Abstract
BackgroundIn the recent phase III trial MPACT the combination of gemcitabine and nab-paclitaxel (Gem/NabP) showed increased overall survival compared to gemcitabine alone in the treatment of advanced pancreatic ductal adenocarcinoma (aPDA). Until now there has been limited information on the clinical benefit and toxicity of the combination regimen in a real world setting. In addition the value for patients with locally advanced rather than metastatic aPDA has been unclear, since the former category of patients was not included in the MPACT trial.MethodsA multicentre retrospective observational study in the South Eastern Region of Sweden was performed, with the first 75 consecutive patients diagnosed with aPDA (both locally advanced and metastatic disease) who received first-line treatment with Gem/NabP.ResultsIn the overall population median progression free survival (PFS) and overall survival (OS) were 5.2 (3.4–7.0 95% CI) and 10.9 (7.8–14.0 95% CI) months, respectively. Patients with metastatic disease displayed a median OS of 9.4 (4.9–13.9) and a median PFS of 4.5 (3.3–5.7) months whereas the same parameters in the locally advanced subgroup were 17.1 (7.6–26.6) and 6.8 (5.2–8.4) months, respectively. Grade 3–4 hematologic toxicity was recorded: Neutropenia, leukopenia, thrombocytopenia, and anaemia were observed in 23, 20, 5, and 4% of patients, respectively. Dose reductions were performed in 80% of the patients.ConclusionThis study confirms the effectiveness and safety of first-line Gem/NabP in both locally advanced and metastatic PDA in a real world setting.
Highlights
In the recent phase III trial MPACT the combination of gemcitabine and nab-paclitaxel (Gem/Gemcitabine and nab-paclitaxel (NabP)) showed increased overall survival compared to gemcitabine alone in the treatment of advanced pancreatic ductal adenocarcinoma
Since the ground breaking trial by Burris et al in 1997 [5], where gemcitabine was proven superior to 5-fluorouracil based therapy, gemcitabine monotherapy has remained the gold standard in the treatment of advanced pancreatic ductal adenocarcinoma
A total of 92 unique patients treated with Gem/NabP were identified
Summary
In the recent phase III trial MPACT the combination of gemcitabine and nab-paclitaxel (Gem/NabP) showed increased overall survival compared to gemcitabine alone in the treatment of advanced pancreatic ductal adenocarcinoma (aPDA). Symptoms are initially scarce which means that diagnosis is often delayed, and the majority of patients already have locally advanced or metastasised disease at the time of diagnosis [1, 3]. At this stage no surgery or other treatment with intention to cure is possible and prognosis without treatment is poor with median overall survival (OS) of less than six months and 5-year survival of less than 5% [1, 4]. The benefit of such combination regimens has been non-existent or very limited, and usually at the expense of increased toxicity [6,7,8,9,10,11,12]
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