title: Phase II trial of topotecan as a 21-day continuous infusion in patients with advanced or metastatic adenocarcinoma of the pancreas.
abstract: The aim of this study was to determine the efficacy and toxicity of topotecan administered as a 21-day continuous intravenous infusion in patients with advanced or metastatic adenocarcinoma of the pancreas. 26 previously untreated patients with advanced or metastatic pancreatic adenocarcinoma received topotecan at a dose of 0.5 mg/m2/day or 0.6 mg/m2/day as a continuous intravenous infusion for 21 days. Courses were repeated every 28 days. 26 patients were assessable for response and toxicity on an intent-to-treat basis. The initial 8 patients at a starting dose of 0.6 mg/m2/day experienced unacceptable myelosuppression and dose delays. The subsequent 18 patients, therefore began therapy at a dose of 0.5 mg/m2/day. The major toxicity of topotecan at this dose and schedule was myelosuppression, which was reversible and non-cumulative. There were no complete responses and two partial responses for a total response rate of 8% (95% confidence interval, 1-25%). Response durations were 17 and 45 weeks. Stable disease was seen in 3 patients. The median time to progression for all patients was 8 weeks and the median survival was 20 weeks. Topotecan given as a 21-day continuous intravenous infusion has a similar response rate and median survival to our previously reported study of the 5-day short infusion regimen in pancreatic carcinoma.
authors.affiliation: Thomas Jefferson University, Kimmel Cancer Center, Philadelphia, PA 19107, USA.
authors.forename: J P
authors.initials: JP
authors.lastname: Stevenson
authors.forename: R M
authors.initials: RM
authors.lastname: Scher
authors.forename: R
authors.initials: R
authors.lastname: Kosierowski
authors.forename: S C
authors.initials: SC
authors.lastname: Fox
authors.forename: M
authors.initials: M
authors.lastname: Simmonds
authors.forename: K S
authors.initials: KS
authors.lastname: Yao
authors.forename: F
authors.initials: F
authors.lastname: Green
authors.forename: C
authors.initials: C
authors.lastname: Broom
authors.forename: S Z
authors.initials: SZ
authors.lastname: Fields
authors.forename: J B
authors.initials: JB
authors.lastname: Krebs
authors.forename: P J
authors.initials: PJ
authors.lastname: O'Dwyer
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000556:secondary; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan