Abstract
325 Background: Superiority of FOLFIRINOX (FFN) and nab-paclitaxel plus gemcitabine (NG) over standard gemcitabine (GEM) monotherapy for UPC was shown in the PRODIGE and MPACT trials, respectively. However, both trials either excluded or limited enrollment of patients with locally advanced disease, elevated bilirubin and advanced age. We sought to determine the impact of age, bilirubin and disease extent on treatment outcomes in the real-world setting. Methods: We identified all patients newly diagnosed with UPC who received palliative chemotherapy at any 1 of 6 British Columbia Cancer Centers and the Cross Cancer Institute in Alberta from January 2014 to April 2016. Receipt of at least one cycle of chemotherapy represented treatment with group assignment based on the initial regimen delivered. Outcomes were compared while adjusting for age, bilirubin, extent of disease, and other measured confounders. Results: A total of 292 consecutive patients were identified of whom 161 (55%) were aged > = 65 years, 164 (56%) were male, 74 (25%) had elevated bilirubin, and 205 (70%) had metastatic disease at the time of presentation. Patients who received FFN or NG had a longer median overall survival (OS) than those treated with GEM alone after adjusting for age, ECOG, bilirubin and extent of metastatic disease (11 vs 10 vs 4 months, respectively; FFN: HR 0.297, 95% CI 0.199-0.445, p < 0.0001, and NG: HR 0.338, 95% CI 0.236 – 0.485, p < 0.0001). Similarly, FFN and NG patients also had longer progression-free survival (PFS) in comparison to GEM alone (8.8 vs 6.9 vs 2.9 months, respectively; FFN: HR 0.33, 95% CI 0.22-0.499, p < 0.0001, and NG: HR 0.47, 95% CI 0.33 – 0.67, p < 0.0001). Advanced age and elevated bilirubin were not significantly associated with OS and PFS (p > 0.05). Conclusions: The efficacy of FFN and NG were superior when compared to GEM alone for patients with UPC in the real-world setting. This population-based study showed that the benefits of FFN and NG persisted regardless of advanced age and hyperbilirubinemia.
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