A phase II open-label randomized study to assess the efficacy and safety of selumetinib (AZD6244 [ARRY-142886]) versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line gemcitabine therapy
Bodoky G.,St Laszlo Hospital |
Timcheva C.,National Oncology Center |
Spigel D.R.,Sarah Cannon Research Institute |
La Stella P.J.,St Joseph Mercy Hospital Cancer Care Center |
And 2 more authors.
Investigational New Drugs | Year: 2012
Selumetinib is a potent, selective MEK inhibitor with efficacy in several tumor models. This study compared selumetinib with capecitabine in patients with advanced or metastatic pancreatic cancer who had been pretreated with a gemcitabine-based regimen. In this randomized, multicenter phase II study (NCT00372944), patients received either 100 mg oral selumetinib twice daily or 1,250 mg/m2 oral capecitabine twice daily for 2 weeks followed by a 1-week break, given in 3-weekly cycles. The primary endpoint was overall survival. In all 70 patients were randomized. The median survival was 5.4 months in the selumetinib group and 5.0 months in the capecitabine group (hazard ratio 1.03; two-sided 80% confidence interval=0.68,1.57; P= 0.92). Disease progression events occurred in 84% and 88% of patients in the selumetinib and capecitabine treatment groups, respectively. Gastrointestinal adverse events (nausea, vomiting and diarrhea) were commonly observed in both treatment groups. Other frequently reported adverse events were acneiform dermatitis and peripheral edema with selumetinib, and palmar-plantar erythrodysaesthesia with capecitabine. There was no statistically significant difference in overall survival between selumetinib and capecitabine as second-line treatment in patients with advanced pancreatic cancer. Selumetinib was well tolerated with a manageable safety profile. © 2012 Springer Science+Business Media, LLC.
A phase II, open-label, randomized study to assess the efficacy and safety of AZD6244 (ARRY-142886) versus pemetrexed in patients with non-small cell lung cancer who have failed one or two prior chemotherapeutic regimens
Hainsworth J.D.,Sarah Cannon Research Institute |
Cebotaru C.L.,Oncology and Radiotherapy Institute |
Kanarev V.,Regional Oncology Dispensary Plovdiv |
Damyanov D.,National Oncology Center |
And 5 more authors.
Journal of Thoracic Oncology | Year: 2010
Introduction: AZD6244 (ARRY-142886) is a potent, selective MEK inhibitor. This study aimed to evaluate the efficacy and safety of AZD6244 versus pemetrexed as second- or third-line treatment in patients with advanced non-small cell lung cancer (NSCLC). Methods: In this randomized phase II study, patients received either 100 mg oral AZD6244 free-base suspension twice daily or 500 mg/m intravenous pemetrexed once every 3 weeks after pretreatment with a corticosteroid, folic acid, and vitamin B12. The primary end point of the study was the disease progression event count. Results: Eighty-four patients were randomized. Disease progression events were experienced by 28 (70%) and 26 (59%) patients in the AZD6244 and pemetrexed groups, respectively. Median progression-free survival was not statistically significantly different between the AZD6244 and pemetrexed groups (67 versus 90 days, respectively; hazard ratio 1.08, two-sided 80% confidence interval = 0.75-1.54; p = 0.79). Two patients in the AZD6244 group had a best response to treatment of partial response. In the pemetrexed group, one patient achieved a complete response and one patient a partial response. Dermatitis acneiform, diarrhea, nausea, and vomiting were the most frequently reported adverse events with AZD6244, compared with fatigue, anemia, nausea, anorexia, and dermatitis acneiform with pemetrexed. Conclusions: Oral AZD6244 showed clinical activity as second- or third-line therapy for patients with advanced NSCLC. In an unselected NSCLC population, there is no suggestion that AZD6244 monotherapy offers any advantage over standard treatment with pemetrexed. Based on preclinical data and recent clinical observations, further development of AZD6244 in NSCLC should focus on BRAF or RAS mutation-positive patients and/or AZD6244-based combination regimens. Copyright © 2010 by the International Association for the Study of Lung Cancer.
PubMed | National Oncology Center and Specialized Hospital for Active Treatment in Oncology SHATO
Type: Journal Article | Journal: Journal of chemotherapy (Florence, Italy) | Year: 2016
We report the identification of OXA-48-producing Klebsiella pneumoniae, causing peritonitis in a cancer patient admitted to the Oncology Hospital in Sofia. The isolate had reduced susceptibility to carbapenems but remained susceptible to extended-spectrum cephalosporins. PCR and sequencing confirmed the presence of blaOXA-48 gene flanked by two intact copies of IS1999 on truncated Tn1999.1. This transposon was located on unusual non-typeable 29-kb plasmid that could be transferred only by transformation. Multilocus sequence typing (MLST) indicated the presence of the sequence type ST530.This is the first documented infection due to OXA-48-producing Enterobacteriaceae strain in Bulgaria.
PubMed | National Oncology Center, Emergency Medical Institute Pirogov and Tokuda Hospital Sofia
Type: Journal Article | Journal: Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy | Year: 2016
We report the first confirmed cases of NDM-1-producing Klebsiella pneumoniae infections in two hospitals in Bulgaria. The isolates were diverse in terms of plasmid and co-resistance gene content. K.pneumoniae PR2682, causing sepsis in patient with polytrauma due to traffic accident, harbored bla
PubMed | Cancer Unit of Girassol Clinic, The Surgical Center, ONCOCIR Education and Care in Oncology, Cancer Unit of Sagrada Esperanca Clinic and 2 more.
Type: | Journal: The Pan African medical journal | Year: 2015
The number of cancer cases and related deaths worldwide is expected to double over the next 20-30 years. African countries will be the most affected by the burden of cancer. The improving economic situation of Angola creates conditions for an increase in life expectancy which by itself is associated with an increased risk of oncological diseases. Because cancer therapy requires a multidisciplinary approach, trained health professionals, satisfactory infrastructure and appropriate facilities, the availability of effective cancer therapy is a difficult task that requires support. The aim of this article is to share our experience achieved in the establishment of cancer units in Angola and to validate our checklist for this action.The survey method was a questionnaire addressed to Angolan cancer units, in order to evaluate the usefulness and feasibility of a checklist developed by the authors--The Cancer Units Assessment Checklist for low or middle income African countries--which was used previously in the establishment of those units. Afterwards, the crucial steps taken for the establishing of the main sites of each cancer unit considering, facilities, resources and professionals, were also recorded.All cancer units reported that the checklist was a useful tool in the development of the cancer program for the improvement of the unit or the establishing of cancer unit sites. This instrument helped identifying resources, defining the best practice and identifying barriers. Local experts, who know the best practices in oncology and who are recognized by the local heads, are also important and they proved to be the major facilitators.The fight against cancer has just started in Angola. The training, education, advocacy and legislation are ongoing. According to our results, the assessment checklist for the establishment of cancer units is a useful instrument.
Movsisyan N.K.,American University of Armenia |
Varduhi P.,American University of Armenia |
Arusyak H.,American University of Armenia |
Diana P.,American University of Armenia |
And 2 more authors.
BMC Public Health | Year: 2012
Background: Smoking cessation counseling by health professionals has been effective in increasing cessation rates. However, little is known about smoking cessation training and practices in transition countries with high smoking prevalence such as Armenia. This study identified smoking-related attitudes and behavior of physicians and nurses in a 500-bed hospital in Yerevan, Armenia, the largest cancer hospital in the country, and explored barriers to their effective participation in smoking cessation interventions. Methods. This study used mixed quantitative and qualitative methods. Trained interviewers conducted a survey with physicians and nurses using a 42-item self-administered questionnaire that assessed their smoking-related attitudes and behavior and smoking cessation counseling training. Four focus group discussions with hospital physicians and nurses explored barriers to effective smoking cessation interventions. The focus group sessions were audio-taped, transcribed, and analyzed. Results: The survey response rate was 58.5% (93/159) for physicians and 72.2% (122/169) for nurses. Smoking prevalence was almost five times higher in physicians compared to nurses (31.2% vs. 6.6%, p < 0.001). Non-smokers and ex-smokers had more positive attitudes toward the hospital's smoke-free policy compared to smokers (90.1% and 88.2% vs. 73.0%). About 42.6% of nurses and 26.9% of physicians reported having had formal training on smoking cessation methods. While both groups showed high support for routinely assisting patients to quit smoking, nurses more often than physicians considered health professionals as role models for patients. Conclusions: This study was the first to explore differences in smoking-related attitudes and behavior among hospital physicians and nurses in Yerevan, Armenia. The study found substantial behavioral and attitudinal differences in these two groups. The study revealed a critical need for integrating cessation counseling training into Armenia's medical education. As nurses had more positive attitudes toward cessation counseling compared to physicians, and more often reported having cessation training, they are an untapped resource that could be more actively engaged in smoking cessation interventions in healthcare settings. © 2012 Movsisyan et al.; licensee BioMed Central Ltd.
Alsirafy S.A.,Cairo University |
Al-Alimi K.A.,National Oncology Center |
Thabet S.M.,National Oncology Center |
Al-Nabhi A.,National Oncology Center |
Aklan N.A.,National Oncology Center
Journal of Community and Supportive Oncology | Year: 2016
Background: Adequate symptom assessment is necessary to relieve the high symptom burden experienced by cancer patients. However, health care professionals may depend only on patient's voluntary reporting (VR) to assess symptoms and therefore some symptoms may be missed. Objective: To assess the symptom burden experienced by Yemeni cancer patients by using VR and systematic assessment (SA). Methods: 50 cancer patients were asked an open question to voluntarily report their symptoms. This was followed by an SA of a list of 20 common physical symptoms that was drawn up based on the literature. Results: From 375 symptom entries related to the 20 symptoms, VR accounted for 66 entries (18%) and SA for 309 (82%). The mean number of VR symptoms/patient was 1.3, and the mean number of VR plus SA symptoms was 7.5 (P <.001). In all, 74% of VR symptoms and 57% of SA symptoms were moderate or severe. For each symptom, the percentage of patients who experienced it and did not report it voluntarily (missed) was 100% for bleeding, constipation, early satiety, hoarseness, taste changes, and weight loss. These were followed by anorexia (97%), skin symptoms (92%), dry mouth (91%), edema (89%), dyspnea (88%), sore mouth (88%), fatigue/weakness (85%), diarrhea (80%), dysphagia (80%), nausea (76%), cough (75%), urinary symptoms (75%), vomiting (62%), and pain (18%). Pain was the most common voluntarily reported symptom (56% of patients), the most commonly distressing (42%), and the least under-reported (18%). Limitations: Relatively small sample size; the SA included only 20 symptoms. Conclusions: SA of symptoms yields a more accurate estimation of symptom burden than does VR. As with many developing countries where the majority of cancer patients present at an incurable disease stage, Yemeni cancer patients suffer a high symptom burden, especially pain. © 2016 Frontline Medical Communications.
Abdul Hamid G.,National Oncology Center |
Bin Harize I.,National Oncology Center
Middle East Journal of Cancer | Year: 2014
A 61-year-old female presented with complaints of fever, general weakness and hepatosplenomegaly. She had a history of nonfamilial peripheral neurofibromatosis diagnosed as von Recklinghausen's disease since 30 years previous. Physical examination was remarkable for skin colored cutaneous circumscribed nodules which appeared soft to the touch in both arms, the upper part of her abdomen, back, and posterior thigh. The liver was palpable 10 cm below the inferior border of the costal margin and she had evidence of significant splenomegaly. Laboratory results were as follows: hemoglobin 7.9 g/dl; ESR142 mm/hour; leukocytes 22400x109/L; neutrophils 35%; eosinophils 3%; basophils 4%; myelocytes40%; myeloblasts 14%; promyelocytes 2%; and band form 2%. The bone marrow picture was chronic myeloid leukemia in blastic form. Chest CT scan showed the presence of numerous cutaneous nodules (neurofibromatosis). A biopsy of the tissue fragment from the nodules confirmed the presence of diffuse neurofibromatosis. Bone marrow cytology that included cytogenetic and immunophenotyping confirmed the presence of chronic myeloid leukemia with a positive Philadelphia chromosome and diploidy female clone in a blastic form (acute myeloid leukemia). Addition of 600 mg oral imatinib mesylate daily for one month and reduced to 400 mg daily yields complete hematological remission and complete cytogenetic responses. This case illustrated an association between chronic myeloid leukemia, acute myeloid leukemia and neurofibromatosis in an adult.
El-Zaemey S.,University of Western Australia |
Nagi N.,National Oncology Center |
Fritschi L.,University of Western Australia |
Heyworth J.,University of Western Australia
Cancer Epidemiology | Year: 2012
Background: In developing countries including Arab countries breast cancer is one of the most common cancers found in women. Even though breast cancer incidence is lower in Arab developing countries than in western countries, Arabic women are more likely to be diagnosed at an earlier age than the women in western countries. Method: A descriptive study was undertaken to investigate the type of breast cancer, lymph node involvement, side of breast and, region and age distribution of breast cancer patients registered in the National Oncology Centre in Yemen. Results: From September 2004 to December 2010, 2654 women across Yemen diagnosed with breast cancer were registered in the National Oncology Centre for treatment. Between the years 2004 and 2010, breast cancer represented 22% of all cancers registered in women. Seventy-one per cent of the women were aged 50 or younger at the time of diagnosis. The most common age group affected was women aged 41-50 years, with (35%) of cases occurring in this age. Invasive ductal carcinoma was the most common pathology (76%) and 79% of the patients had lymph node involvement at the time of diagnosis. Approximately 2% had bilateral disease and the frequency of left (44%) and right breast cancer (42%) were similar. Conclusion: This study has shown that breast cancer is a disease of young women in Yemen. The majority of women presented with lymph node involvement. Hence efforts are needed to increase breast cancer awareness in Yemen for early detection at all age groups, and to target women living in areas that have lower access to health care services. © 2012 Elsevier Ltd.
PubMed | National Oncology Center
Type: Case Reports | Journal: Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery | Year: 2015
Epidermoid cysts are composed of stratified squamous epithelium, which develop from inclusion of ectodermal tissue remnants entrapped during primitive neural tube closure period between the 3rd and 5th weeks of gestation. Intramedullary epidermoid cysts (IEC) are very rare in childhood. Eleven cases have been reported previously. Even though it is a rare entity, early diagnosis with timely fashioned surgical treatment has a great influence on patients symptoms, especially if there are myelopathic findings. In this case report, we demonstrate this fact with a demonstrative clinical case and review radiological, pathological, and surgical perspectives with literature review.