A randomized phase II trial of two schedules of topotecan for the treatment of advanced stage non-small cell lung cancer

John J. Weitz, Robert F. Marschke, Jeff A. Sloan, Joseph P. Grill, James R. Jett, James A. Knost, Alan K. Hatfield, David W. Zenk, Walter W. Bate, Paul L. Schaefer

Research output: Contribution to journalArticle

27 Scopus citations

Abstract

We conducted a randomized phase II trial of two different schedules of topotecan in patients with advanced-stage non small lung cancer (NSCLC) without prior cytotoxic chemotherapy. All patients had histologic or cytologic confirmation of stage IV (M1) or III-B NSCLC. Patients were stratified by performance status, stage and weight loss. Patients were randomized to receive topotecan at intravenous doses of 1.5 mg/m2/day over 30 min for 5 days every 3 weeks (Arm A) or 1.3 mg/m2/day by continuous infusion pump over 72 h every 4 weeks (Arm B). Thirty-eight patients in Arm A and 37 patients in Arm B were deemed evaluable for response and toxicity. Six tumor responses (16%, 4 PR, 2 REGR) were observed among 38 evaluable patients in Arm A and all responses occurred in patients with adenocarcinoma. In Arm B, 3 tumor responses (8%, 2 PR, 1 REGR) occurred among 37 evaluable patients and responses occurred in patients with squamous cell carcinoma (1) and adenocarcinoma (2). Toxicities > grade 3 in both arms included leukopenia, thrombocytopenia, malaise, constipation, diarrhea, lethargy, pulmonary, vomiting, infection and myalgia. Severe (≥ grade 3) thrombocytopenia occurred in 15.8% of Arm A patients and 37.8% of Arm B patients and this difference was statistically significant (P = 0.03). The median times to progression are 101 and 63 days (P = 0.75) and the median survival times are 257 and 179 days (P = 0.83) for Arms A and B, respectively. These differences in time to progression and overall survival are not statistically significant. Topotecan has limited, single agent activity in advanced NSCLC when given as 1.5 mg/m2/day over 30 min for 5 days every 3 weeks. We do not intend to pursue further investigations with topotecan in patients with NSCLC. (C) 2000 Elsevier Science Ireland Ltd.

Original languageEnglish (US)
Pages (from-to)157-162
Number of pages6
JournalLung Cancer
Volume28
Issue number2
DOIs
StatePublished - May 1 2000

Keywords

  • Cell carcinoma
  • Lung cancer
  • Topotecan

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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    Weitz, J. J., Marschke, R. F., Sloan, J. A., Grill, J. P., Jett, J. R., Knost, J. A., Hatfield, A. K., Zenk, D. W., Bate, W. W., & Schaefer, P. L. (2000). A randomized phase II trial of two schedules of topotecan for the treatment of advanced stage non-small cell lung cancer. Lung Cancer, 28(2), 157-162. https://doi.org/10.1016/S0169-5002(99)00128-2