A phase I study of combination therapy with nanoparticle albumin-bound paclitaxel and cyclophosphamide in patients with metastatic or recurrent breast cancer

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)
ID: 605490880
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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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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