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Phase II study of topotecan in patients with advanced non-small-cell lung cancer previously untreated with
R Perez-Soler1, F V Fossella, B S Glisson
1Department of Thoracic/Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, USA.
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.
Insights
Topotecan (TPT) shows moderate anti-tumor activity in advanced non-small-cell lung cancer (NSCLC), particularly in squamous cell carcinoma (SCC) patients. This chemotherapy is well-tolerated, with manageable side effects.
Area of Science:
- Oncology
- Medical Oncology
- Clinical Pharmacology
Background:
- Non-small-cell lung cancer (NSCLC) is a leading cause of cancer mortality.
- Novel therapeutic strategies are needed for previously untreated advanced NSCLC.
- Topotecan (TPT) is a topoisomerase I inhibitor with known cytotoxic effects.
Purpose of the Study:
- To evaluate the anti-tumor activity of topotecan (TPT) in patients with advanced non-small-cell lung cancer (NSCLC).
- To assess the efficacy and safety of TPT in treatment-naive NSCLC patients.
Main Methods:
- A phase II study was conducted on 48 patients with stage IIIB/IV NSCLC.
- TPT was administered at 1.5 mg/m2/d for 5 days every 21 days.
- Patients had measurable disease, adequate organ function, and performance status <= 2.
Main Results:
- 15% partial remission (PR) rate; 36% PR in squamous cell carcinoma (SCC) vs. 4% in other histologies (P=.014).
- Median survival was 38 weeks; 30% alive at 1 year.
- Most common toxicities were manageable granulocytopenia and thrombocytopenia; no severe non-hematologic toxicities.
Conclusions:
- TPT demonstrates moderate anti-tumor activity in advanced NSCLC, primarily in SCC patients.
- The drug is well-tolerated, with myelosuppression as the main dose-limiting toxicity.
- TPT represents a potential treatment option for specific NSCLC patient populations.