New phase III EORTC transatlantic intergroup trial opens for patients with resected head of pancreas adenocarcinoma

Surgical resection is considered a potentially curative treatment for pancreatic adenocarcinoma, however, the five year survival rate of patients receiving this treatment is less than 20 percent. Adjuvant treatment, therefore, is used to prevent recurrence and improve survival for these patients.

EORTC trial 40084-22084 has two primary objectives: to determine if adding erlotinib to gemcitabine adjuvant chemotherapy will improve survival as compared to gemcitabine alone following resection of head of pancreas adenocarcinoma, then, following adjuvant chemotherapy, determine if concurrent fluoropyrimidine and radiotherapy improves survival for patients who have no evidence of progressive disease.

Gemcitabine is a cytotoxic drug which has improved survival in adjuvant chemotherapy for pancreatic cancer. Erlotinib is a tyrosine kinase inhibitor and a strong, reversible, inhibitor of the epidermal growth factor receptor (EGFR). As a targeted agent blocking EGFR signaling, erlotinib has shown a significant albeit modest effect on survival in patients with metastatic pancreatic cancer and should be evaluated in earlier-stage disease where the magnitude of observed benefit may be increased.

Chemoradiation might improve survival for patients with pancreatic cancer, but there is no definitive evidence to establish the inclusion of chemoradiation in their treatment plan. It is thought that adjuvant chemoradiation, i.e. radiation plus concurrent fluoropyrimidine, will increase survival for patients with resected head of pancreas adenocarcinoma who remain disease free after adjuvant chemotherapy with gemcitabine or gemcitabine and erlotinib.

Dr. Jean-Luc Van Laethem of the Hôpitaux Universitaires Bordet-Erasme – Hopital Universitaire Erasme, Brussels and coordinator of this study says, “this protocol is a very good opportunity to definitively answer the question of adding radiation therapy in the adjuvant setting of pancreatic cancer, and to build an ambitious translational research program based on large scale tissue biobanking.”

EORTC trial 40084 – 22084 plans to accrue 950 patients overall and 300 patients at 23 EORTC sites located in seven countries: Belgium, France, the United Kingdom, Germany, Italy, Spain, and Switzerland. Pancreatic adenocarcinoma is a relatively rare disease, and such a study is only possible in an academic intergroup setting.

The trial is sponsored by the sponsored by the NCI in the US and by the EORTC in Europe, led by the Radiation Therapy Oncology Group in collaboration with the EORTC Gastrointestinal Tract Cancer Group, the EORTC Radiation Oncology Group, and the Southwest Oncology Group, and is an academic investigator driven clinical trial without financial support from the industry. Erlotinib is supplied by Roche.

For more information concerning EORTC trial 40084 – 22084 please contact: www.eortc.org/contact

John Bean, PhD
EORTC, Medical Science Writer