Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer
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| 024 | 7 | 0 | |a 10.1007/s10147-015-0820-9 |2 doi |
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| 245 | 0 | 0 | |a Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer |h [Elektronische Daten] |c [Masahiro Nozawa, Hirofumi Mukai, Shunji Takahashi, Hiroji Uemura, Takeo Kosaka, Yusuke Onozawa, Jun Miyazaki, Kazuhiro Suzuki, Koji Okihara, Yoichi Arai, Tomomi Kamba, Masashi Kato, Yasutomo Nakai, Hiroshi Furuse, Haruki Kume, Hisamitsu Ide, Hiroshi Kitamura, Akira Yokomizo, Takahiro Kimura, Yoshihiko Tomita, Keiji Ohno, Yoshiyuki Kakehi] |
| 520 | 3 | |a Background: We previously reported the pharmacokinetic profile and preliminary tolerability of cabazitaxel in a phase I study in Japanese patients with metastatic castration-resistant prostate cancer (mCRPC). Here we report the final safety profile and anti-tumor activity of cabazitaxel in a larger population, including all patients enrolled in the expansion cohort of the study. Methods: Japanese patients with mCRPC previously treated with docetaxel received cabazitaxel intravenously every 3weeks plus daily prednisolone. In patients treated with the maximum tolerated dose of 25mg/m2 we evaluated adverse events including treatment-related neutropenia, prostate-specific antigen (PSA) response and objective response. Results: In total, 44 patients were treated with the maximum tolerated dose. The most frequent adverse events (any grade) were neutropenia (100%), febrile neutropenia (54.5%), fatigue (54.5%), nausea (52.3%) and diarrhea (50.0%). There were no deaths due to treatment-related adverse events. Neutropenia with prior docetaxel did not appear to influence the probability of febrile neutropenia with cabazitaxel. Most patients received therapeutic granulocyte colony-stimulating factor (G-CSF; cycle 1: 86.4%; cycle 2 or later: 81.8%). In the efficacy population, two of 12 patients with measurable disease had partial response (objective response rate: 16.7%), while 10 had stable disease. PSA response rate was 29.3% (12/41 patients). Median time to PSA progression was 3.68months (95% confidence interval 1.35-4.63). Conclusions: In this heavily pretreated Japanese population, the occurrence of neutropenia and febrile neutropenia was high, suggesting G-CSF prophylaxis may be required as part of toxicity management. However, the efficacy of cabazitaxel was consistent with global studies. ClinicalTrials.gov identifier: NCT01324583. | |
| 540 | |a Japan Society of Clinical Oncology, 2015 | ||
| 690 | 7 | |a Adverse event |2 nationallicence | |
| 690 | 7 | |a Cabazitaxel |2 nationallicence | |
| 690 | 7 | |a Japan |2 nationallicence | |
| 690 | 7 | |a Neutropenia |2 nationallicence | |
| 690 | 7 | |a Phase I |2 nationallicence | |
| 690 | 7 | |a Prostate cancer |2 nationallicence | |
| 700 | 1 | |a Nozawa |D Masahiro |u Department of Urology, Faculty of Medicine, Kinki University, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Osaka, Japan |4 aut | |
| 700 | 1 | |a Mukai |D Hirofumi |u National Cancer Center Hospital East, Kashiwa, Chiba, Japan |4 aut | |
| 700 | 1 | |a Takahashi |D Shunji |u Department of Medical Oncology, The Cancer Institute Hospital of JFCR, Koto, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Uemura |D Hiroji |u Department of Urology, Yokohama City University Graduate School of Medicine, Yokohama, Japan |4 aut | |
| 700 | 1 | |a Kosaka |D Takeo |u Department of Urology, Keio University School of Medicine, Minato, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Onozawa |D Yusuke |u Division of Clinical Oncology, Shizuoka Cancer Center, Shizuoka, Japan |4 aut | |
| 700 | 1 | |a Miyazaki |D Jun |u Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan |4 aut | |
| 700 | 1 | |a Suzuki |D Kazuhiro |u Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan |4 aut | |
| 700 | 1 | |a Okihara |D Koji |u Department of Urology, Kyoto Prefectural University of Medicine, Kyoto City, Japan |4 aut | |
| 700 | 1 | |a Arai |D Yoichi |u Tohoku University Hospital, Aoba-ku, Sendai City, Miyagi, Japan |4 aut | |
| 700 | 1 | |a Kamba |D Tomomi |u Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan |4 aut | |
| 700 | 1 | |a Kato |D Masashi |u Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan |4 aut | |
| 700 | 1 | |a Nakai |D Yasutomo |u Department of Urology, Osaka University Graduate School of Medicine, Osaka, Japan |4 aut | |
| 700 | 1 | |a Furuse |D Hiroshi |u Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan |4 aut | |
| 700 | 1 | |a Kume |D Haruki |u The University of Tokyo Hospital, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Ide |D Hisamitsu |u Teikyo University Hospital, Itabashi, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Kitamura |D Hiroshi |u Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan |4 aut | |
| 700 | 1 | |a Yokomizo |D Akira |u Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan |4 aut | |
| 700 | 1 | |a Kimura |D Takahiro |u The Jikei University Hospital, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Tomita |D Yoshihiko |u Yamagata University Hospital, Yamagata, Japan |4 aut | |
| 700 | 1 | |a Ohno |D Keiji |u Sanofi K.K., Tokyo, Japan |4 aut | |
| 700 | 1 | |a Kakehi |D Yoshiyuki |u Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan |4 aut | |
| 773 | 0 | |t International Journal of Clinical Oncology |d Springer Japan |g 20/5(2015-10-01), 1026-1034 |x 1341-9625 |q 20:5<1026 |1 2015 |2 20 |o 10147 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s10147-015-0820-9 |q text/html |z Onlinezugriff via DOI |
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| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s10147-015-0820-9 |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Nozawa |D Masahiro |u Department of Urology, Faculty of Medicine, Kinki University, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Osaka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Mukai |D Hirofumi |u National Cancer Center Hospital East, Kashiwa, Chiba, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Takahashi |D Shunji |u Department of Medical Oncology, The Cancer Institute Hospital of JFCR, Koto, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Uemura |D Hiroji |u Department of Urology, Yokohama City University Graduate School of Medicine, Yokohama, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kosaka |D Takeo |u Department of Urology, Keio University School of Medicine, Minato, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Onozawa |D Yusuke |u Division of Clinical Oncology, Shizuoka Cancer Center, Shizuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Miyazaki |D Jun |u Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Suzuki |D Kazuhiro |u Department of Urology, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Okihara |D Koji |u Department of Urology, Kyoto Prefectural University of Medicine, Kyoto City, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Arai |D Yoichi |u Tohoku University Hospital, Aoba-ku, Sendai City, Miyagi, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kamba |D Tomomi |u Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kato |D Masashi |u Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Nakai |D Yasutomo |u Department of Urology, Osaka University Graduate School of Medicine, Osaka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Furuse |D Hiroshi |u Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kume |D Haruki |u The University of Tokyo Hospital, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ide |D Hisamitsu |u Teikyo University Hospital, Itabashi, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kitamura |D Hiroshi |u Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Yokomizo |D Akira |u Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kimura |D Takahiro |u The Jikei University Hospital, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Tomita |D Yoshihiko |u Yamagata University Hospital, Yamagata, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ohno |D Keiji |u Sanofi K.K., Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kakehi |D Yoshiyuki |u Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t International Journal of Clinical Oncology |d Springer Japan |g 20/5(2015-10-01), 1026-1034 |x 1341-9625 |q 20:5<1026 |1 2015 |2 20 |o 10147 | ||