American Journal of Clinical Oncology-Cancer Clinical Trials最新文献

{"title":"Phase 2, Multicenter, Open-label, Nonrandomized Study of Neoadjuvant Chemotherapy Liposomal Irinotecan With 5-Fluorouracil, Leucovorin, and Oxaliplatin, Followed by Chemoradiotherapy in Patients With Rectal Cancer in a Watch-and-Wait Program.","authors":"César Muñoz, María-C Riesco Martinez, Lisardo Ugidos, Pilar García-Alfonso, Rafael Alvarez-Gallego, Paloma Peinado, Carmen Toledano, Luka Mihic-Góngora, Justo Gabriel Ortega Anselmi, Enrique Sanz Garcia, Emilio Vicente, Yolanda Quijano, Hipólito J Durán, Eduardo Díaz, Valentina Ferri, Carmen Rubio, Ovidio HernandoRequejo, Mercedes López González, Susana Prados, Ulpiano López, María Allona, Virginia PérezDueñas, María Angeles Perez-Escutia, Antonio Cubillo","doi":"10.1097/COC.0000000000001157","DOIUrl":"10.1097/COC.0000000000001157","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy of neoadjuvant chemotherapy combination with liposomal irinotecan, 5-fluorouracil, leucovorin, and oxaliplatin in patients with locally advanced rectal cancer.</p><p><strong>Methods: </strong>This was a phase 2, nonrandomized, multicenter study in adults with stage II or III rectal cancer and an Eastern Cooperative Oncology Group performance status of 0 to 1. Total neoadjuvant therapy (TNT) consisted of neoadjuvant chemotherapy combination with liposomal irinotecan (60 mg/m 2 ), oxaliplatin (60 mg/m 2 ), leucovorin (400 mg/m 2 ), and fluorouracil (2400 mg/m²), followed by chemoradiotherapy [ie, capecitabine (825 mg/m 2 ) and radiotherapy according to the standard of care]. The primary efficacy endpoint was the proportion of patients who achieved clinical complete response (cCR), defined as the normalization of pelvic magnetic resonance imaging, rectoscopy, computed tomography scan, and tumor markers.</p><p><strong>Results: </strong>The median follow-up was 32.3 months. Of the 30 patients who underwent TNT and were evaluated, 6 (20.0%; 95% CI: 5.2%-34.8%) patients achieved a cCR. There were no deaths. The median disease-free survival (DFS) for patients with cCR was not reached after a follow-up of 32 months; the 1-year DFS rate was 90.0% (95% CI: 71.0%-100%), and the 2-year and 3-year DFS rates were 80.0% (95% CI: 55.0%-100%). No grade ≥4 adverse events (AEs) were observed. Grade 3 AEs occurred in 18 patients (60%), most frequent was diarrhea (n = 9, 30%). Eleven (36.7%) patients experienced serious AEs, with diarrhea being the most frequent (n = 6, 20.0%).</p><p><strong>Conclusion: </strong>TNT with 5-fluorouracil, leucovorin, and oxaliplatin and chemoradiation is a safe and effective therapeutic alternative for the management of locally advanced rectal cancer.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"142-147"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142752213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating N-acetylcysteine as a Protective Agent Against Chemotherapy-induced Neuropathy in Breast Cancer: A Triple-blind, Randomized Clinical Trial.","authors":"Elyas Hassanzadeh, Abdolazim Sedighi Pashaki, Ehsan Akbari Hamed, Maryam Mehrpooya, Kamal Mohammadian, Reyhaneh Bayani, Kamran Sheikhi, Hossein Ranjbar, Mohammad Abbasi","doi":"10.1097/COC.0000000000001153","DOIUrl":"10.1097/COC.0000000000001153","url":null,"abstract":"<p><strong>Objectives: </strong>Chemotherapy-induced peripheral neuropathy (CIPN) is a significant clinical issue that affects patients' quality of life and can limit the dosing of chemotherapeutic agents. N-acetylcysteine (NAC) has been proposed as a potential chemoprotective agent against CIPN due to its antioxidant properties. This study aimed to investigate the efficacy of oral NAC in preventing and controlling taxane-induced neuropathy in patients with breast cancer.</p><p><strong>Methods: </strong>This randomized, triple-blind, placebo-controlled trial included 80 breast cancer patients undergoing taxane-based chemotherapy. Participants were divided into 2 groups: an intervention group receiving 1200 mg of oral NAC in divided doses per day and a placebo group. Patients were evaluated for neuropathy grade and functional status at 1 and 12 weeks postintervention.</p><p><strong>Results: </strong>Our analysis revealed no significant difference in the incidence and severity of neuropathy between the intervention and placebo groups at 1 ( P =0.328) and 12 weeks ( P =0.569) postchemotherapy. Baseline characteristics such as age, number of treatment cycles, and disease stage were similar between groups, indicating a homogeneous population.</p><p><strong>Conclusions: </strong>Oral NAC at a dose of 1200 mg per day did not significantly reduce the incidence or severity of taxane-induced neuropathy. These findings suggest that the oral bioavailability of NAC may be insufficient to exert a protective effect and that future studies should consider alternative dosing strategies or routes of administration. The need for further research to optimize NAC's chemoprotective role in CIPN remains evident.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"122-126"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Executive Summary of the American Radium Society Appropriate Use Criteria: Regional Nodal Irradiation for Breast Cancer.","authors":"J Isabelle Choi, Gary M Freedman, David M Guttmann, Kamran Ahmed, Wendy Gao, Eleanor M Walker, Eleanor E Harris, Victor Gonzalez, Jason Ye, Kevin Nead, Neil Taunk, Audree B Tadros, Chau T Dang, Parima Daroui, Kristina Novick","doi":"10.1097/COC.0000000000001154","DOIUrl":"10.1097/COC.0000000000001154","url":null,"abstract":"<p><strong>Objectives: </strong>Recent literature has provided additional data to further individualize treatment recommendations on regional nodal irradiation (RNI) patient selection and delivery techniques, but controversies surrounding optimal RNI utilization remain, including radiation technique, modality selection, and internal mammary lymph node (IMN) inclusion. The American Radium Society (ARS) Breast Appropriate Use Criteria (AUC) Committee performed a systematic review and developed a consensus guideline to summarize recent data and provide evidence-based recommendations.</p><p><strong>Methods: </strong>A multidisciplinary panel comprised of 15 members representing radiation oncologists, medical oncologists, and surgical oncologists specializing in the treatment of breast cancer conducted an analysis of the medical literature from January 1, 2011 to April 1, 2024. Modified Delphi methodology was used to rate the appropriateness of treatments for variants across 3 key questions.</p><p><strong>Results: </strong>Patients with intermediate-risk breast cancer, such as limited nodal involvement or large primary tumor size, are reasonable candidates for RNI, although a subset of patients with overall favorable clinicopathologic features may be considered for treatment de-escalation. Data on the use of advanced radiation techniques for RNI were limited in scope and strength, and the panel agreed that careful patient selection is needed when using these tools. Evidence suggests that the IMN should be included when delivering RNI given the absolute benefit demonstrated in multiple randomized trials.</p><p><strong>Conclusion: </strong>A systematic review and evidence-based summary of recommendations are provided in these consensus guidelines from the ARS Breast AUC Committee to provide current comprehensive guidance on the optimal management of non-metastatic breast cancer patients being considered for RNI.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":"48 3","pages":"111-121"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143469255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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 Probiotics as Adjunctive Therapy in Cancer Treatment: A Comprehensive Systematic Review and Meta-Analysis.","authors":"Zaheer Qureshi, Abdur Jamil, Faryal Altaf, Rimsha Siddique","doi":"10.1097/COC.0000000000001158","DOIUrl":"10.1097/COC.0000000000001158","url":null,"abstract":"<p><strong>Objectives: </strong>The gut microbiome is crucial in influencing cancer progression and response to treatment. We evaluate the efficacy and safety of probiotics and synbiotics in cancer treatment, focusing on the incidence of diarrhea, significant complications, surgical site infections, length of hospital stay, progression-free survival (PFS), and overall survival (OS).</p><p><strong>Methods: </strong>Following PRISMA guidelines, a comprehensive literature search was conducted in PubMed, Scopus, Web of Science, and Cochrane CENTRAL up to June 2024. The risk of bias was assessed using the Cochrane Risk-of-Bias tool. Meta-analysis was performed using a random-effects model.</p><p><strong>Results: </strong>Fifteen studies involving 2197 participants were included. Probiotic use was associated with a significant reduction in the incidence of diarrhea (OR=0.39, 95% CI: 0.15-1.00, P =0.049) with moderate heterogeneity ( I2 =64%). No significant differences were found in major complications (OR=0.50, 95% CI: 0.05-4.92, P =0.4053, I2 =73%), surgical site infections (OR=0.36, 95% CI: 0.12-1.09, P =0.058, I2 =0%), length of hospital stay (SMD=-0.30, 95% CI: -1.00 to 0.41, P =0.2726, I2 =62%), PFS (HR=0.61, 95% CI: 0.03-10.82, P =0.2715, I2 =0%), or OS (HR=0.52, 95% CI: 0.00-58.82, P =0.3298, I2 =0%).</p><p><strong>Conclusions: </strong>Probiotics significantly reduced the incidence of chemotherapy-induced diarrhea, highlighting their potential as supportive care agents in oncology. However, their impact on significant complications, surgical site infections, length of hospital stay, and survival outcomes remains inconclusive.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"148-161"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142808598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beyond Treatment: A Narrative Review of Humanization Practices, Empathetic Communication, and Comprehensive Support in Oncology Patient Care in Brazil Over the Last Two Decades (2003-2023).","authors":"Kalysta Resende Borges, Giulia Manuella Almeida, Bianca Victória Resende Almeida, Cairo Borges, Emanuel Negrão Macêdo","doi":"10.1097/COC.0000000000001149","DOIUrl":"10.1097/COC.0000000000001149","url":null,"abstract":"<p><p>Humanization in oncology patient care represents a significant innovation in health care practice, shifting the traditional focus solely on treating physical conditions to encompass the emotional and psychosocial dimensions of patient experience. This study aimed to explore the importance of humanization in oncology and the application of practices that promote a patient-centered approach. Through a narrative review of the past 2 decades, the objective was to analyze the practices, benefits, and challenges of humanization in the oncology context. The methodology involved reviewing the relevant literature on empathetic communication, psychological support, and the integration of these aspects into oncology care. The results indicated that humanization significantly contributes to improving patients' quality of life, increasing treatment adherence, and fostering a more satisfying work environment for health care teams. However, effective implementation faces challenges, such as the need for ongoing training, resource limitations, and resistance to change. Despite these obstacles, humanization is essential to provide more comprehensive and patient-centered care. The adoption of humanized practices transforms the oncology care experience, making it more empathetic and holistic.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"106-109"},"PeriodicalIF":1.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Cost of Progression-Free Survival in Treating Low-Grade Glioma.","authors":"Shearwood McClelland, Martin C Tom, Michael T Milano","doi":"10.1097/COC.0000000000001141","DOIUrl":"10.1097/COC.0000000000001141","url":null,"abstract":"","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"55-56"},"PeriodicalIF":1.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141983793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Circulating DNA in Rectal Cancer to Unravel the Prognostic Potential for Radiation Oncologist: A Meta-analysis.","authors":"Francesco Fiorica, Marta Mandarà, Jacopo Giuliani, Umberto Tebano, Antonella Franceschetto, Milena Gabbani, Elvira Rampello, Giorgia Condarelli, Giuseppe Napoli, Nicoletta Luca, Daniela Mangiola, Marco Muraro, Navdeep Singh, Andrea Remo, Carlotta Giorgi, Paolo Pinton","doi":"10.1097/COC.0000000000001148","DOIUrl":"10.1097/COC.0000000000001148","url":null,"abstract":"<p><strong>Objectives: </strong>Liquid biopsy, with its noninvasive nature and ability to detect tumor-specific genetic alterations, emerges as an ideal biomarker for monitoring recurrences for locally advanced rectal cancer (LARC). Completed studies have small sample sizes and different experimental methods. To consolidate and assess the collective evidence regarding the prognostic role of circulating DNA (ctDNA) detection in LARC patients undergoing neoadjuvant chemoradiotherapy (nCRT).</p><p><strong>Methods: </strong>Computerized bibliographic searches of MEDLINE and CANCERLIT (2000 to 2023) were supplemented with hand searches of reference lists. Study selection: studies evaluating oncological outcomes of patients with LARC treated with a nCRT comparing patients with positive and negative liquid biopsy at baseline and after nCRT. Data extraction: data on population, intervention, and outcomes were extracted from each study, in accordance with the intention to treat method, by 2 independent observers, and combined using the DerSimonian method and Laird method.</p><p><strong>Results: </strong>Nine studies follow inclusion criteria including 678 patients treated with nCRT. The pooled RD rate of ctDNA negative between measure at baseline and after nCRT is statistically significant 61% (95% CI: 53-70, P =0.0002). The hazard ratio (HR) of progression-free survival between ct-DNA negative and positive is significant 7.41 (95% CI: 4.87-11.289, P <0.00001).</p><p><strong>Conclusions: </strong>ctDNA can identify patients with different recurrence risks following nCRT and assess prognosis in patients with LARC. Further prospective study is necessary to determine the utility of ctDNA in personalised therapy for patients with LARC.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"83-91"},"PeriodicalIF":1.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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 Lenvatinib in Combination With Other Tyrosine Kinase Inhibitors for Metastatic Renal Cell Carcinoma: A Meta-analysis.","authors":"Abdur Jamil, Zaheer Qureshi, Rimsha Siddique, Faryal Altaf, Hamzah Akram","doi":"10.1097/COC.0000000000001150","DOIUrl":"10.1097/COC.0000000000001150","url":null,"abstract":"<p><strong>Objective: </strong>This meta-analysis evaluates the efficacy and safety of lenvatinib, both as monotherapy and in combination with other (tyrosine kinase inhibitors) TKIs, compared with other TKIs in metastatic renal cell carcinoma (RCC) treatment.</p><p><strong>Methods: </strong>We searched for relevant studies from inception to February 2024 using PubMed, Web of Science, Cochrane Library, and Scopus. Eligible studies reported on the efficacy and safety of lenvatinib alone or in combination with other TKIs versus other TKIs for metastatic RCC. Primary outcomes included progression-free survival (PFS) and overall survival (OS). Secondary outcomes included objective response rate (ORR), adverse events (AEs), and health-related quality of life (HRQOL).</p><p><strong>Results: </strong>Seventeen studies met the inclusion criteria. Lenvatinib, especially in combination therapies, significantly improved PFS (HR: 0.46, 95% CI: 0.38-0.54, P <0.001) and OS (HR: 0.80, 95% CI: 0.70-0.91, P <0.001) compared with other TKIs. Quality of life analyses showed mixed results, with EQ-5D demonstrating significant improvement (HR: 1.21, 95% CI: 0.90-1.53, P <0.001), while EORTC QLQ-C30 was not statistically significant. ORR analysis indicated a higher likelihood of achieving a complete or partial response with lenvatinib (OR: 2.04, 95% CI: 1.15-2.93, P =0.00). The analysis of total AEs above grade 3 showed no significant difference between lenvatinib and other TKIs (OR: -0.08, 95% CI: -0.21 to 0.06, P =0.26).</p><p><strong>Conclusions: </strong>Lenvatinib significantly enhances survival outcomes in metastatic RCC patients compared with other TKIs. While associated with various adverse events, its safety profile is comparable to other TKIs.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"92-105"},"PeriodicalIF":1.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic Impact of Low Muscle Mass and Inflammatory Markers in Stage III Nonsmall Cell Lung Cancer Turkish Oncology Group and Turkish Society of Radiation Oncology Thoracic Cancer Study Group (08-005).","authors":"Esra Gumustepe, Güler Yavas, Esra Korkmaz Kirakli, Fazilet Öner Dincbas, Dilek N, Pervin Hurmuz, Elif Berna Koksoy, Tuba Kurt Catal, Talar Özler, Melek Tuğçe Yilmaz Aslan, Serap Akyurek","doi":"10.1097/COC.0000000000001152","DOIUrl":"10.1097/COC.0000000000001152","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this retrospective multicenter study was to evaluate the prognostic significance of low muscle mass, and inflammatory markers in patients with stage III nonsmall cell lung cancer (NSCLC) who received definitive chemoradiotherapy (CRT). Furthermore, the study aimed to determine the threshold value of disease-specific low muscle mass.</p><p><strong>Methods: </strong>A total of 461 patients with stage III NSCLC were evaluated. Low muscle mass, prognostic nutritional index (PNI), and biochemical inflammatory markers were assessed. The Kaplan-Meier method and Cox regression analysis were used to analyze overall survival (OS) and progression-free survival (PFS).</p><p><strong>Results: </strong>This study found a disease-specific low muscle mass threshold of LSMI <38.7 cm²/m² for women and <45.1 cm²/m² for men, with 25.2% of patients having disease-specific low muscle mass. Multivariate cox regression analysis revealed that low PNI was found to be an independent unfavorable prognostic factor for both PFS (HR=0.67; 95% CI: 0.48-0.92, P = 0.015) and OS (HR=0.67; 95% CI: 0.50-0.91, P =0.008). Other factors including ECOG PS 3 (HR=7.76; 95% CI: 1.73-34.76, P =0.007), induction CT (HR=0.66; 95% CI: 0.49-0.88, P = 0.004), and disease-specific low muscle mass (HR=1.40; 95% CI: 1.02-1.92, P = 0.038) also had independent effects on prognosis.</p><p><strong>Conclusions: </strong>The present study provides evidence that the presence of low muscle mass and low PNI significantly impacts the prognosis of patients with stage III NSCLC who undergo definitive CRT. Furthermore, our study is notable for being the first multicenter investigation to identify a disease-specific low muscle mass threshold.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"67-74"},"PeriodicalIF":1.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Efficacy of Neoadjuvant Docetaxel and Radiotherapy in Localized High-Risk Prostate Cancer: Results From a Prospective Pilot Study.","authors":"Kim C Ohaegbulam, Carl M Post, Paige E Farris, Mark Garzotto, Tomasz M Beer, Arthur Hung, Casey W Williamson","doi":"10.1097/COC.0000000000001151","DOIUrl":"10.1097/COC.0000000000001151","url":null,"abstract":"<p><strong>Objectives: </strong>Approximately 15% of patients with localized prostate cancer are at high risk for disease recurrence. Many clinical trials have evaluated the impact of neoadjuvant therapy before radical prostatectomy with mixed results (NCT00321698).</p><p><strong>Methods: </strong>This phase I/II clinical trial evaluated the tolerability and preliminary efficacy of neoadjuvant radiation therapy and docetaxel before prostatectomy in 25 men with high-risk prostate cancer. The treatment regimen included 45 Gy radiotherapy in 25 fractions to the prostate and seminal vesicles over 5 weeks, along with weekly dose-escalated docetaxel up to 30 mg/m², followed by prostatectomy and bilateral lymph node dissection. The primary endpoint was the rate of pathologic complete response (pCR). Secondary endpoints included adverse events, symptom and quality of life measures, and prostate-specific antigen metrics.</p><p><strong>Results: </strong>All 25 patients completed the planned treatment. The primary endpoint of pCR was not achieved. Lymphopenia was the most common grade 3 or higher toxicity, with no grade 3 or higher genitourinary or gastrointestinal toxicities observed. With a median follow-up of 11.6 years, the 10-year biochemical recurrence-free survival was 60%, and distant metastasis-free survival was 80%. Prostate cancer-specific survival and overall survival at 10 years were 84% and 60%, respectively.</p><p><strong>Conclusions: </strong>Although pCR was not met, the treatment demonstrated a modest toxicity profile and reasonable long-term outcomes, suggesting feasibility and safety. Further studies are needed to optimize endpoints and assess the efficacy of neoadjuvant treatments compared with standard approaches in high-risk prostate cancer patients.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"75-82"},"PeriodicalIF":1.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}