The Incidence of Hematological Toxicities in Colorectal Cancer Patients Treated With Fluoropyrimidine-Based Regimens at Princess Noorah Oncology Center.

Background Fluoropyrimidine-based regimens are used for the management of colorectal cancer, which is the second most common cancer in Saudi Arabia. We aimed to study the incidence of hematological toxicities in colorectal cancer patients treated with fluoropyrimidine and fluoropyrimidine-based regimens at Princess Noorah Oncology Center, King Abdulaziz Medical City- Jeddah, Saudi Arabia.  Methods A retrospective cohort study that included adult colorectal cancer patients who were treated with fluoropyrimidine-based regimens from January 1, 2018 to December 31, 2018 at Princess Noorah Oncology Center, Jeddah, Saudi Arabia was performed. Our primary objective was to determine the incidence of anemia, neutropenia, and thrombocytopenia in colorectal cancer patients treated with fluoropyrimidines and fluoropyrimidine-based regimens. Secondary objectives were to assess the grade of hematological toxicities associated with 5-fluorouracil (5-FU) use and to determine the frequency of unplanned hospital admissions or emergency department (ED) visits after receiving fluoropyrimidine-based regimens. The collected data contained patients' characteristics (weight, height, age, gender, and diagnosis), chemotherapy agents, and hematological toxicity-related findings such as absolute neutrophil count, hemoglobin, platelet count, and number of ED visits or hospital admissions during fluoropyrimidine-based chemotherapy regimens. Results Of the 570 cycles of the fluoropyrimidine-based regimen received by 68 patients, hematological toxicities were observed in 508 (89.1%) cycles, and grade ≥ 3 grade toxicities were found in 46 (8.1%) cycles. The results demonstrated a statistically significant difference in the incidence of grade 3-4 neutropenia between patients who received bolus administration of 5-FU and those who did not (8.5% vs. 2.3% respectively, p=0.025). The incidence of grade 3-4 anemia was higher in the bolus group (11.3%) compared to the group where bolus was omitted (4.6%); however, the difference was not statistically significant (p=0.059). Furthermore, there was no significant difference among the two groups for grade 3 and grade 4 thrombocytopenia (0.0% with bolus given and 0.7% with bolus omission p=1.00). Conclusion Our retrospective study showed that there have been significantly higher grade 3-4 hematological toxicities observed with bolus administration of 5-FU, which confirms the previous reports.

Comparison of Biosimilar Filgrastim with Innovator Fligrastim for Peripheral Blood Stem Cells Mobilization, Collection of CD34+ Stem Cells, and Engraftment in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation: A Single-Center Experience.

BACKGROUND In the Middle East, there is lack of data on peripheral blood CD34+stem cells mobilization by using biosimilar filgrastim. We have been using both Neupogen and a biosimilar G-CSF) Zarzio® (as a mobilizing agent since February 2014 for both allogenic and autologous stem cell transplantations. MATERIAL AND METHODS This was a single-center retrospective study. All patients and healthy donors who received either the biosimilar G-CSF (Zarzio®) or original G-CSF (Neupogen®) for mobilization of CD34+ stem cells were included in the study. The primary goal was to determine and compare the rate of successful harvest and amount of CD34+ stem cells collected in either adult cancer patients or healthy donors between Zarzio® and Neupogen® groups. RESULTS A total of 114 patients, including 97 cancer patients and 17 healthy donors, underwent successful CD34+ stem cell mobilization using G-CSF with chemotherapy (35 with Zarzio® +chemotherapy, 39 with Neupogen® +chemotherapy) or G-CSF as monotherapy (14 with Zarzio®, 9 with Neupogen®) in autologous transplantation. In an allogeneic stem cell transplantation, successful harvest was achieved by using G-CSF monotherapy (8 with Zarzio®, 9 with Neupogen®). There was no difference between Zarzio® and Neupogen® in the amount of CD34+ stem cells collected at leukapheresis. There was no difference with regards to secondary outcomes between the 2 groups. CONCLUSIONS Our study showed that biosimilar G-CSF (Zarzio®) has comparable efficacy to the original G-CSF (Neupogen®) when used for mobilization in both autologous and allogenic stem cell transplantation and was associated with significant cost saving.

Real-World Experience of Monitoring Practice of Endocrinopathies Associated with the Use of Novel Targeted Therapies among Patients with Solid Tumors.

BACKGROUND: Cancer treatments have gradually evolved into targeted molecular therapies characterized by a unique mechanism of action instead of non-specific cytotoxic chemotherapies. However, they have unique safety concerns. For instance, endocrinopathies, which are defined as unfavorable metabolic alterations including thyroid disorders, hyperglycemia, dyslipidemia, and adrenal insufficiency necessitate additional monitoring. The aim of this study was to assess the prevalence of monitoring errors and develop strategies for monitoring cancer patients who receive targeted therapies. METHOD: A retrospective chart review was used to assess the prevalence of monitoring errors of endocrinopathies among cancer patients who received targeted therapies over one year. All of the adult cancer patients diagnosed with a solid tumor who received targeted therapies were included. The primary outcome was to determine the prevalence of monitoring errors of endocrinopathies. The secondary outcomes were to assess the incidences of endocrinopathies and referral practice to endocrinology services. RESULTS: A total of 128 adult patients with solid tumors were involved. The primary outcome revealed a total of 148 monitoring errors of endocrinopathies. Monitoring errors of the lipid profile and thyroid functions were the most common error types in 94% and 92.6% of the patients treated with novel targeted therapies, respectively. Subsequently, 57% of the monitoring errors in the blood glucose measures were identified. Targeted therapies caused 63 events of endocrinopathies, hyperglycemia in 32% of the patients, thyroid disorders in 15.6% of them and dyslipidemia in 1.5% of the patients. CONCLUSION: Our study showed a high prevalence of monitoring errors among the cancer patients who received targeted therapies which led to endocrinopathies. It emphasizes the importance of adhering to monitoring strategies and following up on the appropriate referral process.

Safety and discontinuation rate of immune checkpoint inhibitors used in patients with solid and hematological malignancies. A population based retrospective analysis.

BACKGROUND: The discovery of immune checkpoint inhibitors caused a paradigm shift in cancer treatment and led to a major improvement in clinical outcomes. However, they may induce inflammatory side effects that are known as immune-related adverse effect (iRAE). This study aimed to assess the safety profile and discontinuation rate of immune checkpoint inhibitors in cancer patients. METHODS: Adult cancer patients ≥18 years who received at least one dose of immune-checkpoint inhibitor (ICI) were included. The primary endpoint was the rate of permanent discontinuation of immune checkpoint inhibitors due to immune-related adverse effects. The secondary endpoints were rate and type of specific organ iRAEs, interventions used to treat specific organ iRAEs, and discontinuation rate of immune checkpoint inhibitors due to disease progression. RESULTS: A total of 75 patients were included in the study with a median age of 60 years [IQR: 46-72 years]. Of 75 patients, 7 patients (9.33%) have permanently discontinued ICIs due to immune-related adverse effects. Seven iRAEs occurred in the 7 patients who have permanently discontinued ICIs. Steroids were the main treatment used for 8 patients, followed by levothyroxine for 2 patients and one patient did not receive any medication. The discontinuation rate due to disease progression was reported in 32 patients (42.66%). CONCLUSION: Immune checkpoint inhibitors were well tolerated in the majority of our patient population with a comparable rate of immunerelated adverse effects in comparison to the published data. Corticosteroids were fundamentally used to treat immune-related adverse effects.

Emerging Role of Biosimilars in Oncology-Hematology in Saudi Arabia: A Practical Perspective.

Biologics are significant drivers of globally escalating healthcare costs. Biosimilars have potential to offer cost savings with comparable efficacy and safety to innovator products and increase the access of treatment to more patients. This study aimed to increase understanding and perception of biosimilars concept. It also described the pharmacoeconomic impact of biosimilar in oncology and formulary consideration of oncology biosimilars substituting with their originators in major oncology centers in the Saudi Arabia. A biosimilar is a biological product that is similar to a reference biopharmaceutical product. As the manufacturing process hinders the ability to identically replicate the structure of the original product, biosimilar cannot be described as an absolute equivalent of the original medication. Different regulatory agencies such as United States Food and Drug Administration, European Medicines Agency, and Saudi Food and Drug Authority have approved several biosimilars of oncology biologics. The experience of biosimilar use in Europe and USA provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving access without compromising patient outcomes. There is a need for increasing awareness about biosimilars to improve acceptance rates. The use of biosimilar filgrastim in Ministry of National Guard Health Affairs, Saudi Arabia, has resulted in a significant cost saving annually. It was proposed that further substitution and switching to biosimilars in oncology would lead to major savings in resources.

Comparison of the effectiveness of venous thromboembolism prophylaxis with enoxaparin between obese and non-obese patients.

OBJECTIVE: The purpose of this study is to compare the incidence of venous thromboembolism between obese and non-obese hospitalized patients who received United States Food and Drug Administration-approved prophylactic enoxaparin doses and to describe enoxaparin dosing strategies used in obese patients. METHODS: This was a retrospective cohort study including patients who were admitted to Parkview Regional Medical Center, Parkview Hospital, or Parkview Orthopedic Hospital between September 2011 and August 2012 and received at least one dose of enoxaparin 30 mg twice daily or enoxaparin 40 mg once daily for venous thromboembolism prophylaxis. Patients classified based on their body mass index into three groups, Group 1 (non-obese: body mass index < 25 kg/m2), Group 2 (overweight: body mass index ≥ 25 kg/m2 but < 30 kg/m2), and Group 3 (obese: body mass index ≥ 30 kg/m2). The primary endpoint was venous thromboembolism occurrence within 90 days, considering day 1 of hospitalization as day 1. RESULTS: Of the 428 patients included, 8 cases of venous thromboembolism (1.9%) were identified; 3 in the non-obese group, 2 in the overweight group, and 3 in the obese group, no statistically significant differences were found between the three groups, p = 0.81. When venous thromboembolism incidence was adjusted for age and sex, no statistically significant differences were found between overweight (OR = 0.685; 95% CI 0.115-4.095), obese (OR = 0.797; 95% CI 0.353-1.796), and combined overweight and obese (OR = 0.656; 95% CI 0.154-2.799) groups compared to patients with normal body weight. CONCLUSION: This study did not find a statistically significant difference in venous thromboembolism incidence between obese, overweight, and non-obese hospitalized patients receiving approved enoxaparin prophylaxis doses.