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

{"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":"https://doi.org/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":"Cardiovascular Risk Profile of Nivolumab Anti-cancer Therapy: A Review of Current Literature.","authors":"Zaheer Qureshi, Zaofashan Zaheer, Zoha Asghar, Muhammad Bakhtiar, Eeshal Fatima, Faryal Altaf","doi":"10.1097/COC.0000000000001166","DOIUrl":"https://doi.org/10.1097/COC.0000000000001166","url":null,"abstract":"<p><strong>Objectives: </strong>Immune checkpoint inhibitors (ICI) upregulate host antitumor immunity, proving efficacy across diverse tumor types. Currently approved ICI treatment primarily targets the programmed cell death receptor 1 (PD-1) and its ligand PD-L1, and cytotoxic T lymphocyte-antigen 4 (CTLA-4). Nivolumab is a monoclonal antibody that targets the human PD-1 receptor and is an entirely human immunoglobulin G4 (IgG4), approved by the FDA for various cancers like advanced melanoma, metastatic renal cell carcinoma, Hodgkin lymphoma, and advanced lung carcinoma. This review will summarise and discuss the recent literature on cardiotoxicity associated with nivolumab therapy.</p><p><strong>Methods: </strong>We searched online databases like PubMed, Scopus, Google Scholar, and Embase for articles related to Nivolumab.</p><p><strong>Results: </strong>Cardiotoxicity with ICI use is most commonly represented as myocarditis. Patients present with complaints of shortness of breath, palpitations, edema, and fatigue. Takotsubo cardiomyopathy, or broken heart syndrome, is characterized by systolic dysfunction of the left ventricle, mimicking a myocardial infarction but without associated coronary ischemia and with minimal elevation of cardiac enzymes. In the CHECKMATE-037 trial, ventricular arrhythmias occurred in <10% of those who received nivolumab. In a retrospective analysis of patients treated with ICI (predominantly nivolumab monotherapy) for lung cancer, 11% of the patients developed major adverse cardiac events, including myocarditis, non-ST-segment elevated myocardial infarction, supraventricular tachycardia, and pericardial disorders.</p><p><strong>Conclusion: </strong>Close collaboration between cardiology and oncology specialists is crucial for early detection and effective management of cardiac complications, enhancing the safety of nivolumab anticancer therapy.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505843","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":"Impact of Minimal Residual Diseases Status and Depth of Response on Survival Outcomes in Blinatumomab-Treated Acute Lymphoblastic Leukemia: A Systematic Review and Meta-Analysis.","authors":"Abdur Jamil, Zaheer Qureshi, Rida Riaz, Hamzah Akram, Rohma Jamil, Asim Kichloo, Insija Ilyas Selene","doi":"10.1097/COC.0000000000001179","DOIUrl":"https://doi.org/10.1097/COC.0000000000001179","url":null,"abstract":"<p><strong>Objectives: </strong>Acute lymphoblastic leukemia (ALL) is a common hematological malignancy that occurs due to blockage of B-lymphocyte maturation at an early stage of development and differentiation. The Food and Drug Administration approved blinotumomab to manage relapsed/refractory ALL (R/R ALL). This review aimed to determine the comparative efficacy of blinatumomab in treating R/R ALL.</p><p><strong>Methods: </strong>Two reviewers searched 3 electronic databases, PubMed, ScienceDirect, and CENTRAL, for all relevant articles published until July 2024. All the articles that met the inclusion criteria were included in the review.</p><p><strong>Results: </strong>Four hundred thirty-seven articles were found from the electronic search; however, only 21 articles met the inclusion criteria. A pooled analysis of the outcomes found that blinatumomab resulted in an improvement in both the OS (HR: 0.65; 95% CI: 0.51, 0.82; P=0.0003) and the DFS (HR: 0.57; 95% CI: 0.41, 0.80; P=0.001). Further analysis showed that the CR rate and MRD response of ALL patients to blinatumomab was 51.6% (95% CI: 48.5%, 54.6%; P=0.319) and 64.6% (95% CI: 53.4%, 74.3%; P=0.011), respectively. The safety analysis indicated that the incidence of serious AEs was comparable in patients receiving blinotumomab and those receiving standard chemotherapy (OR: 1.34; 95% CI; 0.91, 1.97; P=0.14).</p><p><strong>Conclusions: </strong>The findings show that blinatumomab is superior to standard chemotherapy in improving the OS and DFS of patients with R/R ALL. Furthermore, it has a more favorable safety profile, making it an effective alternative to conventional chemotherapy for managing R/R ALL.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505845","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":"On the Origin of Treatment Paradigms.","authors":"Matthew McFarlane, Whitney Beeler, Matthew Ward, Chirag Shah","doi":"10.1097/COC.0000000000001181","DOIUrl":"https://doi.org/10.1097/COC.0000000000001181","url":null,"abstract":"","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460510","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":"Outcome Predictors of Hardware Complications in Head and Neck Free Flap Reconstruction.","authors":"Abhinav Talwar, Shravan Asthana, Jennifer Silva-Nash, Laila A Gharzai, Sandeep Samant, Urjeet Patel, Katelyn Stepan","doi":"10.1097/COC.0000000000001180","DOIUrl":"https://doi.org/10.1097/COC.0000000000001180","url":null,"abstract":"<p><strong>Objectives: </strong>Osteocutaneous free flap reconstruction can be complicated by hardware failure. The present study investigates the frequency and predictors of hardware failure in head and neck osteocutaneous reconstruction.</p><p><strong>Methods: </strong>Patients who underwent osteocutaneous head and neck free flap reconstruction between the years of 2014 and 2022 were identified at our institution. Hardware failure was defined as hardware infection, screw plate loosening, exposed hardware, migration, deformation, or fracture.</p><p><strong>Results: </strong>We identified 47 patients who met the inclusion criteria for this study. Common indications for intervention included squamous cell carcinoma (35, 74%) and osteoradionecrosis (8, 17%). Most operations used fibular flaps (31, 66%) or osteocutaneous radial forearm flaps (12, 26%). The median age at the time of reconstruction was 66 years (IQR: 59 to 72). In total, 17 (36%) patients experienced hardware failure in the postoperative period. On univariable analysis, estimated blood loss (P=0.01) and early postoperative infectious complication (P=0.03) were the only significant predictors of hardware failure. On multivariable analysis, these factors retained significance. Estimated blood loss had an OR of 1.004 (95% CI: 1.001-1.008; P=0.01), and infectious complication had an OR of 5.22 (95% CI: 1.28-24.84; P=0.03).</p><p><strong>Conclusion: </strong>The incidence of hardware failure among patients who undergo head and neck osteocutaenous free flap reconstruction is high (36%). Patients with infectious complications and high estimated blood loss may be more likely to develop hardware failure.</p><p><strong>Level of evidence: </strong>Level III.</p>","PeriodicalId":50812,"journal":{"name":"American Journal of Clinical Oncology-Cancer Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143450882","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}