TOPLINE: 

Venous thromboembolism (VTE) occurred in 9% of patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC) during perioperative therapy and was associated with worse overall survival. 

METHODOLOGY:

• Patients with PDAC are at high risk for VTE, which is also associated with worse overall survival. Neoadjuvant therapy has become increasingly common among patients with resectable and borderline resectable disease, but there are limited data on VTE risk in this setting.
• To better understand the VTE risk, researchers conducted a secondary analysis of the PREOPANC-2 trial, which included 325 patients with resectable and borderline resectable PDAC.
• Participants were randomly assigned to receive either eight cycles of neoadjuvant 5-FOLFIRINOX (n = 158), followed by surgery for most patients , or three cycles of neoadjuvant gemcitabine with hypofractionated radiotherapy (n = 167), followed by surgery for most and four cycles of adjuvant gemcitabine.
• The analysis looked at the incidence of VTE, both symptomatic and incidental events, and its association with overall survival.

TAKEAWAY:

• In the year following randomization, 9% of patients developed VTE (28 of 325) — 6% in the FOLFIRINOX arm and 11% in the gemcitabine arm (P = .059).
• In terms of VTE timing, 3% developed a VTE during neoadjuvant chemo(radio)therapy — 3% in the FOLFIRINOX arm and 2% in the gemcitabine arm (P = .75), and 8% developed a VTE following resection, which was significantly more common in the gemcitabine arm (12% vs 3%; P = .02).
• The occurrence of VTE was independently associated with worse overall survival (adjusted hazard ratio [aHR], 2.13; P = .002) and worse progression-free survival (aHR, 1.94; P = .009), though only two patients died from pulmonary embolism-related causes (both in the gemcitabine arm).
• Higher BMI (≥ 30), CA 19-9 above 500 U/mL, and WHO performance status (1 vs 0) were risk factors for VTE.

IN PRACTICE:

"Our study revealed that VTE is associated with poorer survival, especially postoperatively," the authors concluded. Given that only two patients died from pulmonary embolism-related causes, the "results suggest that VTE is a marker of more aggressive disease, rather than a direct cause of mortality."

SOURCE:

The study, led by Ruth A.L. Willems, MD, and Aniek E. van Diepen, MD, Maastricht University Medical Center in Maastricht, Netherlands, was published online on January 29 in Journal of Clinical Oncology.

LIMITATIONS:

Data on thromboembolic events were not collected prospectively, and asymptomatic patients were not systematically screened for VTE at standardized time points. This may have resulted in an underestimation of VTE incidence, particularly in the postoperative period when scans were scheduled only every 6 months. Additionally, the study was not powered to detect incidence differences in thromboembolic events between treatment groups.

DISCLOSURES:

The study received support from the Dutch Cancer Society and ZonMw. Ruth A.L. Willems disclosed no relevant conflicts of interest. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.