title: Phase II study of gemcitabine and vinorelbine as second- or third-line therapy in patients with primary refractory or platinum-resistant recurrent ovarian and primary peritoneal cancer by the Korean Cancer Study Group (KCSG)_KCSG GY10-10.
abstract: OBJECTIVE
  The main aim of this study was to evaluate the antitumor activity and safety of vinorelbine and gemcitabine combination chemotherapy in patients with primary refractory or recurrent platinum-resistant epithelial ovarian and primary peritoneal cancers.
  
  
  METHODS
  Patients with platinum-resistant or primary refractory disease were eligible. Patients were allowed one prior chemotherapy for the treatment of platinum-resistant or refractory disease. Vinorelbine 25mg/m(2), followed by gemcitabine 1000mg/m(2), was administered intravenously on days 1 and 8 every 3weeks. Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 and cancer antigen 125 test (CA-125 criteria) were adopted to classify responses.
  
  
  RESULTS
  44 patients received the median of 4 (range, 1-24) treatments with fifteen (34.1%) receiving six or more cycles. The overall objective response rate was 22.7%. One patient (2.3%) had complete while 9 patients (20.4%) had partial responses with median duration of response of 5.9months. 17 patients (38.6%) had stable disease for a median of 3.3months. Median progression-free survival (PFS) was 3.4months and overall survival (OS) was 14.5months. Four (9.1%) patients were not assessable. Neutropenia was the most frequently encountered toxicity, with grade 3 or 4 observed in 22 patients (50.0%). Fifteen patients (34.1%) needed immediate dose reduction. No treatment related death was reported.
  
  
  CONCLUSIONS
  The combination chemotherapy with gemcitabine and vinorelbine achieved the primary end point of our clinical trial in management of platinum resistant recurrent ovarian cancer. However, further sophisticated dosing and scheduling of combination chemotherapy are needed because of a significant proportion of dose reduction.
authors.affiliation: Division of Oncology, Department of Internal Medicine, Cancer Research Institute, The Catholic University of Korea Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.
authors.forename: Sook Hee
authors.initials: SH
authors.lastname: Hong
authors.affiliation: Division of Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Republic of Korea.
authors.forename: Soohyeon
authors.initials: S
authors.lastname: Lee
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Gyeongnam Regional Cancer Center, Institute of Health Sciences, Gyeongsang National University School of Medicine, Republic of Korea.
authors.forename: Hoon-Gu
authors.initials: HG
authors.lastname: Kim
authors.affiliation: Division of Hematology Oncology, Department of Internal Medicine, Chungnam National University Hospital, School of Medicine, Chungnam National University, Republic of Korea.
authors.forename: Hyo Jin
authors.initials: HJ
authors.lastname: Lee
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Republic of Korea.
authors.forename: Kyung Hae
authors.initials: KH
authors.lastname: Jung
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Republic of Korea.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Lee
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Chonbuk National University Medical School, Republic of Korea.
authors.forename: Na-Ri
authors.initials: NR
authors.lastname: Lee
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Republic of Korea.
authors.forename: Jina
authors.initials: J
authors.lastname: Yun
authors.affiliation: Division of Oncology, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.
authors.forename: In Sook
authors.initials: IS
authors.lastname: Woo
authors.affiliation: Division of Oncology and Hematology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Republic of Korea.
authors.forename: Kyong Hwa
authors.initials: KH
authors.lastname: Park
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Republic of Korea.
authors.forename: Kyoung-Ha
authors.initials: KH
authors.lastname: Kim
authors.affiliation: Division of Oncology and Hematology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Republic of Korea.
authors.forename: Ho Young
authors.initials: HY
authors.lastname: Kim
authors.affiliation: Medical Oncology, Deparment of Internal Medicine, Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Republic of Korea.
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Rha
authors.affiliation: Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea. Electronic address: jhbyun37@catholic.ac.kr.
authors.forename: Jae Ho
authors.initials: JH
authors.lastname: Byun
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000494:pharmacology; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D056910:Republic of Korea; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine
keywords: Gemcitabine; Ovarian cancer; Platinum resistant; Vinorelbine