Plain language review: what are biosimilar medicines and how can they be used to treat people with cancer?

WHAT IS THIS SUMMARY ABOUT?: The aim of this plain language review article is to help you to understand biosimilar medicines (called biosimilars) by giving a summary of biologic medicines and biosimilars. It is based on the experience of an international panel of physicians with expertise on biosimilars who discussed and agreed on the topics and information included in this review article. Biologic medicines are medicines that come from living organisms such as bacteria and animal or plant cells. Biosimilars are a group of approved biologic medicines that are similar to original biologic medicines that are already available. This review explains how biosimilars are developed and approved, and how they are used to treat people with cancer. It also answers some common important questions people with cancer might have when taking biosimilars. The purpose of this plain language review is to help you to understand the findings from recent research. This review reports information from peer-reviewed literature and other sources available in the public domain (e.g., regulatory documents or product information labels). The findings may differ from those of other review articles. Health professionals should make treatment decisions based on all available evidence.

The first Middle East and North Africa expert consensus recommendations for the management of advanced colorectal cancer.

Colorectal cancer (CRC) is ranked as the third most prevalent and the second deadliest cancer worldwide. In the Middle East and North Africa (MENA) region, the number of CRC cases increased over the past decades and will nearly double by 2030. The lack of clear MENA guidelines for the management of patients with CRC represents a step backwards in the fight against this burden. Therefore a panel of 24 MENA experts in the field of gastrointestinal oncology developed, using a Delphi process, the first consensus recommendations for the management of patients with advanced CRC. Forty-seven different statements were formulated in the areas of epidemiology, screening, biomarkers and treatment. These recommendations will guide, standardize and unify the management of this cancer in the MENA region.

Clinical value of peripheral blood M2/M1 like monocyte ratio in the diagnosis of breast cancer and the differentiation between benign and malignant breast tumors.

BACKGROUND: During tumor progression, circulating monocytes and macrophages are actively recruited into tumors where they alter the tumor microenvironment to accelerate tumor progression. In response to multiple microenvironmental signals from the tumor and stromal cells, macrophages change their functional phenotypes. Based on their function, macrophages are commonly classified into both, classical M1 and alternative M2 macrophages. M2-like tumor-associated macrophages promote breast tumor growth and survival, and may migrate into the peripheral blood. However, the level of circulating M2/M1-like monocyte ratio in the peripheral blood of breast cancer patients has not been yet clarified. AIM: To compare peripheral blood M2/M1 monocyte ratio among breast cancer patients, benign breast tumor patients and healthy subjects. Also, to investigate the role of peripheral blood M2/M1 monocyte ratio as a circulating breast cancer tumor marker and to asses the validity of this marker in differentiation between benign and malignant breast tumors. METHODS: Flow cytometry technique was used to determine the peripheral blood M2/M1 monocyte ratio in three groups of subjects, i.e. 45 patients with breast cancer, 40 patients with benign breast tumor, and 40 healthy subjects as a control group. The results of carbohydrate antigen15-3 (CA15-3) determination were analyzed comparatively. RESULTS: The peripheral blood M2/M1 monocyte ratio in patients with breast cancer (0.27±0.1) was significantly higher (P<0.001) than that in healthy subjects (0.07±0.05) and than in benign tumor subjects (0.08±0.04). The area under the receiver operating characteristic (ROC) curve of peripheral blood M2/M1 monocyte ratio determination was significantly higher (P≤0.001) than that of CA15-3 levels. CONCLUSION: M2/M1-like monocyte ratio is of a high diagnostic value for breast cancer and is a promising differentiating marker between benign and breast cancer tumor groups.

The diagnostic power of circulating micro ribonucleic acid 34a in combination with cancer antigen 15-3 as a potential biomarker of breast cancer.

OBJECTIVES: To investigate the circulating levels of microRNA-34a (miRNA-34a) as a novel non-invasive biomarker of breast cancer (BC). Methods: The case-control study was conducted at the Department of Chemistry and Biochemistry, College of Medicine, Al-Nahrain University, Baghdad, Iraq, from December 2018 to April 2019. Real-time quantitative polymerase chain reaction has been employed to analyze miRNA-34a expression in the samples of serum from 90 participants (30 patients with BC 30 patients with benign breast tumors and 30 control subjects) after RNA extraction and reverse transcription. Cancer antigen 15-3 (CA15-3) and carcinoembryonic antigen (CEA) were measured by ELISA. Additionally, we analyzed the receiver operating characteristic curves of various markers, including miRNA -34a, CA15-3, and CEA, to assess the diagnostic power of each marker.  Results: The expression of miRNA-34a has been significantly lower in the group of breast cancer compared with that in the group of control, and miRNA-34a expression has been significantly reduced in the group of benign breast tumor compared as that in the group of control. Receiver operating characteristics analysis showed a very good discriminative power of combined miRNA-34a and CA15-3 (specificity=77.7%; sensitivity=83.3% and areas under the curve =0.842) for BC patients. Conclusion: MicroRNA-34a expression is significantly decreased in the patients' serum with the cancer of breast, and miRNA-34a can be employed as a potential non-invasive molecular marker for the early diagnosis of BC.

Serum anti-müllerian hormone levels in evaluation of chemotherapy effect on ovarian reserve in women with breast cancer. A follow-up study.

OBJECTIVES: To investigate the role of serum anti müllerian hormone (AMH) pre-chemotherapy treatment levels in prediction of post-chemotherapy effect on the ovarian reserve of women with breast cancer. METHODS: This cohort prospective study was carried out at the Biochemistry Department, College of Medicine, University of Baghdad and at the Oncology Clinic, Oncology Teaching Hospital, Baghdad, Iraq. It included 58 women with regular menstrual cycle (25-45 years) who were  newly diagnosed with breast cancer. The women were classified into 3 groups: GI: 30 women with breast cancer before starting chemotherapy, GII: the same 30 women of GI who finished 4 cycles of anthracycline chemotherapy (course 1) and GIII: which involved another 28 women who had finished both courses of chemotherapy, (course 1) and (course 2). RESULTS: The mean (±SEM) value of AMH levels was significantly decreased in GII and GIII when compared with GI (for both, p less than 0.0005). However, there was no significant difference in serum AMH levels between GII and GIII. CONCLUSION: The measurement of serum AMH may be a useful biochemical marker of the chemotherapy extent induced ovarian reserve damage and the incidence of amenorrhea.

Epidemiological and prognostic single center study of anal carcinoma / Estudo epidemiológico e prognóstico em um único centro de carcinoma anal

Abstract Background: Anorectal carcinoma includes the anal margin, the anal canal, and the lower rectum. The incidences of anal tumors represent 1.4 % of all gastrointestinal tumors. Patients and methods: Our study is retrospective and was conducted at Baghdad Medical City. Patient's data were collected from the medical records through a predesigned sheet that included the following information: demographic data, medical history, past-history, presenting symptoms, pathological data, and treatment details. Results: The median age was 49 years. As regard tumor extension, 85.71 % of patients had anal disease, while anorectal cancer was encountered in 14.28 % of cases only. Male to female ratio was 1:3. Most of cases were SCC 78.57 %. Only 11 patients (39.28 %) were diagnosed as Stage I, whereas 12 patients (42.85 %) had Stage II-III disease. Moderate differentiated tumors are the most common. The tumor mass located between 5-10 cm das a distance from anal verge in 12 (42.85 %) of patients. We found 6 (21.42 %) patients with positive virology tests with no specificity detected. APR was the mainstay for treatment of stage I disease. Neoadjuvant treatment followed by TME resection was the treatment found in locally advanced tumors. The mean Overall Survival (OS) for patients received neoadjuvant CRT in the study was 43.5 months, while, the mean OS was 45.73 months in the adjuvant setting. Univariate analysis for OS according to prognostic factors revealed that sites of cancer, grades and histopathology were significant independent prognostic factors for OS in this study. The anal canal tumor was associated with shorter OS (33.25) months in comparison to the anorectal cancer (OS = 47.22 months). Based on tumor grade, well and moderate differentiation have better OS (60.21 months) while, poorly grade was associated with shorter OS (43.07 months). On the concern of SCC, it was associated with shorter OS (37 months) in comparison to higher survival in patients with adenocarcinoma (46.13 months). Conclusion: Anal canal cancer has poorer prognosis than anorectal. The early-stage has a better OS that needs more effort for early diagnosis and treatment.

Resumo Antecedentes: O carcinoma anorretal inclui a margem anal, o canal anal e o reto inferior. A incidência de tumores anais representa 1.4 % de todos os tumores gastrointestinais. Pacientes e métodos: Nosso estudo é retrospectivo e foi realizado no Baghdad Medical City. Os dados do paciente foram coletados dos registros médicos por meio de uma folha pré-projetada que incluía as seguintes informações: dados demográficos, histórico médico, histórico anterior, sintomas de apresentação, dados patológicos e detalhes do tratamento. Resultados: A idade média foi de 49 anos. Quanto à extensão do tumor; 85,71 % dos pacientes apresentavam doença anal, enquanto o câncer anorretal foi encontrado em 14,28 % dos casos. A proporção homem/mulher foi de 1:3. A maioria dos casos foi de CEC 78,57 %. Apenas 11 pacientes (39,28 %) foram diagnosticados como Estágio I, enquanto 12 pacientes (42,85 %) apresentavam doença em Estágio II?III. Tumores diferenciados moderados são os mais comuns. A massa tumoral localizada entre 5-10 cm das distâncias da margem anal em 12 (42,85 %) dos pacientes. Foram encontrados 6 (21,42 % pacientes com testes virológicos positivos sem especificidade detectada. A TAEG foi a base para o tratamento da doença em Estágio I. O tratamento neoadjuvante seguido pela ressecção do TME foi o tratamento encontrado em tumores localmente avançados. A sobrevida global média OS dos pacientes que receberam TRC neoadjuvante no estudo foi de 43,5 meses, enquanto a OS média foi de 45,73 meses no cenário adjuvante. A análise univariada para OS de acordo com fatores prognósticos revelou que locais de câncer, notas e histopatologia foram fatores prognósticos independentes significativos para OS neste estudo. O tumor do canal anal foi associado a SG mais curtos 33,25 meses em comparação ao câncer anorretal OS = 47,22 meses. Com base no grau do tumor, a diferenciação boa e moderada apresenta melhor OS 60,21 meses, enquanto o grau ruim foi associado a um OS mais curto 43,07 meses. No que diz respeito ao CEC, este foi associado a uma OS mais curta 37 meses em comparação à maior sobrevida em pacientes com adenocarcinoma 46,13 meses. Conclusão: O câncer de canal anal tem pior prognóstico que o anorretal. O estágio inicial tem um sistema operacional melhor que precisa de mais esforço para diagnóstico e tratamento precoces.

Patrón de agregados de cáncer entre familias en Irak / Cancer Aggregates Pattern among Families in Iraq

Breast cancer is first ranking malignancies in Iraq. Family history of cancer is an important factor for cancer occurrence and development in next generation. The study aimed to determine the validity of family history of cancer by population-based and clinic-based family registries, evaluate the concurrence of cancer affected by family history in their first-, and second-degree relatives. An observational studies of total 62 relatives membered of 44 Iraqi breast cancer families were included. We conducted study at period between December 2018 and June 2019. Data collected according NCCN Genetic Testing Criteria for Hereditary Breast and Ovarian Cancer Syndrome. Risk ratio (RR) used to evaluating predilection of family cancer risk. We addressed forty-four Iraqi breast cancer families who have sixty-two members with cancer. The age mean±SD was 51.8±12.6, and median=48.5 years. Meanwhile the age mean±SD= 51.6±11.9 years for relatives. M:F ratio equal to 3:1. Sister, mother and aunt/uncle were most common relative affected. Breast cancer represented the most frequent types found in 46.7% of patients. Mothers (RR=1.313), and/or sisters (RR=1.6), lead to increased risk of cancer development in other family members or next generation. The first degree relatives recorded more than the second degree relatives. This is the first study conducting in Iraq dealing with cancer risk at the level of families. The age of patients didn't differ from age at diagnosis, concluding there is no active screening programs run through Iraqi families. Sister, mother and aunt/uncle are the most relatives affect. The 1st-degree relatives more frequent than the 2nd-degree. Breast cancer represented the most common types found members studied. Mothers and sisters have highly risk ratio for developing family cancer among other individuals.

Rectal cancer and chemoradiation in Iraq: systematic review and meta-analysis / Câncer retal e quimiorradioterapia no Iraque: revisão sistemática e metanálise

Abstract Background: Rectal cancer is one of the most common malignant tumors of gastrointestinal tract. Combining chemotherapy with radiotherapy has a sound effect on its management. Objectives: Assessment the patterns of characterizations of rectal cancer. Evaluation of the efficacy, and long-term survival of pre-/ postoperative chemoradiation. Collecting all eligible evidence articles and summarize the results. Methods: By this systematic review and meta-analysis study, we include data of chemoradiation of rectal cancer articles from 2015 until 2019. The research was carried out at Baghdad Medical City oncology centers. Accordance with the PRISMA guidelines, and the Newcastle-Ottawa Scale used. Results: Starting with gender distribution as M:F ratio of 0.94:1.06. Regarding the age, recorded mean ± SD of 48.7 ± 14.2 years. Rectosigmoid represented the most common site as 50(49.5%), and adenocarcinoma was common histopathology as 76(75.2%) of patients, with localized stage in 50(49.5%). The moderate differentiation was most grade as 65(64.4%). The distant from anal verge mostly seen was 5-10 cm in 59(58.4%). The pulmonary was commonest site of metastasis in 11(10.9%). Most patients undergo APR operation, which has done in 41(40.6%). Adjuvant chemoradiation received by 40(39.6%) patients, whereas neoadjuvant chemoradiation gave to 25 patients. A total of 2609 articles from 12 databases met our search strategies. The highest Newcastle-Ottawa score (8) demonstrated in three studies, and median score (7) calculated in five studies. Conclusions: The incidence belonged to 5th and 6th decade of life. Rectosigmoid represented the most common site. Mostly, the 5-10 cm distant of tumor from anal verge was common finding. The pulmonary was most site of metastasis. We concluded the formulation of a novel point that survival benefit found in many pre or postoperative chemoradiation trials in rectal cancer.

Resumo Introdução: O câncer retal é um dos tumores malignos mais comuns do trato gastrointestinal. A combinação de quimioterapia e radioterapia em seu tratamento é eficaz. Objetivos: Avaliar os padrões de caracterização do câncer retal. Avaliar a eficácia e sobrevida a longo prazo em pacientes submetidos a quimiorradioterapia pré- ou pós-operatória. Coletar todos os artigos de evidências qualificados e resumir os resultados. Métodos: Esta revisão sistemática e metanálise incluiu dados de ensaios clínicos randomizados por cluster de 2015 até 2019. A pesquisa foi realizada nos centros de oncologia do Baghdad Medical City. As diretrizes PRISMA e a escala de Newcastle-Ottawa foram utilizadas para avaliar os estudos. Resultados: Quanto à distribuição por sexo, observou-se uma relação homem:mulher de 0,94:1,06. Em relação à idade, a média ± DP foi de 48,7 ± 14,2 anos. O retossigmoide fpo o local mais comum em 50 pacientes (49,5%); a histopatologia mais comum foi adenocarcinoma, observada em 76 pacientes (75,2%), com estágio localizado em 50 (49,5%). Diferenciação moderada foi observada em 65 pacientes (64,4%). A distância da borda anal variou entre 5 e 10 cm em 59 pacientes (58,4%). O pulmão foi o local mais comum de metástase, sendo observado em 11 pacientes (10,9%). A maioria dos pacientes (41 [40,6%]) foi submetida à ressecção abdominoperineal. Um total de 40 pacientes (39,6%) foram submetidos a quimiorradioterapia adjuvante e 25, a quimiorradioterapia neoadjuvante. Na revisão da literatura, foram encontrados 2.609 artigos que atendiam aos critérios de pesquisa utilizados em 12 bancos de dados. Três estudos atingiram o escore máximo na escala de Newcastle-Ottawa (8); cinco estudos atingiram o escore mediano (7). Conclusões: No presente estudo, a maior incidência de câncer retal foi observada entre a quinta e sexta décadas de vida. O retossigmoide foi o sítio tumoral mais comum. A maioria dos tumores estava localizado entre 5 a 10 cm de distância da margem anal. O pulmão foi o local mais importante de metástase. No presente estudo, quimiorradioterapia pré- ou pós-operatória estava relacionada a uma maior sobrevida em casos de câncer retal.