Squamous cell carcinoma (SCC) is the second most prevalent type of skin cancer after basal cell carcinoma, with the highest incidence occurring in sun-exposed regions of the body, particularly the head and neck. Approximately 300,000 new cases are diagnosed each year, imposing significant financial burdens on healthcare systems due to treatment costs and on the economy due to productivity losses. Surgery remains the primary treatment option; however, patients, particularly those with advanced-stage disease, may decline surgery due to concerns about functional and cosmetic outcomes. Other effective treatments include cryosurgery, radiotherapy, topical therapies, photodynamic therapy, and Mohs micrographic surgery. Recently, electrochemotherapy (ECT) has emerged as a novel treatment option. ECT involves administering bleomycin followed by electric pulses targeted at the tumor and surrounding margins, inducing transient cell membrane permeabilization. This enhances drug uptake and amplifies cytotoxic effects by over 1,000-fold. Since 2006, ECT has been a standard therapy in Europe and was introduced in Argentina in 2020, offering a new approach for patients who are unsuitable for or decline other treatments. In this study, we present outcomes from six patients with head and neck SCC treated with ECT on an outpatient basis. Most patients required only a single 60-minute treatment session. Observed side effects included grade 1-2 edema, pain, and flu-like symptoms per CTCAE 4.0. Tumor response was assessed using RECIST criteria, with results showing 71.4% complete response (5 of 7 lesions), 14.3% partial response (1 lesion), and 14.3% progressive disease, yielding an objective response rate of 85.7%.In conclusion, electrochemotherapy proved to be a safe and effective treatment for select head and neck SCC patients who are not candidates for surgery, providing a promising alternative in the therapeutic landscape. Felipe H. Maglietti, Sebastian D. Michinski, Lorna A. Evans, Raquel Lertora. Electrochemotherapy for the treatment of head and neck squamous cell carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4707.
Tibial tubercle fractures’ (TTF) preferred repair technique with headed cannulated screws is associated with reoperation rates of 50% to 60% for removal of hardware (ROH). A newer screw design is headless compression screws (HCS). This project hypothesized that utilization of lower-profile HCS would reduce rates of pain and reoperation rates for removal of hardware in pediatric TTF, while maintaining comparable fracture healing and functional outcomes. An institutional review board approved, multicenter, retrospective, case-control study with data collected for all surgeries between 2014 and 2024. A priori power analysis was performed, targeting significant reduction in ROH rates. A total of 283 TTF were identified; 148 met inclusion criteria, with most excluded for alternative fractures, surgical treatment, or insufficient follow-up. 121 were treated with cannulated, headed screws and 27 with HCS. Patients were 93.2% male, most commonly black (55%), average age 14.5 years, weight 85th percentile, height 71st percentile, and body mass index of 79th percentile. Injuries were most often during basketball (47%). All fracture patterns from Ogden 1A to 4B were represented, and the most common pattern was 3A (31%); no patterns were excluded. The typical repair consisted of 2 to 3 screws of 4.5 to 5.5 mm diameter, and 28% with supplemental fixation. The only difference between the headed and HCS groups was washer usage (50% vs. 0%, P <0.001). Given the demographic difference in washer use, subgroup analysis was performed to separate the washer and washer-less headed cannulated screw constructs. There were no differences in postoperative management, including immobilization (71% knee immobilizer), days to motion (29), and days to weight bearing (35). Total follow-up period was similar (266 d). There were no differences in hardware failure. Neither group experienced nonunion. Compared with headed screws with washers, the HCS group had significantly less pain (38% vs. 11%, P =0.005), relatively fewer wound complications and infections (both 2.5% vs. 0%, P =0.12), and significantly lower rates of ROH (40% vs. 7.4%, P <0.001). Compared with the preferred standard TTF fixation of headed cannulated screws, patients who received HCS had equivalent surgical, healing, and management outcomes, with relatively lower rates of wound complications and infections, significantly less pain, and significantly fewer returns to the operating room for ROH. Level III—multicenter case-control.
Pancreatic ductal adenocarcinoma (PDA) is a disease with guarded prognosis with a 5-year overall survival (OS) of 3.1% in patients with metastatic disease. The need for innovative treatments for this lethal disease is paramount. TTFields is a novel treatment modality that employs low intensity, alternating, and intermediate frequency electrical fields that abrogates cancer cell proliferation through different mechanisms. These include inhibition of mitosis, disruption of cancer cell membranes, metabolomic dysregulation of cancer cells, and immunogenic activation of the tumor microenvironment (TME). TTFields are approved in glioblastoma multiforme, non-small cell lung cancer and malignant mesothelioma. The PANOVA trial demonstrated promising efficacy for TTFields plus chemotherapy in patients with PDA. A trial of GCN in patients with PDA demonstrated exceptional efficacy in patients with metastatic disease. Here in, we present our ongoing clinical trial investigating the safety and efficacy of TTFields plus GCN in patients with PDA (NCT04605913). This a phase I/II trial with an initial safety run-in phase followed by the phase II portion. The primary objective of the trial is to determine the safety (CTCAE v 5.0) of GCN plus TTFields. Secondary objectives include determining the 6-month progression free survival (PFS) rate, overall response rate (ORR, RECIST v1.1), 12-month survival rate, OS, and QOL (EORTC QLQ-C30, version 3.0.2.3). Inclusion criteria include PDA with liver metastasis (patients can have additional sites of metastasis), ECOG 0-1, measurable disease, and ability to operate the Novo TTF-100L (P)/Novo TTF-200T system. Treatment consisted of TTFields (150 kHz 18 hours/day) and GCN (G: 1000 mg/m2, C 30 mg/m2, and N: 150 mg/m2 every 2 weeks, 28 days cycle), followed by a maintenance phase after 6 months (G: 1000 mg/m2 every 2 weeks) plus TTFields until progression. Six patients were to be enrolled in the phase I portion and if ≤1/6 patients experienced a dose limiting toxicity (DLT, treatment emergent adverse event, or skin toxicity of Gr4), the plan would be to move to a phase II trial enrolling 34 more patients. If 2/6 patients experienced a DLT, 6 patients would be enrolled in dose level -1 (GCN plus TTFields for 9 hours/day followed by the maintenance treatment) and if tolerated the phase II portion would start with dose level -1 regimen. The phase I portion was completed without any DLTs and the trial is currently enrolling to the phase II portion. The total number of patients (40) was powered to the 6-months PFS rate and ORR (estimated using the lower bound of exact one-sided 90% confidence intervals). The goal is to "reject" a 6-month PFS rate of 66% and an ORR of 71% (based on previous GCN trial). Time-to-event endpoints will be assessed using the Kaplan-Meier method. Hani M. Babiker, Jason Starr, Jeremy Jones, Conor O’Donnell, Robert Jones, Jacqueline Boni, Lashundra Stewart, Josh Cameron, Oudom Kour, Kabir Mody, Robert R. McWilliams, Daniel H. Ahn, Tanios Bekaii-Saab, Mitesh J. Borad, Umair Majeed. A phase I/II pilot trial, single arm, open label, of gemcitabine, cisplatin, protein-bound paclitaxel (GCN) combined with Tumor Treatment Fields (TTFields) in patient with metastatic pancreatic adenocarcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT190.
Epidemiology studies have linked frequent consumption of well-done cooked red meat with aggressive prostate cancer (CaP) risk, whereas rare intake or consuming medium-cooked meat is not. Providing public information about the impact of well-done cooking and its potential role in CaP risk may foster the adoption of evidence-based lifestyle modification of meat consumption to lower CaP risk. This pilot study aimed to provide preliminary data on the occurrence of CaP and the pattern of consumption of cooked red beef among ethnically diverse males in the US. The proposed project is an exploratory study focused on the assessment of the consumption of various beef dishes among ethnically diverse males in the United States. The study included 408 ethnically diverse males from Florida, Georgia, and Texas. Participants were recruited primarily from partnering restaurants, pharmacies, barbershops and collaborating community businesses using QR codes on the study flyer. Participants completed the self-administered survey that captured demographics, as well as information on beef consumption patterns, including cooking methods, frequency and degree of cooking, and the occurrence of CaP. The data were analyzed using descriptive statistics (frequency and percentages) to summarize demographics and variables on beef dishes. Chi-square was employed to determine the relationship between beef consumption patterns, demographic variables, and CaP occurrence. The study showed that about half (49.8%) of the participants were between ages 44-63 years and 34.2% were 30-43 years old. The participants were quite diverse, as 51.7%, 16.3%, 13.1%, 11.%, and 2.7% were African American, African immigrants, White, Caribbean immigrants, and Hispanics, respectively. Rural dwellers comprised 34.2%, 26.8% were suburban, and 35.7% lived in urban areas. Educational status showed that 22.7%, 27.8%, and 22.7% were completed high school, college graduates, and associate degrees. The beef consumption pattern shows that 23.6%, 33.3%, 40.1%, and 30.3% regularly had boiled, fried, grilled, and barbequed beef, respectively, but 63, 2% reported never eating boiled beef. Doneness preferences differed among participants; 26%, 43.9%, 49.3, and 45.1% preferred well-done, while 1.7%, 1.5%, 2..9%, and 2.7% preferred rare, and 9%, 14.5%, 17.4%, and 15.7% preferred medium boiled, fried, grilled, and barbeques beef, respectively. Only 4.4% of the participants reported being diagnosed with CaP in the past. The pattern of beef consumption, such as the degree of doneness, was found for boiled (p=0.045), fried (p<0.001), grilled (p<0.001), and barbequed (p<0.001) beef, as well as frequency of consumption of (p<0.001), fried (p<0.001), grilled (p=0.001), and barbequed (p<0.001) to be associated with CaP. Beef consumption pattern was found to be associated with the risk of CaP among participants. Opeyemi Oreoluwa Bolajoko, Daniel W. Lee, Catherine Adebukola Oladoyinbo, Ernie Kaninjing, Samuel O. Antwi, Dee M. Glaser-Boivin, Robert J. Turesky, Folakemi T. Odedina. Pattern of beef consumption and prostate cancer risk among males in the United States [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 7112.
Bria-IMT™ is an allogeneic whole-cell cancer vaccine, designed to stimulate anti-tumor immunity (Chumsri et al 2024 ASCO). Bria-ABC (NCT06072612) is the multicenter, randomized, open-label trial evaluating overall survival (OS) of Bria-IMT™ regimen vs treatment of physician’s choice (PC) in patients with MBC where no meaningful therapy exists. 3 arm randomized 1:1:1 (Bria-IMT, Bria-IMT+CPI, or PC) in late stage heavily pretreated pts with MBC. Pts can be ECOG <2, Pts w/ CNS mets and/or who have received prior CPI or ADCs are allowed. The Bria-IMT™ regimen includes preconditioning w/ cyclophosphamide (300 mg/m2) on day -2/-3, intradermal SV-BR-1-GM inoculations (x4) on day 0, and interferon at inoculation sites (Days 1-3). CPI (retifanlimab 375 mg) may be given between days -2 to 2. The regimen is administered every 3 weeks (Q3W). Pts randomized to the monotherapy arm (Bria-IMT™ alone) may cross over to the combo arm upon disease progression. Response assessments are planned Q6W for the first cycle, and then Q8W thereafter. Based on prior data, an interim HR of 0.6 at 144 events will constitute early success. Overall study design anticipates 404 total pts. This interim, unaudited data reflects ongoing enrollment and trial feasibility. To date, 61 pts have completed screening, with 40 pts randomized. Screened pts had a median age of 56 (range 35-82). For pts with evaluable data (n=40), median BMI was 25.6 kg/m2 (8.7-45.7) with a median of 6 (2-13) prior lines of therapy. 20 pts (50%) had HR+/HER2- breast cancer, 18 HR-/HER2- (45%), and 2 HER2+ (5%). Baseline ECOG PS were: 0 (55%), 1 (35%), 2 (10%). In biomarker-evaluable pts, circulating tumor cells were present at baseline in 30% (mean: 10.1 cells/mL; range: 0-139), while cancer-associated macrophage-like cells (CAMLs) were present in all pts (mean: 18.3 cells/mL; range: 1-154). In pts with available follow-up data, median change in CAML count from baseline to most recent cycle was -23.5%. In pts with available HLA typing, match distribution was 0 (19%), 1 (35%), 2 (26%), 3 (16%), and 4 (3%), 8 (26%) class 1, 8 (26%) class 2, and 9 (29%) matching both alleles informing potential immune response interactions with Bria-IMT™. Local injection site reaction (DTH), tumor-marker serum level, and circulating cancer cells, will be analyzed across subtypes to further characterize the pt population. The Bria-IMT™ regimen has been generally well tolerated, with no Tx D/C due to adverse events (AEs). The most frequently reported AEs include nausea (30%), constipation (22.5%), injection site rxn (22.5%), and headache (17.5%) w/ no interstitial lung disease reported. Bria-ABC enrollment is ongoing. Future analyses will assess OS, PFS, ORR, CBR, QoL, and CNS event-free survival as data becomes available. Expected to close to enrollment by 2025, with final analyses planned for 2026. Saranya Chumsri, Joyce A. OShaughnessy, Azka Ali, Christopher N. Vaughn, Lawrence M. Negret, Adam Brufsky, Regina Stein, Marcela Salgado, Blaise Bayer, Giuseppe Del Priore, Sara A. Hurvitz. Bria-ABC vs physician choice in late stage MBC: Early biomarker correlates of the randomized registration trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr LB408.
