Abstract
Objectives: The aim of the study was to investigate i) the association between the Ca125 based and the RECIST assessed response in recurrent ovarian cancer patients enrolled in a Phase III randomized trial (MITO-3) comparing salvage treatment with pegylated liposomal doxorubicin (PLD) versus gemcitabine (GEM); ii) the correlation between the early modifications of Ca125 levels during treatment and the RECIST assessed response; iii) the prognostic value of response based on Ca125 and the RECIST criteria. Methods: Assessment of response was performed by the RECIST and the GCIG criteria. The prognostic impact of the response by the RECIST criteria and the GCIG criteria was analyzed by the landmark method. Results: Overall, of 30 cases defined as responders on the basis of the GCIG criteria, 20 resulted as responders according to the RECIST criteria (NPV = 66.7%); conversely, 93.7% of the cases considered not responders based on the GCIG criteria were defined as unresponsive at RECIST evaluation. Early modifications of Ca125 levels were not completely predictive of the ultimate RECIST defined response. Overall survival (OS) was longer in RECIST defined responders versus non responders, although the statistical significance was not reached (p value = 0.092); conversely, median OS was significantly longer in GCIG defined responders than in non responding patients (p value = 0.0059). In multivariate analysis, the GCIG assessed response maintained its independent association with OS. Conclusions: GCIG criteria for tumor response could replace the conventional assessment of response in the decision making process relative to the discontinuation or prolongation of the salvage treatment in ovarian cancer.
| Original language | English |
|---|---|
| Pages (from-to) | 187-193 |
| Number of pages | 7 |
| Journal | Gynecologic Oncology |
| Volume | 109 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - May 2008 |
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Keywords
- Ca125 response
- Prognosis
- Recurrent ovarian cancer
ASJC Scopus subject areas
- Obstetrics and Gynaecology
- Oncology
Cite this
Prognostic role of Ca125 response criteria and RECIST criteria : Analysis of results from the MITO-3 phase III trial of gemcitabine versus pegylated liposomal doxorubicin in recurrent ovarian cancer. / Ferrandina, Gabriella; Ludovisi, Manuela; Corrado, Giacomo; Carone, Vito; Petrillo, Marco; Scambia, Giovanni.
In: Gynecologic Oncology, Vol. 109, No. 2, 05.2008, p. 187-193.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Prognostic role of Ca125 response criteria and RECIST criteria
T2 - Analysis of results from the MITO-3 phase III trial of gemcitabine versus pegylated liposomal doxorubicin in recurrent ovarian cancer
AU - Ferrandina, Gabriella
AU - Ludovisi, Manuela
AU - Corrado, Giacomo
AU - Carone, Vito
AU - Petrillo, Marco
AU - Scambia, Giovanni
PY - 2008/5
Y1 - 2008/5
N2 - Objectives: The aim of the study was to investigate i) the association between the Ca125 based and the RECIST assessed response in recurrent ovarian cancer patients enrolled in a Phase III randomized trial (MITO-3) comparing salvage treatment with pegylated liposomal doxorubicin (PLD) versus gemcitabine (GEM); ii) the correlation between the early modifications of Ca125 levels during treatment and the RECIST assessed response; iii) the prognostic value of response based on Ca125 and the RECIST criteria. Methods: Assessment of response was performed by the RECIST and the GCIG criteria. The prognostic impact of the response by the RECIST criteria and the GCIG criteria was analyzed by the landmark method. Results: Overall, of 30 cases defined as responders on the basis of the GCIG criteria, 20 resulted as responders according to the RECIST criteria (NPV = 66.7%); conversely, 93.7% of the cases considered not responders based on the GCIG criteria were defined as unresponsive at RECIST evaluation. Early modifications of Ca125 levels were not completely predictive of the ultimate RECIST defined response. Overall survival (OS) was longer in RECIST defined responders versus non responders, although the statistical significance was not reached (p value = 0.092); conversely, median OS was significantly longer in GCIG defined responders than in non responding patients (p value = 0.0059). In multivariate analysis, the GCIG assessed response maintained its independent association with OS. Conclusions: GCIG criteria for tumor response could replace the conventional assessment of response in the decision making process relative to the discontinuation or prolongation of the salvage treatment in ovarian cancer.
AB - Objectives: The aim of the study was to investigate i) the association between the Ca125 based and the RECIST assessed response in recurrent ovarian cancer patients enrolled in a Phase III randomized trial (MITO-3) comparing salvage treatment with pegylated liposomal doxorubicin (PLD) versus gemcitabine (GEM); ii) the correlation between the early modifications of Ca125 levels during treatment and the RECIST assessed response; iii) the prognostic value of response based on Ca125 and the RECIST criteria. Methods: Assessment of response was performed by the RECIST and the GCIG criteria. The prognostic impact of the response by the RECIST criteria and the GCIG criteria was analyzed by the landmark method. Results: Overall, of 30 cases defined as responders on the basis of the GCIG criteria, 20 resulted as responders according to the RECIST criteria (NPV = 66.7%); conversely, 93.7% of the cases considered not responders based on the GCIG criteria were defined as unresponsive at RECIST evaluation. Early modifications of Ca125 levels were not completely predictive of the ultimate RECIST defined response. Overall survival (OS) was longer in RECIST defined responders versus non responders, although the statistical significance was not reached (p value = 0.092); conversely, median OS was significantly longer in GCIG defined responders than in non responding patients (p value = 0.0059). In multivariate analysis, the GCIG assessed response maintained its independent association with OS. Conclusions: GCIG criteria for tumor response could replace the conventional assessment of response in the decision making process relative to the discontinuation or prolongation of the salvage treatment in ovarian cancer.
KW - Ca125 response
KW - Prognosis
KW - Recurrent ovarian cancer
UR - http://www.scopus.com/inward/record.url?scp=42749092093&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=42749092093&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2008.01.039
DO - 10.1016/j.ygyno.2008.01.039
M3 - Article
C2 - 18343487
AN - SCOPUS:42749092093
VL - 109
SP - 187
EP - 193
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 2
ER -