title: Phase II clinical study of the combination chemotherapy regimen of irinotecan plus oral etoposide for the treatment of recurrent ovarian cancer (Tohoku Gynecologic Cancer Unit 101 Group Study).
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the combination chemotherapy regimen of irinotecan plus oral etoposide for the treatment of patients with recurrent ovarian cancer after previous treatment with platinum and taxane agents.
  
  
  METHODS
  A total of 42 patients with recurrent ovarian cancer who had an evaluable lesion and provided informed consent for participation in the present study were analyzed. Irinotecan was administered intravenously at a dose of 60 mg/m on days 1 and 15. Etoposide was administered orally at a daily dose of 50 mg/body weight from days 1 to 21. A 28-day period comprised one cycle. The tumor response, adverse events, progression-free survival, and overall survival were examined. Tumor response was evaluated based on the Response Evaluation Criteria in Solid Tumors and the serum CA125 levels (Gynecologic Cancer Intergroup criteria). Adverse events were assessed according to the NCI-CTCAE (version 3.0).
  
  
  RESULTS
  Partial response was observed in 21 patients, stable disease in 14 patients, and progressive disease in 7 patients. The response rate was 50.0%, and the clinical benefit (partial response + stable disease) rate was 83.3%. Hematological toxicities of at least grade 3 severity included leukopenia in 21 patients (50.0%), neutropenia in 22 patients (52.4%), thrombocytopenia in 1 patient (2.4%), anemia in 9 patients (21.4%), and febrile neutropenia in 3 patients (7.1%). Nonhematological toxicities of at least grade 3 severity included queasy feeling in 5 patients (11.9%), vomiting in 3 patients (7.1%), and diarrhea in 2 patients (4.8%). Acute myeloid leukemia occurred in one patient (2.4%).
  
  
  CONCLUSIONS
  It is suggested that combination chemotherapy with irinotecan plus oral etoposide offers significant clinical benefit to patients with recurrent ovarian cancer previously treated with platinum and taxane agents.
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan. tshoji@iwatemed.ac.jp
authors.forename: Tadahiro
authors.initials: T
authors.lastname: Shoji
authors.forename: Eriko
authors.initials: E
authors.lastname: Takatori
authors.forename: Hideo
authors.initials: H
authors.lastname: Omi
authors.forename: Seisuke
authors.initials: S
authors.lastname: Kumagai
authors.forename: Akira
authors.initials: A
authors.lastname: Yoshizaki
authors.forename: Yoshihito
authors.initials: Y
authors.lastname: Yokoyama
authors.forename: Hideki
authors.initials: H
authors.lastname: Mizunuma
authors.forename: Toshio
authors.initials: T
authors.lastname: Fujimoto
authors.forename: Tadao
authors.initials: T
authors.lastname: Takano
authors.forename: Nobuo
authors.initials: N
authors.lastname: Yaegashi
authors.forename: Toru
authors.initials: T
authors.lastname: Tase
authors.forename: Kenji
authors.initials: K
authors.lastname: Nakahara
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Kurachi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nishiyama
authors.forename: Toru
authors.initials: T
authors.lastname: Sugiyama
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001952:Bridged-Ring Compounds; D009944:Organoplatinum Compounds; D043823:Taxoids; C080625:taxane; D005047:Etoposide; D000077146:Irinotecan; D002166:Camptothecin