caa a22 4500 467934827 CHVBK 20180406152954.0 cr unu---uuuuu 170328e20060601xx s 000 0 eng 10.1007/s00408-005-2572-1 doi (NATIONALLICENCE)springer-10.1007/s00408-005-2572-1 Phase I/II Trial of Docetaxel and Carboplatin as a First-Line Therapy in Patients with Stage IV Non-Small-Cell Lung Cancer [Elektronische Daten] [Kensuke Kataoka, Ryujiro Suzuki, Hiroyuki Taniguchi, Yasunobu Noda, Joe Shindoh, Syuichi Matsumoto, Yoshiaki Watanabe, Kousuke Honda, Kiyoshi Suzuki, Kenji Baba, Kazuyoshi Imaizumi, Hiroaki Kume, Yoshinori Hasegawa, Kenzo Takagi] 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. Springer Science+Business Media, Inc., 2006 Non-small cell lung cancer nationallicence Docetaxel nationallicence Carboplatin nationallicence Stage IV nationallicence Phase I/II nationallicence NSCLC : non-small-cell lung cancer nationallicence AUC : area under the concentration time curve nationallicence ECOG : The Eastern Cooperative Oncology Group nationallicence PS : performance status nationallicence WBC : white blood cell count nationallicence CT : computed tomography nationallicence DLT : dose-limiting toxicity nationallicence MTD : the maximum-tolerated dose nationallicence CR : complete response nationallicence PR : partial response nationallicence rhG-CSF : recombinant human granulocyte colony-stimulating factor nationallicence CI : confidence interval nationallicence Kataoka Kensuke Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, 466-8550, Showa-ku, Nagoya, Japan aut Suzuki Ryujiro Department of Respiratory Medicine, Toyohashi Municipal Hospital, 50 Hakken-nishi Aotake-cho, 441-8570, Toyohashi, Aichi, Japan aut Taniguchi Hiroyuki Department of Respiratory Medicine and Allergy, Tosei General Hospital, 160 Nishioiwake-cho, 489-8642, Seto, Aichi, Japan aut Noda Yasunobu Department of Respiratory Medicine, Toyohashi Municipal Hospital, 50 Hakken-nishi Aotake-cho, 441-8570, Toyohashi, Aichi, Japan aut Shindoh Joe Department of Respiratory Medicine, Ogaki Municipal Hospital, 4-86 Minami-no-kawa-cho, 503-8502, Ogaki, Gifu, Japan aut Matsumoto Syuichi Department of Respiratory Medicine and Allergy, Komaki Municipal Hospital, 1-20 Joubushin, 485-8520, Komaki, Aichi, Japan aut Watanabe Yoshiaki Kamo Hospital, 3-17 Motoshiro-cho, 471-8505, Toyota, Aichi, Japan aut Honda Kousuke Department of Respiratory Medicine, Kakegawa City General Hospital, 721 Sugitani, 436-8502, Kakegawa, Shizuoka, Japan aut Suzuki Kiyoshi Department of Respiratory Medicine, Meijo Hospital, 1-3-1 San-no-maru, Naka-ku, 460-0001, Nagoya, Aichi, Japan aut Baba Kenji Department of Respiratory Medicine, Aichi Medical University, 21 Karimata, Yazako, 480-1195, Nagakute-cho, Aichi, Japan aut Imaizumi Kazuyoshi Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, 466-8550, Showa-ku, Nagoya, Japan aut Kume Hiroaki Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, 466-8550, Showa-ku, Nagoya, Japan aut Hasegawa Yoshinori Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, 466-8550, Showa-ku, Nagoya, Japan aut Takagi Kenzo Department of Medical Technology, Nagoya University School of Health Sciences, 1-1-20 Daikominami, Higashi-ku, 461-8763, Nagoya, Aichi, Japan aut Lung Springer-Verlag; www.springer-ny.com 184/3(2006-06-01), 133-139 0341-2040 184:3<133 2006 184 408 https://doi.org/10.1007/s00408-005-2572-1 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00408-005-2572-1 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kataoka Kensuke Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, 466-8550, Showa-ku, Nagoya, Japan aut NATIONALLICENCE 700 1- Suzuki Ryujiro Department of Respiratory Medicine, Toyohashi Municipal Hospital, 50 Hakken-nishi Aotake-cho, 441-8570, Toyohashi, Aichi, Japan aut NATIONALLICENCE 700 1- Taniguchi Hiroyuki Department of Respiratory Medicine and Allergy, Tosei General Hospital, 160 Nishioiwake-cho, 489-8642, Seto, Aichi, Japan aut NATIONALLICENCE 700 1- Noda Yasunobu Department of Respiratory Medicine, Toyohashi Municipal Hospital, 50 Hakken-nishi Aotake-cho, 441-8570, Toyohashi, Aichi, Japan aut NATIONALLICENCE 700 1- Shindoh Joe Department of Respiratory Medicine, Ogaki Municipal Hospital, 4-86 Minami-no-kawa-cho, 503-8502, Ogaki, Gifu, Japan aut NATIONALLICENCE 700 1- Matsumoto Syuichi Department of Respiratory Medicine and Allergy, Komaki Municipal Hospital, 1-20 Joubushin, 485-8520, Komaki, Aichi, Japan aut NATIONALLICENCE 700 1- Watanabe Yoshiaki Kamo Hospital, 3-17 Motoshiro-cho, 471-8505, Toyota, Aichi, Japan aut NATIONALLICENCE 700 1- Honda Kousuke Department of Respiratory Medicine, Kakegawa City General Hospital, 721 Sugitani, 436-8502, Kakegawa, Shizuoka, Japan aut NATIONALLICENCE 700 1- Suzuki Kiyoshi Department of Respiratory Medicine, Meijo Hospital, 1-3-1 San-no-maru, Naka-ku, 460-0001, Nagoya, Aichi, Japan aut NATIONALLICENCE 700 1- Baba Kenji Department of Respiratory Medicine, Aichi Medical University, 21 Karimata, Yazako, 480-1195, Nagakute-cho, Aichi, Japan aut NATIONALLICENCE 700 1- Imaizumi Kazuyoshi Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, 466-8550, Showa-ku, Nagoya, Japan aut NATIONALLICENCE 700 1- Kume Hiroaki Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, 466-8550, Showa-ku, Nagoya, Japan aut NATIONALLICENCE 700 1- Hasegawa Yoshinori Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, 466-8550, Showa-ku, Nagoya, Japan aut NATIONALLICENCE 700 1- Takagi Kenzo Department of Medical Technology, Nagoya University School of Health Sciences, 1-1-20 Daikominami, Higashi-ku, 461-8763, Nagoya, Aichi, Japan aut NATIONALLICENCE 773 0- Lung Springer-Verlag; 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