Targeted Oncology最新文献

{"title":"Role of immunotherapy in early breast cancer: past, present, and future.","authors":"Karissa Britten, Aditya Bardia, Nicholas McAndrew","doi":"10.1007/s11523-025-01157-1","DOIUrl":"10.1007/s11523-025-01157-1","url":null,"abstract":"<p><p>The development of immune checkpoint inhibitors (ICIs) has revolutionized cancer treatment over the last decade, starting with the US Food and Drug Administration (FDA) approval of ipilimumab in 2011. Since that time, the FDA has approved nine additional ICIs, which now serve as frontline agents in lung, colorectal, head and neck, genitourinary, and skin cancers. ICIs have been practice-changing across many cancer subtypes, and their role in breast cancer (particularly in early-stage disease) is a topic of ongoing research. The only current FDA-approved ICI indication in early breast cancer is for the use of pembrolizumab in high-risk, triple-negative breast cancer in combination with chemotherapy, based on results from the KEYNOTE-522 trial. Although numerous trials have further investigated the use of ICIs in early-stage triple-negative breast cancer, survival outcomes have been inconsistent. Studies investigating the use of ICIs in early-stage estrogen receptor-positive and human epidermal growth factor receptor 2-positive breast cancer are even more limited, although available data (especially for estrogen receptor-positive disease) are promising. Numerous studies are ongoing, including critical investigations into biomarkers that may help determine which patients with breast cancer are most likely to benefit from the addition of immunotherapy. In this review, we discuss the history of ICI development, key trials investigating the use of ICIs in early-stage breast cancer, and future directions in the field.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":"615-625"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144333908","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 Podcast on Integrating Genetic Testing for Homologous Recombination Repair Gene Alterations in Patients with Prostate Cancer in the USA: a Multidisciplinary Approach to Overcoming the Obstacles.","authors":"Brittany M Szymaniak, Alicia K Morgans, Neal D Shore","doi":"10.1007/s11523-025-01159-z","DOIUrl":"10.1007/s11523-025-01159-z","url":null,"abstract":"<p><p>Homologous recombination repair (HRR) gene alterations in prostate cancer predispose patients to more aggressive disease and a poorer prognosis. The presence of these HRR gene alterations may inform patient eligibility for clinical trials and targeted therapies, and importantly, through cascade testing, help identify family members at risk of developing an inherited cancer. This finding highlights the importance of testing for HRR gene alterations in patients with prostate cancer. Despite the potential implications of such testing to patient care, in a cross-sectional retrospective study in the USA, only 37.7% of patients with advanced prostate cancer underwent HRR testing between 2014 and 2022. The aim of this podcast is to identify obstacles to testing for HRR gene alterations that healthcare professionals encounter in day-to-day clinical practice, as well as discuss ways to potentially overcome them. In this multidisciplinary podcast, a genetic counselor, a medical oncologist, and a urologist discuss the importance of testing for HRR gene alterations and, using their different clinical perspectives, explore ways that healthcare professionals can integrate testing results into clinical practice.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":"543-550"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144529613","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":"Comparative Effectiveness of Atezolizumab Plus Bevacizumab Versus Tremelimumab Plus Durvalumab in Patients with Hepatocellular Carcinoma (HCC) in a Real-World Setting.","authors":"Federica Lo Prinzi, Federico Rossari, Marianna Silletta, Silvia Camera, Silvia Foti, Mara Persano, Francesco Vitiello, Emanuela Di Giacomo, Mariam Grazia Polito, Margherita Rimini, Andrea Casadei-Gardini","doi":"10.1007/s11523-025-01161-5","DOIUrl":"10.1007/s11523-025-01161-5","url":null,"abstract":"<p><strong>Background: </strong>There are no studies that directly compare atezolizumab plus bevacizumab and tremelimumab plus durvalumab (STRIDE), two first-line options for the systemic therapy of advanced hepatocarcinoma (HCC).</p><p><strong>Objective: </strong>We conducted a real-world retrospective analysis to compare the clinical efficacies of these two regimens.</p><p><strong>Patients and methods: </strong>Using TriNetX data on patients with HCC at Barcelona Clinic Liver Cancer (BCLC) stages B or C, the analysis included patients treated with atezolizumab plus bevacizumab or with the STRIDE regimen. The primary endpoint was overall survival (OS) comparing the two treatment groups.</p><p><strong>Results: </strong>Before applying propensity-score matching, a total of 2,307 consecutive patients were identified. Among them, 1,998 received atezolizumab plus bevacizumab, and 309 were treated with STRIDE. After matching, 618 patients remained, with 309 in each cohort. The analysis showed no significant difference between the two treatments: median OS was 15.4 months (95% confidence interval (CI) 14.7-51.6) and 15.5 months (95% CI 15.0-47.0) for patients treated with atezolizumab plus bevacizumab versus STRIDE, respectively (HR 0.94; 95% CI 0.73-1.22, p = 0.67). The univariate analyses of baseline clinical and laboratory characteristics indicated that the only differentiating factor between the two regimens was better survival for females receiving atezolizumab plus bevacizumab (HR 1.77; 95% CI 1.00-3.16, p = 0.04).</p><p><strong>Conclusions: </strong>Atezolizumab plus bevacizumab and STRIDE demonstrated no statistical difference in OS, showing them to be equally valid alternatives for patients with advanced HCC.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":"707-713"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144476790","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":"Streamlining and Accelerating the Molecular Tumor Board Process at the University Medical Center Hamburg-Eppendorf.","authors":"Layla Tabea Riemann, Maximilian Ataian, Felicia P S Hähner, Benjamin Roth, Alexander Knurr, Anne Kamitz, Maximilian Christopeit, Carsten Bokemeyer, Frank Ückert","doi":"10.1007/s11523-025-01160-6","DOIUrl":"10.1007/s11523-025-01160-6","url":null,"abstract":"<p><strong>Background: </strong>We developed, introduced, and evaluated Molecular ONcology Optimized CLinical Evaluation (MONOCLE), a secure, open-source web application at the University Medical Center Hamburg-Eppendorf (UKE), to optimize the analysis and discussion of complex cancer cases in molecular tumor boards (MTB).</p><p><strong>Objective: </strong>MONOCLE standardizes and harmonizes documentation, while its integrated Knowledge Connector accelerates literature research for personalized treatment.</p><p><strong>Patients and methods: </strong>The system was designed by merging the requirements of the German Network for Personalized Medicine (DNPM), the medical staff involved in the MTB process, and the team developing MONOCLE. The usability was evaluated using the System Usability Scale (SUS) and user tasks. Overall process optimization was measured by the number of automated tasks that can be performed.</p><p><strong>Results: </strong>MONOCLE, introduced into clinical practice in June 2024, significantly reduces time for documentation, as three manual steps now run automatically, and transfer of the data to the DNPM is possible. Its usability and SUS showed positive results, ranging between 92.5 and 97.5.</p><p><strong>Conclusions: </strong>As the first open-source and extendable solution for standardized MTB documentation, MONOCLE enables wider adoption by other medical centers.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":"725-735"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144317895","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 I Study of the Anti-CEACAM6 Antibody Tinurilimab (BAY 1834942) in Patients with Advanced Solid Tumors.","authors":"Lillian L Siu, David S Hong, Wolf-Dietrich Döcke, Reimo Tetzner, Mark Trautwein, Charles Phelps, Joerg Willuda, Xiang Qing Yu, Hendrik Nogai, Melissa Johnson, Boon Cher Goh","doi":"10.1007/s11523-025-01154-4","DOIUrl":"10.1007/s11523-025-01154-4","url":null,"abstract":"<p><strong>Background: </strong>Tinurilimab is a humanized immunoglobulin G subclass 2 antibody that blocks carcinoembryonic antigen-related cell adhesion molecule 6 (CEACAM6), an immune checkpoint regulator that is overexpressed in several tumor types.</p><p><strong>Objectives: </strong>This phase I study evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics, and tumor response profile of tinurilimab in patients with advanced solid tumors with a described expression of CEACAM6.</p><p><strong>Patients and methods: </strong>In this first-in-human, dose-escalation and dose-expansion study, tinurilimab was administered as a 1-h intravenous infusion in 21-day cycles at a starting dose of 2.5 mg, with a planned escalation up to 1800 mg. Following observation of treatment toxicity (cytokine release syndrome in one patient and neutropenia in all patients treated at 30 mg), a premedication regimen was initiated that included dexamethasone 8 mg before and after dosing. Thirty patients received treatment across six dosing cohorts (2.5-100 mg with or without dexamethasone).</p><p><strong>Results: </strong>The maximum tolerated dose was not determined, as the study was terminated due to an unfavorable benefit/risk assessment. All 30 patients (100%) treated with tinurilimab experienced at least one treatment-emergent adverse event of any grade, most commonly fatigue (36.7%), infusion-related reaction (30.0%), and neutropenia (26.7%). The most common grade ≥ 3 treatment-related adverse events were neutropenia (23.3%), followed by febrile neutropenia, cytokine release syndrome, increased hepatic enzymes, decreased lymphocyte count, hypophosphatemia, lactic acidosis, and acute kidney injury (3.3% each). No patients reported an objective response.</p><p><strong>Conclusions: </strong>Following study termination, the clinical development program for tinurilimab was discontinued permanently.</p><p><strong>Clinical trial registration: </strong>www.</p><p><strong>Clinicaltrials: </strong>gov , NCT03596372.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":"637-649"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144216928","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 Podcast on Real-World Evidence with Avelumab First-Line Maintenance and Treatment Sequencing in Locally Advanced or Metastatic Urothelial Carcinoma.","authors":"Petros Grivas, Helen H Moon","doi":"10.1007/s11523-025-01162-4","DOIUrl":"10.1007/s11523-025-01162-4","url":null,"abstract":"<p><p>Avelumab first-line maintenance is an approved treatment for cisplatin-eligible or -ineligible patients with advanced urothelial carcinoma (UC) who are progression free following first-line platinum-based chemotherapy, based on the results of the JAVELIN Bladder 100 phase 3 trial. In recent years, an increasing number of real-world studies have examined the effectiveness and safety of avelumab first-line maintenance in heterogeneous populations from different countries, expanding the clinical evidence base. In this podcast, we discuss findings from these real-world studies, which have complemented clinical trials and provided additional insights about overall effectiveness, treatment sequencing involving second-line enfortumab vedotin monotherapy or other options, and healthcare resource utilization. We also briefly discuss the evolving treatment landscape in advanced UC in addition to benefits and limitations of real-world studies in general. Overall, across multiple studies involving more than 3000 patients worldwide, real-world outcomes with avelumab first-line maintenance treatment have been consistent with findings from the JAVELIN Bladder 100 trial, confirming the clinical benefits of this treatment approach for patients with advanced UC who are encountered in day-to-day practice.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144544884","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":"Relugolix in Combination with Androgen Receptor Pathway Inhibitors in the Treatment of Metastatic Prostate Cancer: A Clinical Perspective.","authors":"Tomas Buchler","doi":"10.1007/s11523-025-01150-8","DOIUrl":"10.1007/s11523-025-01150-8","url":null,"abstract":"<p><p>Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, has been established as an effective androgen deprivation therapy (ADT) for advanced prostate cancer, offering advantages over traditional GnRH agonists. The combination of relugolix with androgen receptor pathway inhibitors (ARPIs) is increasingly utilized in clinical practice, necessitating an understanding of its pharmacokinetics, efficacy, safety, and drug-drug interactions. This review explores the real-world data and clinical studies evaluating relugolix coadministration with ARPIs, including enzalutamide, abiraterone, apalutamide, and darolutamide. Pharmacokinetic interactions, particularly via the CYP3A4 enzyme system and P-glycoprotein (P-gp) transporter, influence drug exposure and, in theory, necessitate dose adjustments in certain combinations. However, clinical studies and real-world studies suggest that relugolix maintains testosterone suppression when combined with ARPIs even if administered in a standard dose. While these findings support the efficacy and safety of relugolix-based combination therapy, further large-scale prospective trials are needed to refine treatment recommendations and provide information on long-term outcomes.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":"627-635"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Outcomes of Pembrolizumab in Advanced Melanoma by Age and Sex: A National Population-Based Study.","authors":"Chin Hang Yiu, Alexander M Menzies, Christine Y Lu","doi":"10.1007/s11523-025-01164-2","DOIUrl":"https://doi.org/10.1007/s11523-025-01164-2","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors are standard treatment for advanced melanoma. Pembrolizumab (programmed cell death-1 inhibitor) monotherapy is recommended as first-line treatment. However, real-world evidence on its efficacy and safety in Australia, a region with the highest melanoma incidence, remains limited.</p><p><strong>Objective: </strong>This study aimed to assess real-world outcomes of pembrolizumab in patients with advanced melanoma in Australia.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted using national Pharmaceutical Benefits Scheme and National Death Index data via the Australian Bureau of Statistics DataLab. Patients who initiated pembrolizumab monotherapy for stage III/IV unresectable melanoma (1 January, 2017-30 June, 2022) were included. Kaplan-Meier analyses and multivariate Cox regressions were performed to assess overall survival and time to treatment discontinuation. Immune-related adverse events were inferred from corticosteroid and levothyroxine prescriptions. Subgroup analyses were performed by age (18-64, 65-84, ≥ 85 years) and sex.</p><p><strong>Results: </strong>Among 4127 patients, the median overall survival was 816 days. Mortality was higher in patients aged 65-84 years (adjusted hazards ratio 1.39, 95% confidence interval 1.24-1.56) and ≥85 years (adjusted hazards ratio 1.93, 95% confidence interval 1.69-2.21) versus 18-64 years. Median time to treatment discontinuation was 377 days, with a higher discontinuation rate in female individuals (adjusted hazards ratio 1.19, 95% confidence interval 1.09-1.29). Incident corticosteroid and levothyroxine prescriptions were observed in 19.3 and 7.6% of patients, respectively.</p><p><strong>Conclusions: </strong>Our findings align with clinical trials, demonstrating similar survival outcomes. Younger patients benefited more from pembrolizumab, while female individuals had shorter treatment durations. Further research is required to explore immune checkpoint inhibitor efficacy, safety, and treatment disparities.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144529615","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":"Dermatologic Adverse Event Mitigation and Management Strategies with Amivantamab + Lazertinib Therapy for Advanced Non-Small Cell Lung Cancer: A Vodcast.","authors":"Danny Nguyen, Edgardo S Santos","doi":"10.1007/s11523-025-01163-3","DOIUrl":"10.1007/s11523-025-01163-3","url":null,"abstract":"<p><p>Targeted therapies have transformed outcomes of patients with advanced non-small cell lung cancer. Amivantamab, a bispecific antibody targeting epidermal growth factor receptor (EGFR) and MET, and lazertinib, a third-generation EGFR tyrosine kinase inhibitor, were approved in 2024 for the first-line treatment of EGFR-mutated (exon 19 deletion/exon 21 L858R substitution) locally advanced or metastatic non-small cell lung cancer. While EGFR-targeted therapies have demonstrated clinical efficacy, they are associated with on-target dermatologic adverse events (AEs). This vodcast aims to educate on strategies to mitigate and manage dermatologic AEs associated with amivantamab + lazertinib. The MARIPOSA study assessed amivantamab + lazertinib versus osimertinib in previously untreated patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer. In the same population, the COCOON study assessed the impact of enhanced versus standard dermatologic management on the incidence of grade ≥ 2 dermatologic AEs. In MARIPOSA, amivantamab + lazertinib significantly improved overall survival (median not reached vs 36.7 months) and progression-free survival (median 23.7 vs 16.6 months) versus osimertinib. The most common EGFR-associated dermatologic AEs were rash and paronychia. To address these AEs, the COCOON study evaluated enhanced dermatologic management strategies (including prophylactic oral and topical antibiotics and moisturizer) versus standard of care dermatologic management, which resulted in a two-fold reduction in grade ≥ 2 dermatologic AEs with COCOON versus standard dermatologic management. We further discuss the COCOON prophylactic regimen together with reactive and expert-recommended dermatologic management approaches. In conclusion, amivantamab + lazertinib is an effective treatment that significantly improves overall survival. While dermatologic AEs are common, effective proactive management strategies, as demonstrated in the COCOON study, can help reduce the incidence and severity of dermatologic AEs. Prioritizing education for healthcare providers and patients will facilitate timely identification and proactive and reactive management of these events, ultimately improving the treatment experience for patients undergoing therapy with amivantamab and lazertinib.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340387","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":"Safety and Tolerability of Relugolix in Combination with Abiraterone or Apalutamide for Treatment of Patients with Advanced Prostate Cancer: Data from a 52-Week Clinical Trial.","authors":"Jose De La Cerda, Laurence Belkoff, Kevin D Courtney, Elan Diamond, James D'Olimpio, Curtis Dunshee, Lawrence Gervasi, Michael Goodman, Kriti Mittal, David Morris, Paul Sieber, Ronald Tutrone, Michael Ryan, Yi Zhong, Mike Ufer, Neal Shore","doi":"10.1007/s11523-025-01139-3","DOIUrl":"10.1007/s11523-025-01139-3","url":null,"abstract":"<p><strong>Background: </strong>The gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix is the only oral androgen deprivation therapy (ADT) indicated for advanced prostate cancer (aPC). Combining ADT with androgen receptor signaling inhibitors (ARSIs) has shown improved clinical outcomes.</p><p><strong>Objective: </strong>To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of relugolix in combination with ARSIs in patients with aPC.</p><p><strong>Methods: </strong>In this 52-week, open-label study, patients received relugolix (120 mg once daily) with abiraterone (1,000 mg once daily) and corticosteroid (Part 1) or relugolix (240 mg once daily) with apalutamide (240 mg once daily) (Part 2). Metastatic castration-sensitive patients were eligible for both parts, whereas castration-resistant patients were eligible for Part 1 if metastatic and Part 2 if non-metastatic. Adverse events and other safety data were evaluated over 52 weeks, while pharmacodynamic and pharmacokinetic (Part 2 only) data were assessed over 12 weeks. Medication adherence to relugolix was measured by pill count.</p><p><strong>Results: </strong>Of 48 patients, 21 completed Part 1 and 20 completed Part 2. Most adverse events were grade 1 or 2, with hypertension (Part 1) and rash (Part 2) being most common. Mean testosterone concentrations remained below castrate level. Median prostate-specific antigen concentration was 0.04 ng/mL at week 12 in both parts. Concentrations of relugolix, apalutamide, and N-desmethyl-apalutamide were stable over 12 weeks similar to previous data. Relugolix adherence rates were > 97% in both parts.</p><p><strong>Conclusions: </strong>The safety/tolerability profile of both combination therapies was consistent with those of the individual drugs. These findings support using relugolix in combination with abiraterone or apalutamide as treatment of aPC.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov identifier NCT04666129.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":"503-517"},"PeriodicalIF":4.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12106149/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143781165","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}