A phase I study of combination therapy with nanoparticle albumin-bound paclitaxel and cyclophosphamide in patients with metastatic or recurrent breast cancer
Gespeichert in:
Verfasser / Beitragende:
[Goro Kutomi, Tousei Ohmura, Fukino Satomi, Hideki Maeda, Hiroaki Shima, Hidekazu Kameshima, Minoru Okazaki, Hideji Masuoka, Kenichi Sasaki, Koichi Hirata]
Ort, Verlag, Jahr:
2015
Enthalten in:
International Journal of Clinical Oncology, 20/3(2015-06-01), 474-479
Format:
Artikel (online)
Online Zugang:
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| 024 | 7 | 0 | |a 10.1007/s10147-014-0725-z |2 doi |
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| 245 | 0 | 2 | |a A phase I study of combination therapy with nanoparticle albumin-bound paclitaxel and cyclophosphamide in patients with metastatic or recurrent breast cancer |h [Elektronische Daten] |c [Goro Kutomi, Tousei Ohmura, Fukino Satomi, Hideki Maeda, Hiroaki Shima, Hidekazu Kameshima, Minoru Okazaki, Hideji Masuoka, Kenichi Sasaki, Koichi Hirata] |
| 520 | 3 | |a Background: The objective of the present clinical study is to determine the maximum tolerated dose (MTD)/recommended dose (RD) of combination therapy with nanoparticle albumin-bound paclitaxel (nab-PTX) and cyclophosphamide (CPA) in patients with metastatic or recurrent breast cancer. Methods: nab-PTX and CPA were administered on the first day of each 21-day treatment cycle. The dose of CPA was fixed at 600mg/m2, while the dose of nab-PTX was increased from 180mg/m2 (Level 1) to 220mg/m2 (Level 2) and then to 260mg/m2 (Level 3). Results: A total of 11 patients from two institutions were enrolled in the present study. At Level 3, a dose-limiting toxicity (DLT) was observed in 1 patient. Considering treatment continuity and the risk of adverse events in Cycle 2 and thereafter at this level, further subject enrollment at Level 3 was discontinued after two patients had been enrolled. Since the doses used at Level 3 were considered the MTD of nab-PTX and CPA and the doses used at Level 2 were considered the RD of nab-PTX and CPA, three additional subjects were enrolled at Level 2. No DLTs were observed at Level 2. Conclusion: The RD of combination therapy with nab-PTX and CPA was 220mg/m2 and 600mg/m2, respectively, in patients with metastatic or recurrent breast cancer. | |
| 540 | |a Japan Society of Clinical Oncology, 2014 | ||
| 690 | 7 | |a Breast cancer |2 nationallicence | |
| 690 | 7 | |a nab-paclitaxel |2 nationallicence | |
| 690 | 7 | |a Cyclophosphamide |2 nationallicence | |
| 690 | 7 | |a Phase I |2 nationallicence | |
| 700 | 1 | |a Kutomi |D Goro |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | |
| 700 | 1 | |a Ohmura |D Tousei |u Department of Surgery, Higashi-Sapporo Hospital, Sapporo, Japan |4 aut | |
| 700 | 1 | |a Satomi |D Fukino |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | |
| 700 | 1 | |a Maeda |D Hideki |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | |
| 700 | 1 | |a Shima |D Hiroaki |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | |
| 700 | 1 | |a Kameshima |D Hidekazu |u Department of Surgery, Higashi-Sapporo Hospital, Sapporo, Japan |4 aut | |
| 700 | 1 | |a Okazaki |D Minoru |u Sapporo Breast Surgical Clinic, Sapporo, Japan |4 aut | |
| 700 | 1 | |a Masuoka |D Hideji |u Sapporo-Kotoni Breast Clinic, Sapporo, Japan |4 aut | |
| 700 | 1 | |a Sasaki |D Kenichi |u Department of Surgery, Muroran City General Hospital, Muroran, Japan |4 aut | |
| 700 | 1 | |a Hirata |D Koichi |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | |
| 773 | 0 | |t International Journal of Clinical Oncology |d Springer Japan |g 20/3(2015-06-01), 474-479 |x 1341-9625 |q 20:3<474 |1 2015 |2 20 |o 10147 | |
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| 908 | |D 1 |a research-article |2 jats | ||
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| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s10147-014-0725-z |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kutomi |D Goro |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ohmura |D Tousei |u Department of Surgery, Higashi-Sapporo Hospital, Sapporo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Satomi |D Fukino |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Maeda |D Hideki |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Shima |D Hiroaki |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kameshima |D Hidekazu |u Department of Surgery, Higashi-Sapporo Hospital, Sapporo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Okazaki |D Minoru |u Sapporo Breast Surgical Clinic, Sapporo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Masuoka |D Hideji |u Sapporo-Kotoni Breast Clinic, Sapporo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Sasaki |D Kenichi |u Department of Surgery, Muroran City General Hospital, Muroran, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Hirata |D Koichi |u Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t International Journal of Clinical Oncology |d Springer Japan |g 20/3(2015-06-01), 474-479 |x 1341-9625 |q 20:3<474 |1 2015 |2 20 |o 10147 | ||