Browsing by Author "Caputo, Damiano"

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    Pathological Complete Response in Patients With Resected Pancreatic Adenocarcinoma After Preoperative Chemotherapy
    (American Medical Association, 2024-06-03) Stoop, Thomas F.; Oba, Atsushi; Wu, Y. H. Andrew; Beaty, Laurel E.; Colborn, Kathryn L.; Janssen, Boris V.; Al-Musawi, Mohammed H.; Rodriguez Franco, Salvador; Sugawara, Toshitaka; Franklin, Oskar; Jain, Ajay; Saiura, Akio; Sauvanet, Alain; Coppola, Alessandro; Javed, Ammar A.; Groot Koerkamp, Bas; Miller, Braden N.; Mack, Claudia E.; Hashimoto, Daisuke; Caputo, Damiano; Kleive, Dyre; Sereni, Elisabetta; Belfiori, Giulio; Ichida, Hirofumi; van Dam, Jacob L.; Dembinski, Jeanne; Akahoshi, Keiichi; Roberts, Keith J.; Tanaka, Kimitaka; Labori, Knut J.; Falconi, Massimo; House, Michael G.; Sugimoto, Motokazu; Tanabe, Minoru; Gotohda, Naoto; Krohn, Paul S.; Burkhart, Richard A.; Thakkar, Rohan G.; Pande, Rupaly; Dokmak, Safi; Hirano, Satoshi; Burgdorf, Stefan K.; Crippa, Stefano; van Roessel, Stijn; Satoi, Sohei; White, Steven A.; Hackert, Thilo; Nguyen, Trang K.; Yamamoto, Tomohisa; Nakamura, Toru; Bachu, Vismaya; Burns, William R.; Inoue, Yosuke; Takahashi, Yu; Ushida, Yuta; Aslami, Zohra V.; Verbeke, Caroline S.; Fariña, Arantza; He, Jin; Wilmink, Johanna W.; Messersmith, Wells; Verheij, Joanne; Kaplan, Jeffrey; Schulick, Richard D.; Besselink, Marc G.; Del Chiaro, Marco; Surgery, School of Medicine
    Importance: Preoperative chemo(radio)therapy is increasingly used in patients with localized pancreatic adenocarcinoma, leading to pathological complete response (pCR) in a small subset of patients. However, multicenter studies with in-depth data about pCR are lacking. Objective: To investigate the incidence, outcome, and risk factors of pCR after preoperative chemo(radio)therapy. Design, setting, and participants: This observational, international, multicenter cohort study assessed all consecutive patients with pathology-proven localized pancreatic adenocarcinoma who underwent resection after 2 or more cycles of chemotherapy (with or without radiotherapy) in 19 centers from 8 countries (January 1, 2010, to December 31, 2018). Data collection was performed from February 1, 2020, to April 30, 2022, and analyses from January 1, 2022, to December 31, 2023. Median follow-up was 19 months. Exposures: Preoperative chemotherapy (with or without radiotherapy) followed by resection. Main outcomes and measures: The incidence of pCR (defined as absence of vital tumor cells in the sampled pancreas specimen after resection), its association with OS from surgery, and factors associated with pCR. Factors associated with overall survival (OS) and pCR were investigated with Cox proportional hazards and logistic regression models, respectively. Results: Overall, 1758 patients (mean [SD] age, 64 [9] years; 879 [50.0%] male) were studied. The rate of pCR was 4.8% (n = 85), and pCR was associated with OS (hazard ratio, 0.46; 95% CI, 0.26-0.83). The 1-, 3-, and 5-year OS rates were 95%, 82%, and 63% in patients with pCR vs 80%, 46%, and 30% in patients without pCR, respectively (P < .001). Factors associated with pCR included preoperative multiagent chemotherapy other than (m)FOLFIRINOX ([modified] leucovorin calcium [folinic acid], fluorouracil, irinotecan hydrochloride, and oxaliplatin) (odds ratio [OR], 0.48; 95% CI, 0.26-0.87), preoperative conventional radiotherapy (OR, 2.03; 95% CI, 1.00-4.10), preoperative stereotactic body radiotherapy (OR, 8.91; 95% CI, 4.17-19.05), radiologic response (OR, 13.00; 95% CI, 7.02-24.08), and normal(ized) serum carbohydrate antigen 19-9 after preoperative therapy (OR, 3.76; 95% CI, 1.79-7.89). Conclusions and relevance: This international, retrospective cohort study found that pCR occurred in 4.8% of patients with resected localized pancreatic adenocarcinoma after preoperative chemo(radio)therapy. Although pCR does not reflect cure, it is associated with improved OS, with a doubled 5-year OS of 63% compared with 30% in patients without pCR. Factors associated with pCR related to preoperative chemo(radio)therapy regimens and anatomical and biological disease response features may have implications for treatment strategies that require validation in prospective studies because they may not universally apply to all patients with pancreatic adenocarcinoma.
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    REDISCOVER International Guidelines on the Perioperative Care of Surgical Patients With Borderline-resectable and Locally Advanced Pancreatic Cancer
    (Wolters Kluwer, 2024) Boggi, Ugo; Kauffmann, Emanuele; Napoli, Niccolò; Barreto, George; Besselink, Marc G.; Fusai, Giuseppe K.; Hackert, Thilo; Hilal, Mohammad Abu; Marchegiani, Giovanni; Salvia, Roberto; Shrikhande, Shailesh V.; Truty, Mark; Werner, Jens; Wolfgang, Christopher L.; Bannone, Elisa; Capretti, Giovanni; Cattelani, Alice; Coppola, Alessandro; Cucchetti, Alessandro; De Sio, Davide; Di Dato, Armando; Di Meo, Giovanna; Fiorillo, Claudio; Gianfaldoni, Cesare; Ginesini, Michael; Hidalgo Salinas, Camila; Lai, Quirino; Miccoli, Mario; Montorsi, Roberto; Pagnanelli, Michele; Poli, Andrea; Ricci, Claudio; Sucameli, Francesco; Tamburrino, Domenico; Viti, Virginia; Addeo, Pietro F.; Alfieri, Sergio; Bachellier, Philippe; Baiocchi, Gian Luca; Balzano, Gianpaolo; Barbarello, Linda; Brolese, Alberto; Busquets, Juli; Butturini, Giovanni; Caniglia, Fabio; Caputo, Damiano; Casadei, Riccardo; Chunhua, Xi; Colangelo, Ettore; Coratti, Andrea; Costa, Francesca; Crafa, Francesco; Dalla Valle, Raffaele; De Carlis, Luciano; de Wilde, Roeland F.; Del Chiaro, Marco; Di Benedetto, Fabrizio; Di Sebastiano, Pierluigi; Dokmak, Safi; Hogg, Melissa; Egorov, Vyacheslav I.; Ercolani, Giorgio; Ettorre, Giuseppe Maria; Falconi, Massimo; Ferrari, Giovanni; Ferrero, Alessandro; Filauro, Marco; Giardino, Alessandro; Grazi, Gian Luca; Gruttadauria, Salvatore; Izbicki, Jakob R.; Jovine, Elio; Katz, Matthew; Keck, Tobias; Khatkov, Igor; Kiguchi, Gozo; Kooby, David; Lang, Hauke; Lombardo, Carlo; Malleo, Giuseppe; Massani, Marco; Mazzaferro, Vincenzo; Memeo, Riccardo; Miao, Yi; Mishima, Kohei; Molino, Carlo; Nagakawa, Yuichi; Nakamura, Masafumi; Nardo, Bruno; Panaro, Fabrizio; Pasquali, Claudio; Perrone, Vittorio; Rangelova, Elena; Liu, Rong; Romagnoli, Renato; Romito, Raffaele; Rosso, Edoardo; Schulick, Richard; Siriwardena, Ajith; Spampinato, Marcello Giuseppe; Strobel, Oliver; Testini, Mario; Troisi, Roberto Ivan; Uzunoglo, Faik G.; Valente, Roberto; Veneroni, Luigi; Zerbi, Alessandro; Vicente, Emilio; Vistoli, Fabio; Vivarelli, Marco; Wakabayashi, Go; Zanus, Giacomo; Zureikat, Amer; Zyromski, Nicholas J.; Coppola, Roberto; D'Andrea, Vito; Davide, José; Dervenis, Christos; Frigerio, Isabella; Konlon, Kevin C.; Michelassi, Fabrizio; Montorsi, Marco; Nealon, William; Portolani, Nazario; Sousa Silva, Donzília; Bozzi, Giuseppe; Ferrari, Viviana; Trivella, Maria G.; Cameron, John; Clavien, Pierre-Alain; Asbun, Horacio J.; REDISCOVER Multidisciplinary Advisory Board; Surgery, School of Medicine
    Objective: The REDISCOVER consensus conference aimed at developing and validating guidelines on the perioperative care of patients with borderline-resectable (BR-) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC). Background: Coupled with improvements in chemotherapy and radiation, the contemporary approach to pancreatic surgery supports the resection of BR-PDAC and, to a lesser extent, LA-PDAC. Guidelines outlining the selection and perioperative care for these patients are lacking. Methods: The Scottish Intercollegiate Guidelines Network (SIGN) methodology was used to develop the REDISCOVER guidelines and create recommendations. The Delphi approach was used to reach a consensus (agreement ≥80%) among experts. Recommendations were approved after a debate and vote among international experts in pancreatic surgery and pancreatic cancer management. A Validation Committee used the AGREE II-GRS tool to assess the methodological quality of the guidelines. Moreover, an independent multidisciplinary advisory group revised the statements to ensure adherence to nonsurgical guidelines. Results: Overall, 34 recommendations were created targeting centralization, training, staging, patient selection for surgery, possibility of surgery in uncommon scenarios, timing of surgery, avoidance of vascular reconstruction, details of vascular resection/reconstruction, arterial divestment, frozen section histology of perivascular tissue, extent of lymphadenectomy, anticoagulation prophylaxis, and role of minimally invasive surgery. The level of evidence was however low for 29 of 34 clinical questions. Participants agreed that the most conducive means to promptly advance our understanding in this field is to establish an international registry addressing this patient population ( https://rediscover.unipi.it/ ). Conclusions: The REDISCOVER guidelines provide clinical recommendations pertaining to pancreatectomy with vascular resection for patients with BR-PDAC and LA-PDAC, and serve as the basis of a new international registry for this patient population.