title: 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.
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 platinum-sensitive 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 platinum-based chemotherapy, and who had measurable disease and gave consent to participate in this study received infusions of pegylated liposomal doxorubicin (30 mg/m(2)) 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.
authors: Department of Gynecology, Aichi Cancer Center Hospital, Nagoya trnakans@aichi-cc.jp.
authors: Toru
authors: T
authors: Nakanishi
authors: Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo.
authors: Daisuke
authors: D
authors: Aoki
authors: Department of Obstetrics and Gynecology, Kinki University Faculty of Medicine, Osaka.
authors: Yoh
authors: Y
authors: Watanabe
authors: Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya.
authors: Yuichi
authors: Y
authors: Ando
authors: Center for Clinical Research, School of Medicine, Keio University, Tokyo.
authors: Naoki
authors: N
authors: Tomotsugu
authors: Center for Clinical Research, School of Medicine, Keio University, Tokyo.
authors: Yuji
authors: Y
authors: Sato
authors: Gynecology Service, National Kyushu Cancer Center, Fukuoka, Japan.
authors: Toshiaki
authors: T
authors: Saito
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D044466:Asian People; D014408:Biomarkers, Tumor / Q000097:blood; D018394:CA-125 Antigen / Q000097:blood; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002277:Carcinoma / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D000077216:Carcinoma, Ovarian Epithelial; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005185:Fallopian Tube Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D010534:Peritoneal Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin
keywords: carboplatin; ovarian cancer; pegylated liposomal doxorubicin