Abstract Tamoxifen plays a key role in hormone therapy for patients with breast cancer. However, studies have reported inconsistent responses to the drug because of different factors. Among these, allelic variants of cytochrome P450 genes are important. This study aims to determine the polymorphic variants of CYP2D6 gene in patients with breast cancer who underwent tamoxifen hormone therapy, classifying them according to their phenotypes as poor, intermediate, extensive, or ultrarapid metabolizers and describing clinical outcomes, such as time to relapse and overall survival (OS). This was a case series study conducted in 47 patients diagnosed with breast cancer, between 2015 and 2018. Whole-blood samples were collected, and DNA was extracted. CYP2D6 gene alterations were assessed. The mean age was 61 ± 11 years. Ductal carcinoma occurred in 85%, of which 42% was grade 2. The predominant stages of breast cancer were IIB in 26% and stage I in 32%. Extensive phenotype metabolizers were identified in 92%, poor in 6%, and intermediate in 2% of participants. Relapse was reported in 30% of participants, with metastatic relapse in 86%, which was more frequently identified in poor metabolizers. The OS at 5 and 10 years was 91%, regardless of phenotype. OS was 90% at 5 and 10 years for extensive metabolizers. Although the sample size was very small to make significant comparisons, it was observed that both poor and extensive metabolizing patients experienced some form of relapse. The OS of patients with the extensive metabolizer phenotype in this study is similar to that reported worldwide.
{"title":"Genotypic variations of the CYP2D6 gene in patients with breast cancer treated with tamoxifen: case series","authors":"Luz Fernanda Sua, Andrés Orlando Castillo, Lisa Ximena Rodriguez, Liliana Fernández-Trujillo","doi":"10.1097/op9.0000000000000050","DOIUrl":"https://doi.org/10.1097/op9.0000000000000050","url":null,"abstract":"Abstract Tamoxifen plays a key role in hormone therapy for patients with breast cancer. However, studies have reported inconsistent responses to the drug because of different factors. Among these, allelic variants of cytochrome P450 genes are important. This study aims to determine the polymorphic variants of CYP2D6 gene in patients with breast cancer who underwent tamoxifen hormone therapy, classifying them according to their phenotypes as poor, intermediate, extensive, or ultrarapid metabolizers and describing clinical outcomes, such as time to relapse and overall survival (OS). This was a case series study conducted in 47 patients diagnosed with breast cancer, between 2015 and 2018. Whole-blood samples were collected, and DNA was extracted. CYP2D6 gene alterations were assessed. The mean age was 61 ± 11 years. Ductal carcinoma occurred in 85%, of which 42% was grade 2. The predominant stages of breast cancer were IIB in 26% and stage I in 32%. Extensive phenotype metabolizers were identified in 92%, poor in 6%, and intermediate in 2% of participants. Relapse was reported in 30% of participants, with metastatic relapse in 86%, which was more frequently identified in poor metabolizers. The OS at 5 and 10 years was 91%, regardless of phenotype. OS was 90% at 5 and 10 years for extensive metabolizers. Although the sample size was very small to make significant comparisons, it was observed that both poor and extensive metabolizing patients experienced some form of relapse. The OS of patients with the extensive metabolizer phenotype in this study is similar to that reported worldwide.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135805128","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 : 2022-07-01DOI: 10.1097/op9.0000000000000038
Gregory Joey, Yuke Nelwan, Max Franz Joseph Mantik, S. Gunawan, V. de Haas, G. Kaspers
{"title":"Alternative chemotherapy for acute myeloid leukemia with Down syndrome","authors":"Gregory Joey, Yuke Nelwan, Max Franz Joseph Mantik, S. Gunawan, V. de Haas, G. Kaspers","doi":"10.1097/op9.0000000000000038","DOIUrl":"https://doi.org/10.1097/op9.0000000000000038","url":null,"abstract":"","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42061442","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 : 2022-04-01DOI: 10.1097/OP9.0000000000000037
Y. Nisse, N. Sobalak, J. Vigneron, B. Demoré
Abstract Introduction: A new pemetrexed salt, pemetrexed diarginine (PDA), was marketed by Mylan company. The product is a ready-to-dilute 25 mg/mL solution. The manufacturer indicates a 24-hour stability after dilution in dextrose 5% (D5W). The objectives were to study the stability of: PDA in D5W and 0.9% sodium chloride (0.9% NaCl) polyolefin bags at 3 and 12 mg/mL protected from light (PFL) between 2 to 8°C and at 25°C, and not PFL at room temperature; PDA vials at 25 mg/mL partially used perforated with a plastic spike PFL between 2 to 8°C and at 25°C and not PFL at room temperature. Methods: The stability study was performed by high-performance liquid chromatography coupled to a photodiode array detector. The method was validated according to International Council for Harmonisation guideline Q2(R1). Physical stability was evaluated by visual and subvisual inspection. pH values were measured. Results: PDA solutions PFL in D5W and in 0.9% NaCl at 3 and 12 mg/mL retained more than 95% of the initial concentration after 7 days at 25°C and after 28 days at 2 to 8°C. PDA ready-to-dilute 25 mg/mL solutions PFL retained more than 95% of the initial concentration after 28 days at 25°C and 2 to 8°C. PDA solutions in D5W and in 0.9% NaCl at 3 mg/mL and 12 mg/mL and PDA ready-to-dilute 25 mg/mL solutions not PFL retained more than 95% of the initial concentration after 7 days at room temperature. All samples had a pH in the range of 8.05 to 8.77. A light colouration, described in SPC, to an intense yellow-brown colouration, appeared depending on concentration and time. No precipitate was observed. Conclusion: According to the manufacturer's specifications and to the chemical stability defined as more than 95% of the initial concentration, PDA solutions in D5W and in 0.9% NaCl at 3 and 12 mg/mL and PDA ready-to-dilute 25 mg/mL solutions PFL at 25°C and not PFL at room temperature were stable for 7 days and for 28 days at 2 to 8°C. The absence of a color change as an acceptance criterion for the 25 mg/mL ready-to-dilute solution perforated with a plastic spike leads to a stability of 7 days at 2 to 8°C and 4 days at room temperature allowing the use of the vial for a preparation in advance with an optimal stability.
{"title":"Physicochemical stability of pemetrexed diarginine at 25 mg/mL in partially-used vials and at 3 and 12 mg/mL diluted in dextrose 5% or in sodium chloride 0.9% in polyolefin bags","authors":"Y. Nisse, N. Sobalak, J. Vigneron, B. Demoré","doi":"10.1097/OP9.0000000000000037","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000037","url":null,"abstract":"Abstract Introduction: A new pemetrexed salt, pemetrexed diarginine (PDA), was marketed by Mylan company. The product is a ready-to-dilute 25 mg/mL solution. The manufacturer indicates a 24-hour stability after dilution in dextrose 5% (D5W). The objectives were to study the stability of: PDA in D5W and 0.9% sodium chloride (0.9% NaCl) polyolefin bags at 3 and 12 mg/mL protected from light (PFL) between 2 to 8°C and at 25°C, and not PFL at room temperature; PDA vials at 25 mg/mL partially used perforated with a plastic spike PFL between 2 to 8°C and at 25°C and not PFL at room temperature. Methods: The stability study was performed by high-performance liquid chromatography coupled to a photodiode array detector. The method was validated according to International Council for Harmonisation guideline Q2(R1). Physical stability was evaluated by visual and subvisual inspection. pH values were measured. Results: PDA solutions PFL in D5W and in 0.9% NaCl at 3 and 12 mg/mL retained more than 95% of the initial concentration after 7 days at 25°C and after 28 days at 2 to 8°C. PDA ready-to-dilute 25 mg/mL solutions PFL retained more than 95% of the initial concentration after 28 days at 25°C and 2 to 8°C. PDA solutions in D5W and in 0.9% NaCl at 3 mg/mL and 12 mg/mL and PDA ready-to-dilute 25 mg/mL solutions not PFL retained more than 95% of the initial concentration after 7 days at room temperature. All samples had a pH in the range of 8.05 to 8.77. A light colouration, described in SPC, to an intense yellow-brown colouration, appeared depending on concentration and time. No precipitate was observed. Conclusion: According to the manufacturer's specifications and to the chemical stability defined as more than 95% of the initial concentration, PDA solutions in D5W and in 0.9% NaCl at 3 and 12 mg/mL and PDA ready-to-dilute 25 mg/mL solutions PFL at 25°C and not PFL at room temperature were stable for 7 days and for 28 days at 2 to 8°C. The absence of a color change as an acceptance criterion for the 25 mg/mL ready-to-dilute solution perforated with a plastic spike leads to a stability of 7 days at 2 to 8°C and 4 days at room temperature allowing the use of the vial for a preparation in advance with an optimal stability.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43463459","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 : 2022-04-01DOI: 10.1097/OP9.0000000000000034
Justin Yeh, W. Black, A. Guddati
Abstract Increasing costs of cancer treatment and anticancer drugs can create a financial burden on society and the individual. Pembrolizumab is an anti-PD-1 inhibitor immunotherapy approved for use in recurrent or metastatic head and neck squamous cell carcinoma. Limited data exists on the cost-effectiveness of pembrolizumab in this setting. This study compares the costeffectiveness of pembrolizumab against traditional chemotherapy using data from KEYNOTE-040. Published data from KEYNOTE-040 were used to create a model estimating treatment costs and overall survival benefit of pembrolizumab and traditional chemotherapy. Costs of treatment of toxicity-related events were obtained from previous literature and were incorporated into the model. Derivation of survival benefit gained from treatment was measured in quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) of pembrolizumab compared to the investigator's choice (IC) was $801,864/QALY. The average drug cost of pembrolizumab would have to approximately decrease by 63% in order to reach the cost-effective threshold of $100,000/ QALY. Pembrolizumab would have to confer a survival benefit of 0.88 QALYs per patient over the IC to reach the cost-effective threshold. Pembrolizumab is not considered cost effective at a threshold of $100,000/QALY based on survival data reported in KEYNOTE-040. Improved long-term outcomes of patients on this relatively new immunotherapy have yet to be reported. Inclusion of these data in the future would likely improve the cost-effectiveness calculations of pembrolizumab and other immunotherapies.
{"title":"Cost-effectiveness analysis of pembrolizumab versus standard of care in recurrent or metastatic squamous cell carcinoma of the head and neck","authors":"Justin Yeh, W. Black, A. Guddati","doi":"10.1097/OP9.0000000000000034","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000034","url":null,"abstract":"Abstract Increasing costs of cancer treatment and anticancer drugs can create a financial burden on society and the individual. Pembrolizumab is an anti-PD-1 inhibitor immunotherapy approved for use in recurrent or metastatic head and neck squamous cell carcinoma. Limited data exists on the cost-effectiveness of pembrolizumab in this setting. This study compares the costeffectiveness of pembrolizumab against traditional chemotherapy using data from KEYNOTE-040. Published data from KEYNOTE-040 were used to create a model estimating treatment costs and overall survival benefit of pembrolizumab and traditional chemotherapy. Costs of treatment of toxicity-related events were obtained from previous literature and were incorporated into the model. Derivation of survival benefit gained from treatment was measured in quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) of pembrolizumab compared to the investigator's choice (IC) was $801,864/QALY. The average drug cost of pembrolizumab would have to approximately decrease by 63% in order to reach the cost-effective threshold of $100,000/ QALY. Pembrolizumab would have to confer a survival benefit of 0.88 QALYs per patient over the IC to reach the cost-effective threshold. Pembrolizumab is not considered cost effective at a threshold of $100,000/QALY based on survival data reported in KEYNOTE-040. Improved long-term outcomes of patients on this relatively new immunotherapy have yet to be reported. Inclusion of these data in the future would likely improve the cost-effectiveness calculations of pembrolizumab and other immunotherapies.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48336951","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 : 2022-01-01DOI: 10.1097/OP9.0000000000000036
A. Bienert, K. Meier, Antonina S. Kokisheva, Rodrigo A. Gama Brambila, Marianna Veraldi, Nuno V. Marques, Maja Kuzmanović, Dan Paul Andreianu, F. Badibouidi, Romina Morales Vallespin
Abstract Introduction: The SARS-CoV-2 pandemic stroke at the beginning of 2020, challenging the health systems worldwide. As hospitals became overwhelmed by the number of cases, and community pharmacies became one of the few non-stop operating services, and the work rhythm and workload of pharmacists changed importantly. Methods: To investigate which and how the changes occurred, especially among oncology pharmacists, the ESOP together with the EAHP developed a survey, translated to 9 languages, and distributed online. The questions were changed over the duration of the survey (August 2020 to March 2021), adapting to the global situation. The answers were analyzed with basic descriptive statistics. Results: Over 1000 health professionals, predominantly pharmacists (over 85%), from 64 countries participated in the monthly survey, providing information relevant to both the hospital and the community pharmacy. More than 50% of hospital pharmacists reported shortage of chemotherapeutics, while the availability of COVID-19 related medications had more fluctuations in the hospital pharmacy. Contrastingly, over 80% of community pharmacists reported medications shortages in April 2020. The survey showed the negative impact of the pandemic on chemotherapeutic preparations, with decreased productions during the first and second waves (February-May 2020, and November 2020 to January 2021). The survey also helped visualize the stress levels and workloads of pharmacists. More than 70% of participants reported in August 2020 to have needed to procure themselves with Personal Protective Equipment. Working hours increased for 43% of the respondents, and more than 60% reported to have felt emotionally stressed. Conclusions: Thus, the presented results give a broad, yet detailed overview of how the pandemic has affected health professionals both in the hospital and the community, how professionals and governments have reacted to the situation, and how the care of oncology patience and the practice of oncology pharmacy has changed and reacted during the first year of the SARS-CoV-2 pandemic.
{"title":"Impact of COVID-19 of oncology pharmacy services: Results of 8-months survey","authors":"A. Bienert, K. Meier, Antonina S. Kokisheva, Rodrigo A. Gama Brambila, Marianna Veraldi, Nuno V. Marques, Maja Kuzmanović, Dan Paul Andreianu, F. Badibouidi, Romina Morales Vallespin","doi":"10.1097/OP9.0000000000000036","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000036","url":null,"abstract":"Abstract Introduction: The SARS-CoV-2 pandemic stroke at the beginning of 2020, challenging the health systems worldwide. As hospitals became overwhelmed by the number of cases, and community pharmacies became one of the few non-stop operating services, and the work rhythm and workload of pharmacists changed importantly. Methods: To investigate which and how the changes occurred, especially among oncology pharmacists, the ESOP together with the EAHP developed a survey, translated to 9 languages, and distributed online. The questions were changed over the duration of the survey (August 2020 to March 2021), adapting to the global situation. The answers were analyzed with basic descriptive statistics. Results: Over 1000 health professionals, predominantly pharmacists (over 85%), from 64 countries participated in the monthly survey, providing information relevant to both the hospital and the community pharmacy. More than 50% of hospital pharmacists reported shortage of chemotherapeutics, while the availability of COVID-19 related medications had more fluctuations in the hospital pharmacy. Contrastingly, over 80% of community pharmacists reported medications shortages in April 2020. The survey showed the negative impact of the pandemic on chemotherapeutic preparations, with decreased productions during the first and second waves (February-May 2020, and November 2020 to January 2021). The survey also helped visualize the stress levels and workloads of pharmacists. More than 70% of participants reported in August 2020 to have needed to procure themselves with Personal Protective Equipment. Working hours increased for 43% of the respondents, and more than 60% reported to have felt emotionally stressed. Conclusions: Thus, the presented results give a broad, yet detailed overview of how the pandemic has affected health professionals both in the hospital and the community, how professionals and governments have reacted to the situation, and how the care of oncology patience and the practice of oncology pharmacy has changed and reacted during the first year of the SARS-CoV-2 pandemic.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47627348","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 : 2021-10-01DOI: 10.1097/OP9.0000000000000035
T. Ohta, Shinya Suzuki, A. Shinohara, Yasukata Ohashi, Daisuke Ueki, Daisuke Konuma, Yasuaki Ryushima, R. Udagawa, T. Kawasaki, M. Yamaguchi
Abstract Introduction: Pharmacists perform regimen checks of physicians’ prescription orders in hospitals for providing appropriate chemotherapy. Details of these steps and procedures are confined to reports within individual facilities. Methods: In July 2016, a questionnaire was sent to the 33 pharmacists of the total 33 National Hospital Organization hospitals that were not cancer hospitals in Japan to survey the items checked in regimen checks and to assess whether the regimen checks are performed for oral anticancer drugs (OACDs) and injected anticancer drugs (IACDs) according to prescription category. The questionnaires included items on characteristics of respondents and their facilities and the 7 items related to regimen checks. Results: All facilities responded to the questionnaires, and 15 and 22 of the facilities performed chemotherapy regimen checks for OACDs and IACDs, respectively. Regimen checks for OACDs were performed for 80% (12/15) of internal and 27% (4/15) of external prescriptions for outpatient care and 93% (14/15) of prescriptions for inpatient care. Regimen checks for IACDs were performed for 91% (20/22) of prescriptions for outpatient care and 100% (22/22) of inpatient care. Conclusions: The surveyed facilities differed in terms of items checked, suggesting that procedures of regimen checks followed protocols unique to each facility. It is vital to establish an adequate procedure to perform safe chemotherapy.
{"title":"Needs of chemotherapy regimen checks procedure: from the survey on chemotherapy regimen checks performed by pharmacists in hospitals other than designated cancer hospitals in Japan","authors":"T. Ohta, Shinya Suzuki, A. Shinohara, Yasukata Ohashi, Daisuke Ueki, Daisuke Konuma, Yasuaki Ryushima, R. Udagawa, T. Kawasaki, M. Yamaguchi","doi":"10.1097/OP9.0000000000000035","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000035","url":null,"abstract":"Abstract Introduction: Pharmacists perform regimen checks of physicians’ prescription orders in hospitals for providing appropriate chemotherapy. Details of these steps and procedures are confined to reports within individual facilities. Methods: In July 2016, a questionnaire was sent to the 33 pharmacists of the total 33 National Hospital Organization hospitals that were not cancer hospitals in Japan to survey the items checked in regimen checks and to assess whether the regimen checks are performed for oral anticancer drugs (OACDs) and injected anticancer drugs (IACDs) according to prescription category. The questionnaires included items on characteristics of respondents and their facilities and the 7 items related to regimen checks. Results: All facilities responded to the questionnaires, and 15 and 22 of the facilities performed chemotherapy regimen checks for OACDs and IACDs, respectively. Regimen checks for OACDs were performed for 80% (12/15) of internal and 27% (4/15) of external prescriptions for outpatient care and 93% (14/15) of prescriptions for inpatient care. Regimen checks for IACDs were performed for 91% (20/22) of prescriptions for outpatient care and 100% (22/22) of inpatient care. Conclusions: The surveyed facilities differed in terms of items checked, suggesting that procedures of regimen checks followed protocols unique to each facility. It is vital to establish an adequate procedure to perform safe chemotherapy.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43080632","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 : 2021-07-01DOI: 10.1097/OP9.0000000000000032
Guillaume Loeuille, J. Vigneron, E. D’huart, B. Demoré
Abstract Background: Lurbinectedin (ZEPZELCA) is a cytotoxic, with alkylating properties. The commercially available pharmaceutical form is a glass vial containing 4 mg of lyophilized powder of lurbinectedin. The recommended dose of lurbinectedin is 3.2 mg/m2. For a 1.7-m2 body surface area, the average dosage is 5.44 mg. The manufacturer indicates a 30-hour stability for the reconstituted solution which cannot give the possibility to re-use the vial for the following days resulting in an average loss of 3600 € per preparation. Objectives: The first objective was to study the stability of 500 μg/mL reconstituted lurbinectedin in water for injection after storage at 2 to 8°C. The second objective was to study the stability of 15 to 70 μg/mL diluted lurbinectedin in 0.9% NaCl or dextrose 5% in water stored at 2 to 8°C. Methods: Three solutions in glass tubes for each condition (reconstituted 15 and 70 μg/mL solutions) were prepared. Due to the high cost, only 1 infusion bag at 30 μg/mL in polyolefin container was prepared. At each time of the analysis, 3 samples for each vial were analyzed by high-performance liquid chromatography coupled to a photodiode array detector. Physical stability was evaluated by visual and subvisual inspection (spectrophotometry). Results: The analytical method was validated according to International Conference on Harmonisation guidelines Q2 (R1). The 500 μg/mL lurbinectedin reconstituted solution retained more than 95% of the initial concentration after 14 days as the 15 to 70 μg/mL diluted solutions. No interaction between the polyolefin infusion bag and lurbinectedin was observed. No physical changes were observed both visually and subvisually. Conclusion: The reconstituted solution and the diluted lurbinectedin solutions were physically and chemically stable for 14 days when stored at 2 to 8°C protected from light. This new data makes it possible to re-use the reconstituted vial and to store a preparation in case of cancellation of an administration.
{"title":"Physicochemical stability of lurbinectedin reconstituted at 500 μg/mL and diluted at 15, 30, and 70 μg/mL in 0.9% sodium chloride and 5% dextrose","authors":"Guillaume Loeuille, J. Vigneron, E. D’huart, B. Demoré","doi":"10.1097/OP9.0000000000000032","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000032","url":null,"abstract":"Abstract Background: Lurbinectedin (ZEPZELCA) is a cytotoxic, with alkylating properties. The commercially available pharmaceutical form is a glass vial containing 4 mg of lyophilized powder of lurbinectedin. The recommended dose of lurbinectedin is 3.2 mg/m2. For a 1.7-m2 body surface area, the average dosage is 5.44 mg. The manufacturer indicates a 30-hour stability for the reconstituted solution which cannot give the possibility to re-use the vial for the following days resulting in an average loss of 3600 € per preparation. Objectives: The first objective was to study the stability of 500 μg/mL reconstituted lurbinectedin in water for injection after storage at 2 to 8°C. The second objective was to study the stability of 15 to 70 μg/mL diluted lurbinectedin in 0.9% NaCl or dextrose 5% in water stored at 2 to 8°C. Methods: Three solutions in glass tubes for each condition (reconstituted 15 and 70 μg/mL solutions) were prepared. Due to the high cost, only 1 infusion bag at 30 μg/mL in polyolefin container was prepared. At each time of the analysis, 3 samples for each vial were analyzed by high-performance liquid chromatography coupled to a photodiode array detector. Physical stability was evaluated by visual and subvisual inspection (spectrophotometry). Results: The analytical method was validated according to International Conference on Harmonisation guidelines Q2 (R1). The 500 μg/mL lurbinectedin reconstituted solution retained more than 95% of the initial concentration after 14 days as the 15 to 70 μg/mL diluted solutions. No interaction between the polyolefin infusion bag and lurbinectedin was observed. No physical changes were observed both visually and subvisually. Conclusion: The reconstituted solution and the diluted lurbinectedin solutions were physically and chemically stable for 14 days when stored at 2 to 8°C protected from light. This new data makes it possible to re-use the reconstituted vial and to store a preparation in case of cancellation of an administration.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44343867","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 : 2021-07-01DOI: 10.1097/OP9.0000000000000031
Rana Fayek, Mostafa Soleyman, W. Jiskoot, M. Crul
Abstract Introduction: This survey aimed to create a snapshot of the post-production handling of monoclonal antibodies in daily practice in health-care facilities in several parts of the world. Methods: A worldwide web-based survey was distributed among pharmacists between November and December 2020. The questions were categorized in sections related to storage conditions, reconstitution practices including the use of medical devices, administration practices, transportation, visual examination and shelf-life of mAbs, education of health-care professionals, and patient's home-administration. Results: A total of 247 responders from 37 countries around the world participated in the survey. Hospital pharmacists were the largest group of respondents (92%). Most of the respondents (92%) reported that they store the mAbs at 2 to 8°C and 71% protect the prepared ready-to-administer mAbs from light by secondary packaging. The participants used spikes (38%), closed system transfer devices (CSTDs) (12%), and needles (22%) or a combination of these (28%) as a medical device, and 89% perform the reconstitution practices manually, versus 4% by semi-automatic pump system, 1% by robot, and 5% by a combination of these reconstitution methods. The respondents reported that in their institution, after compounding mAbs are transported via a logistic employee on foot at ambient temperature (59%) or in a cool-box (20%), or via the tube system (7%). More than half (64%) do not have written guidelines for transportation, but 86% perform a visual examination for particles of prepared mAbs before administration. Furthermore, 52% of the responders answered that nurses as well as pharmacists and pharmacy assistants receive staff training on the potential risks of mAb handling. Conclusion: There is a high level of variability in daily practices of mAb handling in pharmacies worldwide.
{"title":"Evaluation of post-production handling practices of monoclonal antibodies throughout the world","authors":"Rana Fayek, Mostafa Soleyman, W. Jiskoot, M. Crul","doi":"10.1097/OP9.0000000000000031","DOIUrl":"https://doi.org/10.1097/OP9.0000000000000031","url":null,"abstract":"Abstract Introduction: This survey aimed to create a snapshot of the post-production handling of monoclonal antibodies in daily practice in health-care facilities in several parts of the world. Methods: A worldwide web-based survey was distributed among pharmacists between November and December 2020. The questions were categorized in sections related to storage conditions, reconstitution practices including the use of medical devices, administration practices, transportation, visual examination and shelf-life of mAbs, education of health-care professionals, and patient's home-administration. Results: A total of 247 responders from 37 countries around the world participated in the survey. Hospital pharmacists were the largest group of respondents (92%). Most of the respondents (92%) reported that they store the mAbs at 2 to 8°C and 71% protect the prepared ready-to-administer mAbs from light by secondary packaging. The participants used spikes (38%), closed system transfer devices (CSTDs) (12%), and needles (22%) or a combination of these (28%) as a medical device, and 89% perform the reconstitution practices manually, versus 4% by semi-automatic pump system, 1% by robot, and 5% by a combination of these reconstitution methods. The respondents reported that in their institution, after compounding mAbs are transported via a logistic employee on foot at ambient temperature (59%) or in a cool-box (20%), or via the tube system (7%). More than half (64%) do not have written guidelines for transportation, but 86% perform a visual examination for particles of prepared mAbs before administration. Furthermore, 52% of the responders answered that nurses as well as pharmacists and pharmacy assistants receive staff training on the potential risks of mAb handling. Conclusion: There is a high level of variability in daily practices of mAb handling in pharmacies worldwide.","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45613216","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 : 2021-04-01DOI: 10.1097/op9.0000000000000029
M. Deppenweiler, Manon Teytaud, P. Stein, C. Donamaria, B. Lortal
{"title":"Reduction of patient waiting time by the preparation and administration of trastuzumab and pertuzumab in a single infusion bag: a 1-year review, retrospective, single institution experience in a French cancer center","authors":"M. Deppenweiler, Manon Teytaud, P. Stein, C. Donamaria, B. Lortal","doi":"10.1097/op9.0000000000000029","DOIUrl":"https://doi.org/10.1097/op9.0000000000000029","url":null,"abstract":"","PeriodicalId":39134,"journal":{"name":"European Journal of Oncology Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45471751","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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