Mitomycin C plus infusional 5-fluorouracil in platinum-refractory gastric adenocarcinoma: an extended multicenter phase II study.

Abstract

OBJECTIVE:

To assess the toxicity and activity of bolus mitomycin C (MMC) in combination with a 24-hour continuous infusion of 5-fluorouracil (5-FU) in gastric cancer patients who had received at least one prior chemotherapy regimen.

PATIENTS AND METHODS:

Patients were treated with MMC (10 mg/m(2)) on days 1 and 22, 5-FU (2.6 g/m(2)) as a 24-hour infusion, and folinic acid 500 mg/m(2) weekly for 6 weeks.

RESULTS:

Thirty-four patients with gastric cancer, 16 after failure of first-line chemotherapy and 18 after failure of at least two prior chemotherapies, were included. In the intent-to-treat analysis, 9 (26.5%) of the 34 patients had a partial response and 10 (29.4%) a disease stabilization (disease control rate 56%). The median time to progression was 3.3 months (CI95: 2.8-3.7), and the median overall survival was 7.2 months (CI95: 5.9-8.4). Grade III/IV thrombocytopenia occurred in 14.7% of patients (n = 5), while the most frequent nonhematological grade III/IV toxicities were mucositis and diarrhea, each affecting 9% of patients.

CONCLUSIONS:

As the tested regimen was generally safe and well tolerated by the patients, MMC plus infusional 5-FU/folinic acid may be a potential second-line regimen for patients with advanced gastric cancer.

• Authors: Jörg Thomas Hartmann, Jan Peter Pintoffl, Salah-Eddin Al-Batran, Detlef Quietzsch, Ines Meisinger, Marius Horger, Oliver Nehls, Carsten Bokemeyer, Alfred Königsrainer, Elke Jäger, Lothar Kanz
• Journal: Onkologie (Onkologie) Vol. 30 Issue 5 Pg. 235-40 (May 2007) ISSN: 0378-584X [Print] Switzerland
• PMID: 17460417 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Mitomycin
• Leucovorin
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, mortality, pathology)
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Disease Progression
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Drug Resistance, Neoplasm
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Infusions, Intravenous
• Injections, Intravenous
• Leucovorin (administration & dosage, adverse effects)
• Male
• Middle Aged
• Mitomycin (administration & dosage, adverse effects)
• Neoplasm Staging
• Retreatment
• Stomach Neoplasms (drug therapy, mortality, pathology)
• Survival Rate