International Journal of Clinical Oncology最新文献

{"title":"Prognostic significance of lymph node metastasis of soft tissue sarcoma of the extremities. National cancer institute experience.","authors":"Mohamed Shalaby, Rasha M Allam, Mohamed A Elkordy, Mohammad Taher","doi":"10.1007/s10147-024-02674-1","DOIUrl":"https://doi.org/10.1007/s10147-024-02674-1","url":null,"abstract":"<p><strong>Background and objective: </strong>Lymph node metastasis (LNM) in soft tissue sarcoma (STS) of the extremities is relatively rare. We aimed to evaluate the prognosis and the survival of patients with LNM and correlate them to the pattern of metastasis.</p><p><strong>Methods: </strong>A retrospective study of patients diagnosed with STS of the extremities from 2015 to 2019.</p><p><strong>Results: </strong>111/1506 patients (7.4%) had LNM. Nodal metastasis was correlated significantly with old age, advanced tumor stages, high-grade tumors, presence of Lymphovascular invasion (LVI), and resection margins <  = 2 cm. Metachronous LNM was documented in 96 patients (86.5%) and synchronous LNM in 15 patients (13.5%). The 6-year overall survival (OS) was 36.3% for those with LNM and 52.9% for those without LNM. The 6-year disease-free survival (DFS) was 5.7% for those with LNM and 32.6% for those without LNM. Metachronus pattern of LNM showed a significantly poorer outcome regarding 6-year OS and DFS than the synchronous pattern.</p><p><strong>Conclusions: </strong>LNM significantly negatively predicts OS and DFS in the extremities' STS. In particular, the metachronous pattern of LNM indicates a grave prognosis as these patients are supposed to harbor an occult LNM at presentation and were not subjected to lymphadenectomy at their initial primary treatment surgery. Therefore, seeking a valid noninvasive diagnostic tool such as sentinel lymph node biopsy to detect nodal metastasis is necessary.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142864172","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 androgen receptor signaling inhibitors in combination with androgen deprivation therapy for castration-sensitive metastatic prostate cancer: a retrospective analysis in a Japanese cohort.","authors":"Minekatsu Taga, Takeshi Sasaki, Shinichiro Higashi, Shoichi Kimura, Atsuro Sawada, Katsuki Tsuchiyama, Takahiro Inoue, Toshiyuki Kamoto, Naoki Terada","doi":"10.1007/s10147-024-02670-5","DOIUrl":"https://doi.org/10.1007/s10147-024-02670-5","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to evaluate the efficacy of androgen receptor signaling inhibitors (ARSIs) combined with androgen deprivation therapy (ADT) for treating castration-sensitive metastatic prostate cancer in Japanese patients, focusing on the effects on time to the development of castration-resistant prostate cancer (CRPC) and overall survival (OS).</p><p><strong>Methods: </strong>This retrospective muti-institutional analysis included 332 patients diagnosed with metastatic prostate cancer in Japan between 2018 and 2023. The patients were categorized into two groups: patients receiving ADT combined with ARSI (ARSI group) and those receiving ADT alone or with bicalutamide (ADT group). Data on demographics, treatments, and outcomes were compared using the Kaplan-Meier method with propensity score matching.</p><p><strong>Results: </strong>We found an increasing trend in ARSI use over time. The median time to CRPC was significantly longer in the ARSI group than in the ADT group (47.1 vs. 15.2 months, p < 0.001); however, no significant differences in OS were observed before or after propensity score matching. The 1-year-survival rate of patients in the ARSI group tended to be higher than that of patients in the ADT group in subgroups with high tumor volume (96.1% vs. 85.0%) and high Gleason grade (98.1% vs. 85.9%).</p><p><strong>Conclusions: </strong>Adding ARSI to ADT extended the time to CRPC but did not significantly affect OS. However, it potentially suppressed the short-term risk of death in high-risk subgroups. This study highlights the need for further research to explore the characteristics of Japanese patients with metastatic prostate cancer in whom upfront ARSIs are effective.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846566","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":"Postoperative adjuvant therapy with molecularly targeted agents for non-small cell lung cancer.","authors":"Tomohiro Miyoshi, Masahiro Tsuboi","doi":"10.1007/s10147-024-02671-4","DOIUrl":"https://doi.org/10.1007/s10147-024-02671-4","url":null,"abstract":"<p><p>The efficacy of molecularly targeted agents has been established in advanced lung cancer, and their indications have recently expanded to include perioperative treatment of resectable lung cancer. For epidermal growth factor receptor (EGFR) mutation-positive patients, postoperative adjuvant therapy with EGFR-tyrosine kinase inhibitors (EGFR-TKIs) is available in Japan following the results of the ADAURA trial. In addition to EGFR-TKIs, postoperative adjuvant therapy with TKIs targeting anaplastic lymphoma kinase (ALK) and rearranged during transfection (RET) is expected to be established. On the other hand, because adjuvant chemotherapy is ineffective in patients who have been completely cured of cancer through surgery alone, the balance between efficacy and adverse effects must be considered, and further studies will be needed to determine the necessary and sufficient dosage and the appropriate duration of administration. In addition, the cost of adjuvant chemotherapy has recently become an issue that cannot be overlooked. Therefore, it will be imperative to develop biomarkers to effectively narrow down the patients who benefit from adjuvant chemotherapy.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846567","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":"Age-related genomic alterations and chemotherapy sensitivity in osteosarcoma: insights from cancer genome profiling analyses.","authors":"Hidetatsu Outani, Masachika Ikegami, Yoshinori Imura, Sho Nakai, Haruna Takami, Yuki Kotani, Akitomo Inoue, Seiji Okada","doi":"10.1007/s10147-024-02673-2","DOIUrl":"https://doi.org/10.1007/s10147-024-02673-2","url":null,"abstract":"<p><strong>Background: </strong>Osteosarcoma, the most common primary bone malignancy, has a complex genetic basis and two incidence peaks. In younger patients, the standard treatment involves wide surgical resection combined with adjuvant chemotherapy; however, the role of chemotherapy in elderly patients remains controversial. The aims of this study were to investigate genetic differences between younger and elderly patients with osteosarcoma and to identify genetic signatures associated with chemotherapy response.</p><p><strong>Methods: </strong>Genetic alterations were analyzed using cancer genome profiling data for 204 patients with osteosarcoma obtained from the Center for Cancer Genomics and Advanced Therapeutics.</p><p><strong>Results: </strong>The mutation spectrum was consistent with previous results for osteosarcoma. CCNE1, MCL1, MYC, and RB1 alterations were significantly associated with a younger age, while CDK4, CDKN2A, CDKN2B, H3F3A, KMT2D, MDM2, RAC1, and SETD2 alterations were significantly associated with an older age. Age, unsupervised clustering of gene alterations, and MYC amplifications were significantly associated with the response to ifosfamide. Notably, both clustered mutation signatures and MYC amplification were correlated with age.</p><p><strong>Conclusions: </strong>These findings suggest that distinct oncogenic mechanisms contribute to differential sensitivity to chemotherapy in younger and elderly patients. Cancer genome profiling may aid in chemotherapy selection, and its early implementation is recommended to optimize treatment strategies.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835650","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":"Improved prognosis of de novo metastatic prostate cancer after an introduction of life-prolonging agents for castration-resistant prostate cancer.","authors":"Tokiyoshi Tanegashima, Masaki Shiota, Naoki Terada, Toshihiro Saito, Akira Yokomizo, Naoki Kohei, Takayuki Goto, Sadafumi Kawamura, Yasuhiro Hashimoto, Atsushi Takahashi, Takahiro Kimura, Ken-Ichi Tabata, Ryotaro Tomida, Kohei Hashimoto, Toshihiko Sakurai, Toru Shimazui, Shinichi Sakamoto, Manabu Kamiyama, Nobumichi Tanaka, Koji Mitsuzuka, Takuma Kato, Shintaro Narita, Hiroaki Yasumoto, Shogo Teraoka, Masashi Kato, Takahiro Osawa, Yoshiyuki Nagumo, Hiroaki Matsumoto, Hideki Enokida, Takayuki Sugiyama, Kentaro Kuroiwa, Hiroshi Kitamura, Toshiyuki Kamoto, Masatoshi Eto","doi":"10.1007/s10147-024-02681-2","DOIUrl":"https://doi.org/10.1007/s10147-024-02681-2","url":null,"abstract":"<p><strong>Background: </strong>In Japan, since 2014, new treatments such as androgen receptor signaling inhibitors and cabazitaxel have become applicable for metastatic castration-resistant prostate cancer (mCRPC), leading to dramatic changes in treatment options.</p><p><strong>Objective: </strong>This study aims to evaluate the impact of recent advancements in treatment options on the overall survival (OS) of patients diagnosed with de novo metastatic castration-sensitive prostate cancer (mCSPC) in Japan.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on 2450 Japanese men diagnosed with de novo mCSPC between 2008 and 2018. Patients were stratified into two groups based on the period of diagnosis: an earlier period (2008-2013) and a later period (2014-2018). OS was compared between earlier and later periods using Kaplan-Meier analysis in total and propensity score matched subpopulation as well as risk-stratified subgroups.</p><p><strong>Results: </strong>Patients diagnosed in the later period exhibited significantly improved OS compared to those diagnosed in the earlier period. The risk score, calculated based on ISUP grade group, LDH levels, and ALP levels, was a poor prognostic factor. In the later period, compared to the earlier period, there was no improvement in OS in the favorable-risk group, but a significant improvement was observed in the poor-risk group.</p><p><strong>Conclusion: </strong>It was suggested that the introduction of novel androgen receptor signaling inhibitors and chemotherapy treatment regimens since 2014 has led to improved survival outcomes for patients with de novo mCSPC, particularly those with poor-risk profiles. The findings highlight the impact of recent advancements in treatment on the prognosis of patients with metastatic prostate cancer in Japan.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835651","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":"Treatment-related skin reactions in enfortumab vedotin as a surrogate marker of survival and treatment response.","authors":"Jun Nagayama, Satoshi Inoue, Hiroki Sai, Akira Hayakawa, Yuri Yuguchi, Tomohide Suzuki, Hirotaka Matsui, Takuma Yuba, Koya Morishita, Shusuke Akamatsu","doi":"10.1007/s10147-024-02672-3","DOIUrl":"https://doi.org/10.1007/s10147-024-02672-3","url":null,"abstract":"<p><strong>Background: </strong>Treatment-related skin reactions (TRSRs) induced by enfortumab vedotin (EV) targeting nectin-4 are among the most common adverse events. However, their association with survival and treatment response is poorly understood.</p><p><strong>Methods: </strong>We retrospectively identified patients who received EV from December 2021 to April 2023 at Nagoya University Hospital and its affiliated facilities and extracted clinical data from their medical records. We evaluated cancer-specific survival (CSS) and progression-free survival (PFS) as survival outcomes and overall response rate (ORR) and disease control rate (DCR) as treatment responses between patients with and without TRSRs.</p><p><strong>Results: </strong>In total, 67 eligible patients were identified. Thirty-four patients experienced TRSRs, and the remaining 33 did not experience TRSRs. The median follow-up period was 8 months. Patients in the TRSRs group demonstrated significantly longer median CSS (15 vs. 8 months; p = 0.003) and median PFS (10 vs. 5 months; p < 0.001) than the non-TRSRs. Regarding treatment response, the patients in the TRSRs group showed a favorable, albeit nonsignificant, treatment response trend compared with those in the non-TRSRs group (ORR, 73.5% vs. 51.5%; p = 0.107; DCR, 91.2 % vs. 81.8%; p = 0.444).</p><p><strong>Conclusions: </strong>Patients with TRSRs demonstrated more prolonged survival and superior treatment responses to EV treatment. The role of TRSR as a surrogate marker of EV's efficacy should be further explored in prospective and sufficiently powered studies.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835652","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":"Evaluating the impact of atezolizumab on febrile neutropenia occurrence in patients with NSCLC undergoing chemotherapy in Japan: a real-world post-marketing database study.","authors":"Sayuri Nakane, Akinori Yuri, Yuki Miyano, Kana Yamada, Erika Nakatsuji, Nobuki Takei, Yasuhiro Igarashi, Ryousuke Harada","doi":"10.1007/s10147-024-02669-y","DOIUrl":"https://doi.org/10.1007/s10147-024-02669-y","url":null,"abstract":"<p><strong>Background: </strong>Febrile neutropenia (FN) is a recognised adverse event associated with chemotherapy. This study investigates the impact of atezolizumab, an immune checkpoint inhibitor, on the incidence of FN in patients with non-small cell lung cancer receiving concurrent chemotherapy in Japan.</p><p><strong>Methods: </strong>This post-marketing database study was conducted using data from patients with non-small cell lung cancer provided by Medical Data Vision Co., Ltd. covering April 2008 to present. The primary outcome measured was FN incidence, and its causal association with atezolizumab use was examined by comparing the atezolizumab plus bevacizumab plus carboplatin plus paclitaxel [ABCP])-containing regimen to the BCP control group. The data period was from 1 September, 2015, to 31 December, 2021, including approval date of this drug, 21 December, 2018.</p><p><strong>Results: </strong>The database identified 301 subjects for the ABCP regimen (exposure) group, 44 for the BCP regimen (cohort design control) group during the same period, and 207 for BCP regimen (historical cohort design control) group before the approval of atezolizumab. For historical cohort design, the incidence and adjusted incidence ratios of febrile neutropenia in the exposure group to the control group were 6.13 (95% CI 2.78-13.49) and 8.19 (95% CI 3.79-25.33), respectively. Sensitivity analysis showed FN occurred in 17% (52/301) of the exposure group, 4.5% (2/44) of the cohort design control group, and 3% (7/207) of the historical cohort design control group.</p><p><strong>Conclusions: </strong>The incidence of FN was higher in the exposure group. Considering the study results, special caution is needed for FN occurrence in patients receiving atezolizumab.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827789","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":"Impact of presurgical systemic therapy on perioperative outcomes of renal cell carcinoma with inferior vena cava tumor thrombus.","authors":"Kotaro Suzuki, Yasuyoshi Okamura, Yukari Bando, Takuto Hara, Tomoaki Terakawa, Yoji Hyodo, Koji Chiba, Akihisa Yao, Jun Teishima, Hideaki Miyake","doi":"10.1007/s10147-024-02680-3","DOIUrl":"https://doi.org/10.1007/s10147-024-02680-3","url":null,"abstract":"<p><strong>Background: </strong>Surgery for inferior vena cava tumor thrombus (IVC-TT) in patients with renal cell carcinoma (RCC) is highly invasive and is associated with perioperative mortality. This study aimed to assess the efficacy of presurgical systemic therapy (PT) on perioperative outcomes in RCC patients with IVC-TT.</p><p><strong>Methods: </strong>A total of 68 patients with right-sided RCC and level ≥ II IVC-TT were included in this study. The tumor response to PT was investigated, and we compared surgical outcomes and perioperative complications between patients with PT (n = 23) and those who underwent immediate surgical resection (non-PT, n = 45).</p><p><strong>Results: </strong>In the PT group, while 15 patients were treated with tyrosine kinase inhibitors (TKIs) alone, a combination of immune-oncology (IO) therapy and TKIs (IO + TKI) was used in 8 patients. Eleven of 23 (47.8%) patients in the PT group showed a reduction in the level of TT. PT significantly reduced the operation time, intraoperative blood loss, the need for extracorporeal circulation, the incidence of grade ≥ III perioperative complications, and the duration of hospitalization after surgery.</p><p><strong>Conclusion: </strong>Our findings suggest that PT may be effective in reducing surgical invasiveness in RCC patients with IVC-TT. Further prospective studies are needed to identify the optimal drug regimen for PT and to clarify its survival benefits.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813194","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":"Characterization of PSA dynamics and oncological outcomes in patients with metastatic hormone-sensitive prostate cancer treated with androgen receptor signaling inhibitors.","authors":"Yasutaka Yamada, Kodai Sato, Shinichi Sakamoto, Takuya Tsujino, Sinpei Saito, Kazuki Nishimura, Tatsuo Fukushima, Ko Nakamura, Yuki Yoshikawa, Tomohisa Matsunaga, Ryoichi Maenosono, Manato Kanesaka, Takayuki Arai, Tomokazu Sazuka, Yusuke Imamura, Kazumasa Komura, Kazuo Mikami, Kazuyoshi Nakamura, Satoshi Fukasawa, Kazuto Chiba, Yukio Naya, Maki Nagata, Atsushi Komaru, Hiroomi Nakatsu, Haruhito Azuma, Tomohiko Ichikawa","doi":"10.1007/s10147-024-02676-z","DOIUrl":"https://doi.org/10.1007/s10147-024-02676-z","url":null,"abstract":"<p><strong>Background: </strong>This study investigated the characteristics of prostate-specific antigen (PSA) dynamics when androgen receptor signaling inhibitor (ARSI), or vintage agent (bicalutamide) was used for patients with metastatic hormone-sensitive prostate cancer (mHSPC).</p><p><strong>Patients and methods: </strong>A total of 213 mHSPC patients from each of the ARSI and bicalutamide groups treated between 2015 and 2022 were selected from multiple institutions using propensity score-matched analysis to align backgrounds. PSA progression-free survival (PFS) and overall survival (OS) were assessed. PSA level at 3 months, PSA nadir level, and time to PSA nadir were examined to analyze of PSA kinetics.</p><p><strong>Results: </strong>ARSI treatment significantly improved PSA PFS compared to bicalutamide (P = 0.0063), although no significant difference in OS was seen (P = 0.3134). No significant differences were observed between treatment groups in median PSA levels at 3 months (1.47 vs 0.52 ng/ml, P = 0.3042) or PSA nadir levels (0.263 vs 0.1345 ng/ml, P = 0.1228). Bicalutamide treatment demonstrated longer time to nadir than ARSI in progression-free cases (median: 243 vs 213.5 days, P = 0.0003). Survival tree analysis found that PSA nadir ≤ 1.5 ng/ml and time to nadir ≥ 145 days were the optimal cut-offs for best stratifying OS with bicalutamide, while PSA nadir ≤ 0.45 ng/ml and time to nadir ≥ 70 days were optimal with ARSI.</p><p><strong>Conclusion: </strong>No significant differences in PSA response was seen between groups; however, distinct optimal cut-offs were demonstrated for PSA nadir and time to nadir. The present findings will be useful for optimal PSA monitoring for mHSPC patients and for early identification of poor-prognosis populations.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800603","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 mosunetuzumab monotherapy for Japanese patients with relapsed/refractory follicular lymphoma: FLMOON-1.","authors":"Hideki Goto, Takahiro Kumode, Yuko Mishima, Keisuke Kataoka, Yoshiaki Ogawa, Nobuhiro Kanemura, Kazuyuki Shimada, Toshiki Uchida, Yukano Kuroe, Atsuko Kawasaki, Jotaro Sato, Takanori Teshima","doi":"10.1007/s10147-024-02662-5","DOIUrl":"https://doi.org/10.1007/s10147-024-02662-5","url":null,"abstract":"<p><strong>Background: </strong>In a global phase I/II study (GO29781; NCT02500407), single-agent mosunetuzumab had a manageable safety profile and induced durable complete responses in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma, including in patients with R/R follicular lymphoma (FL). In this analysis, the efficacy and safety of mosunetuzumab monotherapy were evaluated in an expansion cohort, FLMOON-1, in Japanese patients with R/R FL who had received  ≥ 2 prior lines of therapy in a phase I study (JO40295, jRCT2080223801).</p><p><strong>Methods: </strong>Mosunetuzumab was administered intravenously at the recommended phase II dose (with cycle 1 step-up dosing) for eight cycles or up to 17 cycles, or until disease progression or unacceptable toxicity. The pre-specified primary endpoint was Independent Review Facility (IRF)-assessed complete response rate (CRR; as best overall response). Secondary objectives included investigator (INV)-assessed CRR, INV- and IRF-assessed objective response rate (ORR), and safety.</p><p><strong>Results: </strong>At the data cutoff (October 13, 2023), 19 patients (median age 72 years) were evaluated. The IRF-assessed CRR and ORR were 68.4% and 78.9%, respectively; the INV-assessed CRR and ORR were 63.2% and 84.2%, respectively. Grade 3-4 adverse events (AEs) were observed in 89.5% of patients, with a low incidence of AEs leading to mosunetuzumab discontinuation (10.5%) and one fatal AE unrelated to mosunetuzumab. Cytokine release syndrome occurred in 47.4% of patients and were mostly Grade 1 in severity.</p><p><strong>Conclusion: </strong>These findings indicate mosunetuzumab has a consistent efficacy and manageable safety profile in Japanese patients with R/R FL compared with previously reported data from the global phase I/II study.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800515","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}