TY - JOUR
T1 - Phase I/II trial of docetaxel and carboplatin as a first-line therapy in patients with stage IV non-small-cell lung cancer
AU - Kataoka, Kensuke
AU - Suzuki, Ryujiro
AU - Taniguchi, Hiroyuki
AU - Noda, Yasunobu
AU - Shindoh, Joe
AU - Matsumoto, Syuichi
AU - Watanabe, Yoshiaki
AU - Honda, Kousuke
AU - Suzuki, Kiyoshi
AU - Baba, Kenji
AU - Imaizumi, Kazuyoshi
AU - Kume, Hiroaki
AU - Hasegawa, Yoshinori
AU - Takagi, Kenzo
PY - 2006/6
Y1 - 2006/6
N2 - A phase I/II study was conducted to determine the maximum-tolerated dose, the safety and tolerability, and the clinical efficacy of carboplatin and docetaxel in combination in patients with stage IV non-small-cell lung cancer. Patients with measurable, previously untreated, good performance status, and stage IV non-small-cell lung cancer were eligible. Increasing doses of docetaxel were given in combination with a fixed dose of carboplatin except at level 5. Cycles were repeated every four weeks. Seventy-seven patients were registered. In phase I, 27 patients were entered at five different dose levels. A docetaxel dose of 60 mg/m2 and carboplatin area under the concentration time curve 6 was recommended for phase II, and an additional 50 patients were entered at this level for a total of 56 patients. Grade 3/4 neutropenia was the most common adverse event and occurred in 70% of the patients. Two patients had febrile neutropenia. Fifty-six patients were assessable for response; 21 partial responses were observed for an overall response rate of 37.5%. The median time to tumor progression was 4.0 months (range, 1.0-21.0 months), and the median survival was 12.9 months (range, 0.4-51.3 months). The one-year survival rate was 46.4%. The combination of docetaxel 60 mg/m2 and carboplatin area under the concentration time curve 6 is feasible and effective in patients with stage IV non-small-cell lung cancer.
AB - A phase I/II study was conducted to determine the maximum-tolerated dose, the safety and tolerability, and the clinical efficacy of carboplatin and docetaxel in combination in patients with stage IV non-small-cell lung cancer. Patients with measurable, previously untreated, good performance status, and stage IV non-small-cell lung cancer were eligible. Increasing doses of docetaxel were given in combination with a fixed dose of carboplatin except at level 5. Cycles were repeated every four weeks. Seventy-seven patients were registered. In phase I, 27 patients were entered at five different dose levels. A docetaxel dose of 60 mg/m2 and carboplatin area under the concentration time curve 6 was recommended for phase II, and an additional 50 patients were entered at this level for a total of 56 patients. Grade 3/4 neutropenia was the most common adverse event and occurred in 70% of the patients. Two patients had febrile neutropenia. Fifty-six patients were assessable for response; 21 partial responses were observed for an overall response rate of 37.5%. The median time to tumor progression was 4.0 months (range, 1.0-21.0 months), and the median survival was 12.9 months (range, 0.4-51.3 months). The one-year survival rate was 46.4%. The combination of docetaxel 60 mg/m2 and carboplatin area under the concentration time curve 6 is feasible and effective in patients with stage IV non-small-cell lung cancer.
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U2 - 10.1007/s00408-005-2572-1
DO - 10.1007/s00408-005-2572-1
M3 - Article
C2 - 16902837
AN - SCOPUS:33747146195
SN - 0341-2040
VL - 184
SP - 133
EP - 139
JO - Lung
JF - Lung
IS - 3
ER -
