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1.
Ann Surg ; 277(4): 664-671, 2023 04 01.
Article in English | MEDLINE | ID: mdl-35766422

ABSTRACT

OBJECTIVE: To evaluate the effect of a liver transplantation (LT) program on the outcomes of resectable hepatocellular carcinoma (HCC). BACKGROUND: Surgical treatment of HCC includes both hepatic resection (HR) and LT. However, the presence of cirrhosis and the possibility of recurrence make the management of this disease complex and probably different according to the presence of a LT program. METHODS: Patients undergoing HR for HCC between January 2005 and December 2019 were identified from a national database of HCC. The main study outcomes were major surgical complications according to the Comprehensive Complication Index, posthepatectomy liver failure (PHLF), 90-day mortality, overall survival, and disease-free survival. Secondary outcomes were salvage liver transplantation (SLT) and postrecurrence survival. RESULTS: A total of 3202 patients were included from 25 hospitals over the study period. Three of 25 (12%) had an LT program. The presence of an LT program within a center was associated with a reduced probability of PHLF (odds ratio=0.38) but not with overall survival and disease-free survival. There was an increased probability of SLT when HR was performed in a transplant hospital (odds ratio=12.05). Among transplant-eligible patients, those who underwent LT had a significantly longer postrecurrence survival. CONCLUSIONS: This study showed that the presence of a LT program was associated with decreased PHLF rates and an increased probability to receive SLT in case of recurrence.


Subject(s)
Carcinoma, Hepatocellular , Liver Failure , Liver Neoplasms , Liver Transplantation , Humans , Carcinoma, Hepatocellular/surgery , Liver Cirrhosis/complications , Liver Failure/complications , Neoplasm Recurrence, Local/epidemiology , Retrospective Studies
2.
HPB (Oxford) ; 25(10): 1223-1234, 2023 10.
Article in English | MEDLINE | ID: mdl-37357112

ABSTRACT

BACKGROUND: Despite second-line transplant(SLT) for recurrent hepatocellular carcinoma(rHCC) leads to the longest survival after recurrence(SAR), its real applicability has never been reported. The aim was to compare the SAR of SLT versus repeated hepatectomy and thermoablation(CUR group). METHODS: Patients were enrolled from the Italian register HE.RC.O.LE.S. between 2008 and 2021. Two groups were created: CUR versus SLT. A propensity score matching (PSM) was run to balance the groups. RESULTS: 743 patients were enrolled, CUR = 611 and SLT = 132. Median age at recurrence was 71(IQR 6575) years old and 60(IQR 53-64, p < 0.001) for CUR and SLT respectively. After PSM, median SAR for CUR was 43 months(95%CI = 37 - 93) and not reached for SLT(p < 0.001). SLT patients gained a survival benefit of 9.4 months if compared with CUR. MilanCriteria(MC)-In patients were 82.7% of the CUR group. SLT(HR 0.386, 95%CI = 0.23 - 0.63, p < 0.001) and the MELD score(HR 1.169, 95%CI = 1.07 - 1.27, p < 0.001) were the only predictors of mortality. In case of MC-Out, the only predictor of mortality was the number of nodules at recurrence(HR 1.45, 95%CI= 1.09 - 1.93, p = 0.011). CONCLUSION: It emerged an important transplant under referral in favour of repeated hepatectomy or thermoablation. In patients with MC-Out relapse, the benefit of SLT over CUR was not observed.


Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Liver Transplantation , Humans , Hepatectomy/adverse effects , Liver Transplantation/adverse effects , Retrospective Studies , Neoplasm Recurrence, Local , Salvage Therapy
3.
Ann Surg ; 275(4): 743-752, 2022 04 01.
Article in English | MEDLINE | ID: mdl-35081572

ABSTRACT

OBJECTIVE: The aim of the study was to compare SURG vs SOR regarding the OS and progression-free survival (PFS) in a real-world clinical scenario. BACKGROUND DATA: The treatment for advanced nonmetastatic HCC belonging to the Barcelona Clinic Liver Cancer stage C (BCLC C) is still controversial. METHODS: BCLC C patients without extrahepatic spread and tumoral invasion of the main portal trunk were considered. Surgical patients were obtained from the HE.RC.O.LE.S. Register, whereas sorafenib patients were obtained from the ITA.LI.CA register The inverse probability weighting (IPW) method was adopted to balance the confounders between the 2 groups. RESULTS: Between 2008 and 2019, 478 patients were enrolled: 303 in SURG and 175 in SOR group. Eastern Cooperative Oncological Group Performance Status (ECOG-PS), presence of cirrhosis, steatosis, Child-Pugh grade, hepatitis B virus and hepatitis C virus, alcohol intake, collateral veins, bilobar disease, localization of the tumor thrombus, number of nodules, alpha-fetoprotein, age, and Charlson Comorbidity index were weighted by IPW to create two balanced pseudo-populations: SURG = 374 and SOR = 263. After IPW, 1-3-5 years OS was 83.6%, 68.1%, 55.9% for SURG, and 42.3%, 17.8%, 12.8% for SOR (P < 0.001). Similar trends were observed after subgrouping patients by ECOG-PS = 0 and ECOG-PS >0, and by the intrahepatic location of portal vein invasion. At Cox regression, sorafenib treatment (hazard ratio 4.436; 95% confidence interval 3.19-6.15; P < 0.001) and Charlson Index (hazard ratio 1.162; 95% confidence interval 1.06-1.27; P = 0.010) were the only independent predictors of mortality. PFS at 1-3-5 years were 65.9%, 40.3%, 24.3% for SURG and 21.6%, 3.5%, 2.9% for SOR (P = 0.007). CONCLUSIONS: In BCLC C patients without extrahepatic spread but with intrahepatic portal invasion, liver resection, if feasible, was followed by better OS and PFS compared with sorafenib.


Subject(s)
Antineoplastic Agents , Carcinoma, Hepatocellular , Liver Neoplasms , Antineoplastic Agents/therapeutic use , Carcinoma, Hepatocellular/drug therapy , Carcinoma, Hepatocellular/pathology , Carcinoma, Hepatocellular/surgery , Hepatectomy , Humans , Liver Neoplasms/drug therapy , Liver Neoplasms/pathology , Liver Neoplasms/surgery , Neoplasm Staging , Niacinamide/therapeutic use , Phenylurea Compounds/therapeutic use , Retrospective Studies , Sorafenib/therapeutic use , Treatment Outcome
4.
HPB (Oxford) ; 24(8): 1291-1304, 2022 08.
Article in English | MEDLINE | ID: mdl-35125292

ABSTRACT

BACKGROUND: We aimed to evaluate, in a large Western cohort, perioperative and long-term oncological outcomes of salvage hepatectomy (SH) for recurrent hepatocellular carcinoma (rHCC) after primary hepatectomy (PH) or locoregional treatments. METHODS: Data were collected from the Hepatocarcinoma Recurrence on the Liver Study Group (He.RC.O.Le.S.) Italian Registry. After 1:1 propensity score-matched analysis (PSM), two groups were compared: the PH group (patients submitted to resection for a first HCC) and the SH group (patients resected for intrahepatic rHCC after previous HCC-related treatments). RESULTS: 2689 patients were enrolled. PH included 2339 patients, SH 350. After PSM, 263 patients were selected in each group with major resected nodule median size, intraoperative blood loss and minimally invasive approach significantly lower in the SH group. Long-term outcomes were compared, with no difference in OS and DFS. Univariate and multivariate analyses revealed only microvascular invasion as an independent prognostic factor for OS. CONCLUSION: SH proved to be equivalent to PH in terms of safety, feasibility and long-term outcomes, consistent with data gathered from East Asia. In the awaiting of reliable treatment-allocating algorithms for rHCC, SH appears to be a suitable alternative in patients fit for surgery, regardless of the previous therapeutic modality implemented.


Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Carcinoma, Hepatocellular/pathology , Hepatectomy/adverse effects , Humans , Liver Neoplasms/pathology , Neoplasm Recurrence, Local/pathology , Propensity Score , Retrospective Studies , Treatment Outcome
5.
HPB (Oxford) ; 24(8): 1365-1375, 2022 08.
Article in English | MEDLINE | ID: mdl-35293320

ABSTRACT

BACKGROUND: Benchmark analysis for open liver surgery for cirrhotic patients with hepatocellular carcinoma (HCC) is still undefined. METHODS: Patients were identified from the Italian national registry HE.RC.O.LE.S. The Achievable Benchmark of Care (ABC) method was employed to identify the benchmarks. The outcomes assessed were the rate of complications, major comorbidities, post-operative ascites (POA), post-hepatectomy liver failure (PHLF), 90-day mortality. Benchmarking was stratified for surgical complexity (CP1, CP2 and CP3). RESULTS: A total of 978 of 2698 patients fulfilled the inclusion criteria. 431 (44.1%) patients were treated with CP1 procedures, 239 (24.4%) with CP2 and 308 (31.5%) with CP3 procedures. Patients submitted to CP1 had a worse underlying liver function, while the tumor burden was more severe in CP3 cases. The ABC for complications (13.1%, 19.2% and 28.1% for CP1, CP2 and CP3 respectively), major complications (7.6%, 11.1%, 12.5%) and 90-day mortality (0%, 3.3%, 3.6%) increased with the surgical difficulty, but not POA (4.4%, 3.3% and 2.6% respectively) and PHLF (0% for all groups). CONCLUSION: We propose benchmarks for open liver resections in HCC cirrhotic patients, stratified for surgical complexity. The difference between the benchmark values and the results obtained during everyday practice reflects the room for potential growth, with the aim to encourage constant improvement among liver surgeons.


Subject(s)
Carcinoma, Hepatocellular , Liver Failure , Liver Neoplasms , Benchmarking , Hepatectomy/adverse effects , Hepatectomy/methods , Humans , Liver Cirrhosis/complications , Liver Cirrhosis/pathology , Liver Cirrhosis/surgery , Liver Failure/etiology , Liver Neoplasms/complications , Liver Neoplasms/surgery , Postoperative Complications , Retrospective Studies
6.
HPB (Oxford) ; 23(6): 889-898, 2021 06.
Article in English | MEDLINE | ID: mdl-33144053

ABSTRACT

BACKGROUND: Management of recurrence after surgery for hepatocellular carcinoma (rHCC) is still a debate. The aim was to compare the Survival after Recurrence (SAR) of curative (surgery or thermoablation) versus palliative (TACE or Sorafenib) treatments for patients with rHCC. METHODS: This is a multicentric Italian study, which collected data between 2007 and 2018 from 16 centers. Selected patients were then divided according to treatment allocation in Curative (CUR) or Palliative (PAL) Group. Inverse Probability Weighting (IPW) was used to weight the groups. RESULTS: 1,560 patients were evaluated, of which 421 experienced recurrence and were then eligible: 156 in CUR group and 256 in PAL group. Tumor burden and liver function were weighted by IPW, and two pseudo-population were obtained (CUR = 397.5 and PAL = 415.38). SAR rates at 1, 3 and 5 years were respectively 98.3%, 76.7%, 63.8% for CUR and 91.7%, 64.2% and 48.9% for PAL (p = 0.007). Median DFS was 43 months (95%CI = 32-74) for CUR group, while it was 23 months (95%CI = 18-27) for PAL (p = 0.017). Being treated by palliative approach (HR = 1.75; 95%CI = 1.14-2.67; p = 0.01) and having a median size of the recurrent nodule>5 cm (HR = 1.875; 95%CI = 1.22-2.86; p = 0.004) were the only predictors of mortality after recurrence, while time to recurrence was the only protective factor (HR = 0.616; 95%CI = 0.54-0.69; p<0.001). CONCLUSION: Curative approaches may guarantee long-term survival in case of recurrence.


Subject(s)
Carcinoma, Hepatocellular , Chemoembolization, Therapeutic , Liver Neoplasms , Carcinoma, Hepatocellular/therapy , Humans , Liver Neoplasms/therapy , Neoplasm Recurrence, Local/therapy , Palliative Care , Retrospective Studies , Treatment Outcome
7.
Ann Surg ; 272(5): 840-846, 2020 11.
Article in English | MEDLINE | ID: mdl-32889868

ABSTRACT

OBJECTIVE: The aim of this study was to evaluate correlation between centers' volume and incidence of failure to rescue (FTR) following liver resection for hepatocellular carcinoma (HCC). SUMMARY BACKGROUND DATA: FTR, defined as the probability of postoperative death among patients with major complication, has been proposed to assess quality of care during hospitalization. Perioperative management is challenging in cirrhotic patients and the ability to recognize and treat a complication may be fundamental to rescue patients from the risk of death. METHODS: Patients undergoing liver resection for HCC between 2008 and 2018 in 18 Centers enrolled in the He.Rc.O.Le.S. Italian register. Early results included major complications (Clavien ≥3), 90-day mortality, and FTR and were analyzed according to center's volume. RESULTS: Among 1935 included patients, major complication rate was 9.4% (8.6%, 12.3%, and 7.0% for low-, intermediate- and high-volume centers, respectively, P = 0.001). Ninety-day mortality rate was 2.6% (3.7%, 4.2% and 0.9% for low-, intermediate- and high-volume centers, respectively, P < 0.001). FTR was significantly higher at low- and intermediate-volume centers (28.6% and 26.5%, respectively) than at high-volume centers (6.1%, P = 0.002). Independent predictors for major complications were American Society of Anesthesiologists (ASA) >2, portal hypertension, intraoperative blood transfusions, and center's volume. Independent predictors for 90-day mortality were ASA >2, Child-Pugh score B, BCLC stage B-C, and center's volume. Center's volume and BCLC stage were strongly associated with FTR. CONCLUSIONS: Risk of major complications and mortality was related with comorbidities, cirrhosis severity, and complexity of surgery. These factors were not correlated with FTR. Center's volume was the only independent predictor related with severe complications, mortality, and FTR.


Subject(s)
Carcinoma, Hepatocellular/surgery , Failure to Rescue, Health Care , Hospitals, High-Volume , Hospitals, Low-Volume , Liver Neoplasms/surgery , Adult , Aged , Aged, 80 and over , Carcinoma, Hepatocellular/mortality , Comorbidity , Female , Hepatectomy , Hospital Mortality , Humans , Italy , Liver Neoplasms/mortality , Male , Middle Aged , Postoperative Complications/mortality , Registries , Risk Factors
9.
Updates Surg ; 75(4): 931-940, 2023 Jun.
Article in English | MEDLINE | ID: mdl-36571661

ABSTRACT

Italian Research Group for Gastric Cancer (GIRCG), during the 2013 annual Consensus Conference to gastric cancer, stated that laparoscopic or robotic approach should be limited only to early gastric cancer (EGC) and no further guidelines were currently available. However, accumulated evidences, mainly from eastern experiences, have supported the application of minimally invasive surgery also for locally advanced gastric cancer (AGC). The aim of our study is to give a snapshot of current surgical propensity of expert Italian upper gastrointestinal surgeons in performing minimally invasive techniques for the treatment of gastric cancer in order to answer to the question if clinical practice overcome the recommendation. Experts in the field among the Italian Research Group for Gastric Cancer (GIRCG) were invited to join a web 30-item survey through a formal e-mail from January 1st, 2020, to June 31st, 2020. Responses were collected from 46 participants out of 100 upper gastrointestinal surgeons. Percentage of surgeons choosing a minimally invasive approach to treat early and advanced gastric cancer was similar. Additionally analyzing data from the centers involved, we obtained that the percentage of minimally invasive total and partial gastrectomies in advanced cases augmented with the increase of surgical procedures performed per year (p = 0.02 and p = 0.04 respectively). It is reasonable to assume that there is a widening of indications given by the current national guideline into clinical practice. Propensity of expert Italian upper gastrointestinal surgeons was to perform minimally invasive surgery not only for early but also for advanced gastric cancer. Of interest volume activity correlated with the propensity of surgeons to select a minimally invasive approach.


Subject(s)
Laparoscopy , Robotic Surgical Procedures , Stomach Neoplasms , Humans , Stomach Neoplasms/surgery , Gastrectomy/methods , Surveys and Questionnaires , Minimally Invasive Surgical Procedures/methods , Robotic Surgical Procedures/methods , Laparoscopy/methods
10.
JAMA Surg ; 158(2): 192-202, 2023 02 01.
Article in English | MEDLINE | ID: mdl-36576813

ABSTRACT

Importance: Clear indications on how to select retreatments for recurrent hepatocellular carcinoma (HCC) are still lacking. Objective: To create a machine learning predictive model of survival after HCC recurrence to allocate patients to their best potential treatment. Design, Setting, and Participants: Real-life data were obtained from an Italian registry of hepatocellular carcinoma between January 2008 and December 2019 after a median (IQR) follow-up of 27 (12-51) months. External validation was made on data derived by another Italian cohort and a Japanese cohort. Patients who experienced a recurrent HCC after a first surgical approach were included. Patients were profiled, and factors predicting survival after recurrence under different treatments that acted also as treatment effect modifiers were assessed. The model was then fitted individually to identify the best potential treatment. Analysis took place between January and April 2021. Exposures: Patients were enrolled if treated by reoperative hepatectomy or thermoablation, chemoembolization, or sorafenib. Main Outcomes and Measures: Survival after recurrence was the end point. Results: A total of 701 patients with recurrent HCC were enrolled (mean [SD] age, 71 [9] years; 151 [21.5%] female). Of those, 293 patients (41.8%) received reoperative hepatectomy or thermoablation, 188 (26.8%) received sorafenib, and 220 (31.4%) received chemoembolization. Treatment, age, cirrhosis, number, size, and lobar localization of the recurrent nodules, extrahepatic spread, and time to recurrence were all treatment effect modifiers and survival after recurrence predictors. The area under the receiver operating characteristic curve of the predictive model was 78.5% (95% CI, 71.7%-85.3%) at 5 years after recurrence. According to the model, 611 patients (87.2%) would have benefited from reoperative hepatectomy or thermoablation, 37 (5.2%) from sorafenib, and 53 (7.6%) from chemoembolization in terms of potential survival after recurrence. Compared with patients for which the best potential treatment was reoperative hepatectomy or thermoablation, sorafenib and chemoembolization would be the best potential treatment for older patients (median [IQR] age, 78.5 [75.2-83.4] years, 77.02 [73.89-80.46] years, and 71.59 [64.76-76.06] years for sorafenib, chemoembolization, and reoperative hepatectomy or thermoablation, respectively), with a lower median (IQR) number of multiple recurrent nodules (1.00 [1.00-2.00] for sorafenib, 1.00 [1.00-2.00] for chemoembolization, and 2.00 [1.00-3.00] for reoperative hepatectomy or thermoablation). Extrahepatic recurrence was observed in 43.2% (n = 16) for sorafenib as the best potential treatment vs 14.6% (n = 89) for reoperative hepatectomy or thermoablation as the best potential treatment and 0% for chemoembolization as the best potential treatment. Those profiles were used to constitute a patient-tailored algorithm for the best potential treatment allocation. Conclusions and Relevance: The herein presented algorithm should help in allocating patients with recurrent HCC to the best potential treatment according to their specific characteristics in a treatment hierarchy fashion.


Subject(s)
Carcinoma, Hepatocellular , Chemoembolization, Therapeutic , Liver Neoplasms , Humans , Female , Aged , Male , Carcinoma, Hepatocellular/surgery , Carcinoma, Hepatocellular/pathology , Sorafenib/therapeutic use , Liver Neoplasms/surgery , Liver Neoplasms/pathology , Retrospective Studies , Neoplasm Recurrence, Local/pathology , Hepatectomy
11.
Eur J Surg Oncol ; 48(1): 103-112, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34325939

ABSTRACT

BACKGROUND AND AIMS: We investigated the clinical impact of the newly defined metabolic-associated fatty liver disease (MAFLD) in patients undergoing hepatectomy for HCC (MAFLD-HCC) comparing the characteristics and outcomes of patients with MAFLD-HCC to viral- and alcoholic-related HCC (HCV-HCC, HBV-HCC, A-HCC). METHODS: A retrospective analysis of patients included in the He.RC.O.Le.S. Group registry was performed. The characteristics, short- and long-term outcomes of 1315 patients included were compared according to the study group before and after an exact propensity score match (PSM). RESULTS: Among the whole study population, 264 (20.1%) had MAFLD-HCC, 205 (15.6%) had HBV-HCC, 671 (51.0%) had HCV-HCC and 175 (13.3%) had A-HCC. MAFLD-HCC patients had higher BMI (p < 0.001), Charlson Comorbidities Index (p < 0.001), size of tumour (p < 0.001), and presence of cirrhosis (p < 0.001). After PSM, the 90-day mortality and severe morbidity rates were 5.9% and 7.1% in MAFLD-HCC, 2.3% and 7.1% in HBV-HCC, 3.5% and 11.7% in HCV-HCC, and 1.2% and 8.2% in A-HCC (p = 0.061 and p = 0.447, respectively). The 5-year OS and RFS rates were 54.4% and 37.1% in MAFLD-HCC, 64.9% and 32.2% in HBV-HCC, 53.4% and 24.7% in HCV-HCC and 62.0% and 37.8% in A-HCC (p = 0.345 and p = 0.389, respectively). Cirrhosis, multiple tumours, size and satellitosis seems to be the independent predictors of OS. CONCLUSION: Hepatectomy for MAFLD-HCC seems to have a higher but acceptable operative risk. However, long-term outcomes seems to be related to clinical and pathological factors rather than aetiological risk factors.


Subject(s)
Carcinoma, Hepatocellular/surgery , Hepatectomy , Hepatitis B, Chronic/complications , Hepatitis C, Chronic/complications , Liver Diseases, Alcoholic/complications , Liver Neoplasms/surgery , Neoplasms, Multiple Primary/surgery , Non-alcoholic Fatty Liver Disease/complications , Aged , Body Mass Index , Carcinoma, Hepatocellular/etiology , Comorbidity , Disease-Free Survival , Female , Humans , Liver Cirrhosis/complications , Liver Neoplasms/etiology , Male , Middle Aged , Neoplasms, Multiple Primary/etiology , Propensity Score , Survival Rate , Tumor Burden
12.
J Gastrointest Surg ; 25(11): 2823-2834, 2021 11.
Article in English | MEDLINE | ID: mdl-33751404

ABSTRACT

BACKGROUND: Postoperative ascites (POA) is the most common complication after liver surgery for hepatocarcinoma (HCC), but its impact on survival is not reported. The aim of the study is to investigate its impact on overall survival (OS) and disease-free survival (DFS), and secondarily to identify the factors that may predict the occurrence. METHOD: Data were collected from 23 centers participating in the Italian Surgical HCC Register (HE.RC.O.LE.S. Group) between 2008 and 2018. POA was defined as ≥500 ml of ascites in the drainage after surgery. Survival analysis was conducted by the Kaplan Meier method. Risk adjustment analysis was conducted by Cox regression to investigate the risk factors for mortality and recurrence. RESULTS: Among 2144 patients resected for HCC, 1871(88.5%) patients did not experience POA while 243(11.5%) had the complication. Median OS for NO-POA group was not reached, while it was 50 months (95%CI = 41-71) for those with POA (p < 0.001). POA independently increased the risk of mortality (HR = 1.696, 95%CI = 1.352-2.129, p < 0.001). Relapse risk after surgery was not predicted by the occurrence of POA. Presence of varices (OR = 2.562, 95%CI = 0.921-1.822, p < 0.001) and bilobar disease (OR = 1.940, 95%CI = 0.921-1.822, p: 0.004) were predictors of POA, while laparoscopic surgery was protective (OR = 0.445, 95%CI = 0.295-0.668, p < 0.001). Ninety-day mortality was higher in the POA group (9.1% vs 1.9% in NO-POA group, p < 0.001). CONCLUSION: The occurrence of POA after surgery for HCC strongly increases the risk of long-term mortality and its occurrence is relatively frequent. More efforts in surgical planning should be made to limit its occurrence.


Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Ascites/epidemiology , Ascites/etiology , Carcinoma, Hepatocellular/surgery , Disease-Free Survival , Hepatectomy/adverse effects , Humans , Liver Neoplasms/surgery , Neoplasm Recurrence, Local/epidemiology , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies
13.
BMC Cancer ; 10: 567, 2010 Oct 19.
Article in English | MEDLINE | ID: mdl-20958992

ABSTRACT

BACKGROUND: This phase II study investigated efficacy and safety of weekly alternating Bevacizumab (BEV)/Irinotecan (CPT-11) or Oxaliplatin (OHP) associated to weekly 5-Fluorouracil (5-FU) in first line treatment of metastatic colorectal carcinoma (MCRC). METHODS: Simon two-step design: delta 20% (p0 50%, p1 70%), power 80%, α 5%, ß 20%. Projected objective responses (ORR): I step, 8/15 patients (pts); II step 26/43 pts. Schedule: weekly 12 h-timed-flat-infusion/5-FU 900 mg/m2, days 1-2, 8-9, 15-16, 22-23; CPT-11 160 mg/m2 plus BEV 5 mg/kg, days 1,15; OHP at three dose-levels, 60-70-80 mg/m2, days 8, 22; every 4 weeks. RESULTS: Fifty consecutive, unselected pts < 75 years were enrolled: median age 63; young-elderly (yE) 24 (48%); liver metastases (LM) 33 pts, 66% Achieved OHP recommended dose, 80 mg/m2. ORR 82% intent-to-treat and 84% as-treated analysis. Median progression-free survival 12 months. Equivalent efficacy was obtained in yE pts. Liver metastasectomies were performed in 26% of all pts and in 39% of pts with LM. After a median follow-up of 21 months, median overall survival was 28 months. Cumulative G3-4 toxicities per patient: diarrhea 28%, mucositis 6%, neutropenia 10%, hypertension 2%. They were equivalent in yE pts. Limiting toxicity syndromes (LTS), consisting of the dose-limiting toxicity, associated or not to G2 or limiting toxicities: 44% overall, 46% in yE. Multiple versus single site LTS, respectively: overall, 24% versus 20%; yE pts, 37.5% versus 8%. CONCLUSION: Poker combination shows high activity and efficacy in first line treatment of MCRC. It increases liver metastasectomies rate and can be safely administered. TRIAL REGISTRATION: Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (OsSC) Agenzia Italiana del Farmaco (AIFA) Numero EudraCT 2007-004946-34.


Subject(s)
Antibodies, Monoclonal/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Camptothecin/analogs & derivatives , Colorectal Neoplasms/drug therapy , Fluorouracil/administration & dosage , Organoplatinum Compounds/administration & dosage , Adult , Aged , Antibodies, Monoclonal, Humanized , Bevacizumab , Camptothecin/administration & dosage , Disease-Free Survival , Drug Administration Schedule , Humans , Irinotecan , Middle Aged , Neoplasm Metastasis , Oxaliplatin , Research Design , Time Factors , Treatment Outcome
14.
Cancers (Basel) ; 12(12)2020 Dec 21.
Article in English | MEDLINE | ID: mdl-33371419

ABSTRACT

BACKGROUND: We aimed to assess the ability of comprehensive complication index (CCI) and Clavien-Dindo complication (CDC) scale to predict excessive length of hospital stay (e-LOS) in patients undergoing liver resection for hepatocellular carcinoma. METHODS: Patients were identified from an Italian multi-institutional database and randomly selected to be included in either a derivation or validation set. Multivariate logistic regression models and ROC curve analysis including either CCI or CDC as predictors of e-LOS were fitted to compare predictive performance. E-LOS was defined as a LOS longer than the 75th percentile among patients with at least one complication. RESULTS: A total of 2669 patients were analyzed (1345 for derivation and 1324 for validation). The odds ratio (OR) was 5.590 (95%CI 4.201; 7.438) for CCI and 5.507 (4.152; 7.304) for CDC. The AUC was 0.964 for CCI and 0.893 for CDC in the derivation set and 0.962 vs. 0.890 in the validation set, respectively. In patients with at least two complications, the OR was 2.793 (1.896; 4.115) for CCI and 2.439 (1.666; 3.570) for CDC with an AUC of 0.850 and 0.673, respectively in the derivation cohort. The AUC was 0.806 for CCI and 0.658 for CDC in the validation set. CONCLUSIONS: When reporting postoperative morbidity in liver surgery, CCI is a preferable scale.

15.
Updates Surg ; 72(2): 399-411, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32170630

ABSTRACT

Liver surgery is the first line treatment for hepatocarcinoma. Hepatocarcinoma Recurrence on the Liver Study (HERCOLES) Group was established in 2018 with the goal to create a network of Italian centres sharing data and promoting scientific research on hepatocellular carcinoma (HCC) in the surgical field. This is the first national report that analyses the trends in surgical and oncological outcomes. Register data were collected by 22 Italian centres between 2008 and 2018. One hundred sixty-four variables were collected, regarding liver functional status, tumour burden, radiological, intraoperative and perioperative data, histological features and oncological follow-up. 2381 Patients were enrolled. Median age was 70 (IQR 63-75) years old. Cirrhosis was present in 1491 patients (62.6%), and Child-A were 89.9% of cases. HCC was staged as BCLC0-A in almost 50% of cases, while BCLC B and C were 20.7% and 17.9% respectively. Major liver resections were 481 (20.2%), and laparoscopy was employed in 753 (31.6%) cases. Severe complications occurred only in 5%. Postoperative ascites was recorded in 10.5% of patients, while posthepatectomy liver failure was observed in 4.9%. Ninety-day mortality was 2.5%. At 5 years, overall survival was 66.1% and disease-free survival was 40.9%. Recurrence was intrahepatic in 74.6% of cases. Redo-surgery and thermoablation for recurrence were performed up to 32% of cases. This is the most updated Italian report of the national experience in surgical treatment for HCC. This dataset is consistently allowing the participating centres in creating multicentric analysis which are already running with a very large sample size and strong power.


Subject(s)
Carcinoma, Hepatocellular/surgery , Datasets as Topic , Liver Neoplasms/surgery , Outcome Assessment, Health Care/methods , Aged , Carcinoma, Hepatocellular/epidemiology , Female , Hepatectomy/methods , Hepatectomy/trends , Humans , Italy/epidemiology , Laparoscopy/methods , Laparoscopy/trends , Liver Neoplasms/epidemiology , Male , Middle Aged , Neoplasm Recurrence, Local , Registries , Reoperation
16.
Ann Surg Oncol ; 14(12): 3443-52, 2007 Dec.
Article in English | MEDLINE | ID: mdl-17909918

ABSTRACT

INTRODUCTION: The purpose of this study was to analyze the postoperative pancreatic morbidity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of peritoneal surface malignancies (PSM). PATIENTS AND METHODS: Two hundred and sixty five patients (87M/178F) with PSM underwent 270 consecutive procedures. The mean age was 52 years (range: 22-79 years). CRS was performed using peritonectomy procedures. HIPEC through the closed abdomen technique was conducted using cisplatin (CDDP 25 mg/m2/L of perfusate)+mitomycin C (MMC 3.3 mg/m2/L of perfusate) or CDDP (43 mg/L of perfusate)+doxorubicin (Dx 15.25 mg/L of perfusate), at 42.5 degrees C. Diagnosis and classification of postoperative pancreatic fistula (POPF) were performed according to the international study group on pancreatic fistula criteria. Serum amylase alterations were graded according to the National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v3. RESULTS: POPF was observed in 13 (4.8%) cases. Three cases were classified as major (grade C). Two cases presented postoperative pancreatitis. G3-4 alteration of amylase was observed in 12.3% of the cases. Performing splenectomy and CDDP dosage for HIPEC >240 mg were proven to be independent risk factors for both G3-4 hyperamylasemia and POPF. CONCLUSIONS: CRS+HIPEC presented an acceptable rate of pancreatic morbidity which did not contribute to the mortality related to the procedure. Most of the POPF were mild and/or easily controlled by conservative measures. Although not specific a normal amylasemia could be a useful marker of pancreatic integrity after CRS+HIPEC.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Hyperamylasemia/etiology , Hyperthermia, Induced , Pancreatic Fistula/etiology , Peritoneal Neoplasms/drug therapy , Peritoneal Neoplasms/surgery , Postoperative Complications/etiology , Adult , Aged , Cisplatin/administration & dosage , Combined Modality Therapy , Doxorubicin/administration & dosage , Female , Humans , Hyperamylasemia/pathology , Infusions, Parenteral , Male , Middle Aged , Mitomycin/administration & dosage , Morbidity , Neoplasm Recurrence, Local , Pancreatic Fistula/pathology , Postoperative Complications/pathology , Treatment Outcome
17.
Clin Colorectal Cancer ; 11(2): 119-26, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22206922

ABSTRACT

BACKGROUND: Intensive medical treatment increases resection rate of liver metastases in patients with metastatic colorectal cancer (MCRC). The effectiveness of liver metastasectomies was evaluated in patients with MCRC who were treated with previously reported FIr-B/FOx (triplet chemotherapy plus bevacizumab). PATIENTS AND METHODS: Fifty patients with MCRC enrolled in the reported phase II study were classified according to involved metastatic sites (liver-only metastatic site, multiple metastatic sites) and the extent of liver metastases (single, multiple). Surgical resectability of liver metastases was evaluated at baseline and every 3 cycles of FIr-B/FOx treatment. The resection rate of liver metastases, activity, and efficacy were evaluated; progression-free survival (PFS) and overall survival (OS) were compared by using the log-rank test. RESULTS: Patients with liver MCRC were 33 of 50 consecutive unselected patients with MCRC: liver limited, 22 patients; multiple metastatic sites, 11 patients. Liver metastasectomies were performed in 13 patients: 26% of 50 patients with MCRC, 39% of 33 patients with liver MCRC. In patients with liver-only MCRC, a secondary liver surgery was performed in 54%: 6 of 9 single and 6 of 13 multiple liver metastases. Also, 1 liver and lung metastasectomy was performed. Pathologic complete responses were achieved in 2 patients (15%). The conversion rate of unresectable liver metastases was 83%. Objective response rate, PFS, OS were, respectively: 84%, 11 and 23 months in 33 liver MCRC; 86%, 17 and 44 months in 22 liver-limited patients. PFS and OS were significantly increased in patients with liver-limited metastases compared with multiple metastatic sites and single compared with multiple liver metastases. CONCLUSION: The FIr-B/FOx regimen may increase the resection rate of liver metastases and improve clinical outcome of patients with liver-only MCRC.


Subject(s)
Adenocarcinoma/surgery , Colonic Neoplasms/pathology , Liver Neoplasms/secondary , Liver Neoplasms/surgery , Metastasectomy/methods , Adenocarcinoma/drug therapy , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bevacizumab , Camptothecin/administration & dosage , Camptothecin/analogs & derivatives , Colonic Neoplasms/drug therapy , Colonic Neoplasms/surgery , Combined Modality Therapy , Disease-Free Survival , Female , Fluorouracil/administration & dosage , Hepatectomy , Humans , Irinotecan , Liver Neoplasms/mortality , Male , Middle Aged , Organoplatinum Compounds/administration & dosage , Oxaliplatin , Treatment Outcome
18.
Liver Transpl ; 12(3): 402-10, 2006 Mar.
Article in English | MEDLINE | ID: mdl-16598843

ABSTRACT

A specific split liver transplantation (SLT) program has been pursued in the North Italian Transplant program (NITp) since November 1997. After 5 yr, 1,449 liver transplants were performed in 7 transplant centers, using 1,304 cadaveric donors. Whole liver transplantation (WLT) and SLT were performed in 1,126 and 323 cases, respectively. SLTs were performed in situ as 147 left lateral segments (LLS), 154 right trisegment liver (RTL) grafts, and 22 modified split livers (MSL), used for couples of adult recipients. After a median posttransplant follow-up of 22 months, SLTs achieved a 3-yr patient and graft survival not significantly different from the entire series of transplants (79.4 and 72.2% vs. 80.6 and 74.9%, respectively). Recipients receiving a WLT or a LLS showed significantly better outcomes than patients receiving RTL and MSL (P < 0.03 for patients and P < 0.04 for graft survival). At the multivariate analysis, donor age of >60 yr, RTL transplant, <50 annual transplants volume, urgent transplantation (United Network for Organ Sharing (UNOS) status I and IIA), ischemia time of >7 hours, and retransplantation were factors independently related to graft failure and to significantly worst patient survival. Right grafts procured from RTL and either split procured as MSL had a similar outcome of marginal whole livers. In conclusion, in 5 yr, the increased number of pediatric transplants due to split liver donation reduced to 3% the in-list children mortality, and a decrease in the adult patient dropout rate from 27.2 to 16.2% was observed. Such results justify a more widespread adoption of SLT protocols, organizational difficulties not being a limit for the application of such technique.


Subject(s)
Liver Transplantation/adverse effects , Liver Transplantation/methods , Postoperative Complications/mortality , Tissue and Organ Procurement , Adult , Analysis of Variance , Cohort Studies , Female , Graft Rejection , Graft Survival , Humans , Italy , Liver Failure/diagnosis , Liver Failure/mortality , Liver Failure/surgery , Male , Middle Aged , Probability , Prognosis , Proportional Hazards Models , Risk Assessment , Survival Analysis , Tissue Donors , Treatment Outcome
19.
Transpl Int ; 18(1): 65-72, 2005 Jan.
Article in English | MEDLINE | ID: mdl-15612986

ABSTRACT

The Model for End-stage Liver Disease (MELD) provides a score able to predict short-term mortality in patients awaiting liver transplantation (LT). In the early 2002, United Network for Organ Sharing (UNOS) has proposed to replace the conventional statuses 3, 2B, and 2A with a modified MELD score. However, the accuracy of the MELD model to predict post-transplantation outcome is fairly elusive. In the present study we investigated the predictive value of the MELD score for short-term patient and graft mortality in comparison with conventional UNOS status. Sixty-nine patients listed at UNOS status 3 (n = 5), 2B (n = 55) or 2A (n = 9) who underwent LT were enrolled according to strict criteria. No donor-related parameters affected 3-month patient survival. Through univariate Cox regression, pretransplantation international normalized ratio (P = 0.049) and activated partial thromboplastin time (P = 0.032) were significantly associated with 3-month patient survival, although not in the subsequent multivariate analysis. The overall MELD score was 17 +/- 6.63 (median: 16, range: 4-34), increasing from UNOS Status 3 to 2A (r(2) = 0.171, P = 0.0001). No significant difference occurred in the median MELD score between patients who underwent a second LT and those who did not (P =0.458). The inter-rate agreement between UNOS status and MELD score after categorization for clinical urgency showed a fair agreement (kappa = 0.244). The 3-month patient and graft mortality was 15.94% and 20.29% respectively. The concordance statistic did not find significance between UNOS status and MELD score for 3-month patient (P = 0.283) or graft mortality (P = 0.957), although the MELD score revealed a major sensitivity for short-term patient mortality (0.637; 95%CI: 0.513-0.75). These findings suggest the need to implement MELD model accuracy for both inter-rate agreement with UNOS Status and patient outcome.


Subject(s)
Liver Failure/diagnosis , Liver Transplantation/mortality , Adult , Aged , Cause of Death , Female , Follow-Up Studies , Graft Survival/physiology , Humans , Liver Failure/classification , Liver Failure/surgery , Liver Failure, Acute/diagnosis , Liver Failure, Acute/surgery , Liver Transplantation/methods , Male , Middle Aged , Multiple Organ Failure , Predictive Value of Tests , Retrospective Studies , Survival Analysis , Time Factors , Tissue and Organ Procurement/methods
20.
Transpl Int ; 16(7): 476-85, 2003 Jul.
Article in English | MEDLINE | ID: mdl-12690436

ABSTRACT

In situ split-liver transplantation (isSLT) is an innovative surgical technique that is effective in expanding the cadaveric organ pool. Through isSLT, the bipartition of a single liver provides a right graft for an adult recipient (75% of the total liver volume, comparable to a normal whole liver of smaller size) and a left lateral graft for a pediatric recipient. In the present study we investigated the potential predictive value of donor and patient characteristics for 1-year survival, early postoperative graft function markers, and hemostatic parameters in 24 adult recipients that underwent isSLT, and we compared this cohort with a group of 29 whole-liver recipients. An overall coagulation abnormality score (CAS) that we derived by assigning one point for each abnormality in the hemostatic tests was also calculated. Through univariate comparison, the age of donor and patient was significantly associated with poor survival after isSLT, though not in the case of whole-liver transplantation. In a multivariate logistic regression model that we fitted for 1-year survival of right-graft recipients by entering donor and patient age, only the latter showed statistical significance ( P=0.04). Among early postoperative graft function markers and hemostatic parameters, a platelet count of 2 on day 8 after isSLT indicated a reduced survival rate after isSLT. A CAS of >2 on day 8 was predictive for 1-year survival in whole-liver recipients as well. Multivariate Cox regression analysis identified the CAS as an independent predictor of survival ( P=0.0214) in right-graft recipients. This study suggests that early postoperative CAS calculation may be a putative survival predictor in right-graft recipients after isSLT.


Subject(s)
Graft Survival , Liver Transplantation , Tissue and Organ Procurement/methods , Adolescent , Adult , Aged , Biomarkers/analysis , Blood Coagulation , Child , Humans , Liver Transplantation/methods , Middle Aged , Multivariate Analysis , Platelet Count , Prognosis , Proportional Hazards Models , Retrospective Studies
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