Clinical Oncology Department Research Articles

DRUG UTILISATION REVIEW IN NONMETASTATIC BREAST CANCER IN A TERTIARY CARE TEACHING HOSPITAL

Background & Aims: Breast cancer is one of the most commonly found cancer among Indian women. Rational therapy plays a major role in the treatment of breast cancer patients1. The risk of breast cancer is alarming, especially in developing countries like India. The purpose of this retrospective study was to review the drug use of patient with breast cancer in a tertiary care teaching hospital. Methodology: The present drug utilization study was conducted on breast cancer patients attending a tertiary care teaching hospital. Results and Discussion: This study was a single-centre interventional retrospective study carried out on a group of 384 breast cancer patients at the Clinical Oncology Department. Results of this study indicated that the given therapy in this study adhered to clinical guidelines and improved patient outcome. Summary and Conclusion: So, with this study, we are able to realize the treatment pattern for breast cancer patients in the selected study setting.

Predictors for Metachronous Metastases in Early Breast Cancer: A Single Institution Study

Background: Breast cancer (BC) is considered the most common women cancer worldwide. The main clinicopathological prognostic factors are tumor size, lymph node status and estrogen/progesterone (ER/PR) receptor status. In addition, some factors are both prognostic and predictive as ER/PR receptors and HER2/neu overexpression. Axillary lymph node status is the most important prognostic factor for breast cancer. Node negative breast cancer patients had the best 5-year overall survival (OS) of 82.8% compared to 73%, 45.7%, and 28.4% for patients with 1 - 3, 4 - 12, and ≥13 positive nodes, respectively. The aim of this study was to determine the association between different clinicopathological features and development of metastasis in a group of Egyptian women with early breast cancer, also, to assess patients’ Relapse-free survival (DFS) and OS and their correlation with different clinicopathological features. Patients and Methods: We retrospectively reviewed the files of breast cancer patients who were treated and followed-up at the clinical oncology department and surgical oncology unit, Alexandria Main University Hospital during the period from January 2014 to December 2017. A total of 1848 breast cancer cases were presented during this period of time. 141 out of the 1848 patients developed metastasis from breast cancer during follow-up. Among the 141 patients, only 102 had adequate clinical, pathological, treatment and follow-up data enough for analysis and were included in our study. Results: The number of patients who developed distant metastasis from breast cancer during the study period (metachronous metastasis) ranges from 17 - 31 cases/year. All the study patients had documented metastatic disease constituting 102 out of 1848 collected patients representing about 5.5%. The median time for development of metastasis from the initial diagnosis among the 102 studied patients was 17.88 months. Seventy-two out of 102 cases had distant recurrence. There was a significant correlation between DFS and tumor size, grade, number of lymph nodes involved and hormone receptor (ER and PR) status. Age, tumor grade, tumor size and Her2 status had a significant impact on the OS. Conclusion: The clinicopathological characteristics of the primary tumor are important for predicting the risk of metastasis among early breast cancer patients and determining their prognosis.

Predictive Factors Increasing the Risk of Radiation Toxicity in Patients with Early Breast Cancer.

Objectives:Radiation induces adverse events on healthy tissues which may be augmented by certain factors. This study aimed to assess patients; tumor and treatment-related factors which increase the risk of radiation-induced toxicity in breast cancer patients. Methods:This prospective study included postmenopausal early breast cancer patients treated at the clinical oncology department, Assiut University, Egypt between January 2015 and December 2018. Patients treated with mastectomy followed by conventional radiotherapy (25x 2 Gy) and either concurrent or sequential letrozole. Acute and late radiation toxicity was scored according to EORTC/RTOG and risk factors were analyzed. Results:A total of 75 patients were included in the study. After a median follow-up of 24 months, 12 patients had > grade 2 acute dermatitis, 5 patients had > grade 2 cardiac toxicity and 3 patients had > grade 2 lung toxicity. Multivariate analysis revealed that trastuzumab use was associated with a decrease risk of acute dermatitis (p= 0.01) but boost irradiation was significantly associated with increased risk of acute dermatitis (p= 0.01). Late toxicity > grade 2 was observed in 6 patients, 14 patients, and 2 patients for skin, heart, and lung respectively.Conclusion:The use of boost irradiation was associated with increased risk of acute dermatitis, in the contrary; the use of trastuzumab seemed to be protective as observed in this study.

Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma.

The development of drug resistance remains the major obstacle to clinical efficacy of cancer chemotherapy. Consequently, finding new therapeutic options for cancerous patients is an urgent need. Sixty newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients were recruited from Clinical Oncology Department, Faculty of Medicine, Menoufia University, Egypt prospectively randomized to three groups (n = 20 for each group). Group one (control group) received R-CHOP standard chemotherapy {Rituximab, Cyclophosphamide, Hydroxyldaunorubicin (Doxorubicin)®, Vincristine (oncovin)®, prednisolone in the first five days of cycle}, group two received lansoprazole (LAN) 60mg p.o. bid for only one week before starting each of cycle + R-CHOP and group three received famotidine (FAM) 40mg p.o. once daily one week before cycle and continues daily through the cycle + R-CHOP for six cycles. Blood samples were obtained for biochemical analysis of transforming growth factor-β (TGF-β), Basic fibroblast growth factor (bFGF), interleukin-9 (IL-9), nuclear factor-kappa B (NF-κB) and Caspase 3 before and after six cycles of therapy. The obtained data showed that LAN and FAM resulted in significant decrease in (LDH, TGF-β, bFGF and IL-9, respectively) and significant increase in (Caspase-3). In addition, LAN produced a significant elevation in the response rate compared to the control group or the FAM group. Both LAN and FAM as adjuvant therapy represents a promising anticancer strategy in DLBCL by modulation of malignancy homeostasis mechanisms and boosting chemotherapy antitumor effects without further toxicity. In addition, LAN has a synergetic effect in improving the response rate.Trial registration Clinical Trial.gov Identifier: NCT0364707.

Gender-based epidemiological study of lung cancer patients

Background In Egypt, lung cancer represents 5.0–7.0% of all cancers and ranks the fifth in males and both sexes, and ninth among females. The current study aims to characterize a cohort of patients with lung cancer based on their sex regarding risk factors, clinical presentation, and results of investigations. Patients and methods A retrospective comparative cross-sectional study was conducted that included all female lung cancer cases that were referred to the Clinical Oncology and Nuclear Medicine Department from year 2014 to year 2018. An equal number of males were randomly selected within the same year interval (as a comparative group). Data (included epidemiological data, relevant medical history, and the histopathologic type of cancer) were retrieved from the electronic database. Results The family history of malignancy was higher among females (8.8 vs. 0%), but the difference was not significant. There were no significant differences in performance status between male and female group. Apart from chronic obstructive pulmonary disease, the prevalence of most chronic diseases was significantly higher among females than males. Adenocarcinoma is the most common histologic subtype regardless of sex, whereas squamous cell carcinoma represented 18.5% among males and 1.9% among females, with significant difference (P=0.001). Bone was the most common site of metastasis. Overall, 14% of males had suprarenal metastasis, compared with 3.5% of females, with significant difference (P=0.047). Conclusion This 4-year single-center analysis concluded that both male and female present at a late stage of lung cancer. Suprarenal metastasis was more common in males than females. Squamous cell carcinoma was the most common among males. There were no sex differences regarding age of diagnosis, performance status, presenting symptoms, and radiological site of tumor.

Do histone deacetylase 1 (HDAC1) and retinoblastoma-associated protein have a synergistic role in the determination of prognosis in renal cell carcinoma? An immunohistochemical study

Background Renal cell carcinoma (RCC) is the most common solid tumor of the kidney and the most lethal of all urological malignancies. Poor prognosis of RCC is caused by that third of patients presented by metastasis and half of them die due to disease. More research is needed to identify molecular markers that could lead to advances in personalized medicine. Aim We aimed to evaluate the protein expression of histone deacetylase 1 (HDAC1) and retinoblastoma-associated protein (RbAp48) in RCC and their relation to the clinicopathological parameters including survival. Materials and methods Fifty-one RCC cases were included in five tissue microarray blocks. Histopathological, clinical, and survival data were collected from patients’ records in Pathology, Clinical Oncology, and Nuclear Medicine Departments, Faculty of Medicine, Menoufia University. All cases were subjected to immunostaining by HDAC1 and RbAp48 antibodies. Expression of both was evaluated by different methods, including percentage, H score, and immunoreactivity score. Results No significant associations were noticed between neither HDAC1 nor RbAp48 expression and the studied clinicopathological variables. High expression of RbAp48 is significantly associated with shorter overall survival. Moreover, RbAp48 percentage of expression is an independent bad prognostic factor (beta=−0.634, P=0.001). Conclusion RbAp48 percentage of expression may be a promising independent bad prognostic factor in RCC. RbAp48 could play an essential role in RCC prognosis independent of HDAC1. Further studies are needed to identify specific HDAC isoforms essential in RCC tumorigenesis to be targeted by specific HDAC inhibitors. Also, molecular research will be helpful to clarify the pathways that help RbAp48 executing its bad prognostic effect in the scarcity of HDAC1.

Frequency of regulatory B cells phenotypes in breast cancer patients in Egypt

Accumulating evidence has indicated that immune regulatory cells are involved in the establishment of the anti-tumor activity, however; the role of regulatory B cells (B-regs) in breast cancer (BC) remains unclear. This study intended to assess the frequency of peripheral B-regs phenotypes in patients with BC, and to determine the relation between these phenotypes and the patient's clinicopathological characters. The expressions of the immune cell populations were analyzed by four-color flow cytometry in 40 naïve BC patients and 10 age-matched apparently healthy individuals as controls attending the department of Clinical Oncology and Nuclear Medicine at Assiut University Hospitals. The percentages of B-regs phenotypes CD19+IL10+ and CD19+CD24hiCD27+IL10+ were higher in BC patients than in the controls. The percentage of CD19+IL10+ B cells phenotype was significantly associated with the HER-2 expression levels, T, and N stages of BC. In conclusion, high percentage of B-regs phenotypes CD19+IL10+ and CD19+CD24hiCD27+IL10+ in BC patients indicates a possible role in immune suppression during the development of BC.

Validation of Online Prognostication Model that Predicts Survival for Women with Early Breast Cancer in Egypt


 Introduction: Breast Cancer is estimated to be the most common female cancer in Egypt. The decision on adjuvant therapy in early breast cancer is complex and requires many considerations. PREDICT is an online prognostication tool for early breast cancer. It was first revealed in 2011 and it has been widely used. This study aimed to illustrate the applicability of this model on Egyptian patients. Methods: This study included 128 female patients treated for early breast cancer with surgery and adjuvant therapy in Alexandria, Egypt in 2005 to validate the efficacy of PREDICT as an online prognostication model to estimate survival in those patients. Patients’ data were obtained from the archives of the Department of Clinical Oncology, Faculty of Medicine, and the Department of Cancer Management and Research, Medical Research Institute, University of Alexandria, Egypt. Patients’ data were manually entered into the prognostication model and the predicted survival results obtained were compared to the actual survival of study patients. Results: The predicted number of survivors after 5 years in the entire cohort was 125 (97.7%) compared to 123 (96.1%) actual survivors. The difference was 1.6% which was not significant (p= 0.625). The predicted number of survivors after 10 years in the entire cohort was 77 (60.2%) compared to 81 (63.3%) actual survivors. The difference was -3.1% which was not significant (p= 0.671). Conclusion: PREDICT accurately predicts 5-year and 10-year OS in the entire study population. This validates the use of this online model to aid in the decision as regard systemic therapy.

Hypofractionated Radiotherapy Using Simultaneous Integrated Boost Technique with Concurrent and Adjuvant Temozolomide for Glioblastoma

Aim: This study was conducted to assess the safety and efficacy of postoperative hypofractionated radiotherapy (HRT) using simultaneous integrated boost (SIB) technique for glioblastoma (GBM) compared to conventional radiotherapy (CRT).
 Study Design: This was a prospective study with historical control arm.
 Place and Duration of the Study: Department of Clinical Oncology and Nuclear Medicine, Mansoura University Hospital, Mansoura, Egypt, between May 2017 and June 2019.
 Methods: The intervention (HRT) group included 30 patients who received 3D conformal HRT with SIB using field in field (FIF) technique to deliver a differential radiation dose to different targets. Planning target volume 60 (PTV60) includes the gross target volume (GTV) plus a 5-mm margin, and PTV45 includes the GTV plus a 15-mm margin. PTV60 will receive 60 Gy in 20 fractions, and PTV45 will receive 45 Gy in the same 20 fractions (one fraction daily and 5 days per week).The CRT group included 30 patients who received 3D conformal CRT with total dose 60 Gy in 2-Gy fractions delivered over 6 weeks. Both groups was planned to receive concurrent and adjuvant temozolamide.
 Results: The median PFS was 10 months in both groups. The median OS was 13 months in HRT group versus 12 months in CRT group which is statistically non significant. The toxicities were mild and acceptable. Performance status and adjuvant temozolamide were significant predictors that affect the overall survival.
 Conclusions: HRT with SIB using 3D conformal RTH with (FIF) technique in patients with GBM is a feasible and safe treatment and its results is comparable to the conventional radiotherapy.

X-ray diagnostics of pneumonia in cancer patients during a pandemic COVID-19. A сase from practice

Background. The outbreak of the new coronavirus disease in 2019 (COVID19) has been the largest global health threat in the world, that infected more than 60 million people and killed more than 1,400,000. At the same time, cancer remains a widespread disease, from which more than 9.6 million patients in the world die each year. Accumulating data suggest that cancer patients are at higher risk of infection COVID-19 and severe course of the disease. This is due to immunosuppression, which is due to both the malignant tumor and antitumor therapy. Clinical manifestations of lung damage in cancer patients are not pathognomonic, because they can be caused by any pathological processes: metastatic lesions, inflammatory processes of viral and bacterial etiology, vascular disorders in the small circulation, etc. This requires not only to determine the nature of pathological changes in the lungs, but also to carry out their differential diagnosis in order to prescribe timely and adequate therapy. Purpose – elucidation of the relevance of X-ray diagnosis of pneumonia in cancer patients during the COVID-19 pandemic. Materials and methods. Follow-up of a patient K., 72 years old, who had coronavirus pneumonia along with complications (febrile neutropenia) resulting from chemoteraphy of recurrent endometrial leiomyosarcoma. The treatment was provided on the premises of Clinical Oncology and Hematology Department of State Organization «Grigoriev Institute for Medical Radiology and Oncology of the National Academy of Medical Sciences of Ukraine». Results and discussion. Over a period of 6 month, the patient was undergoing polychemotherapy (with complications like febrile neutropenia) of recurrent endometrial leiomyosarcoma. The control CT study detected pulmonary involvement. After receiving laboratory confirmation of COVID-19, was treated in the infectious department. The course of the disease was severe. Analyzing this clinical case of a patient with cancer in the process of special treatment, it is impossible to exclude the presence of progression in the lungs or drug pulmonitis. A favorable treatment result (negative PCR test, positive dynamics on CT) proves the non-metastatic nature of lung damage. Conclusions.. Diagnosis of COVID-19 infection should be based on the integrated application of clinical, radiological and laboratory research methods. Chest computed tomography, taking into account its high sensitivity, helps in diagnosis, control of the disease, playing an important role in the differential diagnosis and treatment tactics of COVID-19.

FACTORS INFLUENCING TREATMENT OUTCOME OF NON-NASOPHARYNGEAL HEAD AND NECK SQUAMOUS CELL CARCINOMA IN GERIATRIC PATIENTS

Background: Head and neck squamous cell carcinoma (HNSCC) are a heterogeneous group of malignancy. Their incidenceincreases with age. Therefore, elderly HNSCC patients represent a large population who need special care and treatment considerations.Aim of work:To correlate clinicopathologic factors of non-nasopharyngeal HNSCC geriatric patients with disease free survival (DFS) and overall survival (OS).Patients and methods:A retrospective analysis of fifty non-nasopharyngeal HNSCC elderly patients (≥ 65 years) treated at the head and neck cancer unit at the clinical oncology department, Ain Shams University Hospitals from June 2014 to June 2019. The study correlatedpatients’ age, comorbidities, tumor stage and Eastern Cooperative Oncology Group performance state (ECOG PS) with disease free survival (DFS) and overall survival (OS).Results:Three years DFS rate among the patients aged 65-75 years was 73% versus 40% among patients aged 76-80 years and three years OS rate decreased from 48.2% to 40% respectively. The median OS was 39.5 months for patients without co-morbidities compared to 32.5 months for patients with associated co-morbidities (P=0.9) and the median DFS was nearly about 40 months for both groups (p=0.7).Three years DFS was 78.7% among the patients with PS I and 54% among PS II and III (P=0.56) while three years OS rate was 60.7% among patients with PS I but it was 42% for PS II and III (p=0.5). The mean DFS dropped from 43.9 months to 18.4 months for early stages and locally advanced respectively but with no statistical significance association (P=0.49). There was marked decrease of 2years OS from 100% for early stages to 40.3% for locally advanced stages (p=0.009).Conclusion: In HNSCC geriatric patients age >75 years and locally advanced stages were poor prognostic factors for DFS and OS while co-morbidities and ECOG PS didn’t affect treatment outcome.

Daratumumab in T‐cell acute lymphoblastic leukaemia: A case report and review of the literature

Pediatric Blood & CancerVolume 68, Issue 5 e28829 LETTER TO THE EDITOR Daratumumab in T-cell acute lymphoblastic leukaemia: A case report and review of the literature Sandra D. Ruhayel, Corresponding Author sandra.ruhayel@gmail.com orcid.org/0000-0002-1559-2980 Department of Clinical Haematology, Oncology and Bone Marrow Transplantation, Perth Children's Hospital, Perth, Western Australia, Australia Correspondence Sandra D. Ruhayel, Department of Paediatric and Adolescent Haematology, Oncology, Blood and Marrow Transplantation, Perth Children's Hospital, 15 Hospital Ave, Perth, WA 6009, Australia. Email: sandra.ruhayel@gmail.comSearch for more papers by this authorSantosh Valvi, Department of Clinical Haematology, Oncology and Bone Marrow Transplantation, Perth Children's Hospital, Perth, Western Australia, AustraliaSearch for more papers by this author Sandra D. Ruhayel, Corresponding Author sandra.ruhayel@gmail.com orcid.org/0000-0002-1559-2980 Department of Clinical Haematology, Oncology and Bone Marrow Transplantation, Perth Children's Hospital, Perth, Western Australia, Australia Correspondence Sandra D. Ruhayel, Department of Paediatric and Adolescent Haematology, Oncology, Blood and Marrow Transplantation, Perth Children's Hospital, 15 Hospital Ave, Perth, WA 6009, Australia. Email: sandra.ruhayel@gmail.comSearch for more papers by this authorSantosh Valvi, Department of Clinical Haematology, Oncology and Bone Marrow Transplantation, Perth Children's Hospital, Perth, Western Australia, AustraliaSearch for more papers by this author First published: 27 November 2020 https://doi.org/10.1002/pbc.28829Citations: 3Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat No abstract is available for this article.Citing Literature Volume68, Issue5May 2021e28829 RelatedInformation

Effect of Implementing a Protocol of Nursing Care on Peripheral Venous Access Complications for Patients Undergoing Chemotherapy

Background: Cancer is a group of disease that is characterized by uncontrolled growth of abnormal cells. Chemotherapy is a vital treatment for cancer but in the same time it is associated with serious complications that are need standard of nursing care. Aim of the study: Evaluate the effect of implementing a protocol of nursing care on peripheral venous access complications for patients undergoing chemotherapy. Design and Setting: A quasi-experimental research design was used to collect data from Clinical Oncology and Nuclear Medicine Department of Tanta University Hospital. Subjects: A convenience sampling of (60) patients who were undergoing chemotherapy . They were divided into two equal groups; study and control; each group consisted of (30) patients. Tools: Three tools were used for data collection, Tool (I); Bio- socio-demographic and structured interview schedule evaluate patients’ knowledge, Tool (II); Vein quality assessment to assess the quality of vein and Tool (III): Peripheral venous access complications assessment tool. Results: As a result of this study, it was determined that there was highly significant improvement in the total level of patients' knowledge, vein quality, visual infusion phlebitis and there was decrease in the incidence of extravasation among study group at 2nd month and post ending protocol of care compared to control group. Conclusion and Recommendation: Aprotocol of care has positive effect on reducing peripheral venous access complications among chemotherapeutic patients. So it was recommended that oncology nurses should follow protocol of nursing care while administrating chemotherapy for patients to decrease incidence of peripheral venous access complications.

Brain and Acute Leukemia, Cytoplasmic Gene Overexpression as a Prognostic Factor in Egyptian De novo Adult Acute Myeloid Leukemia Patients

Abstract Background: Brain and acute leukemia, cytoplasmic (BAALC) gene is identified on chromosome 8q22.3 and implicated in normal hematopoiesis. BAALC gene overexpression is associated with poor outcome. Methods: We aimed to evaluate BAALC expression in de novo Egyptian acute myeloid leukemia (AML) cases and determine its prognostic value. We recruited 70 patients with de novo AML diagnosed and treated at clinical pathology and medical oncology departments, fulfilling inclusion criteria in our prospective study and evaluated BAALC expression level. Patients received induction therapy. The Institutional Review Board approved our study. Results: The mean age was 39.2 years ± 11.87, (18–60) with a male/female ratio of 3/2. The cutoff value of BAALC as a prognostic factor was 2.11 with sensitivity (86.1%), specificity (80%), positive predictive value (88.6%), and negative predictive value (76.2%.) (P < 0.001), 43 (61.4%) patients had high BAALC expression. Seventy-two percent of patients in the low BAALC group achieved complete remission (CR) compared to 42.1% in high BAALC expression group (P = 0.03). Patients with low BAALC (123.1 ± 4.9) had longer mean survival time than high BAALC group (45.85 ± 5.1) (P = 0.000). Conclusion: High-BAALC expression is an adverse prognostic factor, with a higher risk of relapse, lower CR rates, and lower survival in Egyptian de novo AML patients.

The predictive value of G8 and the Cancer and aging research group chemotherapy toxicity tool in treatment-related toxicity in older Chinese patients with cancer

IntroductionOlder patients experience a higher risk of treatment-related toxicity (TRT). The G8 screening tool was developed to separate cancer older patients fit to receive standard treatment from those who are frail and experiencing functional decline due to reduced organ function and multiple comorbidities. The Cancer and Aging Research Group chemotherapy toxicity tool (CARG-tt) questionnaire was developed to predict chemotherapy toxicity in geriatric patients. This prospective observational study evaluated the performance of G8 and CARG-tt in predicting severe TRT in older Chinese cancer patients. MethodsChinese patients aged ≥65 with a diagnosis of solid malignancy and scheduled to receive anti-cancer treatment (chemotherapy or targeted therapy) were enrolled from March 2016 to July 2017 at the Department of Clinical Oncology at Queen Mary Hospital in Hong Kong. All patients completed the G8 and CARG-tt screening and pre-treatment assessments before starting treatment. Patients were monitored for any severe TRT, which was defined by grades 3–5 using the National Cancer Institute's Common Terminology Criteria for Adverse Events v4.03, treatment discontinuation, or unexpected hospitalization from starting to 30 days after treatment. ResultsA total of 259 patients (male: 154, 59.5%; median age: 73.4, age range: 65–93) were enrolled in the study. Two hundred and ten (81.1%) patients received chemotherapy while the rest (n = 49, 18.9%) received targeted therapy. Overall, 146 patients (56.8%) experienced severe TRT.The mean G8 score was 12.4 (SD: 2.8). The G8 score had a significant association with unexpected admission (cutoff: 14, 41.3% vs. 26.5%, p = 0.03) but not significant in other types of TRTs. The mean CARG-tt score was 7.67 (SD: 3.7); it was not associated with severe TRTs. ConclusionsThe G8 and CARG-tt demonstrated a weak prediction of severe TRT in older Chinese cancer patients. Future studies need to develop predictive tools for TRT in patients receiving novel antineoplastic therapies, with a focus on subgroup analysis for different populations.

Evaluation of the cardioprotective effect of l-carnitine and silymarin in cancer patients receiving anthracycline-containing chemotherapy

Aim: Anthracycline-induced cardiotoxicity is the most common constraint of its use in the treatment of various types of cancer. This study aimed to investigate the benefits of the addition of the l-carnitine / silymarin to anthracycline chemotherapy in patients with breast cancer. Methods: 83 patients were recruited from Clinical Oncology Department, Tanta University, Egypt, then prospectively randomized to receive their anthracycline-containing therapeutic regimen, control group (n=33), or anthracycline plus l-carnitine, l-carnitine group (n=25), or anthracycline plus silymarin, silymarin group (n= 25). Blood samples were collected at the beginning and after 6 months to measure LDH, CK-MB, cTn I, Anticardiolipin IgG, Fe, ferritin, and TIBC and % of saturation. % EF was documented. Data were statistically analyzed by ANOVA and paired t-test. P Results: The addition of l-carnitine to anthracycline chemotherapy has a significantly improved EF% (P=0.003), Anticardiolipin IgG (P=0.001), ferritin (P=0.001), and TIBC (P=0.011). The supplementation with silymarin to anthracycline chemotherapy had a statistically significant decrease in Anticardiolipin IgG (P=0.000), iron (P=0.001), ferritin (P= 0.001), TIBC (P=0.007), and % saturation (P=0.001). Silymarin group showed a significant decrease in iron profile compared to the l-carnitine group. Conclusion: The co-administration of l-carnitine or silymarin with anthracycline chemotherapy represents a new therapeutic strategy for better control of anthracycline-induced cardiotoxicity. Silymarin resulted in more beneficial effects on the iron profile compared to l-carnitine with anthracycline or anthracycline chemotherapy alone.

ASSESSMENT OF SURGICAL MANAGEMENT OF FEMALE BREAST CANCER PATIENTS AFTER NEOADJUVANT SYSTEMIC THERAPY FOR INVASIVE DUCTAL VERSUS INVASIVE LOBULAR CARCINOMA (T3 STAGE)

Background: In the treatment of locally advanced breast cancer, neoadjuvant chemotherapy approach has several objectives, including downsizing of irresectable tumor into operable disease. ILC is known to be less responsive to NAC. The reported proportions of ILC patients with a pathologic complete response (pCR) range from 1 to 3 % compared with 9 to 15 % for IDC patients Objectives: To assess surgical decision after using neoadjuvant systemic therapy for locally advanced breast cancer patients with invasive ductal carcinoma (IDC) versus whom with invasive lobular carcinoma (ILC). To determine the impact of neoadjuvant chemotherapy (NAC) on different pathological types of locally advanced breast cancer cases. Patients and Methods: This retrospective study included 50 patients in the period from Jun 2018 to Jun 2019 who were diagnosed as invasive ductal and invasive lobular Carcinoma classified into two equal groups. Each group had received neoadjuvant systemic therapy, at Department of Clinical Oncology and Nuclear Medicine, while surgical treatment, in form of modified radical mastectomy (MRM) or breast conserving surgery (BCS), was done between June 2019 and Mar 2020, at the Surgical Oncology Department in Al-Azhar university hospitals. Results: In our study, we observed a reduction in T stage after NAC in 6 cases (24%) of ILC patients compared to clinical down staging in 20 cases (80%) of IDC group. Conclusion: ILC patients were less responsive to neoadjuvant chemotherapy compared with IDC patients. BCS is less frequently achieved after NAC in patients with lobular histology compared with ductal histology.

Osteopontin level and promoter polymorphism in patients with metastatic breast cancer.

Cancer initiation typically occurs when a proto-oncogene's coding region undergoes mutation, resulting in uncontrollable cell growth and division, or when a tumour suppressor gene's coding region is affected by a mutation that inhibits activity of the resulting gene product. The pathophysiologic result is, respectively, exaggerated cell-cycle growth or deficient programmed cell death. Osteopontin (opn) is an integrin-binding phosphoprotein that is expressed on the surface of normal cells. Osteopontin has a major role in diverse tumour components, especially those implicated in invasion and metastasis. In the present study, we aimed to illustrate the value of opn as a possible contributor in breast cancer (bca). This prospective study included 115 patients newly diagnosed with bca and distant metastasis who were recruited from the Oncology Center, Mansoura University, and the Department of Clinical Oncology and Nuclear Medicine, Mansoura University Hospital, Egypt. The patients recruited had been diagnosed with disseminated visceral metastasis (visceral crisis), with or without bone metastasis; patients with cranial metastasis were excluded from the study. All patients received first-line chemotherapy with docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 or carboplatin 6 auc (area under the curve) on day 1 every 21 days for a maximum of 6 cycles or till development of toxicity. Trastuzumab (in cases of her2-positive disease) was given whenever possible (if government assistance or personal finances permitted). Serum levels of opn were assessed by enzyme-linked immunosorbent assay (elisa) before treatment was started. A group of 30 matched healthy women whose median serum opn level was 15 ng/dL were included, and that level was therefore defined as the cut-off value. In addition, opn gene mutation was determined by polymerase chain reaction (pcr). Correlations of pretreatment serum opn and opn gene mutation with various patient clinicopathologic variables, response to the treatment, progression-free survival (pfs), and overall survival (os) were assessed. Mean serum opn was highest in her2-amplified bca (64.4 ± 42.3 ng/dL), and then in triple-negative bca (55.9 ± 34.7 ng/dL), followed by the luminal B and A subtypes (38.4 ± 33.1 ng/dL and 36.3 ± 32.2 ng/dL respectively, p = 0.017). Testing by pcr revealed that opn gene mutation was highest in triple-negative bca (85% opn mutant vs. 15% non-mutant), and then in her2-overexpressed bca (80% opn mutant vs. 20% non-mutant), followed by luminal B bca (61.9% opn mutant vs. 38.1% non-mutant); the least expression was detected in luminal A bca (57.9% opn mutant vs. 42.1% non-mutant). Interestingly, patients with high serum opn and opn gene mutation experienced both poor pfs (median: 12 months vs. 14 months; p = 0.001) and poor os (median: 14 months vs. 18 months; p = 0.001). Moreover, participants with opn gene mutation experienced a poor response: of those with progressive disease, 74% had opn mutation and 26% had unmutated opn (p = 0.04). Additionally, high pretreatment serum opn was correlated with poor treatment response: 49.1 ± 33.8 ng/dL in patients with progressive disease and 35.5 ± 34.3 ng/dL in those who achieved a complete response, a partial response, or stable disease (p = 0.05). Strong concordance was found between high serum opn and opn gene mutation in 69 tumours (79.3%), and strong concordance was detected between normal or low serum opn and non-mutant opn in 28 tumours (60.8%). The current prospective work helps to highlight opn as a valid prognostic biomarker for patients with metastatic bca and reveals that high pretreatment serum opn and opn gene mutation are both strongly linked with poor response and survival. Concordance between elisa and pcr results indicates that either method can be used for the evaluation of opn. Increased opn gene mutation in triple-negative bca could assist in tailoring the treatment response in this very aggressive tumour subtype and could be considered a targetable molecule in future studies.

Role of Metformin in Combination with Neoadjuvant Chemotherapy in Treatment of Breast Cancer

Backgound: Globally, breast cancer is the most frequently diagnosed malignancy and the leading cause of cancer death in women. Improvements in chemotherapy, surgery, lymph node evaluation and hormone receptor blocking therapy have successfully doubled the survival of breast cancer patients. Objective: To determine whether metformin use was associated with improvement in pathologic complete response (PCR) rate in patients with breast cancer receiving neoadjuvant chemotherapy. Patients and Methods: This prospective study was conducted at the Clinical Oncology Department, Aswan University and Upper Egypt Hospitals in the period between 1/7/2016 and 1/9/2019. This study included 50 patients divided into 2 groups, test group (metformin group) and standard group (non-metformin group). Histopathology was confirmed by tissue core biopsy. Results: All patients in the two groups in our study achieved either pathological complete response or partial response. No patients developed disease progression or were still stable disease. Among the patients in test group (metformin group), 15 patients (60%) achieved pathological complete response (PCR) while 10 (40%) patients did not achieve PCR. However, among the patients in standerd group (non-metformin group) 9 patients (36%) achieved pathological complete response (PCR) while 16 (64%) patients did not achieve PCR. There was statistically significant difference between the two groups regarding the response with better PCR in metformin group (p value is 0.089). Conclusion: The addition of metformin to neoadjuvant chemotherapy has a significant impact on pathological complete response (PCR) in female patients with advanced breast cancer.

Role of Metformin in Combination with Trastuzumab and Neoadjuvant Chemotherapy in Treatment of HER-2 Positive Breast Cancer

Backgound: HER2 overexpression is a good predictive marker of HER2 targeted therapy, which means that HER2 therapy will be very effective in reducing the size of HER2 positive breast cancers. Therefore, the size of HER2 positive breast cancer can easily be reduced in patients who wish to have a breast-conserving operation, and potentially improves the outcome of patients if pathologic complete response (PCR) can be achieved. Objective: To determine whether metformin use with trastuzumab was associated with improvement in PCR rate in patients with breast cancer receiving neoadjuvant chemotherapy. Patients and Methods: This prospective study was conducted at the Clinical Oncology Department, Aswan University and Upper Egypt Hospitals in the period between 1/7/2016 and 1/9/2019. This study included 30 patients divided into 2 groups, test group (metformin group) and standard group (non-metformin group). Histopathology was confirmed by tissue core biopsy. Results: All patients in the two groups in our study achieved either pathological complete response or partial response. No patients developed disease progression or were still stable disease. Among the patients in test group (metformin group), 12 patients (80%) achieved pathological complete response (PCR) while 3 (20%) patients did not achieve PCR. However, among the patients in standerd group (non-metformin group) 9 patients (60%) achieved pathological complete response (PCR) while 6 (40%) patients did not achieve PCR. There was statistically significant difference between the two groups regarding the response with better PCR in metformin group (p value is 0.089). Conclusion: The addition of metformin to tratuzumab in neoadjuvant chemotherapy has a significant impact on pathological complete response (PCR) in female patients with HER-2 positive breast cancer.