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

Roman 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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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
StatePublished - Feb 1996
Externally publishedYes

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Topotecan
Non-Small Cell Lung Carcinoma
Drug Therapy
Squamous Cell Carcinoma
Agranulocytosis

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Perez-Soler, R., Fossella, F. V., Glisson, B. S., Lee, J. S., Murphy, W. K., Shin, D. M., ... 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.

Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with chemotherapy. / Perez-Soler, Roman; 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.

In: Journal of Clinical Oncology, Vol. 14, No. 2, 02.1996, p. 503-513.

Research output: Contribution to journalArticle

Perez-Soler, R, Fossella, FV, Glisson, BS, Lee, JS, Murphy, WK, Shin, DM, Kemp, BL, Lee, JJ, Kane, J, Robinson, RA, Lippman, SM, Kurie, JM, Huber, MH, Raber, MN & Hong, WK 1996, 'Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with chemotherapy', Journal of Clinical Oncology, vol. 14, no. 2, pp. 503-513.
Perez-Soler, Roman ; 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. / Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with chemotherapy. In: Journal of Clinical Oncology. 1996 ; Vol. 14, No. 2. pp. 503-513.
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title = "Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with chemotherapy",
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.",
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T1 - Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with chemotherapy

AU - Perez-Soler, Roman

AU - Fossella, F. V.

AU - Glisson, B. S.

AU - Lee, J. S.

AU - Murphy, W. K.

AU - Shin, D. M.

AU - Kemp, B. L.

AU - Lee, J. J.

AU - Kane, J.

AU - Robinson, R. A.

AU - Lippman, S. M.

AU - Kurie, J. M.

AU - Huber, M. H.

AU - Raber, M. N.

AU - Hong, W. K.

PY - 1996/2

Y1 - 1996/2

N2 - 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.

AB - 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.

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