Neoadjuvant phase II trial of chemo-radiotherapy (CRT) in patients with resectable (R) and borderline resectable (BR) pancreatic ductal adenocarcinoma (PDA).

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Eur J Cancer


Background: (PDA) is a largely incurable cancer. Surgical resection remains the only potential option for cure. Even in surgically resectable patients, only about 10e30% of patients are long-term survivors. Micro-metastatic disease has been hypothesized as contributing to recurrence. Emerging data suggest a role for neoadjuvant therapy with (CRT) to target occult micro-metastatic disease. Aim: The aim of the study is to report our institutional experience with a novel neoadjuvant CRT regimen in (R) and (BR) PDA. Methods: Design e Prospective Phase II trial. Eligibility e Patients with (R) and (BR) PDA as defined by the NCCN criteria for resectability. Patients were treated with 2 cycles of induction chemotherapy with FOLFOX and then received CRT with Gemcitabine and Intensity modulated Radiotherapy (IMRT). Gemcitabine was dosed at standard dosing at 1000 mg/m2 on Days 1, 8, 22 and 29 of IMRT. All subjects then received 50.4 Gy to the Gross Tumor Volume. Serial Imaging was performed to determine tumor response and resectability. Results: From April 2014 to June 2017, 24 patients were enrolled. Median age is 63.5 years (range 44 to 80). 23 patients had (BR) disease and 1 patient had (R) disease. 58% of patient had Stage 2 PDA, 29% had Stage I PDA and 12.5% had Stage III PDA. All patients received induction chemotherapy with FOLFOX. 13 patients underwent pancreatectomy after CRT with a resection rate of 62%. R0 resection achieved in 11 patients (84.6%) and 2 patients had R 1 resection (15.4%). For patientswho underwent resection, the median PFS was 31 m, 1 year PFS rate was 69.2% (95% CI: 0.48e0.99) and 2-year PFS rate was 51.9 % (95% CI: 0.3e0.89). Median OS was 34.8 m (95% CI: 1.045 to infinity), 1 year OS rate was 91.7 % (95% CI: 0.77e1.0) and 2 year OS rate was 75% (95% CI: 0.54e1.0). Median CA 19-9 at screening for patients who underwent surgery was 659 (range 18e2154), which decreased to 146.9 (range 18e462) after CRT prior to resection. Conclusions: Neo adjuvant therapy for (BR) and (R) PDA with CRT facilitated R0 resection in 84% patients who underwent surgery in a prospective phase IItrial. These results warrant further investigation of neoadjuvant CRT in a larger cohort of patients. Disclosures: Authors have no financial interest or relationship to disclose.




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