Impact of pharmacist's intervention on decreasing erlotinib interactions in the treatment of lung cancer patients in low resource settings.

BACKGROUND: This study aimed to demonstrate that having clinical pharmacist as a member of oncology team in low and middle income countries might lead to significant reduction in the number of erlotinib interactions in the treatment of non-small cell lung cancer patients. METHODS: A group of 44 patients was labeled as intervention group and they were analyzed prospectively in the period from 1 January 2017 to 1 May 2018 during clinical pharmacist's participation in regular weekly multidisciplinary oncology team meetings. The control group consisted of 44 out of 110 patients treated with erlotinib before the involvement of a clinical pharmacist in oncology team, match paired with 44 patients in intervention group. RESULTS: Clinically significant interactions were identified in two-thirds of studied patients (57 out of 88). Most drug interactions, 38%, potentially result in decrease of serum concentration of erlotinib. Clinical pharmacist provided therapy modification suggestions for 32 out of 44 (72.72%) patients in the intervention group, most of which were accepted by doctors. In the intervention group, there were significantly less clinically significant interactions compared to the control group (10 versus 24, p = 0.002). Progression-free survival was significantly longer in the pharmacist's intervention group (p = 0.001). CONCLUSIONS: Clinical pharmacist's intervention led to significant decrease in erlotinib interactions which may result in treatment optimization of lung cancer patients.

The Influence of Different Risk Factors on COVID-19 Outcomes in Adult Patients - An Observational-Descriptive Study.

OBJECTIVE: The aim of our study was to investigate the predictors of morbidity (age, gender, smoking habits, obesity and the presence of chronic diseases) and COVID-19 outcomes. SUBJECTS AND METHODS: The research was an observational descriptive study, conducted at The Family Medicine Education Center, The Primary Health Care Center, Banja Luka, in the period from 26th June to 31st December 2020. During the research period, seven family medicine teams followed their patients with COVID- 19, and recorded possible predictors for morbidity and their influence on the disease outcome. RESULTS: The study included 934 patients, 46.90% of whom were male. The majority of subjects were non-smokers and overweight. Diabetes was found in 5.57% patients, hypertension in 29.44%, chronic respiratory diseases in 5.25%, cancer in 4.39% patients. In the observed sample, 29.23% subjects contracted pneumonia, 18.52% were hospitalized, while 19 (2.03%) patients with severe clinical features had a fatal outcome. Multivariable regression analysis showed a high risk of pneumonia in male patients [OR=2.45, 95% CI (1.73- 3.46)], elderly [OR=1.07, 95% CI (1.06-1.09)] and obese patients with Body Mass Index ≥30.0 kg/m2 [OR=2.55, 95% CI (1.73- 3.77)]. Male gender [OR=2.19, 95% CI (1.11-4.31)], older age [OR=1.08, 95% CI (1.05-1.11)] and hypertension [OR=2.51, 95% CI (1.06-5.91)] were the most important predictors for the development of severe clinical features in COVID 19. The statistically significant predictors of mortality were male gender [OR=7.16, 95% CI (1.56-32.86)] and older age [OR=1.12, 95% CI (1.06-1.18]. CONCLUSION: Being familiar with the predictors of morbidity and poor outcome in COVID-19 is helpful for carrying out preventive measures, early diagnosis and treatment of risk groups of patients.

Screening of undiagnosed depression among elderly primary care patients: a cross-sectional study from the Republic of Srpska, Bosnia and Herzegovina.

Aim To examine the prevalence of undiagnosed depression among primary care elderly patients in the entity of the Republic of Srpska (Bosnia and Herzegovina) as well as the sociodemographic and clinical risk factors associated with depression. Methods A cross-sectional study was conducted between April and June 2019 in nine towns of the Republic of Srpska. The study sample included 1,198 primary care patients older than 65 years of age. Research instruments included a sociodemographic questionnaire and Geriatric Depression Scale - Short Form (GDS-SF). Results Positive screening test (GDS-SF score > 5), which indicates depression was found in 484 (40.4%) participants. Multivariate regression analysis showed that lower education levels [OR = 1.565, 95% CI (1.13-2.17)], divorced and widowed [OR = 1.366, 95% CI (1.16-1.62)], poor financial situation [OR = 1.690 , 95% CI (1.25-2.29)], non-home residents [OR = 2.200, 95% CI (1.41- 3.44)], non-hobby patients [OR = 2.115, 95% CI (1.54-2.91) ], non-friends [OR = 3.881, 95% CI (2.70-5.57)], patients suffering from chronic pain [OR = 2.414, 95% CI (1.72-3.39)], patients with daily life limitation activities [OR = 1.415, 95% CI (1.03-1.95)], patients with three or more chronic diseases [OR = 1.593, 95% CI (1.12-2.27)], patients using five or more drugs [OR = 1.425. 95% CI (1.00-2.03)], and patients with history of previous depression [OR = 2.858, 95% CI (1.94-4.21)] were at higher risk for depression. Conclusion The prevalence of undiagnosed depression in the elderly in Republic of Srpska is high. Future strategies are needed to strengthen screening of geriatric depression in primary health care.

Correlation of demographic, histological and molecular characteristics and clinical course of the disease in patients with lung adenocarcinoma.

Aim Retrospective analysis of disease clinical course with a purpose of defining potential prognostic parameters which are essential for optimal target therapy. Methods The study involved 29 patients with histologically confirmed lung adenocarcinoma and existing epidermal growth factor receptor (EGFR) mutations, which are treated by tyrosine kinase inhibitors (TKI). Results Allegations of a larger prevalence in women and non-smokers were found. The study confirmed dominance of mutations on exon 19 and exon 21. Usefulness of the treatment with erlotinib in terms of increasing survival time was evident. Median survival of patients in the survey sample was 14.5 months. Median survival in relation to gender or smoking status did not show statistical significance. Conclusion Considering obtained results, we have confirmed that patients with advanced lung adenocarcinoma and present mutations of epidermal growth factor receptor, who had been treated with first generation TKI, had median survival time of over a year.

Our experiences with erlotinib in second and third line treatment patients with advanced stage IIIB/ IV non-small cell lung cancer.

HeadHER1/EGFR is known to play a pivotal role in tumorigenesis and is overexpressed in up to 80% of NSCLCs. The study of an Expanded Access Clinical Program of Erlotinib in NSCLC is a phase IV open-label, non-randomized, multicenter trial in patients with advanced (inoperable stage IIIb/IV) NSCLC who were eligible for treatment with erlotinib but had no access to trial participation. Patients for the study from Bosnia and Herzegovina (B&H) were selected from two Clinical centres (Sarajevo and Banja Luka). The aim of study was to evaluated efficacy and tolerability of erlotinib monotherapy in this setting. All patients who received at least one dose of erlotinib and data were entered in the database as of the CRF cut-off date of 14th May 2008 were included in analysis of data (n = 19). This population is defined as the Intent to Treat (ITT) population and includes all patients who had at least one dose of erlotinib regardless of whether major protocol violations were incurred. The findings are consistent with the results of the randomized, placebo-controlled BR.21 study. Indicating that erlotinib is an effective option for patients with advanced NSCLC who are unsuitable for, or who have previously failed standard chemotherapy. In B&H group of patients DCR was almost 84%, and PFS was approximately 24,7 weeks (compared with 44% and 9,7 weeks for erlotinib reported in phase III). Almost three quarter of the patients received erlotinib as their second line of therapy. Overall, erlotinib was well tolerated; there were no patients who withdrew due to a treatment-related AE (mainly rash) and there were few dose reductions. 24% of patients experienced an SAE (most commonly gastrointestinal (GI) disorders).

[Assessment of recombinant human thyrotropin application in following-up patients with well-differentiated thyroid carcinoma].

BACKGROUND/AIM: The most sensitive indicators for detecting recurrence of well-differentiated thyroid cancer (DTC) are 131I whole body scintigraphy (WBS) and measurement of serum thyroglobulin (Tg). In order to perform it, it is necessary to raise the level of endogenous tiroid-stimulating hormon (TSH), which can be achieved by L-thyroxine withdrawal for 3-5 weeks or administration of recombinant human thyrotropin (rhTSH) without requiring the discontinuation of thyroid hormone therapy. The aim of this study was to assess the effect of rhTSH using in comparison to the traditional thyroid hormone withdrawal in the follow-up of patients with DTC. METHODS: This retrospective study included 44 patients, mean age 48.8 years, with DTC divided into 2 groups. The group I consisted of patients (n = 31) in which the analysis in the follow-up (WBS with 131I, TSH, Tg and antiTgAt) made in the hypothyroid state, and group II patients (n = 13) in which they made after the administration of rhTSH. The presence of 13 symptoms and signs of hypothyroidism was investigated on the day of giving 131I. Quality of life was evaluated using a modified form: the quality of life scale (SF-36) completed on the day of giving 131I. RESULTS: In both groups, serum TSH reached a very good stimulation level, but significantly higher in the group II (group I 30.3-101.5 microlU/mL, group II 68.6-192.0 microlU/mL, p < 0.05). In both groups, TSH-stimulated Tg was higher (group I 0.1-546.0 ng/mL, group II 0.1-7517 ng/mL) comapred to value during the L-thyroxine therapy (group I 0.1-495.0 ng/mL, group II 0.1-2785 ng/mL). There was no difference in technical quality of WBS obtained from both groups. The patients in the group I had attended 8-13 symptoms of hypothyroidism, while patients in group II did not have symptoms of hypothyroidism. The patients after application of rhTSH, showed statistically significantly better quality of life as compared with those who showed to have L-thyroxine withdrawal, (74-91 points vs 43-62 points; p < 0.05). The rhTSH was well tolerated, with nausea occurring in only one patient. CONCLUSION: Administration of rhTSH in the follow-up of patients with DTC prevents the debilitating effects of hypothyroidism contributing to the maintenance of metabolic homeostasis of the organism and preserves the quality of life. RhTSH is safe, effective and easy to use, but is still an expensive product in our country.

Changes in spirometry over time in uremic patients receiving long-term hemodialysis therapy.

Complications of respiratory system in patients suffering from chronic renal failure who are treated with regular haemodialysis are well known. However, the influence of the duration of haemodialysis on pulmonary function is less understood. The aim of this study was to determine spirometry changes in patients on chronic haemodialysis over a five-year period. We tested 21 patients, out of which 11 female and 10 male, mean age of 50 (+/- 11) years. The mean duration of haemodialysis was 52.2 (+/- 44.7) months at the time of the inclusion. We performed spirometry testings in all patients, one hour before start and one hour after completion of haemodialysis. All parameters of spirometry recorded one hour after completion of haemodialysis (FVC, FEV1, FEF75, 50, 25, % of predicted), improved significantly (p < 0.01). After five years, only FVC demonstrated significant decline and none of the recorded spirometry parameters improved significantly one hour post haemodialysis compared to pre-haemodialysis period. Analysis of post-dialysis parameters of spirometry at the study onset and following five years of haemodialysis showed that all parameters, except FEF50 (p > 0.05), significantly deteriorated (p < 0.01). Patients who are on long-term haemodialysis show a significant decline in FVC following five years of treatment. Although the spirometry changes in observed population treated with chronic haemodialysis have reversible character during the first years of renal replacement therapy, five years after these changes become irreversible.