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Association of plasma branched-chain amino acid levels with colorectal cancer risk in a nested case-control study. 一项巢式病例对照研究:血浆支链氨基酸水平与结直肠癌风险的关系
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-13 DOI: 10.1093/jjco/hyae172
Izumi Hisada, Taiki Yamaji, Norie Sawada, Manami Inoue, Shoichiro Tsugane, Motoki Iwasaki

Background: Intake of branched-chain amino acids (BCAA) has been suggested to have a prophylactic effect against carcinogenesis in colorectal cancer (CRC). However, the possible effect of plasma BCAA concentration has not been fully evaluated.

Methods: We conducted a prospective case-control study within a cohort of four public health center areas for which blood sample and questionnaire data from a 5-year follow-up survey were available. We identified 360 newly diagnosed CRC cases during the follow-up period and selected two matched controls for each case. We estimated odds ratio (OR) and 95% confidence intervals (CI) for CRC using conditional logistic regression models adjusted for potential confounding factors.

Results: Increased plasma concentrations of BCAAs were not inversely associated with CRC risk after adjustment for potential confounders. Compared with the lowest quartile, ORs in the highest quartile of leucine, isoleucine, valine, and total BCAA were 0.74 (95% CI, 0.49-1.12), 0.85 (0.56-1.29), 0.75 (0.50-1.13), and 0.70 (0.47-1.05), respectively. After excluding cases diagnosed within the first 6 years of follow-up, total BCAA and leucine were significantly related to a decreased risk of CRC, with ORs in the highest quartile of total BCAA and leucine of 0.58 (0.35-0.96) and 0.56 (0.33-0.93), respectively.

Conclusions: We found no statistically significant inverse association between plasma BCAA concentrations and CRC risk in overall analyses, whereas on 6-year exclusion, total BCAA and leucine were associated with decreased CRC risk. Plasma BCAA concentrations may play a prophylactic role in colorectal carcinogenesis, and further investigation is warranted.

背景:支链氨基酸(BCAA)的摄入被认为具有预防结直肠癌(CRC)发生的作用。然而,血浆BCAA浓度的可能影响尚未得到充分评估。方法:我们在四个公共卫生中心地区进行了一项前瞻性病例对照研究,这些地区的血液样本和问卷数据来自5年的随访调查。我们在随访期间确定了360例新诊断的CRC病例,并为每个病例选择了两个匹配的对照。我们使用经过潜在混杂因素调整的条件逻辑回归模型估计CRC的优势比(OR)和95%置信区间(CI)。结果:调整潜在混杂因素后,血浆BCAAs浓度升高与结直肠癌风险无负相关。与最低四分位数相比,亮氨酸、异亮氨酸、缬氨酸和总BCAA在最高四分位数的or分别为0.74 (95% CI, 0.49-1.12)、0.85(0.56-1.29)、0.75(0.50-1.13)和0.70(0.47-1.05)。在排除随访前6年内诊断的病例后,总BCAA和亮氨酸与CRC风险降低显著相关,总BCAA和亮氨酸最高四分位数的or分别为0.58(0.35-0.96)和0.56(0.33-0.93)。结论:在总体分析中,我们发现血浆BCAA浓度与结直肠癌风险之间没有统计学意义上的负相关,而在6年的排除中,总BCAA和亮氨酸与结直肠癌风险降低相关。血浆BCAA浓度可能在结直肠癌发生中起预防作用,值得进一步研究。
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引用次数: 0
Comparative analysis of surgical outcomes between the hinotori™ surgical robot system and da Vinci® Xi for simple hysterectomy with sentinel lymph node biopsy in low-risk endometrial cancer. hinotori™手术机器人系统与da Vinci®Xi在低危子宫内膜癌单纯性子宫切除术伴前哨淋巴结活检中的手术效果比较分析
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-09 DOI: 10.1093/jjco/hyae170
Shinichi Togami, Nozomi Furuzono, Mika Fukuda, Mika Mizuno, Shintaro Yanazume, Hiroaki Kobayashi

Objectives: This study aimed to compare the surgical outcomes of simple hysterectomy with sentinel lymph node biopsy for low-risk endometrial cancer performed using the hinotori™ Surgical Robot System and the da Vinci® Xi system.

Materials and methods: We retrospectively analyzed the data of 234 patients who underwent simple hysterectomy with sentinel lymph node biopsy at Kagoshima University Hospital between January 2017 and June 2024. Amongst them, 20 patients underwent surgery using the hinotori™ Surgical Robot System and 214 using the da Vinci® Xi. Surgical factors, including operative time, cockpit/console time, blood loss and sentinel lymph node detection, were evaluated. Statistical analyses included chi-square and Wilcoxon tests, with significance set at P < 0.05.

Results: The median operative and cockpit/console times were comparable between the two systems. However, the time from roll-in to the start of cockpit/console surgery was significantly longer for the hinotori™ Surgical Robot System than for the da Vinci® Xi (P = 0.0039). No significant differences were observed for blood loss, length of hospital stay, or complication rates. The sentinel lymph node detection rates and number of sentinel lymph nodes resected were similar between the two systems, with metastatic sentinel lymph node rates of 6% in both groups.

Conclusion: Simple hysterectomy with sentinel lymph node biopsy performed using the hinotori™ Surgical Robot System demonstrated outcomes comparable with those using the da Vinci® Xi system, with no significant differences in key surgical factors. These results suggest that the hinotori™ Surgical Robot System is a viable alternative for minimally invasive surgery in low-risk endometrial cancer. Further studies with larger sample sizes are required to validate these findings.

目的:本研究旨在比较使用hinotori™手术机器人系统和da Vinci®Xi系统对低风险子宫内膜癌进行单纯子宫切除术和前哨淋巴结活检的手术结果。材料与方法:回顾性分析2017年1月至2024年6月在鹿儿岛大学医院行单纯子宫切除术并前哨淋巴结活检的234例患者的资料。其中,20名患者使用hinotori™手术机器人系统进行了手术,214名患者使用了da Vinci®Xi。评估手术因素,包括手术时间、驾驶舱/控制台时间、出血量和前哨淋巴结检测。统计分析包括卡方检验和Wilcoxon检验,显著性设置为P。结果:两种系统的中位操作时间和驾驶舱/控制台时间具有可比性。然而,hinotori™手术机器人系统从滚入到驾驶舱/控制台手术开始的时间明显比da Vinci®Xi更长(P = 0.0039)。在失血量、住院时间或并发症发生率方面没有观察到显著差异。两种系统的前哨淋巴结检出率和切除的前哨淋巴结数量相似,两组的转移性前哨淋巴结率均为6%。结论:使用hinotori™手术机器人系统进行单纯子宫切除术并前哨淋巴结活检的结果与使用da Vinci®Xi系统相当,关键手术因素无显著差异。这些结果表明hinotori™手术机器人系统是低风险子宫内膜癌微创手术的可行替代方案。需要更大样本量的进一步研究来验证这些发现。
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引用次数: 0
Therapeutic efficacy and safety of biweekly administration of enfortumab vedotin for urothelial carcinoma. 每两周服用恩福单抗维多汀治疗尿路上皮癌的疗效和安全性。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-07 DOI: 10.1093/jjco/hyae101
Ryunosuke Nakagawa, Kouji Izumi, Ren Toriumi, Shuhei Aoyama, Taiki Kamijima, Hiroshi Kano, Tomoyuki Makino, Renato Naito, Hiroaki Iwamoto, Hiroshi Yaegashi, Shohei Kawaguchi, Kazuyoshi Shigehara, Takahiro Nohara, Atsushi Mizokami

Objectives: Enfortumab vedotin (EV) is an established pharmacotherapy for metastatic urothelial carcinoma (mUC); however, its adverse events (AEs) cannot be overlooked. The study investigated the efficacy and safety of biweekly EV administration.

Methods: Patients with mUC who received EV at our institution were included in the study. Eligible patients were classified into two groups as follows: those who received EV on a standard schedule (standard group) and those who received EV on a biweekly schedule (biweekly group); the treatment outcomes and AEs between the two groups were compared.

Results: Nine and 19 patients were in the standard group and biweekly groups, respectively. The progression-free survival, overall survival, and overall response rate were not significantly different between the two groups. AEs following EV administration, such as decreased appetite (P < .01), pruritus (P < .01), rash maculopapular (P < .01), anemia (P = .04), and liver dysfunction (P = .04), were significantly more frequent in the standard group. Grade 3 or higher AEs, such as pruritus (P = .03) and rash maculopapular (P < .01), were significantly more frequent in the standard group. Furthermore, significantly more patients in the standard group had to be given a reduced dose due to adverse events (P = .02).

Conclusions: Biweekly administration of EV may be safer without compromising therapeutic efficacy than the standard schedule.

研究目的恩福单抗维多汀(EV)是一种治疗转移性尿路上皮癌(mUC)的成熟药物疗法,但其不良反应(AEs)不容忽视。本研究调查了每两周服用一次EV的疗效和安全性:研究纳入了在我院接受 EV 治疗的 mUC 患者。将符合条件的患者分为两组:按标准时间表接受EV治疗的患者(标准组)和按双周时间表接受EV治疗的患者(双周组);比较两组患者的治疗效果和AEs:标准组和双周组分别有9名和19名患者。两组患者的无进展生存期、总生存期和总反应率无明显差异。服用 EV 后出现的食欲下降等 AEs(P 结论:双周服用 EV 可能会导致食欲下降:在不影响疗效的前提下,双周给药可能比标准给药方案更安全。
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引用次数: 0
Pulmonary metastases from pancreatic cancer have different clinico-radiological features compared with those from colorectal cancer. 胰腺癌肺转移与结直肠癌肺转移相比,具有不同的临床放射学特征。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-07 DOI: 10.1093/jjco/hyae107
Takeshi Kawaguchi, Maiko Takeda, Daiki Yoshikawa, Ryosuke Taiji, Aya Yamada, Ryo Miyata, Masatsugu Hamaji, Mitsuharu Hosono, Noriyoshi Sawabata

Background: Although pulmonary metastasectomy is a commonly-performed procedure, data are lacking on the feasibility and oncological efficacy of removal of pulmonary metastases from pancreatic cancer. In this study, we retrospectively compared features of pulmonary metastases from pancreatic cancer versus colorectal cancer (CRC, patients with CRC being common candidates for pulmonary metastasectomy) and outcomes of removing such metastases, with our aim being to identify specific features of the former.

Methods: Data on removal of 182 pulmonary metastases (29 from pancreatic and 153 from CRC) performed from January 2013 to April 2024 were included in this analysis. Radio-pathological findings were compared between these groups. The study cohort comprised 139 pulmonary metastasectomies in 119 patients (24 with pancreatic cancer and 95 with CRC) in whom R0 resection was achieved and follow-up data were available.

Results: Atypical radiological findings of pulmonary metastases, including polygonal-shape (P < 0.001), spiculae (P < 0.001), air bronchogram (P = 0.012), peripheral ground-glass opacities (P < 0.001), and pleural tags (P < 0.001) were present more frequently in metastases from pancreatic cancer than from CRC. Furthermore, pleural lavage cytology was more frequently positive in pulmonary metastases from pancreatic cancer than in those from CRC (P < 0.001). Disease-free survival was significantly shorter after the removal of metastases from pancreatic than from CRC (P < 0.001).

Conclusions: Some pulmonary metastases from pancreatic cancer have atypical radiological features. Surgical interventions for these may enable diagnosis. The prognosis is significantly poorer after removing metastases from pancreatic cancer than from CRC. The therapeutic significance of our findings requires further investigation.

背景:虽然肺转移灶切除术是一种常见的手术,但目前还缺乏有关胰腺癌肺转移灶切除术的可行性和肿瘤学疗效的数据。在这项研究中,我们回顾性比较了胰腺癌肺转移灶与结直肠癌肺转移灶的特征以及切除这些转移灶的疗效,目的是找出前者的具体特征:本分析纳入了 2013 年 1 月至 2024 年 4 月期间进行的 182 例肺部转移瘤(29 例来自胰腺,153 例来自 CRC)切除术的数据。对这两组患者的放射病理结果进行了比较。研究队列包括119名患者(24名胰腺癌患者和95名CRC患者)的139例肺转移灶切除术,这些患者均实现了R0切除,并获得了随访数据:肺转移瘤的非典型放射学发现,包括多角形(P 结论:肺转移瘤的非典型放射学发现与胰腺癌的非典型放射学发现相似:一些胰腺癌肺转移灶具有非典型放射学特征。对这些肺转移灶进行外科干预可有助于诊断。胰腺癌转移灶切除后的预后明显差于癌症转移灶切除后的预后。我们的研究结果的治疗意义还需要进一步研究。
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引用次数: 0
The Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group: outstanding contribution and entering a new phase. 日本临床肿瘤学组肺癌外科研究小组:杰出贡献,进入新阶段。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-07 DOI: 10.1093/jjco/hyae100
Kazuo Nakagawa, Masaya Yotsukura, Takahiro Mimae, Aritoshi Hattori, Tomohiro Miyoshi, Mitsuhiro Isaka, Makoto Endo, Yasuhiro Tsutani, Tetsuya Isaka, Tomohiro Maniwa, Ryu Nakajima, Hiroshige Yoshioka, Hidefumi Takei, Keiju Aokage, Shun-Ichi Watanabe

The Lung Cancer Surgical Study Group (LCSSG) of the Japan Clinical Oncology Group (JCOG) was organized in 1986 and initially included 26 collaborative institutions, which has increased to 52 institutions currently. JCOG-LCSSG includes thoracic surgeons, medical oncologists, pathologists, and radiotherapists. In the early period, the JCOG-LCSSG mainly focused on combined modality therapies for lung cancer. Since the 2000s, the JCOG-LCSSG has investigated adequate modes of surgical resection for small-sized and peripheral non-small cell lung cancer and based on the radiological findings of whole tumor size and ground-glass opacity. Trials, such as JCOG0802, JCOG0804, and JCOG1211, have shown the appropriateness of sublobar resection, which has significantly influenced routine clinical practice. With the introduction of targeted therapy and immunotherapy, treatment strategies for lung cancer have changed significantly. Additionally, with the increasing aging population and medical costs, tailored medicine is strongly recommended to address medical issues. To ensure comprehensive treatment, strategies, including surgical and nonsurgical approaches, should be developed. Currently, the JCOG-LCSSG has conducted numerous clinical trials to adjust the diversity of lung cancer treatment strategies. This review highlights recent advancements in the surgical field, current status, and future direction of the JCOG-LCSSG.

日本临床肿瘤学组(JCOG)的肺癌外科研究组(LCSSG)成立于 1986 年,最初包括 26 家合作机构,目前已增至 52 家机构。JCOG-LCSSG 的成员包括胸外科医生、肿瘤内科医生、病理学家和放射治疗专家。早期,JCOG-LCSSG 主要关注肺癌的联合模式疗法。自 2000 年代起,JCOG-LCSSG 开始研究针对小面积和周围非小细胞肺癌的适当手术切除模式,并以整个肿瘤大小和磨玻璃不透明的放射学发现为基础。JCOG0802、JCOG0804 和 JCOG1211 等试验证明了肺叶下切除术的适当性,对常规临床实践产生了重大影响。随着靶向治疗和免疫疗法的引入,肺癌的治疗策略也发生了重大变化。此外,随着人口老龄化和医疗费用的增加,人们强烈建议采用定制医疗来解决医疗问题。为确保综合治疗,应制定包括手术和非手术方法在内的策略。目前,JCOG-LCSSG 已经开展了大量临床试验,以调整肺癌治疗策略的多样性。本综述重点介绍了 JCOG-LCSSG 在外科领域的最新进展、现状和未来方向。
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引用次数: 0
Correction to: Geriatric oncology in the most aged societies. 更正:最老龄化社会中的老年肿瘤学。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-07 DOI: 10.1093/jjco/hyae115
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引用次数: 0
Smartphone-based distress screening, information provision, and psychotherapy for reducing psychological distress among AYA cancer survivors: protocol for a fully decentralized multicenter randomized controlled clinical trial. 基于智能手机的困扰筛查、信息提供和心理治疗,以减轻青壮年癌症幸存者的心理困扰:完全分散的多中心随机对照临床试验方案。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-07 DOI: 10.1093/jjco/hyae111
Tatsuo Akechi, Toshi A Furukawa, Hiroya Hashimoto, Yoshihiko Harada, Yoshinori Ito, Yosuke Furukawa, Atsuko Kitano, Naoko Maeda, Yuki Kojima, Yuma Tada, Atsuko Watanabe, Akiko Kurata, Toshio Matsubara, Naomi Sakurai, Yosuke Uchitomi, Masako Okamura, Maiko Fujimori

Fear of cancer recurrence (FCR) is a common and distressing condition among adolescents and young adults (AYAs). This study aims to investigate the efficacy of digital interventions, including distress screening-based information provision and smartphone problem-solving therapy, on common psychological distress, especially FCR, in AYA patients with cancer. Participants will be 224 AYA outpatients with cancer aged 15-39 years who will be randomly assigned to either an 8-week smartphone-based intervention or a waitlist control group. This intervention includes smartphone-based distress screening, information provision, and psychotherapy (problem-solving therapy). The primary endpoint will be the Fear of Cancer Recurrence Inventory-Short Form score at week 8. This study will be conducted as a fully decentralized, randomized, and multicenter trial. The study protocol was approved by the Institutional Review Board of Nagoya City University on 19 April 2024 (ID: 46-23-0005). Trial registration: UMIN-CTR: UMIN000054583.

对癌症复发的恐惧(FCR)是青少年和年轻成人(AYAs)中常见的一种心理困扰。本研究旨在探讨数字化干预措施(包括基于痛苦筛查的信息提供和智能手机问题解决疗法)对青少年癌症患者常见心理困扰(尤其是癌症复发恐惧)的疗效。参与者为 224 名 15-39 岁的亚青门诊癌症患者,他们将被随机分配到为期 8 周的智能手机干预组或候补对照组。该干预包括基于智能手机的痛苦筛查、信息提供和心理治疗(问题解决疗法)。主要终点是第 8 周时的 "癌症复发恐惧量表-短表 "得分。这项研究将以完全分散、随机和多中心试验的形式进行。研究方案已于 2024 年 4 月 19 日获得名古屋市立大学机构审查委员会的批准(ID:46-23-0005)。试验注册:umin-ctr: umin000054583.
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引用次数: 0
Hepatitis B virus reactivation risk associated with immune checkpoint inhibitors in tumor treatment: a retrospective study. 与肿瘤治疗中免疫检查点抑制剂相关的乙型肝炎病毒再激活风险:一项回顾性研究。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-07 DOI: 10.1093/jjco/hyae105
Yue Yin, Bao Jiang Liu, Yan Hua Zhang, Xin Ye Qiu

Background: Hepatitis B virus (HBV) reactivation is a recognized complication of cytotoxic chemotherapy in patients with chronic hepatitis B. However, the risk of HBV reactivation with immune checkpoint inhibitors (ICIs) remains uncertain due to their exclusion from clinical trials. This study aimed to assess the incidence of HBV reactivation in patients with cancer undergoing ICI therapy, exploring associated risk factors.

Methods: This retrospective study included patients with cancer who tested positive for hepatitis B surface antigen (HBsAg). The primary endpoint was incidence of HBV reactivation, whereas the secondary endpoint was occurrence of hepatic adverse events during ICI therapy.

Results: Among the 162 eligible patients (median age 59 years; 85.8% men), HBV reactivation occurred in 4.3% at a median of 13 weeks post-treatment initiation. At baseline, HBV DNA was undetectable in 78 patients; 88 received antiviral prophylaxis, while 74 patients did not. Reactivation rates were 3.5% in HBsAg-positive and 10% in hepatitis B core antibody (HBcAb)-positive individuals, with an overall rate of 4.3%. These rates were 1.1% with prophylaxis and 8.1% without. Twenty-two patients had grade 3-4 hepatitis, and 25 tested HBsAg-negative but HBcAb-positive. No HBV-related fatalities occurred. The absence of antiviral treatment was a significant risk factor for HBV reactivation.

Conclusions: Our study underscores the risk of HBV reactivation in patients with cancer undergoing ICI therapy, especially among those lacking antiviral prophylaxis. Regular HBV DNA testing and antiviral prophylaxis are crucial preventive measures for HBV reactivation. These findings emphasize the importance of monitoring HBV status in patients receiving ICIs.

背景:乙型肝炎病毒(HBV)再活化是慢性乙型肝炎患者接受细胞毒化疗的一种公认并发症。然而,由于免疫检查点抑制剂(ICIs)被排除在临床试验之外,其HBV再活化的风险仍不确定。本研究旨在评估接受 ICI 治疗的癌症患者中 HBV 再激活的发生率,并探讨相关风险因素:这项回顾性研究纳入了乙肝表面抗原(HBsAg)检测呈阳性的癌症患者。主要终点是 HBV 再激活的发生率,次要终点是 ICI 治疗期间肝脏不良事件的发生率:在 162 名符合条件的患者(中位年龄为 59 岁;85.8% 为男性)中,4.3% 的患者在治疗开始后的 13 周内出现了 HBV 再激活。基线时,78 名患者检测不到 HBV DNA;88 名患者接受了抗病毒预防治疗,74 名患者未接受治疗。HBsAg 阳性患者的复活率为 3.5%,乙肝核心抗体(HBcAb)阳性患者的复活率为 10%,总复活率为 4.3%。在使用预防药物的情况下,这一比例为 1.1%,而在未使用预防药物的情况下,这一比例为 8.1%。22 名患者患有 3-4 级肝炎,25 名患者检测出 HBsAg 阴性但 HBcAb 阳性。没有发生与 HBV 相关的死亡病例。未接受抗病毒治疗是导致 HBV 再激活的一个重要风险因素:我们的研究强调了接受 ICI 治疗的癌症患者,尤其是缺乏抗病毒预防治疗的患者中 HBV 再激活的风险。定期进行 HBV DNA 检测和抗病毒预防是预防 HBV 再激活的关键措施。这些发现强调了对接受 ICIs 治疗的患者进行 HBV 状态监测的重要性。
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引用次数: 0
Benefit assessment of novel systemic therapies for bone and soft tissue sarcomas: a cross-sectional study. 骨与软组织肉瘤新型系统疗法的效益评估:横断面研究。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-07 DOI: 10.1093/jjco/hyae102
Qiang He, Zhen Wang, Jie Mei, Chengxin Xie, Xin Sun

Background: Bone and soft tissue sarcomas are rare malignancies, and their heterogeneity has limited the development of novel drugs. This study aimed to apply two validated tools to evaluate the clinical benefits of novel drug therapies for sarcoma developed over the last decade.

Methods: The PubMed and Embase databases were searched for randomized controlled trials (RCTs) of systemic therapies for sarcomas published between 2013 and 2023. Each trial was scored according to the European Society of Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS) and the American Society of Clinical Oncology-Value Framework version 2 (ASCO-VF).

Results: We included 52 RCTs in this study, of which 17 (32.7%) reported positive results that favored the experimental arm. The ESMO-MCBS grades were determined in 14/17 positive trials, and three of them (21.4%) met the threshold for meaningful clinical benefit. Likewise, ASCO-VF scores were calculated for 11/17 positive trials, and three of them (27.3%) met the threshold for meaningful clinical benefit. Weak correlation (r = 0.38, P = 0.277) and agreement (κ = 0.211, P = 0.490) were observed between the two frameworks.

Conclusion: Only a few RCTs with positive results have demonstrated substantial patient benefits for bone and soft tissue sarcomas over the past decade.

背景:骨与软组织肉瘤是罕见的恶性肿瘤,其异质性限制了新型药物的开发。本研究旨在应用两种经过验证的工具来评估过去十年间开发的新型肉瘤药物疗法的临床疗效:方法:在PubMed和Embase数据库中检索2013年至2023年间发表的肉瘤系统疗法随机对照试验(RCT)。根据欧洲肿瘤内科学会临床获益量表 1.1 版(ESMO-MCBS)和美国临床肿瘤学会价值框架 2 版(ASCO-VF)对每项试验进行评分:本研究共纳入了 52 项 RCT,其中 17 项(32.7%)报告了有利于实验组的阳性结果。在 14/17 项阳性试验中确定了 ESMO-MCBS 分级,其中 3 项(21.4%)达到了有意义临床获益的阈值。同样,对11/17项阳性试验计算了ASCO-VF评分,其中3项(27.3%)达到了有意义临床获益的阈值。两个框架之间的相关性(r = 0.38,P = 0.277)和一致性(κ = 0.211,P = 0.490)较弱:结论:在过去的十年中,只有少数具有积极结果的 RCT 证明骨和软组织肉瘤对患者有实质性的益处。
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引用次数: 0
Clinical outcomes and prognostic factors in metastatic nonclear cell renal cell carcinoma treated with immuno-oncology combination therapy. 免疫肿瘤联合疗法治疗转移性非透明细胞肾细胞癌的临床疗效和预后因素。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-07 DOI: 10.1093/jjco/hyae108
Shingo Toyoda, Wataru Fukuokaya, Keiichiro Mori, Tatsushi Kawada, Satoshi Katayama, Shingo Nishimura, Ryoichi Maenosono, Takuya Tsujino, Takahiro Adachi, Yosuke Hirasawa, Masanobu Saruta, Kazumasa Komura, Takuhisa Nukaya, Takafumi Yanagisawa, Kiyoshi Takahara, Takeshi Hashimoto, Haruhito Azuma, Yoshio Ohno, Ryoichi Shiroki, Motoo Araki, Takahiro Kimura, Kazutoshi Fujita

Background: Metastatic nonclear cell renal cell carcinoma (nccRCC) is a heterogeneous disease with poor prognosis. The clinical characteristics and prognostic factors of immuno-oncology (IO) combination therapy for nccRCC are not well known. This study analyzed patients with metastatic nccRCC treated with IO combination therapy.

Methods: We retrospectively collected data from 447 patients with metastatic RCC treated with IO-based combination therapy as first-line treatment between September 2018 and July 2023 in a Japanese multicenter study. The primary endpoints were objective response rate, progression-free survival (PFS), and overall survival (OS), comparing groups treated with IO-IO and IO-tyrosine kinase inhibitor (TKI) therapies.

Results: Seventy-five patients with metastatic nccRCC were eligible for analysis: 39 were classified into the IO-IO group and 36 into the IO-TKI group. Median PFS was 5.4 months (95% CI: 1.6-9.1) for the IO-IO group and 5.6 (95% CI: 3.4-12.0) for the IO + TKI group. Median OS was 24.2 months (95% CI: 7.5-NA) for the IO-IO group and 23.4 (95% CI: 18.8-NA) for the IO + TKI group, with no significant difference. In univariate analysis, International Metastatic Renal Cell Carcinoma Database Consortium scores, Karnofsky performance status, neutrophil-to-lymphocyte ratio, and the presence of liver metastases were significantly associated with OS, whereas in multivariate analysis, only the presence of liver metastases was significantly associated with OS (P = .035).

Conclusions: There was no significant difference in OS or PFS between IO-IO and IO-TKI combination therapy as first-line treatment for patients with nccRCC. Liver metastasis is a poor prognostic factor for such patients.

背景:转移性非透明细胞肾细胞癌(nccRCC)是一种预后不良的异质性疾病。免疫肿瘤学(IO)联合疗法治疗 nccRCC 的临床特点和预后因素尚不清楚。本研究分析了接受IO联合疗法治疗的转移性nccRCC患者:在一项日本多中心研究中,我们回顾性收集了2018年9月至2023年7月期间接受基于IO的联合疗法一线治疗的447例转移性RCC患者的数据。主要终点是客观反应率、无进展生存期(PFS)和总生存期(OS),比较IO-IO治疗组和IO-酪氨酸激酶抑制剂(TKI)治疗组:75名转移性nccRCC患者符合分析条件:39人被归入IO-IO组,36人被归入IO-TKI组。IO-IO组的中位PFS为5.4个月(95% CI:1.6-9.1),IO+TKI组为5.6个月(95% CI:3.4-12.0)。IO-IO组的中位OS为24.2个月(95% CI:7.5-NA),IO+TKI组为23.4个月(95% CI:18.8-NA),无显著差异。在单变量分析中,国际转移性肾细胞癌数据库联盟评分、卡诺夫斯基表现状态、中性粒细胞与淋巴细胞比值以及是否存在肝转移与OS显著相关,而在多变量分析中,只有是否存在肝转移与OS显著相关(P = .035):结论:IO-IO和IO-TKI联合疗法作为nccRCC患者的一线治疗,在OS和PFS方面没有明显差异。肝转移是这类患者的不良预后因素。
{"title":"Clinical outcomes and prognostic factors in metastatic nonclear cell renal cell carcinoma treated with immuno-oncology combination therapy.","authors":"Shingo Toyoda, Wataru Fukuokaya, Keiichiro Mori, Tatsushi Kawada, Satoshi Katayama, Shingo Nishimura, Ryoichi Maenosono, Takuya Tsujino, Takahiro Adachi, Yosuke Hirasawa, Masanobu Saruta, Kazumasa Komura, Takuhisa Nukaya, Takafumi Yanagisawa, Kiyoshi Takahara, Takeshi Hashimoto, Haruhito Azuma, Yoshio Ohno, Ryoichi Shiroki, Motoo Araki, Takahiro Kimura, Kazutoshi Fujita","doi":"10.1093/jjco/hyae108","DOIUrl":"10.1093/jjco/hyae108","url":null,"abstract":"<p><strong>Background: </strong>Metastatic nonclear cell renal cell carcinoma (nccRCC) is a heterogeneous disease with poor prognosis. The clinical characteristics and prognostic factors of immuno-oncology (IO) combination therapy for nccRCC are not well known. This study analyzed patients with metastatic nccRCC treated with IO combination therapy.</p><p><strong>Methods: </strong>We retrospectively collected data from 447 patients with metastatic RCC treated with IO-based combination therapy as first-line treatment between September 2018 and July 2023 in a Japanese multicenter study. The primary endpoints were objective response rate, progression-free survival (PFS), and overall survival (OS), comparing groups treated with IO-IO and IO-tyrosine kinase inhibitor (TKI) therapies.</p><p><strong>Results: </strong>Seventy-five patients with metastatic nccRCC were eligible for analysis: 39 were classified into the IO-IO group and 36 into the IO-TKI group. Median PFS was 5.4 months (95% CI: 1.6-9.1) for the IO-IO group and 5.6 (95% CI: 3.4-12.0) for the IO + TKI group. Median OS was 24.2 months (95% CI: 7.5-NA) for the IO-IO group and 23.4 (95% CI: 18.8-NA) for the IO + TKI group, with no significant difference. In univariate analysis, International Metastatic Renal Cell Carcinoma Database Consortium scores, Karnofsky performance status, neutrophil-to-lymphocyte ratio, and the presence of liver metastases were significantly associated with OS, whereas in multivariate analysis, only the presence of liver metastases was significantly associated with OS (P = .035).</p><p><strong>Conclusions: </strong>There was no significant difference in OS or PFS between IO-IO and IO-TKI combination therapy as first-line treatment for patients with nccRCC. Liver metastasis is a poor prognostic factor for such patients.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":"1336-1342"},"PeriodicalIF":1.9,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142043938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Japanese journal of clinical oncology
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