FX and GN are more active than gemcitabine in patients with APC. However, it is not known if FX is superior to GN in APC. In the absence of a randomized controlled trial this population-based cohort study is undertaken to compare efficacy and safety of the two standard regimens in APC.
All patients with newly diagnosed locally APC in the province of Saskatchewan, Canada, during 2011-2016 who received FX or GN, were assessed. A Cox proportional multivariate analysis was done to evaluate correlation of chemotherapy regimen and survival.
119 eligible patients with median age of 61 yrs (IQR:56-67) & M:F of 70:49 were identified. 93% had WHO performance status (PS) of 0 or 1, and 77% had metastatic PC. 15% received adjuvant therapy and 33% had ≥2 metastatic sites. Of 119 patients, 86 (72%) received FX and 33 (28%) treated with GN. There were significant differences between the two groups with respect to age (59 vs. 64 yrs), WHO PS of 2 (2% vs. 15%) and metastatic disease (81% vs. 64%), in FX and GN groups, respectively. Median progression-free survival of FX group was 6 months (95%CI: 4.5-7.5) vs. 4 months (2.9-5.1) with GN (p = 0.39). Median overall survival (OS) with FX was 9 months (7-11) vs. 9 months (4.2-13.8) with GN (p = 0.88). At 12 months 26% & 27% patients were alive in FX and GN groups, respectively. Median OS of patients who received 2nd line therapy was 15 months (10.5-19.5) vs. 8 months (6.3-9.7) with no 2nd line therapy (0.009). Patients in FX had higher incidences of any grade diarrhea (52% vs.18%), mucositis (21 vs. 3), neuropathy (63 vs.36) and thromboembolism (34 vs. 9) whereas patients in GN group had more often fatigue (66 vs.79) and thrombocytopenia (48 vs. 57). On multivariate analysis normal albumin, HR:0.63 (0.41-0.97), male sex, HR:0.65 (0.43-0.97) and 2nd line therapy, HR:0.50 (0.28-0.86) were correlated with better survival but no correlation between FX or GN and survival was noted.
Our results showed that real world patients with APC treated with FX or GN had comparable survival with different safety profiles. In this selected patients who received combination therapy, male gender and subsequent treatment were correlated with better survival.
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All authors have declared no conflicts of interest.