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<p>Metastatic adenocarcinoma of the pancreas (PDAC) was one of the most common causes of cancer-associated death in Europe and the United States in 2020. <i>nab</i>-Paclitaxel in combination with gemcitabine was approved as first-line therapy for PDAC in the United States in September 2013 and the European Union in January 2014, based on the results of the phase&#xa0;3 trial MPACT. This non-interventional study (NIS) was conducted to gain further knowledge on the effectiveness and safety of <i>nab</i>-paclitaxel and gemcitabine in clinical routine use as first-line therapy in patients with PDAC.</p><p>A&#xa0;total of 192 patients with metastatic PDAC were treated at 31&#xa0;sites in Germany between December 2014 and September 2020 with <i>nab</i>-paclitaxel and gemcitabine. The recommended dose for <i>nab-</i>paclitaxel was 125 mg/m<sup>2</sup> as intravenous infusion and for gemcitabine 1000 mg/m<sup>2</sup> as intravenous infusion over 30 min immediately after <i>nab</i>-paclitaxel.</p><p>The median progression-free survival (PFS) was 5.2&#xa0;months (95% CI: 4.4, 6.1), median time to progression (TTP) was 6.3&#xa0;months (95% CI: 5.4, 7.9), and median overall survival (OS) was 10.3 months (95% CI: 8.2, 11.4). The safety profile observed was comparable to that of previous trials. Most of the numbers reported in this NIS were lower than those reported for the large phase&#xa0;3&#xa0;trial MPACT.</p><p>The effectiveness, toxicity, and safety of first-line chemotherapy with <i>nab</i>-paclitaxel and gemcitabine in patients with metastatic PDAC in daily routine settings are comparable to the results reported in the large phase&#xa0;3&#xa0;trial MPACT. The combination of <i>nab</i>-paclitaxel and gemcitabine remains a&#xa0;feasible first-line standard of therapy for patients with metastatic PDAC.</p>

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EffiXane—Non-interventional study on safety and effectiveness of nab-paclitaxel (Abraxane®) + gemcitabine as first-line treatment of metastatic PDAC in a daily routine setting

  • 期刊论文

  • 发表日期：

    2025年4月16日

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  • Magdalena Wojtasik,
  • R.-B. Kuehn,
  • T. Gaska,
  • D. Reichert,
  • L. Brinkmann,
  • R. Depenbusch,
  • A. Lueck,
  • K. Borchert,
  • B. Tschechne,
  • M. Goern,
  • C. Constantin

摘要

Metastatic adenocarcinoma of the pancreas (PDAC) was one of the most common causes of cancer-associated death in Europe and the United States in 2020. nab-Paclitaxel in combination with gemcitabine was approved as first-line therapy for PDAC in the United States in September 2013 and the European Union in January 2014, based on the results of the phase 3 trial MPACT. This non-interventional study (NIS) was conducted to gain further knowledge on the effectiveness and safety of nab-paclitaxel and gemcitabine in clinical routine use as first-line therapy in patients with PDAC.

A total of 192 patients with metastatic PDAC were treated at 31 sites in Germany between December 2014 and September 2020 with nab-paclitaxel and gemcitabine. The recommended dose for nab-paclitaxel was 125 mg/m2 as intravenous infusion and for gemcitabine 1000 mg/m2 as intravenous infusion over 30 min immediately after nab-paclitaxel.

The median progression-free survival (PFS) was 5.2 months (95% CI: 4.4, 6.1), median time to progression (TTP) was 6.3 months (95% CI: 5.4, 7.9), and median overall survival (OS) was 10.3 months (95% CI: 8.2, 11.4). The safety profile observed was comparable to that of previous trials. Most of the numbers reported in this NIS were lower than those reported for the large phase 3 trial MPACT.

The effectiveness, toxicity, and safety of first-line chemotherapy with nab-paclitaxel and gemcitabine in patients with metastatic PDAC in daily routine settings are comparable to the results reported in the large phase 3 trial MPACT. The combination of nab-paclitaxel and gemcitabine remains a feasible first-line standard of therapy for patients with metastatic PDAC.