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The Italian Rare Pancreatic Exocrine Cancer Initiative

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The Italian Rare Pancreatic Exocrine Cancer Initiative TMJ0010.1177/0300891619839461Tumori JournalBrunetti et al. 839461research-article2019 Tumori Clinical Trials Protocol TJ Journal Tumori Journal 1 –6 The Italian Rare Pancreatic Exocrine © Fondazione IRCCS Istituto Nazionale dei Tumori 2019 Article reuse guidelines: Cancer Initiative sagepub.com/journals-permissions DOI:https://doi.org/10.1177/0300891619839461 10.1177/0300891619839461 journals.sagepub.com/home/tmj Oronzo Brunetti1, Claudio Luchini2, Antonella Argentiero1, Stefania Tommasi3, Anita Mangia4, Giuseppe Aprile5, Paolo Marchetti6, Enrico Vasile7, Andrea Casadei Gardini8 , Mario Scartozzi9, Sandro Barni10, Sara Delfanti11, Fernando De Vita12, Francesco Di Costanzo13, Michele Milella14, Chiara Alessandra Cella15, Rossana Berardi16, Ivana Cataldo17, Daniele Santini18, Claudio Doglioni19, Evaristo Maiello20, Rita T Lawlor21, Vincenzo Mazzaferro22, Sara Lonardi23, Felice Giuliante24, Giovanni Brandi25, Aldo Scarpa2,21, Stefano Cascinu26 and Nicola Silvestris1,27 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. 17 1 Medical Oncology Unit, IRCCS Cancer Institute "Giovanni Paolo II" of Department of Pathology and Diagnostics, University of Verona Bari, Bari, Italy Hospital Trust, Policlinico GB Rossi, Verona, Italy 18 2 Medical Oncology Unit, University Campus Biomedico, Rome, Italy Department of Diagnostics and Public Health, Section of Pathology, 19 University of Verona, Verona, Italy Department of Medical Oncology, IRCCS San Raffaele Scientific 3 Institute, Milan, Italy Molecular Diagnostics and Pharmacogenetics Unit, IRCCS Istituto 20 Tumori "Giovanni Paolo II", Bari, Italy Medical Oncology Unit, IRCCS “Casa Sollievo della Sofferenza” 4 Foundation, San Giovanni Rotondo, Italy Functional Biomorphology Laboratory, IRCCS-Istituto Tumori, Bari, 21 Italy Arc-Net Centre for Applied Research on Cancer, University and 5 Hospital Trust of Verona, Verona, Italy Medical Oncology Unit, Hospital of Vicenza, Vicenza, Italy 22 6 Medical Oncology Unit, Sant’Andrea Hospital, University of Rome La Hepato-Biliary-Pancreatic Surgery, University of Milan, Istituto Sapienza, Rome, Italy Nazionale Tumori, Fondazione IRCCS, Milan, Italy 23 7 Medical Oncology Unit, IRCCS Veneto Institute of Oncology (IOV), Medical Oncology Unit, University Hospital of Pisa, Pisa, Italy 8 Padua, Italy Medical Oncology Unit, Scientific Institute of Romagna for the Study 24 and Treatment of Cancer (IRST), Meldola, Italy Hepatobiliary Surgery Unit, IRCCS A. Gemelli Polyclinic Foundation, 9 Catholic University of the Sacred Heart, Rome, Italy Medical Oncology Unit, University of Cagliari, Cagliari, Italy 25 10Medical Oncology Unit, ASST Bergamo Ovest, Treviglio, Italy Oncology Unit, Department of Experimental, Diagnostic and Specialty 11 Medical Oncology Unit, IRCCS Foundation Polyclinic San Matteo, Medicine, Sant’Orsola-Malpighi Hospital, University of Bologna, Pavia, Italy Bologna, Italy 26 12Medical Oncology Unit, II University of Naples, Naples, Italy Medical Oncology Unit, Modena Cancer Center, University Hospital 13Medical Oncology Unit, Careggi University Hospital, Florence, Italy of Modena, Modena, Italy 27 14 Medical Oncology Unit, “Regina Elena” National Cancer Institute, Scientific Direction, IRCCS Cancer Institute "Giovanni Paolo II" of Rome, Italy Bari, Bari, Italy 15 Gastrointestinal Medical Oncology and Neuroendocrine Tumors, Corresponding author: European Institute of Oncology (IEO), Milan, Italy Nicola Silvestris, Medical Oncology Unit, Cancer Institute “Giovanni 16 Medical Oncology Unit, Polytechnic University of the Marche, Paolo II,” Viale Orazio Flacco, 65, 70124 Bari, Italy. “Ospedali Riuniti Ancona,” Ancona, Italy Email: [email protected] 2 Tumori Journal 00(0) 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. Keywords Rare tumors, pancreatic cancer, chemotherapy, biomolecular characterization Date received: 11 December 2018; revised: 6 February 2019; accepted: 27 February 2019 Introduction underpinning these rare cancers may help clinicians make therapeutic choices. Furthermore, the role of immunother- Common type pancreatic ductal adenocarcinoma (PDAC) apy in these patients is largely unexplored. Previous stud- accounts for 85% of exocrine pancreatic cancers. Cystic ies showed different morphologic features and tumors represent 10% of cases, but only a minority of immunophenotypes in these cancer types,5,6 further sug- these is malignant. According to World Health Organization gesting the importance to clarify their molecular profiles in classification, the remaining exocrine pancreatic cancers order to identify potential novel prognostic biomarkers are represented by rare histotypes, comprising pancreatic and therapeutic vulnerabilities. adenosquamous carcinoma, pancreatic acinar cell carci- The recent whole genome sequencing of 456 PDAC noma, solid pseudopapillary carcinoma, undifferentiated coupled with transcriptomic profiling has furnished infor- carcinoma and its variant with osteoclast-like giant cells mation on their most frequently altered genes and the path- (UCOGC), signet ring cell carcinoma, medullary carci- ways in which they participate, in addition to the noma, pancreatoblastoma, hepatoid carcinoma, and carci- identification of four different cancer subtypes (ADEX, nosarcoma.1 Due to the low incidence of these malignancies, progenitor, squamous, and immunogenic) with potentially their clinical features are usually reported only in case diverse prognosis and response to therapy.7,8 PDAC reports or in small series of retrospective observational molecular subtypes, some of which also were defined studies.2,3 Notably, patients with these rare pancreatic can- using immunohistochemical markers, have been associ- cers are excluded from clinical trials. The clinical dilemma ated with differing response to chemotherapies.9–11 Since in the management of patients with rare pancreas cancers tissue DNA and RNA sets of biomarkers able to identify at advanced stage is as follows: Do chemotherapy regi- molecular subtypes of PDAC were identified in previous mens recommended for PDAC have a clinical activity or studies,7,8 we are generating clinically applicable tests should other therapeutic approaches (different chemother- working on DNA and RNA from paraffin tissue speci- apy combinations, targeted therapies, immunotherapy) be mens, which are the sole source of material for rare pan- considered? creatic cancer. The molecular subclassification of cancers To attempt to address this question, we conducted a entails the molecular characterization of both the cancer multicentric retrospective study that evaluated the efficacy cells and the cells populating cancer tissue microenviron- of different chemotherapy regimens used over time in ment. Tissue biomarkers include next-generation sequenc- patients with advanced stage rare pancreatic cancer types.4 ing (NGS) mutational panels and expression profile Of 4300 exocrine pancreatic cancer patients, 79 advanced nanostring panels capable of classifying these tumours cases affected by rare histologic types were identified, into discrete molecular subgroups. The design and applica- including 23 pancreatic acinar cell cancers, 16 pancreatic tion of NGS mutational panels interrogating the molecular adenosquamous cancers, and 15 mucinous cystic neo- asset of cancer cells applicable to paraffin tissues has been plasms with an associated invasive component. In this amply applied by Scarpa et al.12 and others.13,14 Moreover, study, no statistical significance correlation had been PDAC is characterized by a microenvironment of varying found for survival in relation with the different chemother- cell composition, often rich with cancer-associated fibro- apy regimens used, due to the small sample. Moreover, blasts (CAFs) and tumour-associated macrophages because of their rarity, many clinicopathologic features (TAMs) that play a crucial role in immune regulation remain unclear, and prognostic factors
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