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Topotecan single agent
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Lung Cancer News |
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Lung Cancer |
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Abstract: Phase II study of topotecan in patients with advanced non-small-cell
lung cancer previously untreated with chemotherapy.
PURPOSE: This study was designed to assess the anti-tumor 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)
< or = 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.
References
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. Phase II study of topotecan in patients with advanced non-small-cell
lung cancer previously untreated with chemotherapy. J Clin Oncol. 1996 Feb;14(2):503-13.
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| Regimen |
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Topotecan....... 1.5 mg / M2 / d IV (over 30 min) days 1 - 5
FREQUENCY every 21 days
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