Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study

Abstract

Background: Treatment 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.

Methods: Retrospective, 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.

Results: All 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).

Conclusions: Nab-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.

Keywords: First-line chemotherapy; Gemcitabine; Metastatic pancreatic adenocarcinoma; Nab-paclitaxel; Real-life; Survival.

Fig. 1

Overall survival (a, c and e) and progression-free survival (b, d and f) depending on baseline ECOG (a and b), NLR (c and d) and CA 19.9 (e and f). Survival is presented as median (95% CI); p-values correspond to the Log-rank test for inter-curve differences

Fig. 2

Overall survival (a, c and e) and progression-free survival (b, d and f) depending on baseline age (a and b), presence of hepatobiliary stent (c and d), and relative dose intensity (RDI) (e and f). Survival is presented as median (95% CI); p-values correspond to the Log-rank test for inter-curve differences

Fig. 3

Survival estimate of patients with metastatic pancreatic cancer starting combined treatment with nab-paclitaxel plus gemcitabine in real-life practice. a Nomogram for predicting overall survival and the probability of 3-month, 6-month, 12-month in real-life practice. b Survival (Kaplan Meier estimate) for low-, medium-, and high-risk groups