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

Blanke CD, Haller DG, Benson AB, Rothenberg ML, Berlin J, Mori M, Hsieh YC, Miller LL
Ann Oncol. 2001 12 (11): 1575-80

PMID: 11822757 · DOI:10.1023/a:1013129315036

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.

MeSH Terms (19)

Adenocarcinoma Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols Camptothecin Esophagogastric Junction Female Fluorouracil Humans Irinotecan Leucovorin Male Middle Aged Neoplasm Recurrence, Local Neutropenia Stomach Neoplasms Survival Rate Treatment Outcome

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