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Pancreatic Neoplasms: HELP
Articles by Roberto Labianca
Based on 13 articles published since 2008

Between 2008 and 2019, R. Labianca wrote the following 13 articles about Pancreatic Neoplasms.
+ Citations + Abstracts
1 Guideline Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease. 2018

Ter Veer, Emil / van Rijssen, L Bengt / Besselink, Marc G / Mali, Rosa M A / Berlin, Jordan D / Boeck, Stefan / Bonnetain, Franck / Chau, Ian / Conroy, Thierry / Van Cutsem, Eric / Deplanque, Gael / Friess, Helmut / Glimelius, Bengt / Goldstein, David / Herrmann, Richard / Labianca, Roberto / Van Laethem, Jean-Luc / Macarulla, Teresa / van der Meer, Jonathan H M / Neoptolemos, John P / Okusaka, Takuji / O'Reilly, Eileen M / Pelzer, Uwe / Philip, Philip A / van der Poel, Marcel J / Reni, Michele / Scheithauer, Werner / Siveke, Jens T / Verslype, Chris / Busch, Olivier R / Wilmink, Johanna W / van Oijen, Martijn G H / van Laarhoven, Hanneke W M. ·Department of Medical Oncology, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, Netherlands. · Department of Surgery, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, Netherlands. · Department of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN, USA. · Department of Internal Medicine III, Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany. · Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France. · Royal Marsden NHS Foundation Trust, London and Surrey, UK. · Department of Medical Oncology, Institut de Cancérologie de Lorraine and Lorraine University, Vandoeuvre-lès-Nancy, France. · Department of Gastroenterology and Digestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium. · Department of Oncology, Hôpital Riviera-Chablais, Vevey, Switzerland. · Department of Surgery, Technical University of Munich, Klinikum rechts der Isar, Munich, Germany. · Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden. · Nelune Cancer Centre, Prince of Wales Hospital, Prince of Wales Clinical School University of New South Wales, Randwick, NSW, Australia. · Department of Medical Oncology, University Hospital Basel, Basel, Switzerland. · Cancer Center, ASST Papa Giovanni XXIII, Bergamo, Italy. · Department of Gastroenterology, Gastrointestinal Cancer Unit, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium. · Vall d'Hebron University Hospital (HUVH), Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. · Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK. · Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. · Gastrointestinal Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA. · Department of Hematology, Oncology and Tumor Immunology, Charité-Universitätsmedizin Berlin, Berlin, Germany; Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany. · Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, MI, USA. · Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Internal Medicine I, Medical University Vienna, Vienna, Austria. · Division of Solid Tumor Translational Oncology, West German Cancer Cancer, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK, partner site Essen) and German Cancer Research Center, DKFZ, Heidelberg, Germany. · Department of Digestive Oncology, University Hospitals Leuven, Leuven, Belgium. · Department of Medical Oncology, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, Netherlands. Electronic address: h.vanlaarhoven@amc.uva.nl. ·Lancet Oncol · Pubmed #29508762.

ABSTRACT: Variations in the reporting of potentially confounding variables in studies investigating systemic treatments for unresectable pancreatic cancer pose challenges in drawing accurate comparisons between findings. In this Review, we establish the first international consensus on mandatory baseline and prognostic characteristics in future trials for the treatment of unresectable pancreatic cancer. We did a systematic literature search to find phase 3 trials investigating first-line systemic treatment for locally advanced or metastatic pancreatic cancer to identify baseline characteristics and prognostic variables. We created a structured overview showing the reporting frequencies of baseline characteristics and the prognostic relevance of identified variables. We used a modified Delphi panel of two rounds involving an international panel of 23 leading medical oncologists in the field of pancreatic cancer to develop a consensus on the various variables identified. In total, 39 randomised controlled trials that had data on 15 863 patients were included, of which 32 baseline characteristics and 26 prognostic characteristics were identified. After two consensus rounds, 23 baseline characteristics and 12 prognostic characteristics were designated as mandatory for future pancreatic cancer trials. The COnsensus statement on Mandatory Measurements in unresectable PAncreatic Cancer Trials (COMM-PACT) identifies a mandatory set of baseline and prognostic characteristics to allow adequate comparison of outcomes between pancreatic cancer studies.

2 Guideline Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials). 2014

Bonnetain, Franck / Bonsing, Bert / Conroy, Thierry / Dousseau, Adelaide / Glimelius, Bengt / Haustermans, Karin / Lacaine, François / Van Laethem, Jean Luc / Aparicio, Thomas / Aust, Daniela / Bassi, Claudio / Berger, Virginie / Chamorey, Emmanuel / Chibaudel, Benoist / Dahan, Laeticia / De Gramont, Aimery / Delpero, Jean Robert / Dervenis, Christos / Ducreux, Michel / Gal, Jocelyn / Gerber, Erich / Ghaneh, Paula / Hammel, Pascal / Hendlisz, Alain / Jooste, Valérie / Labianca, Roberto / Latouche, Aurelien / Lutz, Manfred / Macarulla, Teresa / Malka, David / Mauer, Muriel / Mitry, Emmanuel / Neoptolemos, John / Pessaux, Patrick / Sauvanet, Alain / Tabernero, Josep / Taieb, Julien / van Tienhoven, Geertjan / Gourgou-Bourgade, Sophie / Bellera, Carine / Mathoulin-Pélissier, Simone / Collette, Laurence. ·Methodology and Quality of Life Unit in Cancer, EA 3181, University Hospital of Besançon and CTD-INCa Gercor, UNICNCER GERICO, Besançon, France. Electronic address: franck.bonnetain@univ-fcomte.fr. · Leiden University Medical Center, Leiden, Netherlands. · Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-les-Nancy, France. · Bordeaux Segalen University & CHRU, Bordeaux, France. · Department of Radiology, Oncology and Radiation Science, Uppsala University, Uppsala, Sweden. · Department of Radiation Oncology, Leuven, Belgium. · Digestive Surgical Department, Tenon hospital, Paris, France. · Gastro Intestinal Cancer Unit Erasme Hospital Brussels, Belgium. · Gastroenterology Department, Avicenne Hospital, Paris 13, Bobigny, France. · Institute for Pathology, University Hospital Carl-Gustav-Carus, Dresden, Germany. · Surgical and Gastroenterological Department, Endocrine and Pancreatic Unit, Hospital of 'G.B.Rossi', University of Verona, Italy. · Institut de Cancérologie de l'Ouest - Centre Paul Papin Centre de Lutte Contre le Cancer (CLCC), Angers, France. · Biostatistics Unit, Centre Antoine Lacassagne, Nice, France. · Oncology Department, Hôpital Saint-Antoine & CTD-INCa GERCOR, Assistance Publique des Hôpitaux de Paris, UPMC Paris VI, Paris, France. · Gastroenterology Department, Hopital la Timone, Assitance publique des Hopitaux de Marseille, Marseille, France. · Department of Surgery, Institut Paoli Calmettes, Marseille, France. · Department of Surgery, Agia Olga Hospital, Athens, Greece. · Department of Gastroenterology, Institut Gustave Roussy, Villejuif, France. · Biostatistician, Biostatistics Unit, Centre Antoine Lacassagne, Nice, France. · Department of Radiotherapy, Institut fuer Radioonkologie, Vienna, Austria. · Department of Surgical Oncology, Royal Liverpool Hospital, United Kingdom. · Department of Gastroenterology, Beaujon Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France. · Digestive Oncology and Gastro-enterology Department, Jules Bordet Institute, Brussels, Belgium. · Digestive Cancer Registry, INSERM U866, Dijon, France. · Medical Oncology Unit, Ospedali Riuniti di Bergamo, Bergame, Italy. · Inserm, Centre for Research in Epidemiology and Population Health, U1018, Biostatistics Team, Villejuif, France. · Gastroenterology Department, Caritas Hospital, Saarbrücken, Germany. · Department of the Gastrointestinal Tumors and Phase I Unit, Vall d'Hebron University Hospital, Barcelona, Spain. · Statistics Department, EORTC, Brussels, Belgium. · Department of Medical Oncology, Institut Curie, Hôpital René Huguenin, Saint-Cloud, France. · Division of Surgery and Oncology at the University of Liverpool and Royal Liverpool University Hospital, Liverpool, United Kingdom. · Department of Digestive Surgery, Universitu Hospital Strasbourg, France. · Department of Hepato-pancreatic and Biliary Surgery, Beaujon Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France. · Department of Hepato-gastroenterology and Digestive Oncology, Georges Pompidou European hospital, Paris, France. · Department of Radiation Oncology, Academisch Medisch Centrum, Amsterdam, The Netherlands. · Institut Du Cancer de Montpellier, Comprehensive Cancer Centre, and Data Center for Cancer Clinical Trials, CTD-INCa, Montpellier, France. · Clinical and Epidemiological Research Unit, Institut Bergonie, Comprehensive Cancer Centre, Bordeaux, France; Data Center for Cancer Clinical Trials, CTD-INCa, Bordeaux, France; INSERM, Centre d'Investigation Clinique - Épidémiologie Clinique CIC-EC 7, F-33000 Bordeaux, France. ·Eur J Cancer · Pubmed #25256896.

ABSTRACT: BACKGROUND: Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. METHODS: Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). RESULTS: For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. CONCLUSION: The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer.

3 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 / Anonymous4740910. ·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.

4 Review Addressing the challenges of pancreatic cancer: future directions for improving outcomes. 2015

Hidalgo, Manuel / Cascinu, Stefano / Kleeff, Jörg / Labianca, Roberto / Löhr, J-Matthias / Neoptolemos, John / Real, Francisco X / Van Laethem, Jean-Luc / Heinemann, Volker. ·Centro Nacional de Investigaciones Oncológicas (CNIO), Madrid, Spain. Electronic address: mhidalgo@cnio.es. · Department of Medical Oncology, University of Ancona, Ancona, Italy. · Department of General Surgery, Technische Universität München, Munich, Germany. · Ospedale Papa Giovanni XXIII, Bergamo, Italy. · Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden. · National Institutes of Health Research Liverpool Pancreas Biomedical Research Unit and Cancer Research UK Liverpool Clinical Trials Unit Director, University of Liverpool and Royal Liverpool University Hospital, Liverpool, UK. · Centro Nacional de Investigaciones Oncológicas (CNIO), Madrid and Universitat Pompeu Fabra, Barcelona, Spain. · Department of Gastroenterology-GI Cancer Unit, Erasme University Hospital, Brussels, Belgium. · Comprehensive Cancer Centre Munich, Klinikum der Universität München, Munich, Germany. ·Pancreatology · Pubmed #25547205.

ABSTRACT: Pancreatic ductal adenocarcinoma (PDAC), which accounts for more than 90% of all pancreatic tumours, is a devastating malignancy with an extremely poor prognosis, as shown by a 1-year survival rate of around 18% for all stages of the disease. The low survival rates associated with PDAC primarily reflect the fact that tumours progress rapidly with few specific symptoms and are thus at an advanced stage at diagnosis in most patients. As a result, there is an urgent need to develop accurate markers of pre-invasive pancreatic neoplasms in order to facilitate prediction of cancer risk and to help diagnose the disease at an earlier stage. However, screening for early diagnosis of prostate cancer remains challenging and identifying a highly accurate, low-cost screening test for early PDAC for use in clinical practice remains an important unmet need. More effective therapies are also crucial in PDAC, since progress in identifying novel therapies has been hampered by the genetic complexity of the disease and treatment remains a major challenge. Presently, the greatest step towards improved treatment efficacy has been made in the field of palliative chemotherapy by introducing FOLFIRINOX (folinic acid, 5-fluorouracil, irinotecan and oxaliplatin) and gemcitabine/nab-paclitaxel. Strategies designed to raise the profile of PDAC in research and clinical practice are a further requirement in order to ensure the best treatment for patients. This article proposes a number of approaches that may help to accelerate progress in treating patients with PDAC, which, in turn, may be expected to improve the quality of life and survival for those suffering from this devastating disease.

5 Review Venous thromboembolism and pancreatic cancer: incidence, pathogenesis and clinical implications. 2008

Mandalà, Mario / Moro, Cecilia / Labianca, Roberto. ·Unit of Medical Oncology, Ospedali Riuniti, Bergamo, Italy. mariomandala@tin.it ·Onkologie · Pubmed #18322417.

ABSTRACT: Pancreatic cancer is still a major clinical challenge. Recent efforts to improve survival in locally advanced and metastatic disease have focused on combining cytotoxic drugs with targeted therapies. One of the major complications of pancreatic cancer is venous thromboembolism (VTE). Despite the general perception that patients with mucinous carcinoma of the pancreas and gastrointestinal tract present a high incidence of thromboembolic complications, there is little data regarding the incidence and pathogenesis of VTE in pancreatic cancer patients. Clinical data suggest that, among patients with unresectable pancreatic cancer, the occurrence of VTE may be associated with reduced overall survival. Furthermore emerging clinical data strongly suggest that anticoagulant treatments may improve cancer patient survival by decreasing thromboembolic complications as well as by anticancer effects. Given the lack of extensive data and the clinical relevance of this topic for both physicians and basic research scientists, this overview focuses attention on the incidence, pathogenesis and clinical implications of VTE in pancreatic cancer patients.

6 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.

7 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.

8 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.

9 Clinical Trial Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. 2010

Colucci, Giuseppe / Labianca, Roberto / Di Costanzo, Francesco / Gebbia, Vittorio / Cartenì, Giacomo / Massidda, Bruno / Dapretto, Elisa / Manzione, Luigi / Piazza, Elena / Sannicolò, Mirella / Ciaparrone, Marco / Cavanna, Luigi / Giuliani, Francesco / Maiello, Evaristo / Testa, Antonio / Pederzoli, Paolo / Falconi, Massimo / Gallo, Ciro / Di Maio, Massimo / Perrone, Francesco / Anonymous600652 / Anonymous610652 / Anonymous620652. ·Medical and Experimental Oncology Unit, Oncology Institute Giovanni Paolo II, Bari, Italy. ·J Clin Oncol · Pubmed #20194854.

ABSTRACT: PURPOSE: Single-agent gemcitabine became standard first-line treatment for advanced pancreatic cancer after demonstration of superiority compared with fluorouracil. The Gruppo Italiano Pancreas 1 randomized phase III trial aimed to compare gemcitabine plus cisplatin versus gemcitabine alone (ClinicalTrials.gov ID NCT00813696). PATIENTS AND METHODS: Patients with locally advanced or metastatic pancreatic cancer, age 18 to 75 years, and Karnofsky performance status (KPS) > or = 50, were randomly assigned to receive gemcitabine (arm A) or gemcitabine plus cisplatin (arm B). Arm A: gemcitabine 1,000 mg/m(2) weekly for 7 weeks, and, after a 1-week rest, on days 1, 8, and 15 every 4 weeks. Arm B: cisplatin 25 mg/m(2) added weekly to gemcitabine, except cycle 1 day 22. Primary end point was overall survival. To have 8% power of detecting a 0.74 hazard ratio (HR) of death, with bilateral alpha .05, 355 events were needed and 400 patients planned. RESULTS: Four hundred patients were enrolled (arm A: 199; arm B: 201). Median age was 63, 59% were male, 84% had stage IV, and 83% had KPS > or = 80. Median overall survival was 8.3 months versus 7.2 months in arm A and B, respectively (HR, 1.10; 95% CI, 0.89 to 1.35; P = .38). Median progression-free survival was 3.9 months versus 3.8 months in arm A and B, respectively (HR, 0.97; 95% CI, 0.80 to 1.19; P = .80). The objective response rate was 10.1% in A and 12.9% in B (P = .37). Clinical benefit was experienced by 23.0% in A and 15.1% in B (P = .057). Combination therapy produced more hematologic toxicity, without relevant differences in nonhematologic toxicity. CONCLUSION: The addition of weekly cisplatin to gemcitabine failed to demonstrate any improvement as first-line treatment of advanced pancreatic cancer.

10 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 / Anonymous11560889. ·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.

11 Article Clinical and molecular determinants of survival in pancreatic cancer patients treated with second-line chemotherapy: results of an Italian/Swiss multicenter survey. 2010

Mancuso, A / Sacchetta, S / Saletti, P C / Tronconi, C / Milesi, L / Garassino, M / Martelli, O / Leone, A / Zivi, A / Cerbone, L / Recine, F / Sollami, R / Labianca, R / Cavalli, F / Sternberg, C N. ·Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy. mancusoan@gmail.com ·Anticancer Res · Pubmed #21036754.

ABSTRACT: BACKGROUND: Increased knowledge about the treatment of pancreatic cancer has influenced the management of locally advanced and metastatic disease. Nonetheless, prognosis remains dismal (24%, 1-year survival). The impact on overall survival (OS) of second-line therapy has not been clarified and the use of platinum salts and/or fluoropyrimidines is hotly debated. It is the hope that future treatment can be tailored to predict chemosensitivity in order to improve outcomes in patients with locally advanced and metastatic pancreatic cancer. Since DNA-damaging agents could be one therapeutic option, a retrospective multicenter study was performed to evaluate the efficacy of salvage treatment with the hypothesis that levels of the DNA repair gene excision repair cross complementing 1 (ERCC1) could influence OS. PATIENTS AND METHODS: In a population of 160 patients treated with fluoropyrimidine-based second-line chemotherapy, expression levels of ERCC1 were determined by immunohistochemistry and reverse transcription-polymerase chain reaction (RT-PCR). In 108 patients with locally advanced and metastatic pancreatic cancer treated with either fluoropyrimidines and platinum salts (group A=58) or fluoropyrimidines alone (group B=50), ERCC1 levels were correlated with OS, time to progression and response to chemotherapy. RESULTS: Median survival was significantly higher in group A with low ERCC1 levels [11.9 versus 9.9 months; p ≤ 0.05] (median follow-up 24 months). Moreover in the same group, a trend towards longer time to progression was observed. No differences in OS were observed when ERCC1 was studied (low versus high) in patients not treated with platinum salts. On multivariate analysis of pretreatment prognostic factors, ERCC1 emerged as an independent predictive factor for OS. CONCLUSION: The results of this study indicate that ERCC1 may predict survival in pancreatic cancer patients treated by platinum and fluoropyrimidine as second-line chemotherapy.

12 Article Meta-analysis of randomized trials: evaluation of benefit from gemcitabine-based combination chemotherapy applied in advanced pancreatic cancer. 2008

Heinemann, Volker / Boeck, Stefan / Hinke, Axel / Labianca, Roberto / Louvet, Christophe. ·Department of Internal Medicine III, Klinikum Grosshadern, University of Munich, Germany. volker.heinemann@med.uni-muenchen.de ·BMC Cancer · Pubmed #18373843.

ABSTRACT: BACKGROUND: Single-agent gemcitabine (GEM) is a standard treatment for advanced and metastatic pancreatic cancer. This study examines the question whether GEM-based combination chemotherapy can further improve treatment efficacy. METHODS: A meta-analysis was performed to evaluate randomized trials comparing GEM versus GEM+X (X = cytotoxic agent). Fifteen trials including 4465 patients were eligible for an analysis of overall survival, the primary end-point of this investigation. RESULTS: The meta-analysis revealed a significant survival benefit for GEM+X with a pooled hazard ratio (HR) of 0.91 (95% CI: 0.85 - 0.97, p = 0.004). The overall test for heterogeneity resulted in p = 0.82 (I2 = 0%). The analysis of platinum-based combinations indicated a HR of 0.85 (95% CI: 0.76 - 0.96, p = 0.010), while for fluoropyrimidine-based combinations the HR was 0.90 (95% CI: 0.81 - 0.99, p = 0.030). No risk reduction was observed in the group of trials combining GEM with irinotecan, exatecan or pemetrexed (HR = 0.99). A meta-analysis of the trials with adequate information on baseline performance status (PS) was performed in five trials with 1682 patients. This analysis indicated that patients with a good PS had a marked survival benefit when receiving combination chemotherapy (HR = 0.76; 95% CI: 0.67 - 0.87; p < 0.0001). By contrast, application of combination chemotherapy to patients with an initially poor PS appeared to be ineffective (HR = 1.08; 95% CI: 0.90 - 1.29, p = 0.40). CONCLUSION: The meta-analysis of randomized trials indicated a significant survival benefit when GEM was either combined with platinum analogs or fluoropyrimidines. Based on a preliminary subgroup analysis (representing 38% of all patients included in this meta-analysis), pancreatic cancer patients with a good PS appear to benefit from GEM-based cytotoxic combinations, whereas patients with a poor PS seem to have no survival benefit from combination chemotherapy.

13 Unspecified Treatment of advanced pancreatic cancer. 2012

Labianca, R / Merelli, B / Mosconi, S. ·Department of Oncology and Hematology, Ospedali Riuniti, Bergamo, Italy. rlabian@tin.it ·Ann Oncol · Pubmed #22987950.

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