Clinical outcomes and safety of patients treated with NAb-Paclitaxel plus Gemcitabine in metastatic pancreatic cancer: the NAPA study

Martina Catalano; Giandomenico Roviello; Raffaele Conca; Alberto D'Angelo; Valeria Emma Palmieri; Benedetta Panella; Roberto Petrioli; Anna Ianza; Stefania Nobili; Enrico Mini; Monica Ramello

doi:10.2174/1568009620999200918122426

Clinical outcomes and safety of patients treated with NAb-Paclitaxel plus Gemcitabine in metastatic pancreatic cancer: the NAPA study

Martina Catalano, Giandomenico Roviello, Raffaele Conca, Alberto D'Angelo, Valeria Emma Palmieri, Benedetta Panella, Roberto Petrioli, Anna Ianza, Stefania Nobili, Enrico Mini, Monica Ramello

Department of Life Sciences

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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 first-line 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 haematological toxicity frequency was 22.61% for neutropenia, 5.22% for anaemia and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 nonhaematological events were reported. Dose reduction was necessary in 51.3 % of the patients.

CONCLUSIONS: 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.

Original language	English
Pages (from-to)	887-895
Number of pages	9
Journal	Current Cancer Drug Targets
Volume	20
Issue number	11
Early online date	18 Sept 2020
DOIs	https://doi.org/10.2174/1568009620999200918122426
Publication status	Published - 31 Dec 2020

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32957885.PDFAccepted author manuscript, 489 KBLicence: CC BY-NC

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Catalano, M., Roviello, G., Conca, R., D'Angelo, A., Palmieri, V. E., Panella, B., Petrioli, R., Ianza, A., Nobili, S., Mini, E., & Ramello, M. (2020). Clinical outcomes and safety of patients treated with NAb-Paclitaxel plus Gemcitabine in metastatic pancreatic cancer: the NAPA study. Current Cancer Drug Targets, 20(11), 887-895. https://doi.org/10.2174/1568009620999200918122426

Catalano, M, Roviello, G, Conca, R, D'Angelo, A, Palmieri, VE, Panella, B, Petrioli, R, Ianza, A, Nobili, S, Mini, E & Ramello, M 2020, 'Clinical outcomes and safety of patients treated with NAb-Paclitaxel plus Gemcitabine in metastatic pancreatic cancer: the NAPA study', Current Cancer Drug Targets, vol. 20, no. 11, pp. 887-895. https://doi.org/10.2174/1568009620999200918122426

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title = "Clinical outcomes and safety of patients treated with NAb-Paclitaxel plus Gemcitabine in metastatic pancreatic cancer: the NAPA study",

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 first-line 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 haematological toxicity frequency was 22.61% for neutropenia, 5.22% for anaemia and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 nonhaematological events were reported. Dose reduction was necessary in 51.3 % of the patients.CONCLUSIONS: 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.",

author = "Martina Catalano and Giandomenico Roviello and Raffaele Conca and Alberto D'Angelo and Palmieri, {Valeria Emma} and Benedetta Panella and Roberto Petrioli and Anna Ianza and Stefania Nobili and Enrico Mini and Monica Ramello",

note = "Copyright{\textcopyright} Bentham Science Publishers; For any queries, please email at [email protected].",

year = "2020",

month = dec,

day = "31",

doi = "10.2174/1568009620999200918122426",

language = "English",

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TY - JOUR

T1 - Clinical outcomes and safety of patients treated with NAb-Paclitaxel plus Gemcitabine in metastatic pancreatic cancer

T2 - the NAPA study

AU - Catalano, Martina

AU - Roviello, Giandomenico

AU - Conca, Raffaele

AU - D'Angelo, Alberto

AU - Palmieri, Valeria Emma

AU - Panella, Benedetta

AU - Petrioli, Roberto

AU - Ianza, Anna

AU - Nobili, Stefania

AU - Mini, Enrico

AU - Ramello, Monica

PY - 2020/12/31

Y1 - 2020/12/31

N2 - 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 first-line 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 haematological toxicity frequency was 22.61% for neutropenia, 5.22% for anaemia and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 nonhaematological events were reported. Dose reduction was necessary in 51.3 % of the patients.CONCLUSIONS: 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.

AB - 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 first-line 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 haematological toxicity frequency was 22.61% for neutropenia, 5.22% for anaemia and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 nonhaematological events were reported. Dose reduction was necessary in 51.3 % of the patients.CONCLUSIONS: 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.

U2 - 10.2174/1568009620999200918122426

DO - 10.2174/1568009620999200918122426

M3 - Article

C2 - 32957885

SN - 1568-0096

VL - 20

SP - 887

EP - 895

JO - Current Cancer Drug Targets

JF - Current Cancer Drug Targets

IS - 11

ER -

Clinical outcomes and safety of patients treated with NAb-Paclitaxel plus Gemcitabine in metastatic pancreatic cancer: the NAPA study

Abstract

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