title: A feasibility study of carboplatin and weekly paclitaxel combination chemotherapy in endometrial cancer: a Kansai Clinical Oncology Group study (KCOG0015 trial).
abstract: OBJECTIVE
  The optimal chemotherapy regimen for women with endometrial cancer has not been established. We assessed the feasibility, toxicity and clinical efficacy of combination triweekly carboplatin and weekly paclitaxel in women with endometrial cancer.
  
  
  METHODS
  Eligible patients had histologically confirmed primary advanced or recurrent endometrial cancer (Group A), or had localized high-risk features (Group B). All were treated with paclitaxel 80 mg/m(2) (days 1, 8 and 15) and carboplatin AUC 5 (day 1) each 21-day cycle. A minimum of 3 cycles was planned; if 75% or more of patients were able to receive at least 3 cycles with acceptable toxicity, the regimen was declared "feasible."
  
  
  RESULTS
  Forty patients were enrolled and administered 163 cycles of therapy; 38 (95%) were chemo-naive. No patients received radiation previously. Group A (measurable disease) contained 15 patients (5 with recurrent disease, 7 receiving neo-adjuvant chemotherapy, and 3 treated adjuvantly following suboptimal cytoreduction). Group B (non-measurable disease) contained 25 patients (primary stage I:10, II:5, III:8, IV:1 and relapse 1). Hematological toxicities(G3/G4) were neutropenia (31%/33%) and thrombocytopenia (6%/0%). Reversible G3 hypersensitivity (5%) and G2 cardiotoxicity (3%) was uncommon. Thirty-one patients (78%) completed ≥3 cycles (median 4, range: 1-9). Thirteen of 15 (87%) measurable patients responded (3CR, 10PR). Eighty-seven percent of measurable patients were not progressive at 6 months. In Group A, QOL scores were significantly improved after 3 cycles of chemotherapy (p=0.037), and at the completion of chemotherapy (p=0.045). QOL scores in Group B did not change during therapy.
  
  
  CONCLUSIONS
  This combination chemotherapy is feasible and effective for endometrial cancer patients.
authors.affiliation: Department of Obstetrics and Gynecology, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo 660-8511, Japan. kimihiko-ito@kanrou.net
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Ito
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsubamoto
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Itani
authors.forename: Haruo
authors.initials: H
authors.lastname: Kuroboshi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Fujita
authors.forename: Toshikatsu
authors.initials: T
authors.lastname: Nobunaga
authors.forename: Robert L
authors.initials: RL
authors.lastname: Coleman
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D012307:Risk Factors
chemical_list: D016190:Carboplatin; D017239:Paclitaxel