Abstract:
:Attribution of adverse events (AEs) is critical to oncology drug development and the regulatory process. However, processes for determining the causality of AEs are often sub-optimal, unreliable, and inefficient. Thus, we conducted a toxicity-attribution workshop in Silver Springs MD to develop guidance for improving attribution of AEs in oncology clinical trials. Attribution stakeholder experts from regulatory agencies, sponsors and contract research organizations, clinical trial principal investigators, pre-clinical translational scientists, and research staff involved in capturing attribution information participated. We also included patients treated in oncology clinical trials and academic researchers with expertise in attribution. We identified numerous challenges with AE attribution, including the non-informative nature of and burdens associated with the 5-tier system of attribution, increased complexity of trial logistics, costs and time associated with AE attribution data collection, lack of training in attribution for early-career investigators, insufficient baseline assessments, and lack of consistency in the reporting of treatment-related and treatment-emergent AEs in publications and clinical scientific reports. We developed recommendations to improve attribution: we propose transitioning from the present 5-tier system to a 2-3 tier system for attribution, more complete baseline information on patients' clinical status at trial entry, and mechanisms for more rapid sharing of AE information during trials. Oncology societies should develop recommendations and training in attribution of toxicities. We call for further harmonization and synchronization of recommendations regarding causality safety reporting between FDA, EMA and other regulatory agencies. Finally, we suggest that journals maintain or develop standardized requirements for reporting attribution in oncology clinical trials.
journal_name
Cancer Treat Revjournal_title
Cancer treatment reviewsauthors
George GC,Barata PC,Campbell A,Chen A,Cortes JE,Hyman DM,Jones L,Karagiannis T,Klaar S,Le-Rademacher JG,LoRusso P,Mandrekar SJ,Merino DM,Minasian LM,Mitchell SA,Montez S,O'Connor DJ,Pettit S,Silk E,Sloan JA,Stewardoi
10.1016/j.ctrv.2019.04.004subject
Has Abstractpub_date
2019-06-01 00:00:00pages
33-40eissn
0305-7372issn
1532-1967pii
S0305-7372(19)30062-3journal_volume
76pub_type
杂志文章,评审abstract::Single-fraction stereotactic radiosurgery (SRS) and hypofractionated stereotactic radiotherapy (SRT) are radiation planning and delivery techniques used for the treatment of intracranial and spine/spinal cord tumors and targets. For cranial SRS and SRT, critical normal tissues/structures include the brainstem, cranial...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2011.04.004
更新日期:2011-11-01 00:00:00
abstract::Metastatic cervical carcinoma from unknown primary is a metastatic disease in the lymph nodes of the neck without any evidence of a primary tumour after appropriate investigation. The condition is rare and definite evidence is lacking for both diagnosis and treatment. In this review of the literature, we tried to draw...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2016.11.014
更新日期:2017-02-01 00:00:00
abstract::Microtubule stabilization by chemotherapy is a powerful weapon in the war against cancer. Disruption of the mitotic spindle activates a number of signaling pathways, with consequences that may protect the cell or lead to its death via apoptosis. Taxol, the first microtubule stabilizing drug to be identified, has been ...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2006.01.004
更新日期:2006-05-01 00:00:00
abstract::Aflibercept, also known as vascular endothelial growth factor (VEGF)-Trap, is a recombinant, decoy receptor fusion protein, rationally designed to block angiogenesis by targeting not only all forms of VEGF-A, but also VEGF-B and placental growth factor. It inhibits VEGF-induced angiogenesis in preclinical models. In t...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2011.12.008
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abstract::There has been much progress in the understanding of the relationship between the immune system and colorectal cancer. This has led to the use of immunomodulatory therapy in the adjuvant and palliative treatment of the condition. Although attempts at the use of non-specific immunomodulation with agents such as levamis...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1053/ctrv.1999.0160
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abstract::From a theoretical viewpoint, intraperitoneal therapy (IP) in patients with ovarian cancer, a malignancy which remains mainly confined to the peritoneal cavity, is logical. Over the past decades this approach has evolved into a therapeutic strategy for a selected group of patients. Data available at present suggest a ...
journal_title:Cancer treatment reviews
pub_type: 杂志文章
doi:10.1053/ctrv.1999.0152
更新日期:2000-04-01 00:00:00
abstract::Metastatic colorectal cancer remains a public-health issue on a global scale. With development of a new generation of cytotoxic agents, survival has improved for patients with metastatic disease. How to maximize the benefit of chemotherapy with acceptable toxicity remains incompletely answered. Hepatic resection can p...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2006.07.005
更新日期:2006-11-01 00:00:00
abstract::Bruton's tyrosine kinase (BTK) is a non-receptor intracellular kinase that belongs to the TEC-family tyrosine kinases together with bone marrow-expressed kinase (BMX), redundant-resting lymphocyte kinase (RLK), and IL-2 inducible T-Cell kinase (ITK). All these proteins play a key role in the intracellular signaling of...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2017.06.001
更新日期:2017-07-01 00:00:00
abstract:PURPOSE:To evaluate the existing evidence regarding the long-term risk of cardiovascular disease (CVD) after radiotherapy for childhood cancer. PATIENTS AND METHODS:MEDLINE and EMBASE were searched for articles reporting on radiation-induced CVD after childhood cancer published between 1966 and October 2002. Informati...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2005.03.008
更新日期:2005-05-01 00:00:00
abstract::Gastric cancer is still a major health problem and a leading cause of cancer mortality despite a worldwide decline in incidence. Environmental and Helicobacter pylori (Hp) acting early in life in a multistep and multifactorial process may cause intestinal type carcinomas, whereas genetic abnormalities are related more...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1053/ctrv.2000.0164
更新日期:2000-08-01 00:00:00
abstract::Langerhans cell histiocytosis (LCH) is a rare proliferative disorder of cells with the phenotype of activated Langerhans cells. The diagnosis of LCH is often delayed or missed. Many questions about LCH remain to be answered, including whether it is caused by a malignancy or by immune dysregulation. Data from the early...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2010.02.012
更新日期:2010-06-01 00:00:00
abstract::Non-small cell lung cancer (NSCLC) is the biggest cancer killer in the United States and worldwide. In 2011, there are estimated to be 221,130 new cases of lung cancer in the United States. Over a million people will die of lung cancer worldwide this year alone. When possible, surgery to remove the tumor is the best t...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2011.11.008
更新日期:2012-10-01 00:00:00
abstract::Prostate cancer is androgen-dependent in its early stages and androgen deprivation therapy represents the most effective first-line therapeutic approach. However, after an initial remission, prostate cancer progresses towards the castration resistant prostate cancer (CRPC) stage, with increased malignancy and resistan...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2012.12.003
更新日期:2013-10-01 00:00:00
abstract:INTRODUCTION:Cancer is increasingly being viewed as a chronic illness requiring long-term management, and there is a growing need for evidence-based rehabilitation interventions for cancer survivors. Previous reviews have evaluated the benefits of exercise interventions for patients undergoing cancer treatment and long...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2009.11.003
更新日期:2010-04-01 00:00:00
abstract:BACKGROUND:Data on the comparative efficacy of fulvestrant and other endocrine treatments are inconsistent. Clinical markers predictive of greater benefit from fulvestrant compared to the alternate endocrine agents have not been identified. METHODS:We searched the literature from inception to May 2015, using MEDLINE, ...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.ctrv.2016.02.004
更新日期:2016-04-01 00:00:00
abstract::Despite their particular functional consequences, radiotherapy-induced ear injuries remain under-evaluated and under-reported. These reactions may have acute or late character, may affect all structures of the hearing organ, and result in conductive, sensorineural or mixed hearing loss. Up to 40% of patients have acut...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/s0305-7372(03)00066-5
更新日期:2003-10-01 00:00:00
abstract::Triple-negative breast cancer (TNBC) accounts for ∼10-20% of breast cancers and is associated with relatively poor prognosis, earlier disease recurrence and higher number of visceral metastases. Despite an increasing understanding of the molecular heterogeneity of TNBC, clinical trials of targeted agents have thus far...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2016.09.004
更新日期:2016-11-01 00:00:00
abstract::In cancer biology angiogenesis plays a vital role in tumour growth and its subsequent metastatic potential. By targeting the angiogenic process, a new treatment strategy was added in the clinician's therapeutic armamentarium. On the other hand, numerous classic cytotoxic agents are currently considered as potential an...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2011.09.002
更新日期:2012-08-01 00:00:00
abstract::Given its role in cellular metabolism, the proteasome could prove to be a critical target that can be exploited in treating cancer. In preclinical studies, several mechanisms for bortezomib's activity in multiple myeloma cells have been identified (e.g., NF-kappaB inhibition); antitumor activity with bortezomib has be...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/s0305-7372(03)00079-3
更新日期:2003-05-01 00:00:00
abstract::Borderline ovarian tumours (BOT) may occur in young women and have an excellent survival rate. Therefore, there is the obligation to put emphasis on fertility preservation in affected women. On the other hand, it has also been underlined that the disease should be managed with caution because these tumours can relapse...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2016.06.010
更新日期:2016-09-01 00:00:00
abstract::The use of endocrine therapy is well established as a primary treatment for locally advanced breast cancer. However, despite the current popularity of neoadjuvant chemotherapy for operable tumours, there is relatively little published evidence for pre-operative endocrine therapy in operable disease, particularly outsi...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2006.10.003
更新日期:2007-02-01 00:00:00
abstract::The HER2 oncogene encodes a transmembrane protein partially homologous to epidermal growth factor receptor. This oncogene has been studied mainly in breast cancer where it has prognostic, predictive and therapeutic target value. The expression of HER2 in epithelial ovarian cancer has been less studied. HER2 expression...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2006.01.001
更新日期:2006-05-01 00:00:00
abstract:OBJECTIVES:To synthesize the evidence from randomized controlled trials concerning systemic treatment regimens for patients with cancer of unknown primary site (CUP). DATA SOURCES:PubMed and the Cochrane Library Central Registry of Controlled Trials. REVIEW METHODS:We retrieved all randomized controlled trials compar...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.ctrv.2009.05.005
更新日期:2009-11-01 00:00:00
abstract::An increasing number of women are diagnosed with cancer during pregnancy and lactation. Women are usually advised to interrupt breastfeeding during systemic anticancer treatment for fear of serious adverse effects to the nursed infant. However, the issue is poorly addressed in the literature and very few studies have ...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2012.10.002
更新日期:2013-05-01 00:00:00
abstract::Cardiac toxicity has been implicated as the primary reason for excess non-breast cancer mortality in early breast cancer radiotherapy studies. Refinements in radiotherapy techniques have allowed for a considerable reduction of this risk in the majority of breast cancer patients. Recent large population-based studies c...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2007.07.011
更新日期:2007-10-01 00:00:00
abstract::Although surgery provides excellent control for localized prostate cancer, pathologic examination of more than one-third of specimens will reveal positive surgical margins, seminal vesicle invasion, and/or extracapsular extension, thus putting these patients at increased risk of cancer recurrence. "Adjuvant" radiother...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2010.07.001
更新日期:2011-04-01 00:00:00
abstract::The clinical trials of bisantrene are still at an early stage. However, the many Phase II trials currently ongoing in the Southwest Oncology Group are too premature to draw any firm conclusions. However, there was general agreement during the discussion period that bisantrene does have definite clinical activity in ce...
journal_title:Cancer treatment reviews
pub_type: 杂志文章
doi:10.1016/0305-7372(84)90024-0
更新日期:1984-12-01 00:00:00
abstract::Resistance to tyrosine-kinase inhibitors remains an open issue in the treatment of patients with gastrointestinal stromal tumors. The complex biology of disease in the multi-resistant setting has led a progressively growing urgency and interest in development combined or integrated therapies. This mini-review outlines...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2009.10.004
更新日期:2010-02-01 00:00:00
abstract::Poly-ADP-ribosepolymerase inhibitors (PARPis) are the most active and interesting therapies approved for the treatment of epithelial ovarian cancer. They have changed the clinical management of a disease characterized, in almost half of cases, by extreme genetic complexity and alteration of DNA damage repair pathways,...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2018.12.002
更新日期:2019-02-01 00:00:00
abstract::The existence of branchiogenic carcinoma remains controversial. According to some authors, this malignancy is more conceptual than a true clinicopathologic entity. The originally proposed diagnostic criteria of branchiogenic carcinoma have been subsequently challenged. Many reports regarding primary branchiogenic carc...
journal_title:Cancer treatment reviews
pub_type: 杂志文章,评审
doi:10.1016/j.ctrv.2004.12.007
更新日期:2005-04-01 00:00:00