Annals of Oncology 11:281-288, 2000
© 2000 European Society for Medical Oncology
research-article |
Randomized study on adjuvant chemotherapy in stage I high-risk ovarian cancer with evaluation of DNA-ploidy as prognostic instrument
1Department of Gynecologic Oncology, The Norwegian Radium Hospital Oslo
2Department of Pathology, The Norwegian Radium Hospital Oslo
3Department of Cellular Biology, The Norwegian Radium Hospital Oslo
4Department of Gynecology, Trondheim Regional Hospital Trondheim
5Department of Gynecology, Haukeland Hospital Bergen, Norway
6Department of Gynecologic Oncology, University Hospital of Lund Sweden
7Department of Gynecologic Oncology, University Hospital of Linköping Sweden
8Department of Gynecologic Oncology, University Hospital of Leuven Belgium
Correspondence to: C. G. Tropé, MD, Department of Gynecologic Oncology, The Norwegian Radium Hospital, Montebello, N-310 Oslo, Norway. E-mail: claes.trope{at}klinmed.uio.no
Purpose: 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.
Patients and 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.
adjuvant chemotherapy, DNA ploidy, early ovarian cancer, intergroup prospective trials
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  H. Nagar and S. Dobbs Management of early-stage epithelial ovarian cancer Obstet Gynaecol (Lond), October 1, 2007; 9(4): 243 - 247. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. Trope and J. Kaern Adjuvant Chemotherapy for Early-Stage Ovarian Cancer: Review of the Literature J. Clin. Oncol., July 10, 2007; 25(20): 2909 - 2920. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. P. McGuire CA-125 and Early Ovarian Cancer: Does This Help the Clinician or Further Muddy the Water? J. Clin. Oncol., September 1, 2005; 23(25): 5862 - 5864. [Full Text] [PDF]
|
|
|
|
 |
|
 R. T. Penson, D. Sahani, and D. A. Bell Case 37-2004 - A 52-Year-Old Woman with Postmenopausal Bleeding and a Cystic Ovarian Mass N. Engl. J. Med., December 9, 2004; 351(24): 2531 - 2538. [Full Text] [PDF]
|
|
|
|
 |
|
 G. B. Kristensen, W. Kildal, V. M. Abeler, J. Kaern, I. Vergote, C. G. Trope, and H. E. Danielsen Large-scale genomic instability predicts long-term outcome for women with invasive stage I ovarian cancer Ann. Onc., October 1, 2003; 14(10): 1494 - 1500. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. C. Young Early-Stage Ovarian Cancer: To Treat or Not To Treat J Natl Cancer Inst, January 15, 2003; 95(2): 94 - 95. [Full Text] [PDF]
|
|
|
|
|
|
ICON1 and EORTC-ACTION International Collaborative Ovarian Neoplasm Trial 1 and Adjuvant ChemoTherapy In Ovarian Neoplasm Trial: Two Parallel Randomized Phase III Trials of Adjuvant Chemotherapy in Patients With Early-Stage Ovarian Carcinoma J Natl Cancer Inst, January 15, 2003; 95(2): 105 - 112. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. B. Trimbos, I. Vergote, G. Bolis, J. B. Vermorken, C. Mangioni, C. Madronal, M. Franchi, S. Tateo, G. Zanetta, G. Scarfone, et al. Impact of Adjuvant Chemotherapy and Surgical Staging in Early-Stage Ovarian Carcinoma: European Organisation for Research and Treatment of Cancer-Adjuvant ChemoTherapy in Ovarian Neoplasm Trial J Natl Cancer Inst, January 15, 2003; 95(2): 113 - 125. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
ICON1 International Collaborative Ovarian Neoplasm Trial 1: A Randomized Trial of Adjuvant Chemotherapy in Women With Early-Stage Ovarian Cancer J Natl Cancer Inst, January 15, 2003; 95(2): 125 - 132. [Abstract] [Full Text] [PDF]
|
|