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Pancreatic Neoplasms: HELP
Articles by Sandro Barni
Based on 15 articles published since 2010
(Why 15 articles?)
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Between 2010 and 2020, Sandro Barni wrote the following 15 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 Review Disease-free survival is not a surrogate endpoint for overall survival in adjuvant trials of pancreatic cancer: a systematic review of randomized trials. 2017

Petrelli, Fausto / Tomasello, Gianluca / Ghidini, Michele / Lonati, Veronica / Passalacqua, Rodolfo / Barni, Sandro. ·Oncology Unit, Oncology Department, ASST Bergamo Ovest, Piazzale Ospedale 1, 24047, Treviglio, BG, Italy. Electronic address: faupe@libero.it. · Oncology Unit, Oncology Department, ASST Ospedale di Cremona, Viale Concordia 1, 26100, Cremona, Italy. · Oncology Unit, Oncology Department, ASST Bergamo Ovest, Piazzale Ospedale 1, 24047, Treviglio, BG, Italy. ·HPB (Oxford) · Pubmed #28764887.

ABSTRACT: BACKGROUND: Adjuvant chemotherapy (CT) is the standard of care for patients with resected pancreatic cancer (PC). Overall survival (OS) has traditionally represented the primary endpoint in randomized trials assessing adjuvant therapies for PC. The aim of this study was to assess if disease-free survival (DFS) was an adequate surrogate endpoint for OS in randomized trials of adjuvant therapy in PC. METHODS: A systematic literature search was conducted in PubMed, Web of Science, SCOPUS and Embase, Cochrane Library and the World Health Organization International Clinical Trials Registry Platform up to February 2nd, 2017. Surrogacy of DFS with OS was assessed between endpoints and OS through the Spearman rank correlation coefficient, and between the treatment effects on the endpoints using the squared correlation R RESULTS: A total of 12 eligible randomized trials that enrolled 4,888 patients where identified for the final analysis. Correlation of DFS with OS was weak at the individual level (Spearman rank correlation coefficient = 0.31) and moderate at the trial level (R CONCLUSIONS: DFS does not represent an appropriate surrogate for OS in randomized trials of adjuvant therapy for resected PC. Hence, OS should remain the primary endpoint of future trials evaluating new agents in postsurgical setting.

2 Review Second line with oxaliplatin- or irinotecan-based chemotherapy for gemcitabine-pretreated pancreatic cancer: A systematic review. 2017

Petrelli, Fausto / Inno, Alessandro / Ghidini, Antonio / Rimassa, Lorenza / Tomasello, Gianluca / Labianca, Roberto / Barni, Sandro / Anonymous3660910. ·Medical Oncology Unit, ASST Bergamo Ovest, Piazzale Ospedale 1, 24047, Treviglio, BG, Italy. Electronic address: faupe@libero.it. · Medical Oncology Unit, Ospedale Sacro Cuore Don Calabria Cancer Care Center, Via Don A. Sempreboni 5, 37024, Negrar, VR, Italy. · Medical Oncology Unit, Casa di Cura Igea, Via Marcona 69, 20144, Milano, Italy. · Medical Oncology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, Milano, Italy. · Medical Oncology Unit, ASST Cremona, Viale Concordia 1, 26100, Cremona, Italy. · Medical Oncology Unit, ASST Papa Giovanni XXIII Hospital, Piazza Organizzazione Mondiale della Sanità 1, 24127, Bergamo, Italy. · Medical Oncology Unit, ASST Bergamo Ovest, Piazzale Ospedale 1, 24047, Treviglio, BG, Italy. ·Eur J Cancer · Pubmed #28633088.

ABSTRACT: BACKGROUND: oxaliplatin (OXA)- and irinotecan (IRI)-based chemotherapies are the most frequently used salvage regimens in patients with metastatic pancreatic cancer (PC) after first-line gemcitabine-based therapy. There are no prospective comparisons of these regimens in this setting. We conducted a systematic review of published trials to compare the efficacy of these treatments. METHODS: studies that enrolled patients with stage IV disease receiving chemotherapy with OXA or IRI plus fluoropyrimidines were identified using electronic databases (Pubmed, Embase, SCOPUS, CINAHL, Web of Science and Cochrane Library). Clinical outcomes were compared using weighted values of median overall survival (OS), progression-free survival (PFS), response rates (RRs), and clinical benefit rates (CBRs). A 2-tailed t-test with a significance level of 0.05 for comparisons of continuous variables and a Chi-squared test for comparisons of proportions were used. RESULTS: overall, 24 studies were included. The pooled overall response rate (ORR), disease control rate (DCR), PFS and OS were 11%, 37.9%, 2.87 and 5.48 months respectively. There was no significant difference in response rates between OXA-based and IRI-based chemotherapies (11.9% versus 8.7%; Chi-squared P = 0.1), respectively. Also there was no significant difference in median PFS (2.9 months versus 2.7 months; t-test P = 0.72), OS (5.3 months versus 5.5 months; t-test P = 0.72), but a greater DCR with OXA-based chemotherapy (41.1% versus 29.4%; Chi-squared P = 0.0008). CONCLUSION: OXA- and IRI-containing regimens were associated with similar efficacy when used after gemcitabine-based chemotherapy in patients with advanced pancreatic cancer.

3 Review Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. 2017

Petrelli, Fausto / Comito, Tiziana / Ghidini, Antonio / Torri, Valter / Scorsetti, Marta / Barni, Sandro. ·Oncology Unit, Department of Oncology, ASST Bergamo Ovest, Treviglio, Italy. Electronic address: faupe@libero.it. · Department of Radiosurgery and Radiotherapy, Istituto Clinico Humanitas Cancer Center and Research Hospital, Milan, Italy. · Oncology Unit, Igea Hospital, Milan, Italy. · Department of Biomedical Sciences, Humanitas University and Radiotherapy and Radiosurgery Department-Humanitas Research Hospital, Milan, Italy. · Oncology Unit, Department of Oncology, ASST Bergamo Ovest, Treviglio, Italy. ·Int J Radiat Oncol Biol Phys · Pubmed #28068239.

ABSTRACT: PURPOSE: Although surgery is the standard of care for resectable pancreatic cancer (PC), standard-dose chemoradiation therapy and chemotherapy alone are suitable for patients with unresectable disease. Stereotactic body radiation therapy (SBRT) is an alternative, focused local therapy that delivers high radiation doses within a few fractions to the cancer, sparing the surrounding critical tissue. We performed a systematic review and pooled analysis of published trials to evaluate the efficacy and safety of this emerging treatment modality. METHODS AND MATERIALS: We searched the Cochrane Central Register of Controlled Trials, PubMed, EMBASE, SCOPUS, the Web of Science, and CINAHL for publications regarding SBRT for locally advanced PC. The 1-year overall survival (OS) rate was the primary endpoint, and the median OS, 2-year OS rate, 1-year locoregional control (LRC) rate, and grade 3 to 4 toxicities were the secondary endpoints. A multivariate random-effects meta-analysis was performed to calculate the aggregated OS rates at 1 and 2 years and the 1-year LRC rate. RESULTS: A total of 19 studies, encompassing 1009 patients, were included in the present analysis. The pooled 1-year OS was 51.6% in 13 trials with data available. The median OS ranged from 5.7 to 47 months (median 17). The LRC rate at 1 year was 72.3%. Overall, the occurrence of severe adverse events did not exceed 10%. LRC appeared to correlate with the total SBRT dose and the number of fractions. CONCLUSIONS: The advantages of SBRT in terms of treatment time, satisfactory OS, and LRC indicate that it is an effective option for inoperable PC. However, a definitive validation of this treatment modality in large randomized studies is required, owing to the nonrandomized nature of the included studies and the limitations of small single-center series that include mixed populations.

4 Review FOLFIRINOX-based neoadjuvant therapy in borderline resectable or unresectable pancreatic cancer: a meta-analytical review of published studies. 2015

Petrelli, Fausto / Coinu, Andrea / Borgonovo, Karen / Cabiddu, Mary / Ghilardi, Mara / Lonati, Veronica / Aitini, Enrico / Barni, Sandro / Anonymous7040826. ·From the *Department of Oncology, Azienda Ospedaliera Treviglio-Caravaggio, Bergamo; and †Department of Medical Oncology, Carlo Poma Hospital, Mantua, Italy. ·Pancreas · Pubmed #25872127.

ABSTRACT: OBJECTIVE: The use of neoadjuvant chemotherapy can enable surgical resection of borderline resectable or unresectable pancreatic cancer (PC). The aim of this study was to evaluate the effectiveness of the multiagent 5-fluorouracil + oxaliplatin + irinotecan + leucovorin (FOLFIRINOX) regimen as a neoadjuvant treatment for PC. METHODS: Studies in which FOLFIRINOX with or without radiotherapy was given before surgery to patients with borderline resectable or unresectable PC were analyzed using a meta-analytical approach. The primary outcomes were resection rate and radical (R0) resection rate. Data were expressed as weighted pooled proportions with 95% confidence intervals (CIs). RESULTS: Thirteen studies, with a total of 253 patients, were included in this meta-analysis. After undergoing the treatment, 43% (95% CI, 32.8-53.8) of patients were resected and 39.4% (95% CI, 32.4-46.9) underwent R0 resection (85% of surgical specimens). In particular, among borderline resectable PCs, R0 resection was possible in 63.5% (95% CI, 49%-76%) of the cases. The rate of R0 resection in unresectable PCs was 22.5% (95% CI, 13.3-35.4). CONCLUSIONS: This meta-analysis shows that down-staging after neoadjuvant FOLFIRINOX-based therapy is noticeable in patients with borderline resectable/unresectable PC, with a total R0 resection rate of 40%.

5 Review Progression-free survival as surrogate endpoint in advanced pancreatic cancer: meta-analysis of 30 randomized first-line trials. 2015

Petrelli, Fausto / Coinu, Andrea / Borgonovo, Karen / Cabiddu, Mary / Barni, Sandro. ·Medical Oncology Unit, Oncology Department, Azienda Ospedaliera Treviglio, Piazzale Ospedale 1, 24047 Treviglio (BG), Italy. faupe@libero.it. ·Hepatobiliary Pancreat Dis Int · Pubmed #25865683.

ABSTRACT: BACKGROUND: Progression-free survival (PFS) has not been extensively investigated as a surrogate for survival in the first-line treatments of pancreatic cancer. The aim of this review was to evaluate PFS as a potential surrogate endpoint for overall survival (OS) in advanced pancreatic cancer in trials comparing poly-chemotherapy to gemcitabine alone. DATA SOURCES: A systematic literature search in PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials was conducted. The key words included randomized trial, first-line chemotherapy, pancreatic cancer, gemcitabine and poly-chemotherapy. Adjusted weighted linear regression was used to calculate RS (Spearman's rank-order correlation coefficient) between PFS and post-progression survival (PPS) with OS (RS) and between treatment effects on PFS and OS (RHR). RESULTS: A total of 30 trials including 8467 patients met the inclusion criteria. Correlation between the treatment effects on PFS and OS (RHR=0.78) and between the endpoint PFS and OS was high across all studies (RS=0.75). The slope of the regression line was 0.76+/-0.26, indicating that an agent producing a 10% risk reduction for PFS will provide a 7.6%+/-2.6% risk reduction for OS. Correlation between PPS and OS was very strong (RS=0.71) and accounted for more than 50% of the whole OS variability (R2=0.57). CONCLUSION: Because of the robust correlation with OS and the potential influence of PPS caused by the second line therapies, it may be justified to consider PFS as a surrogate endpoint in trials evaluating new cytotoxic agents when gemcitabine is the control arm.

6 Review What else in gemcitabine-pretreated advanced pancreatic cancer? An update of second line therapies. 2010

Petrelli, Fausto / Borgonovo, Karen / Ghilardi, Mara / Cabiddu, Mary / Barni, Sandro. ·Azienda Ospedaliera Treviglio-Caravaggio, Treviglio (BG), Italy. faupe@libero.it ·Rev Recent Clin Trials · Pubmed #20205687.

ABSTRACT: Advanced pancreatic cancer is usually treated with first-line gemcitabine (GEM) (alone or in combination). More recently, GEM has become an established part of an adjuvant therapy based on two recently-reported randomized trials. There remains unresolved the problem of second-line therapy in patients relapsed during or after adjuvant or first-line GEM-based treatment. As of today, platinum analogues in combination with fluoropyrimidine or with GEM represent the most common schedule in clinical practice with data from single-centre or multicentric phase II studies. In 2008, for the first time, a randomized phase III trial conducted on good performance status GEM-refractory patients (CONKO 003) confirmed their benefit in progression-free and overall survival by adding oxaliplatin to a bolus 5-FU/folinic acid schedule. Other agents (irinotecan, taxanes, antifolates, biological) have been tested, although only dismal results have been achieved, as they turned out to be too toxic in combination and to have too low activity when used as single agents. Which the optimal candidate is for second-line therapies, is debatable. Good performance status and discrete progression-free survival since the beginning of the GEM therapy (more than 6 months?) are likely to be the best indicators of subsequent line benefit. The benefit of biological agents is unknown, also given the poor results achieved in the first-line treatment. In summary, as of today, there is one randomized study that confirms the benefit of second-line chemotherapy for the treatment of GEM-relapsed pancreatic cancer. Current data indicate 5-FU plus a platinum agent (oxaliplatin) as the standard of care for PS 0-1 patients. Ongoing clinical trials will clarify whether there is obviously a place for improvement and for other agents. At present, even though no data on benefits in unfit patients (Karnofsky < 70) are available, a fluopyrimidine agent still remains a reasonable treatment option.

7 Clinical Trial The value of lactate dehydrogenase serum levels as a prognostic and predictive factor for advanced pancreatic cancer patients receiving sorafenib. 2015

Faloppi, Luca / Bianconi, Maristella / Giampieri, Riccardo / Sobrero, Alberto / Labianca, Roberto / Ferrari, Daris / Barni, Sandro / Aitini, Enrico / Zaniboni, Alberto / Boni, Corrado / Caprioni, Francesco / Mosconi, Stefania / Fanello, Silvia / Berardi, Rossana / Bittoni, Alessandro / Andrikou, Kalliopi / Cinquini, Michela / Torri, Valter / Scartozzi, Mario / Cascinu, Stefano / Anonymous3600843. ·Medical Oncology Unit, Università Politecnica delle Marche, AOU "Ospedali Riuniti", Ancona, Italy. · Medical Oncology Unit, Ospedale S. Martino, Genova, Italy. · Medical Oncology Unit, Ospedali Riuniti, Bergamo, Italy. · Medical Oncology Unit, Ospedale S. Paolo, Milano, Italy. · Medical Oncology Unit, Treviglio Hospital, Treviglio, Italy. · Medical Oncology Unit, C. Poma Hospital, Mantova, Italy. · Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy. · Medical Oncology Unit, Arcispedale S. Maria Nuova IRCCS, Reggio Emilia, Italy. · New Drug Development Strategies Laboratory, Mario Negri Institute, Milano, Italy. · Medical Oncology Unit, Università degli Studi di Cagliari, Azienda Ospedaliero Universitaria, Cagliari, Italy. ·Oncotarget · Pubmed #26397228.

ABSTRACT: Although lactate dehydrogenase (LDH) serum levels, indirect markers of angiogenesis, are associated with a worse outcome in several tumours, their prognostic value is not defined in pancreatic cancer. Moreover, high levels are associated even with a lack of efficacy of tyrosine kinase inhibitors, contributing to explain negative results in clinical trials. We assessed the role of LDH in advanced pancreatic cancer receiving sorafenib. Seventy-one of 114 patients included in the randomised phase II trial MAPS (chemotherapy plus or not sorafenib) and with available serum LDH levels, were included in this analysis. Patients were categorized according to serum LDH levels (LDH ≤ vs.> upper normal rate). A significant difference was found in progression free survival (PFS) and in overall survival (OS) between patients with LDH values under or above the cut-off (PFS: 5.2 vs. 2.7 months, p = 0.0287; OS: 10.7 vs. 5.9 months, p = 0.0021). After stratification according to LDH serum levels and sorafenib treatment, patients with low LDH serum levels treated with sorafenib showed an advantage in PFS (p = 0.05) and OS (p = 0.0012). LDH appears to be a reliable parameter to assess the prognosis of advanced pancreatic cancer patients, and it may be a predictive parameter to select patients candidate to receive sorafenib.

8 Clinical Trial Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer: A GISCAD randomized phase II study. 2014

Cascinu, Stefano / Berardi, Rossana / Sobrero, Alberto / Bidoli, Paolo / Labianca, Roberto / Siena, Salvatore / Ferrari, Daris / Barni, Sandro / Aitini, Enrico / Zagonel, Vittorina / Caprioni, Francesco / Villa, Federica / Mosconi, Stefania / Faloppi, Luca / Tonini, Giuseppe / Boni, Corrado / Conte, Pierfranco / Di Costanzo, Francesco / Cinquini, Michela / Anonymous2180774. ·Medical Oncology Unit, Università Politecnica delle Marche, Ospedali Riuniti di Ancona, Ancona, Italy. Electronic address: cascinu@yahoo.com. · Medical Oncology Unit, Università Politecnica delle Marche, Ospedali Riuniti di Ancona, Ancona, Italy. · Medical Oncology Unit, Ospedale S. Martino, Genova, Italy. · Medical Oncology Unit, Ospedale S. Gerardo, Monza, Italy. · Medical Oncology Unit, Ospedali Riuniti, Bergamo, Italy. · Niguarda Cancer Center, Ospedale Niguarda Ca' Granda, Milan, Italy. · Medical Oncology Unit, Ospedale S. Paolo, Milano, Italy. · Medical Oncology Unit, Treviglio Hospital, Treviglio, Italy. · Medical Oncology Unit, C. Poma Hospital, Mantova, Italy. · Medical Oncology Unit, Istituto Oncologico Veneto, Padova, Italy. · Medical Oncology Unit, University Campus Bio-Medico, Rome, Italy. · Medical Oncology Unit, Arcispedale S. Maria Nuova IRCCS, Reggio Emilia, Italy. · Medical Oncology Unit, Policlinico Universitario, Modena, Italy. · Medical Oncology Unit Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy. · New Drug Development Strategies Laboratory, Mario Negri Institute, Milano, Italy. ·Dig Liver Dis · Pubmed #24189171.

ABSTRACT: BACKGROUND: The RAF-MEK-ERK pathway is commonly activated in pancreatic cancer because of a high frequency of KRAS-BRAF mutations. A phase II randomized trial was designed to investigate the activity of sorafenib in combination with chemotherapy in advanced pancreatic cancer. METHODS: Locally advanced or metastatic pancreatic adenocarcinoma patients were randomized in a 1:1 ratio to receive cisplatin plus gemcitabine with sorafenib 400mg bid (arm A) or without sorafenib (arm B). RESULTS: One hundred and fourteen patients were enrolled; of these, 43 (74.6%) patients progressed in arm A and 44 (82.4%) in arm B. Median progression-free survival was 4.3 months (95% CI: 2.7-6.5) and 4.5 months (95% CI: 2.5-5.2), respectively (HR=0.92; 95% CI: 0.62-1.35). Median overall survival was 7.5 (95% CI: 5.6-9.7) and 8.3 months (95% CI: 6.2-8.7), respectively (HR=0.95; 95% CI: 0.62-1.48). Response rates were 3.4% in arm A and 3.6% in arm B. CONCLUSIONS: Sorafenib does not significantly enhance activity of chemotherapy in advanced pancreatic cancer patients, and therefore should not be assessed in phase III trials.

9 Clinical Trial FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study. 2012

Zaniboni, Alberto / Aitini, Enrico / Barni, Sandro / Ferrari, Daris / Cascinu, Stefano / Catalano, Vincenzo / Valmadre, Giuseppe / Ferrara, Domenica / Veltri, Enzo / Codignola, Claudio / Labianca, Roberto. ·Medical Oncology Unit, Fondazione Poliambulanza, Via Bissolati 57, 25124, Brescia, Italy. zanib@numerica.it ·Cancer Chemother Pharmacol · Pubmed #22576338.

ABSTRACT: PURPOSE: The purpose of the present study was to evaluate the activity and the tolerability of the FOLFIRI regimen, administered as second-line chemotherapy in patients with locally advanced or metastatic pancreatic cancer after the failure of a gemcitabine-based regimen. METHODS: Patients with locally advanced/metastatic disease who received a first-line chemotherapy (one line only) with gemcitabine ± platinoid (cisplatin, oxaliplatin) and who had measurable disease conform with the RECIST criteria were eligible for the study. FOLFIRI consists of irinotecan 180 mg/m(2) i.v. on day 1, leucovorin (l-form) 200 mg/m(2) i.v. on day 1 and 2, 5-FU 400 mg/m(2) i.v. bolus on days 1 and 2, and 5-FU 600 mg/m(2) i.v. by ci for 22 h on days 1 and 2, repeated every 2 weeks. The primary end point was the response rate. RESULTS: Among the 50 enrolled patients, 4 partial responses (PR) (8%) and 14 stable diseases were observed, for a disease control rate of 18/50 (36%). Forty-one patients (82%) have been pretreated with cisplatin/oxaliplatin+gemcitabine as first-line chemotherapy. The median progression-free and overall survivals were 3.2 and 5 months, respectively. The 6-month survival rate was 32%. Grade 3-4 neutropenia and diarrhea occurred in 10 (20%) and 6 (12%) patients, respectively. CONCLUSION: The FOLFIRI regimen showed a modest clinical activity in this quite heavily pretreated patients' population with locally advanced or metastatic pancreatic cancer with a manageable toxicity profile.

10 Article Outcome of head compared to body and tail pancreatic cancer: a systematic review and meta-analysis of 93 studies. 2019

Tomasello, Gianluca / Ghidini, Michele / Costanzo, Antonio / Ghidini, Antonio / Russo, Alessandro / Barni, Sandro / Passalacqua, Rodolfo / Petrelli, Fausto. ·Oncology Department, ASST Ospedale di Cremona, Cremona, Italy. · Surgical Oncology Unit, Surgery Department, ASST Bergamo Ovest, Treviglio (BG), Italy. · Oncology Unit, Casa di cura Igea, Milano, Italy. · Oncology Unit, Oncology Department, ASST Bergamo Ovest, Treviglio (BG), Italy. ·J Gastrointest Oncol · Pubmed #31032093.

ABSTRACT: Background: Even when resectable pancreatic cancer (PC) is associated with a dismal prognosis. Initial presentation varies according with primary tumor location. Aim of this systematic review and meta-analysis was to evaluate the prognosis associated with site (head versus body/tail) in patients with PC. Methods: We searched PubMed, Cochrane Library, SCOPUS, Web of Science, EMBASE, Google Scholar, LILACS, and CINAHL databases from inception to March 2018. Studies reporting information on the independent prognostic role of site in PC and comparing overall survival (OS) in head versus body/tail tumors were selected. Data were aggregated using hazard ratios (HRs) for OS of head versus body/tail PC according to fixed- or random-effect model. Results: A total of 93 studies including 254,429 patients were identified. Long-term prognosis of head was better than body/tail cancers (HR =0.96, 95% CI: 0.92-0.99; P=0.02). A pooled HR of 0.95 (95% CI: 0.92-0.99, P=0.02) from multivariate analysis only (n=77 publications) showed that head site was an independent prognostic factor for survival. Conclusions: Primary tumor location in the head of the pancreas at the time of diagnosis is a predictor of better survival. Such indicator should be acknowledged when designing future studies, in particular in the operable and neoadjuvant setting.

11 Article The Italian Rare Pancreatic Exocrine Cancer Initiative. 2019

Brunetti, Oronzo / Luchini, Claudio / Argentiero, Antonella / Tommasi, Stefania / Mangia, Anita / Aprile, Giuseppe / Marchetti, Paolo / Vasile, Enrico / Casadei Gardini, Andrea / Scartozzi, Mario / Barni, Sandro / Delfanti, Sara / De Vita, Fernando / Di Costanzo, Francesco / Milella, Michele / Cella, Chiara Alessandra / Berardi, Rossana / Cataldo, Ivana / Santini, Daniele / Doglioni, Claudio / Maiello, Evaristo / Lawlor, Rita T / Mazzaferro, Vincenzo / Lonardi, Sara / Giuliante, Felice / Brandi, Giovanni / Scarpa, Aldo / Cascinu, Stefano / Silvestris, Nicola. ·1 Medical Oncology Unit, IRCCS Cancer Institute "Giovanni Paolo II" of Bari, Bari, Italy. · 2 Department of Diagnostics and Public Health, Section of Pathology, University of Verona, Verona, Italy. · 3 Molecular Diagnostics and Pharmacogenetics Unit, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy. · 4 Functional Biomorphology Laboratory, IRCCS-Istituto Tumori, Bari, Italy. · 5 Medical Oncology Unit, Hospital of Vicenza, Vicenza, Italy. · 6 Medical Oncology Unit, Sant'Andrea Hospital, University of Rome La Sapienza, Rome, Italy. · 7 Medical Oncology Unit, University Hospital of Pisa, Pisa, Italy. · 8 Medical Oncology Unit, Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), Meldola, Italy. · 9 Medical Oncology Unit, University of Cagliari, Cagliari, Italy. · 10 Medical Oncology Unit, ASST Bergamo Ovest, Treviglio, Italy. · 11 Medical Oncology Unit, IRCCS Foundation Polyclinic San Matteo, Pavia, Italy. · 12 Medical Oncology Unit, II University of Naples, Naples, Italy. · 13 Medical Oncology Unit, Careggi University Hospital, Florence, Italy. · 14 Medical Oncology Unit, "Regina Elena" National Cancer Institute, Rome, Italy. · 15 Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology (IEO), Milan, Italy. · 16 Medical Oncology Unit, Polytechnic University of the Marche, "Ospedali Riuniti Ancona," Ancona, Italy. · 17 Department of Pathology and Diagnostics, University of Verona Hospital Trust, Policlinico GB Rossi, Verona, Italy. · 18 Medical Oncology Unit, University Campus Biomedico, Rome, Italy. · 19 Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · 20 Medical Oncology Unit, IRCCS "Casa Sollievo della Sofferenza" Foundation, San Giovanni Rotondo, Italy. · 21 Arc-Net Centre for Applied Research on Cancer, University and Hospital Trust of Verona, Verona, Italy. · 22 Hepato-Biliary-Pancreatic Surgery, University of Milan, Istituto Nazionale Tumori, Fondazione IRCCS, Milan, Italy. · 23 Medical Oncology Unit, IRCCS Veneto Institute of Oncology (IOV), Padua, Italy. · 24 Hepatobiliary Surgery Unit, IRCCS A. Gemelli Polyclinic Foundation, Catholic University of the Sacred Heart, Rome, Italy. · 25 Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. · 26 Medical Oncology Unit, Modena Cancer Center, University Hospital of Modena, Modena, Italy. · 27 Scientific Direction, IRCCS Cancer Institute "Giovanni Paolo II" of Bari, Bari, Italy. ·Tumori · Pubmed #30967031.

ABSTRACT: INTRODUCTION: Exocrine pancreatic cancers include common type pancreatic ductal adenocarcinoma and cystic neoplasms, which account for 85% and 10% of cases, respectively. The remaining 5% are rare histotypes, comprising adenosquamous carcinoma, acinar cell carcinoma, signet ring cell carcinoma, medullary carcinoma, pancreatoblastoma, hepatoid carcinoma, undifferentiated carcinoma and its variant with osteoclast-like giant cells, solid pseudopapillary carcinoma, and carcinosarcoma. Due to their low incidence, little knowledge is available on their clinical and molecular features as well as on treatment choices. The national initiative presented here aims at the molecular characterization of series of rare histotypes for which therapeutic and follow-up data are available. METHODS: A nationwide Italian Rare Pancreatic Cancer (IRaPaCa) task force whose first initiative is a multicentric retrospective study involving 21 Italian cancer centers to retrieve histologic material and clinical and treatment data of at least 100 patients with rare exocrine pancreatic cancers has been created. After histologic revision by a panel of expert pathologists, DNA and RNA from paraffin tissues will be investigated by next-generation sequencing using molecular pathway-oriented and immune-oriented mutational and expression profiling panels constructed availing of the information from the International Cancer Genome Consortium. Bioinformatic analysis of data will drive validation studies by immunohistochemistry and in situ hybridization, as well as nanostring assays. CONCLUSIONS: We expect to gather novel data on rare pancreatic cancer types that will be useful to inform the design of therapeutic choices.

12 Article Systemic Chemotherapy for Advanced Rare Pancreatic Histotype Tumors: A Retrospective Multicenter Analysis. 2018

Brunetti, Oronzo / Aprile, Giuseppe / Marchetti, Paolo / Vasile, Enrico / Casadei Gardini, Andrea / Scartozzi, Mario / Barni, Sandro / Delfanti, Sara / De Vita, Fernando / Di Costanzo, Francesco / Milella, Michele / Cella, Chiara Alessandra / Berardi, Rossana / Cataldo, Ivana / Scarpa, Aldo / Basile, Debora / Mazzuca, Federica / Graziano, Giusi / Argentiero, Antonella / Santini, Daniele / Reni, Michele / Cascinu, Stefano / Silvestris, Nicola. ·Medical Oncology Unit, Sant'Andrea Hospital, University of Rome La Sapienza, Rome. · Medical Oncology Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa. · Department of MedicalOncology, Istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori (IRST) IRCCS, Meldola. · Medical Oncology Unit, University of Cagliari, Cagliari. · Medical Oncology Unit, ASST Bergamo Ovest, Treviglio. · Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia. · Medical Oncology Unit, II University of Naples, Naples. · Medical OncologyUnit, Azienda Ospedaliero-Universitaria Careggi, Florence. · Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, Rome. · Division of Gastrointestinal and Neuroendocrine Tumors, IEO, Milan. · Medical Oncology Unit, Università Politecnica Marche - Ospedali Riuniti Ancona, Ancona. · Department of Pathology and Diagnostics, University of Verona, ARCNET, Verona. · Department of Medical Oncology, University and General Hospital, Udine. · Scientific Direction, Cancer Institute "Giovanni Paolo II," Bari. · Medical Oncology Unit, University Campus Biomedico, Rome. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan. · Modena Cancer Center, University of Modena and Reggio Emilia, Azienda Ospedaliera-Universitaria di Modena, Modena, Italy. ·Pancreas · Pubmed #29771769.

ABSTRACT: OBJECTIVES: Two issues were put forth by clinicians in the management of the advanced stages of rare variants of pancreatic ductal adenocarcinoma and other exocrine histotypes with peculiar clinical and pathological features: Do chemotherapy regimens recommended in pancreatic ductal adenocarcinoma patients have a clinical activity in rare pancreatic tumors? Or should other chemotherapy combinations be considered in this subset of patients? METHODS: We conducted a multicenter retrospective study that collected data from 2005 to 2016 at 14 Italian cancer centers with the aim to evaluate tumor response and time to progression for first- and second-line and overall survival. RESULTS: Of approximately 4300 exocrine pancreatic cancer patients, 79 advanced cases affected by rare histological types were identified, with pancreatic acinar cell cancer (n = 23), pancreatic adenosquamous cancer (n = 16), and mucinous cystic neoplasm with an associated invasive mucinous cystadenocarcinoma (n = 15) most represented. Survival analyses for each subgroup in relation with the different chemotherapy regimens showed the lack of statistical significance correlations. CONCLUSIONS: Because of the lack of clinical trials in patients affected by these rare pancreatic histotypes, only their molecular classification would help clinicians in future therapeutic choice.

13 Article Borderline resectable pancreatic cancer: More than an anatomical concept. 2017

Petrelli, Fausto / Inno, Alessandro / Barni, Sandro / Ghidini, Antonio / Labianca, Roberto / Falconi, Massimo / Reni, Michele / Cascinu, Stefano / Anonymous10430889. ·Medical Oncology Unit, ASST Bergamo Ovest, Bergamo, Italy. Electronic address: faupe@libero.it. · Medical Oncology Unit, Sacro Cuore Don Calabria Hospital, Verona, Italy. · Medical Oncology Unit, ASST Bergamo Ovest, Bergamo, Italy. · Medical Oncology Unit, Casa di Cura Igea, Milano, Italy. · Medical Oncology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy. · Surgical Department of Pancreas, San Raffaele Hospital, IRCCS, Milano, Italy. · Medical Oncology Unit, San Raffaele Hospital, IRCCS, Milano, Italy. · Department of Oncology and Hematology, University of Modena and Reggio Emilia, Modena, Italy. ·Dig Liver Dis · Pubmed #27931968.

ABSTRACT: Borderline resectable pancreatic cancer (BRPC) accounts for about 10-15% of newly diagnosed pancreatic cancer, and its management requires a skilled multidisciplinary team. The main definition of BRPC refers to resectability, but also a high risk of positive surgical margins and recurrence. This raises questions about the value of surgery and suggests an opportunity to utilize preoperative treatment in this subset of patients. Besides technical borderline resectable disease which is defined on anatomical and radiological criteria, there is also a biological borderline resectable disease which is defined on clinical and biological prognostic factors. Technical borderline resectable disease requires tumor shrinkage with aggressive therapy including modern drug combinations +/- radiotherapy to achieve radical surgery. Biological BRPC needs always an early systemic treatment in order to select the best candidates for subsequent radical surgery. It is important to distinguish between these different clinical scenarios, both in clinical practice and for clinical trials design.

14 Article Polychemotherapy or gemcitabine in advanced pancreatic cancer: a meta-analysis. 2014

Petrelli, Fausto / Coinu, Andrea / Borgonovo, Karen / Cabiddu, Mary / Ghilardi, Mara / Barni, Sandro. ·Medical Oncology Unit, Oncology Department, Azienda Ospedaliera Treviglio, Treviglio (BG), Italy. Electronic address: faupe@libero.it. · Medical Oncology Unit, Oncology Department, Azienda Ospedaliera Treviglio, Treviglio (BG), Italy. ·Dig Liver Dis · Pubmed #24565950.

ABSTRACT: BACKGROUND: Gemcitabine monotherapy is the cornerstone of treatment for advanced pancreatic cancer. To date, no clear survival benefit has been found when combination chemotherapy has been compared with gemcitabine alone, except in a few studies. This meta-analysis compared the efficacy of polychemotherapy with gemcitabine alone in advanced pancreatic cancer. METHODS: Randomised trials comparing combination chemotherapy with gemcitabine alone were identified through electronic searches of PubMed, EMBASE, Web of Science, and the Cochrane Central Register of Controlled Trials. Overall survival, reported as the hazard ratio at the 95% confidence interval, was the primary outcome measure. RESULTS: 29 trials (19 phase III and 10 small randomised trials) that included 8421 patients were identified. Overall, polychemotherapy significantly improved overall survival (hazard ratio=0.87; 95% CI, 0.81-0.93; P<0.0001), progression-free survival (hazard ratio=0.77; 95% CI, 0.70-0.84; P<0.00001), and response rate (risk ratio=1.71; 95% CI, 1.42-2.07; P<0.00001) compared with gemcitabine alone. CONCLUSIONS: Compared with gemcitabine monotherapy, combinations of two or more drugs (particularly those with novel agents or associated with >20% response rates and triplets) improved outcomes and response rate in advanced pancreatic cancer, and they could be considered a new standard of care in advanced settings.

15 Article A rare case of metastatic pancreatic hepatoid carcinoma treated with sorafenib. 2012

Petrelli, Fausto / Ghilardi, Maria / Colombo, Silvia / Stringhi, Enrico / Barbara, Cecilia / Cabiddu, Mary / Elia, Stefano / Corti, Daniela / Barni, Sandro. ·Medical Oncology Unit, Treviglio-Caravaggio Hospital, Piazzale Ospedale 1, 24047 Treviglio, Bergamo, Italy. faupe@libero.it ·J Gastrointest Cancer · Pubmed #21365478.

ABSTRACT: BACKGROUND: Hepatoid carcinoma (HC) is a rare histopathological tumor type with prominent features of hepatoid differentiation, and while most of the reported cases are of gastric origin, ten cases of pancreatic HC have been reported to date. The majority of HC cases are metastatic at presentation, mainly to the liver, lymph nodes, and lungs. They are aggressive, invading, and proliferating in the venous and lymphatic systems, with a behavior similar to that of hepatocellular carcinoma. Diagnosis is challenging: alpha-Fetoprotein, the most useful marker, is not always positive. METHODS: We present the first case of metastatic pancreatic HC treated with sorafenib, an oral multikinase inhibitor approved for advanced hepatocellular carcinoma that has antiangiogenic, pro-apoptotic, and raf-kinase inhibitory properties. RESULTS: The patient, a 37-year-old male, was diagnosed with hepatoid carcinoma of the pancreas that had metastasized to liver, lungs, and lymph nodes. The cytokeratin (CK) profile was useful for the diagnosis: Both the hepatoid and adenocarcinoma components of the tumors were CK18+, CK19+, and CK20+/-, whereas normal and neoplastic hepatocytes are CK18+, CK19-, and CK20-. Amylase, lipase, and liver enzyme levels were elevated, but bilirubin was normal. Treatment with sorafenib resulted in more than 7 months of progression-free survival. Therapy was discontinued after 8 months when his bilirubin level increased dramatically. Signs of liver failure resolved temporarily with insertion of a biliary stent, but his condition deteriorated and he died 3 months later, 1 year after diagnosis. CONCLUSION: In the absence of evidence-based experience with this rare and aggressive tumor and given its similarities with hepatocellular carcinoma, sorafenib should be considered as a possible treatment.