Giulia Rovesti1, Francesco Leone2, Giovanni Brandi3, Lorenzo Fornaro4, Mario Scartozzi5, Monica Niger6, Changhoon Yoo7, Francesco Caputo1, Roberto Filippi8, Mariaelena Casagrande9, Nicola Silvestris10, Daniele Santini11, Luca Faloppi12, Andrea Palloni2, Massimo Aglietta13, Caterina Vivaldi4, Hyungwoo Cho7, Eleonora Lai5, Elisabetta Fenocchio14, Federico Nichetti6, Nicoletta Pella9, Stefania De Lorenzo2, Massimo Di Maio15, Enrico Vasile4, Filippo de Braud6,7,8,9,10,11,12,13,14,15,16,17, Jae Ho Jeong7, Giuseppe Aprile, Giulia Orsi18, Stefano Cascinu18, Andrea Casadei-Gardini19. 1. Division of Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy. 2. Division of Medical Oncology, ASL BI, Nuovo Ospedale Degli Infermi, Ponderano, Italy. 3. Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine, Saint Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. 4. Unit of Medical Oncology, Pisa University Hospital, Via Roma 67, 56126, Pisa, Italy. 5. Medical Oncology, University of Cagliari, University Hospital, Cagliari, Italy. 6. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori Di Milano, Milan, Italy. 7. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 8. Department of Oncology, Centro Oncologico Ematologico Subalpino, Azienda Universitaria Ospedaliera Città Della Salute E Della Scienza Di Torino, University of Turin, Turin, Italy. 9. Medical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria Della Misericordia, Udine, Italy. 10. Medical Oncology Unit, IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy. 11. Medical Oncology Department, Campus Biomedico University, Roma, Italy. 12. Oncology Unit, Macerata Hospital, Macerata, Italy. 13. Department of Oncology, Division of Medical Oncology, Candiolo Cancer Institute, FPO-IRCCS, University of Turin, Candiolo, Turin, Italy. 14. Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy. 15. Department of Oncology, Medical Oncology Unit, Ordine Mauriziano Hospital, University of Turin, Turin, Italy. 16. Department of Oncology, San Bortolo General Hospital, ULSS8 Berica, Vicenza, Italy. 17. University of Milan, Milan, Italy. 18. Department of Medical Oncology, Università Vita-Salute, San Raffaele Hospital IRCCS, Milan, Italy. 19. Department of Medical Oncology, Università Vita-Salute, San Raffaele Hospital IRCCS, Milan, Italy. casadeigardini@gmail.com.
Abstract
BACKGROUND AND AIM: The aim of the present study is to evaluate a new index (PECS (PsECogSii)index) influenced by PS ECOG and systemic immune-inflammation index (SII) in unresectable locally advanced or metastatic BTC patients treated with first-line chemotherapy. METHODS: This multicenter, international, study was conducted on a training cohort of 130 patients and in three European and Korean validation cohorts The PECS index was calculated as ECOG × SII index (neutrophil count × platelet count/lymphocyte count). 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, the median overall survival (mOS) was 13.2 months, 8.7 months, and 3.8 months for patients with PECS-0, PECS-1, and PECS-2, respectively (PECS-0: HR = 1; PECS-1: HR 1.41; PECS-2: HR 3.23) (p < 0.0001). In the first validation cohort, the mOS was 12.8 months, 10.1 months, and 5.3 months for patients with PECS-0, PECS-1, and PECS-2, respectively (PECS-0: HR = 1; PECS-1: HR 1.29; PECS-2: HR 2.40) (p < 0.0001). In the second validation cohort, the mOS was 21.2 months, 10.2 months, and 3.0 months for patients with PECS-0, PECS-1, and PECS-2, respectively (PECS-0: HR = 1; PECS-1: HR 2.25; PECS-2: HR 9.00) (p < 0.0001). In the third validation cohort, the median OS was 15.5 months, 7.5 months, and 3.7 months for patients with PECS-0, PECS-1, and PECS-2, respectively (PECS-0: ref HR = 1; PECS-1: HR 2.14; PECS-2: HR 5.00) (p < 0.0001). Multivariate analysis in all cohorts confirmed the PECS index as an independent prognostic factor for OS. CONCLUSIONS: The easy assessment, low cost, and reproducibility make PECS index a promising tool to assess the prognosis of BTC patients in future clinical practice.
BACKGROUND AND AIM: The aim of the present study is to evaluate a new index (PECS (PsECogSii)index) influenced by PS ECOG and systemic immune-inflammation index (SII) in unresectable locally advanced or metastatic BTC patients treated with first-line chemotherapy. METHODS: This multicenter, international, study was conducted on a training cohort of 130 patients and in three European and Korean validation cohorts The PECS index was calculated as ECOG × SII index (neutrophil count × platelet count/lymphocyte count). 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, the median overall survival (mOS) was 13.2 months, 8.7 months, and 3.8 months for patients with PECS-0, PECS-1, and PECS-2, respectively (PECS-0: HR = 1; PECS-1: HR 1.41; PECS-2: HR 3.23) (p < 0.0001). In the first validation cohort, the mOS was 12.8 months, 10.1 months, and 5.3 months for patients with PECS-0, PECS-1, and PECS-2, respectively (PECS-0: HR = 1; PECS-1: HR 1.29; PECS-2: HR 2.40) (p < 0.0001). In the second validation cohort, the mOS was 21.2 months, 10.2 months, and 3.0 months for patients with PECS-0, PECS-1, and PECS-2, respectively (PECS-0: HR = 1; PECS-1: HR 2.25; PECS-2: HR 9.00) (p < 0.0001). In the third validation cohort, the median OS was 15.5 months, 7.5 months, and 3.7 months for patients with PECS-0, PECS-1, and PECS-2, respectively (PECS-0: ref HR = 1; PECS-1: HR 2.14; PECS-2: HR 5.00) (p < 0.0001). Multivariate analysis in all cohorts confirmed the PECS index as an independent prognostic factor for OS. CONCLUSIONS: The easy assessment, low cost, and reproducibility make PECS index a promising tool to assess the prognosis of BTC patients in future clinical practice.
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