The aim of this retrospective study was to describe more than 10 years experience of a single Trauma Center about non operative management of abdominal organ injuries in hemodynamically stable patients MATERIAL OF STUDY: Between January 2001 and December 2014 ,732 consecutive patients were admitted with blunt abdominal trauma, involving liver and/or spleen and/or kidney, at the Bufalini Cesena Hospital .Management of patients included a specific institutional developed protocol :hemodynamic stability was evaluated in shock room according to the patients response to fluid challenge and the patients were classified into three categories A,B,and C.Form 732 Trauma, 356(48.6%) of patients were submitted to a surgical procedure, all the other patient 376(51.4%) underwent an non operative management .Overall mortality was 9.8% (72), mortality in the surgery group was 15.4% eheras in the non operative group was 4.5%; the relative risk of mortality, measured by the odds ratio waith a 95% confidence interval, was 3.417(2.023-5.772) for rhe surgery group; patient over 40 years old has a statistically significant higher mortality.In our series the overall mortality rate of non operative management group was 4.5%, instead in unstable patients, the surgery group, the mortality was 15.3%; the overall mortality mortality rate after the application of our protocol is 9.8%, Although surgery continues to be the standard for hemodically unstable patients with blunt hepatic and splenic trauma. In our experience AAST Organ Injury Scale was useless for the therapeutic decision making process after the CT scan if a source of bleeding was detected and immediate angiography was performed in order to control and solve it.In our experience the AAST Organ Injury Scale was useless for the therapeutic decision making process, The results suggest that the only criteria of choice for therapeutici strategy was the hemodynamic stability, Nonoperative managem,ent can be applied only following strict institutional criteria KEY WORDS: Hemodynmic stability, Nonoperative management, Trauma.Tra gennaio 2001 e dicembre 2014 sono stati reclutati consecutivamente 732 pazienti ricoverati per trauma addominale all’Ospedale Bufalini di Cesena, sede di Trauma Center. I pazienti sono stati suddivisi in due gruppi a seconda che abbiano ricevuto un trattamento non operativo o chirurgico; quindi sono stati classificati in tre categorie a seconda della risposta emodinamica.I pazienti che sono stati sottoposti ad intervento chirurgico sono il 48.6% e il restante 51.4% sono stati sottoposti a TNO. La mortalità complessiva è stata del 9.8% mentre nel gruppo dei pazienti operati era del 15,4% a fronte del 4,5% nel gruppo del trattamento non operativo e vi è stata una differenza statisticamente significativa tra i due gruppi nel rischio relativo di mortalità. I pazienti che non è stato possibile trattare non operativamente hanno avuto un rischio di mortalità relativa aumentato del 3,4%, mentre scomposto per organo è stato del 4,8% per i traumi epatici e del 1,7 per i traumi splenici con un intervallo di confidenza del 95%.La chirurgia resta quindi lo standard per i pazienti emodinamicamente instabili, mentre il TNO viene considerato il trattamento di scelta per i pazienti emodinamicamente stabili o transient responders con un trauma epatico o splenico. Riuscire a trattare non operativamente questi pazienti, sulla base di corrette indicazioni e con procedure codificate e condivise all’interno del Trauma Center riduce in maniera statisticamente significativa il rischio di mortalità relativo.
BACKGROUNDThe TOPAZ-1 phase III trial demonstrated a survival advantage with durvalumab, an anti-programmed death cell ligand 1 (anti-PD-L1), when used with gemcitabine and cisplatin for patients with advanced biliary tract cancer. In order to gain a broader understanding of the efficacy and tolerability of this new combination in a real-world setting we performed a worldwide multicenter retrospective analysis to investigate the efficacy and safety of this new first-line standard treatment.METHODSThe analyzed population included patients with unresectable, locally advanced or metastatic adenocarcinoma of the biliary tract treated with durvalumab in combination with gemcitabine and cisplatin at 39 sites from 11 countries in Europe, United States, and Asia. The primary endpoint of the study was overall survival (OS).
Abstract This retrospective study shows the results of a 2 years application of a clinical pathway concerning the indications to NOM based on the patient's hemodynamic answer instead of on the injury grade of the lesions. We conducted a retrospective study applied on a patient's cohort, admitted in “Azienda Ospedaliero-Universitaria Ospedali Riuniti of Ancona” and in the Digestive and Emergency Surgery Department of the Santa Maria of Terni hospital between September 2015 and December 2017, all affected by blunt abdominal trauma, involving liver, spleen or both of them managed conservatively. Patients were divided into 3 main groups according to their hemodynamic response to a fluid administration: stable (group A), transient responder (group B) and unstable (group C). Management of patients was performed according to specific institutional pathway, and only patients from category A and B were treated conservatively regardless of the injury grade of lesions. From October 2015 to December 2017, a total amount of 111 trauma patients were treated with NOM. Each patient underwent CT scan at his admission. No contrast pooling was found in 50 pts. (45.04%). Contrast pooling was found in 61 patients (54.95%). The NOM overall outcome resulted in success in 107 patients (96.4%). NOM was successful in 100% of cases of liver trauma patients and was successful in 94.7% of splenic trauma patients (72/76). NOM failure occurred in 4 patients (5.3%) treated for spleen injuries. All these patients received splenectomy: in 1 case to treat pseudoaneurysm, (AAST, American Association for the Surgery of Trauma, grade of injury II), in 2 cases because of re-bleeding (AAST grade of injury IV) and in the remaining case was necessary to stop monitoring spleen because the patient should undergo to orthopedic procedure to treat pelvis fracture (AAST grade of injury II). Non-operative management for blunt hepatic and splenic lesions in stable or stabilizable patients seems to be the choice of treatment regardless of the grade of lesions according to the AAST Organ Injury Scale.
The aim of this retrospective proof-of-concept study was to compare different second-line treatments for patients with hepatocellular carcinoma and progressive disease (PD) after first-line lenvatinib or atezolizumab plus bevacizumab.A total of 1381 patients had PD at first-line therapy. 917 patients received lenvatinib as first-line treatment, and 464 patients atezolizumab plus bevacizumab as first-line.49.6% of PD patients received a second-line therapy without any statistical difference in overall survival (OS) between lenvatinib (20.6months) and atezolizumab plus bevacizumab first-line (15.7months; p = 0.12; hazard ratio [HR]= 0.80). After lenvatinib first-line, there wasn't any statistical difference between second-line therapy subgroups (p = 0.27; sorafenib HR: 1; immunotherapy HR: 0.69; other therapies HR: 0.85). Patients who underwent trans-arterial chemo-embolization (TACE) had a significative longer OS than patients who received sorafenib (24.7 versus 15.8months, p < 0.01; HR=0.64). After atezolizumab plus bevacizumab first-line, there was a statistical difference between second-line therapy subgroups (p < 0.01; sorafenib HR: 1; lenvatinib HR: 0.50; cabozantinib HR: 1.29; other therapies HR: 0.54). Patients who received lenvatinib (17.0months) and those who underwent TACE (15.9months) had a significative longer OS than patients treated with sorafenib (14.2months; respectively, p = 0.01; HR=0.45, and p < 0.05; HR=0.46).Approximately half of patients receiving first-line lenvatinib or atezolizumab plus bevacizumab access second-line treatment. Our data suggest that in patients progressed to atezolizumab plus bevacizumab, the systemic therapy able to achieve the longest survival is lenvatinib, while in patients progressed to lenvatinib, the systemic therapy able to achieve the longest survival is immunotherapy.
Introduction: The TOPAZ-1 phase III trial showed a survival benefit with durvalumab plus gemcitabine and cisplatin in patients with advanced biliary tract cancer (BTC). To understand this combination's real-world efficacy and tolerability, we conducted a retrospective analysis of its first-line treatment outcomes. Methods: We included patients with unresectable, locally advanced, or metastatic BTC treated with cisplatin, gemcitabine plus durvalumab. The primary endpoint was overall survival (OS). RESULTS: 33 patients were enrolled. Median OS was NR and median PFS was 7.6 months, after a median follow up of 13.5 months. The investigator-assessed overall response rate was 34.5 %, with stable disease in 53.0 % of patients. High baseline CEA levels were associated with poor survival. Any grade adverse events (AEs) occurred in 97 % of patients. Immune-related AEs (irAEs) occurred in 16 % (grade >2: 6 %). Presence of TP53 mutation was related to a worse OS, conversely the presence of ARID1A genomic alteration was related to a better PFS. A tendence toward a better OS was found for BRCAness patients which did not reach the statistical significance. On the other hand, BRCAness patients showed significantly higher PFS compared to no BRCAness patients Conclusion: This real-world analysis largely confirmed the TOPAZ-1 findings, supporting gemcitabine, cisplatin, and durvalumab as a first-line standard of care for patients with advanced BTC.
Abstract Purpose: Neuroendocrine carcinomas (NECs) are a rare subgroup of neuroendocrine neoplasms that occasionally originate from gastro-entero-pancreatic (GEP) tract. Evidence of the effectiveness of chemotherapy is scarce. Platinum plus Etoposide regimens are currently the standard treatment in first-line, while little data are available on second-line treatments. The aim of this study is to evaluate the efficacy and safety of Irinotecan (IRI)-based chemotherapy in a series of extrapulmonary NECs. Methods: Patients with NEC diagnosis treated at University Hospitals of Modena, Florence, Pisa, and European Institute of Oncology of Milan with an IRI-based regimen (FOLFIRI or XELIRI) after progression to a first-line platinum-based therapy were enrolled. Objective responses were assessed according to RECIST criteria. Progression-free survival (PFS) and overall survival (OS) were calculated. Results: 34 patients, 16 males, and 18 females, median age of 59 years (range 32-77), with metastatic NEC were included. Twenty-seven pts had Ki-67 ≥ 55% and 4 pts Ki-67 of < 55% (for 3 pts data was not available). The median number of treatment cycles of the IRI-based regimen was 7.5 (range 1-16). Six partial responses (17.6%) and 9 stable diseases (26.5%) were observed, with a disease control rate of 44.1%. Median PFS and OS were 4.4 and 5.9 months, respectively. Neutropenia, anemia, and nausea were the only G3-G4 toxicities reported. Conclusion: Despite the relatively small sample size, IRI-based therapy demonstrated to be a valid option for patients with pre-treated extrapulmonary NEC.
