Multivariable analysis for cancer screening, p-value and adjusted R

Objective: While the use of intraoperative laser angiography (SPY) is increasing in mastectomy patients, its impact in the operating room to change the type of reconstruction performed has not been well described. The purpose of this study is to investigate whether SPY angiography influences post-mastectomy reconstruction decisions and outcomes. Methods and materials: A retrospective analysis of mastectomy patients with reconstruction at a single institution was performed from 2015-2017.All patients underwent intraoperative SPY after mastectomy but prior to reconstruction. SPY results were defined as ‘good’, ‘questionable’, ‘bad’, or ‘had skin excised’. Complications within 60 days of surgery were compared between those whose SPY results did not change the type of reconstruction done versus those who did. Preoperative and intraoperative variables were entered into multivariable logistic regression models if significant at the univariate level. A p-value <0.05 was considered significant. Results: 267 mastectomies were identified, 42 underwent a change in the type of planned reconstruction due to intraoperative SPY results. Of the 42 breasts that underwent a change in reconstruction, 6 had a ‘good’ SPY result, 10 ‘questionable’, 25 ‘bad’, and 2 ‘had areas excised’ (p<0.01). After multivariable analysis, predictors of skin necrosis included patients with ‘questionable’ SPY results (p<0.01, OR: 8.1, 95%CI: 2.06 – 32.2) and smokers (p<0.01, OR:5.7, 95%CI: 1.5 – 21.2). Predictors of any complication included a change in reconstruction (p<0.05, OR:4.5, 95%CI: 1.4-14.9) and ‘questionable’ SPY result (p<0.01, OR: 4.4, 95%CI: 1.6-14.9). Conclusion: SPY angiography results strongly influence intraoperative surgical decisions regarding the type of reconstruction performed. Patients most at risk for flap necrosis and complication post-mastectomy are those with questionable SPY results.

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Association Between Awareness of Informal Caregivers and Falls in Elderly Patients with Uncontrolled Diabetes Mellitus

The Open Public Health Journal ◽

10.2174/1874944502013010658 ◽

2020 ◽

Vol 13 (1) ◽

pp. 658-666

Author(s):

Tossapon Chamnankit ◽

Parichat Ong-artborirak ◽

Jukkrit Wangrath

Keyword(s):

Diabetes Mellitus ◽

Elderly Patients ◽

Elderly People ◽

Informal Caregivers ◽

Multivariable Analysis ◽

P Value ◽

Uncontrolled Diabetes ◽

Risk Of Falls ◽

The Mean ◽

Falls In Elderly

Background: Elderly people with uncontrolled diabetes mellitus (DM) are at risk of falls, which can lead to injury and disability. Not much is known of informal caregivers’ awareness of falls in elderly patients with DM. Objective: This study aims to identify an association between caregiver’s awareness and falls in elderly patients with DM. Methods: A total of 136 pairs of DM patients and their respective family caregivers were recruited from a clinical service center at Chiang Mai University, Thailand. The questionnaire regarding the caregiver’s awareness of the risk of falls in elderly patients was given via a face-to-face interview. Each elderly patient was asked about their history of falls in the prior year, and the risk of falls was assessed by Time Up & Go (TUG) test. Logistic regression analysis was performed to determine association. Results: The mean age of the DM patients was 65.7 years. Sixty-two patients (45.6%) had fallen at least once in the prior year. The mean TUG test result was 12.67±1.83 second. Most caregivers demonstrated a high level of awareness regarding the risk of falls in elderly patients. The results of the multivariable analysis showed that three variables – balance problems, risk of falls assessed by TUG test, and scores of caregiver’s awareness of risk of falls – were significantly related to falls in the previous year among elderly patients with DM (p-value<0.05). Conclusion: The caregivers’ awareness of fall risk may influence fall occurrence among older adults with DM. An intervention program to improve awareness among informal caregivers should be considered for fall prevention in elderly people.

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Prostate cancer screening: A survey of medical students’ knowledge in Lome, Togo, and associated determinants in a resource-limited African context

SAGE Open Medicine ◽

10.1177/20503121211032812 ◽

2021 ◽

Vol 9 ◽

pp. 205031212110328

Author(s):

Tchin Darré ◽

Toukilnan Djiwa ◽

Tchilabalo Matchonna Kpatcha ◽

Albadia Sidibé ◽

Edoé Sewa ◽

...

Keyword(s):

Prostate Cancer ◽

Cancer Screening ◽

Medical Students ◽

Confidence Interval ◽

Prostate Cancer Screening ◽

Specific Antigen ◽

Digital Rectal Examination ◽

P Value ◽

Theoretical Knowledge ◽

Practical Level

Objectives: The aims of this study were to assess the knowledge of medical students in Lomé about these means of screening for prostate cancer in a context of limited resources and controversy about prostate cancer screening, and to identify the determinants associated with these results. Methods: This was a prospective descriptive and cross-sectional study conducted in the form of a survey of medical students regularly enrolled at the Faculty of Health Sciences of the University of Lomé for the 2019–2020 academic years. Results: Of the 1635 eligible students, 1017 correctly completed the form, corresponding to a rate of 62.20%. The average age was 22 ± 3.35 years. The sex ratio (M/F) was 2.5. Undergraduate students were the most represented (53.69%). Students who had not received any training on prostate cancer were the most represented (57.13%). Only 12.88% of the students had completed a training course in urology. Concerning the prostate-specific antigen blood test, there was a statistically significant relationship between the students’ knowledge and some of their socio-demographic characteristics, namely age (p value = 0.0037; 95% confidence interval (0.50–1.77)); gender (p value = 0.0034; 95% confidence interval (1.43–2.38)); study cycle (p value ˂ 0.0001; 95% confidence interval (0.56–5.13)) and whether or not they had completed a placement in a urology department (p value ˂ 0.0001; 95% confidence interval (0.49–1.55)). On the contrary, there was no statistically significant relationship between students’ knowledge of the digital rectal examination and their study cycle (p value = 0.082; 95% confidence interval (0.18–3.44)). Conclusion: Medical students in Lomé have a good theoretical knowledge and a fair practical level of the digital rectal examination clinical examination and an average theoretical knowledge and a below average practical level of prostate-specific antigen, increasing however along the curriculum in the context of prostate cancer screening.

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Cervical Cancer: Assessment of Its Knowledge, Utilization of Services and Its Determinant Among Female Undergraduate Students in a Low Resource Setting

International Quarterly of Community Health Education ◽

10.1177/0272684x211006608 ◽

2021 ◽

pp. 0272684X2110066

Author(s):

Chidebe Christian Anikwe ◽

Philip Chidubem Osuagwu ◽

Cyril Chijioke Ikeoha ◽

Okechukwu B Ikechukwu Dimejesi ◽

Bartholomew Chukwunonye Okorochukwu

Keyword(s):

Cervical Cancer ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Pap Smear ◽

Health Workers ◽

P Value ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Resource Setting ◽

Study Population

Background Cervical cancer is a preventable disease that contributes significantly to the death of women. This study is aimed at determining the level of knowledge and utilization of cervical cancer screening and its determinants among female undergraduates of Ebonyi State University. Methods A structured questionnaire was used for a cross-sectional survey of the study population between January 1 and March 3, 2018. The data were analyzed using IBM SPSS Statistics version 20. Data were represented with frequency table, simple percentage, mode, range, Chi square and pie chart. The level of significance is at P-value < 0.05. Results Majority (74.8%) of the respondents were aware of cervical cancer and it could be prevented (70.8%). More than three-fifths (68.30%) were informed via health workers, and 86.8% were aware that post-coital vaginal bleeding is a symptom. Less than half (49.8%) knew that HPV is the primary cause, and only 32.9% were aware of the HPV vaccine. One-quarter of the respondent were aware that early coitarche is a risk factor for cervical cancer. Only 41.8% of the women were aware of Pap smear, 9.2% had undergone screening, and 97.6% were willing to be screened. Marital status was the significant determinant of being screened while class level did not significantly influence uptake of cervical cancer screening. The most common reason (20.6%) for not being screened was lack of awareness of the test. Conclusion Our study population had a good knowledge of cervical cancer, but utilization of cervical cancer screening was poor. Awareness creation through the mass media and provision of affordable screening services can promote the use of cervical cancer screening in the study area.

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Effect of an Information Leaflet on Breast Cancer Screening Participation. A Randomized Controlled Study

10.21203/rs.3.rs-200108/v1 ◽

2021 ◽

Author(s):

Jose Maria Montero-Moraga ◽

Margarita Posso ◽

Marta Román ◽

Andrea Burón ◽

Maria Sala ◽

...

Keyword(s):

Breast Cancer ◽

Socioeconomic Status ◽

Cancer Screening ◽

Breast Cancer Screening ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

P Value ◽

Information Leaflet ◽

Lower Socioeconomic

Abstract Objective: To evaluate the impact of an information leaflet about the risk-benefit balance of breast cancer screening on women’s participation.Methods: This randomized controlled study was conducted within a population-based breast cancer screening program and included women from the catchment areas of two hospitals in Barcelona, Spain. We evaluated women aged 50-69 years invited to screening between September 2019 and January 2020. One hospital attended a population with a lower socioeconomic status than the other. The intervention group received an information leaflet on the benefits and harms of mammography screening. The control group received the usual invitation letter. We compared the participation rate between groups, stratified by hospital and by per-protocol and intention-to-treat analyses. Results: We included 11,119 women in the study: 5,416 in the intervention group and 5,703 in the control group. A total of 36.4% (1,964/5,393) of the women in the intervention group and 37.5% (2,135/5,694) of those in the control group attended screening, respectively. Overall, we found no differences in participation among groups (difference in participation -1.1%; 95% CI; -2.9% to 0.7%, p-value=0.240). In the hospital attending a population with a low socioeconomic status, attendance was lower in the intervention group (-1.4%, 95% CI: -5.7% to -0.03%, p-value=0.029). In the per-protocol analysis, participation was lower in the intervention group (-2.6%, 95% CI: -4.6% to -0.5%, p-value=0.015). Conclusions: Overall participation in our program was unaffected by a new information leaflet on the risk-benefit balance of breast cancer screening. However, participation was lower in certain populations with lower socioeconomic status.

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Medication Adherence and Associated Factors among Chronic Heart Failure Clients on Follow Up Oromia Region, West Ethiopia

Cardiovascular & Hematological Agents in Medicinal Chemistry ◽

10.2174/1871525717666191019162254 ◽

2019 ◽

Vol 17 (2) ◽

pp. 104-114

Author(s):

Getahun Fetensa ◽

Birhanu Yadecha ◽

Tadesse Tolossa ◽

Tariku Tesfaye Bekuma

Keyword(s):

Heart Failure ◽

Medication Adherence ◽

Chronic Heart Failure ◽

Health Education ◽

Study Design ◽

Associated Factors ◽

Multivariable Analysis ◽

Self Care ◽

P Value

Background: Chronic heart failure is a complex clinical syndrome with typical symptoms that can occur at rest or on effort. It requires patients to manage their lifestyle with their disease and when to notify their healthcare provider. The study was aimed to identify medication adherence and associated factors among chronic heart failure clients on follow up Oromia region, West Ethiopia, 2017. Methods: Institutional based cross-sectional study design was employed, after selecting three hospitals by lottery method and allocating respondents to the three hospitals proportionally. A total of 424 patients were admitted to the medical ward and/or chronic follow up of Nekemte referral, Gimbi, and Shambu hospitals. The data was collected using a structured questionnaire. The data was entered into Epi-data version 3.1, cleared, explored, and then exported to SPSS windows version 24.0 for further analysis. Variable having a p-value less than 0.05 in the bivariate analysis was a candidate for multivariable analysis and the effect of confounding variables was observed. Variables having a p-value less than 0.05 in the multivariable analysis were assumed significant. Results: A total of 424 respondents were included in the final analysis giving a 95.3% response rate. The result indicated that more than half of the study participants have adhered to prescribed medication. Respondents with good medication adherence were more likely to adhere to good self-care behavior [AOR (95% CI of OR) = 3.5(2.044, 5.96)]. Respondents whose limited fluid intake was one or half-liter per day were more likely to adhere to the medication [AOR (95% CI of OR) = 2.5(1.43, 4.49)]. It was also found that those patients who avoided spices, sauces and others in food are more likely to adhere to the medication [AOR (95% CI of OR) = 2.2 (1.152, 4.039)]. Conclusion and Recommendation: Even if more than half of the study respondents have good medication and self-care adherence, still it needs great attention in health education over their visit. Health institutions are strongly recommended to give health education for clients and researchers to use advanced study design for measuring medication adherence and self-care behaviors.

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P4591Impact of extent of non-culprit lesions on one-year outcomes in patients with acute myocardial infarction

European Heart Journal ◽

10.1093/eurheartj/ehz745.0976 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

T Tanaka ◽

H Akahori ◽

T Imanaka ◽

K Miki ◽

N Yoshihara ◽

...

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Multivariable Analysis ◽

P Value ◽

Gensini Score ◽

Culprit Lesion ◽

Vessel Disease ◽

Coronary Bypass Grafts ◽

Multivariable Analyses ◽

One Year

Abstract Background Presence of severe stenosis in non-infarct related arteries, i.e. multi-vessel disease (MVD), is associated with poor outcomes after acute myocardial infarction (AMI). However, impact of mild to moderate stenosis in non-culprit lesions remains unclear.Gensini score is an angiographic application grading the extent of coronary artery lesions including mild to moderate stenosis. Purpose To evaluate whether the extent of non-culprit lesion is related to one-year outcomes after AMI. Methods This study consisted of consecutive 168 patients who underwent primary percutaneous coronary intervention (PPCI) for AMI between 2015 and 2017. Patients with coronary bypass grafts were excluded from the analysis. To assess the extent of non-culprit lesions, we used “non-culprit Gensini score”, which is calculated by excluding score of the culprit lesion from the original Gensini score. Patients were divided into 2 groups by the median ofnon-culprit Gensini score: low score (0–14, n=84) and high score (>15, n=84). Major adverse cardiac events (MACE) included all cause of deaths, non-fatal MI, stroke and ischemia driven coronary revascularization during one-year follow-up period. Results MVDwas more frequent in patients with high score than those in those with low score (90% vs 25%, P<0.05). Kaplan-Mayer curves of patients with and without MVD are shown in left figure, and curves of patients with low score and those with high score are shown in right figure. Multivariable analysis showed that high score was an independent predictor of one-year MACE (HR 5.28, 95% CI 1.93–14.9, P<0.05), but MVD was not (HR 0.56, 95% CI 0.23–1.54, P=0.25) (Table). Multivariable analyses Univariable analyses Multivariable analyses HR (95% CI) P-value HR (95% CI) P-value Age 1.03 (1.01, 1.06) <0.05 1.15 (0.99, 1.05) 0.31 eGFR (<45ml/min/1.73m2) 2.95 (1.59, 5.38) <0.05 2.35 (1.26, 4.35) <0.05 Multi-vessel disease 1.84 (1.01, 3.55) <0.05 0.56 (0.23, 1.54) 0.25 Non-culprit-Gensini score (>15) 3.37 (1.79, 6.78) <0.05 5.28 (1.93, 14.9) <0.05 HR = hazard ratio; CI = confidence interval; eGFR = estimated glomerular filtration rate. Kaplan-Meier curves Conclusion These findings suggested that extent of mild to moderate stenosis in non-culprit lesions might affect the prognosis after AMI in patients undergoing PPCI. Non-culprit Gensini score may be useful to predict outcomes of patients with AMI. Acknowledgement/Funding None

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Intended Pregnancy as a Predictor of Good Knowledge on Birth Preparedness and Complication Readiness: the Case of Northern Ethiopia Pregnant Mothers

International Journal of Reproductive Medicine ◽

10.1155/2019/9653526 ◽

2019 ◽

Vol 2019 ◽

pp. 1-10

Author(s):

Haile Zewdu Tsegaw ◽

Endeshaw Admassu Cherkos ◽

Marta Berta Badi ◽

Muhabaw Shumye Mihret

Keyword(s):

Antenatal Care ◽

Pregnant Women ◽

Multivariable Analysis ◽

Good Knowledge ◽

P Value ◽

Northern Ethiopia ◽

Birth Preparedness ◽

Multivariable Logistic Regression Model ◽

Cross Sectional ◽

Complication Readiness

Background. Maternal mortality remains unacceptably high in developing countries. One key strategy to reduce such mortality is utilization of birth preparedness and complication readiness (BP/CR) and creating awareness of BP/CR is an important step for pregnant women, their families, and the community. However, there was limited to no evidence regarding the community’s awareness on BP/CR in the study area. Therefore, this study aimed to assess knowledge on BP/CR and associated factors among pregnant women in Debremarkos town, Northwest Ethiopia, 2017. Methods. A Community based cross-sectional study was conducted from July 1 to 30/2017. A total of 441 pregnant women were included in the study. Structured and pretested questionnaire was administered through face to face interview to collect the data. Simple random sampling technique was used to select the study participants. The data were entered in to Epinfo version 7.0 and then exported to SPSS version 20.0 for analysis. Both bivariate and multivariable logistic regression model were fitted. Crude and adjusted odds ratio with 95 % confidence interval have been computed and variables with p-value < 0.05 were considered statistically significance. Results. The proportion of pregnant women having good knowledge on birth preparedness and complication readiness was found to be 45.2 with 95%CI (40.4, 50.0). In the multivariable analysis, having history of childbirth (AOR=2.17;95%CI:1.18,4.00), having intended pregnancy (AOR=2.13;95%CI: 1.16, 3.90), being governmental employee ( AOR=6.50; 95%CI: 2.50, 16.87), and having Antenatal care visits (AOR=5.50; 95%CI:2.2,13.70) were factors which were independently and significantly associated with good knowledge on birth preparedness and complication readiness. Conclusion. Proportion of pregnant women having good knowledge on birth preparedness and complication readiness was low. Putting emphasis on intended pregnancy and antenatal care visit was recommended.

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Conditioning Intensity in Allogeneic Hematopoietic Cell Transplantation (alloHCT) for Diffuse Large B-Cell Lymphoma (DLBCL)

Blood ◽

10.1182/blood.v118.21.501.501 ◽

2011 ◽

Vol 118 (21) ◽

pp. 501-501 ◽

Cited By ~ 1

Author(s):

Ulrike Bacher ◽

Evgeny Klyuchnikov ◽

Jeanette Carreras ◽

Jennifer Le-Rademacher ◽

Ginna G. Laport ◽

...

Keyword(s):

Hematopoietic Cell Transplantation ◽

Chronic Gvhd ◽

Multivariable Analysis ◽

B Cell Lymphoma ◽

Marrow Transplant ◽

P Value ◽

Unrelated Donor ◽

Resistant Disease ◽

Conditioning Regimens ◽

Conditioning Intensity

Abstract Abstract 501 Non-myeloablative (NMC) and reduced intensity (RIC) conditioning approaches rely primarily on a graft-vs-lymphoma (GVL) effect and aim at reducing transplant-related mortality (TRM) associated with myeloablative conditioning (MAC). We analyzed outcomes for 396 adults (228 male) receiving alloHCT for DLBCL following MAC (n=165), RIC (n=143) or NMC (n=88) regimens between 2000 and 2009 and reported to the Center for International Blood and Marrow Transplant Research (CIBMTR). Conditioning regimens were classified using consensus criteria. Engraftment, cumulative incidences of acute and chronic graft-vs-host disease (GvHD), TRM, progression and probabilities of progression-free (PFS) and overall survival (OS) were compared between MAC and NMC/RIC. Common MAC regimens were cyclophosphamide (CY) + total body irradiation (TBI) (54%) and busulfan (BU) + CY (23%). Common RIC regimens were fludarabine (Flu) with melphalan (44%) or BU (39%) and for NMC, Flu with CY (48%) and low dose TBI (33%). Practice patterns changed with declining use of MAC regimens after 2003 (> 66% of total being MAC pre-2003 and <33% after). Donors were HLA matched siblings in 40%, 26%, 30% of MAC, RIC and NMC recipients, respectively, with 67% overall receiving unrelated donor (URD) grafts. Significant (p <0.05) baseline differences between the cohorts included: RIC and NMC recipients were older (54% and 58% >50 yrs vs 39% for MAC), more likely to have received prior autoHCT (36% and 51% vs 18%), prior radiation and more prior chemotherapy regimens (55 and 70% vs 44% with >3 regimens) than those with MAC. Recipients of RIC and NMC were less likely to have chemotherapy resistant disease (30% and 26% vs. 42% for MAC); and had a longer median interval from diagnosis to alloHCT (median 27 and 36 mo vs. 17 mo). Day 100 engraftment was more frequent in RIC and NMC recipients (99% and 97% with ANC >500/cu.mm vs. 88% for MAC, p <0.001). Acute (43–44%) and chronic GvHD incidence (37–42% at 5 years) was similar across the groups. Outcomes are summarized in Table 1. TRM at day +100 and at 5 years was significantly higher for MAC compared with RIC and NMC groups (See Table 1). Lymphoma relapse/progression at 5 years was significantly lower for MAC vs. RIC and NMC but 5 year PFS and OS at 5-years did not differ significantly. In multivariable analysis, NMC (HR 0.58, p=0.026) and later year of alloHCT (HR 0.49, p<0.001) were associated with lower TRM while Karnofsky status <90 (HR 1.51, p=0.011), chemo-resistant relapse (HR 2.79, p<0.001) and URD (HR 2.32, p<0.001) were associated with higher TRM. Higher incidence of relapse/progression was associated with NMC (HR 2.14, p=0.003), non-receipt of rituximab prior to alloHCT (HR 1.69, p=0.008) and chemo-resistant disease (HR 2.06, p=0.006). Conditioning intensity did not impact OS and PFS. In selected patients with advanced DLBCL, allogeneic HCT can induce long-term PFS irrespective of the intensity of conditioning with a lower incidence of TRM with RIC and NMC regimens. Due to increased toxicity, the use of MAC regimens has been declining in recent years. However, the incidence of RIC/NMC, risk of relapse/progression was concordantly higher in the RIC/NMC recipients so that survival did not differ significantly between conditioning regimens. Further studies are needed to clarify optimal conditioning strategies for advanced DLBCL aiming to further reduce TRM. Table 1: Parameter Intensity of Conditioning (95% CI) p-value MAC RIC NMC TRM @day +100 at 5 yrs 32% (25–39%) 24% (17–31%) 17% (10–26%) 0.029 56% (48–64%) 47% (38–56%) 36% (26–46%) 0.007 Relapse @ 5 yrs 26% (19–33%) 38% (30–46%) 40% (30–50%) 0.031 OS @ 5 yrs 18% (12–25%) 20% (13–29%) 26% (17–36%) 0.365 PFS @ 5 yrs 18% (12–24%) 15% (9–23%) 25% (16–34%) 0.309 Disclosures: Montoto: Genentech: Research Funding; Roche: Honoraria.

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Carboplatin (C) plus paclitaxel (P) versus carboplatin plus pegylated liposomal doxorubicin (PLD) in patients with advanced ovarian cancer (AOC): Final analysis of the MITO-2 randomized multicenter trial.

Journal of Clinical Oncology ◽

10.1200/jco.2010.28.18_suppl.lba5033 ◽

2010 ◽

Vol 28 (18_suppl) ◽

pp. LBA5033-LBA5033 ◽

Cited By ~ 5

Author(s):

S. Pignata ◽

G. Scambia ◽

A. Savarese ◽

R. Sorio ◽

E. Breda ◽

...

Keyword(s):

Ovarian Cancer ◽

Response Rate ◽

Multivariable Analysis ◽

Advanced Ovarian Cancer ◽

Final Analysis ◽

Phase Iii ◽

P Value ◽

First Line ◽

Significant Difference ◽

Line Chemotherapy

LBA5033 Background: CP is standard first-line chemotherapy for AOC. MITO-2 (Multicentre Italian Trials in Ovarian Cancer) is an academic multicenter randomized phase III study, testing whether C-PLD is more effective than CP. Methods: AOC chemo-naïve patients (pts), stage IC-IV, aged≤75, ECOG PS≤2, were randomized to CP (C AUC5 + P 175 mg/m2,d1q3w) or to C-PLD (C AUC5 + PLD 30 mg/m2,d1q3w), both for 6 cycles. Primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), response rate, toxicity and quality of life (QoL). To have 80% power in detecting a 0.80 HR in PFS, with 2-sided α error 0.05, 632 events were needed and 820 pts were planned. Response rate and toxicity have been reported at ASCO 2009 (abs #LBA5508). All analyses are based on intention to treat. Results: From Jan ’03 to Nov ’07, 820 pts were randomized, 410 to each arm. Median age was 57 yrs (range 21-77). Stage III (60%) and IV (21%) were prevalent. A plateau in PFS events was reached before obtaining the planned number. Thus, following an IDMC recommendation, the final analysis was done with 556 events occurred as of December 31, 2009. This size is consistent with HR to be detected equal to 0.79, with 80% power. With a median follow-up of 40.2 months, median PFS was 19.0 and 16.8 months with C-PLD and CP, respectively (HR 0.95, 95%CI 0.81-1.13, log-rank p value=0.58). Lack of significant difference was confirmed (HR 0.96, 95%CI 0.81-1.14) at multivariable analysis adjusted by stage, PS, residual disease, age and size of the institution. There was no heterogeneity of treatment effect among major subgroups. With 313 deaths recorded, median OS was 61.6 and 53.2 months with C-PLD and CP, respectively (HR 0.89, 95%CI 0.72-1.12, log-rank p value=0.32). QoL data will be presented at the meeting. Conclusions: In the MITO-2 trial, C-PLD was not found to be superior to CP, which remains the standard first-line chemotherapy for AOC.However, given the observed confidence interval and the different toxicity profile, C-PLD could be considered an alternative to standard therapy. Study was partially supported by Schering-Plough. [Table: see text]

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