Incidence and severity of acute radiation induced toxicities among breast cancer patients treated with adjuvant radiotherapy at a major cancer treatment center in Ghana.

BACKGROUND: Adjuvant radiotherapy after mastectomy or breast conserving surgery (BCS) is the standard of care for majority of patients with breast cancer. This is however associated with mucosal and epidermal toxicity of organs at risk (OARs). Breast cancer patients are exposed to a plethora of wrong perceptions, misinformation and myths concerning the usefulness and adverse effects of radiotherapy. There is paucity of literature on the incidence and severity of radiation-induced acute toxicities experienced by patients with breast cancer in Ghana. AIM: To assess the occurrence and severity of four main acute radiation-induced toxicities among female breast cancer patients treated with external beam radiotherapy at a major cancer treatment centre in Ghana. METHODS: Data on the occurrence of acute toxicities among patients was collected from patients' medical records, through a semi-structured questionnaire and via weekly clinical assessments. The Common Terminology Criteria for Adverse Events (CTCAE) grading scale (version 4.0) was used to grade the severity of these toxicities. Descriptive and inferential statistics using an independent two-sampled t-test (two-tailed), one-way analysis of variance (ANOVA), Pearson's Chi-square and Fisher's exact tests were performed. RESULTS: Dermatitis, fatigue, pharyngitis, and breast (chest) pain were the radiation toxicities found among the breast cancer patients undergoing treatment on the two machines. The mean predominant radiation doses associated with the onset of dermatitis, fatigue, pharyngitis, and chest pain in the breast cancer patients were 22.32 Gy, 22.48 Gy, 13.59 Gy, and 19.27 Gy respectively for treatment with a statistically significant (p = 0.0173). Radiation dermatitis was the most dominant acute radiation toxicity recorded, and its incidence and severity. The range of Fisher's p-values (0.689-0.999) between the acute radiation toxicities with both machines revealed no statistical significance. CONCLUSION: Radiation dermatitis was the dominant acute toxicity, both in incidence and severity for patients treated. There was no statistical significance in the incidence and severity of acute radiation side effects.

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.

The WHO informal consultation was held to promote the revision of WHO guidelines on evaluation of similar biotherapeutic products (SBPs) adopted by the Expert Committee on Biological Standardization (ECBS) in 2009. It was agreed in the past consultations that the evaluation principles in the guidelines are still valid, but a review was recommended to provide more clarity and case-by-case flexibility. The opportunity was therefore taken to review the experience and identify areas where the current guidance could be more permissive without compromising its basic principles, and where additional explanation could be provided regarding the possibility of reducing the amount of data needed for regulatory approval. The meeting participants applauded the leading role taken by the WHO in providing a much-needed streamlined approach for development and evaluation of SBPs which will provide efficient and cost-effective product development and increase patient access to treatments. It was recognized that the principles as currently described in the draft WHO guidelines are based on sound science and experience gained over the last fifteen years of biosimilar approvals. However, since these guidelines when finalised will constitute the global standard for biosimilar evaluation and assist national regulatory authorities in establishing revised guidance and regulatory practice in this complex area, it was felt that further revision and clarity on certain perspectives in specific areas was necessary to dispel uncertainties arising in the current revised version. This report describes the principles in the draft guidelines, including topics discussed and consensus reached.

Regulation of blood services in Africa.

Blood and blood products save lives and are a part of the WHO Essential Medicines List. Access to safe and quality-assured blood and blood products are essential for health systems strengthening and it is a global concern. Their use is associated with infectious and immunologic risks. At global level, many resolutions have been adopted by the World Health Assembly that urged Member States to ensure regulatory control of access to quality-assured blood and blood products along the entire transfusion chain. The WHO has also developed an action framework to advance universal access to blood. As part of the implementation of these resolutions and guidelines, the WHO Regional Office for Africa and some partners provided support to countries in the region to strengthen their capacity to establish an effective blood regulatory system through organization of regional training workshops on blood regulation, benchmarking of blood regulatory systems, internship at Paul Ehrlich Institut and establishment of the African Blood Regulators Forum. The current status of blood regulation reveals that there are weak transfusion legislation and blood regulatory systems in most African countries, since many national blood transfusion services still rely on self-regulation. However, the national regulatory authorities have reached the maturity level 3 in two countries (Ghana and Tanzania), but only the experience from Ghana has been described in this paper. Like in other low- and middle-income countries, the regulatory systems for associated substances and medical devices including IVDs are not well established in the African region. Misunderstanding by different stakeholders, lack of legislation that provides legal basis, weak capacity and insufficiency of resources are main challenges facing countries to establish an effective national blood regulatory system. To address these challenges, strong advocacy with governments and collaboration with partners are needed to strengthen national blood regulatory systems.

Unsweetened natural cocoa has anti-asthmatic potential.

Unsweetened natural cocoa powder is enriched with nutraceutical abundance of anti-asthmatic compounds theobromine and theophylline. Cocoa powder, which is prepared after removal of the cocoa butter, contains about 1.9% theobromine and 0.21% caffeine. Anecdotal reports indicate that regular consumption of unsweetened natural cocoa powder (UNCP), a common practice in Ghana, West Africa, has the potential to reduce the tendency of asthmatic episodes. In the present paper we studied the effect of regular ingestion of aqueous extract of UNCP on hematological and histopathological changes that occur in ovalbumin (OVA)-sensitized guinea pigs. OVA-sensitized guinea pigs were challenged with aerosolized OVA 1 hour after ingestion of 300 mg/kg (low dose) or 600 mg/kg (high dose) of UNCP for 35 consecutive days. Histopathological and haematological changes in the OVA-sensitized guinea pigs were evaluated. Both negative and positive controls with distilled water and prednisolone, respectively, were used. OVA-sensitized guinea pigs demonstrated concentration-independent reduction in immune response to aerosolized OVA. There were no histo-architectural changes in the bronchiolar smooth muscles of the treated groups. Unsweetened natural cocoa powder has potential anti-asthmatic properties when administered orally at the doses tested.