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DOI: 10.1055/s-0039-1695452
R0-resection following chemotherapy or chemoradiation improves survival of primary inoperable pancreatic cancer patients. Interim results of the CONKO-007 prospective randomized multicenter trial
Publication History
Publication Date:
13 August 2019 (online)
Introduction:
It remains unclear whether patients with initially unresectable pancreatic cancer can achieve resectable status and, if so, whether surgery provides them any additional benefit.
Methods:
CONKO-007 is a multicenter, phase III randomized clinical trial which examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy in patients with non-metastatic, initially locally advanced unresectable pancreatic cancer. The present analysis was based on data from the first 180 patients recruited from 2013 to 2015.
Results:
Induction chemotherapy consisted of gemcitabine in 43 cases and of FOLFIRINOX in 137 cases. After induction chemotherapy, 126/180 patients (70.0%) were randomized to further treatment. The main reasons for non-randomization were distant metastasis (29.6%), patient request (24.1%), local progression (13.0%) and side effects (13.0%). After completion of study treatment 36 patients (20.0%) underwent surgery and 87 (48.3%) received no surgical treatment. R0 resection was achieved in 25 cases (13.9%) versus exploration or R1/R2/Rx resection in 11 cases (6.1%). Five patients (13.9%) developed postoperative major complications: bleeding (n = 1), pancreatic fistula (n = 1), wound healing disturbance (n = 1), ileus (n = 1), and insufficiency of gastric anastomosis (n = 1). Mortality was 5.5%. Overall survival was significantly better in the R0 resection group (26.5 months) than in the non-operated patients (16.5 months) or patients in the exploration or R1/R2/Rx resection group (16.9 months) (p = 0.003).
Conclusion:
Even if pancreatic cancer is staged as locally advanced unresectable at primary diagnosis, resectability should be reassessed after neoadjuvant treatment. Patients with a good probability of R0 resection should undergo surgery as this significantly improves their prognosis.