title: Pilot phase II trial of radiation "sandwiched" between combination paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinoma (UPSC).
abstract: OBJECTIVE
  To evaluate disease-free survival (DFS) and overall survival (OS) in patients treated with pelvic radiation "sandwiched" between six cycles of paclitaxel(T)/platinum(P) chemotherapy with optimally reduced uterine papillary serous carcinoma (UPSC).
  
  
  METHODS
  Surgically staged patients with UPSC and no visible residual disease were enrolled. Treatment involved T (175 mg/m2) and either cisplatin (75 mg/m2) or carboplatin (AUC=6.0, 6.5, 7.5) every 21 days x 3 doses, followed by pelvic RT (45 Gy). Fields were extended for >2 positive pelvic or confirmed para-aortic node disease. Three additional cycles of T/P were administered after RT. Toxicity was graded by NCI CTC Version 3.0. Kaplan-Meier survival statistics were used for DFS/OS.
  
  
  RESULTS
  30 women were enrolled between 1999 and 2004. Median age was 69 years (45-82 years). 60% (18/30) of patients had disease confined to the uterus (Stage I/II) and 40% (12/30) had extra-uterine disease (Stage III/IV). 29 patients completed protocol treatment. One patient was discontinued due to non-compliance and recurred at 7 months. All 30 patients are included in survival analysis. Three-year DFS and OS with Stage I/II disease was 69% and 75% and Stage III/IV disease was 54% and 52%, respectively. Of 177 chemotherapy cycles administered, grade 3 or 4 neutropenia, thrombocytopenia or anemia occurred in 42%, 1% and 3% of cycles, respectively. Six cycles were delayed 1 week for neutropenia. 43% of all neutropenic episodes occurred after RT.
  
  
  CONCLUSIONS
  Radiation "sandwiched" between T/P chemotherapy is a well-tolerated and efficacious regimen for patients with completely resected UPSC. A larger multi-institutional clinical trial should be considered to confirm these pilot data.
authors.affiliation: Virginia Gynecologic Oncology, 7603 Forest Avenue, Suite 207, Richmond, VA 23229, USA. abbiefields@comcast.net
authors.forename: Abbie L
authors.initials: AL
authors.lastname: Fields
authors.forename: Mark H
authors.initials: MH
authors.lastname: Einstein
authors.forename: Akiva P
authors.initials: AP
authors.lastname: Novetsky
authors.forename: Juliana
authors.initials: J
authors.lastname: Gebb
authors.forename: Gary L
authors.initials: GL
authors.lastname: Goldberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018283:Cystadenocarcinoma, Papillary / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects; D011446:Prospective Studies; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin