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author:("jaafar, gabab")
1.  Patient-mediated factors predicting early- and late-stage presentation of breast cancer in Egypt 
Psycho-oncology  2011;20(5):532-537.
Breast cancer fatality rates are high in low- and middle-income countries because of the late stage at diagnosis. We investigated patient-mediated determinants for late-stage presentation of breast cancer in Egypt.
A case–case comparison was performed for 343 women with breast cancer, comparing those who had been initially diagnosed at Stage I or II with those diagnosed at Stage III or IV. Patients were recruited from the National Cancer Institute of Cairo University and Tanta Cancer Center in the Nile delta. Patients were either newly diagnosed or diagnosed within the year preceding the study. Interviews elicited information on disease history and diagnosis, beliefs and attitudes toward screening practices, distance to treatment facility, education, income, and reproductive history.
Forty-six per cent of the patients had presented at late stage. Women seen in Cairo were more likely to present at late stages than patients in Tanta (OR = 5.05; 95% CI = 1.30, 19.70). Women without any pain were more likely to present at later stage (OR = 2.68; 95% CI = 1.18, 6.08). Knowledge of breast self-examination increased the likelihood of women to present in early stages significantly (OR = 0.24; 95% CI = 0.06, 0.94).
Despite increasing numbers of cancer centers in Egypt during the past 20 years, additional regional facilities are needed for cancer management. In addition, increasing awareness about breast cancer will have significant long-term impact on breast cancer prevention.
PMCID: PMC4511958  PMID: 21456061
patient factors; late stage; breast cancer; oncology; Egypt; global health
2.  Magnitude of the Benefit of Progression-Free Survival as a Potential Surrogate Marker in Phase 3 Trials Assessing Targeted Agents in Molecularly Selected Patients with Advanced Non-Small Cell Lung Cancer: Systematic Review 
PLoS ONE  2015;10(3):e0121211.
In evaluation of the clinical benefit of a new targeted agent in a phase 3 trial enrolling molecularly selected patients with advanced non-small cell lung cancer (NSCLC), overall survival (OS) as an endpoint seems to be of limited use because of a high level of treatment crossover for ethical reasons. A more efficient and useful indicator for assessing efficacy is needed.
Methods and Findings
We identified 18 phase 3 trials in the literature investigating EGFR-tyrosine kinase inhibitor (TKIs) or ALK-TKIs, now approved for use to treat NSCLC, compared with standard cytotoxic chemotherapy (eight trials were performed in molecularly selected patients and ten using an “all-comer” design). Receiver operating characteristic analysis was used to identify the best threshold by which to divide the groups. Although trials enrolling molecularly selected patients and all-comer trials had similar OS-hazard ratios (OS-HRs) (0.99 vs. 1.04), the former exhibited greater progression-free survival-hazard ratios (PFS-HR) (mean, 0.40 vs. 1.01; P<0.01). A PFS-HR of 0.60 successfully distinguished between the two types of trials (sensitivity 100%, specificity 100%). The odds ratio for overall response was higher in trials with molecularly selected patients than in all-comer trials (mean: 6.10 vs. 1.64; P<0.01). An odds ratio of 3.40 for response afforded a sensitivity of 88% and a specificity of 90%.
The notably enhanced PFS benefit was quite specific to trials with molecularly selected patients. A PFS-HR cutoff of ∼0.6 may help detect clinical benefit of molecular targeted agents in which OS is of limited use, although desired threshold might differ in an individual trial.
PMCID: PMC4361736  PMID: 25775395
3.  Mistletoe preparation (Viscum Fraxini-2) as palliative treatment for malignant pleural effusion: a feasibility study with comparison to bleomycin 
ecancermedicalscience  2014;8:424.
Malignant pleural effusion is a common problem in patients with solid tumours. It has a significant impact on quality of life, and, hence, there is a substantial need to investigate new agents to treat it.
Patients and methods
This is a prospective randomised controlled study, including patients with symptomatic recurrent malignant pleural effusion of different primaries. Patients were randomised into two groups: the first group received five ampoules of mistletoe preparation with defined lectin content (Viscum Fraxini-2, ATOS Pharma) diluted in 10 cc glucose 5% solution. Re-instillation was repeated every week until complete dryness of the pleural fluid was achieved (the maximum duration of the therapy was eight weeks). The second group received 60 units of bleomycin once intrapleurally.
The primary aim of this paper was to evaluate the efficacy of mistletoe preparation as a palliative treatment for malignant pleural effusions in comparison with bleomycin. The secondary aim was to evaluate the tolerability of the mistletoe preparation.
A total of 23 patients were included and followed up during the study from December 2007 to January 2012: 13 patients received mistletoe preparation, and ten patients received bleomycin. Overall clinical response was reported in 61.5% of the mistletoe preparation arm versus 30% in bleomycin arm (p = 0.2138), 95% CI = (–0.1203, 0.6325). The toxicity of both arms was mild and manageable; the mistletoe preparation arm included fever, chills, headache, malaise, and, in two cases, allergic reaction, which was controlled by discontinuation of the drug and steroid injection.
Mistletoe preparation is an efficient and well tolerated sclerosant agent which needs further investigation.
PMCID: PMC4004388  PMID: 24834119
mistletoe preparation; pleural effusion
4.  Plasma vascular endothelial growth factor 165 in advanced non-small cell lung cancer 
Oncology Letters  2014;7(6):2121-2129.
Currently, there is no serum marker that is routinely recommended for lung cancer. Therefore, the aim of the present study was to demonstrate that plasma vascular endothelial growth factor 165 (VEGF 165) may be a potential marker for advanced lung cancer. Lung cancer is the leading cause of cancer-related mortality worldwide, therefore, it is important to develop novel diagnostic techniques. The present prospective case control study included two groups of patients; a control group of healthy volunteers and a second group of patients with advanced non-small cell lung cancer (NSCLC). The plasma VEGF 165 levels were measured at baseline by ELISA prior to the first-line gemcitabine-cisplatin regimen. The high VEGF 165 expression level cut-off was >703 pg/ml, and the primary endpoint was used to compare the plasma VEGF 165 levels between the NSCLC patients and the control group subjects. The secondary endpoint was used to identify the correlations between high VEGF 165 levels and; clinical response (CR), progression-free survival (PFS) and overall survival (OS) in the advanced NSCLC patients. In total, patients with advanced NSCLC (n=35) were compared with a control group of age- and gender-matched healthy subjects (n=34). The follow-up period was between Oct 2009 and Oct 2012, with a median follow-up time of 10.5 months. The median plasma VEGF 165 level was 707 pg/ml in the NSCLC patients versus 48 pg/ml in the healthy control subjects (P<0.001). However, no significant correlation was found between the plasma VEGF 165 levels and CR (P<0.5), median PFS (P=1.00) or OS (P=0.70). Therefore, it was concluded that plasma VEGF 165 may serve as a potential diagnostic marker for advanced NSCLC.
PMCID: PMC4049695  PMID: 24932301
vascular endothelial growth factor; non-small cell lung cancer
5.  A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer 
BMC Cancer  2012;12:423.
Maintenance therapy for non-small cell lung cancer (NSCLC) aims to extend disease control after first-line chemotherapy with active and well-tolerated agents. The utility of continuation maintenance therapy requires further research.
This multicenter, randomized, phase 2 study compared continuation maintenance therapy with pemetrexed (500 mg/m2 every 21 days) and best supportive care (BSC) versus BSC alone in patients with advanced, non-squamous NSCLC who had not progressed after 4 cycles of induction chemotherapy with pemetrexed (500 mg/m2) and cisplatin (75 mg/m2). The primary endpoint was progression-free survival (PFS) from randomization, was analyzed using a Cox model, stratified for the tumor response at the end of induction therapy, at a one-sided alpha of 0.2. Secondary endpoints: response and disease control rates, overall survival (OS), one year survival rates, and treatment-emergent adverse events (TEAEs).
A total of 106 patients commenced induction therapy, of whom 55 patients were randomized to maintenance pemetrexed/BSC (n = 28) or BSC (n = 27). Although the median PFS time for maintenance phase for both arms was 3.2 months, the one-sided p-value for the PFS HR comparison was less than the prespecified limit of 0.2 (HR = 0.76, two-sided 95% confidence interval [CI]: 0.42 to 1.37; one-sided p-value = 0.1815), indicating that PFS was sufficiently long in the pemetrexed/BSC arm to warrant further investigation. Similar PFS results were observed for the overall study period (induction plus maintenance) and when the PFS analysis was adjusted for sex, baseline disease stage, and the ECOG PS prior to randomization. The median OS for the maintenance phase was 12.2 months (95%CI: 5.6 to 20.6) for the pemetrexed/BSC arm and 11.8 months (95% CI: 6.3 to 25.6) for BSC arm. The one-year survival probabilities were similar for both arms for the maintenance phase and the overall study period. Both the induction and continuation maintenance therapies were generally well-tolerated, and similar proportion of patients in each arm experienced at least 1 grade 3/4 TEAE (pemetrexed/BSC, 17.9%; BSC, 18.5%).
Continuation pemetrexed maintenance therapy resulted in promising PFS with an acceptable safety profile in a Middle Eastern population with advanced non-squamous NSCLC and is worthy of further investigation.
Trial registration
PMCID: PMC3477017  PMID: 23006447
Non-squamous; Non-small cell lung cancer; Pemetrexed; Cisplatin; Induction; Maintenance

Results 1-5 (5)