Nedaplatin is a second-generation platinum showing favorable activity against non-small cell lung cancer (NSCLC). Dose-limiting toxicity (DLT) is thrombocytopenia, predicted by creatinine clearance (Ccr). This study was conducted to determine the recommended dose, and evaluate the toxicities, pharmacokinetics and efficacy for elderly NSCLC patients. Patients a parts per thousand yen70 years were stratified into two groups based on renal functions: Group A, Ccr a parts per thousand yen 60 and Group B, 40 a parts per thousand currency sign Ccr < 60. The initial doses were 80 and 60 mg/m(2) in Groups A and B, respectively. The doses were escalated in 20-mg/m(2) increments to 100 mg/m(2) until DLT. Chemotherapy-na < ve 39 elderly patients (Group A/Group B: 22/17) received a total of 83 cycles. Major toxicities were hematological. In Group A, one of the 15 patients at 100 mg/m(2) experienced DLT (neutropenia) and the recommended dose was determined at 100 mg/m(2). In Group B, three of the five patients had DLTs (leukopenia, neutropenia, thrombocytopenia and febrile neutropenia) at 100 mg/m(2), and the recommended dose was determined at 80 mg/m(2). The percentage decreases of neutrophil were well correlated with total and free-Pt AUCs. Partial responses were observed in 13 (33%) of the 39 patients, and 12 of the 13 patients who responded had a squamous cell carcinoma. Nedaplatin was administered simply and feasibly by stratifying renal function and exerted favorable antitumor activity for elderly patients with NSCLC, especially on squamous cell carcinoma.
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Natl Canc Ctr, Dept Pharm, Tokyo, Japan
Hiroshima Univ, Grad Sch Biomed & Hlth Sci, Dept Pharmaceut & Therapeut, Hiroshima, JapanNatl Canc Ctr, Dept Pharm, Tokyo, Japan
Motonaga, Masanori
Yamamoto, Noboru
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Natl Canc Ctr, Dept Thorac Oncol, Chuo Ku, Tokyo, Japan
Natl Canc Ctr, Exploratory Oncol Res & Clin Trial Ctr, Dept Expt Therapeut, Tokyo, JapanNatl Canc Ctr, Dept Pharm, Tokyo, Japan
Yamamoto, Noboru
Makino, Yoshinori
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Natl Canc Ctr, Dept Pharm, Tokyo, JapanNatl Canc Ctr, Dept Pharm, Tokyo, Japan
Makino, Yoshinori
Ando-Makihara, Reiko
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Natl Canc Ctr, Dept Pharm, Tokyo, JapanNatl Canc Ctr, Dept Pharm, Tokyo, Japan
Ando-Makihara, Reiko
Ohe, Yuichiro
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Natl Canc Ctr, Dept Thorac Oncol, Chuo Ku, Tokyo, JapanNatl Canc Ctr, Dept Pharm, Tokyo, Japan
Ohe, Yuichiro
Takano, Mikihisa
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Hiroshima Univ, Grad Sch Biomed & Hlth Sci, Dept Pharmaceut & Therapeut, Hiroshima, JapanNatl Canc Ctr, Dept Pharm, Tokyo, Japan
Takano, Mikihisa
Hayashi, Yoshikazu
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Natl Canc Ctr, Dept Pharm, Tokyo, JapanNatl Canc Ctr, Dept Pharm, Tokyo, Japan