Recently, nab-paclitaxel/gemcitabine (NPG) became new standard first-line therapy for metastatic pancreatic cancer. Based on this, our study group has established QoliXane for metastatic pancreatic cancer patients receiving 1st line NPG, to deliver real life and Quality of life (QoL) data and build a platform for translational research (TR). This is an interim analysis of our data focused on efficacy outcome.
In this a non-interventional registry study, eligible patients were recruited after written informed consent from 95 German cancer centers. The course of therapy, efficacy-, QoL- data (prior to and during therapy) and archival tumor material were prospectively collected. In the present analysis, efficacy endpoints were analyzed in the intention-to-treat population (ITT), defined as all patients who were enrolled.
539 patients fulfilled the criteria of the ITT. Median age was 70 y (39-86). At the time of analysis, 301 (56%) pts of the ITT were alive. Mean no. of metastatic sites involved was 2. Median no. of cycles administered was 3 (range 0-6). 231 (43%) pts needed any dose modification and 209 (39%) received further therapies beyond progression. 70 (13%) pts had increased bilirubin at baseline, 18 (26%) of them had an intervention e.g. ERCP. Subjects with increased bilirubin without intervention received a median of 3 cycles, with decreasing values under therapy. 135 (25%) pts developed polyneuropathy of any grade. Median progression-free survival was 6 months (95% CI; [5- 6]). Median overall survival (OS) was 10 months (95% CI [8- 10]). 1-year OS was 40%. Median survivals by ECOG PS of 0, 1, 2, and 3 were 12 months, 9 months, 5 months, and 2 months, respectively (p
The “QoliXane” shows excellent real life efficacy data for 1st line therapy with NPG in Germany. In the expansion phase, QoliXane will transform into a permanent, high quality, prospective registry, covering all therapy lines. QoL and translational research data will follow.
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All authors have declared no conflicts of interest.