Knowledge and Attitudes Towards Clinical Trial Participation in Oman: A cross-sectional study

Objectives: Clinical trials are prospective studies on human subjects designed to answer various clinical questions. However, only a limited number of clinical trials have been conducted in Oman. This study aimed to assess the knowledge and attitudes of Omani patients and their relatives towards participating in clinical trials. Methods: This cross-sectional study was conducted between October 2015 and March 2016 among 174 patients and relatives attending the Haematology and Oncology Outpatient Clinics and Day Care Unit of the Sultan Qaboos University Hospital, Muscat, Oman. A self-administered questionnaire was designed to elicit participants’ knowledge of and attitudes towards participation in clinical trials. Results: A total of 100 patients and relatives agreed to take part in the study (response rate: 57.5%). The male-to-female ratio was 1:1.2. Only 31.3% of the studied population knew what clinical trials were and only 6.5% had themselves previously participated in a clinical trial. The majority agreed or strongly agreed that they would participate in clinical trials related to their own condition (59.2%). Overall, 89.7% expected to be informed about potential clinical trials by their treating physicians. Conclusion: Omanis had a low level of knowledge of clinical trials and a very low rate of previous participation in such trials, despite a moderate level of interest. Patients should therefore be educated and informed of ongoing clinical trials in order to improve participation rates for clinical trials conducted in Oman

Outcomes of Women with Non-Metastatic Triple-Negative Breast Cancer in Oman: A single-centre experience

Objectives: Triple-negative breast cancer (TNBC) is one of the most aggressive and heterogeneous variants of breast cancer. However, little is known regarding the prevalence and outcome of this entity in the Middle East. This study aimed to evaluate the outcomes of TNBC patients at a university hospital in Oman. Methods: This retrospective study took place at the Sultan Qaboos University Hospital, Muscat, Oman, in May 2017. All patients diagnosed with non-metastatic TNBC between December 2000 and December 2015 were included. The patients’ electronic medical records were reviewed to identify their clinical and pathological characteristics as well as survival outcomes. Results: A total of 79 patients were diagnosed with non-metastatic TNBC during the study period. The median age was 46 years, with approximately one-third of patients (31.6%) under 40 years of age. Almost half had an advanced tumour size (49.4%) or node-positive disease (48.1%) at presentation and only 16.6% demonstrated a complete pathological response (pCR) to neoadjuvant chemotherapy. The median survival for all patients was not reached within the study period; however, the median overall survival for stage III patients was 44.6 months. The five-year overall survival for all patients was 64%, increasing to 100% and 72% for patients with stage I and II, respectively, and dropping to 47% for those with stage III disease. Conclusion: The findings of this study indicate that the majority of women with TNBC in Oman present at an advanced stage; moreover, such women have low rates of pCR to neoadjuvant chemotherapy and poor five-year survival.Keywords: Breast Cancer; Triple-Negative Breast Cancer; Neoadjuvant Therapy; Survival; Patient Outcome Assessment; Oman

Predictors of Hypersensitivity Reactions to Platinum-Based Chemotherapy in a Tertiary Hospital in Oman: A case-control study

Objectives: Platinum-based compounds (PBC) play an important role in cancer therapy. However, one of the drawbacks of PBC is the occasional occurrence of hypersensitivity reactions (HSR) which can lead to serious consequences. The aim of the study is to estimate the prevalence and evaluate risk factors of HSR to PBC in cancer patients. Methods: A case-control study of patients who received any PBC for the management of non-haematological cancers from 2013 to 2020 at Sultan Qaboos University Hospital, Oman. Data regarding demographic features and diseases and treatment details were collected from the hospital’s electronic patients record. We quantitatively described the data, and Student’s t-test and Wilcoxon Man-Whittney tests were used to detect significant differences. Results: A total of 38 cases and 148 matched controls were studied. The prevalence of HSR to PBC in our cohort was 4.7% (95% confidence interval: 3.33%-6.37%), more with carboplatin compared to cisplatin and oxaliplatin. In our study, female gender (p=0.032), concomitant taxanes (p=0.002) and concurrent radiation (p<0.001) were significant predictors of HSR to PBC. The majority of reactions were of mild to moderate severity and the rechallenge rate after HSR development was 13%. Conclusion: HSR to PBC impact therapy decisions and understanding the risk factors are important to improve treatment outcomes in cancer patients. Keywords: Hypersensitivity; Platinum; Anti-neoplastic; Oncology; Oman

Neoadjuvant Chemotherapy Alters Neuropilin-1, PlGF, and SNAI1 Expression Levels and Predicts Breast Cancer Patients Response

Circulating proteins hold a potential benefit as biomarkers for precision medicine. Previously, we showed that systemic levels of neuropilin-1 (NRP-1) and its associated molecules correlated with poor-prognosis breast cancer. To further identify the role of NRP-1 and its interacting molecules in correspondence with patients' response to neoadjuvant chemotherapy (NAC), we conducted a comparative study on blood and tissue samples collected from a cohort of locally advanced breast cancer patients, before and after neoadjuvant chemotherapy (NAC). From a panel of tested proteins and genes, we found that the levels of plasma NRP-1, placenta growth factor (PlGF) and immune cell expression of the transcription factor SNAI1 before and after NAC were significantly different. Paired t-test analysis of 22 locally advanced breast cancer patients showed that plasma NRP-1 levels were increased significantly (p = 0.018) post-NAC in patients with pathological partial response (pPR). Kaplan–Meier analysis indicated that patients who received NAC cycles and their excised tumors remained with high levels of NRP-1 had a lower overall survival compared with patients whose tissue NRP-1 decreased post-NAC (log-rank p = 0.049). In vitro validation of the former result showed an increase in the secreted and cellular NRP-1 levels in resistant MDA-MB-231 cells to the most common NAC regimen Adriyamicin/cyclophosphamide+Paclitaxel (AC+PAC). In addition, NRP-1 knockdown in MDA-MB-231 cells sensitized the cells to AC and more profoundly to PAC treatment and the cells sensitivity was proportional to the expressed levels of NRP-1. Unlike NRP-1, circulating PlGF was significantly increased (p = 0.014) in patients with a pathological complete response (pCR). SNAI1 expression in immune cells showed a significant increase (p = 0.018) in patients with pCR, consistent with its posited protective role. We conclude that increased plasma and tissue NRP-1 post-NAC correlate with pPR and shorter overall survival, respectively. These observations support the need to consider anti-NRP-1 as a potential targeted therapy for breast cancer patients who are identified with high NRP-1 levels. Meanwhile, the increase in both PlGF and SNAI1 in pCR patients potentially suggests their antitumorigenic role in breast cancer that paves the way for further mechanistic investigation to validate their role as potential predictive markers for pCR in breast cancer

Are Clinical Trial Eligibility Criteria an Accurate Reflection of a Real-World Population of Advanced Non-Small-Cell Lung Cancer Patients?

Background: Advanced non-small-cell lung cancer (NSCLC) represents a major health issue globally. Systemic treatment decisions are informed by clinical trials, which, over years, have improved the survival of patients with advanced NSCLC. The applicability of clinical trial results to the broad lung cancer population is unclear because strict eligibility criteria in trials generally select for optimal patients. Methods: We performed a retrospective chart review of all consecutive patients with advanced NSCLC seen in outpatient consultation at our academic institution between September 2009 and September 2012, collecting data about patient demographics and cancer characteristics, treatment, and survival from hospital and pharmacy records. Two sets of arbitrary trial eligibility criteria were applied to the cohort. Scenario A stipulated Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1, no brain metastasis, creatinine less than 120 μmol/L, and no second malignancy. Less-strict scenario B stipulated ECOG PS 0–2 and creatinine less than 120 μmol/L. We then used the two scenarios to analyze treatment and survival of patients by trial eligibility status. Results: The 528 included patients had a median age of 67 years, with 55% being men and 58% having adenocarcinoma. Of those 528 patients, 291 received at least 1 line of palliative systemic therapy. Using the scenario A eligibility criteria, 73% were trial-ineligible. However, 46% of “ineligible” patients actually received therapy and experienced survival similar to that of the “eligible” treated patients (10.2 months vs. 11.6 months, p = 0.10). Using the scenario B criteria, only 35% were ineligible, but again, the survival of treated patients was similar in the ineligible and eligible groups (10.1 months vs. 10.9 months, p = 0.57). Conclusions: Current trial eligibility criteria are often strict and limit the enrolment of patients in clinical trials. Our results suggest that, depending on the chosen drug, its toxicities and tolerability, eligibility criteria could be carefully reviewed and relaxed

Complications and Management of Totally Implantable Central Venous Access Ports in Cancer Patients at a University Hospital in Oman

Objectives: Totally implantable central venous access ports (port-a-caths) are increasingly used for the safe administration of chemotherapy; however, their use is associated with complications. This study reviews patterns of complications, reasons for premature removal and the duration of the use of port-a-caths in patients receiving cancer treatment at Sultan Qaboos University Hospital (SQUH) and compares the infection rate with the literature and the researchers’ experiences. Methods: This retrospective follow-up study included patients who had received cancer treatment through a port-a-cath and were admitted to SQUH between January 2007 and April 2019. Demographic features, underlying diagnosis, clinical stage, treatment, duration of use and the cause of premature removal of the port-a-cath were recorded. Results: A total of 516 port-a-caths were inserted in 482 cancer patients. The majority of devices were implanted by interventional radiologists (n = 459; 89.0%) and the right internal jugular vein was most frequently accessed (n = 396; 76.7%). The mean indwelling time of a port-a-cath was 288 days (range: 3–1,872 days) for patients with complications and 550 days (range: 7–3,123 days) for patients without complications. Port-a-cath-related infection was the main complication (n = 63; 12.2%). Patient age, gender, treatment intent, underlying diagnosis, clinical stage, chemotherapy regimen, number of treatment courses, operator implanting the port, the type of micro-organism isolated from the port-a-cath and body mass index were significant factors affecting catheter indwelling time (P <0.05). On multivariate analysis, however, none of the factors was found to be significant. Conclusion: Infection was the most common complication necessitating port-a-cath removal. The infection rate was much lower than the researchers’ previous experience and compares favorably with several published reports.   KEYWORDS Port-A-Cath; Vascular Access Ports; Catheter-Related Infections; Cancer; Oman