Randomized study on adjuvant chemotherapy in stage I high-risk ovarian cancer with evaluation of DNA-ploidy as prognostic instrument
(2000) In Annals of oncology : official journal of the European Society for Medical Oncology 11(3). p.8-281- Abstract
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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2000-03
- type
- Contribution to journal
- publication status
- published
- keywords
- Adenocarcinoma/drug therapy, Adult, Aged, Analysis of Variance, Antineoplastic Agents/therapeutic use, Carboplatin/therapeutic use, Chemotherapy, Adjuvant, DNA, Neoplasm/genetics, Female, Humans, Middle Aged, Neoplasm Staging, Ovarian Neoplasms/drug therapy, Ploidies, Prognosis, Prospective Studies, Risk Factors, Survival Analysis
- in
- Annals of oncology : official journal of the European Society for Medical Oncology
- volume
- 11
- issue
- 3
- pages
- 8 pages
- publisher
- Oxford University Press
- external identifiers
-
- scopus:0033996328
- pmid:10811493
- ISSN
- 0923-7534
- DOI
- 10.1023/a:1008399414923
- language
- English
- LU publication?
- yes
- id
- 477e30f0-aae6-4414-8cb0-923cb9a9640b
- date added to LUP
- 2019-09-20 07:57:56
- date last changed
- 2025-01-12 21:20:26
@article{477e30f0-aae6-4414-8cb0-923cb9a9640b, abstract = {{<p>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.</p><p>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.</p><p>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.</p><p>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.</p>}}, author = {{Tropé, C and Kaern, J and Hogberg, T and Abeler, V and Hagen, B and Kristensen, G and Onsrud, M and Pettersen, E and Rosenberg, P and Sandvei, R and Sundfor, K and Vergote, I}}, issn = {{0923-7534}}, keywords = {{Adenocarcinoma/drug therapy; Adult; Aged; Analysis of Variance; Antineoplastic Agents/therapeutic use; Carboplatin/therapeutic use; Chemotherapy, Adjuvant; DNA, Neoplasm/genetics; Female; Humans; Middle Aged; Neoplasm Staging; Ovarian Neoplasms/drug therapy; Ploidies; Prognosis; Prospective Studies; Risk Factors; Survival Analysis}}, language = {{eng}}, number = {{3}}, pages = {{8--281}}, publisher = {{Oxford University Press}}, series = {{Annals of oncology : official journal of the European Society for Medical Oncology}}, title = {{Randomized study on adjuvant chemotherapy in stage I high-risk ovarian cancer with evaluation of DNA-ploidy as prognostic instrument}}, url = {{http://dx.doi.org/10.1023/a:1008399414923}}, doi = {{10.1023/a:1008399414923}}, volume = {{11}}, year = {{2000}}, }