Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with chemotherapy

R. Perez-Soler, F. V. Fossella, B. S. Glisson, J. S. Lee, W. K. Murphy, D. M. Shin, B. L. Kemp, J. J. Lee, J. Kane, R. A. Robinson, S. M. Lippman, J. M. Kurie, M. H. Huber, M. N. Raber, W. K. Hong

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93 Scopus citations

Abstract

Purpose: This study was designed to assess the antitumor activity of topotecan (TPT) in patients with advanced non-small-cell lung cancer (NSCLC) previously untreated with chemotherapy. Patients and Methods: Patients with stage IIIB or IV NSCLC with measurable disease in nonradiated fields were eligible. Other eligibility criteria were Zubrod performance status (PS) ≤ 2 and adequate renal and liver function. TPT was administered at a dose of 1.5 mg/m2/d for 5 days over 30 minutes every 21 days. Of 48 registered patients, 40 were fully assessable. Nineteen patients had adenocarcinoma (AD), 14 squamous carcinoma (SCC), and seven poorly differentiated carcinoma. Results: Six patients (15%) achieved a partial remission (PR) (durations: 8, 14, 18, 28, 56, and 61 weeks) and four patients a minor response; 10 patients had stable disease and 20 patients progressive disease. The PR rate was 36% (five of 14 patients) in patients with SCC versus 4% (one of 26 patients) in those with other histologies (P = .014). The overall median survival time was 38 weeks and 30% of patients were alive at 1 year. Grade 3 to 4 granulocytopenia and thrombocytopenia occurred after 76% and 10% of courses administered, respectively. No grade 3 to 4 nonhematologic toxicities were observed. Grade 1 or 2 nonhematologic toxicities consisted of nausea (46% and 5%), vomiting (31% and 7%), and fatigue (53% and 16%). Conclusion: TPT at the dose and schedule used has moderate antitumor activity in NSCLC; its activity is mostly limited to patients with SCC. TPT is well tolerated, with myelosuppression of short duration being the most common and limiting toxicity.

Original languageEnglish (US)
Pages (from-to)503-513
Number of pages11
JournalJournal of Clinical Oncology
Volume14
Issue number2
DOIs
StatePublished - Feb 1996
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Perez-Soler, R., Fossella, F. V., Glisson, B. S., Lee, J. S., Murphy, W. K., Shin, D. M., Kemp, B. L., Lee, J. J., Kane, J., Robinson, R. A., Lippman, S. M., Kurie, J. M., Huber, M. H., Raber, M. N., & Hong, W. K. (1996). Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with chemotherapy. Journal of Clinical Oncology, 14(2), 503-513. https://doi.org/10.1200/JCO.1996.14.2.503