Adjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: a phase II study

• Published in: British journal of cancer Vol. 95; no. 3; pp. 260 - 265
• Main Authors: BLACKSTOCK, A. W, MORNEX, F, TEPPER, J. E, PARTENSKY, C, DESCOS, L, CASE, L. D, MELIN, S. A, LEVINE, E. A, MISHRA, G, LIMENTANI, S. A, KACHNIC, L. A
• Format: Journal Article
• Language: English
• Published: Basingstoke Nature Publishing Group 07.08.2006
• Subjects: Adenocarcinoma - surgery; Adult; Aged; Biological and medical sciences; Chemotherapy, Adjuvant; Clinical Study; Combined Modality Therapy; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Disease Progression; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Gastroenterology. Liver. Pancreas. Abdomen; Gemcitabine; Humans; Injections, Intravenous; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Middle Aged; Neoplasm Recurrence, Local - therapy; Pancreatic cancer; Pancreatic Neoplasms - drug therapy; Pancreatic Neoplasms - radiotherapy; Pancreatic Neoplasms - surgery; Recurrence; Survival Rate; Treatment Outcome; Tumors; Antineoplastic agent; Human; Gemcitabine; Concurrent; Malignant tumor; Radiotherapy; Chemotherapy; Cancerology; Antimetabolic; Pancreas cancer; Phase II trial; Digestive diseases; Pyrimidine derivatives; pancreatic; Adjuvant; Combined treatment; Fluorine Organic compounds; Pyrimidine nucleoside; chemoradiation; Pancreatic disease
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/sj.bjc.6603270

The safety and efficacy of gemcitabine and concurrent radiation to the upper abdomen followed by weekly gemcitabine in patients with resected pancreatic cancer was determined. Patients with resected adenocarcinoma of the pancreas were treated with intravenous gemcitabine administered twice-weekly (40 mg m(-2)) for 5 weeks concurrent with upper abdominal radiation (50.4 Gy in 5(1/2) weeks). At the completion of the chemoradiation, patients without disease progression were given gemcitabine (1000 mg m(-2)) weekly for two cycles. Each cycle consisted of 3 weeks of treatment followed by 1 week without treatment. Forty-seven patients were entered, 46 of whom are included in this analysis. Characteristics: median age 61 years (range 35-79); 24 females (58%); 73% stage T3/T4; and 70% lymph node positive. Grade III/IV gastrointestinal or haematologic toxicities were infrequent. The median survival was 18.3 months, while the median time to disease recurrence was 10.3 months. Twenty-four percent of patients were alive at 3 years. Only six of 34 patients with progression experienced local regional relapse as a component of the first site of failure. These results confirm the feasibility of delivering adjuvant concurrent gemcitabine and radiation to the upper abdomen. This strategy produced good local regional tumour control.