A phase II study of irinotecan with 5-fluorouracil and leucovorin in patients with previously untreated gastric adenocarcinoma.

Abstract

BACKGROUND:

A phase II study testing the safety and efficacy of irinotecan (CPT-11). 5-fluorouracil (5-FU), and leucovorin (LCV) was conducted in patients with advanced gastric adenocarcinomas.

PATIENTS AND METHODS:

Patients with metastatic or recurrent adenocarcinoma of the gastroesophageal junction (GEJ) or stomach were entered onto this study. Previous chemotherapy for metastatic disease was not allowed. Treatment consisted of repeated 6-week cycles comprising CPT-11 125 mg/m2 intravenously (i.v.) followed immediately by LCV 20 mg/m2 i.v. and 5-FU 500 mg/m2 i.v., all given weekly for four weeks followed by a two-week rest.

RESULTS:

Thirty-eight patients were enrolled and 36 eligible patients received protocol therapy. Grade 3-5 toxicities consisted primarily of neutropenia (36%) and diarrhea (28%). Neutropenic infection was observed in 14% of patients, with 3 (8%) dying of neutropenic sepsis. The overall response rate was 22% (95% confidence interval [CI] 8.5% to 35.5%). Median survival was 7.6 months, and median time to progression was 4.4 months.

CONCLUSION:

This weekly regimen of CPT-11 with bolus 5-FU/LCV is active in patients with advanced adenocarcinomas of the stomach or gastroesophageal junction. While rates of grade 3-4 neutropenia and diarrhea were similar to those observed historically in patients receiving this regimen for colorectal cancer, neutropenic fever/sepsis appeared to be more frequent, and dose modifications were substantial. Future trials of this combination in patients with gastric cancer should decrease the absolute starting drug doses and/ or employ altered scheduling that better accommodates the pattern of toxicity.

• Authors: C D Blanke, D G Haller, A B Benson, M L Rothenberg, J Berlin, M Mori, Y C Hsieh, L L Miller
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 12 Issue 11 Pg. 1575-80 (Nov 2001) ISSN: 0923-7534 [Print] England
• PMID: 11822757 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Irinotecan
• Leucovorin
• Fluorouracil
• Camptothecin

Topics

• Adenocarcinoma (drug therapy, mortality, pathology)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Esophagogastric Junction (drug effects, pathology)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Irinotecan
• Leucovorin (administration & dosage, adverse effects)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Neutropenia (chemically induced)
• Stomach Neoplasms (drug therapy, mortality, pathology)
• Survival Rate
• Treatment Outcome