Association between breast cancer’s prognostic factors and 3D textural features of non-contrast-enhanced T1-weighted breast MRI

2021 ◽  
Author(s):  
Anni Lepola ◽  
Otso Arponen ◽  
Hidemi Okuma ◽  
Kirsi Holli-Helenius ◽  
Heikki Junkkari ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Texture Analysis ◽  
Proportional Hazards Model ◽  
Histological Grade ◽  
Prognostic Index ◽  
Disease Free Survival ◽  
Breast Mri ◽  
Cox Proportional Hazards Model ◽  
Tumour Grade ◽  
Contrast Enhanced

Objectives: The aim of this exploratory study was to evaluate whether three-dimensional texture analysis (3D-TA) features of non-contrast-enhanced T1-weighted MRI associate with traditional prognostic factors and disease-free survival (DFS) of breast cancer. Methods: 3D-T1-weighted images from 78 patients with 81 malignant histopathologically verified breast lesions were retrospectively analysed using standard-size volumes of interest. Grey-level co-occurrence matrix (GLCM) based features were selected for statistical analysis. In statistics the Mann–Whitney U and the Kruskal–Wallis tests, the Cox proportional hazards model and the Kaplan-Meier method were used. Results: Tumours with higher histological grade were significantly associated with higher contrast (1voxel: p = 0.033, two voxels: p = 0.036). All the entropy parameters showed significant correlation with tumour grade (p = 0.015–0.050) but there were no statistically significant associations between other TA parameters and tumour grade. The Nottingham Prognostic Index (NPI) was correlated with contrast and sum entropy parameters. A higher sum variance TA parameter was a significant predictor of shorter DFS. Conclusion: Texture parameters, assessed by 3D-TA from non-enhanced T1-weighted images, indicate tumour heterogeneity but have limited independent prognostic value. However, they are associated with tumour grade, NPI, and DFS. These parameters could be used as an adjunct to contrast-enhanced TA parameters. Advances in knowledge: 3D texture analysis of non-contrast enhanced T1-weighted breast MRI associates with tumour grade, NPI, and DFS. The use of non-contrast 3D TA parameters in adjunct with contrast-enhanced 3D TA parameters warrants further research.

scholarly journals Clinical characteristics and disease outcomes in ER+ breast cancer: a comparison between HER2+ patients treated with trastuzumab and HER2- patients

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shuai Li ◽  
Jiayi Wu ◽  
Ou Huang ◽  
Jianrong He ◽  
Li Zhu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Proportional Hazards Model ◽  
Histological Grade ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Cox Proportional Hazards Model ◽  
Endocrine Treatment ◽  
Breast Cancer Patients ◽  
Her2 Breast Cancer

Abstract Background Trastuzumab has changed the prognosis of HER2+ breast cancer. We aimed to investigate the prognosis of ER+/HER2+ patients treated with trastuzumab, thus to guide escalation endocrine treatment in ER+ breast cancer. Methods ER-positive early breast cancer patients operated at Ruijin Hospital between Jan. 2009 and Dec. 2017 were retrospectively included. Eligible patients were grouped as HER2-negative (HER2-neg) or HER2-positive with trastuzumab treatment (HER2-pos-T). Kaplan-Meier analysis and Cox proportional hazards model were used to compare the disease-free survival (DFS) and overall survival (OS) between these two groups. Results A total of 3761 patients were enrolled: 3313 in the HER2-neg group and 448 in the HER2-pos-T group. Patients in the HER2-pos-T group were associated with pre/peri-menopause, higher histological grade, LVI, higher Ki-67 level, lower ER and PR levels (all P <  0.05). At a median follow-up of 62 months, 443 DFS events and 191 deaths were observed. The estimated 5-year DFS rate was 89.7% in the HER2-neg group and 90.2% in the HER2-pos-T group (P = 0.185), respectively. Multivariable analysis demonstrated that patients in the HER2-pos-T group had a better DFS than patients in the HER2-neg group (HR 0.52, 95% CI: 0.37–0.73, P <  0.001). The estimated 5-year OS rates were 96.0% and 96.3% in the two groups, respectively (P = 0.133). Multivariate analysis found that HER2-pos-T group was still associated with significantly better OS compared with the HER2-neg group (HR 0.38, 95% CI: 0.22–0.67, P = 0.037). Conclusion ER+/HER2+ breast cancer patients treated with trastuzumab were associated with superior outcome compared with ER+/HER2- patients, indicating HER2-positivity itself may not be an adverse factor for ER+ patients in the era of trastuzumab.

scholarly journals A novel prognostic model for angioimmunoblastic T-cell lymphoma: A retrospective study of 55 cases

2021 ◽  
Vol 49 (5) ◽  
pp. 030006052110132
Author(s):  
Jie Sun ◽  
Sha He ◽  
Hong Cen ◽  
Da Zhou ◽  
Zhe Li ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
T Cell ◽  
Prognostic Model ◽  
Proportional Hazards Model ◽  
Cell Lymphoma ◽  
Initial Diagnosis ◽  
Cox Proportional Hazards Model ◽  
T Cell Lymphoma ◽  
Chinese Patients ◽  
Angioimmunoblastic T Cell Lymphoma

Objective To explore prognostic factors and develop an accurate prognostic prediction model for angioimmunoblastic T-cell lymphoma (AITL). Methods Clinical data from Chinese patients with newly diagnosed AITL were retrospectively analysed. Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan-Meier method survival curves; prognostic factors were determined using a Cox proportional hazards model. The sensitivity and specificity of the predicted survival rates were compared using area under the curve (AUC) of receiver operating characteristic (ROC) curves. Results The estimated 5-year OS and PFS of 55 eligible patients with AITL were 22% and 3%, respectively. Multivariate analysis showed that the presence of pneumonia, and serous cavity effusions at initial diagnosis were significant prognostic factors for OS. Based on AUC ROC values, our novel prognostic model was superior to IPI and PIT based models and suggested better diagnostic accuracy. Conclusions Our prognostic model based on pneumonia, and serous cavity effusions at initial diagnosis enabled a balanced classification of AITL patients into different risk groups.

scholarly journals Follicular lymphoma patients with a high FLIPI score and a high tumor burden: A risk stratification model

2015 ◽  
Vol 72 (1) ◽  
pp. 26-32 ◽  
Author(s):  
Bosko Andjelic ◽  
Milena Todorovic-Balint ◽  
Darko Antic ◽  
Jelena Bila ◽  
Vladislava Djurasinovic ◽  
...  
Keyword(s):  
Risk Factors ◽  
Overall Survival ◽  
Prognostic Factors ◽  
Follicular Lymphoma ◽  
Histological Grade ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Tumor Burden ◽  
Cox Regression Analysis ◽  
High Tumor Burden

Background/Aim. The widely accepted Follicular Lymphoma International Prognostic Index (FLIPI) divides patients into three risk groups based on the score of adverse prognostic factors. The estimated 5-year survival in patients with a high FLIPI score is around 50%. The aim of this study was to analyse the prognostic value of clinical and laboratory parameters that are not included in the FLIPI and the New Prognostic Index for Follicular Lymphoma developed by the International Follicular Lymphoma Prognostic Factor Project (FLIPI2) indices, in follicular lymphoma (FL) patients with a high FLIPI score and high tumor burden. Methods. The retrospective analysis included 57 newly diagnosed patients with FL, a high FLIPI score and a high tumor burden. All the patients were diagnosed and treated between April 2000 and June 2007 at the Clinic for Hematology, Clinical Center of Serbia, Belgrade. Results. The patients with a histological grade > 1, erythrocyte sedimentation rate (ESR) ? 45 mm/h and hypoalbuminemia had a significantly worse overall survival (p = 0.015; p = 0.001; p = 0.008, respectively), while there was a tendency toward worse overall survival in the patients with an Eastern Cooperative Oncology Group (ECOG) > 1 (p = 0.075). Multivariate Cox regression analysis identified a histological grade > 1, ESR ? 45 mm/h and hypoalbuminemia as independent risk factors for a poor outcome. Based on a cumulative score of unfavourable prognostic factors, patients who had 0 or 1 unfavourable factors had a significantly better 5-year overall survival compared to patients with 2 or 3 risk factors (75% vs 24.1%, p = 0.000). Conclusion. The obtained results suggest that from the examined prognostic parameters histological grade > 1, ESR ? 45 mm/h and hypoalbuminemia can contribute in defining patients who need more aggressive initial treatment approach, if two or three of these parameters are present on presentation.

scholarly journals Phase 2 trial of infusional cyclophosphamide, doxorubicin, and etoposide in patients with poor-prognosis, intermediate-grade non-Hodgkin lymphoma: an Eastern Cooperative Oncology Group trial (E3493)

Blood ◽  
2002 ◽  
Vol 100 (5) ◽  
pp. 1634-1640 ◽  
Author(s):  
Joseph A. Sparano ◽  
Edie Weller ◽  
Tipu Nazeer ◽  
Thomas Habermann ◽  
Ann E. Traynor ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
International Prognostic Index ◽  
Eastern Cooperative Oncology Group ◽  
Prognostic Index ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Intermediate Grade ◽  
Non Hodgkin Lymphoma

Preclinical and clinical evidence suggest a potential advantage for infusional therapy in lymphoma. Sixty-two analyzable patients with predominantly intermediate-grade non-Hodgkin lymphoma received cyclophosphamide (200 mg/m2 per day), doxorubicin (12.5 mg/m2 per day), and etoposide (60 mg/m2per day) (CDE) by continuous intravenous infusion for 4 days (96 hours) every 3 weeks for a maximum of 8 cycles. By the age-adjusted International Prognostic Index (IPI), 42% were at high risk and 58% were at high-intermediate risk. Complete response (CR) occurred in 30 (48%) patients (95% confidence interval [CI], 35%, 64%), and partial response occurred in 16 (26%) patients, yielding an overall response rate of 74% (95% CI, 62%, 84%). Failure-free survival (FFS) rates at 1 and 2 years were 55% (95% CI, 43%, 67%) and 50% (95% CI, 38%, 62%), respectively. When comparing the outcome for 62 patients receiving infusional CDE with historical data derived from 927 IPI-matched lymphoma patients using a Cox proportional hazards model, there was a nonsignificant trend favoring CDE in FFS (P = .12) and overall survival (P = .09). Severe or life-threatening toxicity included neutropenia (68%), anemia (57%), thrombocytopenia (44%), and infection (24%). Two patients (3%) died of treatment-related infectious complications. The primary end point of improving 1-year FFS from 55% to 70% was not achieved with infusional CDE given as initial therapy in patients with poor-risk intermediate-grade lymphoma. It is unlikely that infusional therapy as used in this study produces a 25% or greater relative improvement in FFS compared with standard therapy.

Relationship between taxane-induced neuropathy and clinical outcomes after adjuvant chemotherapy.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 270-270 ◽  
Author(s):  
B. P. Schneider ◽  
M. Wang ◽  
V. Stearns ◽  
S. Martino ◽  
V. E. Jones ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Disease Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Time Dependent ◽  
Individual Treatment ◽  
Axillary Lymph ◽  
Landmark Analysis

270 Background: Neuropathy is a common and potentially enduring and disabling complication of adjuvant taxane therapy. Recent studies have identified candidate host single nucleotide polymorphisms (SNPs) associated with taxane-induced neuropathy (Schneider et al. ASCO 2011, abstr. 1000). We therefore sought to determine whether neuropathy was associated with breast cancer recurrence. Methods: This study included 4,950 eligible women with axillary lymph node positive or high-risk node-negative breast cancer who received up to 4 cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) every 3 weeks, followed by either: (1) paclitaxel 175 mg/m2 every 3 weeks x 4 (P3), (2) paclitaxel 80 mg/m2 weekly x 12 (P1), (3) docetaxel 100 mg/m2 every 3 weeks x 4 (D3), or (4) docetaxel 35 mg/m2 weekly x 12 (D1). Chemotherapy doses were based on actual body weight. Cox proportional hazards model were used to determine the relationship between neuropathy and disease free survival (DFS) and overall survival (OS) treating neuropathy status as a time dependent covariate and using a landmark analysis. Results: Of 4,702 patients who received at least 1 taxane dose, grade 2-4 neuropathy developed in 20%, 27%, 16%, and 16% in the P3, P1, D3, and D1 arms, respectively. In a model including age, tumor size, nodal status, treatment arm, neuropathy, and the neuropathy- treatment interaction, there was no relationship between neuropathy and DFS and OS in the entire population, for any of the individual treatment arms, or for any breast cancer subtypes, whether analyzed as a time-dependent covariate or using a landmark analysis. Baseline covariates associated with an increase rate of neuropathy included black race (25% vs. 19% grade 2-4, p=0.02) and obesity (21% vs. 19%, p=0.04), but not age. Conclusions: There was no association between taxane-induced neuropathy and DFS or OS in patients treated with contemporary AC-taxane therapy, including weekly paclitaxel. These findings show that taxane-induced neuropathy is not associated with outcome, thus suggesting that validation of SNPs predictive of neuropathy may be useful in identifying patients at higher risk for neuropathy but not taxane benefit and thereby improve therapeutic individualization.

Clinical predictors of second-line chemotherapy (ChT) benefit in pancreatic cancer (PC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15733-e15733
Author(s):  
Ilya Pokataev ◽  
Igor Bazin ◽  
Mikhail Fedyanin ◽  
Alexey Tryakin ◽  
Anna Popova ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Disease Progression ◽  
Proportional Hazards Model ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Prognostic Significance ◽  
Cox Proportional Hazards Model ◽  
Second Line ◽  
Inclusion Criteria ◽  
Prognosis Score

e15733 Background: Second line ChT is shown to improve outcome in selected patients with PC; however there are no approved models predicting its benefit. This retrospective study was aimed to evaluate prognostic factors in patients with PC who had disease progression following 1st line ChT and their value in prediction of 2nd line ChT benefit. Methods: Records of PC patients treated in N.N. Blokhin Russian Cancer Research Center since 2000 to 2015 were analyzed. Inclusion criteria for this retrospective analysis were: morphologically confirmed PC, disease progression after 1st line ChT or adjuvant / induction ChT with ChT-free interval <6 months. The most common clinical factors were evaluated for prognostic significance in the Cox proportional hazards model with overall survival (OS) as the end-point. OS was calculated from the date of progression following previous ChT. Cutoff values for quantitative variables were determined using ROC curve analyses. Results: Records of 172 patients matched the inclusion criteria. Second line ChT was administered in 110 (64%) patients (47% of them received gemcitabine- and/or platinum-based doublets). The Cox multivariate analysis identified two independent prognostic factors: Karnofsky performance status (KPS) ≤70% and neutrophil-to-lymphocyte ratio (NLR) >5 at the time of disease progression after 1st line ChT (Table). Administration of 2nd line ChT improved outcome of patients with favorable prognosis (score ≤1): median OS increased from 1.7 to 5.5 months in groups without (n=23) and with (n=90) ChT, respectively (p=0.02). In patients with poor prognosis (score>1) there were no benefit by administration of 2nd line ChT: medians OS were 2.3 and 1.7 months in groups with (n=20) and without (n=39) ChT, respectively (p=0.23). Conclusions: This novel prognostic model can potentially predict 2nd line ChT benefit in patients with PC, however it needs to be validated in further trials. [Table: see text]

Coexpression of PDGFR-Alpha, PDGFR-Beta and VEGF as a Prognostic Factor in Patients with Hepatocellular Carcinoma

2011 ◽  
Vol 26 (2) ◽  
pp. 108-116 ◽  
Author(s):  
Li Chen ◽  
Yan Shi ◽  
Cheng-ying Jiang ◽  
Li-xin Wei ◽  
Ya-li Lv ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Growth Factor ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Prognostic Significance ◽  
Disease Free Survival ◽  
Hazard Ratio ◽  
Cox Proportional Hazards Model ◽  
Cox Regression Analysis

Aims To evaluate the prognostic value of vascular endothelial growth factor (VEGF), platelet-derived growth factor receptor-alpha (PDGFR-α) and beta (PDGFR-β) expression in patients with hepatocellular carcinoma (HCC). Methods The expression of PDGFR-α, PDGFR-β and VEGF in 63 HCC patients who underwent curative resection was examined by immunohistochemistry (IHC). The correlations between the expression of these biomarkers and the clinicopathological characteristics were analyzed. Patient survival was analyzed by univariate analysis and Cox proportional hazards model. Results Univariate survival analysis showed that PDGFR-α or PDGFR-β overexpression was of no prognostic significance in predicting disease-free survival (DFS) and overall survival (OS) (p>0.05), while VEGF overexpression and PDGFR-α/PDGFR-β/VEGF coexpression were significantly correlated with worse DFS and poorer OS in HCC patients (P<0.05). More importantly, PDGFR-α/PDGFR-β/VEGF coexpression was an independent prognostic marker for poor survival as indicated by multivariate Cox regression analysis (DFS, hazard ratio 3.122, p=0.001; OS, hazard ratio 4.260, p=0.000). Conclusions Coexpression of PDGFR-α, PDGFR-β and VEGF could be considered an independent prognostic biomarker for predicting DFS and OS in HCC patients. This result could be used to identify patients at a higher risk of tumor recurrence and poor prognosis, and help to select therapeutic schemes for the treatment of HCC.

scholarly journals Prognosis of Stage IIB early gastric cancer has a unique and dismal property putatively requiring post operative adjuvant chemothrapy

2017 ◽  
Author(s):  
Hideki Ushiku ◽  
Keishi Yamashita ◽  
Akira Ema ◽  
Natsuya Katada ◽  
Kei Hosoda ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Prognostic Factors ◽  
Lymph Node ◽  
Lymph Node Metastasis ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Cancer Prognosis ◽  
Node Metastasis ◽  
Dismal Prognosis

Abstract Background Pathological T1 (pT1) gastric cancer showed excellent prognosis, however lymph node metastasis sometimes reflects patients with dismal prognosis. In this study, we investigated prognosis of pT1 gastric cancer with lymph node metastasis to identify prognostic factors. Patients and Methods Among 1,442 gastric cancer patients between 2002 and 2010, 73 (5%) of pT1 with lymph node metastasis were identified. Univariate prognostic factors were applied to multivariate Cox proportional hazards model. Results (1) Among the 1,442 patients, pT1 was composed of 333 patients with pT1a and 423 patients with pT1b, which included 9 (2.7%) and 64 cases (15.1%) with lymph node metastasis, respectively. (2) Ten (13.7%) patients of the 73 patients with lymph node metastasis showed tumor relapse.　　Univariate negative prognostic factors were tumor size (p=0.03), intraoperative bleeding (p=0.03), and perioperative transfusion (POT)(p=0.001), as well as 14th JGCA Stage (p&lt;0.0001), and multivariate analysis identified 14th JGCA Stage (p=0.0004) and POT (p=0.03) as independent prognostic factors. (3) pT1 gastric cancer representing pN3 (Stage IIB) was rare (n=4) and unique entity from a prognostic point of view, exhibiting dismal prognosis (0% at 5 years). We thereafter identified 17 such cases from 5,204 gastric cancer including the earliest cases. Prognosis of such 17 patients was very unique, in that recurrences occurred even 5 years after curative operation, and the frequent recurrent sites were bone. Conclusion pT1 gastric cancer prognosis is robustly affected by pN3 and POT, and Stage IIB disease showed unique prognosis requiring special attention even after 5 years of operation.

Prognostic factors for overall survival with sunitinib as first-line therapy in patients with metastatic renal cell carcinoma (mRCC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5042-5042
Author(s):  
S. Patil ◽  
R. A. Figlin ◽  
T. E. Hutson ◽  
M. D. Michaelson ◽  
S. Négrier ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Type I ◽  
First Line

5042 Background: Sunitinib demonstrated superior progression-free survival (PFS; the primary endpoint) over interferon-alfa (IFN-α) as first-line mRCC therapy (NEJM 2007;356:115). Median overall survival (OS) with sunitinib compared to IFN-α was: 26.4 vs. 21.8 months (HR=0.821; P=0.051 by unstratified log-rank test; Proc ASCO 2008;26, May 20 suppl; abstr 5024). An analysis of prognostic factors for OS was performed on data from this trial. Methods: 750 treatment-naïve mRCC patients were randomized 1:1 to receive sunitinib or IFN-α. By Cox proportional hazards model, selected pretreatment variables were evaluated univariately and in a multivariate model for each treatment arm. Multivariate models for each treatment arm were based on a stepwise algorithm with a type I error of 0.25 for entry and 0.15 for elimination. Further elimination was applied to identify variables significant at P<0.05. Results: In multivariate analysis of sunitinib patients, factors associated with longer OS include: interval from diagnosis to treatment ≥1 yr, ECOG PS of 0, lower corrected calcium, absence of bone metastases, lower lactic dehydrogenase (LDH), and higher hemoglobin (Hgb) ( table ). For the IFN-α treatment arm, male gender, absence of bone or lymph node metastases, lower LDH, higher Hgb, lower corrected calcium, higher neutrophil count, and interval from diagnosis to treatment ≥1 yr were associated with longer OS. Conclusions: For patients in the sunitinib treatment arm, prognostic factors identified were similar to the factors previously identified in the MSKCC risk groups (J Clin Oncol 2002;20:289). Additional prognostic factors were identified for the IFN-α arm. Further studies are warranted to independently validate these findings as well as to identify tumor-specific prognostic factors. [Table: see text] [Table: see text]

Effect of metformin on recurrence-free survival and overall survival in diabetic patients affected by advanced ovarian cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5522-5522 ◽  
Author(s):  
Cecilia Simonelli ◽  
Monica Bertolotti ◽  
Paul Sabbatini ◽  
Jonathan S. Berek ◽  
Jacobus Pfisterer ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Prognostic Factors ◽  
Proportional Hazards Model ◽  
Advanced Ovarian Cancer ◽  
Cox Proportional Hazards Model ◽  
Diabetic Patients ◽  
Recurrence Free Survival ◽  
Double Blind ◽  
Free Survival

5522^ Background: Metformin, has recently shown some anti-cancer activities in ovarian cancer, both in vitro and in vivo. Methods: Analysis of Recurrence Free Survival (RFS) and Overall Survival (OS) was performed in patients (pts) with diabetes (D) treated with metformin (DMet+) or not (DMet-) enrolled in the MIMOSA trial, a randomized double-blind placebo-controlled international trial of Abagovomab maintenance therapy in 888 pts with advanced ovarian cancer. In the MIMOSA trial, no differences in the RFS and OS were observed between Abagovomab (n = 593) and Placebo arm (n = 295); hence, the present RFS and OS analysis (DMet+ vs DMet-) was run regardless of treatment allocation. A Cox proportional hazards model was used for adjusting the analysis for the predefined prognostic factors: Figo stage (III, IV), tumor size after debulking (residual tumor <1 cm, >1cm); CA125 serum level after 3th cycle (<35U/ml, >35U/ml). In addition, comparison of RFS and OS was done between DMet+and the overall MIMOSA population not exposed to metformin (ALLMet-), and between the overall diabetic pts (ALLD+) and non-diabetic pts (ALLD-). Results: In the ALL population (n = 888), 42 pts were affected by diabetes (ALLD+) divided to DMet+ (n = 27) and DMet- (n = 15), without difference in the prognostic factors distribution. When analysis was done in ALLD+, RFS median time was not reached in the DMet+ group whereas it was 328 days [CI: 30-660] in DMet- group with HR favoring DMet+=0.419 [CI:0.175-1.002]; p = 0.05. Median OS time was also not reached in the DMet+ group whereas it was 786 days [CI:262-NE] in DMet- group with HR=0.295 [CI:0.109-0.803]; p = 0.02. Interestingly HR for RFS time was still in favour of DMet+ group when compared to the ALLMet- (n=861) with HR=0.575 (CI=0.324-1.022); p = 0.06. When ALLD+ were compared with ALLD-(n = 846), no significant differences was detected in RFS and OS time. Conclusions: The present results are the first prospectively analyzed data demonstrating a favourable impact of metformin treatment on RFS and OS in pts affected by advanced ovarian cancer. Clinical trial information: NCT00418574.

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