1. Validated Nomogram Predicting 6-Month Survival in Pancreatic Cancer Patients Receiving First-Line 5-Fluorouracil, Oxaliplatin, and Irinotecan
- Author
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Lorenzo Fornaro, Cindy Neuzillet, Rosella Spadi, Francesco Montagnani, Alfredo Falcone, Caterina Vivaldi, Mario Clerico, Francesco Leone, Aurélia Meurisse, Maria Antonietta Satolli, Pasquale Lombardi, Gianna Musettini, Elisa Sperti, Enrico Vasile, Emmanuele De Luca, Dewi Vernerey, Astrid Lièvre, Andrea Casadei-Gardini, Paola Buscaglia, Angélique Vienot, Julien Edeline, Alessandro Passardi, Clémence Brac, Giulia Pasquini, Massimo Aglietta, Fornaro, L., Leone, F., Vienot, A., Casadei Gardini, A., Vivaldi, C., Lievre, A., Lombardi, P., De Luca, E., Vernerey, D., Sperti, E., Musettini, G., Satolli, M. A., Edeline, J., Spadi, R., Neuzillet, C., Falcone, A., Pasquini, G., Clerico, M., Passardi, A., Buscaglia, P., Meurisse, A., Aglietta, M., Brac, C., Vasile, E., Montagnani, F., Jonchère, Laurent, Azienda Ospedaliera Universitaria Pisana, Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Università degli Studi di Modena e Reggio Emilia = University of Modena and Reggio Emilia (UNIMORE), Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Università degli studi di Torino = University of Turin (UNITO), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Curie [Paris], CRLCC Eugène Marquis (CRLCC), Fondazione ARCO Onlus, Università degli Studi di Modena e Reggio Emilia, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Turin, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
- Subjects
Oncology ,Male ,Multivariate analysis ,FOLFIRINOX ,[SDV]Life Sciences [q-bio] ,Computer-Assisted ,0302 clinical medicine ,Clinical parameters ,Laboratory parameters ,Prognosis ,Risk categories ,Adult ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Biomarkers, Tumor ,Female ,Fluorouracil ,Follow-Up Studies ,Humans ,Irinotecan ,Middle Aged ,Numerical Analysis, Computer-Assisted ,Oxaliplatin ,Pancreatic Neoplasms ,Retrospective Studies ,Survival Rate ,Nomograms ,Clinical endpoint ,Numerical Analysis ,Tumor ,Gastroenterology ,3. Good health ,[SDV] Life Sciences [q-bio] ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,medicine.drug ,medicine.medical_specialty ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,03 medical and health sciences ,[SDV.CAN] Life Sciences [q-bio]/Cancer ,Internal medicine ,medicine ,Performance status ,business.industry ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,Nomogram ,Confidence interval ,[SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,business ,Biomarkers - Abstract
International audience; BACKGROUND:FOLFIRINOX (leucovorin, 5-fluorouracil, irinotecan, and oxaliplatin) is an option for fit patients with metastatic (MPC) and locally advanced unresectable (LAPC) pancreatic cancer. However, no criteria reliably identify patients with better outcomes.PATIENTS AND METHODS:We investigated putative prognostic factors among 137 MPC/LAPC patients treated with triplet chemotherapy. Association with 6-month survival status (primary endpoint) was assessed by multivariate logistic regression models. A nomogram predicting the risk of death at 6 months was built by assigning a numeric score to each identified variable, weighted on its level of association with survival. External validation was performed in an independent data set of 206 patients. The study was registered at ClinicalTrials.gov (NCT03590275).RESULTS:Four variables (performance status, liver metastases, baseline carbohydrate antigen 19-9 level, and neutrophil-to-lymphocyte ratio) were found to be associated with 6-month survival by multivariate analysis or had sufficient clinical plausibility to be included in the nomogram. Accuracy was confirmed in the validation cohort (C index = 0.762; 95% confidence interval, 0.713-0.825). After grouping all cases, 4 subsets with different outcomes were identified by 0, 1, 2, or > 2 poor prognostic features (P < .0001).CONCLUSION:The nomogram we constructed accurately predicts the risk of death in the first 6 months after initiation of FOLFIRINOX in MPC/LAPC patients. This tool could be useful to guide communication about prognosis, and to inform the design and interpretation of clinical trials.
- Published
- 2019
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