In a German phase III trial (CONKO-007) reported in the Journal of Clinical Oncology, Fietkau et al found that although adding chemoradiotherapy (CRT) to chemotherapy vs chemotherapy alone following induction therapy did not improve overall R0 resection rate in all patients with initially unresectable pancreatic tumors, CRT was associated with an R0 benefit among patients actually undergoing surgery.
Study Details
In the open-label multicenter study, 495 patients with unresectable tumors enrolled between April 2013 and February 2021 were treated with induction chemotherapy consisting of FOLFIRINOX (fluorouracil, irinotecan, and oxaliplatin; n = 402) or gemcitabine (n = 93). A total of 336 patients without disease progression after 3 months of induction therapy were randomly assigned to receive the same chemotherapy (n = 167) or CRT with 50.4 Gy concurrently with gemcitabine (n = 169). Resectability was centrally reassessed by a panel of surgeons, and surgery was recommended if deemed possible. The primary outcome measure was R0 resection rate.
Key Findings
The overall R0 resection rate was 25% in the CRT group vs 18% in the chemotherapy group (P = .113).
No difference was observed in proportions of patients in each group who underwent surgery (P = .91). R0 resection was achieved in 43 (69.4%) of 62 patients in the CRT group who underwent surgery vs 30 (50.0%) of 60 in the chemotherapy group who underwent surgery (P = .04). The ratio of R0/R1/R2/no resection favored CRT (P = .02).
Among all patients, no difference in overall survival was observed between the CRT group vs the chemotherapy group (hazard ratio [HR] = 0.937, 95% confidence interval [CI] = 0.747–1.174, P = .57). Overall, surgery was associated with improved overall survival (HR = 0.525, 95% CI = 0.408–0.676, P < .001).
The investigators concluded: “Although not improving overall R0 resection rate or survival, CRT enables an R0 resection in surgically treated patients more often than chemotherapy alone.”
Rainer Fietkau, MD, of the Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by German Cancer Aid. For full disclosures of all study authors, visit ascopubs.org.
