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A dose-finding and pharmacokinetic study of nedaplatin in elderly patients with advanced non-small cell lung cancer
Cancer Chemotherapy and Pharmacology, 04/29/09
Yamamoto N et al. - In a trial to determine the recommended dose, and evaluate the toxicities, pharmacokinetics, and efficacy for elderly non-small cell lung cancer (NSCLC) pts, it was found that nedaplatin was administered simply and feasibly by stratifying renal function and exerted favorable antitumor activity for elderly pts with NSCLC, especially on squamous cell carcinoma (SCC).
Methods- Pts ≥70 yrs were stratified into 2 groups based on renal functions: Group A, Ccr ≥60 and Group B, 40 ≤Ccr < 60.
- Initial doses were 80 and 60 mg/m2 in Groups A and B, respectively.
- Doses were escalated in 20-mg/m2 increments to 100 mg/m2 until DLT.
- Chemotherapy-naïve 39 elderly pts (Group A/Group B: 22/17) received 83 cycles.
- Major toxicities were hematological.
- In Group A, 1 of 15 pts at 100 mg/m2 experienced DLT (neutropenia) and the recommended dose was determined at 100 mg/m2.
- In Group B, 3 of 5 pts had DLTs (leukopenia, neutropenia, thrombocytopenia and febrile neutropenia) at 100 mg/m2, and the recommended dose was determined at 80 mg/m2.
- Percentage decreases of neutrophil were well correlated with total and free-Pt AUCs.
- Partial responses were observed in 13 (33%) of the 39 pts, and 12 of 13 pts who responded had SCC.
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