2. Candidate Name Ahmad Nasser Ahmad Ghorab Date of Registration : June 2014 a. Occupation : Clinical oncology resident , Cairo university hospitals b. Full mailing address : 50 B wizarit el zeraa street , Dokki , Giza c. Phone number 02 33372188 01222288001 d. Fax number f. E-mail addresses a7mad1310@hotmail. com 3. Investigators Contact Information a. Principal Investigator Prof. Dr. Amr sakr (Professor of clinial oncology,cairo university) b. Other Investigators Dr. Hanan Selim (associate professor of clinial oncology,cairo university).
Dr. wedad bassam ( lecturer of clinial oncology,cairouniversity) c. Department name Kasr Al Ainy Center of Clininical Oncology (NEMROCK) d. Full mailing address Faculty of medicine, Cairo university e. Phone number 01001450259 01001448868 01223255011 f. Fax number g. E-mail addresses amrsakr@yahoo. com hanan. darwish@kasralainy. edu. eg weedo_82@hotmail. com 4. Background and Rationale Brainstem glioma is the most frequent tumor of the region. A clear bimodal age distribution supports the distinction between brainstem gliomas in children and adults.
In contrast with the pediatric population in which brainstem gliomas represent up to 20% of brain tumors and exhibit a rather homogeneous and unfavorable course, adult brainstem gliomas are rare (accounting for only 1%–2% of adult brain gliomas) and heterogeneous with varying radiological patterns and variable prognoses [1-3]. Due to it critical location, biopsies are too rare to allow for an analysis based on histological criteria alone, we used an MRI (magnetic resonance imaging)-based radiological classification. However, autopsy results and stereotactic biopsy have revealed that the majority of the tumors are glial neoplasms .
The tumor’s extension is considered focal when it occupies 50% of the axial brainstem diameter, and the extension is considered diffuse when the lesion is poorly demarcated and is 50% of the brainstem diameter [4-6]. These lesions tend to be clinically and radio-graphically heterogenous, with diffuse intrinsic low grade BSGs having a median survival of 7. 3 years, compared to 11. 2 to 17 months for malignant BSGs. This latter group remains one of the most challenging tumor types, with multiple clinical trials failing to improve survival.
As malignant BSGs account for a minority of BSGs in adults, their natural history, molecular characteristics, and prognostic factors are completely undefined (7-12). 5. Objectives This is a retrospective analysis the demographic and clinical characteristics of adult patients diagnosed with brainstem gliomas treated at the Kasr Al-Aini Center of Radiation Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, between 2005 and 2011 and determine possible prognostic factors associated with survival 6.
Study Design Study Population We searched a comprehensive database containing all patient data from the Kasr Al-Aini Center of Radiation Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University between 2005 and 2011. Our cohort consisted of all patients above 18 years, histo-pathologically confirmation is not mandatory. Tumor-specific data included anatomical location . The brainstem was subdivided in a superior (midbrain) ,middle (pons) and inferior part (medulla oblongata). The tumor was defined as a brainstem glioma when more than 50% of the tumor involved the brainstem and excludes tumors which significantly involve areas adjacent to the brainstem.
Pattern of growth (intrinsic or exophytic ), extent of surgery, WHO grade. Data on demographic ((gender, age at onset, duration of symptoms, initial symptoms and signs location), clinical course of disease, neuro-radiological imaging (the presence of necrosis or contrast enhancement observed at MRI) , therapeutic approaches and survival were collected and analyzed. Outcome Assessment Outcomes assessed were 5 years EFS and overall survival after diagnosis. Event-free survival was defined as either lack of disease progression, development of secondary malignancy, or death from any cause.
Event-free survival was calculated from the date of diagnosis to the date of an event or last contact. Overall survival was determined from the date of diagnosis to the date of last follow-up or death. Statistical Analysis Descriptive statistics were analysed with the SPSS statistical package (13). The Kaplan-Meier method was used to estimate EFS and overall survival, and the log-rank test was performed to determine whether the following variables were predictive of EFS: sex, age (<40 years vs ? 40 years), tumor location, extent of resection, treatment, WHO grade, and pattern of growth.
Statistical significance was defined as p <0. 05. 7. List of Correlative Studies 1. Guillamo JS, Monjour A, Taillandier L et al. Brainstem gliomas in adults: prognostic factors and classification. Brain 2001;124:2528 –2539. 2. Albright AL, Price RA, Guthkelch AN : Brain stem gliomas in children : A clinopathologic study. Cancer1983; 82: 2313-2319. 3. Landolfi JC, Thaler HT, DeAngelis LM. Adult brainstem gliomas. Neurology 1998;51:1136 –1139. 4. Barkovich AJ, Krischer J, Kun LE et al. Brain stem gliomas: a classification system based on magnetic resonance imaging. Pediatr Neurosurg 1990; 16:73– 83. 5.
Donaldson SS, Laningham F, Fisher P et al. Advances toward an understanding of brainstem gliomas. J Clin Oncol 2006; 24:1266 –1272. 6. Fischbein NJ, Prados MD, Wara W et al. Radiologic classification of brain stem tumors: correlationof magnetic resonance imaging appearance with clinical outcome. Pediatr Neurosurg 1996;24:9 –23 7. Mursch K, Halatsch ME, Markakis E, Behnke-Mursch J. Intrinsic brainstem tumours in adults: results of microneurosurgical treatment of 16 consecutive patients. Br J Neurosurg 2005;19:128–136. [PubMed: 16120515].
8. Hargrave D, Bartels U, Bouffet E: Diffuse brainstem glioma in children: critical review of clinical trials. Lancet? Oncol 7: 241–248, 2006 9. Hargrave D, Chuang N, Bouffet E: Conventional MRI cannot predict survival in childhood diffuse intrinsic pontine glioma. J? Neurooncol 86:313–319, 2008 10. Laigle-Donadey F, Doz F, Delattre JY: Brainstem gliomas in children and adults. Curr? Opin? Oncol 20:662–667, 2008 11. Pincus DW, Richter EO, Yachnis AT, Bennett J, Bhatti MT, Smith A: Brainstem stereotactic biopsy sampling in children. J? Neurosurg? (2? Suppl)? 104:108–114, 2006 12.
Pirotte BJ, Lubansu A, Massager N, Wikler D, Goldman S, Levivier M: Results of positron emission tomography guidance and reassessment of the utility of an indications for stereotactic biopsy in children with infiltrative brainstem tumors. J? Neurosurg? (5? Suppl)? 107:392–399, 2007 13. SPSS Inc. SPSS 13. 0 for Windows (Release 10. 0. 1). Chicago: SPSS Inc; 2004 8. Study Methods Population of study & disease condition The study will include all adult patients with brainstem glioma who were treated in Kasr Al Ainy Center of Clininical Oncology (NEMROCK).
In period from 2003 to 2013 and met inclusion and exclusion chriteria Background and Demographic Characteristics Data on demographic ((gender, age at onset, duration of symptoms, initial symptoms and signs location), clinical course of disease, neuro-radiological imaging (the presence of necrosis or contrast enhancement observed at MRI) , therapeutic approaches and survival were collected and analyzed. Inclusion criteria: – adult patients with brainstem glioma -Age above 18 years -Both sexes -histo-pathologically confirmation is not mandatory.
– The tumor was defined as a brainstem glioma when more than 50% of the tumor involved the brainstem and excludes tumors which significantly involve areas adjacent to the brainstem Exclusion criteria: -Age below 18 years Interventions no Possible Risk No possible risk Primary outcome parameter (maximum two) 1- analysis the demographic and clinical characteristics of adult patients diagnosed with brainstem gliomas 2- Secondary outcome parameters determine possible prognostic factors associated with survival Sample size (number of participants included).
All patients who where treated to Kasr Al Ainy Center of Clininical Oncology (NEMROCK) during the period from 2003 to 2013 Statistical analysis All data will be tabulated and statistically studied by descriptive analysis as well as survival analysis in relation to different clinico-epidemiological factors. Survival will be defined as a time from presentation to death or date of last follow up. Disease-free survival will be defined as the time from achieving CR to relapse, death or last follow up.
Source of funding Not applicable. 9. Time plan (when to start/ when expected to finish/ when to publish) To start on May 2014, to finish and publish on January 2015. 10. Ethical committee approval Department ethical committee will review the protocol 11. Cooperation with other departments Name of department.