title: Feasibility study of combination chemotherapy with paclitaxel, doxorubicin and cisplatin without prophylactic granulocyte colony-stimulating factor injection for intermediate-to-high risk or recurrent endometrial cancer.
abstract: OBJECTIVE
  We evaluated the feasibility of combination chemotherapy with paclitaxel, doxorubicin and cisplatin without prophylactic granulocyte colony-stimulating factor injection for intermediate-to-high-risk or recurrent endometrial cancer.
  
  
  METHODS
  Women with histologically confirmed FIGO Stages I-II with >1/2 myometrial invasion, Stage III/IV or recurrent endometrial cancer were enrolled. Patients received intravenous doxorubicin (45 mg/m(2)), followed by cisplatin (50 mg/m(2)) on Day 1 and intravenous paclitaxel (160 mg/m(2)) on Day 2. Granisetron (75 µg) was administered depending on neutrophil counts on Days 3 and 8. Treatment was repeated every 21 days for six cycles or until disease progression or unacceptable toxicity. The primary endpoint was the completion rate of the scheduled chemotherapy; secondary endpoints were Grade 3/4 toxicity and response rate in patients with measurable lesions.
  
  
  RESULTS
  From September 2010 to December 2012, 35 women, including 7 with FIGO Stage I, 4 with Stage II, 13 with Stage III, 10 with Stage IV and 1 with recurrent endometrial cancer, were enrolled. There were 26 endometrial carcinomas (Grade 1, 16; Grade 2, 6; Grade 3, 4), 4 carcinosarcomas, 2 serous adenocarcinomas, 1 neuroendocrine carcinoma, 1 poorly differentiated carcinoma and 1 mixed carcinoma. Twenty-five patients (71%) completed six chemotherapy cycles. Grade 3/4 hematological toxicities included neutrocytopenia (97%), thrombocytopenia (6%) and anemia (34%). Three patients (9%) experienced neutropenic fever. Grade 3/4 non-hematological toxicities were observed in 13 patients. In 15 patients with evaluable lesions, the response rate was 80%.
  
  
  CONCLUSIONS
  Combination chemotherapy with paclitaxel, doxorubicin and cisplatin without prophylactic granulocyte colony-stimulating factor injection is feasible.
authors.affiliation: Department of Gynecologic Oncology, Hyogo Cancer Center, Akashi-city, Hyogo nagao@hp.pref.hyogo.jp.
authors.forename: Shoji
authors.initials: S
authors.lastname: Nagao
authors.affiliation: Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-city, Saitama.
authors.forename: Tadaaki
authors.initials: T
authors.lastname: Nishikawa
authors.affiliation: Department of Obstetrics and Gynecology, Saitama Medical University Saitama Medical Center, Kawagoe-city, Saitama, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Hanaoka
authors.affiliation: Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-city, Saitama.
authors.forename: Akira
authors.initials: A
authors.lastname: Kurosaki
authors.affiliation: Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-city, Saitama.
authors.forename: Norihiro
authors.initials: N
authors.lastname: Iwasa
authors.affiliation: Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-city, Saitama.
authors.forename: Kosei
authors.initials: K
authors.lastname: Hasegawa
authors.affiliation: Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-city, Saitama.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Fujiwara
mesh_terms: D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D018570:Risk Assessment; D012307:Risk Factors; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D004317:Doxorubicin; D017239:Paclitaxel; D002945:Cisplatin
keywords: chemotherapy; cisplatin; doxorubicin; endometrial cancer; paclitaxel