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VTE Affects 9% of Resectable PDAC Patients on Neoadjuvant Therapy, Reducing Survival
Venous thromboembolism occurred in 28 of 325 patients (9%) with resectable or borderline resectable pancreatic ductal adenocarcinoma undergoing neoadjuvant treatment within one year of randomization, and its occurrence was associated with decreased overall survival. These findings highlight a clinically meaningful but underreported complication in this setting, with no formal thromboprophylaxis strategy currently embedded in standard neoadjuvant protocols.
What Was Studied
This analysis investigated the incidence of venous thromboembolic events during perioperative treatment for resectable and borderline resectable pancreatic ductal adenocarcinoma, and whether VTE occurrence influenced overall survival. The question is clinically important because PDAC is among the malignancies most strongly associated with thrombosis, yet data in the neoadjuvant treatment context have been largely absent from the published literature.
How It Was Studied
This was a retrospective analysis of VTE events embedded within the PREOPANC-2 trial, an investigator-initiated, multicenter, randomized controlled phase III study enrolling 325 patients with resectable or borderline resectable PDAC. Patients were randomly assigned to one of two neoadjuvant regimens: FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) followed by surgery, or gemcitabine-based chemoradiotherapy followed by surgery and adjuvant gemcitabine. VTE events — encompassing symptomatic and incidental deep vein thrombosis of the upper and lower extremities, pulmonary embolism, splanchnic vein thrombosis, and catheter-related thrombosis — were systematically reviewed from the time of randomization through twelve months thereafter. The association between VTE and overall survival was assessed using Cox regression analysis.
What Was Observed
- Overall VTE incidence was 9%, with 28 of 325 patients developing at least one thromboembolic event during the observation period. This rate underscores that thrombosis is a frequent and serious complication in patients with PDAC receiving multimodal perioperative treatment.
- The majority of events occurred postoperatively, with 19 patients (approximately 8% of the overall cohort) experiencing VTE after surgery, compared with 9 patients (3%) in the preoperative phase. This distribution suggests the surgical period and its aftermath confer additional thrombotic risk on top of that associated with active malignancy and systemic chemotherapy.
- More than half of all VTEs were symptomatic (54%), indicating that these events were clinically overt rather than incidentally detected on routine imaging in the majority of cases, and therefore likely to have had direct impact on patient outcomes and treatment continuity.
- VTE was associated with decreased overall survival, as determined by Cox regression analysis, though the magnitude of this association — the specific hazard ratio and confidence interval — was not reported in the available abstract text. A higher proportion of postoperative VTE events was observed in the chemoradiotherapy arm compared with the FOLFIRINOX arm (3% in the FFX arm; CRT arm figure not fully reported).
Why This Matters
This analysis provides one of the first systematic assessments of VTE incidence specifically within a neoadjuvant treatment framework for pancreatic cancer, filling an important evidence gap. By demonstrating both the frequency of thrombosis and its association with worse survival, the findings build the rationale for prospective trials evaluating thromboprophylaxis during neoadjuvant PDAC therapy. The authors also highlight the absence of standardized VTE reporting in oncology trials, a methodological gap that limits cross-study comparisons.
How to Read This Result
While drawn from a high-quality randomized controlled trial, the VTE analysis itself was conducted retrospectively, which may have led to underascertainment of events, and the survival effect size was not fully quantified in available reporting, so these findings should be interpreted as hypothesis-generating rather than definitive.
Limitations
VTE occurrence was assessed retrospectively rather than through a prospectively defined, protocol-mandated surveillance schedule, introducing the possibility of detection bias and underestimation of true incidence. Additionally, the abstract reporting is incomplete — the postoperative VTE rate in the chemoradiotherapy arm is truncated — limiting full between-arm comparison. The precise hazard ratio for the association between VTE and overall survival was not extractable from available data.