title: 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).
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.
  
  
  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.
authors.affiliation: Department of Medical Oncology, Oncology Institute, Bari, Italy. giuliani_daniela@libero.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Giuliani
authors.forename: Stefano
authors.initials: S
authors.lastname: Molica
authors.forename: Evaristo
authors.initials: E
authors.lastname: Maiello
authors.forename: C
authors.initials: C
authors.lastname: Battaglia
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Maurizio
authors.initials: M
authors.lastname: Di Bisceglie
authors.forename: Gianluca
authors.initials: G
authors.lastname: Vinciarelli
authors.forename: Nicola
authors.initials: N
authors.lastname: Gebbia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004357:Drug Synergism; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D007558:Italy; D015993:Life Tables; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000556:secondary; D016879:Salvage Therapy; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D016685:Mitomycin; D000077146:Irinotecan; D002166:Camptothecin