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Browsing by Author "Simone, Charles B., II"
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Item Chemoradiotherapy versus chemotherapy alone for unresected intrahepatic cholangiocarcinoma: practice patterns and outcomes from the national cancer data base(AME Publishing Company, 2018-06) Verma, Vivek; Appiah, Adams Kusi; Lautenschlaeger, Tim; Adeberg, Sebastian; Simone, Charles B., II; Lin, Chi; Radiation Oncology, School of MedicineBackground: Current guidelines recommend chemotherapy (CT) with or without radiotherapy (RT) for unresected intrahepatic cholangiocarcinoma (IC). Although there is currently lack of consensus, previous smaller studies have illustrated the efficacy of local therapy for this population. This investigation evaluated outcomes of chemoradiotherapy (CRT) versus CT alone in unresected IC using a large, contemporary national database. Methods: The National Cancer Data Base (NCDB) was queried for primary IC cases (2004-2013) receiving CT alone or CRT. Patients undergoing resection or not receiving CT were excluded, as were those with M1 disease or unknown M classification. Logistic regression analysis ascertained factors associated with CRT administration. Kaplan-Meier analysis evaluated overall survival (OS) between both groups. Cox proportional hazards modeling assessed variables associated with OS. Results: In total, 2,842 patients were analyzed [n=666 (23%) CRT, n=2,176 (77%) CT]. CRT was less likely delivered at community centers, in more recent time periods (2009-2013), to older patients, and in certain geographic locations. Median OS in the CRT and CT groups were 13.6 vs. 10.5 months, respectively (P<0.001). On multivariate analysis, poorer OS was associated with age, male gender, increased comorbidities, treatment at a community center, and treatment at earlier time periods (2004-2008) (P<0.05 for all). Notably, receipt of CRT independently predicted for improved OS (P<0.001). Conclusions: As compared to CT alone, CRT was independently associated with improved survival in unresected IC. These findings support a randomized trial evaluating this question that is currently accruing.Item Effectiveness and safety of camrelizumab-containing neoadjuvant therapy in patients with esophageal squamous cell carcinoma: a prospective multicenter observational cohort study(AME, 2023) Zhang, Yi; Shen, Guoyi; Xu, Rongyu; Huang, Guozhong; Huang, Zhijun; Duan, Hongbing; Yang, Shengsheng; Zheng, Qingfeng; Yang, Libao; Liu, Rongxing; Ma, Liangyun; Chen, Shaogeng; Yi, Yunfeng; Zhang, Zheming; Li, Kezhi; Birdas, Thomas J.; Koyanagi, Kazuo; Simone, Charles B., II; Surgery, School of MedicineBackground: Camrelizumab has been demonstrated to be a feasible treatment option for locally advanced esophageal squamous cell carcinoma (ESCC) when combined with neoadjuvant chemotherapy. This trial was conducted to investigate the effectiveness and safety of camrelizumab-containing neoadjuvant therapy in patients with ESCC in daily practice. Methods: This prospective multicenter observational cohort study was conducted at 13 tertiary hospitals in Southeast China. Patients with histologically or cytologically confirmed ESCC [clinical tumor-node-metastasis (cTNM) stage I-IVA] who had received at least one dose of camrelizumab-containing neoadjuvant therapy were eligible for inclusion. Results: Between June 1, 2020 and July 13, 2022, 255 patients were enrolled and included. The median age was 64 (range, 27 to 82) years. Most participants were male (82.0%) and had clinical stage III-IVA diseases (82.4%). A total of 169 (66.3%) participants underwent surgical resection; 146 (86.4%) achieved R0 resection, and 36 (21.3%) achieved pathological complete response (pCR). Grades 3-5 adverse events (AEs) were experienced by 14.5% of participants. Reactive cutaneous capillary endothelial proliferation occurred in 100 (39.2%) of participants and all were grade 1 or 2. Conclusions: Camrelizumab-containing neoadjuvant therapy has acceptable effectiveness and safety profiles in real-life ESCC patients.Item Understanding High-Dose, Ultra-High Dose-Rate and , Spatially Fractionated Radiotherapy(Elsevier, 2020) Griffin, Robert J.; Ahmed, Mansoor M.; Amendola, Beatriz; Belyakov, Oleg; Bentzen, Søren M.; Butterworth, Karl T.; Chang, Sha; Coleman, C. Norman; Djonov, Valentin; Formenti, Sylvia C.; Glatstein, Eli; Guha, Chandan; Kalnicki, Shalom; Le, Quynh-Thu; Loo, Billy W., Jr.; Mahadevan, Anand; Massaccesi, Mariangela; Maxim, Peter G.; Mohiuddin, Majid; Mohiuddin, Mohammed; Mayr, Nina A.; Obcemea, Ceferino; Petersson, Kristoffer; Regine, William; Roach, Mack; Romanelli, Pantaleo; Simone, Charles B., II; Snider, James W.; Spitz, Douglas; Vikram, Bhadrasain; Vozenin, Marie-Catherine; Abdel-Wahab, May; Welsh, James; Wu, Xiaodong; Limoli, Charles L.; Radiation Oncology, School of MedicineThe National Cancer Institute’s Radiation Research Program in collaboration with the Radiosurgery Society hosted a workshop on Understanding High-Dose, Ultra-High Dose rate and Spatially Fractionated Radiotherapy on August 20-21, 2018 to bring together experts in experimental and clinical experience in these and related fields. Critically, the overall aims were to understand the biological underpinning of these emerging techniques and the technical/physical parameters that must be further defined to drive clinical practice through innovative biologically-based clinical trials.