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Clinical Trial
. 2021 Jan;197(1):8-18.
doi: 10.1007/s00066-020-01680-2. Epub 2020 Sep 10.

R0 resection following chemo (radio)therapy improves survival of primary inoperable pancreatic cancer patients. Interim results of the German randomized CONKO-007± trial

R Fietkau  1 , R Grützmann  2 , U A Wittel  3 , R S Croner  4 , L Jacobasch  5 , U P Neumann  6 , A Reinacher-Schick  7 , D Imhoff  8 , S Boeck  9 , L Keilholz  10 , H Oettle  11 , W M Hohenberger  2 , H Golcher  2 , W O Bechstein  12 , W Uhl  13 , A Pirkl  14 , W Adler  15 , S Semrau  16 , S Rutzner  16 , M Ghadimi  17 , D Lubgan  16
Affiliations
Clinical Trial

R0 resection following chemo (radio)therapy improves survival of primary inoperable pancreatic cancer patients. Interim results of the German randomized CONKO-007± trial

R Fietkau et al. Strahlenther Onkol. 2021 Jan.

Abstract

Purpose: Chemotherapy with or without radiotherapy is the standard in patients with initially nonmetastatic unresectable pancreatic cancer. Additional surgery is in discussion. The CONKO-007 multicenter randomized trial examines the value of radiotherapy. Our interim analysis showed a significant effect of surgery, which may be relevant to clinical practice.

Methods: One hundred eighty patients received induction chemotherapy (gemcitabine or FOLFIRINOX). Patients without tumor progression were randomized to either chemotherapy alone or to concurrent chemoradiotherapy. At the end of therapy, a panel of five independent pancreatic surgeons judged the resectability of the tumor.

Results: Following induction chemotherapy, 126/180 patients (70.0%) were randomized to further treatment. Following study treatment, 36/126 patients (28.5%) underwent surgery; (R0: 25/126 [19.8%]; R1/R2/Rx [n = 11/126; 6.1%]). Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003). In the 25 patients with R0 resected tumors before treatment, only 6/113 (5.3%) of the recommendations of the panel surgeons recommended R0 resectability, compared with 17/48 (35.4%) after treatment (p < 0.001).

Conclusion: Tumor resectability of pancreatic cancer staged as unresectable at primary diagnosis should be reassessed after neoadjuvant treatment. The patient should undergo surgery if a resectability is reached, as this significantly improves their prognosis.

Keywords: Neoadjuvant chemoradiotherapy; Pancreatic adenocarcinoma; Prospective randomized multicenter trial; Surgery; Tumor resectability.

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Conflict of interest statement

R. Fietkau, R. Grützmann, U.A. Wittel, R.S. Croner, L. Jacobasch, U.P. Neumann, A. Reinacher-Schick, D. Imhoff, S. Boeck, L. Keilholz, H. Oettle, W.M. Hohenberger, H. Golcher, W.O. Bechstein, W. Uhl, A. Pirkl, W. Adler, S. Semrau, S. Rutzner, M. Ghadimi, and D. Lubgan declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial schedule including study inclusion, evaluation for resectability, induction chemotherapy, randomization, therapy after randomization, and subsequent evaluation of resectability at the end of the trial
Fig. 2
Fig. 2
CONSORT diagram
Fig. 3
Fig. 3
Disease-free survival rates of randomized patients (n = 126): R0-resected patients (green curve) in relation to R1/R2/Rx-resected patients (red curve) and patients without surgery (black curve). Median survival rates are given in months
Fig. 4
Fig. 4
Overall survival rates of randomized patients (n = 126): R0-resected patients (green curve) in relation to R1/R2/Rx-resected patients (red curve) and patients without surgery (black curve). Median survival rates are given in months
See this image and copyright information in PMC

Comment in

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