Pub Date : 2024-08-07DOI: 10.1177/10781552241269722
Kevin Thai, Jennifer Jupp, Deonne Dersch-Mills, Sunita Ghosh, Mona Shafey, Leanne Fong
Background: Despite evidence demonstrating the effectiveness of aprepitant for chemotherapy-induced nausea and vomiting (CINV), its use in stem cell transplant settings across Canada is not standard. While pharmacokinetic data exists, the clinical significance of cytochrome P450 3A4 (CYP 3A4) inhibition of cyclophosphamide by aprepitant is unclear. Reduced activation of cyclophosphamide may reduce the effectiveness of dose-intensive cyclophosphamide, etoposide, and cisplatin (DICEP).
Objectives: To compare response rates to DICEP in patients with Hodgkin lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL) in the presence and absence of aprepitant.
Methods: A retrospective review of patients who received full-dose DICEP for relapsed/refractory HL or DLBCL between June 1995 and September 2018 at the Foothills Medical Centre (FMC) in Calgary, Alberta, Canada was conducted. Descriptive statistics were used to assess response rate, as defined by the 2007 International Working Group response criteria.
Results: Of the 218 patients included in this study, 87.6% of patients in the control group and 88.5% of patients in the aprepitant group responded to DICEP (difference 0.025 [95% CI, -0.066 to 0.114], p = 0.827). Univariate analyses for age, sex, type of cancer, stage of cancer, number of prior relapses, and relapse status were not significant. No significant differences were observed for secondary outcomes.
Conclusion: Response rates to DICEP in relapsed/refractory HL and DLBCL patients were similar regardless of aprepitant use. Considering these results and the effectiveness of aprepitant in CINV, its addition to standard antiemetic therapy in patients receiving DICEP should be given strong consideration in the transplant setting.
背景:尽管有证据表明阿瑞匹坦对化疗引起的恶心和呕吐(CINV)有效,但在加拿大各地的干细胞移植环境中,阿瑞匹坦的使用并不规范。虽然存在药代动力学数据,但阿普瑞坦抑制环磷酰胺的细胞色素P450 3A4(CYP 3A4)的临床意义尚不清楚。环磷酰胺的活化降低可能会降低剂量强化环磷酰胺、依托泊苷和顺铂(DICEP)的疗效:比较霍奇金淋巴瘤(HL)和弥漫大B细胞淋巴瘤(DLBCL)患者在阿普瑞坦存在和不存在的情况下对DICEP的反应率:对1995年6月至2018年9月期间在加拿大阿尔伯塔省卡尔加里市麓山医疗中心(FMC)接受全剂量DICEP治疗复发/难治性HL或DLBCL的患者进行了回顾性研究。根据2007年国际工作组反应标准的定义,采用描述性统计来评估反应率:在纳入该研究的 218 名患者中,87.6% 的对照组患者和 88.5% 的阿瑞匹坦组患者对 DICEP 有反应(差异为 0.025 [95% CI, -0.066 to 0.114], p = 0.827)。年龄、性别、癌症类型、癌症分期、既往复发次数和复发状况的单变量分析结果均无显著性差异。次要结果无明显差异:无论是否使用阿瑞匹坦,复发/难治性HL和DLBCL患者对DICEP的应答率相似。考虑到这些结果以及阿普瑞坦对CINV的疗效,在移植环境中,接受DICEP的患者在标准止吐疗法的基础上加用阿普瑞坦应得到慎重考虑。
{"title":"Assessing the impact of aprepitant on response to dose-intensive cyclophosphamide, etoposide, and cisplatin (DICEP).","authors":"Kevin Thai, Jennifer Jupp, Deonne Dersch-Mills, Sunita Ghosh, Mona Shafey, Leanne Fong","doi":"10.1177/10781552241269722","DOIUrl":"https://doi.org/10.1177/10781552241269722","url":null,"abstract":"<p><strong>Background: </strong>Despite evidence demonstrating the effectiveness of aprepitant for chemotherapy-induced nausea and vomiting (CINV), its use in stem cell transplant settings across Canada is not standard. While pharmacokinetic data exists, the clinical significance of cytochrome P450 3A4 (CYP 3A4) inhibition of cyclophosphamide by aprepitant is unclear. Reduced activation of cyclophosphamide may reduce the effectiveness of dose-intensive cyclophosphamide, etoposide, and cisplatin (DICEP).</p><p><strong>Objectives: </strong>To compare response rates to DICEP in patients with Hodgkin lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL) in the presence and absence of aprepitant.</p><p><strong>Methods: </strong>A retrospective review of patients who received full-dose DICEP for relapsed/refractory HL or DLBCL between June 1995 and September 2018 at the Foothills Medical Centre (FMC) in Calgary, Alberta, Canada was conducted. Descriptive statistics were used to assess response rate, as defined by the 2007 International Working Group response criteria.</p><p><strong>Results: </strong>Of the 218 patients included in this study, 87.6% of patients in the control group and 88.5% of patients in the aprepitant group responded to DICEP (difference 0.025 [95% CI, -0.066 to 0.114], p = 0.827). Univariate analyses for age, sex, type of cancer, stage of cancer, number of prior relapses, and relapse status were not significant. No significant differences were observed for secondary outcomes.</p><p><strong>Conclusion: </strong>Response rates to DICEP in relapsed/refractory HL and DLBCL patients were similar regardless of aprepitant use. Considering these results and the effectiveness of aprepitant in CINV, its addition to standard antiemetic therapy in patients receiving DICEP should be given strong consideration in the transplant setting.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897595","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 : 2024-08-06DOI: 10.1177/10781552241269690
Amanda Alves Ferreira, Ariel Silvestre Freitas, Juliana Araújo Diniz, Marillin de Castro Cunha, Viviane de Souza Magalhães, Nathalie de Lourdes Souza Dewulf, Angela Ferreira Lopes
Introduction: Veterinary oncology is constituted mainly by human-use drugs with hazardous agents. Occupational risks are present in all stages of handling. Many studies highlighted that veterinarians and pharmacists staff present a lack of knowledge and insufficient structure for promoting safety practices. This study investigated the professional profile and structure of veterinary antineoplastic chemotherapy in Brazilian services.
Methods: A nationwide survey was carried out through digital platforms by a self-applicable from 2020 to 2021. The characteristics of the structure, facilities, professional profiles, practices related to antineoplastic chemotherapy services, and inspections provided by regulatory companies were investigated. Frequency and ranges were used to examine and describe data.
Results: This study analyzed 108 respondents from all Brazilian regions where 36 participants worked in veterinary oncology. Dogs and cats comprised more than 90% of animals assisted. Vincristine, doxorubicin, carboplatin, vinblastine, and cyclophosphamide were the most commonly used drugs. Considering pharmacists-led (n = 4) vs veterinarians-led (n = 18) services, structure with safety for handling hazardous drugs (4 vs 9), correct PPE usage (3 vs 0), and occurrence of occupational accident (0 vs 5) were registered. Almost 60% were dissatisfied with the structure and the managerial unwillingness to promote facility improvements. The majority of participants reported an absence of service inspection.
Conclusion: The results demonstrated worrying concerning the inadequacy of the physical structure of the facilities, human resources, and handling hazardous drugs increased occupational health risk. The lack of competent authority standards and supervision corroborates practices that expose professionals, the population, and the environment to hazardous agents.
{"title":"Professional profile in veterinary oncology: A Brazilian nationwide survey.","authors":"Amanda Alves Ferreira, Ariel Silvestre Freitas, Juliana Araújo Diniz, Marillin de Castro Cunha, Viviane de Souza Magalhães, Nathalie de Lourdes Souza Dewulf, Angela Ferreira Lopes","doi":"10.1177/10781552241269690","DOIUrl":"https://doi.org/10.1177/10781552241269690","url":null,"abstract":"<p><strong>Introduction: </strong>Veterinary oncology is constituted mainly by human-use drugs with hazardous agents. Occupational risks are present in all stages of handling. Many studies highlighted that veterinarians and pharmacists staff present a lack of knowledge and insufficient structure for promoting safety practices. This study investigated the professional profile and structure of veterinary antineoplastic chemotherapy in Brazilian services.</p><p><strong>Methods: </strong>A nationwide survey was carried out through digital platforms by a self-applicable from 2020 to 2021. The characteristics of the structure, facilities, professional profiles, practices related to antineoplastic chemotherapy services, and inspections provided by regulatory companies were investigated. Frequency and ranges were used to examine and describe data.</p><p><strong>Results: </strong>This study analyzed 108 respondents from all Brazilian regions where 36 participants worked in veterinary oncology. Dogs and cats comprised more than 90% of animals assisted. Vincristine, doxorubicin, carboplatin, vinblastine, and cyclophosphamide were the most commonly used drugs. Considering pharmacists-led (n = 4) vs veterinarians-led (n = 18) services, structure with safety for handling hazardous drugs (4 vs 9), correct PPE usage (3 vs 0), and occurrence of occupational accident (0 vs 5) were registered. Almost 60% were dissatisfied with the structure and the managerial unwillingness to promote facility improvements. The majority of participants reported an absence of service inspection.</p><p><strong>Conclusion: </strong>The results demonstrated worrying concerning the inadequacy of the physical structure of the facilities, human resources, and handling hazardous drugs increased occupational health risk. The lack of competent authority standards and supervision corroborates practices that expose professionals, the population, and the environment to hazardous agents.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897553","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}
Introduction: Fanconi anemia (FA) is a genetic disorder characterized by bone marrow failure typically developing in the first decade of life, congenital abnormalities, and an increased predisposition to malignancy. However, patients with FA can remain undiagnosed until adulthood and present with solid organ malignancies. Due to impaired DNA repair mechanisms, patients with FA are highly susceptible to severe bone marrow toxicity when treated with cisplatin.
Case report: A 38-year-old woman, diagnosed with locally advanced squamous cell carcinoma (SCC) of the uterine cervix, underwent treatment with weekly cisplatin concurrent with radiotherapy. After the second week of cisplatin treatment, she presented with severe pancytopenia. The prolonged and severe pancytopenia following cisplatin and radiation, along with cervical SCC in the absence of risk factors and the presence of parental consanguinity, raised the possibility of FA as the underlying cause. Whole exome sequencing revealed a homozygous FANCI c.668A > C (p.Lys223Thr) missense variant confirming the diagnosis of FA.
Management and outcome: The pancytopenia exhibited a protracted course, necessitating admission and supportive treatment with antibiotics, red blood cell and platelet transfusions, as well as filgrastim and eltrombopag. Eventually, the pancytopenia improved after approximately 40 days of hospitalization.
Discussion: SCC of the head and neck or gynecologic organs in a young adult without known risk factors should prompt consideration of FA. Cisplatin should be avoided in patients with FA.
{"title":"Cisplatin-induced bone marrow failure in an adult patient with Fanconi anemia.","authors":"Zeki Gokhan Surmeli, Rehab Helmy Mohamed Ibrahim, Nawaf Alkhalfan, Zeyad Mahmood","doi":"10.1177/10781552241268468","DOIUrl":"https://doi.org/10.1177/10781552241268468","url":null,"abstract":"<p><strong>Introduction: </strong>Fanconi anemia (FA) is a genetic disorder characterized by bone marrow failure typically developing in the first decade of life, congenital abnormalities, and an increased predisposition to malignancy. However, patients with FA can remain undiagnosed until adulthood and present with solid organ malignancies. Due to impaired DNA repair mechanisms, patients with FA are highly susceptible to severe bone marrow toxicity when treated with cisplatin.</p><p><strong>Case report: </strong>A 38-year-old woman, diagnosed with locally advanced squamous cell carcinoma (SCC) of the uterine cervix, underwent treatment with weekly cisplatin concurrent with radiotherapy. After the second week of cisplatin treatment, she presented with severe pancytopenia. The prolonged and severe pancytopenia following cisplatin and radiation, along with cervical SCC in the absence of risk factors and the presence of parental consanguinity, raised the possibility of FA as the underlying cause. Whole exome sequencing revealed a homozygous <i>FANCI</i> c.668A > C (p.Lys223Thr) missense variant confirming the diagnosis of FA.</p><p><strong>Management and outcome: </strong>The pancytopenia exhibited a protracted course, necessitating admission and supportive treatment with antibiotics, red blood cell and platelet transfusions, as well as filgrastim and eltrombopag. Eventually, the pancytopenia improved after approximately 40 days of hospitalization.</p><p><strong>Discussion: </strong>SCC of the head and neck or gynecologic organs in a young adult without known risk factors should prompt consideration of FA. Cisplatin should be avoided in patients with FA.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878916","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 : 2024-08-02DOI: 10.1177/10781552241265933
Rhubain Mageswaran, Zen Yang Ang
Objective: This longitudinal study aimed to evaluate the overall efficacy of mouthwashes in oral mucositis pain and mucositis xerostomia in advanced nasopharyngeal carcinoma (NPC) patients undergoing concurrent chemoradiotherapy (CCRT) at different phases throughout treatment.
Methods: A longitudinal study enrolled 79 advanced NPC subjects receiving CCRT. The subjects were interviewed prospectively three times over 7 weeks for pain and xerostomia scores based on the various types of mouthwash used. The median pain score difference and median xerostomia score difference were utilised to determine mouthwash superiority.
Results: Participants completed three interviews, during which 480 instances of mouthwash use were observed throughout different phases of the treatment period. The results showed that the median pain scores between mouthwashes differed significantly, H-Stat(3) = 30.0, 25.7 and 26.0, respectively, with p < 0.001 for all three interviews. The pain score reductions of lidocaine mouthwash (median = 2, interquartile range (IQR) = 3, 2 and 2.75 over the three interviews, respectively) were significantly higher than those of benzydamine and sodium bicarbonate mouthwashes. There were no significant differences between the studied mouthwashes in their xerostomia score reductions.
Conclusions: Lidocaine mouthwash was superior in managing oral mucositis pain at all phases throughout the entire chemoradiotherapy treatment for advanced NPC patients. There was insufficient evidence to determine the preferred mouthwash for treating oral mucositis xerostomia.
{"title":"A longitudinal assessment of major mouthwashes used in alleviating pain and xerostomia among advanced nasopharyngeal carcinoma patients receiving chemoradiotherapy.","authors":"Rhubain Mageswaran, Zen Yang Ang","doi":"10.1177/10781552241265933","DOIUrl":"https://doi.org/10.1177/10781552241265933","url":null,"abstract":"<p><strong>Objective: </strong>This longitudinal study aimed to evaluate the overall efficacy of mouthwashes in oral mucositis pain and mucositis xerostomia in advanced nasopharyngeal carcinoma (NPC) patients undergoing concurrent chemoradiotherapy (CCRT) at different phases throughout treatment.</p><p><strong>Methods: </strong>A longitudinal study enrolled 79 advanced NPC subjects receiving CCRT. The subjects were interviewed prospectively three times over 7 weeks for pain and xerostomia scores based on the various types of mouthwash used. The median pain score difference and median xerostomia score difference were utilised to determine mouthwash superiority.</p><p><strong>Results: </strong>Participants completed three interviews, during which 480 instances of mouthwash use were observed throughout different phases of the treatment period. The results showed that the median pain scores between mouthwashes differed significantly, <i>H</i>-Stat(3) = 30.0, 25.7 and 26.0, respectively, with <i>p</i> < 0.001 for all three interviews. The pain score reductions of lidocaine mouthwash (median = 2, interquartile range (IQR) = 3, 2 and 2.75 over the three interviews, respectively) were significantly higher than those of benzydamine and sodium bicarbonate mouthwashes. There were no significant differences between the studied mouthwashes in their xerostomia score reductions.</p><p><strong>Conclusions: </strong>Lidocaine mouthwash was superior in managing oral mucositis pain at all phases throughout the entire chemoradiotherapy treatment for advanced NPC patients. There was insufficient evidence to determine the preferred mouthwash for treating oral mucositis xerostomia.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878915","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}
Introduction: Pembrolizumab is a humanized monoclonal antibody IgG4 programmed cell death protein 1 antagonist, and its use in oncology has been increasing in recent years, providing durable and favorable responses and tolerable toxicity profiles in various types of cancer. We describe a case of pembrolizumab related perforated appendicitis in a patient with stage 3C malignant melanoma (MM).
Case report: A 70-year-old male patient who had no known disease was diagnosed with MM as a result of the excision of the mass on his right shoulder. The disease stage was stage 3C (pT4aN1bM0). Subsequently, adjuvant pembrolizumab treatment was started. A few days after the fourth maintenance course, he presented to the emergency department complaining of abdominal pain, nausea and vomiting. Emergency abdominal tomography showed a significant increase in the diameter of the appendix vermiformis, peritoneal thickening and appendiceal wall defects that could be significant in terms of perforation.
Management and outcome: The mentioned finding and given the clinical presentation, was attributed to a perporating of the appendix, so the patient was hospitalized in the Department of Surgery and the patient underwent emergency appendectomy. Histological findings were consistent with appendicitis. After a day in the hospital, the abdominal pain subsided, C-reactive protein tended to decrease and the patient was discharged.
Discussion: In patients who develop acute abdominal pain with or without diarrhea during immunotherapy, urgent imaging, endoscopic and clinical evaluation should be performed, and bowel perforation, although rare, should be considered as a potential complication of any immunotherapy.
{"title":"Pembrolizumab related perforated appendicitis.","authors":"Murat Kiracı, Selin Akturk Esen, Duriye Ozer Turkay, Fahriye Tugba Kos","doi":"10.1177/10781552241271026","DOIUrl":"https://doi.org/10.1177/10781552241271026","url":null,"abstract":"<p><strong>Introduction: </strong>Pembrolizumab is a humanized monoclonal antibody IgG4 programmed cell death protein 1 antagonist, and its use in oncology has been increasing in recent years, providing durable and favorable responses and tolerable toxicity profiles in various types of cancer. We describe a case of pembrolizumab related perforated appendicitis in a patient with stage 3C malignant melanoma (MM).</p><p><strong>Case report: </strong>A 70-year-old male patient who had no known disease was diagnosed with MM as a result of the excision of the mass on his right shoulder. The disease stage was stage 3C (pT4aN1bM0). Subsequently, adjuvant pembrolizumab treatment was started. A few days after the fourth maintenance course, he presented to the emergency department complaining of abdominal pain, nausea and vomiting. Emergency abdominal tomography showed a significant increase in the diameter of the appendix vermiformis, peritoneal thickening and appendiceal wall defects that could be significant in terms of perforation.</p><p><strong>Management and outcome: </strong>The mentioned finding and given the clinical presentation, was attributed to a perporating of the appendix, so the patient was hospitalized in the Department of Surgery and the patient underwent emergency appendectomy. Histological findings were consistent with appendicitis. After a day in the hospital, the abdominal pain subsided, C-reactive protein tended to decrease and the patient was discharged.</p><p><strong>Discussion: </strong>In patients who develop acute abdominal pain with or without diarrhea during immunotherapy, urgent imaging, endoscopic and clinical evaluation should be performed, and bowel perforation, although rare, should be considered as a potential complication of any immunotherapy.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878917","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 : 2024-08-02DOI: 10.1177/10781552241269677
Javier Álvarez Criado, Pilar Zamora Auñon, Virginia Martínez Marín, Macarena GarcíaTrevijano Cabetas, Victoria Lucía Collada Sánchez, Enrique Espinosa Arranz, José Antonio Romero-Garrido, Juana Benedi-González, Mariana Díaz Almirón, Alicia Herrero Ambrosio
Objectives: The objective of this investigation was to assess the impact of concurrent proton pump inhibitors (PPIs) on progression-free survival (PFS) in patients with hormone receptor-positive and HER2-negative metastatic breast cancer (mBC) who received palbociclib as first-line or successives therapy.
Materials and methods: A retrospective observational study was conducted, enrolling patients diagnosed with estrogen receptor-positive, human epidermal growth factor receptor 2-negative mBC, and eligible for palbociclib treatment. Patients were categorized as "concurrent PPIs" if they received PPIs for at least two-thirds of the palbociclib therapy duration, and as "no concurrent PPIs" if they did not receive PPIs during the course of palbociclib treatment.
Results: A total of 165 patients were included in the study. Among first-line patients treated with palbociclib, those using concurrent PPIs exhibited a PFS of 8.88 months, while patients using palbociclib without concurrent PPIs had a PFS of 67.81 months (p < 0.0001). In second-line or subsequent treatments, patients on palbociclib with concurrent PPIs had a PFS of 7.46 months, whereas those using palbociclib without concurrent PPIs had a PFS of 17.29 months (p = 0.122).
Conclusion: This study demonstrates that the concurrent use of PPIs in mBC patients receiving palbociclib negatively affects PFS, particularly in the first-line setting. Nevertheless, further investigation is warranted to explore the impact of PPIs on cycle-dependent kinase 4/6 inhibitors.
{"title":"Proton pump inhibitors decrease efficacy of palbociclib in patients with metastatic breast.","authors":"Javier Álvarez Criado, Pilar Zamora Auñon, Virginia Martínez Marín, Macarena GarcíaTrevijano Cabetas, Victoria Lucía Collada Sánchez, Enrique Espinosa Arranz, José Antonio Romero-Garrido, Juana Benedi-González, Mariana Díaz Almirón, Alicia Herrero Ambrosio","doi":"10.1177/10781552241269677","DOIUrl":"https://doi.org/10.1177/10781552241269677","url":null,"abstract":"<p><strong>Objectives: </strong>The objective of this investigation was to assess the impact of concurrent proton pump inhibitors (PPIs) on progression-free survival (PFS) in patients with hormone receptor-positive and HER2-negative metastatic breast cancer (mBC) who received palbociclib as first-line or successives therapy.</p><p><strong>Materials and methods: </strong>A retrospective observational study was conducted, enrolling patients diagnosed with estrogen receptor-positive, human epidermal growth factor receptor 2-negative mBC, and eligible for palbociclib treatment. Patients were categorized as \"concurrent PPIs\" if they received PPIs for at least two-thirds of the palbociclib therapy duration, and as \"no concurrent PPIs\" if they did not receive PPIs during the course of palbociclib treatment.</p><p><strong>Results: </strong>A total of 165 patients were included in the study. Among first-line patients treated with palbociclib, those using concurrent PPIs exhibited a PFS of 8.88 months, while patients using palbociclib without concurrent PPIs had a PFS of 67.81 months (p < 0.0001). In second-line or subsequent treatments, patients on palbociclib with concurrent PPIs had a PFS of 7.46 months, whereas those using palbociclib without concurrent PPIs had a PFS of 17.29 months (p = 0.122).</p><p><strong>Conclusion: </strong>This study demonstrates that the concurrent use of PPIs in mBC patients receiving palbociclib negatively affects PFS, particularly in the first-line setting. Nevertheless, further investigation is warranted to explore the impact of PPIs on cycle-dependent kinase 4/6 inhibitors.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878918","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 : 2024-08-01DOI: 10.1177/10781552241268429
Yumena Kawasaki, Aaron Paul Steele, Aaron Rosenberg, Julie Guglielmo
Introduction: Teclistamab, a bispecific T-cell engaging antibody targeting B-cell maturation antigen (BCMA), is indicated for the treatment of relapsed or refractory multiple myeloma after at least four lines of therapy. It has boxed warnings for life threatening cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). To mitigate these risks, teclistamab is initiated using step-up doses. This article examines safety event rates following the implementation of a 2-day separation between step-up doses at one institution to streamline patient care.
Methods: This was a retrospective, single-center study encompassing all patients who received teclistamab within a 1-year period. The primary endpoint was the overall incidence of CRS and ICANS. Secondary endpoints included hospital length of stay, hematological toxicities, infection rates, among other adverse events.
Results: A total of 27 patients were included in the analysis and stratified into accelerated (days 1,3,5) or standard (days 1,4,7) dosing groups. CRS occurred in 48% (11) of patients for the accelerated dosing and 50% (2) for the standard dosing group. ICANS was seen in 17% (4) of patients in the accelerated dosing group and none in the standard dosing group. Average length of stay in the accelerated dose was 7.6 days versus 9.2 days in the standard dose group.
Conclusion: Accelerated dose escalation of teclistamab yielded safety event rates comparable to those in the literature. These findings may support outpatient administration for teclistamab. Accelerated dose escalation strategy allowed for the optimization of hospitalization and resources.
{"title":"Safety outcomes of teclistamab accelerated dose escalation.","authors":"Yumena Kawasaki, Aaron Paul Steele, Aaron Rosenberg, Julie Guglielmo","doi":"10.1177/10781552241268429","DOIUrl":"https://doi.org/10.1177/10781552241268429","url":null,"abstract":"<p><strong>Introduction: </strong>Teclistamab, a bispecific T-cell engaging antibody targeting B-cell maturation antigen (BCMA), is indicated for the treatment of relapsed or refractory multiple myeloma after at least four lines of therapy. It has boxed warnings for life threatening cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). To mitigate these risks, teclistamab is initiated using step-up doses. This article examines safety event rates following the implementation of a 2-day separation between step-up doses at one institution to streamline patient care.</p><p><strong>Methods: </strong>This was a retrospective, single-center study encompassing all patients who received teclistamab within a 1-year period. The primary endpoint was the overall incidence of CRS and ICANS. Secondary endpoints included hospital length of stay, hematological toxicities, infection rates, among other adverse events.</p><p><strong>Results: </strong>A total of 27 patients were included in the analysis and stratified into accelerated (days 1,3,5) or standard (days 1,4,7) dosing groups. CRS occurred in 48% (11) of patients for the accelerated dosing and 50% (2) for the standard dosing group. ICANS was seen in 17% (4) of patients in the accelerated dosing group and none in the standard dosing group. Average length of stay in the accelerated dose was 7.6 days versus 9.2 days in the standard dose group.</p><p><strong>Conclusion: </strong>Accelerated dose escalation of teclistamab yielded safety event rates comparable to those in the literature. These findings may support outpatient administration for teclistamab. Accelerated dose escalation strategy allowed for the optimization of hospitalization and resources.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875147","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 : 2024-08-01DOI: 10.1177/10781552241266254
Abdullah, Areesha Abid, Humza Saeed, Zabeehullah, Uswa Iftikhar, Muhammad Khubaib Arshad, Muhammad Uzair Shahid, Tayyab Rasool, Faizan Fazal, Aman Goyal, Anum Akbar
Introduction: Breast cancer is one of the top three malignancies worldwide. While radiotherapy, hormone replacement therapys, and chemotherapy are treatments, chemotherapy causes adverse effects that hinder daily life activities.
Objectives: To assess the prevalence, severity, and association of symptomatic toxicities in female breast cancer patients affecting various organ systems post systemic chemotherapy (adjuvant and neoadjuvant), and their impact on daily activities. Additionally, to determine the severity of adverse effects in specific age groups and their association with family history and disease stage.
Methodology: An observational study was conducted on 253 female breast cancer patients receiving chemotherapy at NORI Cancer Hospital from May to October 2023. Data collection tools included the NCI-PRO-CTCAE standardized questionnaire and patient medical records. Analysis was performed using descriptive statistics, T-tests, and Chi-square tests.
Results: Among the 253 patients, 41.4% were aged 41-50. Significant weight changes (p = 0.034) were observed with more than three chemotherapy cycles. Notable associations included increased chemotherapy cycles with gastrointestinal (mouth/throat sores p = 0.031, vomiting p = 0.021), respiratory (cough p = 0.04), cardiovascular (arm/leg swelling p = 0.007, palpitations p = 0.052), integumentary (hair loss p = 0.000, skin dryness p = 0.054), and musculoskeletal (fatigue p = 0.002) adverse effects. Positive family history and the 18-30 age group also showed significant associations with adverse effect severity. Disease stage significantly influenced the nervous system (stage 2 p = 0.007, stage 3 p = 0.01).
Conclusion: The severity of adverse effects varies among age groups, depending on disease stage, genetics, and treatment duration. These patient-reported outcomes highlight the need for better management strategies considering prognostic factors and treatment adverse effects.
导言乳腺癌是全球三大恶性肿瘤之一。放疗、激素替代疗法和化疗是乳腺癌的治疗方法,但化疗会产生不良反应,妨碍患者的日常生活:目的:评估女性乳腺癌患者在接受全身化疗(辅助和新辅助)后影响各器官系统的症状性毒性反应的发生率、严重程度和关联性,以及它们对日常生活的影响。此外,还要确定特定年龄组不良反应的严重程度及其与家族史和疾病分期的关系:一项观察性研究针对 2023 年 5 月至 10 月期间在日本国立癌症医院接受化疗的 253 名女性乳腺癌患者。数据收集工具包括 NCI-PRO-CTCAE 标准问卷和患者病历。分析方法包括描述性统计、T 检验和卡方检验:在 253 名患者中,41.4% 年龄在 41-50 岁之间。化疗周期超过三个时,体重会发生显著变化(p = 0.034)。化疗周期增加与胃肠道(口腔/咽喉溃疡 p = 0.031,呕吐 p = 0.021)、呼吸道(咳嗽 p = 0.04)、心血管(手臂/腿部肿胀 p = 0.007,心悸 p = 0.052)、皮肤(脱发 p = 0.000,皮肤干燥 p = 0.054)和肌肉骨骼(疲劳 p = 0.002)不良反应有显著关联。阳性家族史和 18-30 岁年龄组与不良反应严重程度也有显著关联。疾病分期对神经系统有明显影响(2期 p = 0.007,3期 p = 0.01):结论:不同年龄组的不良反应严重程度各不相同,取决于疾病分期、遗传学和治疗持续时间。这些患者报告的结果突出表明,有必要在考虑预后因素和治疗不良反应的基础上制定更好的管理策略。
{"title":"A comprehensive study of adverse effects of chemotherapy on female breast cancer patients in NORI Cancer Hospital, Islamabad in a developing country.","authors":"Abdullah, Areesha Abid, Humza Saeed, Zabeehullah, Uswa Iftikhar, Muhammad Khubaib Arshad, Muhammad Uzair Shahid, Tayyab Rasool, Faizan Fazal, Aman Goyal, Anum Akbar","doi":"10.1177/10781552241266254","DOIUrl":"10.1177/10781552241266254","url":null,"abstract":"<p><strong>Introduction: </strong>Breast cancer is one of the top three malignancies worldwide. While radiotherapy, hormone replacement therapys, and chemotherapy are treatments, chemotherapy causes adverse effects that hinder daily life activities.</p><p><strong>Objectives: </strong>To assess the prevalence, severity, and association of symptomatic toxicities in female breast cancer patients affecting various organ systems post systemic chemotherapy (adjuvant and neoadjuvant), and their impact on daily activities. Additionally, to determine the severity of adverse effects in specific age groups and their association with family history and disease stage.</p><p><strong>Methodology: </strong>An observational study was conducted on 253 female breast cancer patients receiving chemotherapy at NORI Cancer Hospital from May to October 2023. Data collection tools included the NCI-PRO-CTCAE standardized questionnaire and patient medical records. Analysis was performed using descriptive statistics, T-tests, and Chi-square tests.</p><p><strong>Results: </strong>Among the 253 patients, 41.4% were aged 41-50. Significant weight changes (<i>p</i> = 0.034) were observed with more than three chemotherapy cycles. Notable associations included increased chemotherapy cycles with gastrointestinal (mouth/throat sores <i>p</i> = 0.031, vomiting <i>p</i> = 0.021), respiratory (cough <i>p</i> = 0.04), cardiovascular (arm/leg swelling <i>p</i> = 0.007, palpitations <i>p</i> = 0.052), integumentary (hair loss <i>p</i> = 0.000, skin dryness <i>p</i> = 0.054), and musculoskeletal (fatigue <i>p</i> = 0.002) adverse effects. Positive family history and the 18-30 age group also showed significant associations with adverse effect severity. Disease stage significantly influenced the nervous system (stage 2 <i>p</i> = 0.007, stage 3 <i>p</i> = 0.01).</p><p><strong>Conclusion: </strong>The severity of adverse effects varies among age groups, depending on disease stage, genetics, and treatment duration. These patient-reported outcomes highlight the need for better management strategies considering prognostic factors and treatment adverse effects.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875125","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 : 2024-08-01DOI: 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":"https://doi.org/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":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-01","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 : 2024-08-01DOI: 10.1177/10781552241265280
Marisela Tan Banez, Sol Atienza, Allison Butts, Megan Derba, Katie Dicke, Kimberly Haverstick, Bernadette B Heron, Sarah K Cimino, Matthew Shane Loop, Shannon Hough, Julianna A Merten, Donald C Moore, Vishal Shah, Kate D Taucher, Junyu Matt Zhang, Zahra Mahmoudjafari
Introduction: The treatment of cancer is associated with high risk for toxicity and high cost. Strategies to enhance the value, quality, and safety of cancer care are often managed independently of one another. Oncology stewardship is a potential framework to unify these efforts and enhance outcomes. This landscape survey establishes baseline information on oncology stewardship in the United States.
Methods: The Hematology/Oncology Pharmacy Association (HOPA) distributed a 38-item survey composed of demographic, institutional, clinical decision-making, support staff, metrics, and technology sections to 675 HOPA members between 9 September 2022 and 9 October 2022.
Results: Most organizations (78%) have adopted general pharmacy stewardship practices; however, only 31% reported having established a formalized oncology stewardship team. More than 70% of respondents reported implementation of biosimilars, formulary management, and dose rounding as oncology stewardship initiatives in both inpatient and outpatient settings. Frequently cited barriers to oncology stewardship included lack of clinical pharmacist availability (74%), lack of oncology stewardship training (62%), lack of physician/provider buy-in (32%), and lack of cost-saving metrics (33%). Only 6.6% of survey respondents reported their organization had defined "value in oncology." Lack of a formalized stewardship program was most often cited (77%) as the rationale for not defining value.
Conclusions: Less than one-third of respondents have established oncology stewardship programs; however, most are providing oncology stewardship practices. This manuscript serves as a call to action for stakeholders to work together to formalize oncology stewardship programs that optimize value, quality, and safety for patients with cancer.
{"title":"Oncology stewardship practice in the United States: A Hematology/Oncology Pharmacy Association national survey.","authors":"Marisela Tan Banez, Sol Atienza, Allison Butts, Megan Derba, Katie Dicke, Kimberly Haverstick, Bernadette B Heron, Sarah K Cimino, Matthew Shane Loop, Shannon Hough, Julianna A Merten, Donald C Moore, Vishal Shah, Kate D Taucher, Junyu Matt Zhang, Zahra Mahmoudjafari","doi":"10.1177/10781552241265280","DOIUrl":"https://doi.org/10.1177/10781552241265280","url":null,"abstract":"<p><strong>Introduction: </strong>The treatment of cancer is associated with high risk for toxicity and high cost. Strategies to enhance the value, quality, and safety of cancer care are often managed independently of one another. Oncology stewardship is a potential framework to unify these efforts and enhance outcomes. This landscape survey establishes baseline information on oncology stewardship in the United States.</p><p><strong>Methods: </strong>The Hematology/Oncology Pharmacy Association (HOPA) distributed a 38-item survey composed of demographic, institutional, clinical decision-making, support staff, metrics, and technology sections to 675 HOPA members between 9 September 2022 and 9 October 2022.</p><p><strong>Results: </strong>Most organizations (78%) have adopted general pharmacy stewardship practices; however, only 31% reported having established a formalized oncology stewardship team. More than 70% of respondents reported implementation of biosimilars, formulary management, and dose rounding as oncology stewardship initiatives in both inpatient and outpatient settings. Frequently cited barriers to oncology stewardship included lack of clinical pharmacist availability (74%), lack of oncology stewardship training (62%), lack of physician/provider buy-in (32%), and lack of cost-saving metrics (33%). Only 6.6% of survey respondents reported their organization had defined \"value in oncology.\" Lack of a formalized stewardship program was most often cited (77%) as the rationale for not defining value.</p><p><strong>Conclusions: </strong>Less than one-third of respondents have established oncology stewardship programs; however, most are providing oncology stewardship practices. This manuscript serves as a call to action for stakeholders to work together to formalize oncology stewardship programs that optimize value, quality, and safety for patients with cancer.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875145","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}