title: An explorative randomised phase II study of sequential chemotherapy in advanced upper gastrointestinal cancer.
abstract: The feasibility, safety, and efficacy of planned sequential administration of docetaxel and irinotecan with 5-fluorouracil (5-FU)/leucovorin in advanced upper gastrointestinal adenocarcinoma (UGIA) are unknown. Seventy-three patients with gastric (GC; n = 22), pancreatic (PC; n = 28) or biliary cancer (BC; n = 23) were randomised to start with 45 mg/m(2) docetaxel or 180 mg/m(2) irinotecan combined with 5-FU/leucovorin every 2nd week. After every 2nd course, the patients were crossed over to the other combination. Treatment was given for a maximum of 12 courses. Quality-of-life (QoL) was evaluated during the first two months using the EORTC QLQ-C30. Eighteen patients (25%; GC 32%, PC 21%, BC 22%) demonstrated partial response (PR) and 21 (29%) had prolonged stable disease. Mean QoL scores were low at baseline. Twenty-three (32%) patients had improved QoL using a summary measure and 13 were stable. Median time to progression was 4.4 months and overall survival 8.2 months. The treatments were reasonably well tolerated. Grade 3-4 toxicities were slightly more common for the docetaxel combination. There were two treatment-related deaths. Planned sequential treatment with docetaxel or irinotecan with 5-FU/leucovorin is feasible, reasonably tolerable and appears active in advanced UGIA.
authors.affiliation: Department of Oncology, Radiology and Clinical Immunology, Akademiska sjukhuset, University of Uppsala, Uppsala, Sweden.
authors.forename: Ake
authors.initials: A
authors.lastname: Berglund
authors.forename: Per
authors.initials: P
authors.lastname: Byström
authors.forename: Birgitta
authors.initials: B
authors.lastname: Johansson
authors.forename: Peter
authors.initials: P
authors.lastname: Nygren
authors.forename: Jan-Erik
authors.initials: JE
authors.lastname: Frödin
authors.forename: Dorte
authors.initials: D
authors.lastname: Pedersen
authors.forename: Henry
authors.initials: H
authors.lastname: Letocha
authors.forename: Bengt
authors.initials: B
authors.lastname: Glimelius
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D001661:Biliary Tract Neoplasms / Q000188:drug therapy; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004067:Digestive System Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D014803:Vitamin B Complex; D000077143:Docetaxel; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin