title: Docetaxel/irinotecan combination chemotherapy in platinum/taxane-refractory and -resistant ovarian cancer: JGOG/WJGOG Intergroup Study.
abstract: BACKGROUND
  The aim of this phase II study was to evaluate the efficacy and toxicity of docetaxel and irinotecan combination chemotherapy in patients with ovarian cancer refractory and resistant to both platinum and taxan treatment.
  
  
  METHODS
  Patients who had been treated with platinum and paclitaxel but whose ovarian cancer progressed or recurred within 6 months of treatment (n = 41) received docetaxel 60 mg/m(2) (day 1) and irinotecan 60 mg/m(2) (days 1, 8), repeated every 21 days [Japan Gynecologic Oncology Group (JGOG) study 3015] or every 28 days [West Japan Gynecologic Oncology Group (WJGOG) study 002] until disease progression was observed or unacceptable toxicity. Sixteen patients had platinum/paclitaxel-refractory disease, and 25 patients had platinum/paclitaxel-resistant disease.
  
  
  RESULTS
  Thirty-two patients were available for determination of the clinical response. The overall response rate [complete response (CR) + partial response (PR)] was 6.3%, and the disease control rate (CR + PR + stable disease) was 34.4%. Among the 23 patients with resistant tumor, the disease control rate was 47.8%. Ten patients with refractory tumor showed a 10% disease control rate. The median progression-free interval was 12.1 weeks and the median overall survival time was 45.3 weeks. The major toxic adverse effect was neutropenia (grade 4, 56.1%), but the incidence of neutropenic fever was less frequent (4.9%). Neurotoxicity and gastro-intestinal toxicity were mild.
  
  
  CONCLUSIONS
  Among our patients, a combination of docetaxel and irinotecan was well tolerated. However, this combination may not be a beneficial option for patients with platinum-refractory and -resistant ovarian cancer in terms of response rate and survival.
authors: Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi machi, Kurume, 830-0011, Japan. kimi@med.kurume-u.ac.jp
authors: Kimio
authors: K
authors: Ushijima
authors: Toshiharu
authors: T
authors: Kamura
authors: Kazuo
authors: K
authors: Tamura
authors: Kazuo
authors: K
authors: Kuzuya
authors: Toru
authors: T
authors: Sugiyama
authors: Kiichiro
authors: K
authors: Noda
authors: Kazunori
authors: K
authors: Ochiai
mesh_terms: D000328:Adult; D000368:Aged; D001952:Bridged-Ring Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000503:physiopathology; D005260:Female; D006801:Humans; D000077146:Irinotecan; D007564:Japan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010984:Platinum / Q000008:administration & dosage* / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001952:Bridged-Ring Compounds; D043823:Taxoids; D000077143:Docetaxel; C080625:taxane; D010984:Platinum; D000077146:Irinotecan; D002166:Camptothecin