抄録
Objective: This single-arm Phase II trial was designed to assess the safety and efficacy of pegylated liposomal doxorubicin and carboplatin combination chemotherapy in patients with platinumsensitive recurrent ovarian cancer. Methods: Patients with a histological diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who were relapse-free at least 6 months after completion of first-line platinumbased chemotherapy, and who had measurable disease and gave consent to participate in this study received infusions of pegylated liposomal doxorubicin (30 mg/m<sup>2</sup>) at 1 mg/min, followed by carboplatin (AUC 5 mg min/ml) over 30 min every 28 days. Results: Thirty-three of 35 enrolled patients were eligible for efficacy analysis. One patient (3.0%) achieved a complete response, while 16 (48.5%) achieved a partial response, with an overall objective response rate of 51.5% (95% confidence interval, 34.5-68.6%). Among the 22 patients who had evaluable CA125 levels at entry, responses were observed in 18 patients, with a response rate of 81.8% (95% confidence interval, 65.3-98.3%). The median progression-free survival and overall survival rates for all 35 patients were 10.7 months (95% confidence interval, 8.1-13.2 months) and 38.8 months (95% confidence interval, 31.0-46.7 months), respectively. The most frequent Grade 3-4 toxicities, regardless of cause,were neutropenia (82.9%), thrombocytopenia (51.4%), leukopenia (45.7%) and anemia (17.1%). Conclusions: The safety and efficacy of pegylated liposomal doxorubicin and carboplatin combination chemotherapy in patients with platinum-sensitive recurrent ovarian cancer were confirmed. Although there were concerns of severe hematological toxicity with this therapy, this potential complication was safely managed through adequate monitoring of bone marrow function.
| 元の言語 | English |
|---|---|
| 記事番号 | hyv016 |
| ページ（範囲） | 422-426 |
| ページ数 | 5 |
| ジャーナル | Japanese Journal of Clinical Oncology |
| 巻 | 45 |
| 発行部数 | 5 |
| DOI | |
| 出版物ステータス | Published - 2015 5 1 |
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ASJC Scopus subject areas
- Oncology
- Cancer Research
- Radiology Nuclear Medicine and imaging
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A Phase II clinical trial of pegylated liposomal doxorubicin and carboplatin in Japanese patients with platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancer. / Nakanishi, Toru; Aoki, Daisuke; Watanabe, Yoh; Ando, Yuichi; Tomotsugu, Naoki; Sato, Yuji; Saito, Toshiaki.
：: Japanese Journal of Clinical Oncology, 巻 45, 番号 5, hyv016, 01.05.2015, p. 422-426.研究成果: Article
}
TY - JOUR
T1 - A Phase II clinical trial of pegylated liposomal doxorubicin and carboplatin in Japanese patients with platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancer
AU - Nakanishi, Toru
AU - Aoki, Daisuke
AU - Watanabe, Yoh
AU - Ando, Yuichi
AU - Tomotsugu, Naoki
AU - Sato, Yuji
AU - Saito, Toshiaki
PY - 2015/5/1
Y1 - 2015/5/1
N2 - Objective: This single-arm Phase II trial was designed to assess the safety and efficacy of pegylated liposomal doxorubicin and carboplatin combination chemotherapy in patients with platinumsensitive recurrent ovarian cancer. Methods: Patients with a histological diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who were relapse-free at least 6 months after completion of first-line platinumbased chemotherapy, and who had measurable disease and gave consent to participate in this study received infusions of pegylated liposomal doxorubicin (30 mg/m2) at 1 mg/min, followed by carboplatin (AUC 5 mg min/ml) over 30 min every 28 days. Results: Thirty-three of 35 enrolled patients were eligible for efficacy analysis. One patient (3.0%) achieved a complete response, while 16 (48.5%) achieved a partial response, with an overall objective response rate of 51.5% (95% confidence interval, 34.5-68.6%). Among the 22 patients who had evaluable CA125 levels at entry, responses were observed in 18 patients, with a response rate of 81.8% (95% confidence interval, 65.3-98.3%). The median progression-free survival and overall survival rates for all 35 patients were 10.7 months (95% confidence interval, 8.1-13.2 months) and 38.8 months (95% confidence interval, 31.0-46.7 months), respectively. The most frequent Grade 3-4 toxicities, regardless of cause,were neutropenia (82.9%), thrombocytopenia (51.4%), leukopenia (45.7%) and anemia (17.1%). Conclusions: The safety and efficacy of pegylated liposomal doxorubicin and carboplatin combination chemotherapy in patients with platinum-sensitive recurrent ovarian cancer were confirmed. Although there were concerns of severe hematological toxicity with this therapy, this potential complication was safely managed through adequate monitoring of bone marrow function.
AB - Objective: This single-arm Phase II trial was designed to assess the safety and efficacy of pegylated liposomal doxorubicin and carboplatin combination chemotherapy in patients with platinumsensitive recurrent ovarian cancer. Methods: Patients with a histological diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who were relapse-free at least 6 months after completion of first-line platinumbased chemotherapy, and who had measurable disease and gave consent to participate in this study received infusions of pegylated liposomal doxorubicin (30 mg/m2) at 1 mg/min, followed by carboplatin (AUC 5 mg min/ml) over 30 min every 28 days. Results: Thirty-three of 35 enrolled patients were eligible for efficacy analysis. One patient (3.0%) achieved a complete response, while 16 (48.5%) achieved a partial response, with an overall objective response rate of 51.5% (95% confidence interval, 34.5-68.6%). Among the 22 patients who had evaluable CA125 levels at entry, responses were observed in 18 patients, with a response rate of 81.8% (95% confidence interval, 65.3-98.3%). The median progression-free survival and overall survival rates for all 35 patients were 10.7 months (95% confidence interval, 8.1-13.2 months) and 38.8 months (95% confidence interval, 31.0-46.7 months), respectively. The most frequent Grade 3-4 toxicities, regardless of cause,were neutropenia (82.9%), thrombocytopenia (51.4%), leukopenia (45.7%) and anemia (17.1%). Conclusions: The safety and efficacy of pegylated liposomal doxorubicin and carboplatin combination chemotherapy in patients with platinum-sensitive recurrent ovarian cancer were confirmed. Although there were concerns of severe hematological toxicity with this therapy, this potential complication was safely managed through adequate monitoring of bone marrow function.
KW - Carboplatin
KW - Ovarian cancer
KW - Pegylated liposomal doxorubicin
UR - http://www.scopus.com/inward/record.url?scp=84930001623&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84930001623&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyv016
DO - 10.1093/jjco/hyv016
M3 - Article
C2 - 25670764
AN - SCOPUS:84930001623
VL - 45
SP - 422
EP - 426
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
SN - 0368-2811
IS - 5
M1 - hyv016
ER -