Risk factors for aseptic preparation of parenteral medicines encompass the growth-promoting nature of the preparation. Although many aqueous parenteral preparations do not have growth-promoting properties, inadvertently introduced microorganisms may remain viable. Knowledge about the viability of microorganisms in parenteral preparations can add useful information for assigning shelf life to preparations used to treat cancer patients. The aim of the study was to assess the viability of four different facultative pathogenic microorganisms in 20 ready-to-administer parenteral preparations aseptically prepared in hospital pharmacies. Samples of 20 different biologics and small molecules for systemic anti-cancer therapy were inoculated either with different bacteria (i.e., Staphylococcus aureus, Pseudomonas aeruginosa, Enterococcus faecium) or with Candida albicans suspension. The resulting test concentrations were 104-105 microorganisms per mL. Aliquots of inoculated test solutions were transferred in duplicate to tryptic soy agar plates at the time points 0, 4, 24, 48, 144 h. The plates were incubated for 24 h (bacterial strains) and 72 h (C. albicans) at 37 °C and colony forming units (CFUs) were counted. In most test solutions, especially in monoclonal antibody solutions, increased CFU counts of P. aeruginosa and unchanged or increased CFU counts of E. faecium and S. aureus were registered. Pronounced nutritive properties of monoclonal antibodies and filgrastim were not registered. Azacitidine, pixantrone and vinflunine containing test solutions revealed species-specific bacteriostatic and even bactericidal activity. All test solutions, except nivolumab and pixantrone containing solutions, showed constant or increasing CFU counts of C. albicans after incubation. Viability of the selected pathogenic microorganisms was retained in most of the tested biological and small molecule preparations used to treat cancer patients. Therefore, in pharmacy departments strict aseptic conditions should be regarded and the lack of antimicrobial activity should be considered when assigning shelf life to RTA parenteral preparations.

Cancer therapy has remarkable potential for drug-related problems due to the high cytotoxicity and narrow therapeutic index of most anti-neoplastic regimens. However, there is a lack of comprehensive studies on drug-related problems in patients with gastrointestinal cancer in Kenya. Therefore, the present study aimed to investigate the prevalence, types and predictors of drug-related problems among gastrointestinal cancer patients at Kenyatta National Hospital. A cross-sectional study was used to assess the prevalence of drug-related problems among a random sample of 160 esophageal, 103 gastric, and 96 colorectal cancer patients. Data were collected using a researcher-administered questionnaire and data abstraction tool after training the data collectors. Patient-specific details such as socio-demographic features, histological cancer types, cancer stage, comorbidity types, and treatment regimen were recorded after the review of medical records and patient interviews. The potential of drug-related problems was determined as per the standard guidelines. The data were entered and analysed using version 26.0 SPSS statistical software. Most esophageal (51.9%), gastric (59.2%), and colorectal (62.5%) cancer patients had a high prevalence of drug-related problems. The need for additional drug therapy and adverse drug reactions were the predominant categories of drug-related problems. Most adverse drug reactions identified had possible categories of causality score, mild severity levels, and definitely preventable types of adverse drug reactions among all gastrointestinal cancer patients. Comorbidity and advanced-stage disease were significant predictors of drug-related problems. Drug-related problems were prevalent among gastrointestinal cancer patients in our setting. Comorbidity and advanced stages of disease were significant predictors of drug-related problems.

Patients with cancer often use complementary and alternative medication (CAM). This research aims to study the current attitude of healthcare professionals toward the use of CAM to improve current care. A questionnaire on both the current practice and opinions about CAM use was sent to healthcare professionals in Amsterdam UMC, who work for the department of hematology or oncology. Oncologists, hematologists, residents, (specialized) nurses, dieticians, (hospital)pharmacists, and pharmacy technicians were asked to participate in this study. Among eligible healthcare professionals, 77 responded to the questionnaire (34%). Overall, 87% of healthcare professionals indicate it is important to be aware of their patient's CAM use, and all find the potential of drug-herb interactions important. However, more than half of the healthcare professionals inquire about the patient's CAM use infrequently. In addition, only 15% of the healthcare professionals stated they had sufficient knowledge of CAM to advise patients on their use of CAM. Healthcare professionals are aware of the potential risks of CAM use in combination with anti-cancer treatment. However, CAM use is not yet discussed with every patient. This may be due to healthcare professionals' lack of knowledge about CAM.

The introduction of CDK 4/6 inhibitors for breast cancer patients has contributed to increased ambulatory patient visits for oncologists. The Medication Assessment by Pharmacist program aims to evaluate the impact of oncology pharmacists performing medication assessment follow-up visits. Breast cancer patients on a CDK 4/6 inhibitor deemed suitable by their oncologist for pharmacist assessment could be booked for a pharmacist medication assessment appointment at alternate treatment cycles. Between February 2019 to November 2021, 29 of 128 patients (22.7%) were selected for 46 total Medication Assessment by Pharmacist visits resulting in 920 min of clinic time savings for physicians. There were similar rates of adhering to provincial protocols for scheduling visits (99% vs. 96%, p  =  0.12) and monitoring investigations (98% vs. 98%, p  =  0.96) between those enrolled in Medication Assessment by Pharmacist or not. Surveys completed by medical oncologists and pharmacists demonstrated that nine of nine oncologists felt Medication Assessment by Pharmacist reduced workload and wanted Medication Assessment by Pharmacist expanded to additional oncology drugs. Pharmacist-completed surveys revealed that nine of nine pharmacists felt Medication Assessment by Pharmacist increased job satisfaction, and allowed further application of clinical skills. All agreed that patients were receptive to meeting with pharmacists. According to survey results, 33% of oncologists versus 100% of pharmacists routinely asked about medication adherence, new medications or supplements. Integrating pharmacists into a shared care model reduces ambulatory patient visits for oncologists without deviating from provincial protocol guidelines for monitoring and visits for patients on CDK 4/6 inhibitors. Leveraging the medication expertise of pharmacists also increases the frequency of addressing medication adherence and concurrent therapies. Medication Assessment by Pharmacist may be an effective strategy in alleviating projected shortages of oncology providers.

This paper reviews comprehensively the most relevant data on single-agent and combination therapies for advanced colorectal cancer with inherited and acquired microsatellite instability (MSI). We performed a systematic search on PubMed and MEDLINE articles published from inception to December 2022. We have also searched independent websites including U.S. Food and Drug Administration and ClinicalTrials.gov. Performing microsatellite stability testing, tumor mutational burden (TMB), and germline mutation analysis could identify patients with metastatic colorectal cancer that benefit from immune checkpoint inhibitor (ICI) therapy. Single-agent pembrolizumab has proven superiority over traditional chemotherapy in these patients. The nivolumab-ipilimumab is the only combination ICI therapy approved in this space. Recently, the anti-PD-1 antibody dostarlimab was granted Food and Drug Administration approval in refractory tissue-agnostic advanced solid cancers with deficient mismatch repair (dMMR). ICIs are also being studied in the adjuvant/neoadjuvant setting in colon cancer patients with dMMR. Newer agents are being scrutinized in this space as well. More solid data on biomarkers predicting responses in patients with MSI-high or TMB-H to various therapies are needed. Given its both clinical and financial toxicity, it is imperative to determine the optimal duration of ICI therapy in individual patients. Overall, the outlook in advanced colorectal cancer patients with MSI appears optimistic as new and efficacious ICI drugs and combinations are being added to the existing therapeutic armamentarium.

With rising rates of complementary and alternative medicine use, the exploration of complementary and alternative medicine integration into oncology treatments is becoming increasingly prevalent. Vitamin B compounds including B1, B2, B3, B5, B6, B9, and B12, have all been proposed as potentially beneficial in cancer prevention and treatment as well as side effect management; however, many studies contain contradicting evidence regarding the utility of B vitamins within oncology. Thus, the aim of this study was to evaluate the safety and efficacy of Vitamin B supplementation in the oncology setting. A systematic review was conducted following The Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Reviews guidelines, using pre-specified search terms in PubMed to include randomized control trials, clinical trials, and case studies. Two reviewers independently reviewed titles, abstracts, and full-text articles for inclusion, with a third reviewer resolving conflicts, before the included articles underwent data extraction and quality appraisal. Data extraction was conducted through COVIDENCE, which was used to manage and track the data during the search process. Out of 694 articles initially identified, 25 articles met the inclusion criteria and were included in the review. Designs of the studies varied, including randomized control trials, clinical trials, and case/cohort studies. The impact of vitamin supplementation on cancer risk varied. Several studies found that certain B vitamin supplementation lowered cancer risk: B9 and B6 in nasopharyngeal carcinoma (n  =  1200 patients) and in pancreatic cancer (n  =  258 patients); B3 in hepatocellular carcinoma (n  =  494,860 patients); B6 in breast cancer (n  =  27,853 patients); and B9 in BRCA1-positive breast cancer (n  =  400 patients). However, some studies found that certain B vitamin supplementation increased the risk or negative outcomes of cancer: B6 during nasopharyngeal carcinoma treatment (n  =  592 patients); B6 in risk of hepatocellular carcinoma (n  =  494,860 patients); and B9 plasma levels in breast cancer (n  =  164 patients). Due to the many adverse effects that occur in cancer treatment, the effectiveness of Vitamin B supplementation in alleviating adverse effects was evaluated. In two separate studies, Vitamin B6 and Vitamin B12 supplementation with acupuncture was found to be effective as adjunct therapies aimed to reduce chemotherapy-induced peripheral neuropathy (n  =  23 patients and n  =  104 patients, respectively). No significant findings were established regarding B vitamin supplementation in chemotherapy-induced hand-foot syndrome. In this systematic review we concluded that B vitamin supplements have varying data regarding safety and efficacy in cancer. Taking into account the etiology of the cancer, the specific B-vitamin, and the presence of any side effects could help guide utilization of the data found in this review. Large, randomized controlled trials are needed to confirm these findings among various cancer diagnoses and stages. Given the widespread utilization of supplements, healthcare providers should understand the safety and efficacy of vitamin B supplementation to address questions that arise in caring for those with cancer.

Extravasation by conventional cytotoxics has been well documented. While monoclonal antibodies are not considered to have the necrotic potential of some cytotoxic medicines, they require appropriate management in case of extravasation. However, fewer data are available on their classification and appropriate management when extravasation occurs. As monoclonal antibodies are being more commonly used in current daily oncology practice, this is an issue that cannot be ignored. A scientific literature review on PubMed was conducted. All findings were critically appraised independently by 6 clinical pharmacists in order to provide a classification according to the extravasation hazard. A classification of non-conjugated and conjugated monoclonal antibodies according to extravasation hazard has been elaborated for different molecules frequently used in oncology. In addition, general management, in case extravasation of monoclonal antibodies occurs, has been proposed and the role of the pharmacist in the extravasation process has been described. A classification of hazard extent of extravasation of monoclonal antibodies with concurrent management based on literature data and expert consensus has been elaborated. In addition, the role of the oncology pharmacist is crucial in terms of follow-up and documentation of the extravasated monoclonal antibody and management is described.

Anti-programmed cell death (PD)-1 and anti-PD-L1 medications inhibit the PD-1 and PD-L1 interaction and have been shown to be effective in treating several forms of advanced cancers. Since the approval of these agents, standard dosing protocols have been utilized. However, a small population of patients in the community setting has received dose-modified PD-1 and PD-L1 inhibitors secondary to a lack of tolerability. Data from this study suggests possible benefit with different dosing strategies. The purpose of this retrospective study is to assess the efficacy and tolerability in terms of time to progression and adverse effects in patients receiving dose-modified PD-1 and PD-L1 inhibitors in Food and Drug Administration (FDA)-labeled indications. This single-institution retrospective chart review was conducted in an outpatient community setting on patients with cancer that received nivolumab, pembrolizumab, durvalumab, or atezolizumab for an FDA indication at one of the Houston Methodist Hospital infusion clinic site between September 1, 2017 and September 30, 2019. Data collection included demographics, adverse effects, dosing, treatment delay, and number of immunotherapy cycles administered per patient. This study included 221 patients, who received either nivolumab (n = 81), pembrolizumab (n = 93), atezolizumab (n = 21), or durvalumab (n = 26). There were 11 patients who experienced a dose reduction and 103 patients who experienced a treatment delay. Of the patients with a treatment delay, the median time to progression was 197 days, and for patients with a dose reduction, the median time to progression was 299 days. The results of this study found that the immunotherapy associated adverse effects led to dosing and frequency changes for tolerance with continued therapy. Our data suggests that there could be potential benefits of dose modifications to immunotherapy treatment, but further large studies are needed to assess the efficacy of specific immunotherapy dose modifications on both outcomes and adverse effects.

Compounding robots are increasingly being implemented in hospital pharmacies. In our hospital, the recent acquisition of a robot (RIVATM, ARxIUM) for intravenous cancer drug compounding obliged us to replace the previously used infusion devices. The objective of the present study was to assess and qualify the new intravenous sets prior to their use in our hospital and prior to the implementation of the compounding robot. The ChemoLockTM (ICU Medical) was compared with the devices used previously for compounding (BD PhaSealTM, Becton-Dickinson) and infusion (Connect-ZTM, Codan Medical). The connection/disconnection of infusion devices to/from 50 mL infusion bags was tested with a dynamometer (Multitest-i, Mecmesin). Leakage contamination was visualized by a methylene blue assay and was quantified in simulated pump infusions with 20 mg/mL quinine sulfate (N = 36/group); after the analytical assay had been validated, quinine was detected by UV-spectrophotometry at 280 and 330 nm. Groups were compared using chi-squared or Mann-Whitney U tests. The connection/disconnection test showed that although all the devices complied with the current standard, there was a statistically significant difference in the mean ± standard deviation compression force (51.5 ± 11.6 for the Connect-ZTM vs. 60.3 ± 11.7 for the ChemoLockTM; p = 0.0005). Leaks were detected in 32 (29.1%) of the 110 tests of the ChemoLockTM. The contamination rates were also significantly different: 13.9% for the BD PhaSealTM versus 75.0% for the ChemoLockTM; p < 0.0001). Our results showed that the new infusion device complied with current standards. However, the presence of contamination emphasizes the need for operators to use the recommended personal protective equipment. Further studies of contamination with cancer drugs are required.

It has long been established that high-dose methotrexate is an essential part of therapy for primary central nervous system lymphoma. When regimens utilizing high-dose methotrexate were first studied, a dose of 8 g/m2 was used. More recently, reduced dosing strategies have been studied and adopted in attempts to reduce rates of adverse events. Studies utilizing 3.5 g/m2 of methotrexate have shown promising outcomes and improved rates of adverse events but there have never been any randomized head-to-head studies of differing dose levels of high-dose methotrexate. The purpose of this study was to compare efficacy and safety of different dosing strategies of high-dose methotrexate (HD-MTX) for primary central nervous system lymphoma (PCNSL). This single center retrospective review was conducted between 07/01/2013 to 6/3/2020. The patient population was separated into two arms based upon dose of methotrexate. The high intensity (HiHD) arm was defined as patients who received doses > 3.5 g/m2, while the low intensity (LiHD) arm received ≤ 3.5 g/m2. The primary endpoint was overall response rate (ORR) and secondary endpoints include efficacy via 2-year overall survival (OS), progression to transplant, and utilization of consolidation or salvage therapy. Safety was assessed through monitoring of relevant laboratory studies. A total of 92 patients were included in this analysis. Baseline demographics were similar between groups, with the LiHD group trending toward older age. There were 78 patients eligible for assessment for ORR; there was no significant difference between the two groups (42.0% LiHD vs. 44.4% HiHD; p = 1.0). Rates of OS, progression to transplant and progression to consolidation chemotherapy were not different between groups. There were statistically significantly higher rates of renal and/or hepatic dysfunction with the first dose in the HiHD group compared with the LiHD group (11.5% LiHD vs. 64.3% HiHD; p ≤ 0.01). In this PCNSL patient cohort, there is no difference in terms of efficacy between HiHD LiHD methotrexate, but patients in the HiHD group had higher rates of renal and hepatic dysfunction. Limitations include small sample size and disparity between group sizes.