Pub Date : 2024-10-01Epub Date: 2024-08-01DOI: 10.1177/10781552241268693
Ruba Alchaikh Hassan, Abram Soliman, Constantin A Dasanu
Introduction: Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR) are linked with side effects involving skin and mucosa. Herein, we present a unique case of oral lichenoid drug eruption (LDE) in a patient treated with osimertinib.
Case report: A 75-year-old woman was diagnosed with metastatic EGFR-mutated lung adenocarcinoma, and started on osimertinib 80 mg PO daily. At 24 months of therapy, the patient developed a painful, red, and white striated oral lesion involving the left buccal mucosa and the adjacent buccal aspect of gingivae. Biopsy showed oral LDE. Causality assessment between osimertinib and the oral LDE via Naranjo Adverse Drug Reaction probability scale revealed a score of 5.
Management and outcome: Osimetinib discontinuation was not felt to be in the best interest of the patient. Therefore, diphenhydramine HCL mouthwash every 6 h PRN (before meals) was started. Spicy and hot foods were discontinued. At a four-week follow-up visit, the patient reported moderate improvement in her symptoms.
Conclusion: Oral LDEs are considered premalignant lesions as they can transform into squamous cell carcinoma; therefore, regular follow-up is needed. Awareness of this potential side effect of osimertinib would also prevent unnecessary (and potentially costly) work-up and lead to its prompt diagnosis and treatment.
{"title":"Oral lichenoid drug eruption due to osimertinib for lung cancer.","authors":"Ruba Alchaikh Hassan, Abram Soliman, Constantin A Dasanu","doi":"10.1177/10781552241268693","DOIUrl":"10.1177/10781552241268693","url":null,"abstract":"<p><strong>Introduction: </strong>Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR) are linked with side effects involving skin and mucosa. Herein, we present a unique case of oral lichenoid drug eruption (LDE) in a patient treated with osimertinib.</p><p><strong>Case report: </strong>A 75-year-old woman was diagnosed with metastatic EGFR-mutated lung adenocarcinoma, and started on osimertinib 80 mg PO daily. At 24 months of therapy, the patient developed a painful, red, and white striated oral lesion involving the left buccal mucosa and the adjacent buccal aspect of gingivae. Biopsy showed oral LDE. Causality assessment between osimertinib and the oral LDE via Naranjo Adverse Drug Reaction probability scale revealed a score of 5.</p><p><strong>Management and outcome: </strong>Osimetinib discontinuation was not felt to be in the best interest of the patient. Therefore, diphenhydramine HCL mouthwash every 6 h PRN (before meals) was started. Spicy and hot foods were discontinued. At a four-week follow-up visit, the patient reported moderate improvement in her symptoms.</p><p><strong>Conclusion: </strong>Oral LDEs are considered premalignant lesions as they can transform into squamous cell carcinoma; therefore, regular follow-up is needed. Awareness of this potential side effect of osimertinib would also prevent unnecessary (and potentially costly) work-up and lead to its prompt diagnosis and treatment.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1278-1281"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2023-09-20DOI: 10.1177/10781552231203371
Grzegorz Charliński, Norbert Grząśko, Łukasz Bołkun, Waldemar Sawicki, Edyta Paczkowska, Agnieszka Druzd-Sitek, Lidia Usnarska-Zubkiewicz, Aleksandra Butrym, Elżbieta Wiater, Piotr Boguradzki, Bożena Budziszewska, Małgorzata Wojciechowska, Monika Mordak-Domagała, Artur Jurczyszyn
Introduction: Therapeutic adherence (TA) is one of the most important factors influencing the effectiveness of treatment. Oral anti-cancer drugs are increasingly used to treat malignancy including multiple myeloma (MM). Our study aimed to determine TA of patients with MM treated with IMiDs, to identify TA risk factors, and to determine satisfaction with medical care during the treatment with IMiDs.
Methods: A cross-sectional survey-based study involving adult patients with MM treated with IMiDs.
Results: Between January 2021 and May 2021, 267 patients with MM were enrolled in the study. The dosing schedule was declared as easy by 71.8% of patients, as standard for 24.0%, and difficult for 4.2% of patients. During MM treatment, 85.0% of patients did not skip any IMiDs dose, and 87.6% did not skip the IMiDs dose in the last cycle of chemotherapy. Identified factors affecting TA included the treatment duration and education level. In addition, depending on the patient's well-being, gender, and household companionship influenced TA. Satisfaction with medical care during the treatment with IMiDs was declared by 95.5% of patients with MM. In our cohort, 95.5% of patients were satisfied with the information they received from the hematologist during treatment with IMiDs.
Conclusions: Patients with MM treated with IMiDs are highly adherent to treatment. With time from the beginning of treatment, patients need more attention and motivation to adhere to the therapy rules.
{"title":"Therapeutic adherence and assessment of satisfaction patients with multiple myeloma treated with immunomodulatory drugs in a \"real-world\" study: Experiences of the Polish Myeloma Group.","authors":"Grzegorz Charliński, Norbert Grząśko, Łukasz Bołkun, Waldemar Sawicki, Edyta Paczkowska, Agnieszka Druzd-Sitek, Lidia Usnarska-Zubkiewicz, Aleksandra Butrym, Elżbieta Wiater, Piotr Boguradzki, Bożena Budziszewska, Małgorzata Wojciechowska, Monika Mordak-Domagała, Artur Jurczyszyn","doi":"10.1177/10781552231203371","DOIUrl":"10.1177/10781552231203371","url":null,"abstract":"<p><strong>Introduction: </strong>Therapeutic adherence (TA) is one of the most important factors influencing the effectiveness of treatment. Oral anti-cancer drugs are increasingly used to treat malignancy including multiple myeloma (MM). Our study aimed to determine TA of patients with MM treated with IMiDs, to identify TA risk factors, and to determine satisfaction with medical care during the treatment with IMiDs.</p><p><strong>Methods: </strong>A cross-sectional survey-based study involving adult patients with MM treated with IMiDs.</p><p><strong>Results: </strong>Between January 2021 and May 2021, 267 patients with MM were enrolled in the study. The dosing schedule was declared as easy by 71.8% of patients, as standard for 24.0%, and difficult for 4.2% of patients. During MM treatment, 85.0% of patients did not skip any IMiDs dose, and 87.6% did not skip the IMiDs dose in the last cycle of chemotherapy. Identified factors affecting TA included the treatment duration and education level. In addition, depending on the patient's well-being, gender, and household companionship influenced TA. Satisfaction with medical care during the treatment with IMiDs was declared by 95.5% of patients with MM. In our cohort, 95.5% of patients were satisfied with the information they received from the hematologist during treatment with IMiDs.</p><p><strong>Conclusions: </strong>Patients with MM treated with IMiDs are highly adherent to treatment. With time from the beginning of treatment, patients need more attention and motivation to adhere to the therapy rules.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1144-1151"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41099486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Bone modifying agents (BMAs) have been used to prevent skeletal-related events (SRE) in cancer patients with bone metastases. In this meta-analysis, efficacy and adverse events (AEs) were studied based on a de-escalation strategy in which the BMA dosing interval was prolonged from 4 to 12 weeks.
Methods: PubMed, Cochrane, ICHUSHI, and CINAHL were searched for articles on BMA dosing intervals from outcomes measured were the incidence of SRE and related various AEs. A quantitative meta-analysis was performed using a random-effects model to calculate relative risk ratios (RRs) and 95% confidence intervals (CIs).
Result: The meta-analysis included three randomized controlled studies (RCTs) of Zoledronic acid hydrate (ZA) (n = 2663) and six RCTs (n = 141) on BMA other than ZA. There was no difference in the incidence of SREs when comparing the dosing frequency of 12 versus 4 weeks for BMA (RR = 1.21, 95% CI [0.82-1.78], p = 0.33). Further, AEs related to treatment discontinuation were significantly less frequent with ZA given every 12 weeks than when given every 4 weeks (RR = 0.51 [0.30-0.89], p = 0.02). In particular, renal dysfunction leading to grade ≥3 or discontinuation of treatment with ZA occurred significantly less frequently with every 12-week dosing (RR = 0.33 [0.12-0.91], p = 0.33).
Conclusion: This meta-analysis showed no influence of BMA de-escalation on the incidence of SRE; nevertheless, AEs appeared to reduce with the de-escalated usage of ZA.
{"title":"Efficacy and safety of bone management agents administered at 12 weeks vs. 4 weeks in patients with bone metastases: A systematic review.","authors":"Junya Sato, Makoto Kodaira, Hiroyuki Harada, Haruo Iguchi, Taichi Yoshida, Hiroyuki Shibata","doi":"10.1177/10781552231203720","DOIUrl":"10.1177/10781552231203720","url":null,"abstract":"<p><strong>Background: </strong>Bone modifying agents (BMAs) have been used to prevent skeletal-related events (SRE) in cancer patients with bone metastases. In this meta-analysis, efficacy and adverse events (AEs) were studied based on a de-escalation strategy in which the BMA dosing interval was prolonged from 4 to 12 weeks.</p><p><strong>Methods: </strong>PubMed, Cochrane, ICHUSHI, and CINAHL were searched for articles on BMA dosing intervals from outcomes measured were the incidence of SRE and related various AEs. A quantitative meta-analysis was performed using a random-effects model to calculate relative risk ratios (RRs) and 95% confidence intervals (CIs).</p><p><strong>Result: </strong>The meta-analysis included three randomized controlled studies (RCTs) of Zoledronic acid hydrate (ZA) (<i>n</i> = 2663) and six RCTs (<i>n</i> = 141) on BMA other than ZA. There was no difference in the incidence of SREs when comparing the dosing frequency of 12 versus 4 weeks for BMA (RR = 1.21, 95% CI [0.82-1.78], <i>p</i> = 0.33). Further, AEs related to treatment discontinuation were significantly less frequent with ZA given every 12 weeks than when given every 4 weeks (RR = 0.51 [0.30-0.89], <i>p</i> = 0.02). In particular, renal dysfunction leading to grade ≥3 or discontinuation of treatment with ZA occurred significantly less frequently with every 12-week dosing (RR = 0.33 [0.12-0.91], <i>p</i> = 0.33).</p><p><strong>Conclusion: </strong>This meta-analysis showed no influence of BMA de-escalation on the incidence of SRE; nevertheless, AEs appeared to reduce with the de-escalated usage of ZA.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1160-1172"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41135964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2023-10-17DOI: 10.1177/10781552231207271
Sidra Awan, Pooja Bharucha, Luke Steventon, Helen Simpson, Tanya Ahmad, Sarah Benafif, Heather Shaw, Pinkie Chambers
Introduction: The incidence of immune-related adverse events (irAEs) from immune checkpoint inhibitors (ICI) is well described. However, the impact on emergency care services is not. This study investigated the incidence of irAEs out-of-hours, and the management used to mitigate symptoms and side effects.
Methods: This retrospective cohort study reviewed all emergency presentations triaged by the acute oncology team between December 2021 and June 2022, between 5 pm and 9 am. Patients were identified from triage audit sheets and remaining data points were retrieved from electronic health records. Inclusion criteria included all adult patients admitted on an ICI at one tertiary centre.
Results: In 7 months, 970 patients called the acute oncology helpline 11% (n = 109) of patients were on an ICI treatment. After clinical review, 78% (n = 70) resulted in hospital admissions, with length of stay cumulating to 496 bed days. 56% (n = 39) of patients delayed reporting symptoms, ranging between 12 hours and 10 days from symptom onset to seeking support. 49% (n = 34) patients received steroids to manage suspected irAEs. Dexamethasone was the most common steroid used in 71% (n = 24) of patients, and variation was found in prescribed doses.
Conclusions: These results underline the urgent need to address patient and staff education on adverse effects related to ICI. Patients require a comprehensive understanding of the symptoms and importance of prompt reporting. Staff education on recognition and treatment management is needed to reduce variation in practice. Further research is needed to identify barriers in symptom reporting and focus on realtime reporting to reduce the out-of-hours burden on services.
{"title":"Out-of-hours admissions in patients treated with immune checkpoint inhibitors and their primary management with steroids.","authors":"Sidra Awan, Pooja Bharucha, Luke Steventon, Helen Simpson, Tanya Ahmad, Sarah Benafif, Heather Shaw, Pinkie Chambers","doi":"10.1177/10781552231207271","DOIUrl":"10.1177/10781552231207271","url":null,"abstract":"<p><strong>Introduction: </strong>The incidence of immune-related adverse events (irAEs) from immune checkpoint inhibitors (ICI) is well described. However, the impact on emergency care services is not. This study investigated the incidence of irAEs out-of-hours, and the management used to mitigate symptoms and side effects.</p><p><strong>Methods: </strong>This retrospective cohort study reviewed all emergency presentations triaged by the acute oncology team between December 2021 and June 2022, between 5 pm and 9 am. Patients were identified from triage audit sheets and remaining data points were retrieved from electronic health records. Inclusion criteria included all adult patients admitted on an ICI at one tertiary centre.</p><p><strong>Results: </strong>In 7 months, 970 patients called the acute oncology helpline 11% (n = 109) of patients were on an ICI treatment. After clinical review, 78% (n = 70) resulted in hospital admissions, with length of stay cumulating to 496 bed days. 56% (n = 39) of patients delayed reporting symptoms, ranging between 12 hours and 10 days from symptom onset to seeking support. 49% (n = 34) patients received steroids to manage suspected irAEs. Dexamethasone was the most common steroid used in 71% (n = 24) of patients, and variation was found in prescribed doses.</p><p><strong>Conclusions: </strong>These results underline the urgent need to address patient and staff education on adverse effects related to ICI. Patients require a comprehensive understanding of the symptoms and importance of prompt reporting. Staff education on recognition and treatment management is needed to reduce variation in practice. Further research is needed to identify barriers in symptom reporting and focus on realtime reporting to reduce the out-of-hours burden on services.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1193-1199"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41236177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-09-02DOI: 10.1177/10781552241280664
Wardah Masood, Omar Akhlaq Bhutta, Muhammad Ahsan Rasheed, Adeel Siddiqui
This article aims to explore the access of patient assistance program (PAPs) and the role of pharmacists in improving access to oncology care in Pakistan. PAPs aim to reduce the financial burden of cancer in Pakistan, with pharmaceutical companies providing medication at reduced costs, ranging from 33% to 90%. Pharmacists play a pivotal role in managing these programs, facilitating PAP, pharmacist, oncology care setting, cancer therapy more accessible to those who faced financial barriers to accessing them.
{"title":"Enhancing access to expensive oncology medications in Pakistan: The critical role of pharmaceutical patient assistance programs in oncology care.","authors":"Wardah Masood, Omar Akhlaq Bhutta, Muhammad Ahsan Rasheed, Adeel Siddiqui","doi":"10.1177/10781552241280664","DOIUrl":"10.1177/10781552241280664","url":null,"abstract":"<p><p>This article aims to explore the access of patient assistance program (PAPs) and the role of pharmacists in improving access to oncology care in Pakistan. PAPs aim to reduce the financial burden of cancer in Pakistan, with pharmaceutical companies providing medication at reduced costs, ranging from 33% to 90%. Pharmacists play a pivotal role in managing these programs, facilitating PAP, pharmacist, oncology care setting, cancer therapy more accessible to those who faced financial barriers to accessing them.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1287-1289"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2023-12-19DOI: 10.1177/10781552231205481
Paul Jm Sessink, Birgit Tans, Isabel Spriet, David Devolder
Introduction: Exposure of healthcare workers to hazardous drugs can lead to adverse health effects supporting the importance of a continuous monitoring program, for example, by taking surface wipe samples. The objective was to describe the results of repeated monitoring of contamination with hazardous drugs on multiple surfaces in a hospital pharmacy and at two wards using standardized preparation techniques and cleaning procedures.
Methods: Twelve surfaces in the hospital pharmacy and at two wards were sampled and analyzed for contamination with the hazardous drugs cyclophosphamide, doxorubicin, 5-fluorouracil, gemcitabine, methotrexate, and paclitaxel. The drugs were prepared with a closed-system drug transfer device (CSTD). Sampling of the drugs was performed in four trials during eight months. Liquid chromatography tandem mass spectrometry was used for the analysis of the drugs.
Results: During the four trials, contamination with five of the six hazardous drugs was found on half of the surfaces in the pharmacy and in a ward. Seventeen out of 288 possible outcomes were positive (6%), with the biological safety cabinet grate (n = 6) and scanner (n = 5) most frequently contaminated. The highest level of contamination was observed on the pass-thru window (cyclophosphamide: 2.90 ng/cm2) and the touch screen of the Diana device (5-fluorouracil: 2.38 ng/cm2). Both levels were below the action level of 10 ng/cm2.
Conclusions: The long-term use of a CSTD in combination with appropriate cleaning has proven effective in achieving low levels of surface contamination with hazardous drugs.
{"title":"Longitudinal evaluation of environmental contamination with hazardous drugs by surface wipe sampling.","authors":"Paul Jm Sessink, Birgit Tans, Isabel Spriet, David Devolder","doi":"10.1177/10781552231205481","DOIUrl":"10.1177/10781552231205481","url":null,"abstract":"<p><strong>Introduction: </strong>Exposure of healthcare workers to hazardous drugs can lead to adverse health effects supporting the importance of a continuous monitoring program, for example, by taking surface wipe samples. The objective was to describe the results of repeated monitoring of contamination with hazardous drugs on multiple surfaces in a hospital pharmacy and at two wards using standardized preparation techniques and cleaning procedures.</p><p><strong>Methods: </strong>Twelve surfaces in the hospital pharmacy and at two wards were sampled and analyzed for contamination with the hazardous drugs cyclophosphamide, doxorubicin, 5-fluorouracil, gemcitabine, methotrexate, and paclitaxel. The drugs were prepared with a closed-system drug transfer device (CSTD). Sampling of the drugs was performed in four trials during eight months. Liquid chromatography tandem mass spectrometry was used for the analysis of the drugs.</p><p><strong>Results: </strong>During the four trials, contamination with five of the six hazardous drugs was found on half of the surfaces in the pharmacy and in a ward. Seventeen out of 288 possible outcomes were positive (6%), with the biological safety cabinet grate (<i>n</i> = 6) and scanner (<i>n</i> = 5) most frequently contaminated. The highest level of contamination was observed on the pass-thru window (cyclophosphamide: 2.90 ng/cm<sup>2</sup>) and the touch screen of the Diana device (5-fluorouracil: 2.38 ng/cm<sup>2</sup>). Both levels were below the action level of 10 ng/cm<sup>2</sup>.</p><p><strong>Conclusions: </strong>The long-term use of a CSTD in combination with appropriate cleaning has proven effective in achieving low levels of surface contamination with hazardous drugs.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1181-1185"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138804938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-06-11DOI: 10.1177/10781552241260864
Safa Can Efil, Burak Bilgin, Furkan Ceylan, Hilal Karakaş, İrfan Karahan, Sema Nur Özsan, Hakan Kosku, Şebnem Yaman, Muhammed Bülent Akıncı, Didem Şener Dede, Bülent Yalçın, Mehmet Ali Nahit Şendur
Objective: The objective of this article is to review the efficacy, safety, and evidence for current use and potential future uses of immune-checkpoint inhibitors (ICIs) in the management of resectable non-small cell lung cancer (NSCLC).
Data sources: A literature review was carried out through PubMed to identify completed and ongoing clinical trials evaluating the use, efficacy, and safety of ICIs in the management of resectable NSCLC.
Data summary: To date, four phase 3 trials have emerged that have changed our treatment practice concerning the utilization of ICIs during the adjuvant and neoadjuvant settings. The IMpower010 and KEYNOTE-091 trials examined the application of adjuvant atezolizumab and pembrolizumab, respectively, following surgical resection and adjuvant chemotherapy. In the CheckMate 816 trial, the combination of nivolumab and chemotherapy as a neoadjuvant therapy received approval for patients with resectable NSCLC. Also, for patients with resectable NSCLC, the use of a pembrolizumab and chemotherapy combination as a perioperative therapy received approval based on the results of the KEYNOTE-671 trial. Apart from these trials, there are numerous phase 2 and phase 3 trials, some of which have been published while others are still in progress.
Conclusion: Despite the promising outcomes from these trials there remain several unanswered questions. In this review, we will assess clinical trials involving adjuvant, neoadjuvant, and perioperative ICIs, aiming to address the unresolved questions related to these therapeutic approaches.
{"title":"A current comprehensive role of immune-checkpoint inhibitors in resectable non-small cell lung cancer: A narrative review.","authors":"Safa Can Efil, Burak Bilgin, Furkan Ceylan, Hilal Karakaş, İrfan Karahan, Sema Nur Özsan, Hakan Kosku, Şebnem Yaman, Muhammed Bülent Akıncı, Didem Şener Dede, Bülent Yalçın, Mehmet Ali Nahit Şendur","doi":"10.1177/10781552241260864","DOIUrl":"10.1177/10781552241260864","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this article is to review the efficacy, safety, and evidence for current use and potential future uses of immune-checkpoint inhibitors (ICIs) in the management of resectable non-small cell lung cancer (NSCLC).</p><p><strong>Data sources: </strong>A literature review was carried out through PubMed to identify completed and ongoing clinical trials evaluating the use, efficacy, and safety of ICIs in the management of resectable NSCLC.</p><p><strong>Data summary: </strong>To date, four phase 3 trials have emerged that have changed our treatment practice concerning the utilization of ICIs during the adjuvant and neoadjuvant settings. The IMpower010 and KEYNOTE-091 trials examined the application of adjuvant atezolizumab and pembrolizumab, respectively, following surgical resection and adjuvant chemotherapy. In the CheckMate 816 trial, the combination of nivolumab and chemotherapy as a neoadjuvant therapy received approval for patients with resectable NSCLC. Also, for patients with resectable NSCLC, the use of a pembrolizumab and chemotherapy combination as a perioperative therapy received approval based on the results of the KEYNOTE-671 trial. Apart from these trials, there are numerous phase 2 and phase 3 trials, some of which have been published while others are still in progress.</p><p><strong>Conclusion: </strong>Despite the promising outcomes from these trials there remain several unanswered questions. In this review, we will assess clinical trials involving adjuvant, neoadjuvant, and perioperative ICIs, aiming to address the unresolved questions related to these therapeutic approaches.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1214-1239"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2023-11-19DOI: 10.1177/10781552231213883
Emma F Lodl, Mohammad H Alshaer, C Brooke Adams, Ashley Richards, Charles Peloquin, Veena Venugopalan
Introduction: Cefepime is a fourth-generation cephalosporin and is a workhorse for the empiric treatment of febrile neutropenia (FN). Beta-lactam therapeutic drug monitoring (TDM) has emerged as a dose optimization strategy in patient populations with altered kinetics. Prior literature has demonstrated that patients with FN exhibit augmented renal clearance which may lead to subtherapeutic drug concentrations with standard dosing regimens. The aim of this study was to evaluate pharmacokinetic/pharmacodynamic (PK/PD) target attainment and clinical outcomes in patients with hematologic malignancies and FN who were treated empirically with cefepime.
Methods: This was a prospective, single-center study of adults with hematologic malignancies and FN admitted to the inpatient unit. The primary outcome was PK/PD target attainment (defined as 100% free time greater than minimum inhibitory concentration (100% fT > MIC)). Secondary clinical outcomes were time to defervescence, time to ANC recovery, in-hospital mortality, and cefepime failure.
Results: There were 55 patients in our study. Forty-three (78%) patients achieved the primary outcome of PK/PD target attainment. The mean time to defervescence was similar between those that achieved PK/PD target attainment and those that did not (95% CI -0.75 to 1.25, p = 0.62).
Conclusions: This study showed that standard cefepime dosing in patients with hematologic malignancies and FN does not result in achievement of 100% fT > MIC in all patients. Patients in the group that did not achieve PK/PD target attainment were younger with increased creatinine clearance, indicating that cefepime TDM may be especially beneficial in these patients.
头孢吡肟是第四代头孢菌素,是经验性治疗发热性中性粒细胞减少症(FN)的主力军。β -内酰胺治疗药物监测(TDM)已成为一种剂量优化策略,在患者群体与改变动力学。先前的文献表明,FN患者表现出增强的肾脏清除率,这可能导致标准剂量方案下的亚治疗药物浓度。本研究的目的是评估经验性使用头孢吡肟治疗的血液恶性肿瘤和FN患者的药代动力学/药效学(PK/PD)目标达到情况和临床结果。方法:这是一项前瞻性的、单中心的研究,研究对象是住院病房的成人血液恶性肿瘤和FN患者。主要终点是PK/PD目标达到(定义为100%空闲时间大于最小抑制浓度(100% fT > MIC))。次要临床结果为退热时间、ANC恢复时间、住院死亡率和头孢吡肟失效。结果:本组共55例患者。43例(78%)患者达到了主要终点PK/PD目标。达到PK/PD目标的患者与未达到目标的患者的平均退热时间相似(95% CI -0.75至1.25,p = 0.62)。结论:本研究表明,血液恶性肿瘤和FN患者的标准头孢吡肟剂量并不能使所有患者达到100%的fT > MIC。未达到PK/PD目标的患者年龄更小,肌酐清除率增加,表明头孢吡肟TDM可能对这些患者特别有益。
{"title":"Utilization of cefepime therapeutic drug monitoring in febrile neutropenia patients with hematologic malignancies.","authors":"Emma F Lodl, Mohammad H Alshaer, C Brooke Adams, Ashley Richards, Charles Peloquin, Veena Venugopalan","doi":"10.1177/10781552231213883","DOIUrl":"10.1177/10781552231213883","url":null,"abstract":"<p><strong>Introduction: </strong>Cefepime is a fourth-generation cephalosporin and is a workhorse for the empiric treatment of febrile neutropenia (FN). Beta-lactam therapeutic drug monitoring (TDM) has emerged as a dose optimization strategy in patient populations with altered kinetics. Prior literature has demonstrated that patients with FN exhibit augmented renal clearance which may lead to subtherapeutic drug concentrations with standard dosing regimens. The aim of this study was to evaluate pharmacokinetic/pharmacodynamic (PK/PD) target attainment and clinical outcomes in patients with hematologic malignancies and FN who were treated empirically with cefepime.</p><p><strong>Methods: </strong>This was a prospective, single-center study of adults with hematologic malignancies and FN admitted to the inpatient unit. The primary outcome was PK/PD target attainment (defined as 100% free time greater than minimum inhibitory concentration (100% <i>f</i>T > MIC)). Secondary clinical outcomes were time to defervescence, time to ANC recovery, in-hospital mortality, and cefepime failure.</p><p><strong>Results: </strong>There were 55 patients in our study. Forty-three (78%) patients achieved the primary outcome of PK/PD target attainment. The mean time to defervescence was similar between those that achieved PK/PD target attainment and those that did not (95% CI -0.75 to 1.25, p = 0.62).</p><p><strong>Conclusions: </strong>This study showed that standard cefepime dosing in patients with hematologic malignancies and FN does not result in achievement of 100% <i>f</i>T > MIC in all patients. Patients in the group that did not achieve PK/PD target attainment were younger with increased creatinine clearance, indicating that cefepime TDM may be especially beneficial in these patients.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1207-1213"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138047202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2024-07-23DOI: 10.1177/10781552241264530
Beatriz Somoza-Fernández, Vicente Escudero-Vilaplana, Roberto Collado-Borrell, Sara Pérez-Ramírez, Cristina Villanueva-Bueno, María Del Pilar Montero-Antón, Ana Herranz-Alonso, María Sanjurjo-Saez
Introduction: Abiraterone and enzalutamide are two androgen receptor pathway inhibitors approved, among others, for the treatment of metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based regimen. Although hematological effects, especially neutropenia, are one of the main complications of other oral antineoplastic drugs, these adverse effects are infrequent in the case of androgen receptor pathway inhibitors.
Case report: We report the case of a patient diagnosed with metastatic castration-resistant prostate cancer who discontinued an androgen receptor pathway inhibitor due to drug-related grade 4 neutropenia. His control blood counts before enzalutamide starting were normal. After one month of treatment, he developed a grade 4 neutropenia, with complete neutrophil count recovery four weeks later. He underwent a bone marrow aspiration, which revealed normocelullar results, and enzalutamide was restarted. Three weeks later, the treatment was eventually discontinued due to neutropenia reappearance. Neutrophil count recovery was achieved one month later. Then, he started treatment with abiraterone, but two weeks later neutropenia reappeared. Abiraterone was withdrawn, and the patient recovered from neutropenia 2 weeks later.
Management and outcomes: This case exposes not only the occurrence of rare toxicity of two individual drugs but also the description of a probable drug-class adverse event not reported before. The patient recovered from neutropenia after the androgen receptor pathway inhibitor was withdrawn, thereby supporting the diagnosis of probable drug-induced neutropenia.
Discussion: There is scarce evidence in the literature concerning androgen receptor pathway inhibitor-related neutropenia. However, its life-threatening potential cannot be ignored, so healthcare professionals should be warned of the possibility of the occurrence of such adverse reactions.
{"title":"Severe neutropenia probably caused by enzalutamide and abiraterone in a prostate cancer patient.","authors":"Beatriz Somoza-Fernández, Vicente Escudero-Vilaplana, Roberto Collado-Borrell, Sara Pérez-Ramírez, Cristina Villanueva-Bueno, María Del Pilar Montero-Antón, Ana Herranz-Alonso, María Sanjurjo-Saez","doi":"10.1177/10781552241264530","DOIUrl":"10.1177/10781552241264530","url":null,"abstract":"<p><strong>Introduction: </strong>Abiraterone and enzalutamide are two androgen receptor pathway inhibitors approved, among others, for the treatment of metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based regimen. Although hematological effects, especially neutropenia, are one of the main complications of other oral antineoplastic drugs, these adverse effects are infrequent in the case of androgen receptor pathway inhibitors.</p><p><strong>Case report: </strong>We report the case of a patient diagnosed with metastatic castration-resistant prostate cancer who discontinued an androgen receptor pathway inhibitor due to drug-related grade 4 neutropenia. His control blood counts before enzalutamide starting were normal. After one month of treatment, he developed a grade 4 neutropenia, with complete neutrophil count recovery four weeks later. He underwent a bone marrow aspiration, which revealed normocelullar results, and enzalutamide was restarted. Three weeks later, the treatment was eventually discontinued due to neutropenia reappearance. Neutrophil count recovery was achieved one month later. Then, he started treatment with abiraterone, but two weeks later neutropenia reappeared. Abiraterone was withdrawn, and the patient recovered from neutropenia 2 weeks later.</p><p><strong>Management and outcomes: </strong>This case exposes not only the occurrence of rare toxicity of two individual drugs but also the description of a probable drug-class adverse event not reported before. The patient recovered from neutropenia after the androgen receptor pathway inhibitor was withdrawn, thereby supporting the diagnosis of probable drug-induced neutropenia.</p><p><strong>Discussion: </strong>There is scarce evidence in the literature concerning androgen receptor pathway inhibitor-related neutropenia. However, its life-threatening potential cannot be ignored, so healthcare professionals should be warned of the possibility of the occurrence of such adverse reactions.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1268-1273"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01Epub Date: 2023-09-20DOI: 10.1177/10781552231202221
Ashley Mull, Courtney Hawkins, Alexandra Punke, Shannon Parkey, Courtney Mallon
Introduction: Outpatient oncology practice is a growing area of opportunity for pharmacists to provide clinical services and evidence-based care.
Methods: This single-center, retrospective chart review analyzed the clinical and economic benefits of a board-certified oncology pharmacist after integration into the ambulatory oncology clinic setting. Primary outcomes were total cost avoidance for pharmacist interventions and impact on Centers for Medicare and Medicaid Services (CMS) OP-35 measures. Pharmacist interventions were characterized into distinct types which were then assigned a cost avoidance value. Cost avoidance was calculated per hour and then extrapolated to a yearly estimate based on a 40-h work week for one year for one full-time equivalent pharmacist. Data collection for the primary clinical outcome was performed by compiling provider-specific emergency department (ED) and inpatient admission rates for diagnoses specified in CMS OP-35 measures within 30 days after receiving outpatient chemotherapy. The rates for the data collection period were compared to the rates six months prior to pharmacist integration to assess pharmacist impact.
Results: In six months, 516 total interventions were made by the oncology pharmacist. The incidence of ED visits was 3.34% and 1.72% during the pre- and post-pharmacist intervention periods, respectively. The incidence of inpatient admissions was 2.43% and 0.34% pre- and post-pharmacist intervention, respectively. Total cost avoidance was estimated to be US$375,795 and when accounted for the median pharmacist salary at our institution, total cost savings was US$204,437.
Conclusion: The presence of an oncology pharmacist specialist in the ambulatory cancer clinic provided clinical and economic benefits to the cancer clinic.
{"title":"Clinical and economic impact of oncology-trained pharmacist integration in an ambulatory cancer clinic.","authors":"Ashley Mull, Courtney Hawkins, Alexandra Punke, Shannon Parkey, Courtney Mallon","doi":"10.1177/10781552231202221","DOIUrl":"10.1177/10781552231202221","url":null,"abstract":"<p><strong>Introduction: </strong>Outpatient oncology practice is a growing area of opportunity for pharmacists to provide clinical services and evidence-based care.</p><p><strong>Methods: </strong>This single-center, retrospective chart review analyzed the clinical and economic benefits of a board-certified oncology pharmacist after integration into the ambulatory oncology clinic setting. Primary outcomes were total cost avoidance for pharmacist interventions and impact on Centers for Medicare and Medicaid Services (CMS) OP-35 measures. Pharmacist interventions were characterized into distinct types which were then assigned a cost avoidance value. Cost avoidance was calculated per hour and then extrapolated to a yearly estimate based on a 40-h work week for one year for one full-time equivalent pharmacist. Data collection for the primary clinical outcome was performed by compiling provider-specific emergency department (ED) and inpatient admission rates for diagnoses specified in CMS OP-35 measures within 30 days after receiving outpatient chemotherapy. The rates for the data collection period were compared to the rates six months prior to pharmacist integration to assess pharmacist impact.</p><p><strong>Results: </strong>In six months, 516 total interventions were made by the oncology pharmacist. The incidence of ED visits was 3.34% and 1.72% during the pre- and post-pharmacist intervention periods, respectively. The incidence of inpatient admissions was 2.43% and 0.34% pre- and post-pharmacist intervention, respectively. Total cost avoidance was estimated to be US$375,795 and when accounted for the median pharmacist salary at our institution, total cost savings was US$204,437.</p><p><strong>Conclusion: </strong>The presence of an oncology pharmacist specialist in the ambulatory cancer clinic provided clinical and economic benefits to the cancer clinic.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1138-1143"},"PeriodicalIF":1.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41135970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}