International Journal of Clinical Oncology最新文献

{"title":"Correction to: Effect of extending the period from oral administration of 5-aminolevulinic acid hydrochloride to photodynamic diagnosis during transurethral resection for non-muscle invasive bladder cancer on diagnostic accuracy and safety: a single-arm multicenter phase III trial.","authors":"Rikiya Taoka, Hideo Fukuhara, Makito Miyake, Keita Kobayashi, Atsushi Ikeda, Kent Kanao, Yoshinobu Komai, Ryo Fujiwara, Yusuke Sato, Mikio Sugimoto, Toyonori Tsuzuki, Kiyohide Fujimoto, Keiji Inoue, Mototsugu Oya","doi":"10.1007/s10147-024-02654-5","DOIUrl":"https://doi.org/10.1007/s10147-024-02654-5","url":null,"abstract":"","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142667913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Electronic patient-reported outcomes as digital therapeutics for patients with cancer: a narrative review of current practices and future directions.","authors":"Ken Yamaguchi, Nozomi Higashiyama, Maki Umemiya, Yoshihide Inayama, Ayami Koike, Akihiko Ueda, Rin Mizuno, Mana Taki, Koji Yamanoi, Ryusuke Murakami, Junzo Hamanishi, Masaki Mandai","doi":"10.1007/s10147-024-02651-8","DOIUrl":"https://doi.org/10.1007/s10147-024-02651-8","url":null,"abstract":"<p><p>Improved cancer treatment outcomes have increased the demand for medical care that considers the quality of life of patients with cancer. Patient-reported outcomes (PROs) help assess the quality of life because they involve direct evaluation of the patients. Recently, electronic PROs (ePROs) have been used in clinical cancer care settings in Europe and the United States. Electronic PROs positively affected communication between patients with cancer and healthcare providers, enhanced education, optimized self-management, contributed to healthcare economics, assisted in monitoring adverse events, and improved prognosis. However, challenges such as adherence, burden on healthcare providers, lack of personalized formats, low digital literacy, and implementation costs remain. Therefore, carefully selecting the items to be recorded by ePROs in alignment with specific objectives is essential. Additionally, developing systems using lifelogs-digital records of daily activities-and creating mechanisms that automatically encourage patient behavioral changes based on the reported data are crucial. This review delineates the advantages and challenges of ePROs according to their history and proposes the prospects of ePRO.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world outcomes of avelumab plus axitinib in patients with advanced renal cell carcinoma in Japan: long-term follow-up from the J-DART2 retrospective study.","authors":"Taigo Kato, Junya Furukawa, Nobuyuki Hinata, Kosuke Ueda, Isao Hara, Fumiya Hongo, Ryuichi Mizuno, Teppei Okamoto, Hiroshi Okuno, Takayuki Ito, Masahiro Kajita, Mototsugu Oya, Yoshihiko Tomita, Nobuo Shinohara, Masatoshi Eto, Hirotsugu Uemura","doi":"10.1007/s10147-024-02618-9","DOIUrl":"https://doi.org/10.1007/s10147-024-02618-9","url":null,"abstract":"<p><strong>Background: </strong>Avelumab + axitinib was approved for advanced renal cell carcinoma (aRCC) in Japan in December 2019. We report long-term real-world outcomes with first-line avelumab + axitinib from the J-DART2 study in Japan.</p><p><strong>Methods: </strong>J-DART2 was a multicenter, noninterventional, retrospective study examining clinical data from patients with curatively unresectable locally advanced or metastatic RCC who started treatment with first-line avelumab + axitinib in Japan between December 2019 and October 2022. Endpoints included patient characteristics, treatment patterns, and outcomes.</p><p><strong>Results: </strong>Data from 150 patients across 19 sites were analyzed; median follow-up was 18.7 months (95% CI, 16.3-20.6 months). Median age was 70.5 years; 26.0% of patients were aged ≤64 years, 42.7% were aged 65-74 years, and 31.3% were aged ≥75 years. International Metastatic RCC Database Consortium risk was favorable in 26.0%, intermediate in 54.7% (1 risk factor in 30.7%; 2 risk factors in 24.0%), and poor in 19.3% of patients. Median progression-free survival (PFS) was 17.1 months, with 1- and 2-year PFS rates of 57.7% and 37.5%, respectively. Median overall survival (OS) was not reached, with 1- and 2-year OS rates of 90.6% and 84.7%, respectively. Objective response rate was 53.3%; disease control rate was 88.9%. Outcomes were similar across age groups, including patients aged ≥75 years.</p><p><strong>Conclusions: </strong>J-DART2 is the largest retrospective study to report long-term real-world outcomes in patients with aRCC treated with avelumab + axitinib in Japan. Findings were similar to those observed in previous studies and support the benefit of avelumab + axitinib in clinical practice in Japan.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phase Ib study of the oral PI3Kδ inhibitor linperlisib in patients with advanced solid tumors.","authors":"Jin Li, Junli Xue, Tianshu Liu, Yi Feng, Nong Xu, Jianjin Huang, Yongmei Yin, Jun Zhang, Haibo Mou, Jiangzhong Shentu, Hanying Bao, Zusheng Xu, Zuhong Xu","doi":"10.1007/s10147-024-02657-2","DOIUrl":"https://doi.org/10.1007/s10147-024-02657-2","url":null,"abstract":"<p><strong>Background: </strong>Patients with advanced solid tumors have a suboptimal prognosis. This study investigated the safety and feasibility of linperlisib, a selective phosphatidylinositol 3-kinase delta isoform (PI3Kδ) inhibitor, for treating patients with advanced solid tumors.</p><p><strong>Methods: </strong>In this phase Ib, single-arm, open-label, multi-center clinical trial, patients with histologically confirmed advanced solid tumors from eight centers in China were enrolled to receive oral linperlisib (80 mg/day). The primary endpoint was safety.</p><p><strong>Results: </strong>Between August 2019 and June 2022, 94 patients were enrolled in the trial and received the study treatment. The most common (≥ 20%) treatment emergent adverse events (TEAEs) of all grades irrespective of causality were increased aspartate aminotransferase (AST) (26.6%), proteinuria (26.6%), decreased appetite (25.5%), increased alanine aminotransferase (ALT) (22.3%), weight loss (21.3%), and anemia (21.3%). The most common grade ≥ 3 TEAEs were diarrhea (4.3%), increased AST (3.2%), increased ALT (3.2%), neutropenia (3.2%), anemia (3.2%), increased blood alkaline phosphatase (3.2%). The objective response rate (ORR) was 1.1% (95% confidence interval [CI] 0.0-5.8), and the disease control rate (DCR) was 37.2% (95% CI 27.5-47.8). As of the data cutoff, the median follow-up time was 4.2 months (95% CI 2.8-6.9). The median progression-free survival (PFS) was 1.85 months (95% CI 1.79-1.88). The median overall survival (OS) was not reached.</p><p><strong>Conclusion: </strong>Linperlisib showed an acceptable safety profile and preliminary clinical benefit in patients with a range of advanced solid tumors. Further studies of linperlisib safety and efficacy are warranted.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of multi-day antiemetic treatment for patients undergoing multi-day chemotherapy: a systematic review of Clinical Practice Guidelines for Antiemesis 2023 from Japan Society of Clinical Oncology.","authors":"Kazuhisa Nakashima, Saki Harashima, Rena Kaneko, Ryuhei Tanaka, Masakazu Abe, Makoto Wada, Keiko Iino, Tatsuo Akechi, Hirotoshi Iihara, Chiyo K Imamura, Ayako Okuyama, Keiko Ozawa, Yong-Il Kim, Eriko Satomi, Masayuki Takeda, Takako Eguchi Nakajima, Naoki Nakamura, Junichi Nishimura, Mayumi Noda, Kazumi Hayashi, Takahiro Higashi, Narikazu Boku, Koji Matsumoto, Yoko Matsumoto, Kenji Okita, Nobuyuki Yamamoto, Kenjiro Aogi, Hidenori Sasaki","doi":"10.1007/s10147-024-02652-7","DOIUrl":"https://doi.org/10.1007/s10147-024-02652-7","url":null,"abstract":"<p><strong>Background: </strong>A standardized multi-day antiemetic regimen for multi-day chemotherapy remains elusive. This systematic review evaluated the efficacy and safety of multi-day antiemetic regimens in patients undergoing multi-day intravenous chemotherapy.</p><p><strong>Methods: </strong>We conducted a comprehensive search of PubMed, Cochrane Library, and Ichushi-Web databases for relevant studies published from January 1990 to December 2020. We included studies comparing multi-day and single-day antiemetic regimens for preventing chemotherapy-induced nausea and vomiting.</p><p><strong>Results: </strong>No studies directly comparing multi-day versus single-day antiemetic regimens were found. Despite expanding control group criteria beyond \"single-day antiemetic therapy\" limited high-quality studies and variations in cancer types, chemotherapy regimens, and antiemetic treatments precluded meta-analysis. Among the included studies, some randomized controlled trials (RCTs) focused on complete response and vomiting rates. Two studies comparing two- and three-drug combinations reported higher complete response and no-vomiting rates with the three-drug regimen. Limited RCTs explored \"nausea control\" and \"cost,\" and assessing \"adverse events\" proved challenging due to inconsistent reporting.</p><p><strong>Conclusion: </strong>The research on multi-day antiemetic therapy is limited, necessitating further investigation. Nonetheless, our findings suggest that three-drug combination therapy, including aprepitant, may offer superior antiemetic efficacy compared to two-drug regimens. Multi-day antiemetic therapy is strongly recommended during multi-day intravenous administration of cytotoxic anticancer drugs.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of carmustine wafers, followed by radiation, temozolomide, and bevacizumab therapy, for newly diagnosed glioblastoma with maximal resection.","authors":"Masayuki Kanamori, Ichiyo Shibahara, Yoshiteru Shimoda, Yukinori Akiyama, Takaaki Beppu, Shigeo Ohba, Toshiyuki Enomoto, Takahiro Ono, Yuta Mitobe, Mitsuto Hanihara, Yohei Mineharu, Joji Ishida, Kenichiro Asano, Yasuyuki Yoshida, Manabu Natsumeda, Sadahiro Nomura, Tatsuya Abe, Hajime Yonezawa, Ryuichi Katakura, Soichiro Shibui, Toshihiko Kuroiwa, Hiroyoshi Suzuki, Hidehiro Takei, Haruo Matsushita, Ryuta Saito, Yoshiki Arakawa, Yukihiko Sonoda, Yuichi Hirose, Toshihiro Kumabe, Takuhiro Yamaguchi, Hidenori Endo, Teiji Tominaga","doi":"10.1007/s10147-024-02650-9","DOIUrl":"https://doi.org/10.1007/s10147-024-02650-9","url":null,"abstract":"<p><strong>Background: </strong>To improve the outcome in newly diagnosed glioblastoma patients with maximal resection, we aimed to evaluate the efficacy and safety of implantation of carmustine wafers (CWs), radiation concomitant with temozolomide and bevacizumab, and maintenance chemotherapy with six cycles of temozolomide and bevacizumab.</p><p><strong>Method: </strong>This prospective phase II study enrolled glioblastoma patients considered candidates for complete resection (> 90%) of a contrast-enhanced lesion. The CWs were intraoperatively implanted into the resection cavity after achieving maximal resection. Patients without a measurable contrast-enhanced lesion on magnetic resonance imaging within 48 h after resection received concomitant radiotherapy and chemotherapy with temozolomide and bevacizumab, followed by maintenance treatment with up to six cycles of temozolomide and bevacizumab. The primary endpoint was the 2-year overall survival rate in glioblastoma patients with protocol treatment.</p><p><strong>Results: </strong>From October 2015 to April 2018, we obtained consent for the first registration from 70 patients across 17 institutions in Japan, and 49 patients were treated according to the protocol. We evaluated the safety in 49 patients who were part of the second registration and the efficacy in 45 glioblastoma patients treated according to the protocol. The profile of hematological and most of the non-hematological adverse effects was similar to that in previous studies, but stroke occurred in 12% of cases (6/49 patients). The estimated 2-year overall survival rate was 51.3%.</p><p><strong>Conclusion: </strong>Implantation of CWs, followed by concomitant radiation, temozolomide, and bevacizumab, and six cycles of temozolomide and bevacizumab may offer some benefit to survival in Japanese glioblastoma patients with maximal resection.</p><p><strong>Trial id: </strong>jRCTs021180007.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lymphadenectomy and chemotherapy are effective treatments for patients with 2023 international federation of gynecology and obstetrics stage IIC-high risk endometrial cancer in Japan.","authors":"Yoshinori Tani, Keiichiro Nakamura, Masae Yorimitsu, Noriko Seki, Mie Nakanishi, Hironori Itou, Miyuki Shimizu, Dan Yamamoto, Etsuko Takahara, Hisashi Masuyama","doi":"10.1007/s10147-024-02647-4","DOIUrl":"https://doi.org/10.1007/s10147-024-02647-4","url":null,"abstract":"<p><strong>Background: </strong>In early-stage endometrial cancer (EC), the treatment of aggressive histological subtypes (endometrioid carcinoma grade 3, serous carcinoma, clear-cell carcinoma, undifferentiated carcinoma, mixed carcinoma, and carcinosarcoma) is controversial. We aimed to investigate the treatment of patients with International Federation of Gynecology and Obstetrics (FIGO) stage IC and stage IIC EC according to the 2023 classification.</p><p><strong>Methods: </strong>We retrospectively identified patients with FIGO 2023 stage IC, IIC-intermediate risk (IIC-I), and IIC-high risk (IIC-H) EC who underwent adjuvant therapy or observation after surgery at eight medical institutions from 2004 to 2023. Progression-free survival (PFS) and overall survival (OS) were evaluated using Kaplan-Meier estimates and univariate and multivariate analyses.</p><p><strong>Results: </strong>The PFS and OS were significantly worse in patients with FIGO 2023 stage IIC-H EC than in those with FIGO 2023 stage IIC-I EC (PFS: p = 0.008 and OS: p = 0.006). According to the FIGO 2023 stage IIC-H classification, lymphadenectomy and chemotherapy resulted in better prognoses regarding both PFS and OS (p < 0.001 for both) than other treatments. Our findings suggest that lymphadenectomy and chemotherapy effectively reduced vaginal stump and lymph node metastases in FIGO 2023 stage IIC-H EC (p < 0.001 and p = 0.008, respectively). Furthermore, in the multivariate analysis, not undergoing lymphadenectomy or chemotherapy were independent predictors of recurrence and poor prognoses in patients with FIGO 2023 stage IIC-H EC (p < 0.001 and p = 0.031, respectively).</p><p><strong>Conclusion: </strong>Lymphadenectomy and chemotherapy resulted in better prognoses regarding both recurrence and survival in patients with FIGO 2023 stage IIC high-risk EC.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}