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A Novel Prognostic Tool in Western and Eastern Biliary Tract Cancer Patients Treated in First-line Setting: the ECSIPOT Index

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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.

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Authors and Affiliations

  1. Department of Oncology and Hematology, Division of Oncology, University Hospital of Modena, Modena, Italy

    Giulia Rovesti

  2. Division of Medical Oncology, Nuovo Ospedale Degli Infermi, Ponderano, BI, Italy

    Francesco Leone

  3. Oncology Unit, Sant’Orsola Malpighi Hospital, University of Bologna, Bologna, Italy

    Giovanni Brandi, Andrea Palloni & Stefania De Lorenzo

  4. Medical Oncology Unit, Pisa University Hospital, Pisa, Italy

    Silvia Cesario, Laura Bernardini & Valentina Massa

  5. Medical Oncology, University Hospital of Cagliari, Cagliari, Italy

    Mario Scartozzi & Eleonora Lai

  6. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Italy

    Monica Niger, Chiara Pircher & Filippo De Braud

  7. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Changhoon Yoo, Hyungwoo Cho & Jae Ho Jeong

  8. Department of Oncology, Centro Oncologico Ematologico Subalpino, Azienda Universitaria Ospedaliera Città della Salute e Della Scienza di Torino, Torino, Italy

    Roberto Filippi

  9. Medical Oncology Unit, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia, Udine, Italy

    Mariaelena Casagrande & Donatella Iacono

  10. Medical Oncology Department, IRCCS IstitutoTumori “Giovanni Paolo II”, Bari, Italy

    Nicola Silvestris

  11. Department of Biomedical Sciences and Human Oncology, University of Bari “Aldo Moro”, Bari, Italy

    Nicola Silvestris

  12. Medical Oncology Department, Campus Biomedico University, Roma, Italy

    Daniele Santini

  13. Oncology Unit, Macerata Hospital, Macerata, Italy

    Luca Faloppi

  14. Department of Oncology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, TO, Italy

    Massimo Aglietta

  15. Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institure FPO-IRCCS, Candiolo, TO, Italy

    Elisabetta Fenocchio

  16. Medical Oncology Unit, Ordine Mauriziano Hospital, Torino, Italy

    Elisa Sperti

  17. Department of Clinical Oncology, ULSS8 Berica, Vicenza, Italy

    Giuseppe Aprile

  18. School of Medicine, Vita-Salute San Raffaele University, Milan, Italy

    Valentina Burgio, Stefano Cascinu & Andrea Casadei-Gardini

  19. Unit of Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy

    Valentina Burgio, Stefano Cascinu & Andrea Casadei-Gardini

  20. Department of Medical Oncology, Università Vita- Salute, San Raffaele Hospital IRCCS, Via Olgettina 58, Milan, Italy

    Andrea Casadei-Gardini

Authors
  1. Giulia Rovesti
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  2. Francesco Leone
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  3. Giovanni Brandi
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  4. Silvia Cesario
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  5. Mario Scartozzi
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  6. Monica Niger
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  7. Changhoon Yoo
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  8. Roberto Filippi
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  9. Mariaelena Casagrande
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  29. Andrea Casadei-Gardini
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Contributions

Conception and design: Andrea Casadei Gardini, Giulia Rovesti. Acquisition of data (acquired and managed patients): Giulia Rovesti, Francesco Leone, Giovanni Brandi, Silvia Cesario, Mario Scartozzi, Monica Niger, Changhoon Yoo, Francesco Caputo, Roberto Filippi, Mariaelena Casagrande, Nicola Silvestris, Daniele Santini, Luca Faloppi, Andrea Palloni, Massimo Aglietta, Laura Bernardini, Hyungwoo Cho, Eleonora Lai, Elisabetta Fenocchio, Federico Nichetti, Nicoletta Pella, Stefania De Lorenzo, Elisa Sperti, Valentina Massa, Filippo De Braud, Jae Ho Jeong, Giuseppe Aprile, Stefano Cascinu, Andrea Casadei Gardini. Analysis and interpretation of data: Andrea Casadei Gardini, Giulia Rovesti. Writing, review, and/or revision of the manuscript: Andrea Casadei Gardini, Giulia Rovesti, Final approval of manuscript: All the authors.

Corresponding author

Correspondence to Andrea Casadei-Gardini.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

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Lay Summary

The aim of the present study is to evaluate a new prognostic index composed by PS ECOG, SII, PNI, and GOT [ECSIPOT index: psECogSIiPnigOT] for advanced biliary tract cancer patients treated with first-line chemotherapy. The results, externally validated in three cohorts, show that ECSIPOT index is an independent predictor of survival. The low cost, easy assessment and reproducibility make the ECSIPOT index a readily available tool to improve the assessment of patients’ prognosis both in routine practice and clinical trials.

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Rovesti, G., Leone, F., Brandi, G. et al. A Novel Prognostic Tool in Western and Eastern Biliary Tract Cancer Patients Treated in First-line Setting: the ECSIPOT Index. J Gastrointest Canc 53, 528–536 (2022). https://doi.org/10.1007/s12029-021-00649-3

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