Thromboembolic Events During Perioperative Therapy for Resectable and Borderline Resectable Pancreatic Cancer in the PREOPANC-2 Trial.
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Willems Ruth A L, van Diepen Aniek E, Dekker Esther N, Janssen Quisette P, van Dam Jacob L, Michiels Nynke, van Eijck Casper W F, Hermans Karlijn E P E, Bonsing Bert A, Bosscha Koop P, Bouwense Stefan A W, Busch Olivier R, Ten Cate Hugo, Coene Peter-Paul L O, van Eijck Casper H J, van Es Nick, van der Harst Erwin, de Hingh Ignace H J T, Karsten Tom M, Kazemier Geert, van der Kolk Marion B, de Laat Bas, Liem Mike S L, Mieog J Sven D, Nieuwenhuijs Vincent B, Patijn Gijsbert A, Roest Mark, van Santvoort Hjalmar C, Valkenburg-van Iersel Liselot, de Wilde Roeland F, Wit Fennie, Zonderhuis Barbara M, Besselink Marc G, Homs Marjolein Y V, van Tienhoven Geertjan, Wilmink Johanna W, Groot Koerkamp Bas, de Vos-Geelen Judith, Dutch Pancreatic Cancer Group
Аннотация
METHODS: This study included patients from the investigator-initiated, multicenter, randomized controlled phase III PREOPANC-2 trial. Patients were randomly assigned to neoadjuvant 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin followed by surgery (FFX arm) or neoadjuvant gemcitabine-based chemoradiotherapy (CRT), followed by surgery and adjuvant gemcitabine (CRT arm). VTE was defined as both incidental and symptomatic lower- or upper-extremity deep vein thrombosis, pulmonary embolism (PE), splanchnic vein thrombosis, and catheter-related thrombosis. VTE occurrence was retrospectively evaluated from random assignment to 12 months after random assignment. The association with overall survival (OS) was analyzed using Cox regression analysis.
RESULTS: VTE was diagnosed in 28 of 325 patients (9%): nine (3%) preoperatively and 19 (8%) postoperatively. Most VTEs were symptomatic (54%). Although a higher proportion of patients developed postoperative VTE in the CRT arm (FFX 3% v CRT 12%, P = .02), the 12-month cumulative incidence did not differ between arms (6% v 11%, P = .06). Two patients died from PE-related causes in the CRT arm. VTE was independently associated with reduced OS (adjusted time-varying hazard ratio, 2.13, P = .002).
CONCLUSION: VTE occurred in 9% of patients with (borderline) resectable PDAC undergoing (neo)adjuvant treatment in the year after random assignment and was associated with decreased OS. These results underscore the need for standardized reporting of thromboembolic events in clinical trials and future studies assessing the potential benefits of thromboprophylaxis during neoadjuvant therapy.