Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer : Results of the first prospective randomized phase II trial

Golcher H, Brunner T, Witzigmann H, Marti L, Bechstein WO, Bruns C, Jungnickel H, Schreiber S, Grabenbauer G, Meyer T, Merkel S, Fietkau R, Hohenberger W (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Strahlentherapie und Onkologie Urban & Vogel

Book Volume: 191

Pages Range: 7-16

Journal Issue: 1

DOI: 10.1007/s00066-014-0737-7

Abstract

In 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 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).The 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).This 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.

Authors with CRIS profile

Susanne Merkel Department of Surgery Rainer Fietkau Lehrstuhl für Strahlentherapie Werner Hohenberger Department of Surgery

Involved external institutions

Universitätsklinikum Leipzig DE Germany (DE) Krankenhaus Dresden-Friedrichstadt, Städtisches Klinikum DE Germany (DE) Klinikum der Universität München (Großhadern und Innenstadt) DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) Kantonsspital St.Gallen CH Switzerland (CH)

How to cite

APA:

Golcher, H., Brunner, T., Witzigmann, H., Marti, L., Bechstein, W.-O., Bruns, C.,... Hohenberger, W. (2015). Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer : Results of the first prospective randomized phase II trial. Strahlentherapie und Onkologie, 191(1), 7-16. https://doi.org/10.1007/s00066-014-0737-7

MLA:

Golcher, Henriette, et al. "Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer : Results of the first prospective randomized phase II trial." Strahlentherapie und Onkologie 191.1 (2015): 7-16.

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