Japanese journal of clinical oncology最新文献

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Study protocol: randomized phase III trial of neo-adjuvant and adjuvant chemotherapy vs. immediate surgery and adjuvant chemotherapy for localized soft tissue sarcoma: Japan Clinical Oncology Group study JCOG2102 (NACLESS). 研究方案:局部软组织肉瘤新辅助和辅助化疗与立即手术和辅助化疗的随机III期试验:日本临床肿瘤学小组研究 JCOG2102 (NACLESS)。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-05 DOI: 10.1093/jjco/hyae160
Yuki Funauchi, Satoshi Tsukushi, Hiroaki Hiraga, Akio Sakamoto, Toshiyuki Kunisada, Akihito Nagano, Koji Hiraoka, Kazutaka Kikuta, Tsukasa Yonemoto, Keisuke Ae, Akira Kawai, Makoto Endo, Yusuke Sano, Ryunosuke Machida, Tetsuya Sekita, Haruhiko Fukuda, Yoshinao Oda, Toshifumi Ozaki, Kazuhiro Tanaka
{"title":"Study protocol: randomized phase III trial of neo-adjuvant and adjuvant chemotherapy vs. immediate surgery and adjuvant chemotherapy for localized soft tissue sarcoma: Japan Clinical Oncology Group study JCOG2102 (NACLESS).","authors":"Yuki Funauchi, Satoshi Tsukushi, Hiroaki Hiraga, Akio Sakamoto, Toshiyuki Kunisada, Akihito Nagano, Koji Hiraoka, Kazutaka Kikuta, Tsukasa Yonemoto, Keisuke Ae, Akira Kawai, Makoto Endo, Yusuke Sano, Ryunosuke Machida, Tetsuya Sekita, Haruhiko Fukuda, Yoshinao Oda, Toshifumi Ozaki, Kazuhiro Tanaka","doi":"10.1093/jjco/hyae160","DOIUrl":"https://doi.org/10.1093/jjco/hyae160","url":null,"abstract":"<p><p>The optimal timing of surgery and the number of courses of perioperative chemotherapy for high-risk soft tissue sarcoma patients are still controversial. Tumour growth during neoadjuvant chemotherapy led to limb amputation in some patients. This study aims to confirm the non-inferiority of surgery and three courses of adjuvant chemotherapy with adriamycin (30 mg/m2, days 1 and 2) plus ifosfamide (2 g/m2, days 1-5) compared with our standard treatment of three courses of neoadjuvant chemotherapy and surgery followed by two courses of adjuvant chemotherapy with adriamycin plus ifosfamide for localized high-risk soft tissue sarcoma patients. This is a multi-center, two-arm, open-label, randomized phase III trial. The primary aim is to confirm the non-inferiority in overall survival (margin: hazard ratio of 1.61). This is the first randomized controlled trial to compare neoadjuvant chemotherapy and immediate surgery for soft tissue sarcoma. This trial was initiated on 16 November 2022 and registered with the Japan Clinical Trials Registry (jRCTs031220446).</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583075","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
Low-dose add-on methadone for cancer pain management: a retrospective analysis of 102 Japanese patients. 低剂量添加美沙酮治疗癌症疼痛:对 102 名日本患者的回顾性分析。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-05 DOI: 10.1093/jjco/hyae156
Tetsumi Sato, Akira Fukutomi, Taiichi Kawamura, Kyohei Kawakami, Tetsu Sato, Yoshiko Kamo, Tomomi Suzuki, Shota Hagiya, Rei Tanaka
{"title":"Low-dose add-on methadone for cancer pain management: a retrospective analysis of 102 Japanese patients.","authors":"Tetsumi Sato, Akira Fukutomi, Taiichi Kawamura, Kyohei Kawakami, Tetsu Sato, Yoshiko Kamo, Tomomi Suzuki, Shota Hagiya, Rei Tanaka","doi":"10.1093/jjco/hyae156","DOIUrl":"https://doi.org/10.1093/jjco/hyae156","url":null,"abstract":"<p><strong>Background: </strong>Methadone was introduced in 2013 for the treatment of intractable cancer pain in Japan and is indicated for patients receiving opioid doses ≧60 mg/day as an oral morphine equivalent. Low-dose (≦10 mg/day) add-on methadone to prior opioids has been reported from European countries to successfully relieve various types of intractable cancer pain; however, there are few reports of such use in Japan. The aim of this study was to analyze more than a hundred cases with low-dose add-on methadone to treat intractable pain in Japanese cancer patients.</p><p><strong>Methods: </strong>All cases in which 5 or 10 mg/day of methadone was added to prior opioids by the Palliative Care Team or Division of Palliative Medicine in our hospital during the period between April 2016 and September 2023 were extracted and analyzed retrospectively on electrical medical charts.</p><p><strong>Results and conclusions: </strong>A total of 102 cases were extracted with a male-to-female ratio of 60:42, and the age (mean ± SD) was 62.8 ± 14.7 years old. Methadone was introduced in an inpatient setting to 86 patients. The major pathologies that caused intractable pain were spinal metastases in 48, pelvis or pelvic floor lesions in 29 and pleural and/or chest wall lesions in 16. The most common mechanism of pain was the mixture of somatic and neuropathic components. The major opioids administered prior to methadone included tapentadol in 46 patients, hydromorphone in 36 and oxycodone in 19. The dose of the prior opioids [median, (interquartile range: IQR)] was 97, (62.8-167.3) (range: 15-1313) mg/day of oral morphine equivalent. Radiotherapy, chemotherapy and nerve blocks were performed as concomitant therapies in 48, 22 and 11 patients, respectively (with some overlap). The number of rescue doses [median (IQR)] was significantly decreased from three (two to five) on the day before methadone to one (zero to four) after seven days from methadone initiation. The side effects leading to discontinuation of methadone were drowsiness in three cases, nausea in three cases and dizziness in one case (with some overlap). Compared with complete switching from other opioids, low-dose add-on methadone can reduce the possibility of major dose discrepancies and can be quickly adjusted by combined opioid reduction/increase. Low-dose add-on methadone can be an effective and safe method for intractable cancer pain.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583062","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 role of external-beam radiotherapy for differentiated thyroid cancer. 体外放射治疗在分化型甲状腺癌中的作用。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-05 DOI: 10.1093/jjco/hyae158
Terufumi Kawamoto, Naoto Shikama, Naoki Nakamura, Takashi Mizowaki
{"title":"The role of external-beam radiotherapy for differentiated thyroid cancer.","authors":"Terufumi Kawamoto, Naoto Shikama, Naoki Nakamura, Takashi Mizowaki","doi":"10.1093/jjco/hyae158","DOIUrl":"https://doi.org/10.1093/jjco/hyae158","url":null,"abstract":"<p><p>The treatment options for differentiated thyroid cancer (DTC) are surgery, thyroid stimulating hormone suppression, radioactive iodine, and multitargeted tyrosine kinase inhibitors. The role of external-beam radiotherapy (EBRT) for DTC is controversial because of the lack of randomized controlled trials, but prospective single-arm studies and propensity score matching analyses have shown its efficacy and safety. This review discusses the role of EBRT after resection of gross disease, when there is a high risk of locoregional failure, as well as its role for locoregionally gross recurrent and unresectable disease. As in other tumor sites, EBRT has an important role in the palliative management and local control of patients with metastatic DTC, especially with bone and brain metastases.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583077","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
Awareness and implementation of comprehensive genomic profiling and cancer support for adolescents and young adults among healthcare professionals in Osaka, Japan. 日本大阪医疗保健专业人员对青少年综合基因组剖析和癌症支持的认识和实施情况。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-05 DOI: 10.1093/jjco/hyae159
Tsutomu Nishida, Miwa Miyamoto, Junko Yasuda, Yukie Ninomiya, Satoru Kosugi, Masao Mizuki, Hidetoshi Eguchi, Hiroshi Imamura
{"title":"Awareness and implementation of comprehensive genomic profiling and cancer support for adolescents and young adults among healthcare professionals in Osaka, Japan.","authors":"Tsutomu Nishida, Miwa Miyamoto, Junko Yasuda, Yukie Ninomiya, Satoru Kosugi, Masao Mizuki, Hidetoshi Eguchi, Hiroshi Imamura","doi":"10.1093/jjco/hyae159","DOIUrl":"https://doi.org/10.1093/jjco/hyae159","url":null,"abstract":"<p><strong>Background: </strong>Comprehensive genomic profiling (CGP) and specialized support for adolescent and young adult (AYA) cancer patients are crucial yet underexplored areas of healthcare in Japan. This study investigated awareness of CGP testing and support for AYA cancer patients among healthcare professionals in Osaka.</p><p><strong>Methods: </strong>An anonymous online survey was conducted from 31 January to 31 March 2024. The survey targeted all staff, including doctors, nurses, technicians, pharmacists and others, from eight Toyono Medical Area Cancer Medical Network Council hospitals. The survey included questions on basic demographics, awareness of CGP testing and support provided to patients with AYA cancer.</p><p><strong>Results: </strong>Among the 720 respondents, 41.9% were aware of CGP testing, while 20.3% were unaware. Regarding AYA cancer, 60.7% were aware and 14.3% were unaware. Only 7.5% had frequent contact with AYA patients and 96.8% recognized the need for education and information. Awareness of CGP was greater among doctors (72.5%) than among other professionals (34.4%); similarly, AYA cancer awareness was higher among doctors (73.9%) than among other professionals (57.7%). CGP awareness among doctors varied by years of experience and institutional type, being highest in core and cooperative hospitals (80 and 78.6%, respectively) and among doctors with more than 21 years of experience (90%).</p><p><strong>Conclusions: </strong>This study reveals significant gaps in CGP and AYA cancer awareness among healthcare professionals in Osaka, Japan, with doctors demonstrating higher awareness levels than other professionals. There is a pressing need for targeted educational programs to enhance the understanding and implementation of CGP and support AYA cancer patients.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583057","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
Identifying physicians' needs in community-based palliative care consultation for cancer patients in palliative care specialist-deficient settings: a qualitative study. 在缺乏姑息关怀专家的环境中,确定医生对癌症患者社区姑息关怀咨询的需求:一项定性研究。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-05 DOI: 10.1093/jjco/hyae157
Miwa Aoki, Sena Yamamoto, Ayumi Takao, Saori Tamura, Yoshiyuki Kizawa, Harue Arao
{"title":"Identifying physicians' needs in community-based palliative care consultation for cancer patients in palliative care specialist-deficient settings: a qualitative study.","authors":"Miwa Aoki, Sena Yamamoto, Ayumi Takao, Saori Tamura, Yoshiyuki Kizawa, Harue Arao","doi":"10.1093/jjco/hyae157","DOIUrl":"https://doi.org/10.1093/jjco/hyae157","url":null,"abstract":"<p><strong>Background: </strong>Consultation with palliative care specialists can be beneficial in addressing the numerous demands of patients with cancers and their families within communities. In settings lacking palliative care specialists, establishing a new community-based palliative care consultation system necessitates gathering evidence to support its development. This study aimed to identify the specific palliative care consultation needs and the consultation methods requested by Japanese physicians in settings without palliative care specialists.</p><p><strong>Methods: </strong>A qualitative descriptive study utilizing semi-structured virtual interviews. From August 2023 to October 2023, we conducted interviews with 11 physicians providing cancer treatment in hospitals or clinics in a prefecture within the Kanto region of Japan without palliative care specialists. Participants were asked about the specific palliative care consultation needs they have and the need for consultation methods.</p><p><strong>Results: </strong>Of the 11 physicians, nine had completed the nationwide basic primary palliative care education program. The survey revealed three themes regarding their consultation needs: 'receiving specialized insight', 'inspiring confidence', and 'improving care capacity', Two themes emerged regarding the need for consultation methods: 'enhancing care collaboration' and 'improving accessibility'.</p><p><strong>Conclusions: </strong>Physicians require consultation systems to empower them and enhance the community care capacity, in addition to providing specialized knowledge. These systems would include collaboration with specialists through outreach consultations, utilization of information and communications technology, and the establishment of nurse-led consultation teams to improve access to palliative care teams.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583059","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
Association of the modified Glasgow prognostic score and prognostic nutritional index with duration of oral anamorelin administration in patients with cancer cachexia: a retrospective cohort study. 癌症恶病质患者改良格拉斯哥预后评分和预后营养指数与口服阿那莫林用药时间的关系:一项回顾性队列研究。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-02 DOI: 10.1093/jjco/hyae086
Kazuma Fujita, Yumiko Akamine, Haruka Igarashi, Yayoi Fukushi, Katsuya Sasaki, Koji Fukuda, Masafumi Kikuchi, Hiroyuki Shibata
{"title":"Association of the modified Glasgow prognostic score and prognostic nutritional index with duration of oral anamorelin administration in patients with cancer cachexia: a retrospective cohort study.","authors":"Kazuma Fujita, Yumiko Akamine, Haruka Igarashi, Yayoi Fukushi, Katsuya Sasaki, Koji Fukuda, Masafumi Kikuchi, Hiroyuki Shibata","doi":"10.1093/jjco/hyae086","DOIUrl":"10.1093/jjco/hyae086","url":null,"abstract":"<p><strong>Background: </strong>The modified Glasgow Prognostic Score (mGPS) and Prognostic Nutritional Index (PNI) are indicators of nutritional status in cancer patients; however, the effects of baseline mGPS and PNI on the duration of administration of the ghrelin receptor agonist anamorelin, which is used to treat cachexia in patients with cancer, are unclear. This study aimed to clarify the association of mGPS and PNI with the duration of oral anamorelin administration for patients who did not have beneficial effects from anamorelin.</p><p><strong>Methods: </strong>The attending physician determined the duration of oral anamorelin administration based on discontinuation due to cancer progression, poor efficacy, adverse events, or death.</p><p><strong>Results: </strong>The 12-week continuation rate of oral anamorelin was 30.4%. Univariate analysis revealed that an Eastern Cooperative Oncology Group performance status (ECOG-PS) of ≥2 (P < .001), concurrent chemotherapy (P = .002), albumin level (P = .005), C-reactive protein level (P = .013), and a mGPS of 2 (P = .014) were statistically significant predictors of the 12-week continuation rate of oral anamorelin. In the multivariate analysis, a mGPS of 2 remained a significant risk factor, and the ECOG-PS and concurrent chemotherapy had no effect on the association between the mGPS and 12-week continuation rate of oral anamorelin.</p><p><strong>Conclusion: </strong>Patients with a mGPS of 2, compared with mGPS of 0 or 1, are less likely to maintain oral anamorelin therapy, regardless of the ECOG-PS or concurrent chemotherapy. Therefore, it is necessary to consider initiating anamorelin administration at mGPS 0 or 1.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141467932","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
Awareness, information sources, and beliefs regarding palliative care in the general population in Japan: a nationwide cross-sectional survey (INFORM study 2023). 日本普通民众对姑息关怀的认识、信息来源和信念:一项全国性横断面调查(INFORM 研究 2023)。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-02 DOI: 10.1093/jjco/hyae092
Yu Uneno, Masanori Mori, Junko Saito, Aki Otsuki, Aya Kuchiba, Naomi Sakurai, Naoki Nakaya, Maiko Fujimori, Taichi Shimazu
{"title":"Awareness, information sources, and beliefs regarding palliative care in the general population in Japan: a nationwide cross-sectional survey (INFORM study 2023).","authors":"Yu Uneno, Masanori Mori, Junko Saito, Aki Otsuki, Aya Kuchiba, Naomi Sakurai, Naoki Nakaya, Maiko Fujimori, Taichi Shimazu","doi":"10.1093/jjco/hyae092","DOIUrl":"10.1093/jjco/hyae092","url":null,"abstract":"<p><strong>Background: </strong>The diversification of information sources and changes in social structures necessitates updates on the state of public awareness of palliative care. Therefore, we clarified the status and determinants of awareness, information sources, and beliefs, regarding palliative care in Japan.</p><p><strong>Methods: </strong>This nationwide cross-sectional survey included 10 000 participants aged ≥20 years enrolled through random sampling using a two-stage stratification in 2023. We used a mailed self-administered questionnaire (INFORM Study 2023). The questionnaire items were selected (partially modified) from the Health Information National Trends Survey (USA) to ensure comparability, included palliative care awareness, information sources, and beliefs. Weighted logistic regression was conducted to explore the determinants of awareness.</p><p><strong>Results: </strong>Of the 3452 participants that responded (response rate: 35.3%), 65.2% had palliative care awareness. The weighted logistic regression analysis revealed that respondents less likely to have any palliative care awareness were younger, were male, had limited education history, had lower household income, and were non-Internet users. Of these, sex had the clear association (adjusted odds ratio for female vs. male: 3.20 [95% CI: 2.66-3.85]). Across all age groups, healthcare professionals (58.5%) and the Internet (30.5%) were the most trusted source of information. Younger participants frequently received information online. Most participants believed that palliative care was beneficial, although 82.0% associated it with death.</p><p><strong>Conclusions: </strong>The Japanese population had a relatively high palliative care awareness, with the majority trusting information from healthcare professionals rather than the Internet. Further efforts are warranted to address barriers to receiving trustworthy palliative care information.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734172","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
Projection of the number of new lymphoma cases in the world. 全球新增淋巴瘤病例数量预测。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-02 DOI: 10.1093/jjco/hyae147
Laureline Gatellier, Kayo Nakata
{"title":"Projection of the number of new lymphoma cases in the world.","authors":"Laureline Gatellier, Kayo Nakata","doi":"10.1093/jjco/hyae147","DOIUrl":"10.1093/jjco/hyae147","url":null,"abstract":"","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521868","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
Real-world evidence of triplet therapy efficacy in patients with metastatic castration-sensitive prostate cancer: a Japanese multicenter study. 转移性阉割敏感性前列腺癌患者三联疗法疗效的现实证据:一项日本多中心研究。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-02 DOI: 10.1093/jjco/hyae098
Fumihiko Urabe, Yu Imai, Yuma Goto, Kojiro Tashiro, Masaki Hashimoto, Kentaro Yoshihara, Shutaro Yamamoto, Shuhei Hara, Keiichiro Miyajima, Wataru Fukuokaya, Yuki Enei, Kosuke Iwatani, Sotaro Kayano, Taro Igarashi, Koichi Aikawa, Takafumi Yanagisawa, Shoji Kimura, Shunsuke Tsuzuki, Masaya Murakami, Kenichi Hata, Tatsuya Shimomura, Hiroki Yamada, Jun Miki, Takahiro Kimura
{"title":"Real-world evidence of triplet therapy efficacy in patients with metastatic castration-sensitive prostate cancer: a Japanese multicenter study.","authors":"Fumihiko Urabe, Yu Imai, Yuma Goto, Kojiro Tashiro, Masaki Hashimoto, Kentaro Yoshihara, Shutaro Yamamoto, Shuhei Hara, Keiichiro Miyajima, Wataru Fukuokaya, Yuki Enei, Kosuke Iwatani, Sotaro Kayano, Taro Igarashi, Koichi Aikawa, Takafumi Yanagisawa, Shoji Kimura, Shunsuke Tsuzuki, Masaya Murakami, Kenichi Hata, Tatsuya Shimomura, Hiroki Yamada, Jun Miki, Takahiro Kimura","doi":"10.1093/jjco/hyae098","DOIUrl":"10.1093/jjco/hyae098","url":null,"abstract":"<p><strong>Background: </strong>Two randomized trials demonstrated that the survival benefits afforded by triplet therapy were greater than those of doublet therapy, thus changing the treatment paradigm for metastatic castration-sensitive prostate cancer (mCSPC). This is the first study to assess the real-world use, performance, and safety of triplet therapy in Japanese patients.</p><p><strong>Methods: </strong>This retrospective multicenter study included 45 consecutive mCSPC patients who received triplet therapy composed of androgen deprivation therapy (ADT), docetaxel, and darolutamide between January 2023 and June 2024. Baseline patient characteristics and their clinical parameters during triplet therapy were collected. Adverse events (AEs) were graded using Common Terminology Criteria for Adverse Events version 5.0, and imaging responses were evaluated following the RECIST criteria. The prostate-specific antigen (PSA) nadir was defined as the lowest PSA value during follow-up, and the PSA decrease was the initial PSA value minus the PSA nadir.</p><p><strong>Results: </strong>The median patient age was 70 years and the median follow-up duration was 10 months. High-volume disease was present in 82.2% of patients. Concurrent administration of docetaxel and darolutamide was scheduled for 22.2% of cases. The incidence of any AE was 86.7%, with 55.5% of patients experiencing grade 3-4 AEs. Neutropenia was common, but prophylactic granulocyte colony-stimulating factor (G-CSF) significantly reduced the incidence of neutropenia of grade 3 or higher. Febrile neutropenia occurred in four patients (8.9%); these patients had not received prophylactic G-CSF. A decline in PSA of 90% was observed in 95.6% of patients, and an imaging response was seen in 97.8%.</p><p><strong>Conclusions: </strong>Triplet therapy with ADT, darolutamide, and docetaxel was highly efficacious and tolerable in Japanese mCSPC patients, particularly those with high-volume disease. Prophylactic G-CSF prescription is crucial to manage neutropenia effectively. Further studies with longer follow-ups are needed to confirm these findings and explore the long-term outcomes.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748171","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
Association between response to enfortumab vedotin and peripheral neuropathy in urothelial carcinoma patients: a multicenter retrospective study. 尿路癌患者对恩福单抗维多汀的反应与周围神经病变之间的关系:一项多中心回顾性研究。
IF 1.9 4区 医学
Japanese journal of clinical oncology Pub Date : 2024-11-02 DOI: 10.1093/jjco/hyae082
Nozomi Hayakawa, Eiji Kikuchi, Go Kaneko, Ryo Yamashita, Daiki Ikarashi, Yuki Endo, Kimitsugu Usui, Wataru Obara, Masafumi Oyama, Yukihiro Kondo
{"title":"Association between response to enfortumab vedotin and peripheral neuropathy in urothelial carcinoma patients: a multicenter retrospective study.","authors":"Nozomi Hayakawa, Eiji Kikuchi, Go Kaneko, Ryo Yamashita, Daiki Ikarashi, Yuki Endo, Kimitsugu Usui, Wataru Obara, Masafumi Oyama, Yukihiro Kondo","doi":"10.1093/jjco/hyae082","DOIUrl":"10.1093/jjco/hyae082","url":null,"abstract":"<p><strong>Background: </strong>Enfortumab vedotin (EV) was approved for patients with metastatic urothelial carcinoma (mUC) who progressed after anticancer therapy on September 2021 in Japan. The association between the occurrence of EV-related side effects and clinical outcome remains to be elucidated.</p><p><strong>Methods: </strong>We identified 97 mUC patients treated with EV therapy at our five institutions from the date of approval to March 2023. The median follow-up period was 7.0 months. We retrospectively analyzed the efficacy and safety of EV.</p><p><strong>Results: </strong>The median age of the patients was 71 years old, 39% had PS of 1 or more, and 56.7% had primary tumor in upper urinary tract. Overall response rate (ORR) to EV therapy, median progression-free survival (PFS), and overall survival (OS) were 43.3%, 7.52 months, and 12.78 months, respectively. Any grade of treatment-related skin disorder, dysgeusia, peripheral neuropathy, gastrointestinal disorder, and hyperglycemia occurred in 61 (62.9%), 36 (37.1%), 34 (35.1%), 29 (29.9%), and 18 (18.6%) patients, respectively. The patients with EV-associated peripheral neuropathy had significantly higher ORR (58.8% vs. 34.9%, P = .032) and longer median PFS (8.05 vs. 6.31 months, P = .017) and OS (not reached vs. 11.57 months, P = .008, respectively) than those without. The occurrence of peripheral neuropathy after EV treatment and the presence of peritoneal dissemination were factors independently associated with PFS (hazard ratio = 0.46, P = .008 and hazard raito = 3.83, P = .004, respectively) and OS (hazard ratio = 0.30, P = .005 and hazard raito = 4.53, P = .002, respectively).</p><p><strong>Conclusions: </strong>The occurrence of EV-related peripheral neuropathy might be associated with the efficacy of EV therapy in mUC patients.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141467931","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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