Abstract
BackgroundTreatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in routine practice.MethodsRetrospective, multicenter study including patients with metastatic pancreatic cancer, who started first-line treatment with nab-paclitaxel plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. In addition to describing the treatment pattern, overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on the treatment and patients’ clinical characteristics.ResultsAll 210 eligible patients had a median age of 65.0 years (range 37–81). Metastatic pancreatic adenocarcinoma was recurrent in 46 (21.9%) patients and de novo in 164 (78.1%); 38 (18%) patients had a biliary stent. At baseline, 33 (18.1%) patients had an ECOG performance status ≥2. Patients received a median of four cycles of treatment (range 1–21), with a median duration of 3.5 months; 137 (65.2%) patients had a dose reduction of nab-paclitaxel and/or gemcitabine during treatment, and 33 (17.2%) discontinued treatment due to toxicity. Relative dose intensity (RDI) for nab-paclitaxel, gemcitabine, and the combined treatment was 66.7%. Median OS was 7.2 months (95% CI 6.0–8.5), and median PFS was 5.0 months (95% CI 4.3–5.9); 50 patients achieved either a partial or complete response (ORR 24.6%). OS was influenced by baseline ECOG PS, NLR and CA 19.9, but not by age ≥ 70 years and/or the presence of hepatobiliary stent or RDI < 85%. All included variables, computed as dichotomous, showed a significant contribution to the Cox regression model to build a nomogram for predicting survival in these patients: baseline ECOG 0–1 vs. 2–3 (p = 0.030), baseline NLR > 3 vs. ≤ 3 (p = 0.043), and baseline CA 19.9 > 37 U/mL vs. ≤37 U/mL (p = 0.004).ConclusionsNab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients. A nomogram to predict survival using baseline ECOG performance status, NLR and CA 19.9 is proposed.
Highlights
Treatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer
Nab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients
In this observational retrospective study including all the patients with metastatic pancreatic cancer treated at the participating centers with first-line nab-paclitaxel plus gemcitabine in a real-life setting, 25% of patients were aged 70 years or more and 18% had a baseline ECOG score of 2 or 3
Summary
Treatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. Two combination regimens, FOLFIRINOX (folinic acid, fluorouracil, irinotecan, oxaliplatin) and more recently, nab-paclitaxel plus gemcitabine, have been associated with a median OS of 11.1 months and 8.5 months in the ACCORD4/ PRODIGE11 and MPACT phase III clinical trials, respectively [8, 9]. These encouraging results have set a new standard and international guidelines recommend FOLFIRINOX and nab-paclitaxel plus gemcitabine as first-line treatments in patients with metastatic pancreatic cancer [10, 11]
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