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

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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 2000

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Topotecan
Non-Small Cell Lung Carcinoma
Appointments and Schedules
Therapeutics
Adenocarcinoma
Infusion Pumps
Lethargy
Survival
Myalgia
Leukopenia
Constipation
Thrombocytopenia
Vomiting

Keywords

  • Cell carcinoma
  • Lung cancer
  • Topotecan

ASJC Scopus subject areas

  • Oncology

Cite this

A randomized phase II trial of two schedules of topotecan for the treatment of advanced stage non-small cell lung cancer. / Weitz, John J.; Marschke, Robert F.; Sloan, Jeff A; Grill, Joseph P.; Jett, James R.; Knost, James A.; Hatfield, Alan K.; Zenk, David W.; Bate, Walter W.; Schaefer, Paul L.

In: Lung Cancer, Vol. 28, No. 2, 05.2000, p. 157-162.

Research output: Contribution to journalArticle

Weitz, JJ, Marschke, RF, Sloan, JA, Grill, JP, Jett, JR, Knost, JA, Hatfield, AK, Zenk, DW, Bate, WW & Schaefer, PL 2000, 'A randomized phase II trial of two schedules of topotecan for the treatment of advanced stage non-small cell lung cancer', Lung Cancer, vol. 28, no. 2, pp. 157-162. https://doi.org/10.1016/S0169-5002(99)00128-2
Weitz, John J. ; Marschke, Robert F. ; Sloan, Jeff A ; Grill, Joseph P. ; Jett, James R. ; Knost, James A. ; Hatfield, Alan K. ; Zenk, David W. ; Bate, Walter W. ; Schaefer, Paul L. / A randomized phase II trial of two schedules of topotecan for the treatment of advanced stage non-small cell lung cancer. In: Lung Cancer. 2000 ; Vol. 28, No. 2. pp. 157-162.
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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.",
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AU - Jett, James R.

AU - Knost, James A.

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