Abstract
BackgroundIn Ontario, FOLFIRINOX (FFX) and gemcitabine + nab‐paclitaxel (GnP) have been publicly funded for first‐line unresectable locally advanced pancreatic cancer (uLAPC) or metastatic pancreatic cancer (mPC) since April 2015. We examined the real‐world effectiveness and safety of FFX vs GnP for advanced pancreatic cancer, and in uLAPC and mPC.MethodsPatients receiving first‐line FFX or GnP from April 2015 to March 2017 were identified in the New Drug Funding Program database. Baseline characteristics and outcomes were obtained through the Ontario Cancer Registry and other population‐based databases. Overall survival (OS) was assessed using Kaplan‐Meier and weighted Cox proportional hazard models, weighted by the inverse propensity score adjusting for baseline characteristics. Weighted odds ratio (OR) for hospitalization and emergency department visits (EDV) were estimated from weighted logistic regression models.ResultsFor 1130 patients (632 FFX, 498 GnP), crude median OS was 9.6 and 6.1 months for FFX and GnP, respectively. Weighted OS was improved for FFX vs GnP (HR = 0.77, 0.70‐0.85). Less frequent EDV and hospitalization were observed in FFX (EDV: 67.8%; Hospitalization: 49.2%) than GnP (EDV: 77.7%; Hospitalization: 59.3%). More frequent febrile neutropenia‐related hospitalization was observed in FFX (5.8%) than GnP (3.3%). Risk of EDV and hospitalization were significantly lower for FFX vs GnP (EDV: OR = 0.68, P = .0001; Hospitalization: OR = 0.76, P = .002), whereas the risk of febrile neutropenia‐related hospitalization was significantly higher (OR = 2.12, P = .001). Outcomes for uLAPC and mPC were similar.ConclusionIn the real world, FFX had longer OS, less frequent all‐cause EDV and all‐cause hospitalization, but more febrile neutropenia‐related hospitalization compared to GnP.
Highlights
Pancreatic cancer is the fourth leading cause of cancer-related death in the USA as well as in Europe, with over 55 000 estimated new cases and over 44 000 estimated deaths in the United States in 2018.1,2 Pancreatic cancer is projected to become the second leading cause of cancer-related death by 2030.3 Despite some advances in the management of pancreatic cancer, outcomes for patients with this disease remain poor, with a 5-year survival rate of 8% for all disease stages.[1]
Risk of febrile neutropenia-related hospitalization was significantly higher for FFX vs gemcitabine + nab-paclitaxel (GnP) group, with weighted odds ratio (OR) of 2.12 (1.35, 3.31), P =
The weighted OR for emergency department (ED) was 0.63 (0.50, 0.80), P = .0001, whereas the risk of febrile neutropenia-related hospitalization was significantly higher for FFX vs GnP patients with weighted OR of 2.10 (1.22, 3.63), P =
Summary
Pancreatic cancer is the fourth leading cause of cancer-related death in the USA as well as in Europe, with over 55 000 estimated new cases and over 44 000 estimated deaths in the United States in 2018.1,2 Pancreatic cancer is projected to become the second leading cause of cancer-related death by 2030.3 Despite some advances in the management of pancreatic cancer, outcomes for patients with this disease remain poor, with a 5-year survival rate of 8% for all disease stages.[1]. The PRODIGE/ACCORD 11 trial compared FFX against gemcitabine in patients with mPC and Eastern Cooperative Oncology Group performance status (ECOG PS).[6]. FFX did have increased toxicity compared to gemcitabine, with 5.4% of patients having febrile neutropenia, and one population-based study determined that only 26% of patients would have been found to meet the criteria to receive FFX treatment from the ACCORD 11 trial.[6,8]. For mPC, the American Society of Clinical Oncology (ACSO) recommends FFX for patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1, favorable comorbidity profile, patient preference, and a support system for aggressive medical therapy, and access to chemotherapy port and infusion pump management services.[9,10]. The pivotal trials of both FFX and GnP have shown both treatments improve OS, PFS as well as response rate, distinctive patient populations, and differences in trial design limit the generalizability of indirect comparisons. This study aimed to examine the real-world comparative effectiveness and safety of publicly funded FFX vs GnP in Ontario, Canada for patients with advanced pancreatic cancer, and patients with uLAPC and patients with mPC
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