Austrian real world data in elderly and younger metastatic pancreatic cancer patients: Interim results of a multicenter non-interventional study with nab-paclitaxel/gemcitabine

Abstract

Introduction: Pancreatic cancer is the 4th leading cause of cancer‐related death while accounting for only 3% of newly diagnosed cancer cases.[1] Nab‐paclitaxel (AbraxaneVR , Celgene) plus gemcitabine (nab‐P/G) has proven tolerability and superior efficacy as first‐line treatment for metastatic pancreatic cancer (mPCa) compared to gemcitabine alone in the MPACT randomized phase III trial.[2] Real‐life clinical practice, however, is comprised of diverse treatment conditions and heterogenous patient populations. Here we report on prospective, non‐interventional real‐world data regarding the use of nab‐paclitaxel in mPCa patients (pts) in the Austrian clinical routine. Methods: Pts with confirmed mPCa who met the eligibility criteria were treated with nab‐P/G at a dose regimen of nab‐paclitaxel 125mg/m2 plus gemcitabine 1000mg/m2 on days 1, 8, 15 of every 28day cycle in its labeled indication until progression and prospectively observed until disease progression or unacceptable toxicity. Primary objectives were safety and tolerability of nab‐paclitaxel, secondary objectives were the objective response rate (ORR) and assessment of real life dosing in daily clinical routine. Descriptive statistics were used to analyze the data. Results: Between 5/2015 and 1/2018, 237 pts (median age: 70 years, range 44‐89; 55% male, 108 (46%)>70 years) were included across 20 sites, 219 pts were eligible for analysis. At baseline, 46% (67/145) had grade 2 and 46% (66/145) grade 3 disease; CA19‐9 was elevated in 85% of pts (161/190). A total of 1011 treatment cycles were applied, 46% (463 cycles) on days 1/8/15, while 34% (345 cycles) were initiated at a reduced dose intensity (days 1/0/15). Median treatment duration was 4 cycles (n=219; range 1‐17). Patients' performance status was ECOG 0‐1 in 96% of administered cycles. The ORR of this interim analysis was conducted in 145 patients and consisted of 43% partial responses (PR), 41% had stable disease (SD) for a disease control rate (DCR) of 83%. In the elderly cohort (>70, n=62), 45% had a PR and 42% had SD for a DCR of 87%. Median PFS was 5.1 months both in all pts (n=151) and in evaluated subgroups (‐/ >70 years, n=82/n=69, HR=0.941). Nab‐P/G was well tolerated with comparable rates of adverse drug reactions (495 vs. 455) in the respective subgroups (‐/>70 years), 86% (both) being non‐serious, 13 vs. 11% required hospitalization. Pts in both subgroups benefited from the scheduled dose regimen mostly on days 1/8/15 (n=41/ n=32) with a median PFS of 5.8 months. A less dose dense application mostly on days 1/0/15 resulted in a PFS of 6.1 vs. 5.1 months in pts‐ 70 vs.> 70 years (n=14/n=18; HR=0.82). The most common reasons for treatment discontinuation (n=171) were tumor progression (45%) or death in (19%); 5% of pts discontinued treatment due to toxicity. No new safety signals were identified. Conclusion: These preliminary real‐world data confirm the effectiveness and tolerability of nab‐P/G in the clinical routine treatment of metastatic pancreatic cancer patients including a large cohort of elderly patients>70 years.