Giulia Rovesti1, Francesco Leone2, Giovanni Brandi3, Silvia Cesario4, Mario Scartozzi5, Monica Niger6, Changhoon Yoo7, Roberto Filippi8, Mariaelena Casagrande9, Nicola Silvestris10,11, Daniele Santini12, Luca Faloppi13, Andrea Palloni3, Massimo Aglietta14, Laura Bernardini4, Hyungwoo Cho7, Eleonora Lai5, Elisabetta Fenocchio15, Chiara Pircher6, Donatella Iacono9, Stefania De Lorenzo3, Elisa Sperti16, Valentina Massa4, Filippo De Braud6, Jae Ho Jeong7, Giuseppe Aprile17, Valentina Burgio18,19, Stefano Cascinu18,19, Andrea Casadei-Gardini20,21,22. 1. Department of Oncology and Hematology, Division of Oncology, University Hospital of Modena, Modena, Italy. 2. Division of Medical Oncology, Nuovo Ospedale Degli Infermi, Ponderano, BI, Italy. 3. Oncology Unit, Sant'Orsola Malpighi Hospital, University of Bologna, Bologna, Italy. 4. Medical Oncology Unit, Pisa University Hospital, Pisa, Italy. 5. Medical Oncology, University Hospital of Cagliari, Cagliari, Italy. 6. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Italy. 7. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 8. Department of Oncology, Centro Oncologico Ematologico Subalpino, Azienda Universitaria Ospedaliera Città della Salute e Della Scienza di Torino, Torino, Italy. 9. Medical Oncology Unit, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia, Udine, Italy. 10. Medical Oncology Department, IRCCS IstitutoTumori "Giovanni Paolo II", Bari, Italy. 11. Department of Biomedical Sciences and Human Oncology, University of Bari "Aldo Moro", Bari, Italy. 12. Medical Oncology Department, Campus Biomedico University, Roma, Italy. 13. Oncology Unit, Macerata Hospital, Macerata, Italy. 14. Department of Oncology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, TO, Italy. 15. Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institure FPO-IRCCS, Candiolo, TO, Italy. 16. Medical Oncology Unit, Ordine Mauriziano Hospital, Torino, Italy. 17. Department of Clinical Oncology, ULSS8 Berica, Vicenza, Italy. 18. School of Medicine, Vita-Salute San Raffaele University, Milan, Italy. 19. Unit of Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. 20. School of Medicine, Vita-Salute San Raffaele University, Milan, Italy. casadeigardini@gmail.com. 21. Unit of Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy. casadeigardini@gmail.com. 22. Department of Medical Oncology, Università Vita- Salute, San Raffaele Hospital IRCCS, Via Olgettina 58, Milan, Italy. casadeigardini@gmail.com.
Abstract
BACKGROUND AND AIM: The need to estimate prognosis of advanced BTC (aBTC) patients treated with first-line chemotherapy is compelling. The aim of the study is to evaluate the ECSIPOT (psECogSIiPnigOT) index, influenced by PECS (PsECogSii) index, prognostic nutritional index (PNI), and GOT. METHODS: This international study was conducted on a training cohort of 126 patients and in three validation cohorts, both European and Korean. ECSIPOT index formula: (PECS:0 = 1 point; PECS:1 = 1.4 points; PECS:2 = 3.2 points) + (PNI > 36.7 = 1 point; PNI < 36.7 = 2 points) + (GOT < 100 = 1 point; GOT > 100 = 2 points). Event-time distributions were estimated using the Kaplan-Meier method, and survival curves were compared using the log-rank test. RESULTS: In the training cohort, mOS was 12.9, 6.3, and 2.8 months for patients with ECSIPOT-0, ECSIPOT-1, and ECSIPOT-2, respectively (ECSIPOT-0: HR 1; ECSIPOT-1: HR 2.11; ECSIPOT-2: HR 4.93; p < 0.0001). In the first validation cohort, mOS was 11.5, 7.3, and 3.3 months for ECSIPOT-0, ECSIPOT-1, and ECSIPOT-2, respectively (ECSIPOT-0: HR 1; ECSIPOT-1: HR 1.74; ECSIPOT-2: HR 3.41; p < 0.0001). In the second validation cohort, mOS was 25.2, 12.5, and 3.0 months for ECSIPOT-0, ECSIPOT-1, and ECSIPOT-2, respectively (ECSIPOT-0: HR = 1; ECSIPOT-1: HR 2.33; ECSIPOT-2: HR 8.46; p < 0.0001). In the third validation cohort, mOS was 11.8, 8.1, and 4.6 months for ECSIPOT-0, ECSIPOT-1, and ECSIPOT-2, respectively (ECSIPOT-0: HR = 1; ECSIPOT-1: HR 1.47; ECSIPOT-2: HR 3.17; p < 0.0001). Multivariate analysis in all cohorts confirmed the ECSIPOT index as an independent prognostic factor for OS. CONCLUSION: The easy assessment and good risk-stratification performance make the ECSIPOT index a promising tool to comprehensively estimate the prognosis of aBTC patients.
BACKGROUND AND AIM: The need to estimate prognosis of advanced BTC (aBTC) patients treated with first-line chemotherapy is compelling. The aim of the study is to evaluate the ECSIPOT (psECogSIiPnigOT) index, influenced by PECS (PsECogSii) index, prognostic nutritional index (PNI), and GOT. METHODS: This international study was conducted on a training cohort of 126 patients and in three validation cohorts, both European and Korean. ECSIPOT index formula: (PECS:0 = 1 point; PECS:1 = 1.4 points; PECS:2 = 3.2 points) + (PNI > 36.7 = 1 point; PNI < 36.7 = 2 points) + (GOT < 100 = 1 point; GOT > 100 = 2 points). Event-time distributions were estimated using the Kaplan-Meier method, and survival curves were compared using the log-rank test. RESULTS: In the training cohort, mOS was 12.9, 6.3, and 2.8 months for patients with ECSIPOT-0, ECSIPOT-1, and ECSIPOT-2, respectively (ECSIPOT-0: HR 1; ECSIPOT-1: HR 2.11; ECSIPOT-2: HR 4.93; p < 0.0001). In the first validation cohort, mOS was 11.5, 7.3, and 3.3 months for ECSIPOT-0, ECSIPOT-1, and ECSIPOT-2, respectively (ECSIPOT-0: HR 1; ECSIPOT-1: HR 1.74; ECSIPOT-2: HR 3.41; p < 0.0001). In the second validation cohort, mOS was 25.2, 12.5, and 3.0 months for ECSIPOT-0, ECSIPOT-1, and ECSIPOT-2, respectively (ECSIPOT-0: HR = 1; ECSIPOT-1: HR 2.33; ECSIPOT-2: HR 8.46; p < 0.0001). In the third validation cohort, mOS was 11.8, 8.1, and 4.6 months for ECSIPOT-0, ECSIPOT-1, and ECSIPOT-2, respectively (ECSIPOT-0: HR = 1; ECSIPOT-1: HR 1.47; ECSIPOT-2: HR 3.17; p < 0.0001). Multivariate analysis in all cohorts confirmed the ECSIPOT index as an independent prognostic factor for OS. CONCLUSION: The easy assessment and good risk-stratification performance make the ECSIPOT index a promising tool to comprehensively estimate the prognosis of aBTC patients.