Pub Date : 2020-07-01DOI: 10.1097/OP9.0000000000000026
Antoine De Coucy, Julien Ollivier, L. Malifarge, M. Deppenweiler, C. Donamaria, B. Lortal
Purpose:Biophysical and analytical assays have demonstrated the physical and chemical stabilities of an admixture of pertuzumab and trastuzumab co-administered via a single infusion bag. Few data are available concerning the use of this practice in real life. We report the safety of pertuzumab and trastuzumab co-administered via a single infusion bag for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Methods: A cancer data registry was used to identify all patients with HER2-positive breast cancer. In cycle 1, patients received intravenous loading doses of pertuzumab and trastuzumab, and in cycle 2 and onward, patients received maintenance doses via a single infusion bag (cohort 1) or as separate infusions (cohort 2). Patients in cohort 3 received both regimens: separate infusions followed by a single infusion bag. Records were reviewed for general and cardiac safety Results: In total, 72 patients were eligible for analysis: 25 in cohort 1, 23 in cohort 2, and 24 in cohort 3. One patient (4%) in cohort 1 and 1 patient (4.3%) in cohort 2 had left ventricular dysfunction that led to treatment discontinuation, but this dysfunction was not observed in cohort 3. No significant differences in general or cardiac toxicities were observed between cohort 1 and cohort 2, or cohort 3 after switching to a single infusion bag. Conclusion: Pertuzumab and trastuzumab co-administered in a single infusion bag, in a non-clinical-trial setting, had acceptable general and cardiac tolerance profiles. This strategy could improve the comfort of patients while saving active healthcare professionals’ time. Implications for practice: Combined treatment of pertuzumab, trastuzumab, and a third chemotherapeutic agent is the standard of care for first-line HER2-positive locally advanced/metastatic breast cancer and can be used as (neo)adjuvant treatment for breast cancer. In practice, the 2 antibodies are administered separately, but this study supports co-administration of pertuzumab and trastuzumab via a single infusion bag. Co-administration has acceptable general and cardiac tolerances in a non-clinical-trial population. This strategy could improve the compliance and comfort of patients while saving active healthcare professionals’ time and medical resource utilization.
{"title":"Safety of pertuzumab and trastuzumab administered in a single infusion bag in breast cancer","authors":"Antoine De Coucy, Julien Ollivier, L. Malifarge, M. Deppenweiler, C. Donamaria, B. Lortal","doi":"10.1097/OP9.0000000000000026","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000026","url":null,"abstract":"Purpose:Biophysical and analytical assays have demonstrated the physical and chemical stabilities of an admixture of pertuzumab and trastuzumab co-administered via a single infusion bag. Few data are available concerning the use of this practice in real life. We report the safety of pertuzumab and trastuzumab co-administered via a single infusion bag for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Methods: A cancer data registry was used to identify all patients with HER2-positive breast cancer. In cycle 1, patients received intravenous loading doses of pertuzumab and trastuzumab, and in cycle 2 and onward, patients received maintenance doses via a single infusion bag (cohort 1) or as separate infusions (cohort 2). Patients in cohort 3 received both regimens: separate infusions followed by a single infusion bag. Records were reviewed for general and cardiac safety Results: In total, 72 patients were eligible for analysis: 25 in cohort 1, 23 in cohort 2, and 24 in cohort 3. One patient (4%) in cohort 1 and 1 patient (4.3%) in cohort 2 had left ventricular dysfunction that led to treatment discontinuation, but this dysfunction was not observed in cohort 3. No significant differences in general or cardiac toxicities were observed between cohort 1 and cohort 2, or cohort 3 after switching to a single infusion bag. Conclusion: Pertuzumab and trastuzumab co-administered in a single infusion bag, in a non-clinical-trial setting, had acceptable general and cardiac tolerance profiles. This strategy could improve the comfort of patients while saving active healthcare professionals’ time. Implications for practice: Combined treatment of pertuzumab, trastuzumab, and a third chemotherapeutic agent is the standard of care for first-line HER2-positive locally advanced/metastatic breast cancer and can be used as (neo)adjuvant treatment for breast cancer. In practice, the 2 antibodies are administered separately, but this study supports co-administration of pertuzumab and trastuzumab via a single infusion bag. Co-administration has acceptable general and cardiac tolerances in a non-clinical-trial population. This strategy could improve the compliance and comfort of patients while saving active healthcare professionals’ time and medical resource utilization.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42333642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-04-28DOI: 10.1097/OP9.0000000000000024
E. Korczowska, M. Crul, J. Tuerk, K. Meier
Background: Evaluating environmental contamination with cytotoxic drugs in hospitals is one of the fundamental requirements to ensure the occupational safety of all healthcare professionals. The European Society of Oncology Pharmacy (ESOP) undertook the first independent, multicenter, pan-European study, involving over a dozen hospitals from 11 different countries, to measure the state of cytotoxic contamination in the workplace. Objective: To obtain an overview of the current situation in European hospitals with regards to cytotoxic drug contamination at various sites, including drug preparation (pharmacy) and administration areas (ward). The secondary objectives are to evaluate the environmental contamination with cytotoxic drugs circulating within a facility known as the hospital medication system (process flow of drug) and to evaluate the impact of changes in local cleaning practices. Materials and methods: The study was carried out at 15 hospitals in Europe evaluating the surface contamination in the preparation and administration areas before (part I) and after (part II and part III) training and the implementation of ESOP cleaning recommendations. Assessment of surface contamination with 11 antineoplastic drugs was performed using wipe samples taken from 10 comparable surfaces (5 each in the preparation and administration areas). These samples were analyzed by liquid chromatography–tandem mass spectrometry. Results: The study demonstrated the presence of surface contamination in preparation and administration areas in all hospitals, with measurable amounts of at least 1 agent detected on sampled surfaces. Before the implementation of the ESOP cleaning recommendations, 324 out of 1595 results were positive (20%). In 11 of 15 hospitals (73%), substances were detected which were not prepared or administrated in the sampling day. After implementation of the ESOP recommendations, only 14% of results were positive (226/1639). Sixty-nine percent of wards (9/13) improved or stayed at the same level in the number of positive samples. The floors on the wards were shown to be the most frequently contaminated (42% of samples were positive). The amount of contamination in the pharmacies was not correlated to the amount of chemotherapy prepared nor to the use of special devices such as closed-system transfer devices. Conclusion:The MASHA study provides an overview of the contamination levels with cytotoxic drugs in European hospitals. Upon implementation of ESOP cleaning recommendations, improvements could be seen, with a reduced number of positive-wipe samples and lower amounts of surface concentration detected. The study demonstrates that improving standard work procedures is able to substantially reduce contamination in the workplace.
{"title":"Environmental contamination with cytotoxic drugs in 15 hospitals from 11 European countries—results of the MASHA project","authors":"E. Korczowska, M. Crul, J. Tuerk, K. Meier","doi":"10.1097/OP9.0000000000000024","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000024","url":null,"abstract":"Background: Evaluating environmental contamination with cytotoxic drugs in hospitals is one of the fundamental requirements to ensure the occupational safety of all healthcare professionals. The European Society of Oncology Pharmacy (ESOP) undertook the first independent, multicenter, pan-European study, involving over a dozen hospitals from 11 different countries, to measure the state of cytotoxic contamination in the workplace. Objective: To obtain an overview of the current situation in European hospitals with regards to cytotoxic drug contamination at various sites, including drug preparation (pharmacy) and administration areas (ward). The secondary objectives are to evaluate the environmental contamination with cytotoxic drugs circulating within a facility known as the hospital medication system (process flow of drug) and to evaluate the impact of changes in local cleaning practices. Materials and methods: The study was carried out at 15 hospitals in Europe evaluating the surface contamination in the preparation and administration areas before (part I) and after (part II and part III) training and the implementation of ESOP cleaning recommendations. Assessment of surface contamination with 11 antineoplastic drugs was performed using wipe samples taken from 10 comparable surfaces (5 each in the preparation and administration areas). These samples were analyzed by liquid chromatography–tandem mass spectrometry. Results: The study demonstrated the presence of surface contamination in preparation and administration areas in all hospitals, with measurable amounts of at least 1 agent detected on sampled surfaces. Before the implementation of the ESOP cleaning recommendations, 324 out of 1595 results were positive (20%). In 11 of 15 hospitals (73%), substances were detected which were not prepared or administrated in the sampling day. After implementation of the ESOP recommendations, only 14% of results were positive (226/1639). Sixty-nine percent of wards (9/13) improved or stayed at the same level in the number of positive samples. The floors on the wards were shown to be the most frequently contaminated (42% of samples were positive). The amount of contamination in the pharmacies was not correlated to the amount of chemotherapy prepared nor to the use of special devices such as closed-system transfer devices. Conclusion:The MASHA study provides an overview of the contamination levels with cytotoxic drugs in European hospitals. Upon implementation of ESOP cleaning recommendations, improvements could be seen, with a reduced number of positive-wipe samples and lower amounts of surface concentration detected. The study demonstrates that improving standard work procedures is able to substantially reduce contamination in the workplace.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/OP9.0000000000000024","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48468638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.1097/OP9.0000000000000023
D. K. Farrag, N. Sabri, Amr Shafik Tawfik, S. Shaheen
Introduction:Breast cancer is one of the most common cancers among Egyptian women. Health-related quality of life (QOL) and reduction of side-effects play an important role for the treatment of cancer patients. The purpose of this prospective study was to determine if pharmacist’s intervention could improve clinical outcomes of patient with breast cancer. Patients and methods: This study was a single-center interventional prospective study carried out on a group of 60 breast cancer patients at Clinical Oncology Department, Ain Shams University Hospitals from June 2017 to May 2018 patients were subjected to a thorough history taking, assessment of treatment-related adverse events before each cycle and at the end of the treatment. In addition, assessment of QOL was done at the baseline and at the end of treatment to evaluate the effect of the pharmacist’s interventions. Results:The present study has shown that the clinical pharmacist interventions were associatedwith significant decrease of toxicity grades of patients, for example, anemia where the percentage of patients of grade 2 decreased from 17% to 1.7%; moreover, 5% of patients had grade 4 nausea/vomiting, while after pharmacist intervention, it became 0%. Regarding patients’ QOL, results of the present study showed improvement of mean±standard deviation of most of the QOL scales such as systematic therapy side-effects decreased from 80.8±19.53 to 42.8±16.8, all with P<0.001. Conclusions:Most treatments for breast cancer despite beneficial result in toxicities, primarily anemia, neutropenia, nausea, and pain. These side-effects adversely impact patient QOL and can lead to treatment discontinuation. Clinical pharmacist intervention resulted in beneficial clinical outcomes in patients with breast cancer such as the reduction of treatment-related side-effects and the improvement of patients’ QOL. Abbreviations: QOL = quality of life; SD = standard deviation; SPSS = Statistical Package for Social Sciences.
{"title":"Evaluation of the clinical effect of pharmacist intervention","authors":"D. K. Farrag, N. Sabri, Amr Shafik Tawfik, S. Shaheen","doi":"10.1097/OP9.0000000000000023","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000023","url":null,"abstract":"Introduction:Breast cancer is one of the most common cancers among Egyptian women. Health-related quality of life (QOL) and reduction of side-effects play an important role for the treatment of cancer patients. The purpose of this prospective study was to determine if pharmacist’s intervention could improve clinical outcomes of patient with breast cancer. Patients and methods: This study was a single-center interventional prospective study carried out on a group of 60 breast cancer patients at Clinical Oncology Department, Ain Shams University Hospitals from June 2017 to May 2018 patients were subjected to a thorough history taking, assessment of treatment-related adverse events before each cycle and at the end of the treatment. In addition, assessment of QOL was done at the baseline and at the end of treatment to evaluate the effect of the pharmacist’s interventions. Results:The present study has shown that the clinical pharmacist interventions were associatedwith significant decrease of toxicity grades of patients, for example, anemia where the percentage of patients of grade 2 decreased from 17% to 1.7%; moreover, 5% of patients had grade 4 nausea/vomiting, while after pharmacist intervention, it became 0%. Regarding patients’ QOL, results of the present study showed improvement of mean±standard deviation of most of the QOL scales such as systematic therapy side-effects decreased from 80.8±19.53 to 42.8±16.8, all with P<0.001. Conclusions:Most treatments for breast cancer despite beneficial result in toxicities, primarily anemia, neutropenia, nausea, and pain. These side-effects adversely impact patient QOL and can lead to treatment discontinuation. Clinical pharmacist intervention resulted in beneficial clinical outcomes in patients with breast cancer such as the reduction of treatment-related side-effects and the improvement of patients’ QOL. Abbreviations: QOL = quality of life; SD = standard deviation; SPSS = Statistical Package for Social Sciences.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/OP9.0000000000000023","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61744344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.1097/OP9.0000000000000022
Hayato Kamata, Shinya Suzuki, K. Demachi, Hidetaka Suzuki, Yuka Sugama, K. Ikegawa, T. Igarashi, M. Yamaguchi, H. Okudera, M. Tahara, T. Kawasaki
Objectives: Impact of outpatient collaborative pharmacy services performed by pharmacists on drug costs has not yet been reported. Therefore, this study evaluated direct interventions made by pharmacists in the form of prescription proposals that resulted in drug cost savings from outpatient collaborative pharmacy services performed by pharmacists to support outpatient cancer chemotherapy. Methods:This was a retrospective cohort study wherein the drug cost savings resulting from the outpatient collaborative pharmacy services performed by 6 pharmacists and physicians from 6 medical departments were calculated and investigated from June 2016 to November 2016. Drug costs as of August 31, 2016 were used to calculate the drug cost savings. Results: During the 6-month study period, 6 pharmacists performed outpatient collaborative pharmacy services on weekdays within a span of 120 days for a total of 2177hours each. The total drug cost savings were <6984,637, including <5842,061 for anticancer drugs, <1086,484 for oral drugs other than anticancer, <39,388 for premedications, and <16,704 for drugs for abuse. The total cost of the added drugs was<3224,227, allocated as follows: nonanticancer medicines,<1441,317; supportivemedicines for adverse drug reactions in chemotherapy, <359,127; premedications for chemotherapy, <307,961; and anticancer medicines, <1115,822. Conclusion: The results of the present study are limited to “pharmacists assisting in reducing drugs by adjusting expensive anticancer drugs through a collaborative effort with physicians via outpatient consultations”; however, it indicated a significant overall health economic effect.
{"title":"Drug cost savings resulting from the outpatient pharmacy services collaborating with oncologists at outpatient clinics","authors":"Hayato Kamata, Shinya Suzuki, K. Demachi, Hidetaka Suzuki, Yuka Sugama, K. Ikegawa, T. Igarashi, M. Yamaguchi, H. Okudera, M. Tahara, T. Kawasaki","doi":"10.1097/OP9.0000000000000022","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000022","url":null,"abstract":"Objectives: Impact of outpatient collaborative pharmacy services performed by pharmacists on drug costs has not yet been reported. Therefore, this study evaluated direct interventions made by pharmacists in the form of prescription proposals that resulted in drug cost savings from outpatient collaborative pharmacy services performed by pharmacists to support outpatient cancer chemotherapy. Methods:This was a retrospective cohort study wherein the drug cost savings resulting from the outpatient collaborative pharmacy services performed by 6 pharmacists and physicians from 6 medical departments were calculated and investigated from June 2016 to November 2016. Drug costs as of August 31, 2016 were used to calculate the drug cost savings. Results: During the 6-month study period, 6 pharmacists performed outpatient collaborative pharmacy services on weekdays within a span of 120 days for a total of 2177hours each. The total drug cost savings were <6984,637, including <5842,061 for anticancer drugs, <1086,484 for oral drugs other than anticancer, <39,388 for premedications, and <16,704 for drugs for abuse. The total cost of the added drugs was<3224,227, allocated as follows: nonanticancer medicines,<1441,317; supportivemedicines for adverse drug reactions in chemotherapy, <359,127; premedications for chemotherapy, <307,961; and anticancer medicines, <1115,822. Conclusion: The results of the present study are limited to “pharmacists assisting in reducing drugs by adjusting expensive anticancer drugs through a collaborative effort with physicians via outpatient consultations”; however, it indicated a significant overall health economic effect.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/OP9.0000000000000022","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61744295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.1097/OP9.0000000000000021
A. Horinouchi, Shinya Suzuki, T. Enokida, Hayato Kamata, A. Kaneko, C. Matsuyama, T. Fujisawa, Yuri Ueda, S. Okano, T. Kawasaki, M. Tahara
Cetuximab (Cmab), an Immunoglobulin G1 monoclonal antibody targeting the epidermal growth factor receptor, is associated with Epidermal Growth Factor Receptor inhibitor-specific adverse drug reactions, such as skin toxicities and infusion-related reactions (IRRs). IRRs have been reported in 6–18% of patients receiving Cmab, with grade 3 and 4 reactions in 1–5% in head and neck cancer patients. Premedication with corticosteroids may prevent or dampen non-Immunoglobulin E (IgE) mediated infusion reactions. We encountered a case in which a grade 3 IRR occurred secondary to Cmab that was combined with 5-fluorouracil and cisplatin (5fluorouracil and Cisplatin +Cmab) chemotherapy for a recurrent and metastatic head and neck cancer patient who had received premedication consisting of chlorpheniramine 5mg, dexamethasone 13.2mg, and aprepitant 125mg. Non-IgE-mediated reaction and cytokine release syndrome can be prevented by premedication. The patient had grade 3 IRRs because of Cmab, even though we used a higher dose of corticosteroid, dexamethasone 13.2mg, and aprepitant. Severe IRRs because of Cmab occurred despite administration of a higher dose of dexamethasone, compared with the ordinary dose that ranges from 3.3 to 6.6mg. Furthermore, his rapid symptom after Cmab intravenous administration confirmed to typical IgE-mediated reaction even though he received high dose of dexamethasone and chlorpheniramine. To prevent a critical situation due to severe Cmab IRRs is early first aid treatment when a patient has hypertensive reactions. Monitoring for symptoms of Cmab-induced IRRs requires not only the supervision of oncologists, nurses, and pharmacists but also patient awareness of the condition.
{"title":"Grade 3 infusion-related reaction because of cetuximab administered with 5-fluorouracil and cisplatin chemotherapy for a recurrent and metastatic head and neck cancer patient who received chlorpheniramine 5 mg, dexamethasone 13.2 mg, and aprepitant 125 mg premedication","authors":"A. Horinouchi, Shinya Suzuki, T. Enokida, Hayato Kamata, A. Kaneko, C. Matsuyama, T. Fujisawa, Yuri Ueda, S. Okano, T. Kawasaki, M. Tahara","doi":"10.1097/OP9.0000000000000021","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000021","url":null,"abstract":"Cetuximab (Cmab), an Immunoglobulin G1 monoclonal antibody targeting the epidermal growth factor receptor, is associated with Epidermal Growth Factor Receptor inhibitor-specific adverse drug reactions, such as skin toxicities and infusion-related reactions (IRRs). IRRs have been reported in 6–18% of patients receiving Cmab, with grade 3 and 4 reactions in 1–5% in head and neck cancer patients. Premedication with corticosteroids may prevent or dampen non-Immunoglobulin E (IgE) mediated infusion reactions. We encountered a case in which a grade 3 IRR occurred secondary to Cmab that was combined with 5-fluorouracil and cisplatin (5fluorouracil and Cisplatin +Cmab) chemotherapy for a recurrent and metastatic head and neck cancer patient who had received premedication consisting of chlorpheniramine 5mg, dexamethasone 13.2mg, and aprepitant 125mg. Non-IgE-mediated reaction and cytokine release syndrome can be prevented by premedication. The patient had grade 3 IRRs because of Cmab, even though we used a higher dose of corticosteroid, dexamethasone 13.2mg, and aprepitant. Severe IRRs because of Cmab occurred despite administration of a higher dose of dexamethasone, compared with the ordinary dose that ranges from 3.3 to 6.6mg. Furthermore, his rapid symptom after Cmab intravenous administration confirmed to typical IgE-mediated reaction even though he received high dose of dexamethasone and chlorpheniramine. To prevent a critical situation due to severe Cmab IRRs is early first aid treatment when a patient has hypertensive reactions. Monitoring for symptoms of Cmab-induced IRRs requires not only the supervision of oncologists, nurses, and pharmacists but also patient awareness of the condition.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/OP9.0000000000000021","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61743798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-01DOI: 10.1097/OP9.0000000000000018
Y. Summers, D. Graham
Targeted inhibition of epidermal growth factor receptor (EGFR) signaling has emerged as the standard of care for EGFR mutationpositive non-small cell lung cancer (EGFRm+ NSCLC). Afatinib, an oral irreversible ErbB-family blocker, has been extensively studied in this context. Recent studies have highlighted the benefit and tolerability of afatinib treatment in patients with EGFRm+ advanced/ metastatic NSCLC. The LUX-Lung 3 and 6 phase III studies showed greater efficacy with first-line afatinib compared with platinumdoublet chemotherapy, whereas LUX-Lung 7 highlighted the enhanced benefits of afatinib over the first-generation EGFR tyrosine kinase inhibitor (TKI), gefitinib. The nearly inevitable emergence of resistance to afatinib, coupled with recent data for the thirdgeneration TKI osimertinib, highlight the need to identify an optimal treatment sequencing strategy to achieve long-term benefit and survival. The available data suggest that optimal treatment could involve first-line afatinib, followed by osimertinib upon acquired resistance to afatinib through the T790M mutation. This review discusses the pharmacology of afatinib, efficacy and safety results of key trials in the afatinib clinical study program, management of adverse events, and sequencing strategies following acquired resistance. Afatinib data are discussed in the context of recent studies of other EGFR TKIs, to provide considerations around their use and inform potential sequential treatment approaches. Abbreviations: ALK = anaplastic lymphoma kinase; CI = confidence interval; CNS = central nervous system; CYP = cytochrome P450; EGFR = epidermal growth factor receptor; HER = human epidermal growth factor receptor; NSCLC = non-small cell lung cancer; ORR= objective response rate; OS= overall survival; PD-L1= programmed death-ligand 1; PFS= progression-free survival; P-gp = P-glycoprotein; TKI = tyrosine kinase inhibitor.
{"title":"Afatinib, an irreversible ErbB family blocker for the treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer","authors":"Y. Summers, D. Graham","doi":"10.1097/OP9.0000000000000018","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000018","url":null,"abstract":"Targeted inhibition of epidermal growth factor receptor (EGFR) signaling has emerged as the standard of care for EGFR mutationpositive non-small cell lung cancer (EGFRm+ NSCLC). Afatinib, an oral irreversible ErbB-family blocker, has been extensively studied in this context. Recent studies have highlighted the benefit and tolerability of afatinib treatment in patients with EGFRm+ advanced/ metastatic NSCLC. The LUX-Lung 3 and 6 phase III studies showed greater efficacy with first-line afatinib compared with platinumdoublet chemotherapy, whereas LUX-Lung 7 highlighted the enhanced benefits of afatinib over the first-generation EGFR tyrosine kinase inhibitor (TKI), gefitinib. The nearly inevitable emergence of resistance to afatinib, coupled with recent data for the thirdgeneration TKI osimertinib, highlight the need to identify an optimal treatment sequencing strategy to achieve long-term benefit and survival. The available data suggest that optimal treatment could involve first-line afatinib, followed by osimertinib upon acquired resistance to afatinib through the T790M mutation. This review discusses the pharmacology of afatinib, efficacy and safety results of key trials in the afatinib clinical study program, management of adverse events, and sequencing strategies following acquired resistance. Afatinib data are discussed in the context of recent studies of other EGFR TKIs, to provide considerations around their use and inform potential sequential treatment approaches. Abbreviations: ALK = anaplastic lymphoma kinase; CI = confidence interval; CNS = central nervous system; CYP = cytochrome P450; EGFR = epidermal growth factor receptor; HER = human epidermal growth factor receptor; NSCLC = non-small cell lung cancer; ORR= objective response rate; OS= overall survival; PD-L1= programmed death-ligand 1; PFS= progression-free survival; P-gp = P-glycoprotein; TKI = tyrosine kinase inhibitor.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/OP9.0000000000000018","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48018287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-01DOI: 10.1097/OP9.0000000000000020
K. Meier, A. Astier, A. Boşnak, R. Goněc
The way we treat cancer is changing. Scientific and technological advances such as tumour profiling, ‘big data,’ and an increasing number of targeted therapies and combination regimens will result in a paradigm shift away from a ‘one-size-fits-all’ concept toward personalized, on-demand, precision medicine, which will result in smaller, more defined patient populations. In parallel, the global incidence of cancer is rising, which is placing an increasing strain onmedical oncology centres, and driving the evolution of oncology pharmacy. Clinical pharmacists can reduce the pressures on other healthcare resources by taking an increased role in patient care and providing a broader range of services. Pharmacists recognize that technological developments will lead to significant changes in pharmacy services, which will require greater integration with other services within the healthcare system. Members of the European Society of Oncology Pharmacy (ESOP) met at the 4th European Conference of Oncology Pharmacy (ECOP) meeting in October 2018 for a symposium entitled The Future of Oncology Pharmacy 2025. This review summarizes several topics discussed at the meeting, including the future of medicine, oncology and pharmacy healthcare, provides an update on ESOP activities and presents the ECOP 2018 resolution. This position statement outlines the ESOP perspective on how oncology pharmacy will change over the next decade, and how it will respond to these changes to support oncology pharmacists and achieve better outcomes for patients with cancer. Abbreviations: ECCO = European Cancer Organisation; EPIC = Empowering pharmacists to improve health care for oral chemotherapy patients; ERQCC = Essential Requirements for Quality Cancer Care; ESOP = European Society of Oncology Pharmacy; EU = European Union; EUSOP = European Specialization in Oncology Pharmacy; HCPs = Healthcare professionals.
{"title":"The future of oncology pharmacy: European Conference of Oncology Pharmacy 2018","authors":"K. Meier, A. Astier, A. Boşnak, R. Goněc","doi":"10.1097/OP9.0000000000000020","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000020","url":null,"abstract":"The way we treat cancer is changing. Scientific and technological advances such as tumour profiling, ‘big data,’ and an increasing number of targeted therapies and combination regimens will result in a paradigm shift away from a ‘one-size-fits-all’ concept toward personalized, on-demand, precision medicine, which will result in smaller, more defined patient populations. In parallel, the global incidence of cancer is rising, which is placing an increasing strain onmedical oncology centres, and driving the evolution of oncology pharmacy. Clinical pharmacists can reduce the pressures on other healthcare resources by taking an increased role in patient care and providing a broader range of services. Pharmacists recognize that technological developments will lead to significant changes in pharmacy services, which will require greater integration with other services within the healthcare system. Members of the European Society of Oncology Pharmacy (ESOP) met at the 4th European Conference of Oncology Pharmacy (ECOP) meeting in October 2018 for a symposium entitled The Future of Oncology Pharmacy 2025. This review summarizes several topics discussed at the meeting, including the future of medicine, oncology and pharmacy healthcare, provides an update on ESOP activities and presents the ECOP 2018 resolution. This position statement outlines the ESOP perspective on how oncology pharmacy will change over the next decade, and how it will respond to these changes to support oncology pharmacists and achieve better outcomes for patients with cancer. Abbreviations: ECCO = European Cancer Organisation; EPIC = Empowering pharmacists to improve health care for oral chemotherapy patients; ERQCC = Essential Requirements for Quality Cancer Care; ESOP = European Society of Oncology Pharmacy; EU = European Union; EUSOP = European Specialization in Oncology Pharmacy; HCPs = Healthcare professionals.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/OP9.0000000000000020","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46782939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-01DOI: 10.1097/OP9.0000000000000019
A. Ouasrhir, Z. Bourhaleb, R. Rahhali, N. Boukhatem
Objectives: Chemotherapy compounding is a main step of chemotherapy cancer process. This step is formed by many parts. A multidisciplinary team is assembled to define critical points and failures linked to this process and proposed different actions to secure them and improve chemotherapy cancer process. Methodology: By a prospective analysis risks tool: the failure modes, effects, and criticality analysis (FMECA), anticancer drug process compounding was sequenced in many parts. During the brainstorming, different ideas expressed and were classified into an Ishikawa cause–effect diagram. The criticality indexes (CI) are calculated from occurrence, severity, and the detection probability. Results: The sum of CIs of 18 identified failure modes was CI=3607 for the decentralized system and CI=726 after the new organization of compounding process. The chemotherapy production step represents 37.17% (CI=1341) of all failures in the old process. The greatest risk reductions between the old and the new process concerned the risk of ‘Double check missing before delivery to the ward’ by a factor reduction of 28.0). Among the CIs remaining superior to 100, there was one failure: ‘Typing error during prescription’ (CI=144). Conclusion: Modification of the chemotherapy-compounding process by centralization, training program, and implementation of procedures resulted in an important risk reduction as shownby risk analysis.Our study illustrates the usefulness of risk analysismethods in the healthcare system. A systematic use of risk analysis is needed to improve the safety of high-risk activities in healthcare processes.
{"title":"Improving the safety of chemotherapy process by a risks management tool","authors":"A. Ouasrhir, Z. Bourhaleb, R. Rahhali, N. Boukhatem","doi":"10.1097/OP9.0000000000000019","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000019","url":null,"abstract":"Objectives: Chemotherapy compounding is a main step of chemotherapy cancer process. This step is formed by many parts. A multidisciplinary team is assembled to define critical points and failures linked to this process and proposed different actions to secure them and improve chemotherapy cancer process. Methodology: By a prospective analysis risks tool: the failure modes, effects, and criticality analysis (FMECA), anticancer drug process compounding was sequenced in many parts. During the brainstorming, different ideas expressed and were classified into an Ishikawa cause–effect diagram. The criticality indexes (CI) are calculated from occurrence, severity, and the detection probability. Results: The sum of CIs of 18 identified failure modes was CI=3607 for the decentralized system and CI=726 after the new organization of compounding process. The chemotherapy production step represents 37.17% (CI=1341) of all failures in the old process. The greatest risk reductions between the old and the new process concerned the risk of ‘Double check missing before delivery to the ward’ by a factor reduction of 28.0). Among the CIs remaining superior to 100, there was one failure: ‘Typing error during prescription’ (CI=144). Conclusion: Modification of the chemotherapy-compounding process by centralization, training program, and implementation of procedures resulted in an important risk reduction as shownby risk analysis.Our study illustrates the usefulness of risk analysismethods in the healthcare system. A systematic use of risk analysis is needed to improve the safety of high-risk activities in healthcare processes.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/OP9.0000000000000019","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43382623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-01DOI: 10.1097/OP9.0000000000000017
M. Laplace, B. Lefranc, B. Dalifard
Introduction: DRUGCAM is a new approach to control the chemotherapy preparations with an intelligent video system to assist the pharmacy technician during compounding process. This tool is able to control all of our production (except for colored and dark anticancer drugs) with an in-process control and a posteriori inspection. We first aimed to estimate DRUGCAM’s performance in reallife production by simulation and to compare it with the double human control. Furthermore, factors influencing the performance of both controls were observed and preventive solutions will be envisaged to optimize our activity. Equipment and methods: Each day during 30 days, between 11:30 AM and 12:30 AM, we controlled 20 different volumes contained in syringes, in real production conditions (clean room) both by human visual inspection then by automated video control. Working conditions have been observed and tasks disturbances and interruptions have been noted. A set of information has been collected: the syringe’s model, the volume of product and the disturbances. A statistical analysis has been conducted to interpret results. Results: With 24 errors throughout the 600 volume controls, the error rate for the visual human control is 4%. Seven checked volumes were superior to the expected volume (overdosing) and 17 were inferior (underdosing). The error rate for DRUGCAM is 0.17%. Among the disturbance factors, the type of syringe used is responsible for errors: 13 errors have been noticed with the 1mL syringe and 8 errors with the 10mL syringe which represent higher error rates than with the other syringes. The “permanent” staff members of the unit present an error rate of 5.3%, more important than the “non-permanent” ones (1.8%). More mistakes are done in the presence of a pharmacist than in its absence (13% against 4%). Conclusion: Our studies justify the superiority of the DRUGCAM system toward double human control. Moreover, the double human control could possibly be disturbed by external factors whereas DRUGCAM is not. Using DRUGCAM is to be considered to establish preventive measures and reduce tasks interruptions or disturbance factors thanks to video analysis.
{"title":"Simulation to assess intelligent video camera system's actual production performance during chemotherapy preparation","authors":"M. Laplace, B. Lefranc, B. Dalifard","doi":"10.1097/OP9.0000000000000017","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000017","url":null,"abstract":"Introduction: DRUGCAM is a new approach to control the chemotherapy preparations with an intelligent video system to assist the pharmacy technician during compounding process. This tool is able to control all of our production (except for colored and dark anticancer drugs) with an in-process control and a posteriori inspection. We first aimed to estimate DRUGCAM’s performance in reallife production by simulation and to compare it with the double human control. Furthermore, factors influencing the performance of both controls were observed and preventive solutions will be envisaged to optimize our activity. Equipment and methods: Each day during 30 days, between 11:30 AM and 12:30 AM, we controlled 20 different volumes contained in syringes, in real production conditions (clean room) both by human visual inspection then by automated video control. Working conditions have been observed and tasks disturbances and interruptions have been noted. A set of information has been collected: the syringe’s model, the volume of product and the disturbances. A statistical analysis has been conducted to interpret results. Results: With 24 errors throughout the 600 volume controls, the error rate for the visual human control is 4%. Seven checked volumes were superior to the expected volume (overdosing) and 17 were inferior (underdosing). The error rate for DRUGCAM is 0.17%. Among the disturbance factors, the type of syringe used is responsible for errors: 13 errors have been noticed with the 1mL syringe and 8 errors with the 10mL syringe which represent higher error rates than with the other syringes. The “permanent” staff members of the unit present an error rate of 5.3%, more important than the “non-permanent” ones (1.8%). More mistakes are done in the presence of a pharmacist than in its absence (13% against 4%). Conclusion: Our studies justify the superiority of the DRUGCAM system toward double human control. Moreover, the double human control could possibly be disturbed by external factors whereas DRUGCAM is not. Using DRUGCAM is to be considered to establish preventive measures and reduce tasks interruptions or disturbance factors thanks to video analysis.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/OP9.0000000000000017","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45645074","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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