title: A phase I/II study of hypofractionated whole abdominal radiation therapy in patients with chemoresistant ovarian carcinoma: Karnofsky score determines treatment outcome.
abstract: OBJECTIVE
  Radiation therapy can provide useful palliation in chemorefractory ovarian cancer patients. The purpose of this study was to prospectively study the palliative effect of a hypofractionated radiation treatment regimen. Change in quality-of-life scores (Functional Assessment of Cancer Therapy [FACT], Karnofsky scale), pain score, and tolerance to therapy were also assessed.
  
  
  METHODS
  A single-institution Phase I/II trial was initiated in patients with chemoresistant recurrent or progressive ovarian cancer. All patients had symptomatic and measurable intra-abdominal disease. Patients were treated with a single radiation fraction (700 cGy) or two fractions (300 cGy twice a day) to the whole abdomen over 1 day. Quality-of-life scale (FACT G version 2) was assessed at baseline and 1 and 3 months following treatment. Karnofsky scale and pain score were also evaluated in the same time frame.
  
  
  RESULTS
  Sixteen patients were prospectively entered into this protocol between February 1996 and September 1998. Twelve patients received a single 700 cGy fraction and four 300 cGy twice a day. All were heavily pretreated and 9 (56%) had a poor performance status prior to treatment. Symptoms needing palliation included pain (14), ascites (10), and bleeding (2). Symptomatic improvement occurred in all patients with pain (5 complete response [CR] and 7 partial response [PR], all patients with bleeding (CR 2), and two (20%) with ascites. Five patients (31%) had a reduction in lesion size documented radiologically in three. The mean duration of response was 22 weeks in patients with a Karnofsky score >70. Thirteen patients developed transient nausea and vomiting which resolved in 48 hours in all. All patients developed a transient lymphopenia. Thirteen patients completed a follow-up quality-of-life scale. There was an improvement in the physical and functional components of the scale in patients with Karnofsky score of 90-100. There was no improvement in quality of life in patients with Karnofsky score <90 despite symptomatic response. Median survival was 3 months from the date of treatment.
  
  
  CONCLUSIONS
  Hypofractionated radiation therapy is an effective palliative treatment for end-stage ovarian cancer patients. Karnofsky score can help determine the duration of response and survival for this high-risk population.
authors.affiliation: Department of Radiation Oncology, Magee Womens Hospital, Pittsburgh, PA 15213, USA. faulc+@pitt.edu
authors.forename: C
authors.initials: C
authors.lastname: Faul
authors.forename: K
authors.initials: K
authors.lastname: Gerszten
authors.forename: R
authors.initials: R
authors.lastname: Edwards
authors.forename: S
authors.initials: S
authors.lastname: Land
authors.forename: G
authors.initials: G
authors.lastname: D'Angelo
authors.forename: J
authors.initials: J
authors.lastname: Kelley
authors.forename: F
authors.initials: F
authors.lastname: Price
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019583:Dose Fractionation, Radiation; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D017567:Karnofsky Performance Status; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy*; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D014839:Vomiting / Q000209:etiology