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

Curr Cancer Drug Targets. 2020;20(11):887-895. doi: 10.2174/1568009620999200918122426.

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; cancer; combined chemotherapy; gemcitabine; nab-paclitaxel; prognostic factor.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adenocarcinoma* / drug therapy
  • Adenocarcinoma* / pathology
  • Aged
  • Albumins* / administration & dosage
  • Albumins* / adverse effects
  • Anemia / chemically induced
  • Anemia / diagnosis
  • Antimetabolites, Antineoplastic / administration & dosage
  • Antimetabolites, Antineoplastic / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Carcinoma, Pancreatic Ductal* / drug therapy
  • Carcinoma, Pancreatic Ductal* / pathology
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Drug Monitoring / methods
  • Female
  • Gemcitabine
  • Humans
  • Male
  • Neoplasm Metastasis* / drug therapy
  • Neoplasm Metastasis* / pathology
  • Neoplasm Staging
  • Neutropenia* / chemically induced
  • Neutropenia* / diagnosis
  • Paclitaxel* / administration & dosage
  • Paclitaxel* / adverse effects
  • Prognosis
  • Progression-Free Survival
  • Radiation-Sensitizing Agents / administration & dosage
  • Radiation-Sensitizing Agents / adverse effects
  • Thrombocytopenia / chemically induced
  • Thrombocytopenia / diagnosis
  • Treatment Outcome

Substances

  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Antimetabolites, Antineoplastic
  • Radiation-Sensitizing Agents
  • Deoxycytidine
  • Paclitaxel
  • Gemcitabine