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Randomized study on adjuvant chemotherapy in stage I high-risk ovarian cancer with evaluation of DNA-ploidy as prognostic instrument

Tropé, C ; Kaern, J ; Hogberg, T LU ; Abeler, V ; Hagen, B ; Kristensen, G ; Onsrud, M ; Pettersen, E ; Rosenberg, P and Sandvei, R , et al. (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.

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organization
publishing date
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
  • 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
2020-12-19 04:03:07
@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 &lt; 0.0001 for the model in the multivariate Cox analysis. FIGO substage (P = 0.01), DNA ploidy (P &lt; 0.05), and histologic grade (P = 0.05) were prognostic for DSS with a P-value for the model &lt; 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},
  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},
}