The Impact of Thromboprophylaxis on the Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer and Tinzaparin (PaCT) Study

SIMPLE SUMMARY: Pancreatic cancer (PaC) induces a prothrombotic and hypercoagulable state. Thrombosis occurs in 20% of PaC patients and is associated with worse prognosis and reduced progression-free survival (PFS). The aim of this retrospective observational study (PaCT) was to investigate the effect of thromboprophylaxis with an intermediate dose of tinzaparin on the PFS of patients treated with nab-paclitaxel and gemcitabine. Data obtained from 110 patients with active PaC administered prophylaxis with tinzaparin during the study resulted in median PFS of 7.9 months; data for the PFS of patients without simultaneous anticoagulation were obtained bibliographically from 14 studies, and after applying meta-analysis was 5.6 months. Patients receiving anticoagulation with tinzaparin had 39.5% higher PFS than patients without such thromboprophylaxis (p < 0.05). During follow-up, three (2.7%) thrombotic events and two (1.9%) clinically relevant non-major bleeding events occurred. Concluding, PFS in advanced PaC patients undergoing chemotherapy was positively impacted by thromboprophylaxis with intermediate dose tinzaparin. ABSTRACT: Pancreatic cancer (PaC) induces a prothrombotic and hypercoagulable state. The aim of this study was to investigate the effect of tinzaparin in combination with chemotherapy. The PaCT (pancreatic cancer and tinzaparin) study was a retrospective observational study that collected data regarding progression free survival (PFS) in advanced or metastatic PaC patients who received thromboprophylaxis with tinzaparin during chemotherapy with nab-paclitaxel (N) and gemcitabine (G). The primary end point was to compare, from already published data, the PFS of patients receiving thromboprophylaxis with tinzaparin with the PFS of patients receiving chemotherapy with N–G but no thromboprophylaxis. Secondary end points were efficacy and safety of anticoagulation. In total, 110 PaC patients, 93% with advanced or metastatic disease, treated with N–G and tinzaparin (10,291 ± 1176 Anti-Xa IU, OD, median duration 8.7, IQR: 5.6–11.9 months) were enrolled. Of these, 52% were males and; the median age was 68 (40–86 years). The tumor was located to in the pancreatic head at in 45% of the patients. The median PFS was 7.9 months (IQR: 5.0–11.8 months). Out of 14 similar studies (involving 2994 patients) identified via systematic search, it was determined that the weighted PFS of patients receiving N–G but no anticoagulation was 5.6 months. Therefore, patients receiving tinzaparin had 39.54% higher PFS than patients without thromboprophylaxis (p < 0.05). During the follow-up period of 18.3 ± 11.7 months, three (2.7%) thrombotic events were recorded while two clinically relevant non-major bleeding events occurred (1.9%). In conclusion, PFS in advanced PaC patients undergoing chemotherapy is positively impacted by anticoagulation. Thromboprophylaxis with tinzaparin in treatment dose is efficient and safe.