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Adjuvant Radiotherapy and 5-Fluorouracil After Curative Resection of Cancer of the Pancreas and Periampullary Region: Phase III Trial of the EORTC Gastrointestinal Tract Cancer Cooperative Group

Klinkenbijl, Jean H. MD, PhD*; Jeekel, Johannes MD, PhD*; Sahmoud, Tarek MD, PhD; van Pel, Renée MD, PhD; Couvreur, Marie Laure MSc; Veenhof, Cees H. MD, PhD§; Arnaud, Jean Pierre MD, PhD; Gonzalez, Dionisio Gonzalez MD, PhD; de Wit, Laurens Th. MD, PhD#; Hennipman, Adriaan MD, PhD**; Wils, Jacques MD, PhD††

SCIENTIFIC PAPERS OF THE EUROPEAN SURGICAL ASSOCIATION

Objective The survival benefit of adjuvant radiotherapy and 5-fluorouracil versus observation alone after surgery was investigated in patients with pancreatic head and periampullary cancers.

Summary Background Data A previous study of adjuvant radiotherapy and chemotherapy in these cancers by the Gastrointestinal Tract Cancer Cooperative Group of EORTC has been followed by other studies with conflicting results.

Methods Eligible patients with T1-2N0-1aM0 pancreatic head or T1-3N0-1aM0 periampullary cancer and histologically proven adenocarcinoma were randomized after resection.

Results Between 1987 and 1995, 218 patients were randomized (108 patients in the observation group, 110 patients in the treatment group). Eleven patients were ineligible (five in the observation group and six in the treatment group). Baseline characteristics were comparable between the two groups. One hundred fourteen patients (55%) had pancreatic cancer (54 in the observation group and 60 in the treatment group). In the treatment arm, 21 patients (20%) received no treatment because of postoperative complications or patient refusal. In the treatment group, only minor toxicity was observed. The median duration of survival was 19.0 months for the observation group and 24.5 months in the treatment group (log-rank, p = 0.208). The 2-year survival estimates were 41% and 51%, respectively. The results when stratifying for tumor location showed a 2-year survival rate of 26% in the observation group and 34% in the treatment group (log-rank, p = 0.099) in pancreatic head cancer; in periampullary cancer, the 2-year survival rate was 63% in the observation group and 67% in the treatment group (log-rank, p = 0.737). No reduction of locoregional recurrence rates was apparent in the groups.

Conclusions Adjuvant radiotherapy in combination with 5-fluorouracil is safe and well tolerated. However, the benefit in this study was small; routine use of adjuvant chemoradiotherapy is not warranted as standard treatment in cancer of the head of the pancreas or periampullary region.

From the Departments of *Surgery and ‡Pathology, University Hospital Rotterdam-Dijkzigt, The Netherlands; †the EORTC, Brussels, Belgium; the Departments of §Medical Oncology, ¶Radiotherapy, and #Surgery, Academic Medical Center Amsterdam, Amsterdam, The Netherlands; ∥Department of Surgery, University Hospital, Angers, France; **Department of Surgery, University Hospital, Utrecht, The Netherlands; and ††Department of Oncology, St. Laurentius Hospital, Roermond, The Netherlands

Reprint requests: Johannes Jeekel, MD, PhD, University Hospital Rotterdam-Dijkzigt, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.

Presented at the Sixth Annual Meeting of the European Surgical Association, at the Royal College of Surgeons of England, London, United Kingdom, April 23–24, 1999.

The Parthenon Trust provided the EORTC Data Center with support for this research.

Accepted for publication July 1999.

© 1999 Lippincott Williams & Wilkins, Inc.