson regression was used to compare the number of presentations between the intervention and control groups. Patients self-completed the Hospital Anxiety and Depression Scale, the Cancer Behavior Inventory and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) at the start of the first four cycles. Linear regression techniques were used to compare quality of life outcomes.
    RESULTS: The reduction in unplanned presentations in the intervention group relative to the control group was 12% (95% CI, - 25%, 37%; P = 0.48). At the start of cycle 4, there was no difference in anxiety (difference = 0.47 (95% CI, - 0.28, 1.22; P = 0.22)), depression (difference = 0.57 (95% CI, - 0.18, 1.31; P = 0.13)) or EORTC QLQ-C30 summary score (difference = 0.16 (95% CI, - 2.67, 3.00; P = 0.91)). Scores for self-efficacy as measured by the Cancer Behavior Inventory were higher in the intervention group (difference = 4.3 (95% CI, 0.7, 7.9; P = 0.02)).
    CONCLUSIONS: This RCT did not demonstrate a benefit in reducing unplanned presentations to hospital. The trial identified improved cancer-based self-efficacy in patients receiving the intervention.
    BACKGROUND: Registered at Australian and New Zealand Clinical Trials Registry: ACTRN12614001113640, registered 21/10/2014.
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  • 文章类型: Journal Article
    背景:使用热疗和全身化疗进行长期随访的视网膜母细胞瘤(RB)保守治疗的安全性和有效性的确凿证据很少,特别是在资源匮乏的国家。
    目的:这项研究检查了越南的这种治疗的结果和相关预测因素,以加强当前的RB治疗方案,重点是在低资源环境中保持眼睛和视力。
    结果:2005年至2019年在越南胡志明市眼科医院进行了一项前瞻性队列研究。招募所有符合条件的双侧RB患者(一只眼睛已经切除,另一只眼睛分类为A或B组),并且没有先前治疗。所有患者均接受热疗,每4周重复6个周期的全身三剂化疗。标准化问卷用于收集研究参与者的年龄信息,症状,肿瘤特征,治疗,和结果。在所有50例患者的50只眼睛中,中位年龄为9(4-20)个月,B组34只眼(68%)。中位随访时间为60(60~84)个月。所有139个保留的肿瘤大多退化为4型(70.4%)和3型(23.7%)疤痕。Kaplan-Meier分析发现,5年的总体全球抢救率为91.9%(95%CI:80.1%-97.7%)。大多数眼睛(41/50,82%,95%CI:69.2%-90.2%)最终视力≥0.1。当肿瘤消退为4型瘢痕时,视力较高(p=.007,AOR=8.098,95%CI:1.79-36.53),也显示出比3型瘢痕更少的摘除(p=.002,AOR=0.06,95%CI:0.01-0.37%)。性别对治疗后视力的影响显着,可能是由于歧视。无重大并发症记录。
    结论:保守治疗早期RB是安全有效的。长期的,需要对治疗后的患者进行彻底的随访。疤痕的回归模式可能是治疗失败的有用指标。
    Solid evidence of the safety and effectiveness of retinoblastoma (RB) conservative treatment using thermotherapy and systemic chemotherapy with long-term follow-up is scarce, especially in low-resource countries.
    This study examined the outcomes of this treatment and associated predictors in Vietnam to strengthen the current RB treatment protocol focusing on preserving eye and vision in low-resource settings.
    A prospective cohort study was conducted at Ho Chi Minh City Eye Hospital in Vietnam from 2005 to 2019. All eligible patients with bilateral RB (one eye already removed and another eye classified as group A or B) and without previous treatment were recruited. All patients received thermotherapy and six cycles of systemic three-agent chemotherapy repeated every 4 weeks. A standardized questionnaire was used to collect information on study participants\' age, symptoms, tumor characteristics, treatment, and outcomes. Among 50 eyes of all 50 patients with a median age of 9 (4-20) months, 34 eyes were in group B (68%). The median follow-up time was 60 (60-84) months. All 139 preserved tumors regressed mostly to type 4 (70.4%) and type 3 (23.7%) scars. Kaplan-Meier analysis found the overall globe-salvage rate at 5 years of 91.9% (95% CI: 80.1%-97.7%). Most eyes (41/50, 82%, 95% CI: 69.2%-90.2%) had a final visual acuity ≥0.1. The visual acuity is higher when tumors regressed to a type 4 scar (p = .007, AOR = 8.098, 95% CI: 1.79-36.53) which also shows less enucleation than a type 3 scar (p = .002, AOR = 0.06, 95% CI: 0.01-0.37%). Gender effect on visual acuity after treatment was significant and may be due to discrimination. No major complications were recorded.
    Conservative treatment of early-stage RB is safe and effective. Long-term, thorough follow-ups of patients post-treatment are needed. The regression patterns of scars could be a useful indicator of treatment failure.
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  • 文章类型: Journal Article
    大多数晚期胃癌(GC)患者接受全身化疗,许多因素对其预后有显著影响。然而,心理状况对晚期GC患者预后的重要性尚不清楚。这项前瞻性研究旨在分析负面情绪对接受全身化疗的GC患者的影响。
    对2017年1月至2019年3月我院收治的晚期GC患者进行前瞻性招募。收集人口统计学和临床数据,以及与全身化疗相关的任何不良事件(AE)。采用焦虑自评量表(SAS)和抑郁自评量表(SDS)评定负性情绪。主要结果是无进展生存期(PFS)和总生存期(OS),次要结局是生活质量,由欧洲生活质量研究和治疗组织核心问卷30评估。采用Cox比例风险模型分析负性情绪对预后的影响,采用logistic回归模型分析与负性情绪相关的危险因素。
    本研究共纳入178例晚期GC患者。将83例患者分为负性情绪组,95例患者分为正常情绪组。72例患者在治疗期间出现AE。与正常情绪组相比,负面情绪组出现AE的患者更多(62.7%vs.21.1%,P<0.001)。登记的患者随访至少3年。研究发现,负性情绪组的PFS和OS均远低于正常情绪组(P分别为0.0186和0.0387)。负性情绪组的参与者健康状况较低,症状较严重。负面情绪,较低的体重指数(BMI),和IV期肿瘤被确定为危险因素。此外,较高的BMI和婚姻状况是负性情绪的保护因素。
    负性情绪对GC患者的预后有显著的不良影响。负面情绪的主要危险因素是治疗期间的不良事件。有必要密切监测治疗过程,改善患者的心理状况。
    UNASSIGNED: Most patients with advanced gastric cancer (GC) are treated with systemic chemotherapy and many factors have remarkable impacts on their prognosis. However, the importance of psychological status in the prognosis of advanced GC patients is still unclear. This prospective study was performed to analyze the impact of negative emotions on GC patients treated with systemic chemotherapy.
    UNASSIGNED: Advanced GC patients admitted to our hospital between January 2017 and March 2019 were prospectively enrolled. Demographic and clinical data were collected, as were any adverse events (AEs) related to systemic chemotherapy. Self-rating anxiety scale (SAS) and self-rating depression scale (SDS) were used to assess negative emotions. The primary outcome was progression-free survival (PFS) and overall survival (OS), and the secondary outcome was the quality of life which was assessed by The European Organization for Research and Treatment of Quality of Life Questionnaire-Core 30. Cox proportional hazards models were used to analyze the effects of negative emotions on prognosis, and logistic regression models were used to analyze the risk factors related to negative emotions.
    UNASSIGNED: A total of 178 advanced GC patients were enrolled in this study. A total of 83 patients were divided into a negative emotion group and 95 patients were divided into normal emotion group. 72 patients experienced AEs during treatment. Many more patients experienced AEs in the negative emotion group than in the normal emotion group (62.7% vs. 21.1%, P<0.001). Enrolled patients were followed up for at least 3 years. It was found both PFS and OS were much lower in the negative emotion group than in the normal emotion group (P=0.0186 and 0.0387, respectively). Participants in negative emotion group had lower health status and more severe symptoms. Negative emotions, lower body mass index (BMI), and IV tumor stage were identified as risk factors. In addition, higher BMI and marital status were identified as protective factors of negative emotions.
    UNASSIGNED: Negative emotions have a significant adverse effect on the prognosis of GC patients. The main risk factor of negative emotions is AEs during treatment. It is necessary to closely monitor the treatment process and improve the psychological status of patients.
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  • 文章类型: Journal Article
    简介被诊断患有广泛期小细胞肺癌(SCLC)的老年患者群体在临床研究中代表性不足。我们的目的是评估临床病理特征,65岁或以上广泛期SCLC患者的一线治疗模式和治疗结果.材料和方法在这个多中心,回顾性队列研究,65岁或以上的患者,诊断为广泛期SCLC,包括2009年1月至2021年12月。在诊断时年龄在65岁以下且在治愈性治疗后未出现进展的患者和患有第二种恶性肿瘤的患者被排除在研究之外。临床病理特征,分析了一线治疗模式和治疗结局.结果共纳入132例患者。中位年龄为70岁(范围:65-91岁),118例(89.4%)患者为男性。有77例(58.3%)患者的东方肿瘤协作组(ECOG)表现状态(PS)为0-1。在诊断时,有26名(19.7%)患者处于局限期疾病,而106名(80.3%)患者处于广泛期疾病。86例(65.2%)患者接受一线化疗。在无法接受治疗的患者中,18名患者(13.6%)因患者拒绝,28例(21.2%)由于共病和器官功能障碍的不良表现状态。最常用的一线治疗方案是顺铂+依托泊苷(n=47,54.7%),其次是卡铂+依托泊苷(n=39,45.3%)。4例(4.7%)患者的一线化疗反应为完全缓解,35例(40.7%)患者有部分反应,13例(15.1%)患者病情稳定,34例(39.5%)患者病情进展。最常见的3-4级不良事件是33例(38.4%)患者的中性粒细胞减少症。49名患者(57.0%)完成了计划的一线治疗。一线治疗的mPFS为6.1个月,mOS为8.2个月。我们发现ECOGPS状态是PFS和OS最重要的负面预后因素。卡铂+依托泊苷和顺铂+依托泊苷方案在PFS方面没有差异,操作系统,不良事件和治疗依从性。结论因此,对于诊断为广泛期SCLC的老年患者,不轻易放弃化疗可能是一种合适的方法.应该记住,在老年癌症患者中,发现可能影响预后的因素并根据具体情况精确调整治疗方案对生存率有影响。
    Introduction The geriatric patient population diagnosed with extensive stage small cell lung cancer (SCLC) is underrepresented in clinical studies. We aimed to evaluate the clinicopathological characteristics, first-line treatment patterns and treatment outcomes of patients aged 65 years or older with extensive stage SCLC. Material and methods In this multicenter, retrospective cohort study, patients aged 65 years or older, diagnosed with extensive-stage SCLC, between January 2009 and December 2021 were included. Patients who were under 65 years of age at the time of diagnosis and did not develop progression after curative treatment and patients with a second malignancy were excluded from the study. The clinicopathological characteristics, first-line treatment patterns and treatment outcomes were analyzed. Results A total of 132 patients were included in the study. The median age was 70 years (range:65-91), and 118 (89.4%) patients were male. There were 77 (58.3%) patients with eastern cooperative oncology group (ECOG) performance status (PS) of 0-1. There were 26 (19.7%) patients in the limited stage disease and 106 (80.3%) patients in the extensive stage disease at the time of diagnosis. First-line chemotherapy was given to 86 (65.2%) patients. Of the patients who could not receive treatment, 18 patients (13.6%) due to patient refusal, and 28 patients (21.2%) due to comorbid diseases and poor performance status with organ dysfunctions. The most common treatment regimen used as first-line treatment was cisplatin+etoposide (n=47, 54.7%), and followed by carboplatin+etoposide (n=39, 45.3%). First-line chemotherapy responses were complete response in 4 (4.7%) patients, partial response in 35 (40.7%) patients, stable disease in 13 (15.1%) patients, and progressive disease in 34 (39.5%) patients. The most common grade 3-4 adverse events was neutropenia in 33 (38.4%) patients. Forty nine patients (57.0%) completed the planned first-line treatment. The mPFS was 6.1 months and the mOS was 8.2 months with first-line treatment. We found that ECOG PS status was the most important negative prognostic factor for both PFS and OS. There was no difference between carboplatin+etoposide and cisplatin+etoposide regimens in terms of PFS, OS, adverse events and treatment compliance. Conclusion Thus, it may be an appropriate approach not to give up chemotherapy treatment easily in elderly patients with a diagnosis of extensive stage SCLC. It should be kept in mind that finding factors that might affect the prognosis and tailoring the tretment precisely on case-by-case basis in geriatric cancer patients have an impact on survival.
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  • 文章类型: Clinical Trial, Phase II
    背景:吉西他滨和顺铂是晚期胆管癌(CCA)患者的标准一线全身治疗方法。然而,相当数量的患者由于合并症或不良的表现状态而不符合顺铂治疗的条件.II期试点研究NACHO评估了每4周第1、8和15天给予nab-紫杉醇(125mg/m2)和吉西他滨(1000mg/m2)作为一线治疗对不适合顺铂化疗的晚期CCA患者的疗效。
    方法:任何合并症排除顺铂治疗的患者,如肾功能损害,听力受损,血栓栓塞事件的风险或病史增加,不耐受广泛的水合作用,或显著的心血管疾病均符合条件.主要终点是根据RECIST1.1的总体缓解率(ORR)。次要终点是无进展生存期(PFS),总生存期(OS),安全,和患者报告的结果。
    结果:从2016年12月至2017年7月,有10例患者被前瞻性纳入并接受治疗。nab-紫杉醇/吉西他滨的ORR为50%,疾病控制率(DCR)为90%。中位PFS为5.7个月(95%CI:5.3-6.1),中位OS为7.8个月(95%CI:5.4-10.2)。总的来说,记录了13种SAE,没有任何新的安全性信号。在ITT人群的10例患者中,有14例3-4级治疗相关不良事件(TRAEs)。进行了包括已知预后标志物的探索性亚组分析。
    结论:NACHO试验支持nab-紫杉醇和吉西他滨在不适合以顺铂为基础治疗的晚期CCA患者中的安全性和有效性,应在更大的前瞻性试验中进一步评估。
    BACKGROUND: Gemcitabine and cisplatin is the standard first-line systemic treatment in patients with advanced cholangiocarcinoma (CCA). However, a substantial number of patients do not qualify for cisplatin due to comorbidities or poor performance status. The phase II pilot study NACHO evaluated the efficacy of nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) given on days 1, 8, and 15 every 4 weeks as first-line therapy in patients with advanced CCA ineligible for cisplatin-based chemotherapy.
    METHODS: Patients with any comorbidity precluding cisplatin therapy, such as renal impairment, impaired hearing, increased risk or history for thromboembolic events, intolerance of extensive hydration, or significant cardiovascular disease were eligible. Primary endpoint was overall response rate (ORR) per RECIST 1.1. Secondary endpoints were progression-free survival (PFS), overall survival (OS), safety, and patient reported outcome.
    RESULTS: From December 2016 to July 2017, 10 patients were prospectively enrolled and treated. The ORR with nab-paclitaxel/gemcitabine was 50%, the disease control rate (DCR) was 90%. Median PFS was 5.7 months (95% CI: 5.3-6.1), and median OS was 7.8 months (95% CI: 5.4-10.2). In total, 13 SAEs were documented without any new safety signals. There were 14 grade 3-4 treatment-related adverse events (TRAEs) in 10 patients of the ITT population. Exploratory subgroup analyses including known prognostic markers were performed.
    CONCLUSIONS: The NACHO trial supports safety and efficacy of nab-paclitaxel and gemcitabine in patients with advanced CCA ineligible for cisplatin-based therapy and should be further evaluated in a larger prospective trial.
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