A.H. Harsono1, M. Holland1, C. Annesi1, E. Grant2, M. Reardon3, M.C. McLeod1, M.J. Heslin1, H. Chen1, A.L. Fonseca1 1University Of Alabama at Birmingham, Department Of Surgery, Birmingham, Alabama, USA 2University Of Alabama at Birmingham, School Of Medicine, Birmingham, Alabama, USA 3Auburn University, Auburn, ALABAMA, USA
Introduction: Pancreatic ductal adenocarcinoma (PDAC) is the third leading cause of cancer deaths with a 5-year-survival rate of 13%. While neoadjuvant chemotherapy (NAC) is recommended for patients with borderline resectable PDAC and is considered to be an acceptable approach for patients with upfront resectable PDAC, its efficacy in early, node negative PDAC has not been established. In this study, we analyze the impact of NAC versus upfront surgery (UFS) approach in patients with T1-2 N0 PDAC.
Methods: Using the National Cancer Database (NCDB), patients with T1N0M0 and T2N0M0 diagnosed between 2010 and 2021were identified. Bivariate analysis was conducted using chi-square or t-test relevant to the variable types. Survival analyses were performed using Kaplan-Meier method as well as both univariable and multivariable Cox regression models.
Results: Of the 16,439 patients identified, 13,694 were white (83.3%); 8,660 were female (52.7%) and 9,630 were between the ages of 60-79 years (58.6%). Approximately 50% (n=8,067) were treated at academic facilities and 42.8% (n=7,032) were treated at high volume facilities. A total of 49.3% (n=8,099) patients received chemotherapy as first-line therapy, 13.9% (n=2,283) patients had surgery, and 36.9% (n=6,057) patients did not receive any treatment. Of the patients who received surgery, 830 (36.4%) went on to receive adjuvant chemotherapy, while 15.1% (n=1,220) of the patients who received NAC received curative intent surgical resection. Survival difference of patients receiving NAC and UFS is shown in Figure 1. Patients receiving NAC has a higher median survival time of 33.8 months as compared to those with UFS approach, with median survival of 26.7 months (p=0.0010). Cox regression analysis demonstrated that after adjustment for covariates, NAC approach was associated with improved overall survival (HR 0.84, 95% CI 0.75-0.94) compared with UFS.
Conclusion: This study of patients demonstrates a survival benefit for patients with Stage 1 PDAC who receive NAC. While the NCDB does not allow for the degree of granularity required to assess for decision making and details regarding chemotherapy regimens, these results demonstrate a positive impact on survival even in early stage, node negative PDAC. PDAC is a heterogenous disease and as such, there is no one-size-fits-all model. This study adds to the growing body of evidence supporting NAC as a treatment strategy for early stage PDAC.