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A real-world survey on expensive drugs used as first-line chemotherapy in patients with HER2-negative unresectable advanced/recurrent gastric cancer in the stomach cancer study group of the Japan clinical oncology group. 日本临床肿瘤学组胃癌研究小组对HER2阴性不可切除的晚期/复发性胃癌患者一线化疗所用昂贵药物的实际情况调查。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-10-03 DOI: 10.1093/jjco/hyae104
Tomohiro Nishina, Narikazu Boku, Yukinori Kurokawa, Keita Sasaki, Ryunosuke Machida, Takaki Yoshikawa

Background: Molecular-targeted drugs and immune checkpoint inhibitors have been developed for various malignant diseases, thereby improving clinical outcomes. However, these drugs are expensive, and few studies have assessed their actual use and costs in Japan. This study aimed to survey the use and costs of first-line chemotherapy for advanced/recurrent gastric cancer (AGC) in real-world settings.

Methods: The survey included patients with human epidermal growth factor receptor type2 (HER2)-negative AGC who initiated first-line chemotherapy from January 2022 to December 2022 at the participating 92 institutions in the Japan Clinical Oncology Group. Data on the regimens were collected using Google Forms. A regimen that costs >500 000 Japanese yen (JPY) per month was defined as expensive.

Results: Data on chemotherapy regimens were collected from 2173 patients at all 92 institutions between March 2023 and May 2023. We analyzed 2113 patients who underwent the chemotherapy with recommended regimens and conditionally recommended regimens according to the Japanese Gastric Cancer Treatment Guidelines sixth edition. The expensive regimens were triplet chemotherapy with fluoropyrimidine (S-1 or capecitabine or 5-fluorouracil/levofolinate), oxaliplatin, and nivolumab. Their monthly costs ranged from 767 648 to 771 046 JPY. Nivolumab-containing regimens cost more than 20 times the price of conventional chemotherapy with fluoropyrimidine and oxaliplatin. These regimens were used in 1416 (67%) of 2113 patients: in 71% of patients aged ≤74 years and in 59% of patients aged ≥75 years.

Conclusion: The regimens with >20-fold cost of conventional chemotherapy were used as first-line chemotherapy in two-thirds of patients and more than half even in the elderly population with HER2-negative AGC. This finding is important for future health economic studies on drug cost-efficacy.

背景:针对各种恶性疾病开发了分子靶向药物和免疫检查点抑制剂,从而改善了临床疗效。然而,这些药物价格昂贵,很少有研究对其在日本的实际使用情况和成本进行评估。本研究旨在调查现实世界中晚期/复发性胃癌(AGC)一线化疗的使用情况和成本:调查对象包括2022年1月至2022年12月期间在日本临床肿瘤学组的92家参与机构接受一线化疗的人表皮生长因子受体2型(HER2)阴性AGC患者。有关治疗方案的数据通过谷歌表格收集。每月费用大于 500 000 日元(JPY)的方案被定义为昂贵方案:结果:我们收集了 2023 年 3 月至 2023 年 5 月期间所有 92 家机构的 2173 名患者的化疗方案数据。我们分析了根据《日本胃癌治疗指南》第六版接受推荐方案和有条件推荐方案化疗的 2113 名患者。昂贵的化疗方案是氟嘧啶(S-1 或卡培他滨或 5-氟尿嘧啶/赖呋酸)、奥沙利铂和尼伐单抗三联化疗。其每月费用从 767 648 日元到 771 046 日元不等。含尼伐单抗的治疗方案的费用是含氟嘧啶和奥沙利铂的传统化疗方案的 20 多倍。2113例患者中有1416例(67%)使用了这些方案:71%的患者年龄≤74岁,59%的患者年龄≥75岁:结论:三分之二的HER2阴性AGC患者将常规化疗成本大于20倍的方案作为一线化疗方案,即使在老年人群中也有半数以上的患者将常规化疗成本大于20倍的方案作为一线化疗方案。这一发现对未来有关药物成本效益的卫生经济学研究具有重要意义。
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引用次数: 0
Cost of medical care for malignant brain tumors at hospitals in the Japan Clinical Oncology Group brain-tumor study group. 日本临床肿瘤学小组脑肿瘤研究组医院恶性脑肿瘤的医疗费用。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-10-03 DOI: 10.1093/jjco/hyae116
Kazuya Motomura, Keita Sasaki, Narushi Sugii, Shigeru Yamaguchi, Hirotaka Inoue, Akito Oshima, Kazuhiro Tanaka, Yoshihiro Otani, Mitsuaki Shirahata, Ichiyo Shibahara, Motoo Nagane, Shunsuke Tsuzuki, Tomoo Matsutani, Yoshihiro Tsukamoto, Noriyuki Kijima, Kenichiro Asano, Makoto Ohno, Akihiro Inoue, Yohei Mineharu, Keisuke Miyake, Yuta Mitobe, Mitsuto Hanihara, Yu Kawanishi, Shoichi Deguchi, Masato Saito, Ryosuke Matsuda, Kenta Ujifuku, Hideyuki Arita, Yuichi Sato, Shinji Yamashita, Ushio Yonezawa, Junya Yamaguchi, Yasutomo Momii, Takahiro Ogawa, Atsushi Kambe, Shigeo Ohba, Junya Fukai, Norihiko Saito, Masashi Kinoshita, Koichiro Sumi, Ryohei Otani, Takeo Uzuka, Noriyoshi Takebe, Shinichiro Koizumi, Ryuta Saito, Yoshiki Arakawa, Yoshitaka Narita

Background: This study aimed to investigate what treatment are selected for malignant brain tumors, particularly glioblastoma (GBM) and primary central nervous system lymphoma (PCNSL), in real-world Japan and the costs involved.

Methods: We conducted a questionnaire survey regarding treatment selections for newly diagnosed GBM and PCNSL treated between July 2021 and June 2022 among 47 institutions in the Japan Clinical Oncology Group-Brain Tumor Study Group. We calculated the total cost and cost per month of the initial therapy for newly diagnosed GBM or PCNSL.

Results: The most used regimen (46.8%) for GBM in patients aged ≤74 years was 'Surgery + radiotherapy concomitant with temozolomide'. This regimen's total cost was 7.50 million JPY (Japanese yen). Adding carmustine wafer implantation (used in 15.0%), TTFields (used in 14.1%), and bevacizumab (BEV) (used in 14.5%) to the standard treatment of GBM increased the cost by 1.24 million JPY for initial treatment, and 1.44 and 0.22 million JPY per month, respectively. Regarding PCNSL, 'Surgery (biopsy) + rituximab, methotrexate, procarbazine, and vincristine (R-MPV) therapy' was the most used regimen (42.5%) for patients of all ages. This regimen incurred 1.07 million JPY per month. The three PCNSL regimens based on R-MPV therapy were in ultra-high-cost medical care (exceeding 1 million JPY per month).

Conclusions: Treatment of malignant brain tumors is generally expensive, and cost-ineffective treatments such as BEV are frequently used. We believe that the results of this study can be used to design future economic health studies examining the cost-effectiveness of malignant brain tumors.

背景:本研究旨在调查现实世界中日本恶性脑肿瘤(尤其是胶质母细胞瘤(GBM)和原发性中枢神经系统淋巴瘤(PCNSL))的治疗选择以及相关费用:我们就 2021 年 7 月至 2022 年 6 月期间新诊断的 GBM 和 PCNSL 的治疗选择在日本临床肿瘤学组-脑肿瘤研究组的 47 家机构中进行了问卷调查。我们计算了新诊断的 GBM 或 PCNSL 初始治疗的总费用和每月费用:对于年龄小于 74 岁的 GBM 患者,使用最多的治疗方案(46.8%)是 "手术+放疗联合替莫唑胺"。该方案的总费用为 750 万日元。在 GBM 标准治疗的基础上增加卡莫司汀晶片植入术(15.0% 采用)、TTFields(14.1% 采用)和贝伐珠单抗(BEV)(14.5% 采用),初始治疗费用增加 124 万日元,每月费用分别增加 144 万日元和 22 万日元。关于 PCNSL,"手术(活检)+利妥昔单抗、甲氨蝶呤、丙卡巴嗪和长春新碱(R-MPV)疗法 "是所有年龄段患者使用最多的疗法(42.5%)。该疗法每月花费 107 万日元。基于 R-MPV 疗法的三种 PCNSL 方案属于超高医疗费用(每月超过 100 万日元):结论:恶性脑肿瘤的治疗费用普遍较高,经常使用 BEV 等成本效益不高的治疗方法。我们认为,本研究的结果可用于设计未来的经济健康研究,以考察恶性脑肿瘤的成本效益。
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引用次数: 0
Real-world treatment trends for patients with advanced prostate cancer and renal cell carcinoma and their cost-a survey in Japan. 日本晚期前列腺癌和肾细胞癌患者的实际治疗趋势及其费用调查。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-10-03 DOI: 10.1093/jjco/hyae045
Takahiro Osawa, Keita Sasaki, Ryunosuke Machida, Takashi Matsumoto, Yoshiyuki Matsui, Hiroshi Kitamura, Hiroyuki Nishiyama

Background: Advanced (Stage IV) prostate and renal cancer have poor prognosis, and several therapies have been developed, but many are very costly. This study investigated drug regimens used in patients with untreated Stage IV prostate cancer and renal cell carcinoma and calculated the monthly cost of each.

Methods: We surveyed first-line drugs administered to patients with untreated Stage IV prostate cancer and renal cancer at Japan Clinical Oncology Group affiliated centers from April 2022 to March 2023. Drug costs were calculated according to drug prices in September 2023. Individual drug costs were calculated or converted to 28-day costs.

Results: A total of 700 patients with untreated Stage IV prostate cancer were surveyed. Androgen deprivation therapy + androgen receptor signaling inhibitor was the most common regimen (56%). The cost of androgen deprivation therapy + androgen receptor signaling inhibitor was 10.6-30.8-fold compared with conventional treatments. A total of 137 patients with Stage IV renal cancer were surveyed. Among them, 91% of patients received immune-oncology drug-based regimen. All patients received treatments with a monthly cost of ≥500 000 Japanese yen, and 80.4% of patients received treatments with a monthly cost of ≥1 million Japanese yen, of combination treatments. The cost of immune-oncology drug-based regimen was 1.2-3.1-fold that of TKI alone.

Conclusion: To the best of our knowledge, this is the first report of a survey of first-line drug therapy in untreated Stage IV prostate cancer and renal cell carcinoma stratified by age and treatment costs. Our results show that most Japanese patients received state-of-the-art, effective treatments with high financial burden.

背景:晚期(IV 期)前列腺癌和肾癌的预后较差,目前已开发出多种疗法,但许多疗法都非常昂贵。本研究调查了未经治疗的 IV 期前列腺癌和肾细胞癌患者的用药方案,并计算了每种方案的月费用:我们调查了 2022 年 4 月至 2023 年 3 月期间日本临床肿瘤学集团附属中心对 IV 期前列腺癌和肾癌未治疗患者使用的一线药物。药物费用根据 2023 年 9 月的药物价格计算。单个药物成本被计算或转换为 28 天的成本:共调查了 700 名未经治疗的 IV 期前列腺癌患者。雄激素剥夺疗法+雄激素受体信号转导抑制剂是最常见的治疗方案(56%)。雄激素剥夺疗法+雄激素受体信号转导抑制剂的费用是传统疗法的10.6-30.8倍。共调查了137名IV期肾癌患者。其中,91%的患者接受了以免疫肿瘤药物为基础的治疗方案。所有患者接受治疗的月费用均≥50 万日元,80.4% 的患者接受治疗的月费用≥100 万日元,其中包括联合治疗。以免疫肿瘤药物为基础的治疗方案的费用是单用TKI的1.2-3.1倍:据我们所知,这是第一份按年龄和治疗费用对未经治疗的 IV 期前列腺癌和肾细胞癌的一线药物治疗进行分层的调查报告。我们的结果表明,大多数日本患者接受了最先进、有效的治疗,但经济负担较重。
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引用次数: 0
Confronting the problems we had hoped to avoid. 面对我们希望避免的问题。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-10-03 DOI: 10.1093/jjco/hyae131
Hideo Kunitoh, Tadao Kakizoe
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引用次数: 0
Correction to: Current status of the cost burden of first-line systemic treatment for patients with advanced hepatocellular carcinoma in Japan, 2021-22. 更正:2021-22 年日本晚期肝细胞癌患者一线系统治疗的成本负担现状。
IF 1.9 4区 医学 Q3 ONCOLOGY Pub Date : 2024-10-03 DOI: 10.1093/jjco/hyae083
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引用次数: 0
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。
{"title":"A randomized phase III study evaluating dexamethasone-based mouthwash to prevent chemotherapy-induced stomatitis in patients with breast cancer.","authors":"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","doi":"10.1093/jjco/hyae136","DOIUrl":"https://doi.org/10.1093/jjco/hyae136","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361512","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
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。
{"title":"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.","authors":"Takaomi Kessoku, Toshikazu Akamatsu, Yasuhide Morioka, Takaaki Yokota, Masayuki Kobayashi, Kohei Uchida, Yuichi Koretaka, Atsushi Nakajima","doi":"10.1093/jjco/hyae135","DOIUrl":"https://doi.org/10.1093/jjco/hyae135","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the additive effect of naldemedine tosylate (naldemedine) on opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361513","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
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
{"title":"Correction to: Immune-related adverse event-associated sclerosing cholangitis due to immune checkpoint inhibitors: imaging findings and treatments.","authors":"","doi":"10.1093/jjco/hyae134","DOIUrl":"https://doi.org/10.1093/jjco/hyae134","url":null,"abstract":"","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346772","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
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。
{"title":"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).","authors":"Nobuyuki Katakami, Kazuma Nagata, Akiyoshi Nakakura, Tadashi Okamoto, Toshihiko Kaneda, Masahide Oki, Kana Watanabe, Takaaki Tokito, Yoshihiro Amano, Motohiro Tamiya, Satoshi Morita, Yukimasa Hatachi","doi":"10.1093/jjco/hyae132","DOIUrl":"https://doi.org/10.1093/jjco/hyae132","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287485","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
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。
{"title":"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.","authors":"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","doi":"10.1093/jjco/hyae127","DOIUrl":"https://doi.org/10.1093/jjco/hyae127","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287484","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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