title: Low-dose abdominal radiation as a docetaxel chemosensitizer for recurrent epithelial ovarian cancer: a phase I study of the Gynecologic Oncology Group.
abstract: OBJECTIVE
  The aim of this study was to determine the maximum tolerated dose and dose-limiting toxicity (DLT) of whole abdomen radiation as a chemosensitizer of weekly docetaxel for women with recurrent epithelial ovarian fallopian tube, or peritoneal cancers.
  
  
  METHODS
  Women were enrolled on one of three dose levels of docetaxel (20, 25, or 30 mg/m(2)) administered weekly with concurrent low-dose whole abdominal radiation given as 60 cGy bid 2 days weekly for a total of 6 weeks.
  
  
  RESULTS
  Thirteen women were enrolled and received 70 weekly treatments of docetaxel in combination with radiation therapy. At the first dose level, docetaxel 25mg/m(2), grade 3 fatigue and thrombocytopenia were observed. At the next dose level, docetaxel 30 mg/m(2), grade 3 febrile neutropenia, grade 4 thrombocytopenia with epistaxis, and grade 3 diarrhea were observed. Given these dose-limiting toxicities, a lower dose of docetaxel 20mg/m(2) was administered and found to be tolerable. No objective responses were observed among the 10 patients with measurable disease; however, the median progression-free survival (PFS) in all patients was 3.3 months, and 3 of the patients with measurable disease were free of tumor progression after 6 months (30%; 90% confidence interval 8.7-61%).
  
  
  CONCLUSIONS
  Twice weekly low-dose whole abdomen radiation during weekly docetaxel 20 mg/m(2) was well-tolerated. Given the PFS demonstrated in these women with resistant ovarian cancer, further study of whole abdominal radiation and concurrent chemotherapy may be warranted.
authors.affiliation: Department of Radiation Oncology, University Hospitals Case Medical Center, Cleveland, OH 44106, USA.
authors.forename: Charles A
authors.initials: CA
authors.lastname: Kunos
authors.forename: Michael W
authors.initials: MW
authors.lastname: Sill
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Buekers
authors.forename: Joan L
authors.initials: JL
authors.lastname: Walker
authors.forename: Jeanne M
authors.initials: JM
authors.lastname: Schilder
authors.forename: S Diane
authors.initials: SD
authors.lastname: Yamada
authors.forename: Steven E
authors.initials: SE
authors.lastname: Waggoner
authors.forename: Mohammed
authors.initials: M
authors.lastname: Mohiuddin
authors.forename: Paula M
authors.initials: PM
authors.lastname: Fracasso
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000077216:Carcinoma, Ovarian Epithelial; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004307:Dose-Response Relationship, Radiation; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000532:radiotherapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy / Q000532:radiotherapy; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000532:radiotherapy; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel