{"title":"Prognosis based on postoperative PSA levels and treatment in prostate cancer with lymph node involvement.","authors":"Tokiyoshi Tanegashima, Masaki Shiota, Takahiro Kimura, Dai Takamatsu, Yoshiyuki Matsui, Akira Yokomizo, Ryoichi Saito, Shuichi Morizane, Makito Miyake, Masakazu Tsutsumi, Yoshiyuki Yamamoto, Kojiro Tashiro, Ryotaro Tomida, Kohei Edamura, Shintaro Narita, Takahiro Yamaguchi, Takashi Kasahara, Kohei Hashimoto, Masashi Kato, Takayuki Yoshino, Shusuke Akamatsu, Akihiro Matsukawa, Tomoyuki Kaneko, Ryuji Matsumoto, Akira Joraku, Manabu Kato, Toshihiro Saito, Takuma Kato, Shuichi Tatarano, Shinichi Sakamoto, Hidenori Kanno, Naoki Terada, Naotaka Nishiyama, Hiroshi Kitamura, Masatoshi Eto","doi":"10.1007/s10147-024-02580-6","DOIUrl":"10.1007/s10147-024-02580-6","url":null,"abstract":"<p><strong>Background: </strong>The therapeutic role of pelvic lymph node dissection (PLND) during radical prostatectomy (RP) for prostate cancer is not established. In clinical practice, PLND is primarily performed in cases of high-risk prostate cancer. The detection of lymph node metastasis plays a crucial role in determining the need for subsequent treatments. This study aims to evaluate the prognosis of prostate cancer patients with lymph node involvement (LNI) by stratifying them based on postoperative prostate-specific antigen (PSA) levels to identify biomarkers that can guide postoperative treatment strategies.</p><p><strong>Methods: </strong>Analysis was conducted on 383 patients, selected from 572 initially eligible, who underwent RP with LNI across 33 Japanese Urological Oncology Group institutions from 2006 to 2019. Patients were grouped according to postoperative PSA levels and salvage treatments received. Follow-up focused on castration resistance-free survival (CRFS), metastasis-free survival (MFS), and overall survival (OS).</p><p><strong>Results: </strong>In the persistent PSA group (PSA ≥ 0.1 ng/mL), CRFS and MFS were significantly shorter compared to the non-persistent PSA group (PSA < 0.1 ng/mL), and there was a tendency for shorter OS. In the persistent PSA group, patients with postoperative PSA values above the median (PSA ≥ 0.52 ng/mL) showed shorter CRFS and MFS. Furthermore, in the PSA ≥ 0.52 group, androgen deprivation therapy (ADT) plus radiotherapy (RT) combination had prolonged CRFS and MFS compared with ADT alone.</p><p><strong>Conclusions: </strong>This study provides valuable insights into stratifying patients based on postoperative PSA levels to tailor postoperative treatment strategies, potentially improving the prognosis of prostate cancer patients with LNI.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1586-1593"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554786","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":"A phase 2 study of mobocertinib as first-line treatment in Japanese patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations.","authors":"Kiyotaka Yoh, Koichi Azuma, Hidetoshi Hayashi, Makoto Nishio, Kenichi Chikamori, Eiki Ichihara, Yasutaka Watanabe, Takayuki Asato, Tadayuki Kitagawa, Robert J Fram, Yuichiro Ohe","doi":"10.1007/s10147-024-02588-y","DOIUrl":"10.1007/s10147-024-02588-y","url":null,"abstract":"<p><strong>Background: </strong>Mobocertinib is a novel, synthetic, orally administered tyrosine kinase inhibitor that inhibits many activated forms of epidermal growth factor receptor (EGFR), including those containing exon 20 insertion (ex20ins) mutations. This study aimed to assess the efficacy of mobocertinib in Japanese patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations.</p><p><strong>Methods: </strong>This was a phase 2, open-label study. Patients with NSCLC harboring EGFR ex20ins mutations who had not had previous systemic treatment received mobocertinib 160 mg once daily. The primary endpoint was the confirmed objective response rate. A planned interim analysis was completed for the first 14 patients with a centrally confirmed EGFR ex20ins mutation, with enrollment stopped if the number of patients with an objective response was five or fewer.</p><p><strong>Results: </strong>In total, 33 patients were enrolled into the study (63.6% women; median age: 66 years). At the interim analysis, the objective response rate evaluated by a central independent review committee was 28.6% (4/14, 90% confidence interval: 10.4-54.0); therefore, enrollment was stopped for futility. In the full analysis set, the objective response rate was 18.2% (6/33, 95% confidence interval: 7.0-35.5); of the six responders, one patient (3.0%) had a complete response and five patients (15.2%) had partial responses. The most common treatment-related adverse events were diarrhea, paronychia, stomatitis, and nausea.</p><p><strong>Conclusion: </strong>Although study enrollment was terminated early owing to futility, our results showed modest activity of mobocertinib in Japanese patients with NSCLC with EGFR ex20ins mutations with no additional safety concerns.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1461-1474"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11420270/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142072686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparative analysis of dual immune checkpoint inhibitor combination therapy versus immune checkpoint inhibitor plus tyrosine kinase inhibitor combination therapy for renal cell carcinoma with inferior vena cava tumor thrombosis.","authors":"Kazuhiko Yoshida, Naoki Nagasaka, Tsunenori Kondo, Yuki Kobari, Hiroki Ishihara, Hironori Fukuda, Junpei Iizuka, Hideki Ishida, Toshio Takagi","doi":"10.1007/s10147-024-02598-w","DOIUrl":"10.1007/s10147-024-02598-w","url":null,"abstract":"<p><strong>Background: </strong>Whether immune checkpoint inhibitor (ICI) plus ICI combination therapy or ICI plus tyrosine kinase inhibitor (TKI) combination therapy is useful for renal cell carcinoma (RCC) with inferior vena cava tumor thrombosis (IVCTT) remains unclear.</p><p><strong>Methods: </strong>We retrospectively evaluated the therapeutic effects and incidence of treatment-related adverse events (TRAEs) associated with ICI-based combination therapy in 36 patients with advanced RCC with IVCTT.</p><p><strong>Results: </strong>The median age at initiation of treatment was 71 years; the IVCTT stages were cT3b in 22 patients and cT3c in 14. The ICI-ICI and ICI-TKI groups comprised 15 and 21 patients, respectively. Median tumor shrinkage at the best response showed that the primary tumor diameter decreased by 1.8 cm (22%), and the IVCTT height decreased by 1.5 cm (26%). A higher proportion of patients in the ICI-TKI group experienced tumor shrinkage than those in the ICI-ICI group (primary tumor, p = 0.0325; IVCTT, p = 0.0112). Approximately 27% of patients experienced an increase in the IVCTT height with ICI-ICI combination therapy. No significant difference was observed in the relative tumor shrinkage of IVCTT, primary or level-down staging of IVCTT, other treatment effects, incidence of TRAEs, surgical outcomes, or prognosis between the groups.</p><p><strong>Conclusion: </strong>ICI-based combination therapy is effective against IVCTT and primary RCC. Although ICI-ICI is associated with a higher probability of tumor growth compared with ICI-TKI in the frequency of tumor regression, both therapies may be almost equally effective against primary RCC with IVCTT.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1538-1547"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897392","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":"Re-administration of platinum-based chemotherapy for recurrent endometrial cancer: an ancillary analysis of the SGSG-012/GOTIC-004/Intergroup study.","authors":"Shoji Nagao, Shin Nishio, Kazuhiro Takehara, Shinya Sato, Toyomi Satoh, Muneaki Shimada, Satoshi Yamaguchi, Hiroshi Tanabe, Masashi Takano, Kouji Horie, Yuji Takei, Yuichi Imai, Yumi Hibino, Kosei Hasegawa, Munetaka Takekuma, Kazuto Nakamura, Hirokuni Takano, Keiichi Fujiwara, Hisashi Masuyama","doi":"10.1007/s10147-024-02585-1","DOIUrl":"10.1007/s10147-024-02585-1","url":null,"abstract":"<p><strong>Background: </strong>We previously demonstrated the applicability of the concept of \"platinum sensitivity\" in recurrent endometrial cancer. Although immune checkpoint inhibitors have been widely incorporated into endometrial cancer treatment, the debate continues regarding treatment options in patients with recurrent endometrial cancer who have previously received platinum-based chemotherapy. In this study, we assessed the duration of response to secondary platinum-based treatment using pooled data from the SGSG-012/GOTIC-004/Intergroup study.</p><p><strong>Methods: </strong>Among the 279 participants in the SGSG-012/GOTIC-004/Intergroup study wherein platinum-based chemotherapy was re-administered for managing recurrent endometrial cancer between January 2005 and December 2009, 130 (47%) responded to chemotherapy. We compared the relationship between platinum-free interval and duration of secondary platinum-based treatment using pooled data.</p><p><strong>Results: </strong>In 40 patients (31%), the duration of response to secondary platinum-based treatment exceeded the platinum-free interval. The duration of response to secondary platinum-based treatment exceeded 12 months in 51 patients (39%) [platinum-free interval: < 12 months, 14/48 (29%); 12-23 months, 18/43 (42%); 24-35 months, 8/19 (42%); ≥ 36 months, 11/20 (55%)]. In particular, in eight patients (6%), the duration of response to secondary platinum-based treatment exceeded 36 months [platinum-free interval: < 12 months, 3/48 (6%); 12-23 months, 0/19 (0%); 24-35 months, 2/19 (11%); ≥ 36 months, 3/20 (15%)].</p><p><strong>Conclusions: </strong>Re-administration of platinum-based chemotherapy for recurrent endometrial cancer may result in a long-term response exceeding the platinum-free interval in some patients. Even in the current situation, where immune checkpoint inhibitors have been introduced, re-administration of platinum-based chemotherapy is worth considering.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1594-1601"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11420358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Toshiyuki Mukai, Kenya Kobayashi, Koji Yamamura, Osamu Fukuoka, Kenji Kondo, Yuki Saito
{"title":"Prognostic value of pretreatment temporal muscle thickness after curative surgery for oral cavity squamous cell carcinoma.","authors":"Toshiyuki Mukai, Kenya Kobayashi, Koji Yamamura, Osamu Fukuoka, Kenji Kondo, Yuki Saito","doi":"10.1007/s10147-024-02591-3","DOIUrl":"10.1007/s10147-024-02591-3","url":null,"abstract":"<p><strong>Background: </strong>Sarcopenia is a poor prognostic factor in various diseases. Temporal muscle thickness (TMT) has been reported to be associated with sarcopenia. We investigated the prognostic value of TMT in patients with oral squamous cell carcinoma.</p><p><strong>Methods: </strong>This study included 61 patients with oral squamous cell carcinoma. Two board-certified otolaryngologists measured TMT based on pre-treatment CT. The following sex-specific TMT cut-off values were used in accordance with previous reports: ≤ 6.3 mm in men, and ≤ 5.2 mm in women. We classified patients into normal TMT group and low TMT group according to the cutoff values. The correlation between the TMT measurements of the two readers was tested using the interclass correlation coefficient (ICC). Cox regression models were used to verify the association between TMT and prognostic factors.</p><p><strong>Results: </strong>The low TMT group had a significantly lower BMI than the normal TMT group. Patients with low TMT at baseline had a significantly higher risk of death than those with normal TMT (hazard ratio 4.51; 95% confidence interval [CI] 1.49-13.61; p = 0.0076). There were no significant differences in disease-specific survival between the two groups. The correlation between the two evaluators' TMT measurements was excellent (ICC 0.988, 95% CI 0.981-0.933).</p><p><strong>Conclusions: </strong>Sex-specific TMT was associated with overall survival in patients with oral squamous cell carcinoma. TMT is easy to assess and its measurement is consistent between evaluators.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1444-1450"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855496","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 of robot-assisted partial nephrectomy compared to conventional laparoscopic partial nephrectomy for completely endophytic renal tumor: a multicenter, prospective study.","authors":"Nobuyuki Hinata, Sae Murakami, Yuzo Nakano, Isao Hara, Tsunenori Kondo, Shuzo Hamamoto, Ryoichi Shiroki, Jun Nagayama, Mutsushi Kawakita, Masatoshi Eto, Osamu Ukimura, Atsushi Takenaka, Toshio Takagi, Masaki Shimbo, Haruhito Azuma, Tetsuya Yoshida, Junya Furukawa, Naoki Kawamorita, Masato Fujisawa","doi":"10.1007/s10147-024-02599-9","DOIUrl":"10.1007/s10147-024-02599-9","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to compare the efficacy of robot-assisted partial nephrectomy for completely endophytic renal tumors with the reported outcomes of conventional laparoscopic partial nephrectomy and investigate the transition of renal function after robot-assisted partial nephrectomy.</p><p><strong>Methods: </strong>We conducted a prospective, multicenter, single-arm, open-label trial across 17 academic centers in Japan. Patients with endophytic renal tumors classified as cT1, cN0, cM0 were included and underwent robot-assisted partial nephrectomy. We defined two primary outcomes to assess functional and oncological aspects of the procedure, which were represented by the warm ischemic time and positive surgical margin, respectively. Comparisons were made using control values previously reported in laparoscopic partial nephrectomy studies. In the historical control group, the warm ischemia time was 25.2, and the positive surgical margin was 13%.</p><p><strong>Results: </strong>Our per-protocol analysis included 98 participants. The mean warm ischemic time was 20.3 min (99% confidence interval 18.3-22.3; p < 0.0001 vs. 25.2). None of the 98 participants had a positive surgical margin (99% confidence interval 0-5.3%; p < 0.0001 vs. 13.0%). The renal function ratio of eGFR before and after protocol treatment multiplied by splits was 0.70 (95% confidence interval: 0.66-0.75). Factors such as preoperative eGFR, resected weight, and warm ischemic time influenced the functional loss of the partially nephrectomized kidney after robot-assisted partial nephrectomy.</p><p><strong>Conclusions: </strong>Robot-assisted partial nephrectomy for completely endophytic renal tumors offers a shorter warm ischemia time and comparable positive surgical margin rate compared with conventional laparoscopic partial nephrectomy.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1548-1556"},"PeriodicalIF":2.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11420261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical utility of a comprehensive genomic profiling test for patient with advanced biliary tract cancer","authors":"Hiroki Inada, Hideaki Miyamoto, Satoru Shinriki, Hisanobu Oda, Satoshi Narahara, Motohiro Yoshinari, Katsuya Nagaoka, Daiki Yoshii, Kotaro Fukubayashi, Hiromitsu Hayashi, Hideo Baba, Kisato Nosaka, Yasuhito Tanaka","doi":"10.1007/s10147-024-02616-x","DOIUrl":"https://doi.org/10.1007/s10147-024-02616-x","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Biliary tract cancer (BTC) comprises a heterogeneous group of malignancies with poor prognosis because of the limited treatment options. With the recent advances of next generation sequencing technologies, comprehensive genomic profiling (CGP) tests have been widely introduced into daily clinical practice.</p><h3 data-test=\"abstract-sub-heading\">Patients and methods</h3><p>We performed a retrospective, multicenter, observation cohort study. The genomic and clinical data of 85 BTC patients, who underwent CGP testing from August 2021 to September 2023, were analyzed.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>There were 62 (73%) cases in which treatment recommendations were raised during expert meetings, including 34 intrahepatic cholangiocarcinoma (ICC), 20 extrahepatic cholangiocarcinoma (ECC) and 8 gall bladder carcinoma (GBC). The drug accessibility rate of the BTC patients was 15.3% (13 cases): ten ICCs, two ECCs, and one GBC. Five ICC patients (three male and two female) with the <i>FGFR2</i> fusion gene were treated with pemigatinib. Those patients who received a genomically matched therapy had significantly longer median overall survival than those patients who not received. (n = 13; not reached [95% CI not reached-not reached] vs n = 72; 8.6 months [95% CI 6.6–10.0]; hazard ratio 0.24 [95% CI 0.12–0.49], p = 0.013). The median observation period of pemigatinib treatment was 15.4 months (range 10.1–27.4). The responses were classified as PR in three patients, SD in one patient and PD in one patient. The median progression free survival is 9.0 months. No patient had grade 3/4 AEs requiring discontinuation of the treatment.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>The drug accessibility rate of ICC is high and pemigatinib is effective and well-tolerated in ICC patients harboring <i>FGFR2</i> gene fusions.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":"194 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142255751","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":"Current status and prospects of breast cancer imaging-based diagnosis using artificial intelligence","authors":"Chikako Sekine, Jun Horiguchi","doi":"10.1007/s10147-024-02594-0","DOIUrl":"https://doi.org/10.1007/s10147-024-02594-0","url":null,"abstract":"<p>Breast imaging has several modalities, each unique in terms of its imaging position, evaluation index, and imaging method. Breast diagnosis is made by combining a large number of past imaging features with the clinical course and histological findings. Artificial intelligence (AI), which extracts the features from image data and evaluates them based on comprehensive analysis, has been making rapid progress in this regard. Many previous studies have demonstrated the usefulness and development potential of AI, such as machine learning and deep learning, in breast imaging. However, despite studies showing the good performance of AI models, their overall utilization remains low, since a large amount of diverse imaging data is required, and prospective verification is necessary to prove its high reproducibility and robustness. Sharing information and collaborating with multiple institutions to collect and verify images of different conditions and backgrounds are vital. If image diagnosis using AI can indeed ensure a more detailed diagnosis, such as breast cancer subtypes or prognosis, it can help develop personalized medicine, which is urgently required. The positive results of AI research, using such image information, can make each modality more valuable than ever. The current review summarized the results of previous studies using AI in each evaluation field and discussed the related future prospects.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":"7 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142255752","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}
Koji Kato, Sosuke Nakamura, Akira Wakana, Yasuhiro Koh, Koji Izutsu
{"title":"Pembrolizumab in Japanese patients with primary mediastinal large B-cell lymphoma: results from the KEYNOTE-A33 study","authors":"Koji Kato, Sosuke Nakamura, Akira Wakana, Yasuhiro Koh, Koji Izutsu","doi":"10.1007/s10147-024-02627-8","DOIUrl":"https://doi.org/10.1007/s10147-024-02627-8","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>KEYNOTE-A33 (NCT04317066) is an open-label, single-arm, phase 1 trial designed to evaluate the safety and efficacy of pembrolizumab in Japanese patients with relapsed or refractory (R/R) primary mediastinal large B-cell lymphoma (PMBCL).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Patients received pembrolizumab 200 mg every 3 weeks for up to 35 cycles. The primary endpoints were safety and objective response rate (ORR) per International Working Group 2007 criteria by independent central review. The secondary endpoint was disease control rate (DCR). Duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were exploratory.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Seven patients were enrolled and treated; the median age was 32 years (range 26–43) and 86% were female. The median time from the first dose to data cutoff (April 12, 2022) was 5.6 months (range 2.4–21.2). Grade 3–5 treatment-related adverse events (AEs) occurred in 2 patients (29%; 2 grade 4 neutropenia, 1 grade 3 febrile neutropenia); however, no patient discontinued pembrolizumab or died because of treatment-related AEs. The ORR was 43% [95% confidence interval (CI) 10–82]. DCR was 57% (95% CI 18–90). Median DOR was not reached (NR). Four (57%) patients had a reduction in target lesion size of ≥ 50%. The median PFS was 2.9 months (95% CI 2.6–NR). The median OS was 17.5 months (95% CI NE–NE), and the 12 months OS rate was 100%.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Overall, pembrolizumab had manageable safety and clinically meaningful antitumor activity in Japanese patients with R/R PMBCL, results that were consistent with those observed in prior global studies.</p><h3 data-test=\"abstract-sub-heading\">Trial Registry</h3><p>Registry and the Registration No. of the study/trial: Clinicaltrials.gov: NCT04317066.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":"6 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142255750","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}
Marco A. De Velasco, Kazuko Sakai, Seiichiro Mitani, Yurie Kura, Shuji Minamoto, Takahiro Haeno, Hidetoshi Hayashi, Kazuto Nishio
{"title":"A machine learning-based method for feature reduction of methylation data for the classification of cancer tissue origin","authors":"Marco A. De Velasco, Kazuko Sakai, Seiichiro Mitani, Yurie Kura, Shuji Minamoto, Takahiro Haeno, Hidetoshi Hayashi, Kazuto Nishio","doi":"10.1007/s10147-024-02617-w","DOIUrl":"https://doi.org/10.1007/s10147-024-02617-w","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Genome DNA methylation profiling is a promising yet costly method for cancer classification, involving substantial data. We developed an ensemble learning model to identify cancer types using methylation profiles from a limited number of CpG sites.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Analyzing methylation data from 890 samples across 10 cancer types from the TCGA database, we utilized ANOVA and Gain Ratio to select the most significant CpG sites, then employed Gradient Boosting to reduce these to just 100 sites.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>This approach maintained high accuracy across multiple machine learning models, with classification accuracy rates between 87.7% and 93.5% for methods including Extreme Gradient Boosting, CatBoost, and Random Forest. This method effectively minimizes the number of features needed without losing performance, helping to classify primary organs and uncover subgroups within specific cancers like breast and lung.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Using a gradient boosting feature selector shows potential for streamlining methylation-based cancer classification.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":"102 1","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142255754","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}