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

Author:

Giordano Guido1ORCID,Milella Michele2ORCID,Landriscina Matteo1,Bergamo Francesca3,Tirino Giuseppe4,Santaniello Antonio5,Zaniboni Alberto6,Vasile Enrico7,De Vita Ferdinando8,Re Giovanni Lo9ORCID,Vaccaro Vanja10,Giommoni Elisa11ORCID,Natale Donato12,Conca Raffaele13,Santini Daniele14,Maiorino Luigi15,Sanna Gianni16,Ricci Vincenzo17,Iop Aldo18,Montesarchio Vincenzo19,Procaccio Letizia3,Noventa Silvia6,Bianco Roberto5,Febbraro Antonio4,Lonardi Sara3ORCID,Tortora Giampaolo2021,Sperduti Isabella22,Melisi Davide22324

Affiliation:

1. Unit of Medical Oncology and Biomolecular Therapy, Department of Medical and Surgical Sciences University of Foggia Foggia Italy

2. Section of Oncology, Department of Medicine University of Verona School of Medicine and Verona University Hospital Trust Verona Italy

3. Department of Oncology Veneto Institute of Oncology IRCCS Padova Italy

4. Unit of Medical Oncology, Sacro Cuore di Gesu'—Fatebenefratelli Hospital Benevento Italy

5. Department of Clinical Medicine and Surgery University of Naples "Federico II" Naples Italy

6. Medical Oncology Unit Fondazione Poliambulanza Brescia Italy

7. Unit of Medical Oncology 2 Azienda Ospedaliero‐Universitaria Pisana Pisa Italy

8. Division of Medical Oncology, Department of Precision Medicine University of Campania "L. Vanvitelli" Naples Italy

9. Medical Oncology and Immune‐Related Tumors Centro di Riferimento Oncologico di Aviano (CRO), IRCCS Aviano Italy

10. Medical Oncology 1 IRCCS Regina Elena National Cancer Institute Rome Italy

11. Medical Oncology Unit Careggi University Hospital Florence Italy

12. Ospedale San Massimo Penne Italy

13. Division of Medical Oncology, Department of Onco‐Hematology IRCCS‐CROB, Referral Cancer Center of Basilicata Rionero in Vulture Italy

14. Medical Oncology A University of Rome, Policlinico Umberto I, "La Sapienza Rome Italy

15. Medical Oncology Unit San Gennaro Hospital Naples Italy

16. Medical Oncology Istituto Ospedaliero dell'Università di Sassari Sassari Italy

17. Medical Oncology Unit Azienda Ospedaliera di Rilievo Nazionale ‘San Pio’ Benevento Italy

18. Department of Oncology Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) Trieste Italy

19. Oncology Unit—A.O.R.N. dei Colli Monaldi Hospital Naples Italy

20. Oncologia Medica Fondazione Policlinico Universitario Gemelli IRCCS Rome Italy

21. Oncologia Medica Università Cattolica del Sacro Cuore Rome Italy

22. Biostatistical Unit IRCCS Regina Elena National Cancer Institute, Istituti Fisioterapici Ospitalieri Rome Italy

23. Investigational Cancer Therapeutics Clinical Unit Azienda Ospedaliera Universitaria Integrata Verona Italy

24. Digestive Molecular Clinical Oncology Research Unit University of Verona Verona Italy

Abstract

AbstractBackgroundPancreatic 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.

Publisher

Wiley

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