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Background Due to their low bioavailability, biopharmaceuticals are typically administered via injection or infusion in a hospital setting. Home-based therapy could be a valuable alternative for cancer patients. However, when exposed to stressors, such as high or low temperatures, particles can form in the biopharmaceutical solution, compromising the safety and efficacy of the biopharmaceutical. Aim This research investigated current practises with ready-to-administer biopharmaceuticals to determine if it is possible to offer cancer patients home-based therapy with monoclonal antibodies. Methods First, a questionnaire was conducted with the survey tool Survalyzer among Amsterdam UMC patients receiving immunoglobulins at home. Secondly, a web-based questionnaire (Survalyzer) was sent to pharmacists throughout Europe with a home-based therapy programme in place. Results The patient questionnaire (n = 52) showed that the biopharmaceutical is stored outside the recommended temperature range by 38% of the patients. Additionally, 17% of the patients do not recall getting any information on how to store their biopharmaceuticals, and 23% would like more information on the subject. Furthermore, the questionnaire amongst pharmacists (n = 21) showed that there is a lack of resources and logistical challenges when home-based therapy is applied to biopharmaceuticals used in cancer therapy. Conclusion Home-based therapy with monoclonal antibodies for cancer patients is challenging to implement.

Cancer research is a crucial pillar for countries to deliver more affordable, higher quality, and more equitable cancer care. Patients treated in research-active hospitals have better outcomes than patients who are not treated in these settings. However, cancer in Europe is at a crossroads. Cancer was already a leading cause of premature death before the COVID-19 pandemic, and the disastrous effects of the pandemic on early diagnosis and treatment will probably set back cancer outcomes in Europe by almost a decade. Recognising the pivotal importance of research not just to mitigate the pandemic today, but to build better European cancer services and systems for patients tomorrow, the Lancet Oncology European Groundshot Commission on cancer research brings together a wide range of experts, together with detailed new data on cancer research activity across Europe during the past 12 years. We have deployed this knowledge to help inform Europe's Beating Cancer Plan and the EU Cancer Mission, and to set out an evidence-driven, patient-centred cancer research roadmap for Europe. The high-resolution cancer research data we have generated show current activities, captured through different metrics, including by region, disease burden, research domain, and effect on outcomes. We have also included granular data on research collaboration, gender of researchers, and research funding. The inclusion of granular data has facilitated the identification of areas that are perhaps overemphasised in current cancer research in Europe, while also highlighting domains that are underserved. Our detailed data emphasise the need for more information-driven and data-driven cancer research strategies and planning going forward. A particular focus must be on central and eastern Europe, because our findings emphasise the widening gap in cancer research activity, and capacity and outcomes, compared with the rest of Europe. Citizens and patients, no matter where they are, must benefit from advances in cancer research. This Commission also highlights that the narrow focus on discovery science and biopharmaceutical research in Europe needs to be widened to include such areas as prevention and early diagnosis; treatment modalities such as radiotherapy and surgery; and a larger concentration on developing a research and innovation strategy for the 20 million Europeans living beyond a cancer diagnosis. Our data highlight the important role of comprehensive cancer centres in driving the European cancer research agenda. Crucial to a functioning cancer research strategy and its translation into patient benefit is the need for a greater emphasis on health policy and systems research, including implementation science, so that the innovative technological outputs from cancer research have a clear pathway to delivery. This European cancer research Commission has identified 12 key recommendations within a call to action to reimagine cancer research and its implementation in Europe. We hope this call to action will help to achieve our ambitious 70:35 target: 70% average 10-year survival for all European cancer patients by 2035.

Objective Some drugs need processing before they can be administered or dispensed. We measured airborne exposure of pharmacy staff to small particles when performing these tasks. Methods Reconstitution of powdered drugs in vials; crushing, splitting, and counting of tablets; and opening of capsules, using different ventilation strategies, were investigated in five pharmacies after in a worst-case approach. Airborne particulate matter was determined for a range of particles sizes. Results Mean particle concentrations ranged from not detectable to 1.03 μg/m3 (

OBJECTIVES: The closure integrity and process validation of closed system transfer devices (CSTDs) should be confirmed before implementation in clinical settings. We aimed to investigate the closure integrity and validate the aseptic procedure of two types of CSTDs by using a combination of the dye ingress test and a media fill test.METHODS: The dye ingress test with methylene blue was used for both CSTDs with 10 samples of drug vials of three brands. A media fill test was performed with both CSTDs (300 samples per CSTD, 150 carried out in a safety cabinet and 150 under non-classified environmental conditions).RESULTS: In all samples of both CSTDs, methylene blue was absent after visual inspection and spectrophotometric analysis. The nutrient media of one sample with CSTD A and none of the CSTD B samples were contaminated when reconstituted in a GMP grade A environment. Under non-classified environmental conditions, one sample of CSTD A and two samples of CSTD B were contaminated.CONCLUSIONS: Both CSTDs connected to the drug vials met the terms of closure integrity by using the dye ingress test. The aseptic procedure of CSTD B was validated with the media fill test when reconstituted in a GMP grade A environment, but failed for CSTD A. Both CSTDs failed the media fill test when reconstituted under non-classified environmental conditions.

OBJECTIVES: Due to their mechanism of action, most classical cytostatic drugs have carcinogenic, mutagenic and/or reprotoxic properties. Therefore, occupational exposure of healthcare staff to these drugs should be prevented. Our objective was to lay out European legislation on this topic and reflect on the process of revising the European CM-directive. We summarise independent European and Dutch studies, and give a concise set of basic recommendations for safe working with cytotoxic drugs in healthcare facilities.METHODS: We were directly involved in the process of revising the CM-directive: first, through an EU commissioned workshop in the Netherlands, and after that by contributing to the pan-European stakeholder symposium. For this aim, we had to gather the relevant study data from the Netherlands and from Europe. We analysed all relevant industry-independent studies and collated a set of basic recommendations.RESULTS: Independent studies show that the development of measures in recent years can lead to a safe work environment. Standardising the cleaning process leads to a significant improvement in environmental contamination in the majority of hospitals. In the Netherlands, exposure of workers was shown to be well beneath the limit value of 0.74 µg cyclophosphamide per week, therefore showing that the measures taken in recent years are adequate.CONCLUSIONS: The safety of healthcare workers is of the utmost importance. Current practice in the Netherlands show that measures taken in recent years are adequate. European legislation should be based on independent scientific research and practice. The first goal should be to bring countries with less safe working levels to a higher level instead of introducing measures that only increase healthcare budgets but not healthcare safety.

Background Manual compounding of expensive cytotoxic drugs often leads to drug wastage, due to residual product in vials not being used. Aim To determine the cost savings that can be achieved by implementing an automated compounding process with a vial sharing strategy, instead of manually compounding drugs. Method The drug wastage during automated compounding was compared with that of three simulation scenarios using manual compounding, in a general teaching hospital. All automatically compounded preparations of rituximab, pemetrexed, bevacizumab, and trastuzumab from September 2019 and up until February 2020 were included. A vial sharing strategy was implemented during the automated compounding process (scenario 1). In this scenario, all residual drugs could be reused for up to seven days. Two of the simulation scenarios for manual compounding were executed using a batch compounding strategy, for an entire working day (scenario 2), and twice a day (scenario 3). The third manual compounding simulation was executed without making use of a batch compounding strategy (scenario 4). Results There was no drug wastage during automated compounding with vial sharing (scenario 1). The cost of drug wastage for 1001 preparations, over a period of six months for rituximab, pemetrexed, bevacizumab, and trastuzumab combined, were € 34,133 for scenario 2, € 46,688 for scenario 3, and € 88,255 for scenario 4. The estimated total cost savings between 2017, when the compounding robot was commissioned, and 2021, was more than € 280,000. Conclusion Vial sharing of expensive drugs during automated compounding can prevent drug wastage, resulting in an economic and environmental advantage as opposed to manual compounding.

OBJECTIVES: Most cytostatics used in cancer treatment are dosed on body surface area (BSA). To administer an appropriate dose it is therefore necessary to know the patient's correct body weight. However, evidence is lacking on how often, after initiation of treatment, body weight should be measured to recalculate BSA. We aimed to assess the relevance of weight measurements during chemotherapy treatment.METHODS: Over a 2 year period we analysed BSA changes in adult patients undergoing chemotherapy treatment. The frequency of and median time to ≥10% BSA change was determined. We assumed a 10% BSA change required dose adjustment and was therefore clinically relevant.RESULTS: Using a database query, data from 2276 patients were used for descriptive statistics, life table analyses and generalised estimating equations. The frequency of ≥10% BSA change occurred in a maximum of 7.6% of the patients, depending on the tumour type. Descriptive statistics in the indications with more than 100 patients showed that BSA changes of ≥10% occurred after 84 days. The groups with the earliest BSA changes were patients with acute leukaemia, lymphoma and pancreatic cancer.CONCLUSIONS: Our observations from real-world data indicate it is safe to omit the current requirement for monthly weight measurements. We advise that during chemotherapy, measuring the body weight in patients who have acute leukaemia, lymphoma or pancreatic cancer or who are under 20 years of age, should be performed at least every 3 months. For other patients, extending this period to a 6-monthly weight measurement should be considered.

Background Manual compounding of expensive cytotoxic drugs often leads to drug wastage, due to residual product in vials not being used. Aim To determine the cost savings that can be achieved by implementing an automated compounding process with a vial sharing strategy, instead of manually compounding drugs. Method The drug wastage during automated compounding was compared with that of three simulation scenarios using manual compounding, in a general teaching hospital. All automatically compounded preparations of rituximab, pemetrexed, bevacizumab, and trastuzumab from September 2019 and up until February 2020 were included. A vial sharing strategy was implemented during the automated compounding process (scenario 1). In this scenario, all residual drugs could be reused for up to seven days. Two of the simulation scenarios for manual compounding were executed using a batch compounding strategy, for an entire working day (scenario 2), and twice a day (scenario 3). The third manual compounding simulation was executed without making use of a batch compounding strategy (scenario 4). Results There was no drug wastage during automated compounding with vial sharing (scenario 1). The cost of drug wastage for 1001 preparations, over a period of six months for rituximab, pemetrexed, bevacizumab, and trastuzumab combined, were € 34,133 for scenario 2, € 46,688 for scenario 3, and € 88,255 for scenario 4. The estimated total cost savings between 2017, when the compounding robot was commissioned, and 2021, was more than € 280,000. Conclusion Vial sharing of expensive drugs during automated compounding can prevent drug wastage, resulting in an economic and environmental advantage as opposed to manual compounding.

What is known and objective Chemotherapy drugs are often administered in combinations with predefined interdependent doses and cycle intervals. As yet, there is no global standardization system to describe these complex regimens in a universally comprehensive manner. The aim of this review is to identify which efforts for standardization have been undertaken and which recommendations for databases and nomenclature of chemotherapy regimens are available. Methods A literature review was performed to identify all peer‐reviewed full‐text articles about oncology therapy regimen codification. In addition, the results of this search were evaluated and consensus recommendations from a European expert panel were subsequently added. Results This review gives an overview of attempts to standardize chemotherapy nomenclature described in the literature, as well as of previously published identified gaps in regimen codification. In addition, we summarized the suggestions for improvement of chemotherapy codification found in the available literature, combining them with the expertise from a European expert panel of oncology pharmacists. What is new and conclusions We believe that one of the most important error‐prevention measures is standardization. However, there is a paucity of data how it may be achieved. Currently available data suggest that standardization has a positive impact on usability for data networks, prescription software, safety and the measurement of the quality of cancer care delivery. Standardization is also a strong pre‐requisite for all discussions including oncology pharmacists and oncologists when evaluating chemotherapy regimen in countries in Europe but also all over the world. The recommendations compiled in this review can help to support overdue standardization efforts in this important therapeutic area., Improving oncology therapy regimen codification: A concise review of the literature and suggestions from an expert panel yielding 21 opportunities for standardization.

European Cancer Organisation Essential Requirements for Quality Cancer Care (ERQCC) are written by experts representing all disciplines involved in cancer care in Europe. They give patients, health professionals, managers and policymakers a guide to essential care throughout the patient journey. Pancreatic cancer is an increasing cause of cancer mortality and has wide variation in treatment and care in Europe. It is a major healthcare burden and has complex diagnosis and treatment challenges. Care must be carried out only in pancreatic cancer units or centres that have a core multidisciplinary team (MDT) and an extended team of health professionals detailed here. Such units are far from universal in European countries. To meet European aspirations for comprehensive cancer control, healthcare organisations must consider the requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis, to treatment, to survivorship.

Many studies into surface contamination of hospital environments have demonstrated that occupational exposure to cytotoxics through the dermal route remains a possible risk. In this study, we assess the actual dermal exposure of the hands of pharmacy technicians and cleaning personnel in a panel of hospitals performing tasks that pose a risk of exposure. We compare the dermal exposure to a tentative limit value for cyclophosphamide. Pharmacy technicians and cleaning personnel were asked for hand rinsing after performance of nine tasks previously identified as posing a risk of occupational exposure. All samples were analyzed for the presence and quantity of eight antineoplastic drugs. By using data on both the frequency of the performance of the tasks and the measured dermal contamination during these tasks, weekly exposure to the marker drug (cyclophosphamide) was calculated. In five Dutch hospitals, 70 hand rinse samples and 8 blanks were collected. These were analyzed and results were used to calculate weekly exposure. The tentative limit value used was 0.74 µg of cyclophosphamide. For cleaning personnel, all results remained below this threshold value. For pharmacy technicians, the compounding itself also remained well below the limit; however, the task involving preparatory work, as well as the checking of compounded drugs, had a 13% chance of exceeding the limit. All of the highest values were found when employees were not wearing gloves on these tasks. Cleaning personnel and pharmacy technicians compounding cytotoxic drugs in our study were sufficiently protected from occupational exposure. In contrast, pharmacy technicians who perform preparatory and finishing tasks (before and after the actual compounding) are not protected enough when they do not wear gloves.

Palliative cancer patients can benefit from deprescribing of potentially inappropriate medications (PIMs). Tools and guidelines developed for the geriatric population are mainly available. This systematic review gives an overview of available guidelines and tools to deprescribe for palliative cancer patients.A systematic search was carried out using the databases SCOPUS and PubMed. Studies focused on palliative cancer patients were included.The search identified 137 studies of which 15 studies were included in this systematic review. Six of the included tools were developed specifically for cancer patients. One of these tools was externally validated and applied in several studies and settings. Guidelines or tools that were not specifically developed for cancer patients but that were applied on cohorts of palliative cancer patients were also included.Tools developed for geriatric patients contain drugs that are not inappropriate when used in the palliative cancer care setting. Tools developed for cancer patients are more suitable and can be applied in combination with stepwise methods to individualize deprescribing per patient. The tools and guidelines described in this systematic review can be used to further implement deprescribing in the clinical routine for palliative cancer patients.

Pharmacy technicians are exposed to volatile organic compounds, like the disinfectant isopropyl alcohol (IPA), during the process of aseptic compounding of parenteral cytotoxic drugs. The occupational exposure to nebulized IPA during aseptic compounding has not been investigated. The aim of this study was to investigate the exposure to IPA during aseptic compounding of parenteral cytotoxic drugs and to assess compliance with legal and regulatory limits. As a secondary endpoint, the difference between two disinfection methods was compared regarding the exposure to IPA. The exposure to IPA was measured during five working shifts of 8 hr and one shift of 4 hr. The concentration IPA was measured by using a six-gas monitor. Total daily exposure was calculated as 8-hr Time Weighted Average (TWA) air concentration in mg/m3 and compared with an Occupational Exposure Limit (OEL) value of 500 mg/m3 and incidental peak exposure of 5,000 mg/m3. To assess whether the 8-hr TWA air concentration meets the legal and regulatory limits the Similar Exposure Groups (SEG) compliance test was used. A paired sample t-test was conducted to assess difference in exposure between two disinfection methods. The average 8-hr TWA exposure to IPA during the six measurements varied from 2.6 mg/m3 to 43.9 mg/m3 and the highest momentary concentration measured was 860 mg/m3. The result of the SEG compliance test was 3.392 (Ur value) and was greater than the Ut value of 2.187 which means the exposure to IPA is in compliance with the OEL value. No significant difference in exposure was shown between two disinfection methods (p = 0.49). In conclusion, exposure to IPA during aseptic compounding of parenteral cytotoxic drugs showed compliance to the OEL values with no significant difference in exposure between two disinfection methods.

Purpose Palliative cancer patients can benefit from deprescribing of potentially inappropriate medications (PIMs). Tools and guidelines developed for the geriatric population are mainly available. This systematic review gives an overview of available guidelines and tools to deprescribe for palliative cancer patients. Methods A systematic search was carried out using the databases SCOPUS and PubMed. Studies focused on palliative cancer patients were included. Results The search identified 137 studies of which 15 studies were included in this systematic review. Six of the included tools were developed specifically for cancer patients. One of these tools was externally validated and applied in several studies and settings. Guidelines or tools that were not specifically developed for cancer patients but that were applied on cohorts of palliative cancer patients were also included. Conclusion Tools developed for geriatric patients contain drugs that are not inappropriate when used in the palliative cancer care setting. Tools developed for cancer patients are more suitable and can be applied in combination with stepwise methods to individualize deprescribing per patient. The tools and guidelines described in this systematic review can be used to further implement deprescribing in the clinical routine for palliative cancer patients.

Cytotoxic drugs can be harmful when healthcare workers are exposed to them, because of their carcinogenic, mutagenic and reprotoxic properties. There are many European and national laws and guidelines, plus local protocols that must be complied with, to protect healthcare workers against cytotoxic drugs. In the Netherlands, the current guidelines for hospitals are well structured and have been proven effective. Compliance to these guidelines remains pivotal, and further attempts to improve worker safety should be aimed at established risks, such as contamination on the outside of commercial drug vials. Non-proven and costly extra measures should not be introduced until their effectiveness has been demonstrated through independent research.

Background and importance Several studies have shown that antineoplastic drug contamination is found on various work surfaces in hospitals and varies widely on wards. The MASHA project (research about environmental contamination by cytotoxics and management of safe handling procedures) was to set up to conduct new research, in cooperation with the European Society for Medical Oncology, into contamination levels in hospital wards. Aim and objectives To obtain an overview of the current levels of cytotoxic contamination in European hospital wards and increase awareness among healthcare workers and their employers about the risks associated with working with hazardous drugs, and to provide them with additional measures to improve safety. Material and methods The assessment of surface contamination with cytotoxic drugs was done by evaluating wipe samples collected from four comparable surfaces on the wards (work benches, floors, armrest of patient’s chair and lids of waste containers). Each sample was analysed for the presence of five commonly used cytotoxic drugs (cyclophosphamide, 5-fluorouracil, paclitaxel, gemcitabine and total platinum for platinum drugs), using ICP-MS for total platinum and LC-MS/MS for other substances. Results The database includes results collected from 28 hospital units from 16 European countries. Of the 560 samples collected, 268 were positive (48%). Measurable amounts of at least one substance were detected on investigated surfaces in every hospital: 21/28 (75%) hospitals had over 30% positive samples. Contamination was detected mostly on the floors (58%), armrests (50%), lids (42%) and work benches (40%). The highest values were found for cyclophosphamide (380 ng/cm2) and 5-fluorouracil (130 ng/cm2) on the lids. The highest number of positive results were recorded with platinum drugs (33%), 5-fluorouracil (25%), gemcitabine (19%) and cyclophosphamide (18%). Substances were detected on 45/112 of surfaces (40%) which had not been used for cytotoxic drug preparation on the day of the wipe sampling. Conclusion and relevance Contamination is detectable on the ward but at different levels in different hospitals. Cleaning procedures are still not effective. Therefore, evaluation of exposure of healthcare workers is crucial. Greater collaboration with medical and nurse societies, to improve safe handling procedures in hospitals and thus improve the safety of all healthcare workers, is required. References and/or acknowledgements No conflict of interest.

BACKGROUND: Patients with cancer who are treated with monoclonal antibodies are at risk for developing infusion reactions. However, for some monoclonal antibodies, the incidence of infusion reactions is low or can be lowered by the use of adequate premedication schedules. It is often feasible to increase the infusion rate/lower the post-administration observation time. This review gives an overview of infusion reactions and the possibility of accelerating infusion rates.MATERIALS AND METHODS: Data on infusion reactions and infusion rates for all monoclonal antibodies that are licensed in the European Union for treatment of solid tumors or hematological malignancies, found by a literature search, were included in this review.RESULTS: For 11 out of the 21 monoclonal antibodies data exceeding the registration text were found and described. Faster infusion schedules are possible for bevacizumab, ipilimumab, nivolumab, panitimumab, and rituximab.CONCLUSION: We propose optimal infusion schedules for each drug.

Objectives The primary aim of the study was to compare environmental and external (cross-) contamination of traces of cytostatics, during preparation of 5-fluorouracil and cyclophosphamide using a robotic system (APOTECAchemo) or the conventional manual compounding procedure. The secondary aim was to validate the cleaning procedure of the robot. Methods Eighty ready-to-administer (RTA) infusion bags with 5-fluorouracil, cyclophosphamide or sodium chloride were compounded using both techniques on 3–5 days. Wipe samples were taken from several locations in the compounding room before and after cleaning, and also from the technician’s gloves. These samples were analysed for 5-fluorouracil and cyclophosphamide concentrations using GC/MS/MS. Key findings A total of 284 wipe samples were collected during the study (113 from the manual and 171 from the robotic process). External contamination on the outside of infusion bags was 3.75% for both manual and robotic compounding. For manual compounding, external cross-contamination occurred on 2.5% of the prepared infusion bags. External cross-contamination occurred on 1.25% of the infusion bags for the robotic procedure. Inside the compounding room, 9% of the environmental wipe samples were contaminated in case of manual production and 24% for robotic compounding. Since 50% of the contaminated environmental samples for the robotic system were taken after cleaning, the cleaning procedure was extended and parameter setting for cyclophosphamide handling was performed. After this, residual environmental or external contamination was no longer detectable. Conclusion Comparison of both preparation methods showed that external (cross-)contamination of infusion bags was lower using the robotic system. An optimized cleaning procedure showed the best results in environmental contamination for the robot.

Eight Dutch hospital pharmacies took wipe samples of prepared infusion bags containing 5 fluorouracil just before distribution to the wards. The samples were tested with high-performance liquid chromatography and triple quadrupole mass spectroscopy. The limit of detection was 10 ng per swipe. None of the 146 samples had a detectable amount of 5-fluorouracil. The outside of infusion bags containing antineoplastic drugs prepared in these eight Dutch hospital pharmacies were not contaminated and, therefore, were not a risk factor with regard to exposure of hospital workers to antineoplastic drugs.

Objectives Patients who are no longer eligible for curative treatment often suffer from multiple complaints and require a multidisciplinary treatment approach. We incorporated two pharmacists in the palliative team, one hospital pharmacist and one pharmacist who were trained as a community pharmacist. The objective of our study was to evaluate their contribution to the palliative team. Methods During 13 months, the two pharmacists participated in all regular patient reviews and rounds and were available for individual consultation by all members of the palliative team on a daily basis. Each intervention (consults at request or during the patient rounds) was logged and categorised. Key findings During the study period, 115 patients were under the care of the palliative treatment team. The pharmacists were actively involved in 107 of these (93%). Pharmacists interventions occurred in 76% of patients, with an average of 1.5 interventions per patient. The most common intervention types were giving general therapeutic advice, starting of a drug for an uncontrolled symptom and stopping a drug that was given as prophylaxis. When comparing the contribution of the hospital pharmacist and the outpatient pharmacist, their interventions overlapped with regard to starting drugs, choice of drugs and side-effect management. However, interventions on parenteral drugs or optimising the route of administration mostly came from the hospital pharmacist, whereas the outpatient pharmacist more often intervened in increasing adherence and stopping drugs. Conclusion The palliative pharmacist team adds expertise to the palliative treatment team, with an active contribution in 76% of patients.

Introduction: Patients, who are starting systemic treatment for an oncological disease, receive a large amount of information on their treatment at multiple time points from several different healthcare professionals. In the OLVG hospital in Amsterdam, the information provision was harmonized in a multiprofessional treatment team. Afterward, the satisfaction with drug information was measured in ambulatory patients. Methods: The clinical care pathway of the oncology patient who receives antineoplastic drug treatment was mapped out, identifying the different moments where information can be given and by whom. In 3 multidisciplinary meetings, the different time points for patient contact were assigned to one of the healthcare professionals and the content of the information to be given was agreed upon by the team. For measurement of patient satisfaction, the validated Satisfaction with Information about Medicines Scale (SIMS) questionnaire was used during a 1-week period at the oncology day-care department. Results: Information at each contact with the patient was standardized in a map of the patients' clinical care pathway. Forty-eight patients returned a SIMS questionnaire showing a high overall satisfaction rate of 81%. Conclusion: This study has shown that harmonizing information provision to patients on anticancer drug treatment is feasible and results in high levels of information satisfaction in oncology patients.

Objectives As yet, there is no European data standard for naming and describing oncology regimens. To enable real-world cancer treatment data comparisons, the Oncology Data Network created a unified reference database for systemic anti-cancer regimens used in practice across Europe. Data are extracted from clinical systems and mapped to a single standard called the “Core Regimen Reference Library (CRRL)”. An automated matching algorithm has been designed based on: drug combinations; administration schedule; and dosing and route of administration. Incomplete matches are flagged for expert review. The aim of this pilot study is to have an expert pharmacist panel test the algorithm’s feasibility by comparing computerised and manual matching of regimens that are currently in use in different European countries. Methods The combined team pooled a diverse sample of 47 reference regimens used in Europe for solid and haematological cancers. These were then codified to the developed common data standard and the algorithm was used to match them to the CRRL. The expert pharmacist panel from the European Society of Oncology Pharmacy (ESOP) selected 12 regimens from the sample set, ranging from simple to complex, and performed a single-blind test of the algorithm, by systematically matching each original regimen to the CRRL. Results ESOP validated the algorithm’s feasibility based on full concurrence between manual and computer matches thereby validating the algorithm rules and logic with regard to what defines the core characteristics of a regimen and how to compare similarities and differences. Conclusions ESOP’s validation of the matching algorithm and approach to curating a master library provides confidence in their utility for reliable comparison of real-world regimen usage across Europe.

Background Lung cancer patients have a high risk for drug–drug interactions, as they use numerous types of concomitant medicines including antineoplastic agents, cancer treatment co-medication, and medicines aimed at several types of comorbidities. Objective The primary objective of this study is to determine the incidence and the clinical relevance of the drug–drug interactions between antineoplastic agents and regular medication used by lung cancer patients. Secondary objectives are (i) to determine the effectiveness of the medication review by the hospital pharmacists concerned, (ii) to establish which patients are most at risk of drug–drug interactions and (iii) to determine whether physicians comply with advice given by hospital pharmacists. Setting This prospective study was undertaken in a Dutch hospital pharmacy, at Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam. Methods All lung cancer patients receiving one or more cytotoxic agents during the period 21 June 2010 till 2 December 2014 at OLVG were included. The medication list of the patients was obtained electronically from the community pharmacy and checked for interactions by a hospital pharmacist. Interactions that required intervention according to the national database were the only ones taken into account. Interventions were recorded in the patients’ electronic charts. All medication reviews were cross-checked and analyzed by an independent pharmacist at the end of the study period. Main outcome measure Prevalence and clinical relevance of drug–drug interactions between antineoplastic agents and other types of medication in lung cancer patients. Results A total of 298 lung cancer patients were included in this study. In 53 patients (18%), a total of 73 interactions with potential clinical relevance were found. The most frequent interaction was between cytostatics and coumarins while the most relevant one was between cisplatin and furosemide. According to statistical analysis, gender as well as the number of drugs prescribed were significant predictors for drug–drug interactions. Eighty-four percent of the interactions were discovered by pharmacists during daily routine. In 92% of the cases, the pulmonary physicians complied with the advice of the pharmacist. Conclusion Eighteen percent of lung cancer patients treated with cytotoxic therapy had one or more relevant drug–drug interactions. This study shows that medication surveillance by a hospital pharmacist is necessary to prevent possible negative drug–drug interactions. Further research should focus on the clinical outcome of the interactions as well as on interactions between cytostatics and alternative medicines and/or over-the-counter medicines.

Background Cytostatic drugs are increasingly being prepared with a cytostatic robot, though it is not known whether the dose of the final product is more accurate after automated or manual preparation. This study is the first to compare accuracy and precision of automated preparations with manual preparations by measuring volumes and drug concentrations. Methods The accuracy and precision of automated and manual preparations were compared by gravimetric and concentration measurements. During ten days 80 solutions were prepared; 40 robot preparations and 40 manual preparations. With both preparation methods, 20 methotrexate (MTX) and 20 cyclophosphamide (CP) bags were compounded. We simulated normal working conditions by performing the preparations on Monday till Friday. The MTX and CP concentrations were measured with validated ultra high performance liquid chromatography (UHPLC) methods on the last preparation day. Results With UHPLC analysis, dose accuracy (mean dose error) of robotic or manual preparation of MTX were 1.70% and 0,96% respectively. With gravimetric analysis, these values were 0.50% and 1.96%. Precision (standard error) of the robotic preparation for MTX was significantly smaller than that of manual preparation (p Dose accuracy (mean dose error) of robotic or manual preparation of CP, with UHPLC analysis, were 6.10% and 5.20% respectively. With gravimetric analysis, these values were 0,67% and 0,18%. Conclusion We conclude that both robotic and manual compounding produce accurate cytostatic products in which the mean percentage of active substance differs by less than 10% from the prescribed amount. Both preparation methods are compliant with the Dutch Medicines Act and the European Pharmacopoeia.

BACKGROUND: Compounding of cytostatic drugs requires strict aseptic procedures, while exposure to toxic drugs and repetitive manual movements should be minimized. Furthermore, reuse of vials is desirable to lower the costs. To assess if all this might be safely achieved with a robot, this study aimed at qualifying the aseptic preparation process with the robotic system APOTECAchemo.METHODS: The aseptic compounding of patient-individual cytostatic solutions was simulated with media fill simulation tests to qualify the performance according to European GMP Annex 1. The contamination in the environment was measured in critical places using settle plates, contact plates, active air sampling and particle counting. Media-fill simulation tests were prepared in 3 production batches. The second part of the study evaluated the microbiological shelf-life of commercial drug vials after repeated puncturing. On six days, fifty syringes of 15 ml media were prepared from the same 50 vials with the robot. After each preparation, vials were covered with an IVA seal upon unloading from the robot to protect them from microbiological contamination.RESULTS: No microbiological contamination was found in any of the 96 media fill preparations, nor in any of the 300 syringes that were prepared with repeated puncturing. The compounding area met class A limits, while class A criteria were not fulfilled by the contact plates and settle plates placed on the right side of the loading area. There, the average colony forming units (cfu) were 3 and 1.17, respectively, meeting class B criteria.CONCLUSIONS: Robotical compounding of cytostatic drugs with APOTECAchemo meets the microbiological requirements of the European GMP. In addition, the robot can reuse vials repeatedly and safely, thereby enabling extended usage.

Background: ECCO essential requirements for quality cancer care (ERQCC) are checklists and explanations of organisation and actions that are necessary to give high-quality care to patients who have a specific tumour type. They are written by European experts representing all disciplines involved in cancer care. ERQCC papers give oncology teams, patients, policymakers and managers an overview of the elements needed in any healthcare system to provide high quality of care throughout the patient journey. References are made to clinical guidelines and other resources where appropriate, and the focus is on care in Europe. Colorectal cancer: essential requirements for quality care Colorectal cancer (CRC) is the second most common cause of cancer death in Europe and has wide variation in outcomes among countries. Increasing numbers of older people are contracting the disease, and treatments for advanced stages are becoming more complex. A growing number of survivors also require specialist support. High-quality care can only be a carried out in specialised CRC units or centres which have both a core multidisciplinary team and an extended team of allied professionals, and which are subject to quality and audit procedures. Such units or centres are far from universal in all European countries. It is essential that, to meet European aspirations for comprehensive cancer control, healthcare organisations implement the essential requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis, to treatment, to survivorship. Conclusion: Taken together, the information presented in this paper provides a comprehensive description of the essential requirements for establishing a high-quality CRC service. The ECCO expert group is aware that it is not possible to propose a 'one size fits all' system for all countries, but urges that access to multidisciplinary units or centres must be guaranteed for all those with CRC. (C) 2016 The Authors. Published by Elsevier Ireland Ltd.

Background: ECCO essential requirements for quality cancer care (ERQCC) are checklists and explanations of organisation and actions that are necessary to give high-quality care to patients who have a specific tumour type. They are written by European experts representing all disciplines involved in cancer care. ERQCC papers give oncology teams, patients, policymakers and managers an overview of the elements needed in any healthcare system to provide high quality of care throughout the patient journey. References are made to clinical guidelines and other resources where appropriate, and the focus is on care in Europe. Sarcoma: essential requirements for quality care Sarcomas - which can be classified into soft tissue and bone sarcomas - are rare, but all rare cancers make up more than 20% of cancers in Europe, and there are substantial inequalities in access to high-quality care. Sarcomas, of which there are many subtypes, comprise a particularly complex and demanding challenge for healthcare systems and providers. This paper presents essential requirements for quality cancer care of soft tissue sarcomas in adults and bone sarcomas. High-quality care must only be carried out in specialised sarcoma centres (including paediatric cancer centres) which have both a core multidisciplinary team and an extended team of allied professionals, and which are subject to quality and audit procedures. Access to such units is far from universal in all European countries. It is essential that, to meet European aspirations for high-quality comprehensive cancer control, healthcare organisations implement the requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis and follow-up, to treatment, to improve survival and quality of life for patients. Conclusion: Taken together, the information presented in this paper provides a comprehensive description of the essential requirements for establishing a high-quality service for soft tissue sarcomas in adults and bone sarcomas. The ECCO expert group is aware that it is not possible to propose a 'one size fits all' system for all countries, but urges that access to multidisciplinary teams is guaranteed to all patients with sarcoma. (C) 2016 The Authors. Published by Elsevier Ireland Ltd.

Background Hyperkalemia is a potentially dangerous electrolyte abnormality with a reported incidence of 1-10 % in hospitals. Patients are especially at risk of developing this complication if they use a combination of potassium supplements and potassium sparing diuretics or renin-angiotensin-aldosterone- system (RAAS) inhibitors. Previous studies on the occurrence of hyperkalemia in patients who use multiple potassium influencing drugs simultaneously were either small in sample size or did not investigate the full range of drugs involved. Objective To assess the prevalence of hyperkalemia and to identify risk factors for its development in hospitalised patients using potassium supplements, potassium-sparing diuretics and/or RAAS-inhibitors concurrently. Setting The study was conducted at the Onze Lieve Vrouwe Hospital in Amsterdam, The Netherlands from January 2009 to May 2010. Method A retrospective, nested case-control study included hospitalised patients who used a combination of potassium-influencing drugs. Cases were patients with serum potassium C5.5 mmol/l, controls were patients with normal serum potassium levels. Cases and controls were included in a ratio of 1:2. The following known risk factors associated with hyperkalemia were recorded and statistically analyzed: diabetes mellitus, congestive heart failure, decreased renal function, advanced age, gender and use of heparin, digoxin, non-steroidal anti-inflammatory drugs, beta-blockers, calcineurin antagonists and trimethoprim. Main outcome measure Identify risk factors for the development of hyperkalemia as a result of the concurrent use of potassium supplements, RAAS inhibitors and/or potassium-sparing diuretics. Results Of 774 patients included in this study, 52 patients developed hyperkalemia; a prevalence of 6.7 %. The only risk factor found to be significantly associated with hyperkalemia was lowered renal function, expressed as estimated glomerular filtration rate (eGFR) \50 ml/min (adjusted OR 5.08; 95 % CI 2.46-10.48). None of the other tested risk factors was identified as significant. Conclusion This study showed that decreased renal function (eGFR\50 ml/min) was associated with a fivefold increased risk for hyperkalemia in patients using potassium-influencing drugs. While previous studies showed that hyperkalemia substantially increases below a threshold of eGFR\30 or 40 ml/min, we observed a lower threshold of eGFR \50 ml/min. It is therefore recommended that physicians should be particularly alert while monitoring the use of potassium-influencing drugs in patients with decreased renal function.

Chong Kun Dang is developing the camptothecin analog CKD-602 for the potential treatment of cancer. By August 2000, phase II trials of CKD-602 were underway.

To establish the maximum dose intensity of cisplatin plus gemcitabine on a weekly or two-weekly schedule in patients with advanced non-small cell lung cancer (NSCLC).Patients with NSCLC stage IIIB or IV were randomized to receive weekly or two-weekly courses of gemcitabine on day 1 and cisplatin on day 2. An interpatient dose escalation scheme was used, and pharmacokinetics were determined for both agents in plasma and WBCs.Seventy-three patients were included, 32 on the weekly schedule and 41 on the two-weekly schedule. Fifty patients received all planned courses. Dose-limiting toxicities were leukocytopenia, neutropenia, and trombocytopenia on the weekly schedule and ototoxicity on the two-weekly schedule. Most common nonhematological toxicities consisted of nausea, vomiting, and fatigue. The highest dose intensity of cisplatin could be achieved on the two-weekly schedule, and therefore, further development of the weekly schedule was abandoned. The maximum tolerated dose was established at 1500 mg/m(2) gemcitabine in combination with cisplatin 90 mg/m(2). More than half (53%) of patients achieved an objective response on the two-weekly schedule, versus 23% in the weekly treatment arm. The pharmacokinetic studies revealed a significant interaction: gemcitabine reduced both GG and AG platinum-DNA intrastrand adducts in WBCs.The combination of gemcitabine (1500 mg/m(2)) with cisplatin at a dose intensity of 50 mg/m(2)/week is feasible on a two-weekly administration scheme in NSCLC patients.