Gianpaolo Balzano

San Raffaele Scientific Institute, Milano, Lombardy, Italy

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Publications (68)243.33 Total impact

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    ABSTRACT: To determine the maximum tolerated radiation dose (MTD) of an integrated boost to the tumor subvolume infiltrating vessels, delivered simultaneously with radical dose to the whole tumor and concomitant capecitabine in patients with pretreated advanced pancreatic adenocarcinoma. Patients with stage III or IV pancreatic adenocarcinoma without progressive disease after induction chemotherapy were eligible. Patients underwent simulated contrast-enhanced four-dimensional computed tomography and fluorodeoxyglucose-labeled positron emission tomography. Gross tumor volume 1 (GTV1), the tumor, and GTV2, the tumor subvolume 1 cm around the infiltrated vessels, were contoured. GTVs were fused to generate Internal Target Volume (ITV)1 and ITV2. Biological tumor volume (BTV) was fused with ITV1 to create the BTV+Internal Target Volume (ITV) 1. A margin of 5/5/7 mm (7 mm in cranium-caudal) was added to BTV+ITV1 and to ITV2 to create Planning Target Volume (PTV) 1 and PTV2, respectively. Radiation therapy was delivered with tomotherapy. PTV1 received a fixed dose of 44.25 Gy in 15 fractions, and PTV2 received a dose escalation from 48 to 58 Gy as simultaneous integrated boost (SIB) in consecutive groups of at least 3 patients. Concomitant chemotherapy was capecitabine, 1250 mg/m(2) daily. Dose-limiting toxicity (DLT) was defined as any treatment-related G3 nonhematological or G4 hematological toxicity occurring during the treatment or within 90 days from its completion. From June 2005 to February 2010, 25 patients were enrolled. The dose escalation on the SIB was stopped at 58 Gy without reaching the MTD. One patient in the 2(nd) dose level (50 Gy) had a DLT: G3 acute gastric ulcer. Three patients had G3 late adverse effects associated with gastric and/or duodenal mucosal damage. All patients received the planned dose of radiation. A dose of 44.25 Gy in 15 fractions to the whole tumor with an SIB of 58 Gy to small tumor subvolumes concomitant with capecitabine is feasible in chemotherapy-pretreated patients with advanced pancreatic cancer.
    International journal of radiation oncology, biology, physics 12/2013; 87(5):1000-1006. · 4.59 Impact Factor
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    ABSTRACT: This is a medical position statement developed by the Exocrine Pancreatic Insufficiency collaborative group which is a part of the Italian Association for the Study of the Pancreas (AISP). We covered the main diseases associated with exocrine pancreatic insufficiency (EPI) which are of common interest to internists/gastroenterologists, oncologists and surgeons, fully aware that EPI may also occur together with many other diseases, but less frequently. A preliminary manuscript based on an extended literature search (Medline/PubMed, Cochrane Library and Google Scholar) of published reports was prepared, and key recommendations were proposed. The evidence was discussed at a dedicated meeting in Bologna during the National Meeting of the Association in October 2012. Each of the proposed recommendations and algorithms was discussed and an initial consensus was reached. The final draft of the manuscript was then sent to the AISP Council for approval and/or modification. All concerned parties approved the final version of the manuscript in June 2013.
    World Journal of Gastroenterology 11/2013; 19(44):7930-7946. · 2.55 Impact Factor
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    ABSTRACT: OBJECTIVE:: To assess metabolic and oncologic outcomes of islet autotransplantation (IAT) in patients undergoing pancreatic surgery for either benign or malignant disease. BACKGROUND:: IAT is performed to improve glycemic control after extended pancreatectomy, almost exclusively in patients with chronic pancreatitis. Limited experience is available for other indications or in patients with pancreatic malignancy. METHODS:: In addition to chronic pancreatitis, indications for IAT were grade C pancreatic fistula (treated with completion or left pancreatectomy, as indicated); total pancreatectomy as an alternative to high-risk anastomosis during pancreaticoduodenectomy; and distal pancreatectomy for benign/borderline neoplasm of pancreatic body-neck. Malignancy was not an exclusion criterion. Metabolic and oncologic follow-up is presented. RESULTS:: From November 2008 to June 2012, 41 patients were candidates to IAT (accounting for 7.5% of all pancreatic resections). Seven of 41 did not receive transplantation for inadequate islet mass (4 pts), patient instability (2 pts), or contamination of islet culture (1 pt). IAT-related complications occurred in 8 pts (23.5%): 4 bleeding, 3 portal thromboses (1 complete, 2 partial), and 1 sepsis. Median follow-up was 546 days. Fifteen of 34 patients (44%) reached insulin independence, 16 patients (47%) had partial graft function, 2 patients (6%) had primary graft nonfunction, and 1 patient (3%) had early graft loss. Seventeen IAT recipients had malignancy (pancreatic or periampullary adenocarcinoma in 14). Two of them had already liver metastases at surgery, 13 were disease-free at last follow-up, and none of 2 patients with tumor recurrence developed metastases in the transplantation site. CONCLUSIONS:: Although larger data are needed to definitely exclude the risk of disease dissemination, the present study suggests that IAT indications can be extended to selected patients with neoplasm.
    Annals of surgery 06/2013; · 7.90 Impact Factor
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    ABSTRACT: The liver is the current site of choice for pancreatic islet transplantation, even though it is far from being ideal. In mice we have recently shown that the bone marrow (BM) may be a valid alternative to the liver and here we report a pilot study to test feasibility and safety of BM as a site for islet transplantation in humans. Four patients who developed diabetes after total pancreatectomy were candidates for the autologous transplantation of pancreatic islet. Since the patients had contraindications for intraportal infusion, islets were infused in the BM. In all recipients islets engrafted successfully, as shown by measurable post-transplantation C-peptide levels and histopathological evidence of insulin producing cells and/or molecular markers of endocrine tissue on BM biopsies performed during follow-up. Thus far we have recorded no adverse events related to the infusion procedure or the presence of islets in the BM. Islet function was sustained up to the maximum follow-up of 944 days. The encouraging results of this pilot study open new perspectives in identifying alternative sites for islet infusion in patients with type 1 diabetes. Moreover, this is the first unequivocal example of successful engraftment of an endocrine tissue in the BM in humans.
    Diabetes 06/2013; · 7.90 Impact Factor
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    ABSTRACT: INTRODUCTION: A relaparotomy for a pancreatic fistula (PF) after a pancreaticoduodenectomy (PD) is a formidable operation, and the appropriate treatment of anastomotic leakage is under debate. The objective of this study was to compare the outcomes of different strategies in managing the pancreatic remnant during a relaparotomy for PF after a PD. METHODS: In this retrospective study on prospectively collected data, 669 PD were performed between 2004 and 2011. The study group comprised 31 patients requiring a relaparotomy, because of delayed haemorrhage (n = 19) or sepsis (n = 12). The pancreatic stump was treated either using pancreas-preserving techniques (simple drainage or duct occlusion) or completion of a pancreatectomy (CP). In 2008, autologous islet transplantation (AIT) was introduced for endocrine tissue rescue of CP. RESULTS: The mortality rate, blood loss and transfusion requirement were similar for all techniques. Patients undergoing a CP required a further relaparotomy less frequently than patients with pancreas preservation (7% versus 59%, P < 0.01), and the intensive care unit (ICU) stay was reduced after CP (P = 0.058). PF persisted at discharge in 66% of patients after pancreas-preserving techniques. AIT was associated with CP in 7 patients, of whom one died post-operatively. Long-term graft function was maintained in four out of six surviving patients, with one insulin-independent patient at 36 months after transplantation. CONCLUSIONS: When a PF requires a relaparotomy, CP has become our favoured technique. AIT can reduce the metabolic impact of the procedure.
    HPB 02/2013; · 1.94 Impact Factor
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    ABSTRACT: BACKGROUND: Preoperative chemotherapy (PCHT) has recently been proposed also in patients with resectable pancreatic adenocarcinoma. Few data are currently available on the impact of PCHT on short-term postoperative outcome after pancreatic resection. The objective of this study is to assess the impact of PCHT on pancreatic structure and short-term outcome after surgical resection. METHODS: Fifty consecutive patients successfully underwent resection after PCHT. Each patient was matched with two control patients with pancreatic adenocarcinoma selected from our prospective electronic database. Match criteria were age (±3 years), gender, American Society of Anesthesiologist score, type of resection, pancreatic duct diameter (±1 mm), and tumor size (±5 mm). Primary endpoint was morbidity rate. Secondary endpoints were pancreatic parenchymal structure, mortality rate, and length of hospital stay (LOS). RESULTS: Both degree of fibrosis and fatty infiltration of the pancreas were similar in the two groups. Overall morbidity rate was 48.0 % in the PCHT group vs. 54.0 % in the control group (p = 0.37). Pancreatic fistula rate was 18.0 % in the PCHT group vs. 25.0 % in the control group (p = 0.41). Mortality was 4.0 % in the PCHT group vs. 2.0 % in the control group (p = 0.60). Mean LOS (days) was 12.7 in the PCHT group vs. 12.4 in the control group (p = 0.74). There was no difference in resection margin status, while the rate of patients without nodal involvement was higher in the PCHT group (46.0 vs. 23.0 %, p = 0.004). CONCLUSION: PCHT did not induce significant structural changes in pancreatic parenchyma and did not adversely affect short-term outcome after surgery.
    Journal of Gastrointestinal Surgery 11/2012; · 2.36 Impact Factor
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    ABSTRACT: BACKGROUND: New therapies are needed for pancreatic cancer. OBJECTIVE: To determine the feasibility and safety of a new endoscopic treatment. Secondary endpoints were to determine: effects on tumor growth measured with CT scan and to find the overall survival. DESIGN: A cohort study of patients with local progression of advanced pancreatic adenocarcinoma after neoadjuvant therapy. The cryotherm probe (CTP), a flexible bipolar device that combines radiofrequency with cryogenic cooling, was used under EUS guidance. SETTING: San Raffaele Hospital, Milan, Italy; University Medical Center, Hamburg-Eppendorf, Germany. PATIENTS: A total of 22 patients (male/female 11/11; mean age 61.9 years) were enrolled from September 2009 to May 2011. INTERVENTION: Radiofrequency heating: 18 W; pressure for cooling: 650 psi (Pounds per Square Inch); application time: depending on tumor size. MAIN OUTCOME MEASUREMENTS: Feasibility was evaluated during the procedure. A clinical and radiologic follow-up was planned. RESULTS: The CTP was successfully applied in 16 patients (72.8%); in 6 it was not possible because of stiffness of the GI wall and of the tumor. Amylase arose in 3 of 16 patients; none had clinical signs of pancreatitis. Late complications arose in 4 cases: 3 were mostly related to tumor progression. Median postablation survival time was 6 months. A CT scan was performed in all patients, but only in 6 of 16 was it possible to clearly define the tumor margins after ablation. In these patients, the tumor appeared smaller compared with the initial mass (P = .07). LIMITATIONS: Small sample of patients, difficulty of objectifying the size of the ablated zone by CT scan. CONCLUSION: EUS-guided CTP ablation is feasible and safe. Further investigations are needed to demonstrate progression-free survival and local control.
    Gastrointestinal endoscopy 09/2012; · 6.71 Impact Factor
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    ABSTRACT: Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions is recently becoming the treatment of choice in experienced centres. No data have been published on learning curve so far. The purpose of this study was to identify the learning curve period for performing LDP. Between March 2009 and August 2010 all patients with lesions of pancreatic body or tail were assessed for eligibility for LDP. Exclusion criteria were: major vessels contact in cancer patients, severe organ dysfunction, BMI > 35, and refusing laparoscopic approach. All laparoscopic procedures were carried out by the same surgical team with large experience in open pancreatic surgery. All patients were treated according to an early recovery after surgery protocol. Primary endpoint was conversion rate. Secondary endpoints were operative time, operative blood loss, postoperative morbidity, and length of stay (LOS). Sixty patients were assessed for eligibility. Thirty (50.0 %) patients met the exclusion criteria, while the other 30 patients underwent LDP. Spleen-preserving procedure was planned in the 17 patients with benign lesion and successfully performed in 15 (82.3 %). Overall conversion rate was 23.3 %, but it dropped significantly after the first ten patients (p = 0.01). Mean operative time progressively declined from 254 min in the first subgroup of ten patients to 206 min in the second (p = 0.09 vs. first), and 183 min in the third subgroup (p = 0.006 vs. first). No significant difference was found for operative blood loss, postoperative morbidity rate, and LOS in the different subgroups. Both conversion rate and operative time dropped after the first ten patients who underwent LDP. Strict selection criteria, high-volume hospital, and experienced team in open pancreatic surgery may have played a role in shortening the learning curve.
    Updates in surgery. 07/2012; 64(3):179-83.
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    ABSTRACT: To analyze the characteristics and outcomes following enucleation and pancreatic resections of insulinomas. Retrospective cohort study; prospective database. Academic, tertiary, and referral centers. Consecutive patients with insulinomas (symptoms of hyperinsulinism and positive fasting glucose test) who underwent surgical treatment between January 1990 and December 2009. Operative morbidity, tumor recurrence, and survival after treatment. A total of 198 patients (58.5% women; median age, 48 years) were identified. There were 175 (88%) neuroendocrine tumors grade G1 and 23 (12%) neuroendocrine tumors grade G2. Malignant insulinomas defined by lymph node/liver metastases were found in 7 patients (3.5%). Multiple insulinomas were found in 8% of patients, and 5.5% of patients had multiple endocrine neoplasia type 1. Surgical procedures included 106 enucleations (54%) and 92 pancreatic resections (46%). Mortality was nil. Rate of clinically significant pancreatic fistula was 18%. Enucleations had a higher reoperation rate compared with pancreatic resections (8.5% vs 1%; P = .02). Multiple endocrine neoplasia type 1 was significantly associated with younger age at onset (P < .005) and higher rates of malignancies and multiple lesions. Median follow-up was 65 months. Six patients (3%; 5 patients had neuroendocrine tumors grade G2) developed tumor recurrence. Four patients (2%) died of disease. New exocrine (1.5%) and endocrine (4%) insufficiencies were associated only with pancreatic resections. Outcomes following surgical resection of insulinomas are satisfactory, with no mortality and good functional results. Recurrence is uncommon (3%), and it is more likely associated with neuroendocrine tumors grade G2. Insulinomas in multiple endocrine neoplasia type 1 are at higher risk for being malignant and multifocal, requiring pancreatic resections.
    Archives of surgery (Chicago, Ill.: 1960) 03/2012; 147(3):261-6. · 4.32 Impact Factor
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    ABSTRACT: Information from randomized trials on the role of combination chemotherapy in the adjuvant treatment of pancreatic adenocarcinoma is limited. This randomized phase II trial aimed to identify the most promising regimen warranting phase III evaluation. Therapy-naive patients, age 18-75 years, Karnofsky Performance Status (KPS)>60, gross total resection of stage IB-III pancreatic adenocarcinoma, stratified for center and surgical margins, were randomly assigned to receive either gemcitabine 1 g/m2 weekly on days 1, 8, and 15 (arm A) or the PEFG regimen (cisplatin and epirubicin 40 mg/m2, day 1; gemcitabine 600 mg/m2, days 1, 8; 5-fluorouracil 200 mg/m2 daily, days 1-28) (arm B). Chemotherapy was administered every 4 weeks for 3 months and followed by irradiation concurrent to continuous infusion of 5-fluorouracil 250 mg/m2 daily. Primary endpoint was the probability of being disease-free at 1 year from surgery. Assuming P0=35% and P1=55%, α=.05 and β=.10, the study was to enroll 51 patients per arm. A total of 102 patients were randomized; 100 were eligible (arm A: 51; arm B: 49). Baseline characteristic (A/B) were: Median age was 61/60 years; 75% had KPS>80 75/76%; 36% grade 3 tumor 29/43%, 79% stage IIB/III 75/84%, 31% R1 resection 35/29%. Survival figures (A/B) were: Median disease-free survival was 11.7 and 15.2 months; 1-year disease-free survival 49.0% (95% confidence interval [95% CI] 35-63%) and 69.4% (95% CI 56-83%); median survival 24.8 and 28.9 months. Combination chemotherapy produced more hematological toxicity without relevant differences in nonhematological toxicities. The 4-drug regimen deserves further assessment in resectable pancreatic cancer.
    Annals of Surgical Oncology 01/2012; 19(7):2256-63. · 4.12 Impact Factor
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    ABSTRACT: Despite the close relationship between hospital volume and mortality after pancreaticoduodenectomy (PD), the role of surgeon volume still remains an open issue. Retrospective multi-institutional reviews considered only in-hospital mortality, whereas no data about major complications are available so far. The aim of this study is to assess the independent impact of surgeon volume on outcome after PD in a single high-volume institution. Demographics and clinical and surgical variables were prospectively collected on 610 patients who underwent PD from August 2001 to August 2009. The cutoff value to categorize high- and low-volume surgeons (HVS and LVS, respectively) was 12 PD/year. The primary endpoint was operative mortality (death within 30-day post-discharge). Secondary endpoints were morbidity, pancreatic fistula (PF), and length of hospital stay (LOS). In the whole series, mortality was 4.1%, overall morbidity was 61.3%, and PF rate was 27.5%. Two HVS performed 358 PD (58.6%), while six LVS performed 252 PD (41.4%). Mortality was 3.9% for HVS and 4.3% for LVS (p=0.84). The major complication rate was similar for HVS and LVS (14.5% vs. 16.2%). The PF rate was higher for LVS (32.4% vs. 24.1%, p=0.03). The mean LOS was 15.5 days for HVS vs. 16.9 days for LVS (p=0.11). At multivariate analysis, risk factors for PF occurrence were LVS, soft pancreatic stump, small duct diameter, and longer operative time. Low-volume surgeons had a higher PF rate. However, this did not increase mortality and major morbidity rates probably because of the protective effect of high-volume hospital in improving patient rescue from life-threatening complications.
    Journal of Gastrointestinal Surgery 11/2011; 16(3):518-23. · 2.36 Impact Factor
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    ABSTRACT: To develop and validate a simple prognostic score to predict major postoperative complications after pancreaticoduodenectomy (PD). PD still carries a high rate of severe postoperative complications. No specific score is currently available to stratify the patient's risk of major morbidity. Between 2002 and 2010, preoperative, intraoperative, and outcome data from 700 consecutive patients undergoing PD in our institution were prospectively collected in an electronic database. Major complications were defined as levels III to V of Clavien-Dindo classification. On the basis of a multivariate regression model, the score was developed using a random two-thirds of the population (n = 469) and was validated on the remaining 231 patients. Major complication rate was 16.7% (117/700). Significant predictors included in the scoring system were: pancreas texture, pancreatic duct diameter, operative blood loss, and ASA score. The mean risk of developing major postoperative complications was 7% in patients with score 0 to 3, 13% in patients with score 4 to 7, 23% in patients with score 8 to 11, and 36% in patients with score 12 to 15. In the validation population, the predicted risk of major complications was 15.2% versus a 16.9% observed risk (C-statistic index = 0.743). This new score may accurately predict a patient's postoperative outcome. Early identification of high-risk patients could help the surgeon to adopt intraoperative and postoperative strategies tailored on individual basis.
    Annals of surgery 11/2011; 254(5):702-7; discussion 707-8. · 7.90 Impact Factor
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    ABSTRACT: More than half of patients with pancreatic adenocarcinoma (PA) are candidates for further treatment when they experience upfront treatment failure. Patients with gemcitabine-resistant PA, age <76 years and Karnofski performance status (KPS) >50 were treated with a XELIRI or FOLFIRI regimen until progressive disease or a maximum of six months. As this was an observational study, no statistical design was performed. Between July 2007 and December 2009, 34 patients (median age 60 years; median KPS 90) were treated with XELIRI (26) or FOLFIRI (8) regimen. Grade >2 toxicity consisted of neutropenia in 9% of patients, anemia and fatigue in 3% and hand-foot syndrome in 12%. Median progression-free survival was two months (range 1-4). Maximum response was stable disease in four patients (12%). Median survival was 4.2 (range 1-15) months. Fluoropyrimidine and irinotecan combination does not seem to have any role in the treatment of gemcitabine-resistant PA.
    Anticancer research 11/2010; 30(11):4785-90. · 1.71 Impact Factor
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    ABSTRACT: This paper gives practical guidelines for diagnosis and treatment of chronic pancreatitis. Statements have been elaborated by working teams of experts, by searching for and analysing the literature, and submitted to a consensus process by using a Delphi modified procedure. The statements report recommendations on clinical and nutritional approach, assessment of pancreatic function, treatment of exocrine pancreatic failure and of secondary diabetes, treatment of pain and prevention of painful relapses. Moreover, the role of endoscopy in approaching pancreatic pain, pancreatic stones, duct narrowing and dilation, and complications was considered. Recommendations for most appropriate use of various imaging techniques and of ultrasound endoscopy are reported. Finally, a group of recommendations are addressed to the surgical treatment, with definition of right indications, timing, most appropriate procedures and techniques in different clinical conditions and targets, and clinical and functional outcomes following surgery.
    Digestive and Liver Disease 11/2010; 42 Suppl 6:S381-406. · 3.16 Impact Factor
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    ABSTRACT: The pancreatic stump is the major source of morbidity and mortality of pancreatoduodenectomy (PD). Any surgeon experienced in pancreatic surgery is often dealing with the dramatic consequences of the failure of the technique he or she adopted; thus we ask ourselves what technical errors we have committed, or whether it would have been better to perform a different reconstruction, maybe an anastomosis with the stomach, or an interrupted suture instead of a continuous one, or to use a Roux-en-Y limb, or to close the stump without anastomosis. In these circumstances the questions are many and legitimate, because pancreatic surgery requires an extremely accurate technique and we need to choose the proper solution based on the pancreas’ characteristics and on our own experience. However, it is important, first of all, to realize that the main actor in the dramatic consequences of pancreatic surgery is the pancreas itself, with the destructive potential of its digestive secretions. There is no evidence that any given technique is able to solve the problems of the pancreatic remnant, and no comparative study has proved one specific technique to be clearly better than another. Nevertheless, if our aim is to expose our patient who is a candidate for a PD to the smallest possible risk of death (for that is what is at issue), there is one vital element that is frequently ignored.
    05/2010: pages 297-304;
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    ABSTRACT: Parenchyma-preserving resections (PPRs), including enucleation and middle pancreatectomy (MP), are accepted procedures for insulinomas, but their role in the treatment of nonfunctioning pancreatic endocrine tumors (NF-PETs) is debated. The aim of this study was to evaluate perioperative and long-term outcomes after PPRs for NF-PETs. All patients who underwent PPRs for NF-PETs between 1990 and 2005 were included. Patients with multiple endocrine neoplasia type 1 were excluded. Overall, 50 patients (23 men, 27 women, median age 59 years) underwent 26 enucleations and 24 MP. A total of 58% of NF-PETs were incidentally discovered. Median size of the tumors was 13.5 mm with no preoperative suspicion of malignancy in all patients. Overall morbidity and pancreatic fistula rates were 58 and 50%, respectively. Reoperation rate was 4%, with no mortality. Postoperative complications were higher in the MP group. At pathology, there were 34 (68%) benign lesions, 13 (26%) neoplasms of uncertain behavior, and 3 (6%) well-differentiated carcinomas. Forty-one patients (82%) had tumors < or =2 cm in size. Only eight patients (16%) had at least one lymph node removed. After a median follow-up of 58 months, no patient died of disease. Overall, four patients (8%) experienced tumor recurrence after a mean of 68 months. The incidence of exocrine/endocrine insufficiency was 8%. PPRs are generally safe and effective procedures for treating small NF-PETs. However, better selection criteria must be identified, and lymph node sampling should be performed routinely to avoid understaging. Long-term follow-up evaluation (>5 years) is of paramount importance given the possible risk of late recurrence.
    Annals of Surgical Oncology 02/2010; 17(6):1621-7. · 4.12 Impact Factor
  • Anticancer Res. 01/2010;
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    ABSTRACT: The role and timing of chemotherapy and radiation for treating stage III pancreatic adenocarcinoma remains controversial. Treatment-naive patients with stage III non-resectable pancreatic adenocarcinoma were treated with PEFG/PEXG (cisplatin, epirubicin, 5-fluorouracil (F)/capecitabine (X), gemcitabine) or PDXG (docetaxel substituting epirubicin) regimen for 6 months followed by radiotherapy (50-60 Gy) with concurrent F or X or G. Ninety-one patients were registered between April 1997 and December 2007. Forty-three patients (47%) had a partial remission and 38 (42%) had a stable disease. Thirteen patients (14%) were radically resected yielding one pathologic complete remission. Median survival (OS) was 16.2 months. Median progression-free survival was 9.9 months. Pattern of failure consisted of isolated local failure (N = 26, 35%); both local and systemic failure (N = 14, 19%); isolated systemic failure (N = 35, 47%). Combination chemotherapy with four-drug regimens followed by chemoradiation was a feasible strategy showing relevant results in stage III pancreatic adenocarcinoma.
    Cancer Chemotherapy and Pharmacology 05/2009; 64(6):1253-9. · 2.80 Impact Factor
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    ABSTRACT: Radiologic assessment of tumor response in pancreatic cancer is complicated by desmoplastic reactions within or around the tumor. The objective of this study was to evaluate the correlation between a decline in carbohydrate antigen 19-9 (CA 19-9) and survival in patients with advanced pancreatic cancer who received upfront chemotherapy. CA 19-9 serum basal values were measured in 247 patients with advanced pancreatic cancer who were enrolled in 5 consecutive trials between 1997 and 2007. Survival curves were compared among patients who had a predefined CA 19-9 nadir variation (<50%. Group 1; 50% to 89%, Group 2; or >89%, Group 3). To eliminate guarantee-time bias, survival analysis was repeated using the landmark method. In both univariate and multivariate analysis, the basal CA 19-9 value significantly predicted survival. The median survival was 15.5 months for 34 patients who had normal basal CA 19-9 values, 11.9 months for 108 patients who had basal values between 38 U/mL and 1,167 U/mL, and 8 months for 105 patients who had basal values >1,167 U/mL. At least 1 CA 19-9 follow-up value was available for 204 patients who had baseline values greater than normal. A significant difference in overall survival was observed in univariate and multivariate analyses between Groups 1 and 2, between Groups 1 and 3, and between Groups 2 and 3. The results were confirmed using the landmark method. In this study, baseline CA 19-9 was confirmed as an independent prognostic factor for survival, and it may be considered as a stratification factor in trials in patients with advanced pancreatic cancer. Biochemical response may be used as a complementary measure to radiologic response to provide a better assessment of chemotherapy activity and to drive treatment decisions in clinical practice.
    Cancer 04/2009; 115(12):2630-9. · 5.20 Impact Factor
  • Ejc Supplements - EJC SUPPL. 01/2009; 7(2):390-390.

Publication Stats

1k Citations
243.33 Total Impact Points

Institutions

  • 1995–2013
    • San Raffaele Scientific Institute
      Milano, Lombardy, Italy
  • 2006–2012
    • Università Vita-Salute San Raffaele
      Milano, Lombardy, Italy
  • 2001–2008
    • Ospedale di San Raffaele Istituto di Ricovero e Cura a Carattere Scientifico
      Milano, Lombardy, Italy
  • 1994–1998
    • University of Milan
      • • Department of Internal Medicine
      • • Sezione I - Chirurgia Generale, Oncologica, Toracica e Addominale
      Milano, Lombardy, Italy