TY - JOUR
T1 - Phase I study of the combination of nedaplatin and gemcitabine in previously untreated advanced squamous cell lung cancer
AU - Masago, Katsuhiro
AU - Fujita, Shiro
AU - Kim, Young Hak
AU - Hatachi, Yukimasa
AU - Fukuhara, Akiko
AU - Irisa, Kaoru
AU - Nagai, Hiroki
AU - Sakamori, Yuichi
AU - Togashi, Yosuke
AU - Mio, Tadashi
AU - Mishima, Michiaki
PY - 2011/2
Y1 - 2011/2
N2 - Purpose: The objectives of this phase I trial were to evaluate the toxicity of the nedaplatin/gemcitabine regimen, determine the maximum tolerated doses (MTDs) of these agents, and observe the anti-tumor effects of this regimen on advanced squamous cell lung cancer. Methods: Patients with previously untreated advanced squamous cell lung cancer were eligible if they had a performance status of 0 or 1 with adequate organ function. The doses of gemcitabine (days 1 and 8) and nedaplatin (day 8) studied were 800/70, 1,000/80, 1,000/90, and 1,000/100 (mg/m2), repeated every 3 weeks. Results: Toxicity and response could be assessed in all 13 patients enrolled. The patients included 12 men and one woman with a median age of 69 years (range 57-81 years). Three patients had stage IIIB disease and 10 patients had stage IV disease. The MTDs were reached at 1,000 mg/m2 gemcitabine and 80 mg/m2 nedaplatin. The most frequent toxic effects were thrombocytopenia and neutropenia; grade 3 or 4 thrombocytopenia was observed in 23% of patients, and grade 3 or 4 neutropenia was seen in 46% of patients. Non-hematologic toxicities were mild. Grade 3 fatigue, nausea/vomiting, and appetite loss occurred in two patients. The overall response rate was 62%. Conclusions: We recommend doses of 800 mg/m2 gemcitabine and 70 mg/m2 nedaplatin for phase II study. This combination chemotherapeutic regimen is active and well tolerated.
AB - Purpose: The objectives of this phase I trial were to evaluate the toxicity of the nedaplatin/gemcitabine regimen, determine the maximum tolerated doses (MTDs) of these agents, and observe the anti-tumor effects of this regimen on advanced squamous cell lung cancer. Methods: Patients with previously untreated advanced squamous cell lung cancer were eligible if they had a performance status of 0 or 1 with adequate organ function. The doses of gemcitabine (days 1 and 8) and nedaplatin (day 8) studied were 800/70, 1,000/80, 1,000/90, and 1,000/100 (mg/m2), repeated every 3 weeks. Results: Toxicity and response could be assessed in all 13 patients enrolled. The patients included 12 men and one woman with a median age of 69 years (range 57-81 years). Three patients had stage IIIB disease and 10 patients had stage IV disease. The MTDs were reached at 1,000 mg/m2 gemcitabine and 80 mg/m2 nedaplatin. The most frequent toxic effects were thrombocytopenia and neutropenia; grade 3 or 4 thrombocytopenia was observed in 23% of patients, and grade 3 or 4 neutropenia was seen in 46% of patients. Non-hematologic toxicities were mild. Grade 3 fatigue, nausea/vomiting, and appetite loss occurred in two patients. The overall response rate was 62%. Conclusions: We recommend doses of 800 mg/m2 gemcitabine and 70 mg/m2 nedaplatin for phase II study. This combination chemotherapeutic regimen is active and well tolerated.
KW - Gemcitabine
KW - Nedaplatin
KW - Phase I
KW - Squamous cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=79953805329&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79953805329&partnerID=8YFLogxK
U2 - 10.1007/s00280-010-1321-1
DO - 10.1007/s00280-010-1321-1
M3 - Article
C2 - 20401614
AN - SCOPUS:79953805329
VL - 67
SP - 325
EP - 330
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 2
ER -