title: Randomized study on adjuvant chemotherapy in stage I high-risk ovarian cancer with evaluation of DNA-ploidy as prognostic instrument.
abstract: OBJECTIVE
  Adjuvant chemotherapy versus observation and chemotherapy at progression was evaluated in 162 patients in a prospective randomized multicenter study. We also evaluated DNA-measurements as an additional prognostic factor.
  
  
  METHODS
  Patients received adjuvant carboplatin AUC 7 every 28 days for six courses (n = 81) or no adjuvant treatment (n = 81). Eligibility included surgically staged and treated patients with FIGO stage I disease, grade 1 aneuploid or grade 2 or 3 non-clear cell carcinomas or clear cell carcinomas. Disease-free (DFS) and disease-specific (DSS) survival were end-points.
  
  
  RESULTS
  Median follow-up time was 46 months and progression was observed in 20 patients in the treatment group and 19 in the control group. Estimated five-year DFS and DSS were 70% and 86% in the treatment group and 71% and 85% in the control group. The hazard ratio was 0.98 (95% confidence interval (95% CI): 0.52-1.83) regarding DFS and 0.94 (95% CI: 0.37-2.36) regarding DSS. No significant differences in DFS or DSS could be seen when the log-rank test was stratified for prognostic variables. Therefore, data from both groups were pooled for the analysis of prognostic factors. DNA-ploidy (P = 0.003), extracapsular growth (P = 0.005), tumor rupture (P = 0.04), and WHO histologic grade (P = 0.04) were significant independent prognostic factors for DFS with P < 0.0001 for the model in the multivariate Cox analysis. FIGO substage (P = 0.01), DNA ploidy (P < 0.05), and histologic grade (P = 0.05) were prognostic for DSS with a P-value for the model < 0.0001.
  
  
  CONCLUSIONS
  Due to the small number of patients the study was inconclusive as regards the question of adjuvant chemotherapy. The survival curves were superimposable, but with wide confidence intervals. DNA-ploidy adds objective independent prognostic information regarding both DFS and DSS in early ovarian cancer.
authors.affiliation: Department of Gynecologic Oncology, The Norwegian Radium Hospital, Oslo. claes.trope@klinmed.uio.no
authors.forename: C
authors.initials: C
authors.lastname: Tropé
authors.forename: J
authors.initials: J
authors.lastname: Kaern
authors.forename: T
authors.initials: T
authors.lastname: Hogberg
authors.forename: V
authors.initials: V
authors.lastname: Abeler
authors.forename: B
authors.initials: B
authors.lastname: Hagen
authors.forename: G
authors.initials: G
authors.lastname: Kristensen
authors.forename: M
authors.initials: M
authors.lastname: Onsrud
authors.forename: E
authors.initials: E
authors.lastname: Pettersen
authors.forename: P
authors.initials: P
authors.lastname: Rosenberg
authors.forename: R
authors.initials: R
authors.lastname: Sandvei
authors.forename: K
authors.initials: K
authors.lastname: Sundfor
authors.forename: I
authors.initials: I
authors.lastname: Vergote
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D004273:DNA, Neoplasm / Q000235:genetics*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology / Q000601:surgery; D011003:Ploidies; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D004273:DNA, Neoplasm; D016190:Carboplatin