Evaluating preoperative gemcitabine-based chemoradiation for resectable and borderline resectable pancreatic cancer: a phase 1 study.

[PURPOSE] Neoadjuvant pancreatic ductal adenocarcinoma (PDAC) treatment is evolving, and chemoradiotherapy (CRT) is emerging as a promising strategy for neoadjuvant therapy. Given the variability in radiotherapy protocols, this study aimed to evaluate the feasibility and safety of gemcitabine-based neoadjuvant chemoradiotherapy.

[METHODS] In this single-arm, phase 1 clinical trial, 31 patients with PDAC were enrolled between April 2016 and August 2019. All patients received preoperative gemcitabine-based chemoradiotherapy with adverse events as the primary endpoint. Multichannel radiation was administered at a total dose of 54 Gy in daily fractions of 1.8 Gy (five fractions per week), which represents a novel aspect of this study.

[RESULTS] Neoadjuvant therapy was completed in 24 patients, while seven were discontinued due to disease progression. The common adverse events included leukopenia (48.3%), thrombocytopenia (12.9%), and anemia (3.2%). Among the patients who underwent pancreatectomy, the R0 resection rate was 95.8%. Intention-to-treat analysis indicated a 2-year overall survival rate of 49.8% and a 2-year recurrence-free survival rate of 42.4%. High pretreatment CA19-9 levels were identified as predictive factors for overall survival (HR = 28.7, 95% CI:5.00-164.3).

[CONCLUSIONS] Gemcitabine-based neoadjuvant chemoradiotherapy is a feasible and effective approach for achieving high R0 resection rates in resectable and borderline PDAC.