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)

Francesco Giuliani, Stefano Molica, Evaristo Maiello, C. Battaglia, Vittorio Gebbia, Maurizio Di Bisceglie, Gianluca Vinciarelli, Nicola Gebbia, Giuseppe Colucci

Research output: Contribution to journalArticlepeer-review

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 ≥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.

Original languageEnglish
Pages (from-to)581-585
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume28
Issue number6
DOIs
Publication statusPublished - Dec 2005

Keywords

  • CPT-11
  • Gastric cancer
  • Metastases
  • Mitomycin C

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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