title: A phase II trial of irinotecan in patients with previously untreated advanced esophageal and gastric adenocarcinoma.
abstract: Chemotherapy options for esophagogastric adenocarcinoma remain limited. Irinotecan has demonstrated broad activity in a variety of epithelial malignancies. Forty-six patients with previously untreated, measurable, unresectable, or metastatic esophagogastric adenocarcinoma were enrolled. Patients received irinotecan (125 mg/m2 intravenously over 90 min weekly) for 4 consecutive weeks followed by a 2-week rest. Forty-three patients received at least one treatment and were evaluable for response and toxicity. One complete and five partial responses were observed, for an overall response rate of 14% (95% CI, 4-24%). Median survival for all 43 patients was 6.4 months (95% CI, 4.6-8.2 months). Grade 3 to 4 toxicity included 10 patients (23%) with neutropenia, 13 patients (30%) with late diarrhea, 6 patients (14%) with vomiting, and 6 patients (14%) with fatigue. We conclude that although single-agent irinotecan is an active agent for esophagogastric adenocarcinoma, the schedule utilized in this trial is associated with moderate toxicity. When used as a single-agent, a tri-weekly schedule may be preferable for this patient population.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts 02115, USA. Peter_Enzinger@dfci.harvard.edu
authors.forename: Peter C
authors.initials: PC
authors.lastname: Enzinger
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Kulke
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Clark
authors.forename: David P
authors.initials: DP
authors.lastname: Ryan
authors.forename: Haesook
authors.initials: H
authors.lastname: Kim
authors.forename: Craig C
authors.initials: CC
authors.lastname: Earle
authors.forename: Michele M
authors.initials: MM
authors.lastname: Vincitore
authors.forename: Ann L
authors.initials: AL
authors.lastname: Michelini
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mayer
authors.forename: Charles S
authors.initials: CS
authors.lastname: Fuchs
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004943:Esophagogastric Junction / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D010166:Palliative Care / Q000379:methods; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis; D019452:Terminally Ill; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002166:Camptothecin