AI Article Synopsis
- Irinotecan combined with cisplatin shows promise for treating advanced non-small cell lung cancer (NSCLC), leading to a phase I study that explored chemoradiotherapy.
- The study involved patients with locally advanced NSCLC receiving escalating doses of irinotecan and a daily low dose of cisplatin alongside concurrent radiation therapy.
- Results indicated that the maximum tolerable dose of irinotecan was 50 mg/m², with a 50% tumor response rate and a median survival time of 10.1 months, guiding the recommended dose for future phase II trials.
Article Abstract
Background: Irinotecan, when combined with cisplatin, is an effective treatment for advanced non-small cell lung cancer (NSCLC). This constitutes a rationale for conducting a phase I study of chemoradiotherapy including this combination for locally advanced NSCLC.
Patients And Methods: Patients with locally advanced NSCLC and a performance status of 0 or 1 were eligible. The protocol consisted of escalating doses of irinotecan on days 1 and 15, and daily low-dose cisplatin (6 mg/m(2) daily for a total dose of 120 mg/m(2)) combined with concurrent hyperfractionated accelerated thoracic irradiation (1.5 Gy twice daily for a total dose of 60 Gy).
Results: The maximum tolerable dose was 50 mg/m(2) of irinotecan, and the dose-limiting toxicity was esophagitis. Tumor response was observed in 50% of cases, and the median survival time of the 12 patients enrolled was 10.1 months, including two patients with 5-year disease-free survival. A pharmacokinetics study demonstrated an accumulation of total platinum, but not of free platinum, during the 26-day treatment period.
Conclusion: The recommended dose for phase II studies was determined.
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| http://dx.doi.org/10.1007/s10147-005-0525-6 | DOI Listing |
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