A randomized phase II trial of cisplatinum plus mitomycin-C plus vinorelbine and carboplatin plus vinorelbine in advanced non-small cell lung cancer

Marco Colleoni, Giovanni Vicario, Francesca Pancheri, Gigliola Sgarbossa, Patrizia Nelli, Paolo Manente

Research output: Contribution to journalArticle

Abstract

Vinorelbine represents one of the most active agents in advanced non-small cell lung cancer (NSCLC), with response rates of 14-33%. We therefore evaluated the activity and tolerability of two novel vinorelbine-containing regimens in stage IIIB-IV NSCLC. Fifty-two patients were enrolled in a randomized phase II study of cisplatinum (100 mg/m2) day 1, mitomycin-C (8 mg/m2) day 1, and vinorelbine (25 mg/m2) days 1 and 8 (Arm A); and carboplatin (400 mg/m2) day 1, in combination with vinorelbine (25 mg/m2) days 1 and 8 (Arm B). Cycles were repeated every 3 weeks. All patients were assessable for reponse and side effects. Patients were well balanced between the two Arms in terms of major characteristics. A total of 98 and 91 cycles were delivered respectively in Arm A and Arm B. Eleven objective responses (42%; 95% confidence interval 26-63%) were observed in Arm A and 7 responses (27%; 95% confidence interval 12-48%) in Arm B. Main toxicity was mild or moderate, nausea and vomiting for Arm A and hematological for Arm B. Other side effects included infections and phlebitis and were similar for the two Arms. In conclusion, both schedules demonstrated activity in advanced NSCLC. The three-drug regimen appeared very promising in terms of activity and manageable toxicity.

Original languageEnglish
Pages (from-to)619-622
Number of pages4
JournalInternational Journal of Oncology
Volume10
Issue number3
Publication statusPublished - 1997

Keywords

  • carboplatin
  • cisplatinum
  • mitomycin-C
  • NSCLC
  • vinorelbine

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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