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, Michele; Bernardini, Ilaria; Rulli, Er.; Macchini, Marina; Orsi, Giulia; Peretti, Umberto; Valente, Mariamaddalena; Giommoni, Elisa; Antonuzzo, Lorenzo; Costanzo, Francesco Di; Bergamo, Francesca; Zagonel, Vittorina; Lonardi, Sara; Buggin, Federica; Milella, Michèle; Palmerio, Silvia; Cavanna, Luigi; Nunzio, Camilla Di; Marco, Maria Cristina Di; Grassi, Elisa; Spada, Massimiliano; Messina, Marco; Cordio, S.; 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, F.; Basso, Marco; Silvestris, Nicola; Curatolo, Sabina Del; Zustovich, Fable; Bongiovanni, Francesca; Longobardi, Ciro; Sandi, Ilenia; Fontanella, Caterina; Montelatici, Silvia; Giordano, Monica; Luchena, Giovanna; Gilardoni, Micol; Tamburini, Emiliano; Rudnas, Britt; Venturini, B.; Merelli, Barbara; Negrini, Giorgia; Vici, Elio Maria; Marabese, Alessandra; Garetto, Cristina; Curcio, Paola; Cinieri, Saverio; Cinefra, M.; Ferrara, Pasqualinda; Cantore, Maurizio; Morselli, Patrizia; Fumi, Guglielmo; Isidori, Agnese; Ciccarese, Giovanni; 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, A.; Zannori, Cristina; Bassanelli, Maria; Mambrini, Andrea; Ginocchi, Laura; Orlandi, M.; Celio, Luigi; Niger, Monica; Biamonte, Lavinia; Tamberi, Stefano; Piancastelli, A; Papiani, Giorgio; Valli, Irene; Allione, P.; 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; Tagliaferri, Pierosandro; Ciliberto, Domenico; Ierardi, Antonella; Calandruccio, Natale Daniele; Minotti, Vincenzo; Matocci, Roberta; Torri, Valter; Porcu, Luca; Rulli, Erica; Simone, Irene De; Carlucci, Luciano; Rulli, Eliana; Poli, Davide; Tonto, Paola; Scellato, Francesca; Pinto, Carmine

doi:10.1016/j.esmoop.2022.100777

Cited by 4 publications

(2 citation statements)

References 19 publications

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“…Overall, FOLFIRINOX has historically been reported to provide higher ORR and superior survival outcomes at the cost of greater toxic effects compared with GEM-NABP, although without a formal head-to-head comparison . As a result, there is heterogeneity in the choice of the appropriate first-line of treatment in daily clinical practice, with GEM-NABP administered to a wider patient population, while FOLFIRINOX is preferred for carefully selected patients, according to country-specific prescription regulations, patient age, clinical conditions, and treatment aim (eg, disease control vs tumor shrinkage) . With the introduction of NALIRIFOX as a new active regimen in this setting, there is an ongoing debate on how this regimen compares with the very similar FOLFIRINOX.…”

Section: Discussionmentioning

confidence: 99%

NALIRIFOX, FOLFIRINOX, and Gemcitabine With Nab-Paclitaxel as First-Line Chemotherapy for Metastatic Pancreatic Cancer

Nichetti,

Rota,

Ambrosini

et al. 2024

JAMA Netw Open

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ImportanceThe NAPOLI 3 trial showed the superiority of fluorouracil, leucovorin, liposomal irinotecan, and oxaliplatin (NALIRIFOX) over the combination of gemcitabine and nab-paclitaxel (GEM-NABP) as first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC). Analyses comparing NALIRIFOX and GEM-NABP with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) have not yet been reported.ObjectiveTo derive survival, response, and toxic effects data from phase 3 clinical trials and compare NALIRIFOX, FOLFIRINOX, and GEM-NABP.Data SourcesAfter a systematic search of PubMed, Scopus, Embase, and American Society of Clinical Oncology and European Society for Medical Oncology meetings’ libraries, Kaplan-Meier curves were extracted from phase 3 clinical trials conducted from January 1, 2011, until September 12, 2023.Study SelectionPhase 3 clinical trials that tested NALIRIFOX, FOLFIRINOX, or GEM-NABP as first-line treatment of metastatic PDAC and reported overall survival (OS) and progression-free survival (PFS) curves were selected. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses of Individual Participant Data reporting guidelines.Data Extraction And SynthesisIndividual patient OS and PFS data were extracted from Kaplan-Meier plots of original trials via a graphic reconstructive algorithm. Overall response rates (ORRs) and grade 3 or higher toxic effects rates were also collected. A pooled analysis was conducted, and results were validated via a network meta-analysis.Main Outcomes and MeasuresThe primary end point was OS. Secondary outcomes included PFS, ORR, and toxic effects rates.ResultsA total of 7 trials with data on 2581 patients were analyzed, including 383 patients treated with NALIRIFOX, 433 patients treated with FOLFIRINOX, and 1756 patients treated with GEM-NABP. Median PFS was longer in patients treated with NALIRIFOX (7.4 [95% CI, 6.1-7.7] months) or FOLFIRINOX (7.3 [95% CI, 6.5-7.9] months; [HR], 1.21 [95% CI, 0.86-1.70]; P = .28) compared with patients treated with GEM-NABP (5.7 [95% CI, 5.6-6.1] months; HR vs NALIRIFOX, 1.45 [95% CI, 1.22-1.73]; P &lt; .001). Similarly, GEM-NABP was associated with poorer OS (10.4 [95% CI, 9.8-10.8]; months) compared with NALIRIFOX (HR, 1.18 [95% CI, 1.00-1.39]; P = .05], while no difference was observed between FOLFIRINOX (11.7 [95% CI, 10.4-13.0] months) and NALIRIFOX (11.1 [95% CI, 10.1-12.3] months; HR, 1.06 [95% CI, 0.81-1.39]; P = .65). There were no statistically significant differences in ORR among NALIRIFOX (41.8%), FOLFIRINOX (31.6%), and GEM-NABP (35.0%). NALIRIFOX was associated with lower incidence of grade 3 or higher hematological toxic effects (eg, platelet count decreased 1.6% vs 11.8% with FOLFIRINOX and 10.8% with GEM-NABP), but higher rates of severe diarrhea compared with GEM-NABP (20.3% vs 15.7%).Conclusions and RelevanceIn this systematic review and meta-analysis, NALIRIFOX and FOLFIRINOX were associated with similar PFS and OS as first-line treatment of advanced PDAC, although NALIRIFOX was associated with a different toxicity profile. Careful patient selection, financial toxic effects consideration, and direct comparison between FOLFIRINOX and NALIRIFOX are warranted.

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Section: Discussionmentioning

confidence: 99%

NALIRIFOX, FOLFIRINOX, and Gemcitabine With Nab-Paclitaxel as First-Line Chemotherapy for Metastatic Pancreatic Cancer

Nichetti,

Rota,

Ambrosini

et al. 2024

JAMA Netw Open

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“… 8 , 9 One randomized trial and several meta‐analyses conducted in the gemcitabine monotherapy era have suggested that second‐line chemotherapy may impact on survival (vs. BSC) and that multiagent, fluoropyrimidine‐based, regimens may obtain better results. 10 , 11 , 12 In the current scenario, in which AG and FOLFIRINOX/NALIRIFOX are the preferred first‐line regimens, 13 national and international guidelines recommend differential second‐line treatment paths, depending on the first‐line regimen received. 14 , 15 , 16 Fluoropyrimidines, alone or in combination represent the preferred second‐line therapeutic choices in patients progressed to first‐line AG; 17 , 18 among fluoropyrimidine‐based doublets, the OFF regimen and nal ‐IRI and 5‐FU/folinic acid (nal‐IRI/FUFA) are supported by randomized phase III trials.…”

Section: Introductionmentioning

confidence: 99%

Prognostic analysis and outcomes of metastatic pancreatic cancer patients receiving nab‐paclitaxel plus gemcitabine as second or later‐line treatment

Giordano,

Milella,

Landriscina

et al. 2024

Cancer Medicine

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BackgroundPancreatic cancer (PC) first‐line therapy often consists of polychemotherapy regimens, but choosing a second‐line therapy after disease progression, especially following first‐line FOLFIRINOX, remains a clinical challenge. This study presents results from a large, multicenter, retrospective analysis of Italian patients with metastatic PC (mPC) treated with Nab‐paclitaxel/Gemcitabine (AG) as second or later line of treatment. Main objective of the study is to identify prognostic factors that could inform treatment decisions.MethodsThe study included 160 mPC patients treated with AG in 17 Italian institutions. AG was administered according to labelling dose, until disease progression, unacceptable toxicity or patient refusal. Variations in schedules, dose modifications, supportive measures, and response evaluation were determined by individual clinicians' practice.ResultsAG was well‐tolerated and exhibited promising clinical activity. The overall response rate (ORR) and the disease control rate (DCR) were 22.5% and 45.6%, respectively. Median progression‐free survival (PFS) and overall survival (OS) were 3.9 and 6.8 months, respectively. Among the patients who received AG as a second‐line therapy (n = 111, 66.9%), median PFS and OS were 4.2 and 7.4 months, respectively. Notably, in the 76 patients (68%) receiving AG after first‐line FOLFIRINOX, an ORR of 19.7% and a DCR of 46.0% were observed, resulting in a median PFS of 3.5 and median OS of 5.7 months. The study identified specific clinical or laboratory parameters (LDH, NLR, fasting serum glucose, liver metastases, ECOG PS, and first‐line PFS) as independent prognostic factors at multivariate level. These factors were used to create a prognostic nomogram that divided patients into three risk classes, helping to predict second‐line OS and PFS.ConclusionsThis study represents the largest real‐world population of mPC patients treated with AG as a second or later line of therapy. It supports the feasibility of this regimen following first‐line FOLFIRINOX, particularly in patients with specific clinical and laboratory characteristics who derived prolonged benefit from first‐line therapy.

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Survival analysis of the metastatic cohort of Italian Association of Medical Oncology (AIOM) GARIBALDI survey

Reni,

Giommoni,

Bergamo

et al. 2024

Pancreatology

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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

Cited by 4 publications

References 19 publications

NALIRIFOX, FOLFIRINOX, and Gemcitabine With Nab-Paclitaxel as First-Line Chemotherapy for Metastatic Pancreatic Cancer

NALIRIFOX, FOLFIRINOX, and Gemcitabine With Nab-Paclitaxel as First-Line Chemotherapy for Metastatic Pancreatic Cancer

Prognostic analysis and outcomes of metastatic pancreatic cancer patients receiving nab‐paclitaxel plus gemcitabine as second or later‐line treatment

Survival analysis of the metastatic cohort of Italian Association of Medical Oncology (AIOM) GARIBALDI survey

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