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

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.

Validated Nomogram Predicting 6-Month Survival in Pancreatic Cancer Patients Receiving First-Line 5-Fluorouracil, Oxaliplatin, and Irinotecan

“…In this regard, a recently published study confirmed the role of PS, NLR and CA19.9 in a prognostic nomogram developed from a retrospective series of 210 patients treated with first-line Gem-Nab. 28 When planning the study design, we decided to build an instrument specifically addressing the risk of early death instead of general OS. This decision was taken in light of the risks of toxicity associated with FOLFIRINOX and other potential issues impacting on patient daily life, such as the need to implant a central venous catheter for prolonged infusions.…”

Prognostic and predictive factors in pancreatic cancer

“…However, up to date, the standard of care for PDAC is a combined regimen with gemcitabine and nab-paclitaxel or FOLFIRINOX. In the ANICE Pac study, the authors retrospectively investigated prognostic factors in patients treated with gemcitabine plus nab-paclitaxel in real life and found normal baseline level of CA19-9 to be an independent prognostic marker for better survival [81].…”

Proposal of predictive model on survival in unresectable pancreatic cancer receiving systemic chemotherapy

“…We anticipate that a simple predictive model for OS in unresectable PaC patients will be useful in our daily clinical practice. However, to the best of our knowledge, there have been few reports regarding predictive models in unresectable PaC patients undergoing systemic chemotherapy, although numerous predictive models in PaC patients undergoing surgery has been reported [16][17][18][19][20][21][22][23][24][25]. The goal of the current study is to construct a simple predictive model for OS in unresectable PaC patients treated with systemic chemotherapy and to confirm its accuracy in an independent cohort.…”