Pub Date : 2019-04-01DOI: 10.6004/jadpro.2019.10.3.12
{"title":"Sequencing Therapies in Renal Cell Carcinoma","authors":"","doi":"10.6004/jadpro.2019.10.3.12","DOIUrl":"https://doi.org/10.6004/jadpro.2019.10.3.12","url":null,"abstract":"","PeriodicalId":94110,"journal":{"name":"Journal of the advanced practitioner in oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49354017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-04-01DOI: 10.6004/jadpro.2019.10.3.13
{"title":"Therapeutic Advances in Prostate Cancer","authors":"","doi":"10.6004/jadpro.2019.10.3.13","DOIUrl":"https://doi.org/10.6004/jadpro.2019.10.3.13","url":null,"abstract":"","PeriodicalId":94110,"journal":{"name":"Journal of the advanced practitioner in oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48770053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-04-01DOI: 10.6004/jadpro.2019.10.3.1
{"title":"JADPRO Live 2018: Bringing Clarity to Complexity","authors":"","doi":"10.6004/jadpro.2019.10.3.1","DOIUrl":"https://doi.org/10.6004/jadpro.2019.10.3.1","url":null,"abstract":"","PeriodicalId":94110,"journal":{"name":"Journal of the advanced practitioner in oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48408734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-04-01DOI: 10.6004/jadpro.2019.10.3.14
{"title":"Differential Diagnosis and Testing for Hematologic Malignancies","authors":"","doi":"10.6004/jadpro.2019.10.3.14","DOIUrl":"https://doi.org/10.6004/jadpro.2019.10.3.14","url":null,"abstract":"","PeriodicalId":94110,"journal":{"name":"Journal of the advanced practitioner in oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46833165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-03-01DOI: 10.6004/jadpro.2019.10.2.16
Arnp Josh Epworth
1995 Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Part 2 Safety and E cacy Update of the Open-Label, Multicenter, Phase 1b Study (PAVO) Ajai Chari, MD, Maria-Victoria Mateos, MD, PhD, Niels W. C. J. van de Donk, Jonathan L. Kaufman, MD, Philippe Moreau, Albert Oriol, MD, Torben Plesner, MD, DSc, Lotfi Benboubker, MD, Hareth Nahi, MD, PhD, Jie Tang, Peter Hellemans, Brenda Tromp, MSc, Pamela L. Clemens, PhD, Andrew Farnsworth, Visit http://www.bloodjournal.org/content/132/ Suppl_1/1995 for a complete list of contributor affiliations and full graphics. Introduction: man IgGκ anti-CD38 monoclonal antibody with a direct on-tumor and immunomodulatory mechanism of action. DARA (16 mg/kg administered intravenously [IV]) is approved in many countries as monotherapy and in combination with standard of care (SOC) treatment regimens for patients with relapsed/refractory (RR) multiple myeloma (MM) and newly diagnosed MM. Three phase 3 studies have now demonstrated that DARA in combination with SOC treatment doubles complete response (CR) rates, triples minimal residual disease-negative rates, and reduces the risk of progression or death by at least 50% vs SOC alone. The median durations of the first, second, and subsequent DARA IV infusions are 7.0, 4.3, and 3.4 hours, respectively. To determine whether the duration of infusion can be shortened without coman open-label, multicenter, phase 1b clinical trial (PAVO; NCT02519452) was conducted to evaluate a subcutaneous (SC) formulation of DARA with recombinant human hyaluronidase enzyme PH20 ogy, Halozyme, Inc.) in patients with RRMM. Part 1 of the study revealed that a mix-and-deliver SC administration was well tolerated, with low rates of infusion-related reactions (IRRs) and similar stract 1149). Here, we present updated safety and where a concentrated, pre-mixed SC co-formulation of DARA and rHuPH20 (DARA SC) was evaluated in patients with RRMM. Methods: ceived ≥2 prior lines of therapy, including a proteasome inhibitor (PI) and immunomodulatory drug (IMiD). In Part 2 of the study, a concentrated co-formulation of DARA (1,800 mg) and rHuPH20 (30,000 U; in 15 mL) in a single, premixed vial was administered over 3 to 5 minutes by manual SC injection into the abdomen. DARA SC was given QW during Cycles 1-2, Q2W during Cycles 3-6, and Q4W thereafter in 28-day cycles. Preand/or post infusion medications included acetaminophen, diphenhydramine, montelukast, and methylprednisolone. Co-primary endpoints were safety and Ctrough QW dosing. Secondary endpoints included the overall response rate (ORR) and CR rate according to the International Myeloma Working Group response criteria. Results: ber 13, 2017, 25 patients were enrolled in Part 2 of the study. Patients received a median of 3 (range: 2-9) prior lines of therapy, with 56% double refractory to both PI and IMiD. No treatment discontinuations occurred due to treatment-emergent adverse events (TEAEs). The most common (≥20%) T
1995复发性或难治性多发性骨髓瘤患者皮下注射Daratumumab:开放标签、多中心、1b期研究(PAVO)的第2部分安全性和疗效更新医学博士Ajai Chari、医学博士Maria Victoria Mateos、博士Niels W.C.J.van de Donk、医学博士Jonathan L.Kaufman、医学博士Philippe Moreau、医学博士Albert Oriol、医学博士Torben Plesner、DSc、医学博士Lotfi Benboubker、医学博士Hareth Nahi、医学博士Jie Tang,Peter Hellemans,Brenda Tromp,理学硕士,Pamela L.Clemens,博士,Andrew Farnsworth,访问http://www.bloodjournal.org/content/132/Suppl_1/1995提供了一份完整的投稿人名单和完整的图片。人IgGκ抗CD38单克隆抗体具有直接对肿瘤和免疫调节作用机制。DARA(16 mg/kg静脉注射[IV])在许多国家被批准为单一疗法,并与标准护理(SOC)治疗方案相结合,用于复发/难治性(RR)多发性骨髓瘤(MM)和新诊断的MM患者。三项3期研究现已证明,DARA与SOC治疗相结合使完全缓解(CR)率翻倍,使最小残留疾病阴性率增加三倍,并将进展或死亡风险比单独SOC降低至少50%。第一次、第二次和随后的DARA IV输注的中位持续时间分别为7.0、4.3和3.4小时。为了确定输注持续时间是否可以在没有coman开放标签的情况下缩短,进行了多中心1b期临床试验(PAVO;NCT02519452),以评估在RRMM患者中使用重组人透明质酸酶PH20-ogy(Halozyme,股份有限公司)的DARA皮下(SC)制剂。该研究的第1部分显示,混合和递送SC给药具有良好的耐受性,输注相关反应(IRRs)发生率较低,类似情况1149)。在这里,我们介绍了最新的安全性,并在RRMM患者中评估了DARA和rHuPH20的浓缩、预混合SC联合制剂(DARA SC)。方法:接受≥2种既往治疗,包括蛋白酶体抑制剂(PI)和免疫调节药物(IMiD)。在该研究的第2部分中,通过将SC手动注射到腹部,在3至5分钟内将DARA(1800 mg)和rHuPH20(30000 U;15 mL)在单个预混小瓶中的浓缩共制剂给药。DARA SC在周期1-2期间给予QW,在周期3-6期间给予Q2W,此后在28天周期给予Q4W。输注前后药物包括对乙酰氨基酚、苯海拉明、孟鲁司特和甲基强的松龙。共同的主要终点是安全性和Ctrough QW给药。次要终点包括根据国际骨髓瘤工作组反应标准的总有效率(ORR)和CR率。结果:2017年12月13日,25名患者被纳入本研究的第2部分。患者接受了中位数为3(范围:2-9)的既往治疗,其中56%的患者对PI和IMiD都有双重难治性。没有因治疗突发不良事件(TEAE)而中断治疗。最常见(≥20%)的TEAE包括淋巴细胞减少症(32%)、血小板减少症(24%)、疲劳、乏力、背痛、腹泻、恶心、头痛和病毒性上呼吸道感染(各20%)。DARA SC的IRRs发生率(16%)和严重程度(主要为1-2级)较低,大多数发生在第1周期第1天,未观察到因IRRs而中断。《多发性骨髓瘤杂志2019年临床肿瘤学》报道了短暂性3级高血压;10(补充2):4-9https://doi.org/10.6004/jadpro.2019.10.2.16这是Cr ea tiv e C om m on s A ttr ibu tio n n on-C om m cia l n on-d er iva tiv e l ice ns e的三个部分,即它的非结构化无nco m er cia l A和非私有化、三个部分、一个在一个y m d ium中的操作过程,以及它的内部或外部。
{"title":"Multiple Myeloma","authors":"Arnp Josh Epworth","doi":"10.6004/jadpro.2019.10.2.16","DOIUrl":"https://doi.org/10.6004/jadpro.2019.10.2.16","url":null,"abstract":"1995 Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Part 2 Safety and E cacy Update of the Open-Label, Multicenter, Phase 1b Study (PAVO) Ajai Chari, MD, Maria-Victoria Mateos, MD, PhD, Niels W. C. J. van de Donk, Jonathan L. Kaufman, MD, Philippe Moreau, Albert Oriol, MD, Torben Plesner, MD, DSc, Lotfi Benboubker, MD, Hareth Nahi, MD, PhD, Jie Tang, Peter Hellemans, Brenda Tromp, MSc, Pamela L. Clemens, PhD, Andrew Farnsworth, Visit http://www.bloodjournal.org/content/132/ Suppl_1/1995 for a complete list of contributor affiliations and full graphics. Introduction: man IgGκ anti-CD38 monoclonal antibody with a direct on-tumor and immunomodulatory mechanism of action. DARA (16 mg/kg administered intravenously [IV]) is approved in many countries as monotherapy and in combination with standard of care (SOC) treatment regimens for patients with relapsed/refractory (RR) multiple myeloma (MM) and newly diagnosed MM. Three phase 3 studies have now demonstrated that DARA in combination with SOC treatment doubles complete response (CR) rates, triples minimal residual disease-negative rates, and reduces the risk of progression or death by at least 50% vs SOC alone. The median durations of the first, second, and subsequent DARA IV infusions are 7.0, 4.3, and 3.4 hours, respectively. To determine whether the duration of infusion can be shortened without coman open-label, multicenter, phase 1b clinical trial (PAVO; NCT02519452) was conducted to evaluate a subcutaneous (SC) formulation of DARA with recombinant human hyaluronidase enzyme PH20 ogy, Halozyme, Inc.) in patients with RRMM. Part 1 of the study revealed that a mix-and-deliver SC administration was well tolerated, with low rates of infusion-related reactions (IRRs) and similar stract 1149). Here, we present updated safety and where a concentrated, pre-mixed SC co-formulation of DARA and rHuPH20 (DARA SC) was evaluated in patients with RRMM. Methods: ceived ≥2 prior lines of therapy, including a proteasome inhibitor (PI) and immunomodulatory drug (IMiD). In Part 2 of the study, a concentrated co-formulation of DARA (1,800 mg) and rHuPH20 (30,000 U; in 15 mL) in a single, premixed vial was administered over 3 to 5 minutes by manual SC injection into the abdomen. DARA SC was given QW during Cycles 1-2, Q2W during Cycles 3-6, and Q4W thereafter in 28-day cycles. Preand/or post infusion medications included acetaminophen, diphenhydramine, montelukast, and methylprednisolone. Co-primary endpoints were safety and Ctrough QW dosing. Secondary endpoints included the overall response rate (ORR) and CR rate according to the International Myeloma Working Group response criteria. Results: ber 13, 2017, 25 patients were enrolled in Part 2 of the study. Patients received a median of 3 (range: 2-9) prior lines of therapy, with 56% double refractory to both PI and IMiD. No treatment discontinuations occurred due to treatment-emergent adverse events (TEAEs). The most common (≥20%) T","PeriodicalId":94110,"journal":{"name":"Journal of the advanced practitioner in oncology","volume":"10 1","pages":"4 - 6"},"PeriodicalIF":0.0,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46483694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-03-01DOI: 10.6004/jadpro.2019.10.2.18
S. Kurtin, Anp-C, Aocn
{"title":"Leukemias and Lymphomas","authors":"S. Kurtin, Anp-C, Aocn","doi":"10.6004/jadpro.2019.10.2.18","DOIUrl":"https://doi.org/10.6004/jadpro.2019.10.2.18","url":null,"abstract":"","PeriodicalId":94110,"journal":{"name":"Journal of the advanced practitioner in oncology","volume":"10 1","pages":"26 - 32"},"PeriodicalIF":0.0,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42387792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-03-01DOI: 10.6004/JADPRO.2019.10.2.1
P. Viale
The American Cancer Society estimates 101,420 new cases of colon cancer and 44,180 new cases of rectal cancer in the United States this year (American Cancer Society, 2019). Colorectal cancer remains the third leading cause of death from cancer in both sexes, with approximately 51,020 deaths expected this year (American Cancer Society, 2019). And disturbingly, although the overall death rate has dropped, the death rate for younger people (aged 55 or younger) has increased 1% per year from 2007 through 2016 (American Cancer Society, 2019). These statistics are sobering to me, as this is a cancer that is largely preventable through rigorous screening. It is one of the cancers we can successfully do something about. And yet, we still see colorectal cancer. For this reason, I am always interested in data that show variables that may reduce colorectal cancer and death in patients with this disease.
{"title":"The Benefits of Nuts for Cancer Prevention","authors":"P. Viale","doi":"10.6004/JADPRO.2019.10.2.1","DOIUrl":"https://doi.org/10.6004/JADPRO.2019.10.2.1","url":null,"abstract":"The American Cancer Society estimates 101,420 new cases of colon cancer and 44,180 new cases of rectal cancer in the United States this year (American Cancer Society, 2019). Colorectal cancer remains the third leading cause of death from cancer in both sexes, with approximately 51,020 deaths expected this year (American Cancer Society, 2019). And disturbingly, although the overall death rate has dropped, the death rate for younger people (aged 55 or younger) has increased 1% per year from 2007 through 2016 (American Cancer Society, 2019). These statistics are sobering to me, as this is a cancer that is largely preventable through rigorous screening. It is one of the cancers we can successfully do something about. And yet, we still see colorectal cancer. For this reason, I am always interested in data that show variables that may reduce colorectal cancer and death in patients with this disease.","PeriodicalId":94110,"journal":{"name":"Journal of the advanced practitioner in oncology","volume":"10 1","pages":"102 - 103"},"PeriodicalIF":0.0,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48973506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-03-01DOI: 10.6004/jadpro.2019.10.2.17
L. Lyle, Pa-C
Acute myeloid leukemia (AML) is a group of neoplasms arising from precursor cells committed to the myeloid cell-line differentiation. All of them are characterized by clonal expansion of myeloid blasts. AML manifests by fever, pallor, anemia, hemorrhages and recurrent infections.
{"title":"Acute Myeloid Leukemia","authors":"L. Lyle, Pa-C","doi":"10.6004/jadpro.2019.10.2.17","DOIUrl":"https://doi.org/10.6004/jadpro.2019.10.2.17","url":null,"abstract":"Acute myeloid leukemia (AML) is a group of neoplasms arising from precursor cells committed to the myeloid cell-line differentiation. All of them are characterized by clonal expansion of myeloid blasts. AML manifests by fever, pallor, anemia, hemorrhages and recurrent infections.","PeriodicalId":94110,"journal":{"name":"Journal of the advanced practitioner in oncology","volume":"10 1","pages":"19 - 25"},"PeriodicalIF":0.0,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48446970","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}