Irinotecan (CPT-11) and mitomycin-C (MMC) as second-line therapy in advanced gastric cancer: a phase II study of the Gruppo Oncologico dell' Italia Meridionale (prot. 2106)

Am J Clin Oncol. 2005 Dec;28(6):581-5. doi: 10.1097/01.coc.0000190398.52142.7f.

Abstract

Objective: The aim of this study was to evaluate the activity and toxicity of a combination regimen of CPT-11 and mitomycin-c as second-line chemotherapy for pretreated patients with advanced, metastatic, or both, gastric adenocarcinoma.

Materials and methods: Patients with pretreated metastatic disease or early relapsed after adjuvant chemotherapy were enrolled. Entry criteria included histologic/cytologic diagnosis of gastric adenocarcinoma, age 18 to 75 years, performance status > or =70 (Karnofsky scale), bi-dimensionally measurable disease. Patients received CPT-11 and mitomycin-c at the dosage of 150 mg/m2 on days 1 and 15, and 8 mg/m2 on day 1, respectively, every 4 weeks. The disease evaluation was done every 3 cycles.

Results: Among the 38 patients we observed, 1 (3%) complete response and 11 (29%) partial responses for an overall response rate of 32% according to an intent-to-treat analysis. The median duration of response was 6.5 months. The median time to progression was 4 months with a median overall survival 8 months. All patients were evaluable for toxicity and the only grade 3-4 observed toxicities were leukopenia (8%), neutropenia (21%), and anemia (5%).

Conclusions: The combination of CPT-11 and mitomycin-c is an active and well tolerated second-line treatment in pretreated gastric cancer patients. Further studies are needed to test its role in first-line treatment.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / secondary
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / adverse effects
  • Camptothecin / analogs & derivatives
  • Disease-Free Survival
  • Drug Synergism
  • Female
  • Granulocyte Colony-Stimulating Factor / therapeutic use
  • Humans
  • Irinotecan
  • Italy
  • Life Tables
  • Liver Neoplasms / drug therapy
  • Liver Neoplasms / secondary
  • Lung Neoplasms / drug therapy
  • Lung Neoplasms / secondary
  • Lymphatic Metastasis
  • Male
  • Middle Aged
  • Mitomycin / administration & dosage
  • Mitomycin / adverse effects
  • Neutropenia / chemically induced
  • Neutropenia / drug therapy
  • Peritoneal Neoplasms / drug therapy
  • Peritoneal Neoplasms / secondary
  • Salvage Therapy*
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Survival Analysis
  • Treatment Outcome

Substances

  • Granulocyte Colony-Stimulating Factor
  • Mitomycin
  • Irinotecan
  • Camptothecin