Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma

Susanna Hegewisch-Becker, Ali Aldaoud, Thomas Wolf, Beate Krammer-Steiner, Hartmut Linde, Renate Scheiner-Sparna, David Hamm, Martina Jänicke, Norbert Marschner, TPK-Group (Tumour Registry Pancreatic Cancer), Susanna Hegewisch-Becker, Ali Aldaoud, Thomas Wolf, Beate Krammer-Steiner, Hartmut Linde, Renate Scheiner-Sparna, David Hamm, Martina Jänicke, Norbert Marschner, TPK-Group (Tumour Registry Pancreatic Cancer)

Abstract

Pancreatic cancer is a highly lethal malignancy. Developments in recent years have broadened our therapeutic armamentarium. Novel drugs such as nab-paclitaxel, liposomal irinotecan and chemotherapy regimens such as FOLFIRINOX have been successfully tested in clinical trials. Data on patients outside of clinical trials are scarce but necessary to assess and improve the standard of care. We present data on treatment and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Between February 2014 and June 2017, patients were recruited by 104 sites at start of first-line therapy into the ongoing, prospective clinical cohort study TPK (Tumour Registry Pancreatic Cancer). As first-line therapy, 89% of patients received one of the three treatment regimens: gemcitabine monotherapy (23%), nab-paclitaxel plus gemcitabine (42%), or FOLFIRINOX (24%). The corresponding subgroups differed: Patients receiving gemcitabine monotherapy were older and more comorbid (median age 78 years, 73% ECOG ≥ 1) than patients receiving nab-paclitaxel plus gemcitabine (median age 71, 64% ECOG ≥ 1) or patients receiving FOLFIRINOX (median age 60, 52% ECOG ≥ 1). At least 40% of patients died before receiving second-line treatment. First-line progression-free survival was 4.6 months (95% CI: 3.7-5.2) for gemcitabine, 5.6 months (95% CI: 5.0-6.2) for nab-paclitaxel plus gemcitabine, and 6.3 months (95% CI: 5.5-6.9) for FOLFIRINOX. Our data represent the treatment reality in a German community setting. Although there are no stringent inclusion criteria for our cohort study, overall survival is comparable to that reported by randomised clinical trials.

Keywords: Cohort Studies; Outpatients; Palliative Care; Pancreatic Neoplasms.

© 2018 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.

Figures

Figure 1
Figure 1
Treatment reality in LAPC/MPC. (a) Top 5 first‐line chemotherapy regimens sorted by frequency (n = 1,174), (b) Top 5 second‐line chemotherapy regimens sorted by frequency (n = 391). (c) All patients starting first‐line therapy until June 30, 2016 (n = 862) were included in this analysis. Shown is the proportion of patients receiving a palliative first‐line, second‐line, and third‐line treatment. Potential: further treatment possible (current line ongoing or therapy paused).
Figure 2
Figure 2
Progression‐free survival (PFS) and overall survival (OS) since start of first‐line therapy of patients with LAPC/MPC. (a) PFS and (b) OS of the whole TPK cohort (n = 1,174), (c) PFS and (d) OS of the patients receiving gemcitabine monotherapy (n = 272), (e) PFS, and (f) OS of the patients receiving nab‐paclitaxel plus gemcitabine (n = 489), (g) PFS and (h) OS of the patients receiving FOLFIRINOX (n = 284). Abbreviations: CI, confidence interval; OS, overall survival; PFS, progression‐free survival.
Figure 3
Figure 3
Disease‐specific survival (DSS) since start of first‐line therapy of patients with LAPC/MPC. DSS of (a) the whole TPK cohort (n = 1,174), (b) of the patients receiving gemcitabine monotherapy (n = 272), (c) of the patients receiving nab‐paclitaxel plus gemcitabine (n = 489), and (d) of the patients receiving FOLFIRINOX (n = 284). Abbreviations: CI, confidence interval; DSS, disease‐specific survival.

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