Background: Information about the adherence to scientific societies guidelines in the 'real-world' therapeutic management of oncological patients are lacking. This multicenter, prospective survey was aimed to improve the knowledge relative to 2017-2018 recommendations of the Italian Association of Medical Oncology (AIOM).Patients and methods: Treatment-naive adult patients with pancreatic adenocarcinoma were enrolled. Group A received adjuvant therapy, group B received primary chemotherapy, and group C had metastatic disease. The results on patients accrued until 31 October 2019 with a mature follow-up were presented.Results: Since July 2017, 833 eligible patients of 923 (90%) were enrolled in 44 Italian centers. The median age was 69 years (range 36-89 years; 24% >75 years); 48% were female; 93% had Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; group A: 16%, group B: 30%; group C: 54%; 72% Nord, 13% Center, 15% South. In group A, guidelines adherence was 68% [95% confidence interval (CI) 59% to 76%]; 53% of patients received gemcitabine and 15% gemcitabine + capecitabine; median CA19.9 was 29 (range 0-7300; not reported 15%); median survival was 36.4 months (95% CI 27.5-47.3 months). In group B, guidelines adherence was 96% (95% CI 92% to 98%); 55% of patients received nab-paclitaxel + gemcitabine, 27% FOLFIRINOX, 12% gemcitabine, and 3% clinical trial; median CA19.9 was 337 (range 0-20220; not reported 9%); median survival was 18.1 months (95% CI 15.6-19.9 months). In group C, guidelines adherence was 96% (95% CI 94% to 98%); 71% of patients received nab-paclitaxel + gemcitabine, 16% gemcitabine, 8% FOLFIRINOX, and 4% clinical trial; liver and lung metastases were reported in 76% and 23% of patients, respectively; median CA19.9 value was 760 (range 0-1374500; not reported 9%); median survival was 10.0 months (95% CI 9.1-11.1 months).Conclusions: The GARIBALDI survey shows a very high rate of adherence to guidelines and survival outcome in line with the literature. CA19.9 testing should be enhanced; nutritional and psychological counseling represent an unmet need. Enrollment to assess adherence to updated AIOM guidelines is ongoing.
Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey / Reni, M.; Giommoni, E.; Bergamo, F.; Milella, M.; Cavanna, L.; Di Marco, M. C.; Spada, M.; Cordio, S.; Aprile, G.; Cardellino, G. G.; Maiello, E.; Bernardini, I.; Ghidini, M.; Bozzarelli, S.; Macchini, M.; Orsi, G.; De Simone, I.; Rulli, Er.; Porcu, L.; Torri, V.; Pinto, C.; Reni, Michele; Macchini, Marina; Orsi, Giulia; Peretti, Umberto; Valente, Mariamaddalena; Giommoni, Elisa; Antonuzzo, Lorenzo; Di Costanzo, Francesco; Bergamo, Francesca; Zagonel, Vittorina; Lonardi, Sara; Buggin, Federica; Milella, Michele; Palmerio, Silvia; Cavanna, Luigi; Di Nunzio, Camilla; Di Marco, Maria Cristina; Grassi, Elisa; Spada, Massimiliano; Messina, Marco; Cordio, Stefano; Avola, Francesco; Aprile, Giuseppe; Pagano, Salvatore; Simionato, Francesca; Cardellino, Giovanni Gerardo; Majer, Federica; Maiello, Evaristo; Latiano, Tiziana Pia; Chiarazzo, Cinzia; Artioli, Fabrizio; Razzini, Giorgia; Pasqualini, Antonella; Ghidini, Michele; Binda, Elisa; Lazzarelli, Silvia; Bozzarelli, Silvia; Sala, Simona; Luppi, Gabriele; Pettorelli, Elisa; Spallanzani, Andrea; Vicario, Giovanni; Salmaso, Flavia; Basso, Marco; Silvestris, Nicola; Del Curatolo, Sabina; Zustovich, Fable; Bongiovanni, Francesca; Longobardi, Ciro; Sandi, Ilenia; Fontanella, Caterina; Montelatici, Silvia; Giordano, Monica; Luchena, Giovanna; Gilardoni, Micol; Tamburini, Emiliano; Rudnas, Britt; Venturini, Barbara; Merelli, Barbara; Negrini, Giorgia; Vici, Elio Maria; Marabese, Alessandra; Garetto, Cristina; Curcio, Paola; Cinieri, Saverio; Cinefra, Margherita; Ferrara, Pasqualinda; Cantore, Maurizio; Morselli, Patrizia; Fumi, Guglielmo; Isidori, Agnese; Ciccarese, Giovanni; Paolo Frassineti, Giovanni Luca; Pagan, Flavia; Vaccaro, Vanja; Spoto, Chiara; Ferrara, Marianna; Garufi, Carlo; Caporale, Marta; Vasile, Enrico; Salani, Francesca; Barone, Elisa; Berardi, Rossana; Onofri, Azzurra; Ballatore, Zelmira; Lucarelli, Alessandra; Barucca, Alessandra; Pancotti, Amedeo; Scipioni, Teresa; Bencardino, Katia; Marrapese, Giovanna; Idotta, Laura; Petrelli, Fausto; Lonati, Veronica; Ceribelli, Anna; Giuli, Angelo; Zannori, Cristina; Bassanelli, Maria; Mambrini, Andrea; Ginocchi, Laura; Orlandi, Massimo; Celio, Luigi; Niger, Monica; Biamonte, Lavinia; Tamberi, Stefano; Piancastelli, Alessandra; Papiani, Giorgio; Valli, Irene; Allione, Paolo; Boe, Maria Giovanna; Scartozzi, Mario; Lai, Eleonora; Pireddu, Annagrazia; Ziranu, Pina; Demurtas, Laura; Puzzoni, Marco; Mariani, Stefano; Pretta, Andrea; Liscia, Nicole; Savastano, Clementina; Malaspina, Valentina; Tonini, Giuseppe; Grassani, Teresa; Barco, Barbara; Pierosandro, Tagliaferri; Ciliberto, Domenico; Ierardi, Antonella; Calandruccio, Natale Daniele; Minotti, Vincenzo; Matocci, Roberta; Torri, Valter; Porcu, Luca; Rulli, Erica; De Simone, Irene; Carlucci, Luciano; Rulli, Eliana; Poli, Davide; Tonto, Paola; Scellato, Francesca; Pinto, Carmine. - In: ESMO OPEN. - ISSN 2059-7029. - 8:1(2023). [10.1016/j.esmoop.2022.100777]
Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey
Berardi, RossanaMembro del Collaboration Group
;
2023-01-01
Abstract
Background: Information about the adherence to scientific societies guidelines in the 'real-world' therapeutic management of oncological patients are lacking. This multicenter, prospective survey was aimed to improve the knowledge relative to 2017-2018 recommendations of the Italian Association of Medical Oncology (AIOM).Patients and methods: Treatment-naive adult patients with pancreatic adenocarcinoma were enrolled. Group A received adjuvant therapy, group B received primary chemotherapy, and group C had metastatic disease. The results on patients accrued until 31 October 2019 with a mature follow-up were presented.Results: Since July 2017, 833 eligible patients of 923 (90%) were enrolled in 44 Italian centers. The median age was 69 years (range 36-89 years; 24% >75 years); 48% were female; 93% had Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; group A: 16%, group B: 30%; group C: 54%; 72% Nord, 13% Center, 15% South. In group A, guidelines adherence was 68% [95% confidence interval (CI) 59% to 76%]; 53% of patients received gemcitabine and 15% gemcitabine + capecitabine; median CA19.9 was 29 (range 0-7300; not reported 15%); median survival was 36.4 months (95% CI 27.5-47.3 months). In group B, guidelines adherence was 96% (95% CI 92% to 98%); 55% of patients received nab-paclitaxel + gemcitabine, 27% FOLFIRINOX, 12% gemcitabine, and 3% clinical trial; median CA19.9 was 337 (range 0-20220; not reported 9%); median survival was 18.1 months (95% CI 15.6-19.9 months). In group C, guidelines adherence was 96% (95% CI 94% to 98%); 71% of patients received nab-paclitaxel + gemcitabine, 16% gemcitabine, 8% FOLFIRINOX, and 4% clinical trial; liver and lung metastases were reported in 76% and 23% of patients, respectively; median CA19.9 value was 760 (range 0-1374500; not reported 9%); median survival was 10.0 months (95% CI 9.1-11.1 months).Conclusions: The GARIBALDI survey shows a very high rate of adherence to guidelines and survival outcome in line with the literature. CA19.9 testing should be enhanced; nutritional and psychological counseling represent an unmet need. Enrollment to assess adherence to updated AIOM guidelines is ongoing.| File | Dimensione | Formato | |
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