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

Toru Nakanishi, Daisuke Aoki, Yoh Watanabe, Yuichi Ando, Naoki Tomotsugu, Yuji Sato, Toshiaki Saito

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article numberhyv016
Pages (from-to)422-426
Number of pages5
JournalJapanese Journal of Clinical Oncology
Volume45
Issue number5
DOIs
Publication statusPublished - 2015 May 1

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Phase II Clinical Trials
Fallopian Tubes
Carboplatin
Platinum
Neoplasms
Confidence Intervals
Combination Drug Therapy
Ovarian Neoplasms
Safety
liposomal doxorubicin
Leukopenia
Neutropenia
Thrombocytopenia
Disease-Free Survival
Area Under Curve
Anemia
Survival Rate
Bone Marrow
Carcinoma
Recurrence

Keywords

  • Carboplatin
  • Ovarian cancer
  • Pegylated liposomal doxorubicin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging

Cite this

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.

In: Japanese Journal of Clinical Oncology, Vol. 45, No. 5, hyv016, 01.05.2015, p. 422-426.

Research output: Contribution to journalArticle

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abstract = "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.",
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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

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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.

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