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A randomized phase III study evaluating dexamethasone-based mouthwash to prevent chemotherapy-induced stomatitis in patients with breast cancer. 一项随机 III 期研究,评估地塞米松漱口水对乳腺癌患者化疗引起的口腔炎的预防作用。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-10-01 DOI: 10.1093/jjco/hyae136
Sayaka Kuba, Sakiko Soutome, Yasuhiro Hagiwara, Yuichiro Kikawa, Takayuki Iwamoto, Takafumi Sangai, Michiko Harao, Takeshi Yamaguchi, Tomoe Taji, Ataru Igarashi, Yusuke Kajimoto, Naomi Sakurai, Kosho Yamanouchi, Kenichi Watanabe, Noriko Maeda, Masahiko Suzuki, Shigeto Maeda, Uhi Toh, Akiko Ebata, Nobutaka Iwakuma, Ryoichi Matsunuma, Miki Yamaguchi, Hirofumi Mukai

Stomatitis, which is a common side effect of chemotherapy, currently lacks a standardized approach for its prevention. Therefore, this multicenter, randomized, open-label, controlled phase III trial aims to assess the efficacy and safety of a dexamethasone-based mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. We will randomly assign 230 patients with early breast cancer scheduled to receive chemotherapy in a 1:1 ratio to either the dexamethasone-based mouthwash group (10 ml, 0.1 mg/ml; swish for 2 min and spit 4 times daily for 8 weeks) or the mouthwash-with-tap-water group. The incidence of stomatitis, measured using electronic patient-reported outcomes, is the primary endpoint.

口腔炎是化疗的一种常见副作用,目前缺乏一种标准化的预防方法。因此,这项多中心、随机、开放标签、对照 III 期试验旨在评估地塞米松漱口水预防早期乳腺癌患者化疗引起的口腔炎的有效性和安全性。我们将把 230 名计划接受化疗的早期乳腺癌患者按 1:1 的比例随机分配到地塞米松漱口水组(10 毫升,0.1 毫克/毫升;漱口 2 分钟后吐掉,每天 4 次,持续 8 周)或漱口水加自来水组。主要终点是口腔炎的发病率,采用患者报告的电子结果进行测量。
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引用次数: 0
Effect of add-on naldemedine treatment in patients with cancer and opioid-induced constipation insufficiently responding to magnesium oxide: a pooled, subgroup analysis of two randomized controlled trials. 对氧化镁反应不充分的癌症和阿片类药物引起的便秘患者加用纳尔代丁治疗的效果:两项随机对照试验的分组汇总分析。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-10-01 DOI: 10.1093/jjco/hyae135
Takaomi Kessoku, Toshikazu Akamatsu, Yasuhide Morioka, Takaaki Yokota, Masayuki Kobayashi, Kohei Uchida, Yuichi Koretaka, Atsushi Nakajima

Objective: To evaluate the additive effect of naldemedine tosylate (naldemedine) on opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.

Methods: We combined two randomized, double-blind, placebo-controlled, phase IIb and III trials of naldemedine and conducted a post hoc subgroup analysis. We evaluated the effect and safety of naldemedine in 116 patients who received naldemedine in addition to magnesium oxide (naldemedine group) and 117 patients who received placebo in addition to magnesium oxide (placebo group). Both groups included patients insufficiently responding to magnesium oxide for opioid-induced constipation. Effect was assessed using spontaneous bowel movement responder rate, complete spontaneous bowel movement responder rate, changes in spontaneous bowel movements and complete spontaneous bowel movements. Safety was also assessed.

Results: During the 2-week treatment period, the responder rates for spontaneous bowel movement and complete spontaneous bowel movement were 73.3 and 43.1% in naldemedine group, respectively, which were significantly higher (P < 0.0001) than 41.9 and 14.5% in placebo group, respectively. Median time to first spontaneous bowel movement and first complete spontaneous bowel movement was significantly shorter (P < 0.0001) in the naldemedine group (4.0 and 21.3 h, respectively) than in the placebo group (27.7 and 211.7 h, respectively). The incidence of adverse events and diarrhoea was significantly higher (P < 0.05) in the naldemedine group than in the placebo group, while the incidence of serious adverse events and severe diarrhoea was not significantly different between the naldemedine and placebo groups.

Conclusion: The study suggested the addition of naldemedine as an effective treatment option for opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.

目的评估对氧化镁治疗反应不佳的癌症患者服用甲磺酸纳尔代丁(naldemedine tosylate)对阿片类药物引起的便秘的叠加效应:我们合并了纳尔代明的两项随机、双盲、安慰剂对照的IIb期和III期试验,并进行了事后亚组分析。我们评估了116名在接受氧化镁治疗的同时接受纳尔代丁治疗的患者(纳尔代丁组)和117名在接受氧化镁治疗的同时接受安慰剂治疗的患者(安慰剂组)的纳尔代丁治疗效果和安全性。两组患者都包括对氧化镁治疗阿片类药物引起的便秘反应不足的患者。疗效通过自发性排便应答率、完全自发性排便应答率、自发性排便变化和完全自发性排便来评估。此外,还对安全性进行了评估:结果:在为期两周的治疗期间,纳尔德美定组的自发性排便应答率和完全自发性排便应答率分别为 73.3%和 43.1%,显著高于其他组(P 结论:纳尔德美定组的自发性排便应答率和完全自发性排便应答率显著高于其他组(P该研究表明,对氧化镁治疗反应不佳的癌症患者而言,添加纳尔代丁是治疗阿片类药物所致便秘的一种有效方法。
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引用次数: 0
Correction to: Immune-related adverse event-associated sclerosing cholangitis due to immune checkpoint inhibitors: imaging findings and treatments. 更正:免疫检查点抑制剂导致的免疫相关不良事件相关硬化性胆管炎:影像学发现与治疗。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-27 DOI: 10.1093/jjco/hyae134
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引用次数: 0
Phase II study of carboplatin plus weekly paclitaxel with bevacizumab for non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonia (Hanshin Cancer Group IP002). 卡铂加每周紫杉醇与贝伐珠单抗治疗伴有特发性间质性肺炎的非鳞状非小细胞肺癌的 II 期研究(阪神癌症小组 IP002)。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-23 DOI: 10.1093/jjco/hyae132
Nobuyuki Katakami, Kazuma Nagata, Akiyoshi Nakakura, Tadashi Okamoto, Toshihiko Kaneda, Masahide Oki, Kana Watanabe, Takaaki Tokito, Yoshihiro Amano, Motohiro Tamiya, Satoshi Morita, Yukimasa Hatachi

Background: There is an increased risk of acute exacerbation of idiopathic interstitial pneumonia when treating patients with advanced non-small cell lung cancer with idiopathic interstitial pneumonia. There is no standard optimal treatment regimen for patients with lung cancer complicated with idiopathic interstitial pneumonia. We aimed to evaluate the efficacy and safety of carboplatin (CBDCA), bevacizumab (Bmab) and weekly paclitaxel (PXT) in patients with idiopathic interstitial pneumonia.

Methods: This phase 2 study involved chemotherapy-naïve patients with advanced non-small cell lung cancer with idiopathic interstitial pneumonia. Patients received CBDCA (area under the curve: 5 on day 1), PXT (70 mg/m2 on days 1, 8 and 15) and Bmab (15 mg/kg on day 1) every 4 weeks. The primary endpoint was the overall response rate.

Results: Twenty-one patients were enrolled between January 2013 and October 2018 and received at least one course of the protocol treatment. The study was terminated before enrolling the planned number of patients because of poor accrual. The median patient age was 69 (range: 62-79) years, and 19 (90.5%) patients were men. The overall response rate was 61.9% (95% confidence interval [CI], 38.4-81.9), meeting the primary endpoint. The median progression-free survival, time to treatment failure, and overall survival were 9.69 (95% CI, 5.78-11.63), 8.21 (95% CI, 3.75-11.63) and 20.93 (95% CI, 13.17-29.83) months, respectively. There was no acute exacerbation or treatment-related death during protocol treatment.

Conclusion: The results indicate that patients with advanced non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonia could be effectively and safely treated using a combination of CBDCA, PXT and Bmab.

背景:治疗晚期非小细胞肺癌合并特发性间质性肺炎患者时,特发性间质性肺炎急性加重的风险会增加。目前还没有针对肺癌并发特发性间质性肺炎患者的标准最佳治疗方案。我们旨在评估卡铂(CBDCA)、贝伐单抗(Bmab)和每周紫杉醇(PXT)对特发性间质性肺炎患者的疗效和安全性:这项2期研究涉及化疗无效的特发性间质性肺炎晚期非小细胞肺癌患者。患者接受 CBDCA(曲线下面积:第 1 天 5)、PXT(第 1、8 和 15 天 70 mg/m2)和 Bmab(第 1 天 15 mg/kg)治疗,每 4 周一次。主要终点是总体反应率:21名患者于2013年1月至2018年10月期间入组,接受了至少一个疗程的方案治疗。由于应征人数不足,研究在达到计划人数前终止。患者年龄中位数为 69 岁(范围:62-79),19 名(90.5%)患者为男性。总体反应率为 61.9%(95% 置信区间 [CI],38.4-81.9),达到了主要终点。无进展生存期、治疗失败时间和总生存期的中位数分别为9.69个月(95% CI,5.78-11.63)、8.21个月(95% CI,3.75-11.63)和20.93个月(95% CI,13.17-29.83)。在方案治疗期间,没有出现急性加重或与治疗相关的死亡:结果表明,晚期非鳞状非小细胞肺癌合并特发性间质性肺炎的患者可以通过联合使用CBDCA、PXT和Bmab得到有效、安全的治疗。
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引用次数: 0
Laparoscopic versus open colectomy for locally advanced colon cancer in obese patients: a nationwide, multicenter, propensity score-based analysis of short- and long-term outcomes. 肥胖患者局部晚期结肠癌的腹腔镜结肠切除术与开腹结肠切除术:基于倾向评分的全国多中心短期和长期疗效分析。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-22 DOI: 10.1093/jjco/hyae127
Kentaro Nakajima, Tomonori Akagi, Yohei Kono, Hidefumi Shiroshita, Tetsuji Ohyama, Shuji Saito, Yoshinori Kagawa, Takatoshi Nakamura, Shinobu Ohnuma, Yutaka Kojima, Masafumi Inomata, Seiichiro Yamamoto, Takeshi Naitoh, Yoshiharu Sakai, Masahiko Watanabe

Objective: This study evaluated the short-and long-term outcomes of laparoscopic colectomy versus open surgery in obese patients (body mass index ≥25 kg/m2) with locally advanced colon cancer to ascertain the non-inferiority of laparoscopic surgery to open surgery.

Methods: In this large cohort study (UMIN-ID: UMIN000033529), we retrospectively reviewed prospectively collected data from consecutive patients who underwent laparoscopic or open surgery for pathological stage II-III colon cancer between 2009 and 2013. A comparative analysis was performed after propensity score matching between the laparoscopic and open surgery groups. The primary endpoint was the 3-year relapse-free survival (RFS).

Results: We identified 1575 eligible patients from 46 institutions. Each group comprised 526 propensity score-matched patients. Comparing the laparoscopic versus open surgery group, laparoscopic surgery was significantly associated with increased median operating time (225 vs. 192.5 min; P < .0001) and decreased median estimated blood loss (20 vs. 140 ml; P < .0001). Lymph node retrieval (20 vs. 19; P = 0.4392) and postoperative complications (4.6% vs. 5.7%; P = 0.4851) were similar, postoperative hospital stay was shorter (10 vs. 12 days; P < .0001), and the 3-year RFS rates were similar (82.8 vs. 81.2%). The hazard ratio (HR) for relapse-free survival for laparoscopic versus open surgery was 0.927 (90% confidence interval [CI], 0.747-1.150, one-sided P for non-inferiority = .001), indicating that for obese patients with colon cancer, laparoscopic surgery was non-inferior to open surgery.

Conclusion: Laparoscopic surgery in obese patients with colon cancer offers advantages in terms of short-term outcomes and no disadvantages in terms of long-term outcomes.

研究目的本研究评估了局部晚期结肠癌肥胖患者(体重指数≥25 kg/m2)腹腔镜结肠切除术与开腹手术的短期和长期疗效,以确定腹腔镜手术与开腹手术的非劣效性:在这项大型队列研究(UMIN-ID:UMIN000033529)中,我们回顾性审查了前瞻性收集的数据,这些数据来自2009年至2013年期间因病理分期为II-III期结肠癌而接受腹腔镜手术或开腹手术的连续患者。在对腹腔镜手术组和开腹手术组进行倾向评分匹配后,进行了对比分析。主要终点是3年无复发生存率(RFS):我们确定了来自 46 家机构的 1575 名符合条件的患者。每组包括526名倾向评分匹配患者。腹腔镜手术组与开腹手术组相比,腹腔镜手术显著延长了中位手术时间(225 分钟对 192.5 分钟;P 结论:腹腔镜手术在肥胖症患者中的疗效显著:对肥胖结肠癌患者进行腹腔镜手术在短期疗效方面有优势,在长期疗效方面没有劣势。
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引用次数: 0
Japan's cancer survivorship guidelines for exercise and physical activity. 日本癌症幸存者运动和体育锻炼指南。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-19 DOI: 10.1093/jjco/hyae126
Katsunori Tsuji, Hiroyuki Sasai, Kosuke Kiyohara, Yoshio Nakata, Hiroki Nishiwaki, Takahisa Ohta, Eisuke Ochi, Toshimi Takano, Noriatsu Tatematsu, Yutaka J Matsuoka

Objective: This research aimed to establish the inaugural evidence-based cancer survivorship guidelines for Japan, with a particular focus on exercise and physical activity, in order to enhance health outcomes for cancer survivors.

Methods: A panel of experts, including oncologists, physicians, exercise scientists, epidemiologists and patient advocates, utilized a modified Delphi process and systematic reviews to establish consensus on exercise recommendations for cancer survivors. The panel focused on setting the objectives of the Clinical Practice Guidelines and addressing crucial clinical issues in Japan. Recommendations were formulated based on the strength and certainty of evidence, the benefit-harm balance and patient values and preferences.

Results: The panel formulated exercise recommendations for cancer survivors of two age groups: 18-64 years and ≥65 years. The recommendations for both age groups are consistent, emphasizing the importance of regular exercise and physical activity tailored to individual capabilities and health conditions. The guidelines underline the benefits of exercise in improving the overall health and quality of life of cancer survivors. This consensus on exercise recommendations marks a significant step in the development of comprehensive cancer survivorship guidelines in Japan, with potential implications for improving clinical outcomes and advancing research in cancer survivorship.

Conclusions: These guidelines will serve as a critical resource for cancer survivors, highlighting exercise as a key component of survivorship care, and for clinicians, in recommending appropriate physical activities to improve survivor health and well-being.

研究目的这项研究旨在为日本制定首份以证据为基础的癌症幸存者指南,其中特别关注运动和体育锻炼,以提高癌症幸存者的健康状况:一个由肿瘤学家、医生、运动科学家、流行病学家和患者权益倡导者组成的专家小组利用修改过的德尔菲程序和系统性回顾,就癌症幸存者的运动建议达成了共识。小组的工作重点是制定《临床实践指南》的目标,并解决日本的关键临床问题。建议是根据证据的强度和确定性、益处与危害的平衡以及患者的价值观和偏好制定的:专家组为两个年龄组的癌症幸存者制定了运动建议:18-64 岁和≥65 岁。针对这两个年龄组的建议是一致的,都强调了定期锻炼和根据个人能力和健康状况进行体育锻炼的重要性。指南强调了运动对改善癌症幸存者整体健康和生活质量的益处。就运动建议达成的共识标志着日本在制定全面的癌症幸存者指南方面迈出了重要一步,对改善临床结果和推进癌症幸存者研究具有潜在影响:这些指南将成为癌症幸存者和临床医生的重要资源,前者强调运动是幸存者护理的重要组成部分,后者则推荐适当的体育活动,以改善幸存者的健康和福祉。
{"title":"Japan's cancer survivorship guidelines for exercise and physical activity.","authors":"Katsunori Tsuji, Hiroyuki Sasai, Kosuke Kiyohara, Yoshio Nakata, Hiroki Nishiwaki, Takahisa Ohta, Eisuke Ochi, Toshimi Takano, Noriatsu Tatematsu, Yutaka J Matsuoka","doi":"10.1093/jjco/hyae126","DOIUrl":"https://doi.org/10.1093/jjco/hyae126","url":null,"abstract":"<p><strong>Objective: </strong>This research aimed to establish the inaugural evidence-based cancer survivorship guidelines for Japan, with a particular focus on exercise and physical activity, in order to enhance health outcomes for cancer survivors.</p><p><strong>Methods: </strong>A panel of experts, including oncologists, physicians, exercise scientists, epidemiologists and patient advocates, utilized a modified Delphi process and systematic reviews to establish consensus on exercise recommendations for cancer survivors. The panel focused on setting the objectives of the Clinical Practice Guidelines and addressing crucial clinical issues in Japan. Recommendations were formulated based on the strength and certainty of evidence, the benefit-harm balance and patient values and preferences.</p><p><strong>Results: </strong>The panel formulated exercise recommendations for cancer survivors of two age groups: 18-64 years and ≥65 years. The recommendations for both age groups are consistent, emphasizing the importance of regular exercise and physical activity tailored to individual capabilities and health conditions. The guidelines underline the benefits of exercise in improving the overall health and quality of life of cancer survivors. This consensus on exercise recommendations marks a significant step in the development of comprehensive cancer survivorship guidelines in Japan, with potential implications for improving clinical outcomes and advancing research in cancer survivorship.</p><p><strong>Conclusions: </strong>These guidelines will serve as a critical resource for cancer survivors, highlighting exercise as a key component of survivorship care, and for clinicians, in recommending appropriate physical activities to improve survivor health and well-being.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287483","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}
引用次数: 0
A single-institution retrospective study of comprehensive genomic profiling tests based on C-CAT findings for advanced solid cancers. 基于 C-CAT 检测结果的晚期实体瘤综合基因组分析测试的单一机构回顾性研究。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-19 DOI: 10.1093/jjco/hyae128
Susumu Takeuchi, Akinobu Yoshimura, Atsushi Sofuni, Yuri Ueda, Tomohiro Umezu, Masahiko Kuroda, Aoi Sukeda, Jun Matsubayashi, Toshitaka Nagao, Masato Bingo, Natsuko Inagaki, Tatsuo Ohira, Masahiro Seike, Norihiko Ikeda

Background: In recent years, as the availability of precision therapies expands, there is increasing reliance on genomic profiling assays to help identify the most appropriate treatment options for patients with advanced cancers. We retrospectively investigated the results of comprehensive genomic profiling tests from the time insurance coverage began until recently and examined the status of genetic analysis.

Methods: We retrospectively reviewed the analysis results of 300 patients with advanced solid tumors who consented to comprehensive genomic profiling tests from October 2019 to December 2022.

Results: Of the 300 patients who underwent comprehensive genomic profiling tests, analysis results for 274 patients were obtained, and were reviewed by the Clinical Genome Expert Panel. Six specimens (2%) were discontinued due to patient deaths and deteriorations in general condition. The three most frequently occurring actionable genomic alterations observed were TP53 (47.4%), KRAS (28.1%) and CDKN2A (20.4%). The most common druggable variant was CDKN2A, which was noted in 52 (19%) of 274 patients. The next most common were PIK3CA, BRAF, KRAS and PTEN. The cancer types that showed a greater median number of actionable alterations comprised thyroid cancer, pancreatic cancer and colorectal cancer.

Conclusions: In conclusion, comprehensive genomic profiling tests have the potential to be valuable in identifying genomic abnormalities. Even if there is no effective treatment at present, it may lead to a treatment in the future. Comprehensive genomic profiling tests should be considered for any cancer.

背景:近年来,随着精准疗法的普及,人们越来越依赖基因组分析检测来帮助晚期癌症患者确定最合适的治疗方案。我们回顾性地调查了从保险覆盖开始到最近的全面基因组分析测试结果,并研究了基因分析的现状:我们回顾性地查看了2019年10月至2022年12月期间同意接受综合基因组图谱检测的300名晚期实体瘤患者的分析结果:在接受全面基因组图谱检测的300名患者中,有274名患者的分析结果已获得临床基因组专家小组的审核。6份样本(2%)因患者死亡或病情恶化而中止。观察到的三种最常见的可操作基因组改变是 TP53(47.4%)、KRAS(28.1%)和 CDKN2A(20.4%)。最常见的可药用变异是 CDKN2A,274 例患者中有 52 例(19%)出现了这种变异。其次是 PIK3CA、BRAF、KRAS 和 PTEN。显示可操作变异中位数较多的癌症类型包括甲状腺癌、胰腺癌和结直肠癌:总之,综合基因组分析测试在识别基因组异常方面具有重要价值。即使目前没有有效的治疗方法,将来也有可能找到治疗方法。任何癌症都应考虑进行全面的基因组分析测试。
{"title":"A single-institution retrospective study of comprehensive genomic profiling tests based on C-CAT findings for advanced solid cancers.","authors":"Susumu Takeuchi, Akinobu Yoshimura, Atsushi Sofuni, Yuri Ueda, Tomohiro Umezu, Masahiko Kuroda, Aoi Sukeda, Jun Matsubayashi, Toshitaka Nagao, Masato Bingo, Natsuko Inagaki, Tatsuo Ohira, Masahiro Seike, Norihiko Ikeda","doi":"10.1093/jjco/hyae128","DOIUrl":"https://doi.org/10.1093/jjco/hyae128","url":null,"abstract":"<p><strong>Background: </strong>In recent years, as the availability of precision therapies expands, there is increasing reliance on genomic profiling assays to help identify the most appropriate treatment options for patients with advanced cancers. We retrospectively investigated the results of comprehensive genomic profiling tests from the time insurance coverage began until recently and examined the status of genetic analysis.</p><p><strong>Methods: </strong>We retrospectively reviewed the analysis results of 300 patients with advanced solid tumors who consented to comprehensive genomic profiling tests from October 2019 to December 2022.</p><p><strong>Results: </strong>Of the 300 patients who underwent comprehensive genomic profiling tests, analysis results for 274 patients were obtained, and were reviewed by the Clinical Genome Expert Panel. Six specimens (2%) were discontinued due to patient deaths and deteriorations in general condition. The three most frequently occurring actionable genomic alterations observed were TP53 (47.4%), KRAS (28.1%) and CDKN2A (20.4%). The most common druggable variant was CDKN2A, which was noted in 52 (19%) of 274 patients. The next most common were PIK3CA, BRAF, KRAS and PTEN. The cancer types that showed a greater median number of actionable alterations comprised thyroid cancer, pancreatic cancer and colorectal cancer.</p><p><strong>Conclusions: </strong>In conclusion, comprehensive genomic profiling tests have the potential to be valuable in identifying genomic abnormalities. Even if there is no effective treatment at present, it may lead to a treatment in the future. Comprehensive genomic profiling tests should be considered for any cancer.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287477","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}
引用次数: 0
Protocol digest of a phase III randomized trial of gross total resection versus possible resection of fluid-attenuated inversion recovery-hyperintense lesion on MRI for newly diagnosed supratentorial glioblastoma: JCOG2209 (FLAMINGO). 对新诊断的脑室上部胶质母细胞瘤进行全切除与可能切除磁共振成像上液体增强反转恢复高密度病灶的 III 期随机试验的方案摘要:JCOG2209 (FLAMINGO)。
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-17 DOI: 10.1093/jjco/hyae130
Yuta Sekino,Yukihiko Sonoda,Ichiyo Shibahara,Junki Mizusawa,Keita Sasaki,Tetsuya Sekita,Mayumi Ichikawa,Hiroshi Igaki,Manabu Kinoshita,Toshihiro Kumabe,Junji Shibahara,Koichi Ichimura,Yoshiki Arakawa,Haruhiko Fukuda,,Yoshitaka Narita
The goal of surgery for patients with newly diagnosed glioblastoma (GBM) is maximum safe resection of the contrast-enhancing (CE) lesion on magnetic resonance imaging. However, there is no consensus on the efficacy of FLAIRectomy, which is defined as the possible resection of fluid-attenuated inversion recovery (FLAIR)-hyperintense lesions surrounding the CE lesion. Although retrospective analyses suggested the potential benefits of FLAIRectomy, such outcomes have not been confirmed by prospective studies. Therefore, we planned a multicenter, open-label, randomized controlled phase III trial to evaluate the efficacy of FLAIRectomy compared with gross total resection of CE lesions in patients with newly diagnosed GBM. The primary endpoint is overall survival. In total, 130 patients will be enrolled from 47 institutions over 5 years. This trial has been registered at the Japan Registry of Clinical Trials (study number jRCT1031230245).
对新诊断的胶质母细胞瘤(GBM)患者进行手术的目的是最大限度地安全切除磁共振成像中的对比度增强(CE)病灶。然而,FLAIR切除术的疗效尚未达成共识,FLAIR切除术的定义是可能切除CE病灶周围的流体增强反转恢复(FLAIR)高密度病灶。虽然回顾性分析表明了FLAIR切除术的潜在益处,但前瞻性研究尚未证实这种结果。因此,我们计划进行一项多中心、开放标签、随机对照的 III 期试验,以评估在新诊断的 GBM 患者中,FLAIR 切除术与 CE 病灶全切术相比的疗效。主要终点是总生存期。共有来自 47 家机构的 130 名患者将在 5 年内入组。该试验已在日本临床试验注册中心注册(研究编号为 jRCT1031230245)。
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引用次数: 0
COVID-19 in patients receiving treatment at an outpatient chemotherapy unit. 在门诊化疗病房接受治疗的患者中使用 COVID-19。
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-17 DOI: 10.1093/jjco/hyae129
Shiori Kinoshita,Masashi Takemoto,Minami Asaoka,Yoko Haraguchi,Tamami Adachi,Shinsuke Iida,Hirokazu Komatsu
During the COVID-19 pandemic period, many patients who required outpatient chemotherapy developed COVID-19, requiring chemotherapy interruption. However, there are no clear guidelines regarding the safe timing for restarting chemotherapy. We conducted a retrospective study to assess when such patients can safely recommence chemotherapy. Of the 40 patients included in this study, 34 restarted anticancer drug therapy after COVID-19 infection. Six patients, four with multiple myeloma, and one each with follicular lymphoma and glioma, remained SARS-CoV-2 antigen positive >20 days after COVID-19 onset. Multiple myeloma patients recorded significantly higher frequencies of SARS-CoV-2 antigen positivity >20 days after COVID-19 onset compared with solid tumor patients, with no significant differences in the frequency of SARS-CoV-2 positivity during 5-20 days from COVID-19 onset between them. According to our data, most solid tumor patients achieved SARS-CoV-2 antigen negativity after 20 days from COVID-19 onset. On the other hand, multiple myeloma patients might need serial antigen tests before restarting anticancer therapy in the outpatient chemotherapy setting.
在 COVID-19 大流行期间,许多需要门诊化疗的患者出现了 COVID-19,需要中断化疗。然而,关于重新开始化疗的安全时机,目前还没有明确的指导方针。我们开展了一项回顾性研究,以评估此类患者何时可以安全地重新开始化疗。在纳入本研究的 40 名患者中,有 34 人在感染 COVID-19 后重新开始了抗癌药物治疗。有六名患者(多发性骨髓瘤患者四名,滤泡性淋巴瘤和胶质瘤患者各一名)在 COVID-19 感染后 20 天以上仍为 SARS-CoV-2 抗原阳性。与实体瘤患者相比,多发性骨髓瘤患者在 COVID-19 发病后 20 天内 SARS-CoV-2 抗原阳性的频率明显更高,而他们在 COVID-19 发病后 5-20 天内 SARS-CoV-2 抗原阳性的频率没有明显差异。根据我们的数据,大多数实体瘤患者在 COVID-19 发病 20 天后 SARS-CoV-2 抗原呈阴性。另一方面,多发性骨髓瘤患者在门诊化疗环境中重新开始抗癌治疗前可能需要进行连续的抗原检测。
{"title":"COVID-19 in patients receiving treatment at an outpatient chemotherapy unit.","authors":"Shiori Kinoshita,Masashi Takemoto,Minami Asaoka,Yoko Haraguchi,Tamami Adachi,Shinsuke Iida,Hirokazu Komatsu","doi":"10.1093/jjco/hyae129","DOIUrl":"https://doi.org/10.1093/jjco/hyae129","url":null,"abstract":"During the COVID-19 pandemic period, many patients who required outpatient chemotherapy developed COVID-19, requiring chemotherapy interruption. However, there are no clear guidelines regarding the safe timing for restarting chemotherapy. We conducted a retrospective study to assess when such patients can safely recommence chemotherapy. Of the 40 patients included in this study, 34 restarted anticancer drug therapy after COVID-19 infection. Six patients, four with multiple myeloma, and one each with follicular lymphoma and glioma, remained SARS-CoV-2 antigen positive >20 days after COVID-19 onset. Multiple myeloma patients recorded significantly higher frequencies of SARS-CoV-2 antigen positivity >20 days after COVID-19 onset compared with solid tumor patients, with no significant differences in the frequency of SARS-CoV-2 positivity during 5-20 days from COVID-19 onset between them. According to our data, most solid tumor patients achieved SARS-CoV-2 antigen negativity after 20 days from COVID-19 onset. On the other hand, multiple myeloma patients might need serial antigen tests before restarting anticancer therapy in the outpatient chemotherapy setting.","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":"93 1","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142263515","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}
引用次数: 0
The effect of epidermal growth factor receptor mutation on adjuvant chemotherapy with tegafur/uracil for patients with completely resected, non-lymph node metastatic non-small cell lung cancer (> 2 cm): a multicenter, retrospective, observational study as exploratory analysis of the CSPOR-LC03 study. 表皮生长因子受体突变对完全切除、非淋巴结转移性非小细胞肺癌(> 2 cm)患者替加氟/脲嘧啶辅助化疗的影响:作为 CSPOR-LC03 研究探索性分析的一项多中心、回顾性、观察性研究。
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2024-09-11 DOI: 10.1093/jjco/hyae073
Tomohiro Miyoshi,Keiju Aokage,Shun-Ichi Watanabe,Hiroyuki Ito,Noriaki Sakakura,Mingyon Mun,Motohiro Yamashita,Yasuhisa Ohde,Tadashi Aoki,Wataru Nishio,Masataka Taguri,Masahiro Tsuboi
BACKGROUNDThe use of adjuvant osimertinib for epidermal growth factor receptor (EGFR) mutants is expected to expand to earlier stage I in the future, potentially competing with the current standard of care, oral tegafur/uracil (UFT), in Japan. However, the effect of EGFR mutation status on the therapeutic effect of UFT remains unclear. This study was conducted as an exploratory analysis of a retrospective observational study that investigated the real-world data of postoperative adjuvant chemotherapy in Japan (CSPOR-LC03).METHODSBetween 2008 and 2013, 1812 patients with completely resected adenocarcinoma diagnosed as pathologic stage I (T1 > 2 cm, TNM classification, sixth edition) who have maintained organ function, and no history of other cancers were included. The primary endpoint was the 5-year disease-free survival (DFS) rate, and we compared this rate between four groups classified based on the administration of adjuvant UFT and EGFR mutation status.RESULTSOf the 933 (51%) patients with EGFR mutations, 394 underwent adjuvant UFT therapy. Of the 879 (49%) patients without EGFR mutations, 393 underwent adjuvant UFT therapy. The 5-year DFS of UFT+/EGFR+ and UFT-/EGFR+ patients were 82.0 and 87.1%, respectively, and those of UFT+/EGFR- and UFT-/EGFR- patients were 80.0 and 86.9%, respectively. DFS was significantly worse in the UFT+ group than in the UFT- group (P = 0.015). Adjuvant UFT therapy was not an independent prognostic factor for DFS, regardless of the EGFR mutation status.CONCLUSIONIn pathologic stage I (>2 cm) lung adenocarcinomas with EGFR mutation, the survival benefit of adjuvant UFT was not observed.
背景在日本,奥希替尼辅助治疗表皮生长因子受体(EGFR)突变体有望扩展到早期I期,有可能与目前的治疗标准--口服替加氟/脲嘧啶(UFT)--形成竞争。然而,表皮生长因子受体突变状态对 UFT 治疗效果的影响仍不清楚。本研究是一项回顾性观察研究的探索性分析,该研究调查了日本术后辅助化疗的真实世界数据(CSPOR-LC03)。方法在2008年至2013年间,纳入了1812例完全切除的腺癌患者,这些患者被诊断为病理分期I期(T1 > 2 cm,TNM分类,第六版),器官功能保持良好,且无其他癌症病史。主要终点是 5 年无病生存率(DFS),我们根据 UFT 辅助治疗和表皮生长因子受体(EGFR)突变状态划分了四个组别,并对这一比率进行了比较。结果 在 933 例(51%)EGFR 突变患者中,394 例接受了 UFT 辅助治疗。在 879 例(49%)未发生表皮生长因子受体突变的患者中,393 例接受了 UFT 辅助治疗。UFT+/EGFR+和UFT-/EGFR+患者的5年DFS分别为82.0%和87.1%,UFT+/EGFR-和UFT-/EGFR-患者的5年DFS分别为80.0%和86.9%。UFT+组的DFS明显差于UFT-组(P = 0.015)。无论EGFR突变状态如何,UFT辅助治疗都不是DFS的独立预后因素。
{"title":"The effect of epidermal growth factor receptor mutation on adjuvant chemotherapy with tegafur/uracil for patients with completely resected, non-lymph node metastatic non-small cell lung cancer (> 2 cm): a multicenter, retrospective, observational study as exploratory analysis of the CSPOR-LC03 study.","authors":"Tomohiro Miyoshi,Keiju Aokage,Shun-Ichi Watanabe,Hiroyuki Ito,Noriaki Sakakura,Mingyon Mun,Motohiro Yamashita,Yasuhisa Ohde,Tadashi Aoki,Wataru Nishio,Masataka Taguri,Masahiro Tsuboi","doi":"10.1093/jjco/hyae073","DOIUrl":"https://doi.org/10.1093/jjco/hyae073","url":null,"abstract":"BACKGROUNDThe use of adjuvant osimertinib for epidermal growth factor receptor (EGFR) mutants is expected to expand to earlier stage I in the future, potentially competing with the current standard of care, oral tegafur/uracil (UFT), in Japan. However, the effect of EGFR mutation status on the therapeutic effect of UFT remains unclear. This study was conducted as an exploratory analysis of a retrospective observational study that investigated the real-world data of postoperative adjuvant chemotherapy in Japan (CSPOR-LC03).METHODSBetween 2008 and 2013, 1812 patients with completely resected adenocarcinoma diagnosed as pathologic stage I (T1 > 2 cm, TNM classification, sixth edition) who have maintained organ function, and no history of other cancers were included. The primary endpoint was the 5-year disease-free survival (DFS) rate, and we compared this rate between four groups classified based on the administration of adjuvant UFT and EGFR mutation status.RESULTSOf the 933 (51%) patients with EGFR mutations, 394 underwent adjuvant UFT therapy. Of the 879 (49%) patients without EGFR mutations, 393 underwent adjuvant UFT therapy. The 5-year DFS of UFT+/EGFR+ and UFT-/EGFR+ patients were 82.0 and 87.1%, respectively, and those of UFT+/EGFR- and UFT-/EGFR- patients were 80.0 and 86.9%, respectively. DFS was significantly worse in the UFT+ group than in the UFT- group (P = 0.015). Adjuvant UFT therapy was not an independent prognostic factor for DFS, regardless of the EGFR mutation status.CONCLUSIONIn pathologic stage I (>2 cm) lung adenocarcinomas with EGFR mutation, the survival benefit of adjuvant UFT was not observed.","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":"105 1","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142175940","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}
引用次数: 0
期刊
Japanese journal of clinical oncology
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