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Plasma ctDNA kinetics as a predictor of systemic therapy response for advanced non-small cell lung cancer: a systematic review and meta-analysis.
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-02-06 DOI: 10.1093/oncolo/oyae344
Luís F Leite da Silva, Erick F Saldanha, Júnior Samuel Alonso de Menezes, Leonardo Halamy Pereira, João Alexandre R de Bragança Dos Santos, Isabella Romagnoli Buonopane, Erito M de Souza, Caio Ulysses Galvani de Menezes, Gilberto Lopes

Background: Predicting early treatment response in advanced non-small cell lung cancer (NSCLC) is challenging. Longitudinal monitoring of circulating tumor DNA (ctDNA) can track tumor response to treatments like immune checkpoint blockade (ICB) and correlate with outcomes. This meta-analysis evaluated whether ctDNA clearance or decrease is associated with improved survival across various settings in NSCLC.

Methods: A systematic review of MEDLINE, EMBASE, and Cochrane databases (up to April 2024) identified studies evaluating the impact of ctDNA kinetics on survival outcomes in non-curative NSCLC settings. Pooled hazard ratios (HR) for progression-free survival (PFS) and overall survival (OS) were calculated using a random effects model.

Results: We included 32 studies with 3047 NSCLC patients receiving systemic therapies such as targeted therapy (TT), ICB, and chemotherapy. Meta-analysis of 31 studies showed that ctDNA decrease/clearance was linked to improved PFS (HR: 0.32 [0.26, 0.40], I² = 63%, P < .01). Subgroup analysis indicated strong PFS benefits from ctDNA clearance (HR: 0.27 [0.20, 0.36]). Similar improvements were seen across patients undergoing targeted therapy (HR: 0.34) and ICB (HR: 0.33). Analysis of 25 studies revealed a significant association between ctDNA reduction and better OS (HR: 0.31 [0.23, 0.42], I² = 47%, P < .01). Subgroup findings were consistent for both TT (HR: 0.41) and ICB (HR: 0.32). Sensitivity analysis demonstrated that ctDNA clearance/decrease was consistently associated with improved PFS across study designs and ctDNA analysis methods. There was no significant variation in hazard ratios for PFS based on NSCLC subtypes, smoking status, or sex.

Conclusion: Plasma ctDNA kinetics was associated with improved survival outcomes in patients diagnosed with advanced NSCLC undergoing treatment with TT and ICB.

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引用次数: 0
Select updates from ASCO and ESMO 2024 for gastrointestinal cancer care.
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-02-06 DOI: 10.1093/oncolo/oyaf020
Tim Jang, George P Kim, Thomas J George

Background: Gastrointestinal (GI) malignancies remain the culprit behind a substantial portion of cancer-related mortality worldwide, and outcomes for patients with advanced or metastatic GI cancers remain poor despite continued efforts to improve care. In 2024, the ongoing clinical trials to optimize and improve GI cancer care showcased progress in molecular diagnostics, systemic therapies, and localized treatment approaches, providing hope for continued progress toward improved patient outcomes.

Materials and methods: This review summarizes selected updates in GI cancer care from the 2024 ASCO and ESMO Annual Meetings, including both positive and negative trials that, while not universally practice-changing, contribute to shaping GI cancer care, clinical management, or address key questions in the field. The selected trials cover early detection and diagnostic advances, perioperative management, metastatic disease management, and immune checkpoint inhibitor (ICI)'s emerging role in GI cancer.

Results: Various clinical trials in perioperative management and their results continue to reshape or strengthen the current treatment paradigms. The use of ICIs for microsatellite instability-high colorectal cancer (CRC) presented a notable advancement with the potential to improve patient outcomes. Localized treatments such as thermal ablation appear to benefit some patients with CRC and liver metastases.

Conclusions: The collection of trial results presented at the 2024 ASCO and ESMO Annual Meetings denote the ongoing efforts of the medical and scientific community for optimizing GI cancer care. The ongoing efforts of the GI cancer research and patient community provide hope for continued progress toward improved patient outcomes and new standards of care.

{"title":"Select updates from ASCO and ESMO 2024 for gastrointestinal cancer care.","authors":"Tim Jang, George P Kim, Thomas J George","doi":"10.1093/oncolo/oyaf020","DOIUrl":"10.1093/oncolo/oyaf020","url":null,"abstract":"<p><strong>Background: </strong>Gastrointestinal (GI) malignancies remain the culprit behind a substantial portion of cancer-related mortality worldwide, and outcomes for patients with advanced or metastatic GI cancers remain poor despite continued efforts to improve care. In 2024, the ongoing clinical trials to optimize and improve GI cancer care showcased progress in molecular diagnostics, systemic therapies, and localized treatment approaches, providing hope for continued progress toward improved patient outcomes.</p><p><strong>Materials and methods: </strong>This review summarizes selected updates in GI cancer care from the 2024 ASCO and ESMO Annual Meetings, including both positive and negative trials that, while not universally practice-changing, contribute to shaping GI cancer care, clinical management, or address key questions in the field. The selected trials cover early detection and diagnostic advances, perioperative management, metastatic disease management, and immune checkpoint inhibitor (ICI)'s emerging role in GI cancer.</p><p><strong>Results: </strong>Various clinical trials in perioperative management and their results continue to reshape or strengthen the current treatment paradigms. The use of ICIs for microsatellite instability-high colorectal cancer (CRC) presented a notable advancement with the potential to improve patient outcomes. Localized treatments such as thermal ablation appear to benefit some patients with CRC and liver metastases.</p><p><strong>Conclusions: </strong>The collection of trial results presented at the 2024 ASCO and ESMO Annual Meetings denote the ongoing efforts of the medical and scientific community for optimizing GI cancer care. The ongoing efforts of the GI cancer research and patient community provide hope for continued progress toward improved patient outcomes and new standards of care.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 2","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11853594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143506076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-world pan-tumor comprehensive genomic profiling sample adequacy and success rates in tissue and liquid specimens. 真实世界泛肿瘤综合基因组图谱样本的充分性和组织与液体标本的成功率。
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-02-06 DOI: 10.1093/oncolo/oyae258
Douglas I Lin, Lincoln W Pasquina, Estefany Mavares, Julia A Elvin, Richard S P Huang

Real-world success rate of liquid and tissue-based comprehensive genomic profiling (CGP) is unknown. We analyzed real-world pan-tumor cohorts that underwent CGP during clinical care via FoundationOne CDx (F1CDx) and FoundationOne Liquid CDx (F1LCDx) to determine tissue and liquid sample adequacy based on tumor type. Pan-tumor presequencing adequacy was high (>90%) by both tissue-based F1CDx (median: 92.3%; range: 88.2%-96.9%) and liquid-based F1LCDx (median: 94.8%; range: 86.6%-96.7%). Similarly, postsequencing analysis revealed that most tissue and liquid samples yielded successful sequencing results with a median sequencing success rate of 97.9% and 98.1% for F1CDx and F1LCDx, respectively. One exception is central nervous system (CNS) tumors, for which F1CDx had dramatically higher sample sufficiency (96.9%) and postsequencing success rate (97.0%) compared with F1LCDx (86.6% and 92.9%, respectively). The pan-tumor median sample-to-success rate was 90.4% (range: 84.8%-94.4%) for F1CDx. The equivalent rate for F1LCDx was slightly higher at 93.2% (range: 80.4%-95.7%). Conversely, when examining the prevalence of F1LCDx results with high tumor fraction (TF≥1%), the sample-to-high TF results rate was dramatically lower (median: 37.7%, range: 2.1% [CNS tumors]-46.0%). In conclusion, except in CNS tumors or when accounting for liquid TF, success rates of F1CDx and F1LCDx are equivalently high. These results may guide informed decision on when to pursue tissue vs liquid testing of patients with cancer.

基于液体和组织的全面基因组分析(CGP)的实际成功率尚不清楚。我们分析了在临床治疗期间通过FoundationOne CDx(F1CDx)和FoundationOne Liquid CDx(F1LCDx)进行CGP的真实世界泛肿瘤队列,以确定基于肿瘤类型的组织和液体样本的充分性。基于组织的 F1CDx(中位数:92.3%;范围:88.2%-96.9%)和基于液体的 F1LCDx(中位数:94.8%;范围:86.6%-96.7%)的泛肿瘤前测序充分性都很高(>90%)。同样,测序后分析表明,大多数组织和液体样本都获得了成功的测序结果,F1CDx 和 F1LCDx 的中位测序成功率分别为 97.9% 和 98.1%。但中枢神经系统(CNS)肿瘤是个例外,与 F1LCDx(分别为 86.6% 和 92.9%)相比,F1CDx 的样本充分率(96.9%)和测序后成功率(97.0%)大幅提高。F1CDx的泛肿瘤中位样本成功率为90.4%(范围:84.8%-94.4%)。F1LCDx 的相应比率略高,为 93.2%(范围:80.4%-95.7%)。相反,当检查高肿瘤分数(TF≥1%)的 F1LCDx 结果的流行率时,样本到高 TF 结果的比率大幅降低(中位数:37.7%,范围:2.1% [中枢神经系统肿瘤]-46.0%)。总之,除中枢神经系统肿瘤或考虑液体 TF 外,F1CDx 和 F1LCDx 的成功率相当高。这些结果可以指导人们做出明智的决定,决定何时对癌症患者进行组织检验和液体检验。
{"title":"Real-world pan-tumor comprehensive genomic profiling sample adequacy and success rates in tissue and liquid specimens.","authors":"Douglas I Lin, Lincoln W Pasquina, Estefany Mavares, Julia A Elvin, Richard S P Huang","doi":"10.1093/oncolo/oyae258","DOIUrl":"10.1093/oncolo/oyae258","url":null,"abstract":"<p><p>Real-world success rate of liquid and tissue-based comprehensive genomic profiling (CGP) is unknown. We analyzed real-world pan-tumor cohorts that underwent CGP during clinical care via FoundationOne CDx (F1CDx) and FoundationOne Liquid CDx (F1LCDx) to determine tissue and liquid sample adequacy based on tumor type. Pan-tumor presequencing adequacy was high (>90%) by both tissue-based F1CDx (median: 92.3%; range: 88.2%-96.9%) and liquid-based F1LCDx (median: 94.8%; range: 86.6%-96.7%). Similarly, postsequencing analysis revealed that most tissue and liquid samples yielded successful sequencing results with a median sequencing success rate of 97.9% and 98.1% for F1CDx and F1LCDx, respectively. One exception is central nervous system (CNS) tumors, for which F1CDx had dramatically higher sample sufficiency (96.9%) and postsequencing success rate (97.0%) compared with F1LCDx (86.6% and 92.9%, respectively). The pan-tumor median sample-to-success rate was 90.4% (range: 84.8%-94.4%) for F1CDx. The equivalent rate for F1LCDx was slightly higher at 93.2% (range: 80.4%-95.7%). Conversely, when examining the prevalence of F1LCDx results with high tumor fraction (TF≥1%), the sample-to-high TF results rate was dramatically lower (median: 37.7%, range: 2.1% [CNS tumors]-46.0%). In conclusion, except in CNS tumors or when accounting for liquid TF, success rates of F1CDx and F1LCDx are equivalently high. These results may guide informed decision on when to pursue tissue vs liquid testing of patients with cancer.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11881061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Treatment with programmed-death-1 inhibitors for non-melanoma skin cancer among immunocompromised patients with subgroup analysis of solid organ transplant patients.
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-02-06 DOI: 10.1093/oncolo/oyaf022
Eyal Yosefof, Nofar Edri, Idan Ben-Nachum, Dan Yaniv, Aviram Mizrachi, Nethanel Asher, Naomi Ben-Dor, Avital Ben-Artzi, Itamar Averbuch, Noga Kurman

Background: Programmed-cell death protein 1 (PD-1) inhibitors have emerged as a standard of care treatment among advanced-stage or metastatic cutaneous squamous cell carcinoma (cSCC). Immune-compromised patients and particularly solid organ transplant recipients (SOTRs) are considered at high risk for cSCC. When treated with PD-1 inhibitors, the possibility of organ rejection, autoimmune flare, or insufficient response to treatment is feared. As these patients were excluded from past prospective clinical trials, we aim to describe our institute's experience regarding these patients.

Methods: A retrospective analysis was conducted on cSCC patients treated with PD-1 inhibitors. Comparisons were made between immune-compromised and immune-competent groups, with a subgroup analysis of SOTR.

Results: The study cohort comprised of 133 patients, including 97.8% receiving Cemiplimab with a mean age of 77.2 ± 11.7 years. Immune-compromised patients constituted 26.9% (n = 35) of the cohort, including 10 SOTR (all kidney transplant recipients). Objective response rates (ORRs) and disease control rates (DCR) were comparable between immunocompetent and immunosuppressed patients receiving Cemiplimab (ORR: 76.8% vs 62.9%, P = .12; DCR: 81.1% vs 68.6%, P = .13). SOTR demonstrated an 80% ORR and DCR. Progression-free survival was comparable across all groups. Toxicity rates were similar between immunosuppressed and immunocompetent subgroups (68.6% vs 62.1%, P = .5). Two OTRs (20%) experienced acute graft rejection.

Conclusions: PD-1 inhibitors demonstrate efficacy and safety in immunosuppressed cSCC patients. While effective in SOTR, treatment requires multidisciplinary management due to the potential risk of organ rejection. These findings provide valuable insights into this understudied population and support the use of PD-1 inhibitors in immunosuppressed patients with advanced cSCC.

{"title":"Treatment with programmed-death-1 inhibitors for non-melanoma skin cancer among immunocompromised patients with subgroup analysis of solid organ transplant patients.","authors":"Eyal Yosefof, Nofar Edri, Idan Ben-Nachum, Dan Yaniv, Aviram Mizrachi, Nethanel Asher, Naomi Ben-Dor, Avital Ben-Artzi, Itamar Averbuch, Noga Kurman","doi":"10.1093/oncolo/oyaf022","DOIUrl":"10.1093/oncolo/oyaf022","url":null,"abstract":"<p><strong>Background: </strong>Programmed-cell death protein 1 (PD-1) inhibitors have emerged as a standard of care treatment among advanced-stage or metastatic cutaneous squamous cell carcinoma (cSCC). Immune-compromised patients and particularly solid organ transplant recipients (SOTRs) are considered at high risk for cSCC. When treated with PD-1 inhibitors, the possibility of organ rejection, autoimmune flare, or insufficient response to treatment is feared. As these patients were excluded from past prospective clinical trials, we aim to describe our institute's experience regarding these patients.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on cSCC patients treated with PD-1 inhibitors. Comparisons were made between immune-compromised and immune-competent groups, with a subgroup analysis of SOTR.</p><p><strong>Results: </strong>The study cohort comprised of 133 patients, including 97.8% receiving Cemiplimab with a mean age of 77.2 ± 11.7 years. Immune-compromised patients constituted 26.9% (n = 35) of the cohort, including 10 SOTR (all kidney transplant recipients). Objective response rates (ORRs) and disease control rates (DCR) were comparable between immunocompetent and immunosuppressed patients receiving Cemiplimab (ORR: 76.8% vs 62.9%, P = .12; DCR: 81.1% vs 68.6%, P = .13). SOTR demonstrated an 80% ORR and DCR. Progression-free survival was comparable across all groups. Toxicity rates were similar between immunosuppressed and immunocompetent subgroups (68.6% vs 62.1%, P = .5). Two OTRs (20%) experienced acute graft rejection.</p><p><strong>Conclusions: </strong>PD-1 inhibitors demonstrate efficacy and safety in immunosuppressed cSCC patients. While effective in SOTR, treatment requires multidisciplinary management due to the potential risk of organ rejection. These findings provide valuable insights into this understudied population and support the use of PD-1 inhibitors in immunosuppressed patients with advanced cSCC.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 2","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11879445/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Benefit of adjuvant chemotherapy for T1cN0M0 and selected T1bN0M0 triple-negative breast cancer: a nationwide cancer registry-based study. T1cN0M0和部分T1bN0M0三阴性乳腺癌辅助化疗的益处:一项基于全国癌症登记处的研究。
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-02-06 DOI: 10.1093/oncolo/oyae346
Chiao Lo, Dwan-Ying Chang, Yen-Shen Lu, Ming-Yang Wang, Li-Wei Tsai, Chiun-Sheng Huang, Chao-Hsiun Tang, Ching-Hung Lin

Background: The efficacy of adjuvant chemotherapy for T1N0M0 triple-negative breast cancer (TNBC) has not been clearly elucidated. Thus, we aimed to evaluate the efficacy of adjuvant chemotherapy for patients with T1a-cN0M0 TNBC.

Patients and methods: Patients newly diagnosed with TNBC between 2011 and 2015 were identified and followed up until the end of 2020 using the Taiwan Cancer Registry. Univariate and multivariate Cox proportional hazards regression analyses were performed to compare the recurrence-free survival (RFS) and OS between patients who received and those who did not receive adjuvant chemotherapy.

Results: Of the 62 483 patients registered during 2011-2015, 1074 patients with T1N0M0 TNBC (T1a, n = 103; T1b, n = 167; and T1c, n = 804) who underwent definitive breast surgery were included. Overall, 850 (79%) patients received adjuvant chemotherapy; these comprised 24.3%, 67.7%, and 88.6% of the patients with T1a, T1b, and T1c disease, respectively. Over a median follow-up of 7.18 years, a significant RFS and OS benefit from adjuvant chemotherapy was observed in the T1c subgroup but not in the T1a and T1b subgroups. However, subgroup analysis of T1b disease indicated that adjuvant chemotherapy yielded an OS benefit to patients with histological grade III disease (adjusted hazard ratio = 0.08, 95% CI, 0.01-0.77; P = .03).

Conclusions: Adjuvant chemotherapy improved the RFS and OS in patients with T1cN0M0 TNBC and improved the OS in patients with histological grade III T1bN0M0 disease. Our study advocates for the utilization of adjuvant chemotherapy in patients diagnosed with T1cN0M0 and histological grade III T1bN0M0 TNBC.

{"title":"Benefit of adjuvant chemotherapy for T1cN0M0 and selected T1bN0M0 triple-negative breast cancer: a nationwide cancer registry-based study.","authors":"Chiao Lo, Dwan-Ying Chang, Yen-Shen Lu, Ming-Yang Wang, Li-Wei Tsai, Chiun-Sheng Huang, Chao-Hsiun Tang, Ching-Hung Lin","doi":"10.1093/oncolo/oyae346","DOIUrl":"10.1093/oncolo/oyae346","url":null,"abstract":"<p><strong>Background: </strong>The efficacy of adjuvant chemotherapy for T1N0M0 triple-negative breast cancer (TNBC) has not been clearly elucidated. Thus, we aimed to evaluate the efficacy of adjuvant chemotherapy for patients with T1a-cN0M0 TNBC.</p><p><strong>Patients and methods: </strong>Patients newly diagnosed with TNBC between 2011 and 2015 were identified and followed up until the end of 2020 using the Taiwan Cancer Registry. Univariate and multivariate Cox proportional hazards regression analyses were performed to compare the recurrence-free survival (RFS) and OS between patients who received and those who did not receive adjuvant chemotherapy.</p><p><strong>Results: </strong>Of the 62 483 patients registered during 2011-2015, 1074 patients with T1N0M0 TNBC (T1a, n = 103; T1b, n = 167; and T1c, n = 804) who underwent definitive breast surgery were included. Overall, 850 (79%) patients received adjuvant chemotherapy; these comprised 24.3%, 67.7%, and 88.6% of the patients with T1a, T1b, and T1c disease, respectively. Over a median follow-up of 7.18 years, a significant RFS and OS benefit from adjuvant chemotherapy was observed in the T1c subgroup but not in the T1a and T1b subgroups. However, subgroup analysis of T1b disease indicated that adjuvant chemotherapy yielded an OS benefit to patients with histological grade III disease (adjusted hazard ratio = 0.08, 95% CI, 0.01-0.77; P = .03).</p><p><strong>Conclusions: </strong>Adjuvant chemotherapy improved the RFS and OS in patients with T1cN0M0 TNBC and improved the OS in patients with histological grade III T1bN0M0 disease. Our study advocates for the utilization of adjuvant chemotherapy in patients diagnosed with T1cN0M0 and histological grade III T1bN0M0 TNBC.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 2","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The association of azole antifungals with overall survival in patients with non-small cell lung cancer receiving immune checkpoint inhibitors. 唑类抗真菌药物与接受免疫检查点抑制剂治疗的非小细胞肺癌患者总生存期的关系。
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-02-06 DOI: 10.1093/oncolo/oyae262
Nikhil T Sebastian, William A Stokes, Madhusmita Behera, Renjian Jiang, David A Gutman, Zhonglu Huang, Abigail Burns, Vidula Sukhatme, Michael C Lowe, Suresh S Ramalingam, Vikas P Sukhatme, Drew Moghanaki

Background: Preclinical data suggest antifungal azole derivatives have antitumor efficacy that may modulate response to immune checkpoint inhibitors (ICIs). We aimed to evaluate the association of azole drugs with overall survival (OS) in a population of patients with non-small cell lung cancer (NSCLC) treated with ICI within the Veterans Health Administration (VHA).

Methods: In this retrospective study, the VA Corporate Data Warehouse was queried for patients diagnosed with NSCLC and treated with ICI from 2010 to 2018. Concomitant oral azole use was defined as dispensation by a VA pharmacy within 90 days of the first ICI infusion. Patients who received azole after 30 days were excluded from the analysis to mitigate immortal time bias. OS was measured from the start of ICI. Cox regression and propensity score matching were used to adjust for confounders.

Results: We identified 3413 patients with NSCLC receiving ICI; 324 (9.5%) were exposed to concomitant azoles. As a group, azole use was not associated with OS (hazard ratio [HR] = 0.96; 95% CI, 0.84-1.09; P = .51). After stratification by azole type, clotrimazole had an association with better OS on univariable (HR = 0.75; 95% CI, 0.59-0.96; P = .024) and multivariable analysis (HR = 0.71; 95% CI, 0.56-0.91; P = .007). Propensity score matching of patients who received clotrimazole vs no azole yielded 101 patients per matched cohort. Clotrimazole was associated with improved OS, although this did not meet the threshold for statistical significance (HR = 0.74; 0.54-1.01; P = .058).

Conclusion: This observational study demonstrated an association between clotrimazole and OS among patients with advanced NSCLC receiving ICI. These findings build upon preclinical evidence and support further investigation into the potential for clotrimazole as a repurposed FDA drug to improve cancer outcomes.

背景:临床前数据表明,抗真菌唑衍生物具有抗肿瘤功效,可调节对免疫检查点抑制剂(ICIs)的反应。我们的目的是评估退伍军人健康管理局(VHA)中接受 ICI 治疗的非小细胞肺癌(NSCLC)患者中唑类药物与总生存期(OS)的关系:在这项回顾性研究中,我们在退伍军人健康管理局企业数据仓库中查询了2010年至2018年期间确诊为NSCLC并接受ICI治疗的患者。首次输注 ICI 后 90 天内由退伍军人事务部药房配药即为同时口服唑类药物。分析中排除了30天后接受阿唑治疗的患者,以减少不死时间偏倚。OS 从 ICI 输注开始计算。Cox回归和倾向评分匹配用于调整混杂因素:我们确定了3413名接受ICI治疗的NSCLC患者,其中324人(9.5%)同时使用了唑类药物。作为一个群体,使用唑类与OS无关(危险比[HR] = 0.96; 95% CI, 0.84-1.09; P = .51)。根据唑类进行分层后,克霉唑在单变量分析(HR = 0.75;95% CI,0.59-0.96;P = .024)和多变量分析(HR = 0.71;95% CI,0.56-0.91;P = .007)中与更好的OS相关。对接受克霉唑治疗与未接受唑类治疗的患者进行倾向评分匹配,每个匹配队列中有 101 名患者。克霉唑与OS的改善有关,但未达到统计学显著性阈值(HR = 0.74; 0.54-1.01; P = .058):这项观察性研究表明,在接受 ICI 治疗的晚期 NSCLC 患者中,克霉唑与 OS 之间存在关联。这些研究结果建立在临床前证据的基础上,支持进一步研究克霉唑作为 FDA 改用药物改善癌症预后的潜力。
{"title":"The association of azole antifungals with overall survival in patients with non-small cell lung cancer receiving immune checkpoint inhibitors.","authors":"Nikhil T Sebastian, William A Stokes, Madhusmita Behera, Renjian Jiang, David A Gutman, Zhonglu Huang, Abigail Burns, Vidula Sukhatme, Michael C Lowe, Suresh S Ramalingam, Vikas P Sukhatme, Drew Moghanaki","doi":"10.1093/oncolo/oyae262","DOIUrl":"10.1093/oncolo/oyae262","url":null,"abstract":"<p><strong>Background: </strong>Preclinical data suggest antifungal azole derivatives have antitumor efficacy that may modulate response to immune checkpoint inhibitors (ICIs). We aimed to evaluate the association of azole drugs with overall survival (OS) in a population of patients with non-small cell lung cancer (NSCLC) treated with ICI within the Veterans Health Administration (VHA).</p><p><strong>Methods: </strong>In this retrospective study, the VA Corporate Data Warehouse was queried for patients diagnosed with NSCLC and treated with ICI from 2010 to 2018. Concomitant oral azole use was defined as dispensation by a VA pharmacy within 90 days of the first ICI infusion. Patients who received azole after 30 days were excluded from the analysis to mitigate immortal time bias. OS was measured from the start of ICI. Cox regression and propensity score matching were used to adjust for confounders.</p><p><strong>Results: </strong>We identified 3413 patients with NSCLC receiving ICI; 324 (9.5%) were exposed to concomitant azoles. As a group, azole use was not associated with OS (hazard ratio [HR] = 0.96; 95% CI, 0.84-1.09; P = .51). After stratification by azole type, clotrimazole had an association with better OS on univariable (HR = 0.75; 95% CI, 0.59-0.96; P = .024) and multivariable analysis (HR = 0.71; 95% CI, 0.56-0.91; P = .007). Propensity score matching of patients who received clotrimazole vs no azole yielded 101 patients per matched cohort. Clotrimazole was associated with improved OS, although this did not meet the threshold for statistical significance (HR = 0.74; 0.54-1.01; P = .058).</p><p><strong>Conclusion: </strong>This observational study demonstrated an association between clotrimazole and OS among patients with advanced NSCLC receiving ICI. These findings build upon preclinical evidence and support further investigation into the potential for clotrimazole as a repurposed FDA drug to improve cancer outcomes.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142332563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction to: Clinical and economic impact of pharmacist interventions to identify drug-related problems in multidisciplinary cancer care: a prospective trial.
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-17 DOI: 10.1093/oncolo/oyae363
{"title":"Correction to: Clinical and economic impact of pharmacist interventions to identify drug-related problems in multidisciplinary cancer care: a prospective trial.","authors":"","doi":"10.1093/oncolo/oyae363","DOIUrl":"10.1093/oncolo/oyae363","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 1","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11756270/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143025873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Steroid-refractory immune mediated hepatitis managed with budesonide in patients with metastatic melanoma: proof of concept and literature review. 布地奈德治疗转移性黑色素瘤患者的类固醇难治性免疫介导肝炎:概念证明和文献综述。
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-17 DOI: 10.1093/oncolo/oyae361
Roma A Kankaria, Douglas B Johnson

Immune checkpoint inhibitors (ICIs) have advanced the treatment of metastatic melanoma. However, some patients develop ICI-associated toxicities like hepatitis (ie, immune-mediated hepatitis; IMH). Although these toxicities usually resolve with steroids, steroid-refractory events may occur, which may be a major source of morbidity and mortality without obviously defined treatment algorithms. Herein, we present 2 patients with metastatic melanoma who had IMH that was steroid-refractory and only partially mycophenolate-responsive, but fully resolved with budesonide. The case suggests that budesonide is a potential option to treat IMH that is refractory to standard treatments, but further investigation in a larger series is needed to identify the most optimal setting for budesonide use.

免疫检查点抑制剂(ICIs)促进了转移性黑色素瘤的治疗。然而,一些患者会出现ici相关的毒性,如肝炎(即免疫介导性肝炎;IMH)。虽然这些毒性通常用类固醇解决,但类固醇难治性事件可能会发生,这可能是发病率和死亡率的主要来源,没有明确的治疗方法。在此,我们报告了2例转移性黑色素瘤患者,他们的IMH是类固醇难治性的,只有部分霉酚酸反应,但布地奈德完全解决。该病例表明布地奈德是治疗标准治疗难治性IMH的潜在选择,但需要在更大的系列中进一步调查以确定使用布地奈德的最佳环境。
{"title":"Steroid-refractory immune mediated hepatitis managed with budesonide in patients with metastatic melanoma: proof of concept and literature review.","authors":"Roma A Kankaria, Douglas B Johnson","doi":"10.1093/oncolo/oyae361","DOIUrl":"10.1093/oncolo/oyae361","url":null,"abstract":"<p><p>Immune checkpoint inhibitors (ICIs) have advanced the treatment of metastatic melanoma. However, some patients develop ICI-associated toxicities like hepatitis (ie, immune-mediated hepatitis; IMH). Although these toxicities usually resolve with steroids, steroid-refractory events may occur, which may be a major source of morbidity and mortality without obviously defined treatment algorithms. Herein, we present 2 patients with metastatic melanoma who had IMH that was steroid-refractory and only partially mycophenolate-responsive, but fully resolved with budesonide. The case suggests that budesonide is a potential option to treat IMH that is refractory to standard treatments, but further investigation in a larger series is needed to identify the most optimal setting for budesonide use.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 1","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11745016/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143016032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical and molecular characteristics of patients with brain metastasis secondary to pancreatic ductal adenocarcinoma. 胰腺导管腺癌继发脑转移患者的临床和分子特征。
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-17 DOI: 10.1093/oncolo/oyae182
Mahmoud Yousef, Mark W Hurd, Abdelrahman Yousef, Ethan B Ludmir, Ashwathy B Pillai, Jennifer Peterson, Eugene J Koay, Sali Albarouki, Ching-Wei Tzeng, Rebecca Snyder, Matthew H G Katz, Huamin Wang, Michael J Overman, Anirban Maitra, Shubham Pant, Brandon G Smaglo, Robert A Wolff, James Yao, John P Shen, Dan Zhao

Background: The prognosis for patients with pancreatic ductal adenocarcinoma (PDAC) is poor. Secondary brain metastasis (Br-M) occurs in less than 1% of patients. Clinical characteristics and molecular alterations have not been characterized in this rare patients' subset.

Materials and methods: The Foundry software platform was used to retrospectively query electronic health records for patients with Br-M secondary to PDAC from 2005 to 2023; clinical, molecular, and overall survival (OS) data were analyzed.

Results: Br-M was diagnosed in 44 patients with PDAC. Median follow-up was 78 months; median OS from initial PDAC diagnosis was 47 months. Median duration from PDAC diagnosis to Br-M detection was 24 months; median OS from Br-M diagnosis was 3 months. At Br-M diagnosis, 82% (n = 36) of patients had elevated CA19-9. Lung was the most common preexisting metastatic location (71%) with Br-M, followed by liver (66%). Br-M were most frequently observed in the frontal lobe (34%, n = 15), cerebellar region (23%, n = 10), and leptomeninges (18%, n = 8). KRAS mutations were detected in 94.1% (n = 16) of patients who had molecular data available (n = 17) with KRASG12V being the most frequent subtype 47% (n = 8); KRASG12D in 29% (n = 5); KRASG12R in 18% (n = 3). Patients who underwent Br-M surgical resection (n = 5) had median OS of 8.6 months, while median OS following stereotactic radiosurgery only (n = 11) or whole-brain radiation only (n = 20) was 3.3 and 2.8 months, respectively.

Conclusion: Br-M is a late PDAC complication, resulting in an extremely poor prognosis especially in leptomeningeal disease. KRAS was mutated in 94.1% of the patients and the KRASG12V subtype was prevalent.

背景:胰腺导管腺癌(PDAC)患者的预后很差。继发性脑转移(Br-M)发生率不到 1%。这一罕见患者亚群的临床特征和分子改变尚未定性:使用Foundry软件平台回顾性查询2005年至2023年PDAC继发Br-M患者的电子健康记录,分析临床、分子和总生存期(OS)数据:结果:44名PDAC患者确诊为Br-M。中位随访时间为78个月;自最初诊断为PDAC起的中位OS为47个月。从 PDAC 诊断到发现 Br-M 的中位持续时间为 24 个月;从诊断出 Br-M 起的中位 OS 为 3 个月。在确诊Br-M时,82%(n = 36)的患者CA19-9升高。肺部是Br-M最常见的转移部位(71%),其次是肝脏(66%)。Br-M最常出现在额叶(34%,15 人)、小脑区(23%,10 人)和脑膜(18%,8 人)。在有分子数据的患者中,94.1%(n = 16)(n = 17)检测到KRAS突变,其中KRASG12V是最常见的亚型,占47%(n = 8);KRASG12D占29%(n = 5);KRASG12R占18%(n = 3)。接受Br-M手术切除的患者(5例)的中位OS为8.6个月,而仅接受立体定向放射外科治疗(11例)或仅接受全脑放射治疗(20例)的患者的中位OS分别为3.3个月和2.8个月:结论:Br-M是PDAC的晚期并发症,预后极差,尤其是在脑室疾病中。94.1%的患者发生了KRAS突变,KRASG12V亚型最为常见。
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引用次数: 0
Immune-related encephalitis after immune checkpoint inhibitor therapy. 免疫检查点抑制剂治疗后的免疫相关脑炎。
IF 4.8 2区 医学 Q1 ONCOLOGY Pub Date : 2025-01-17 DOI: 10.1093/oncolo/oyae186
Monica W Buckley, Aanika Balaji Warner, Julie Brahmer, Laura C Cappelli, William H Sharfman, Ephraim Fuchs, Hyunseok Kang, Patrick M Forde, Douglas E Gladstone, Richard Ambinder, Ronan J Kelly, Evan J Lipson, Ivana Gojo, Edward J Lee, Tory P Johnson, Shiv Saidha, Rafael Llinas, Lyle W Ostrow, Jarushka Naidoo, John C Probasco

Background: Immune checkpoint inhibitors (ICI) have revolutionized cancer treatment but can trigger immune-related encephalitis. We report one of the largest case series of patients with immune-related encephalitis and review of the literature.

Methods: Retrospective series of patients with immune-related encephalitis and literature review.

Results: Fourteen patients with cancer treated with ICI (50% combination therapy) developed immune-related encephalitis. Diagnostic testing revealed cerebral spinal fluid (CSF) lymphocytic pleocytosis (85%) and elevated protein (69%), abnormal brain magnetic resonance imaging(MRI) (33%) or brain FDG-PET (25%), electroencephalogram (EEG) abnormalities (30%), and autoantibodies (31%). Encephalitis treatment included: corticosteroids (86%), intravenous immunoglobulin (IVIg) (36%), plasmapheresis (7%), and rituximab (29%). There were no deaths and 12 patients had significant recovery, although long-term complications were observed. All patients discontinued ICI. Longitudinal follow-up demonstrated anti-cancer response to ICI at 3 months (85%) and 6 months post-ICI initiation (77%). A literature review identified 132 patients with immune-related encephalitis. Most were treated with PD-1 inhibitors (18% combination). Common abnormalities included elevated CSF protein (84%) or pleocytosis (77%), abnormal brain MRI (65%), or autoantibodies (47%). Nearly all were treated with corticosteroids, many required additional therapy with IVIg (26%) or rituximab (12%). Most patients had clinical improvement (81%) but a minority (10%) had a clinical relapse after completing corticosteroid taper. ICIs were resumed in 7 patients (5%), with relapse in 3.

Conclusions and relevance: Immune-related encephalitis is treatable and improves with corticosteroids in most cases but may require additional immunosuppression. Re-emergence of encephalitis is rare and does not typically result in adverse outcomes, and this should be considered in neurological immune-related adverse event management guidelines.

背景:免疫检查点抑制剂(ICI)彻底改变了癌症治疗,但也可能引发免疫相关脑炎。我们报告了最大的免疫相关脑炎患者病例系列之一,并回顾了相关文献:方法:对免疫相关脑炎患者进行回顾性系列研究和文献综述:结果:14名接受ICI治疗(50%为联合治疗)的癌症患者出现了免疫相关性脑炎。诊断测试显示脑脊液(CSF)淋巴细胞增多(85%)和蛋白升高(69%)、脑磁共振成像(MRI)异常(33%)或脑FDG-PET异常(25%)、脑电图异常(30%)和自身抗体(31%)。脑炎治疗包括:皮质类固醇(86%)、静脉注射免疫球蛋白(IVIg)(36%)、血浆置换术(7%)和利妥昔单抗(29%)。虽然出现了长期并发症,但没有死亡病例,12 名患者明显康复。所有患者都停用了 ICI。纵向随访结果表明,在开始使用 ICI 后 3 个月(85%)和 6 个月(77%),患者对 ICI 产生了抗癌反应。文献综述确定了 132 例免疫相关脑炎患者。大多数患者接受了PD-1抑制剂治疗(18%为联合用药)。常见异常包括脑脊液蛋白升高(84%)或多血细胞增多(77%)、脑磁共振成像异常(65%)或自身抗体(47%)。几乎所有患者都接受了皮质类固醇治疗,许多患者还需要额外接受IVIg(26%)或利妥昔单抗(12%)治疗。大多数患者的临床症状有所改善(81%),但少数患者(10%)在完成皮质类固醇减量治疗后临床症状复发。有 7 名患者(5%)恢复使用 ICIs,其中 3 人复发:免疫相关脑炎是可以治疗的,大多数病例使用皮质类固醇后病情会有所改善,但可能需要额外的免疫抑制。脑炎再次发作的情况很少见,通常不会导致不良后果,神经系统免疫相关不良事件管理指南应考虑到这一点。
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引用次数: 0
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