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AGO-OVAR OP.2
(AGO DESKTOP OVAR II)
Validation of a score of predictive factors
for complete resection in platinum-sensitive
recurrent ovarian cancer
A project of the AGO Kommission OVAR and
AGO Study Group Ovarian Cancer (AGO-OVAR)
An open-label prospective multicenter-trial
Objectives of the DESKTOP-series
Phase I:
- Identification of surgical aim
- Creation of a predictive score
for resectability
Phase II:
- Validation of this score
Phase III: - Prospective randomized trial
© P. Harter 2006
DESKTOP- OVAR I: Results
• what is the surgical endpoint ?
1
0,9
survival probability
0,8
no residuals
median OS 45.2 mos.
0,7
0,6
0,5
0,4
0,3
0 vs. 1-10 mm:
0,2 HR: 4.17 (CI 2,42 - 7,16); p < 0.001
0,1 0 vs. 10+ mm:
HR: 3.31 (CI 1,86 - 5,88); p < 0.001
residuals > 10 mm
median OS 19.7 mos.
residuals 1 - 10 mm
median OS 19.6 mos.
0
0
DESKTOP
12
24
36
48
months
Harter P, du Bois A, Hahmann M et al. Ann Surg Oncol (in press)
© P. Harter 2006
DESKTOP- OVAR I
• who benefits ? multivariate analysis (survival)
Variable
OR
(95% CI)
p-value
Residual after surgery (0 vs. > 0 mm)
2.94 (1.68-5.17)
< 0.001
Ascites (cut-off 500 ml)
2.30 (1.31-4.04)
0.004
Pt-based chx after surgery (yes vs. no)
1.84 (1.13-3.01)
0.015
Not an independent prognostic factor for survival after surgery for recurrence are:
• Localization of recurrence (pelvic vs. others)
• PS (ECOG 0 vs. > 0)
• Residuals after 1st surgery ( 0 vs. > 0 mm)
• TFI (< 6 vs. > 6-12 vs. > 12 months), but small no. of pts with TFI < 6 months
• FIGO-stage at primary diagnosis (I/II vs. III/IV)
© P. Harter 2006
DESKTOP-OVAR I
• Predictors of successful surgery ( = complete resection)
multivariate analysis
pre-OP variable
OR
(95%CI)
p-value
PS (ECOG 0 vs. > 0)
2.65 (1.56-4.52)
< 0.001
Residual disease 1st. Surgery ( 0 vs. > 0)
2.46 (1.45-4.20)
< 0.001
or: initial FIGO-stage (I/II vs. III/IV)
1.87 (1.04-3.37)
0.036
Ascites (cut-off 500 ml)*
5.08 (1.97-13.16)
< 0.001
* exclusively CA 125 (Correlation with ascites)
Not significant for complete resection in multivariate model
(multivariate Model with all significant pre-OP variables)
• Localization of Recurrent disease (Pelvic vs. others)
• Treatment-free-interval
© P. Harter 2006
AGO-DESKTOP II: Prospective Validation of a Predictive
Score for Resectability in Platinum-Sensitive ROC (PFS > 6 mos)
• PS ECOG = 0
• no residuals after primary surgery (or, if unknown: initially FIGO I/II)
• absence of ascites > 500 ml
Surgery is planned ?
Yes (basic collective 2)
No (basic collective 1)
predictive score positive (all items) ?
Yes (CRR 79%)
= study collective
Laparotomy
calculated
numbers
No (CRR
43%) (1st endpoint):
122 pts. with positive score and a
complete
resection rate
(CRR)
of at least
only descriptive
analysis
of further
therapy
75% will show with 95% probability that a
positive score can predict CR in >2 of 3
pts.
Platinum-based combination chemotherapy
* CRR: Results from DESKTOP-OVAR I
© P. Harter 2006
DESKTOP II
Primary objective:
With which frequency can macroscopically complete tumour
resections be achieved in platinum-sensitive recurrent ovarian-,
fallopian tube- or peritoneal cancer when applying the AGO-score?
(frequency = positive predictive factor; PPF)
Secondary objectives:
1. Description of the collective which underwent surgery despite
absence of at least one of the three items (AGO-score negative), and
analysis according to the score. Sub-score for patients who only meet
parts of the items of the score – negative predictive factor (NPF) for this
selected collective.
3. Feasibility and complications in surgery in relapsed ovarian
cancer in a multicentre setting (descriptive analysis)
© P. Harter 2006
DESKTOP II
Study collectives
1. Basic collective 1: All pts. with relapsed platinum-sensitive ovarian-,
fallopian tube- or peritoneal cancer who present to participating
centres will be included in the documentation. For this basic
collective, baseline documentation of patient- and disease
characteristics will be carried out.
2. Basic collective 2 consists of patients from basic collective 1 who will
have surgery for recurrence. For these patients, an additional
documentation of surgery will be carried out.
3. Primary study collective: patients from basic collective 2 with
positive AGO-score
© P. Harter 2006
Recruitment AGO-OVAR OP.2/ DESKTOP II
(10.05.2007)
100
80
60
40
20
0
10 MAY 2007
sugery (score positive)
score negative
screening only
Ad oggi:…
Numero di centri MITO
partecipanti
11
Numero di centri che hanno
ottenuto l’approvazione da
parte del C.E.
5 (UCSC-CB, UCSC-RM,
Ospedale Fatebenefratelli-RM,
INT-Napoli, Ospedale
Fatebenefratelli-BN)
Centri che hanno arruolato
2 (UCSC-CB 4 pts, UCSC-RM
5 pts)