Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer

Abstract

BackgroundIn nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging.Patients and methodsPatients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS).ResultsThe trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79).ConclusionThis worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543.Electronic supplementary materialThe online version of this article (doi: 10.1007/s00066-014-0737-7) contains supplementary material, which is available to authorized users.

Comparison of toxicity after IMRT and 3D-conformal radiotherapy for patients with pancreatic cancer – A systematic review

“…In addition, seven more studies with conventional 3D-conformal radiation therapy planning were selected for comparison http://dx.doi.org/10.1016/j.radonc.2014.11.043 0167-8140/Ó 2014 Elsevier Ireland Ltd. All rights reserved. [18][19][20][21][22][23][24]. The studies selected for this purpose were large, recent trials recognized for their high clinical quality and unanimously agreed upon by the research team.…”

The clinical benefit of hyperthermia in pancreatic cancer: a systematic review

“…For (borderline) resectable pancreatic cancer, the standard treatment is exploratory laparotomy, with resection and adjuvant chemotherapy when a resection was performed [3][4][5]. The impact of neoadjuvant chemoradiotherapy is under investigation; its suggested beneficial effect on overall survival has been studied in two randomised trials that were terminated prematurely [6,7], as well as in one recently completed randomised multicenter trial [8]. However, the vast majority of patients present with either locally advanced or metastatic pancreatic cancer [9].…”

Impact of early disease progression and surgical complications on adjuvant chemotherapy completion rates and survival in patients undergoing the surgery first approach for resectable pancreatic ductal adenocarcinoma – A population-based cohort study

“…There are several ongoing randomised studies on NT versus the SF approach. The only published randomised study so far is on neoadjuvant chemoradiotherapy versus SF [10]. However, the results were not significant and the study was terminated early due to slow recruiting.…”