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Clinical Outcomes and Safety of Patients Treated with NAb-Paclitaxel Plus Gemcitabine in Metastatic Pancreatic Cancer: The NAPA Study

[ Vol. 20 , Issue. 11 ]

Author(s):

Martina Catalano, Giandomenico Roviello*, Raffaele Conca, Alberto D’Angelo, Valeria Emma Palmieri, Benedetta Panella, Roberto Petrioli, Anna Ianza, Stefania Nobili, Enrico Mini and Monica RamelloPages 887-895 (9)

Abstract:


Background: The phase III MPACT trial demonstrated the superiority of gemcitabine (Gem) combined with Nab-paclitaxel (Nab-P) versus gemcitabine alone in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this study was to evaluate the effect of Gem/Nab-P in routine clinical practice.

Methods: From January 2015 to December 2018, patients with metastatic PDAC receiving firstline treatment with a combination of gemcitabine and Nab-paclitaxel were included in a multicentre retrospective observational study. Exploratory analyses of efficacy, and prognostic and predictive markers, were performed.

Results: The cohort comprised 115 patients (median age 65 [range 50-84] years) with good performance status (ECOG PS 0-1). The median overall survival (OS) was 11 months (95% CI; 9-13) and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and stable disease were achieved in 44 and 30 patients, respectively, yielding an overall disease control rate (DCR) of 64.3%. Grade 3-4 hematological toxicity frequency was 22.61% for neutropenia, 5.22% for anemia, and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 non-hematological events were reported. Dose reduction was necessary in 51.3% of the patients.

Conclusion: Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.

Keywords:

Metastatic pancreatic adenocarcinoma, combined chemotherapy, nab-paclitaxel, gemcitabine, prognostic factor, cancer.

Affiliation:

School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, viale Pieraccini, 6, 50139, Florence, Division of Medical Oncology, Department of Onco-Hematology, IRCCS-CROB, Referral Cancer Center of Basilicata, via Padre Pio 1, 85028 Rionero, Vulture (PZ), Department of Biology and Biochemistry, University of Bath, Bath BA2 7AY, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Department of Medicine, Surgery and Neurosciences, Medical Oncology Unit, University of Siena, Viale Bracci - Policlinico “Le Scotte” 53100, Siena, Oncology Unit, Department of Medical, Surgical, & Health Sciences, University of Trieste, Piazza Ospitale, Trieste, Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, viale Pieraccini, 6, 50139, Florence, Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, viale Pieraccini, 6, 50139, Florence, 6Oncology Unit, Department of Medical, Surgical, & Health Sciences, University of Trieste, Piazza Ospitale, Trieste

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