title: Adjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: a phase II study.
abstract: 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.
authors.affiliation: Department of Radiation Oncology, Wake Forest University School of Medicine, Medical Center Blvd, Winston-Salem, NC 27157, USA. ablackst@wfubmc.edu
authors.forename: A W
authors.initials: AW
authors.lastname: Blackstock
authors.forename: F
authors.initials: F
authors.lastname: Mornex
authors.forename: C
authors.initials: C
authors.lastname: Partensky
authors.forename: L
authors.initials: L
authors.lastname: Descos
authors.forename: L D
authors.initials: LD
authors.lastname: Case
authors.forename: S A
authors.initials: SA
authors.lastname: Melin
authors.forename: E A
authors.initials: EA
authors.lastname: Levine
authors.forename: G
authors.initials: G
authors.lastname: Mishra
authors.forename: S A
authors.initials: SA
authors.lastname: Limentani
authors.forename: L A
authors.initials: LA
authors.lastname: Kachnic
authors.forename: J E
authors.initials: JE
authors.lastname: Tepper
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery*; D000328:Adult; D000368:Aged; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000628:therapy; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D012008:Recurrence; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000093542:Gemcitabine