title: Gemcitabine combined with continuous infusion 5-fluorouracil in advanced and symptomatic pancreatic cancer: a clinical benefit-oriented phase II study.
abstract: Gemcitabine and 5-fluorouracil are the only two compounds with reproducible activity against advanced pancreatic cancer (APC). We have evaluated a novel combination of gemcitabine and 5-fluorouracil on the clinical benefit response (CBR) end point. Eleven consecutive patients with symptomatic APC were entered in a two-stage phase II trial. Gemcitabine was administered by intravenous (i.v.) bolus injection at the dose of 1,000 mg m(-2) on days 1, 8, 15 and 5-fluorouracil 500 mg m(-2) was given by continuous i.v. infusion on days 1-5. Treatment was repeated every 28 days. A CBR was achieved in 7/11 patients. The mean time to loss of CBR was 26.5 weeks (range 14-18, median 22). Toxicity was mild and no APC patient experienced WHO grade 3 toxicity. The gemcitabine/5-fluorouracil combination is well tolerated and produces a symptomatic relief in the majority of APC patients.
authors.affiliation: Cattedra di Oncologia Medica, Dipartimento di Endocrinologia ed Oncologia Molecolare a Clinica, Facoltà di Medicina e Chirurgia, Università Federico II, Napoli, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Matano
authors.forename: P
authors.initials: P
authors.lastname: Tagliaferri
authors.forename: A
authors.initials: A
authors.lastname: Libroia
authors.forename: V
authors.initials: V
authors.lastname: Damiano
authors.forename: A
authors.initials: A
authors.lastname: Fabbrocini
authors.forename: S
authors.initials: S
authors.lastname: De Lorenzo
authors.forename: A R
authors.initials: AR
authors.lastname: Bianco
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine