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

{"title":"Geospatial Mapping of Head and Neck Cancer Research: Assessing Access, Disparities, and Characteristics of Head and Neck Cancer Clinical Trials Across the United States.","authors":"Alexander Glehan, Talitha Kumaresan, Tam Ramsey, Jonathan Kumaresan, Neil Gildener-Leapman","doi":"10.1097/COC.0000000000001160","DOIUrl":"10.1097/COC.0000000000001160","url":null,"abstract":"<p><strong>Objective: </strong>To report geographic distribution and characteristics of head and neck cancer (HNC) clinical trials in the United States.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of U.S. HNC clinical trials searching ClinicalTrials.gov from January 1, 2017 to December 31, 2021 using the terms \"head and neck cancer\" or \"head and neck neoplasms.\"</p><p><strong>Results: </strong>A total of 381 clinical trials met inclusion criteria with 2181 trial opportunities, which were correlated with population density. Of the U.S. population, 72% live within a 25-mile radius of trials. California, Pennsylvania, and New York had the greatest number of clinical trial entries. The majority of patients living more than 25 miles from an HNC clinical trial site are located in rural areas. One hundred sixty-five (43.3%) trials were about systemic therapy, of which 138 (83.6%) involved targeted immunotherapy. There were 286 unique principal investigators. One hundred six (37.1%) were females and 180 (62.9%) were males.</p><p><strong>Conclusions: </strong>We demonstrate disparity in the geographic distribution of HNC trials favoring densely populated urban areas, which may limit patient access due to travel burden. Studies are skewed towards immunotherapy drug trials, with fewer radiation and surgery investigations.</p><p><strong>Level of evidence: </strong>Level III.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"180-184"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142752212","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":"Treatment of Cutaneous Adnexal Carcinoma With Radiotherapy: A 20-Year, Single-Institution Experience in 49 Patients.","authors":"Nader Mohamed, Sarah Mattessich, Daphna Y Gelblum, Nancy Y Lee, Christopher A Barker","doi":"10.1097/COC.0000000000001163","DOIUrl":"10.1097/COC.0000000000001163","url":null,"abstract":"<p><strong>Objectives: </strong>Cutaneous adnexal carcinomas (CACs) are rare skin cancers with no established treatment guidelines. Given the limited data, this study aims to explore the characteristics and outcomes of patients with CAC treated with radiation therapy (RT).</p><p><strong>Methods: </strong>Patients diagnosed with CAC between 2000 and 2020 who received RT were included. Kaplan-Meier methods measured time to local recurrence (LR), regional recurrence (RR), locoregional recurrence (LRR), distant metastasis (DM), and progression-free survival (PFS). Fisher exact test compared frequency distributions.</p><p><strong>Results: </strong>Forty-nine patients with an average age of 65 years were studied. Most were White males with head and neck tumors. Common subtypes were adnexal adenocarcinoma, sebaceous carcinoma, and microcystic adnexal carcinoma. Patients received RT diagnosis or recurrence. The median overall survival was 44 months, with a median follow-up of 41 months for surviving patients. For patients with de novo cancer treated with surgery and adjuvant RT (n=22), 2-year PFS, LR, RR, LRR, DM, and OS were 77%, 5%, 0%, 5%, 10%, and 95%, respectively, with all LRR occurring outside the irradiated area. Patients with de novo cancer who received definitive RT (n=9) experienced 2-year PFS, LR, RR, LRR, DM, and OS of 30%, 46%, 13%, 55%, 40%, and 67%, respectively, with all LRR events occurring within the irradiated area. LR within the irradiated volume was associated with immunosuppression (95% CI: 19-99). Patients treated at recurrence had inferior outcomes.</p><p><strong>Conclusions: </strong>Surgical resection and adjuvant RT effectively control CAC, while definitive RT shows lower disease control. Novel strategies are needed to improve outcomes in patients receiving definitive RT.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"193-199"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143061058","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 for Management of Squamous Cell Carcinoma of the Cervical Esophagus: Systematic Review and Guidelines.","authors":"Vonetta M Williams, Christopher L Hallemeier, Krishan R Jethwa, J Eva Selfridge, Pari Shah, Christopher J Anker, Gerard Abood, Dmitriy Akselrod, Jordan Berlin, Ed Kim, Timothy Kennedy, Percy Lee, Navesh Sharma, Small William, Leila Tchelebi, Suzanne Russo","doi":"10.1097/COC.0000000000001165","DOIUrl":"10.1097/COC.0000000000001165","url":null,"abstract":"<p><strong>Objectives: </strong>Cervical esophageal cancer (CEC) is an uncommon malignancy accounting for <5% of all esophageal carcinomas. Treatment of CEC varies and is adapted from established regimens used for squamous cell carcinoma (SCC) or the lower esophageal and head and neck. The present systematic review and guidelines are intended to assist treatment decision making for patients with CEC based on the available evidence.</p><p><strong>Methods: </strong>Using the Population, Intervention, Comparator, Outcome, Timing, and Study Design (PICOTS) framework, the evidence regarding treatment outcomes was assessed using Cochrane and PRISMA 2020 methodology. Eligible studies included prospective Phase II to III trials and retrospective analyses published between January 1, 2013 and February 23, 2024 in the Ovid Medline database. These references were assessed through the American Radium Society (ARS) Appropriate Use Criteria (AUC) methodology. A systematic review PRISMA 2020 checklist confirmed the completion of essential elements. RAND-UCLA consensus methodology was used by the expert panel to rate the appropriateness of the treatment options.</p><p><strong>Results: </strong>ARS AUC recommendations include (1) larynx preservation using endoscopic resection (EMR or ESD) alone for the typical case with pT1a cN0 cM0 CEC, (2) definitive CRT for the typical case with cT1bN0M0 in patients who cannot undergo endoscopic resection, (3) larynx-preserving using definitive CRT (with or without induction chemotherapy) for the typical case with nonmetastatic locally advanced CEC (advanced T-stage tumors or involved lymph nodes), with surgery reserved for those patients with incomplete response or locoregional recurrence.</p><p><strong>Conclusions: </strong>This ARS AUC summary provides guidelines for the management of SCC of the cervical esophagus provides based on available evidence. Topics that warrant further investigation include optimization of (1) patient selection; (2) multimodality therapies including chemotherapy, immunotherapy, and targeted agents; (3) radiation dose, schedule, and treatment volume; and (4) supportive care for patients with CEC. Ongoing trials continue to improve outcomes for patients with CEC.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"163-179"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143257264","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":"KRAS Mutations in Cancer: From Molecular Insights to Therapeutic Strategies.","authors":"Yuanzhu Zhang, Yujie Ma, Kexin Zhang, Yuqun Wang, Xiaodong Sun, Chengxia Kan, Fang Han","doi":"10.1097/COC.0000000000001192","DOIUrl":"https://doi.org/10.1097/COC.0000000000001192","url":null,"abstract":"<p><p>The global burden of cancer remains a major public health challenge, with Kirsten rat sarcoma viral oncogene homolog (KRAS) emerging as the most common mutated oncogene across diverse malignancies. Once considered \"undruggable\" due to its unique structure, KRAS has garnered intense research focus, resulting in significant advancements. This paper aims to review recent developments in our understanding of KRAS biology, including its structural and functional aspects, and to explore the latest insights into its mutations across various cancer types. Emphasis is placed on prognosis, predictive roles, and emerging therapeutic strategies targeting KRAS. This review aspires to deepen our comprehension of KRAS and potentially enhance treatment outcomes for cancer patients harboring KRAS mutations in the future.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755679","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":"Subtype-Specific Patterns of Tumor Purity and Mutation Load Suggest Treatment Implications: A Cross-Sectional Analysis of 7494 Soft Tissue and Bone Sarcomas (MSK Cohort).","authors":"Daniel Schneider, Ethan D L Brown, Jacob Gluski, Akash Mishra, Harshal A Shah, Daniel M Sciubba, Sheng-Fu Larry Lo","doi":"10.1097/COC.0000000000001161","DOIUrl":"10.1097/COC.0000000000001161","url":null,"abstract":"<p><strong>Objectives: </strong>Sarcomas are complex mesenchymal malignancies whose molecular characteristics can significantly influence treatment strategies. This study aimed to investigate the relationship between tumor purity, mutation load, and clinical characteristics across sarcoma subtypes, focusing on potential implications for therapeutic stratification.</p><p><strong>Methods: </strong>This study analyzed the molecular characteristics of 7494 sarcoma cases from the Soft Tissue and Bone Sarcoma (MSK, Nat Commun 2022) data set using available case analysis. Correlations between tumor purity, mutation load, age, and sex were analyzed using nonparametric methods, with subtype-specific analyses conducted using Kruskal-Wallis tests and Bonferroni-corrected post hoc comparisons. A comprehensive analysis of mutation patterns was performed using microsatellite instability (MSI) status.</p><p><strong>Results: </strong>Significant correlations between mutation load and tumor purity (ρ=0.320, P <0.001) were identified, with marked heterogeneity across subtypes. Tumor purity ranged from 20.0% in brain sarcomas to 78.5% in dermatofibrosarcoma protuberans. Age-related molecular changes were observed in brain (ρ=0.711, P =0.006) and skin sarcomas (ρ=0.450, P =0.006), suggesting distinct evolutionary patterns. A subset of hypermutated, microsatellite stable cases (0.15%) with mutation loads exceeding 100 mutations/mb were identified, suggesting alternative mechanisms of genomic instability. MSI-high status was rare (0.24%) but associated with higher mutation loads (median: 25.84 vs. 2.42, P <0.001), particularly in uterine sarcomas (0.7% prevalence).</p><p><strong>Conclusions: </strong>The identification of distinct molecular patterns across sarcoma subtypes challenge existing morphology-based classification systems and may hold implications for therapeutic stratification. These findings may help inform future immunotherapeutic and molecular-guided approaches to treatment in sarcoma patients, particularly for elderly patients with brain sarcomas or females with uterine sarcomas.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"185-192"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143631033","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 Effect of PD-1/PD-L1 Inhibitor and Statin Combination Therapy on Overall Survival and Gastrointestinal Toxicity.","authors":"Jay Shah, Andres Caleb Urias Rivera, Irene Jeong-Ah Lee, Kei Takigawa, Antony Mathew, Deanna Wu, Eric Lu, Malek Shatila, Anusha S Thomas, Hao Chi Zhang, Mehmet Altan, Dan Zhao, Qinghuan Xiao, Yinghong Wang","doi":"10.1097/COC.0000000000001156","DOIUrl":"10.1097/COC.0000000000001156","url":null,"abstract":"<p><strong>Objectives: </strong>Immune checkpoint inhibitors (ICIs), such as programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors, have been approved to treat a variety of cancers. Recently, studies have suggested that ICIs and statins are synergistic. However, the addition of statins to ICI therapy may increase the risk of gastrointestinal immune-related adverse events (irAEs). We investigated the effect of combination therapy with PD-1 and/or L1 inhibitors and statins on overall survival and gastrointestinal irAEs.</p><p><strong>Methods: </strong>We reviewed the charts of patients with select cancers who received PD-1 and/or PD-L1 inhibitors and statins. The incidence of gastrointestinal irAEs and overall survival were compared with that in a matched control group of patients who received PD-1 and/or PD-L1 inhibitors without statins.</p><p><strong>Results: </strong>Of the 823 patients in the statin group, 707 received PD-1 inhibitors, 86 received PD-L1 inhibitors, and 30 received both. Patients taking any statins (10.8%) and those taking high-intensity statins (15.8%) had higher rates of gastrointestinal irAEs than patients not taking statins (8.7%; P =0.046 and 0.006, respectively). Compared with the nonstatin treatments, statin use was associated with improved overall survival for patients taking PD-1 inhibitors ( P <0.001) and for patients with ( P =0.021) and without ( P <0.001) gastrointestinal irAEs.</p><p><strong>Conclusions: </strong>Synergism of statins with PD-1 and PD-L1 inhibitors continues to be a developing field of interest. Our data demonstrate the survival benefit of combination therapy with PD-1 and/or PD-L1 inhibitors and statins, warranting further investigation.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"136-141"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548777","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":"Complications, Costs, and Health Care Resource Use with Tissue Biopsy Followed by Liquid Biopsy Versus Tissue Re-biopsy in Patients With Newly Diagnosed Metastatic Nonsmall-cell Lung Cancer.","authors":"Anne Shah, Jon Apple, Saad Aslam, Nicole M Engel-Nitz, Lisa Le, Marilou Terpenning","doi":"10.1097/COC.0000000000001155","DOIUrl":"10.1097/COC.0000000000001155","url":null,"abstract":"<p><strong>Objectives: </strong>We compared complications, costs, and health care resource utilization (HCRU) of patients with newly diagnosed metastatic nonsmall-cell lung cancer (mNSCLC) who had a tissue biopsy followed by either liquid biopsy (TFLB) (identified with a novel algorithm) or tissue re-biopsy (TRB).</p><p><strong>Methods: </strong>This claims-based retrospective analysis included commercial and Medicare Advantage members in the Optum Research Database with mNSCLC (January 2017 to June 2021) and ≥2 tissue biopsy claims (7 to 90 d apart) (TRB) or ≥1 tissue and ≥1 liquid biopsy claim within 90 days (TFLB). Patients in the TFLB group were matched 1:1 to patients in the TRB group using propensity score matching. Surgical biopsy-related complications and complication-related and all-cause medical costs and HCRU during the 6-month follow-up were compared.</p><p><strong>Results: </strong>Both groups had 235 patients post-match. During the follow-up, the surgical biopsy-related complication rate was lower in the TFLB group than the TRB group (65.1% [153/235] vs. 84.7% [199/235], P <0.001). Mean complication-related medical costs were significantly lower with TFLB ($8494 vs. $19,741, P <0.001) during the follow-up; mean (SD) duration of complication-related inpatient stays was significantly lower with TFLB (3.5 [7.0] vs. 6.6 [13.3] d, P =0.002). Mean all-cause medical costs were not significantly different between the groups; the TFLB group had fewer all-cause inpatient stays, inpatient days, and outpatient visits.</p><p><strong>Conclusions: </strong>Multiple tissue biopsy procedures may be associated with significantly higher biopsy complication rates, higher complication-related medical costs, and longer complication-related inpatient stays than TFLB. All-cause medical costs were similar between groups.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":"127-135"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11837954/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142584916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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}