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Effects of treatment on the abdomen and pelvis
Published in Anju Sahdev, Sarah J. Vinnicombe, Husband & Reznek's Imaging in Oncology, 2020
The Common Terminology Criteria for Adverse Events (CTCAE) (5) provide a clearly delineated severity scale across organ systems and assign a grade between 1 and 5 to describe the severity of an adverse event as detailed next: Grade 1 (mild): Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.Grade 2 (moderate): Minimal, local, or non-invasive intervention indicated; limiting age-appropriate activities of daily living.Grade 3 (severe or medically significant but not immediately life threatening): Hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care.Grade 4 (life-threatening consequences): Urgent intervention indicated.Grade 5: Death related to the adverse event.
Selection of Endpoints
Published in Susan Halabi, Stefan Michiels, Textbook of Clinical Trials in Oncology, 2019
Katherine S. Panageas, Andrea Knezevic
The National Cancer Institute issues the Common Terminology Criteria for Adverse Events (CTCAE), a descriptive terminology utilized for AE reporting [9]. The CTCAE is widely accepted throughout the oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings. In the CTCAE, AEs are grouped by System Organ Class, and a grade (severity) scale is provided for each AE term. The CTCAE displays grades 1 through 5 with unique clinical descriptions of severity for each AE based on general guidelines (Table 2.3) [9].
Photosensitivity and Photoreactions
Published in Gabriella Fabbrocini, Mario E. Lacouture, Antonella Tosti, Dermatologic Reactions to Cancer Therapies, 2019
Cecilia A. Larocca, Mackenzie Asel, Mario E. Lacouture
Several cancer treatments provoke photosensitive eruptions. This skin toxicity is recognized by the Common Terminology Criteria for Adverse Events (CTCAE), created by the National Cancer Institute (NCI) for reporting in cancer clinical trials. Photosensitivity is defined as “a disorder characterized by an increase in sensitivity of the skin to light.” In many cases, the mechanism of photosensitivity is not described, as it falls outside the scope of the clinical trial and it is not further defined by the CTCAE.
Feasibility of Integrating a Mobile Decision-Support App into a Multicomponent CME Initiative: Developing Clinician Competence at the Point of Care
Published in Journal of European CME, 2020
Anne Jacobson, Cara L. Macfarlane, Eugene Pozniak
The IO Toxicity Tool launched at the 2018 ASCO Annual Meeting, joining a suite of existing oncology decision-support tools embedded within the ONCOassist mobile app. To use the tool, clinicians select the toxicity of interest (e.g., colitis, pneumonitis) and the grade of the event, per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, to access the grade-specific care pathway for each irAE. Additional tool features include options to save specific irAE algorithms as favourites, share algorithms via email, and access the full CTCAE version 4.0 criteria. Companion tools within the ONCOassist app, which may drive clinician engagement with the IO Toxicity Tool, include tumour staging criteria, tumour-specific prognostic scores, response criteria, and calculators for predicting the survival benefit of adjuvant therapy. ONCOassist is the only point-of-care app classified as a medical device and CE-approved for use in European Economic Area countries to aid in clinical decisions.
Efficacy and safety of nivolumab in 100 patients with recurrent or metastatic head and neck cancer – a retrospective multicentre study
Published in Acta Oto-Laryngologica, 2019
Isaku Okamoto, Hiroki Sato, Takahito Kondo, Nobuyuki Koyama, Chihiro Fushimi, Takuro Okada, Kouki Miura, Takashi Matsuki, Taku Yamashita, Go Omura, Kiyoaki Tsukahara
The primary endpoint was overall response rate (ORR) and secondary endpoints were OS and PFS. ORR was determined as the best overall response rate (BOR). ORR was examined in patients who had received nivolumab at least 4 times and had undergone imaging evaluation, and in those patients for whom nivolumab had been withdrawn due to PD. ORR, PFS, and OS were examined for all subjects, and for subjects divided into squamous cell carcinoma (SCC) and non-SCC groups. Antitumour efficacy was determined by the doctor in charge at each facility based on RECIST version 1.1 guidelines. The doctors in charge and supervisors at each facility were all qualified head and neck cancer specialists. PFS and OS were also examined by the presence and absence of irAEs. To evaluate safety, Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 were used to examine adverse event occurrence rates by grade, deaths and the appearance of severe adverse events. TNM classification was performed in accordance with the 2009 version from the Unio Internationalis Contra Cancrum.
Patient-reported outcomes in ovarian cancer: are they key factors for decision making?
Published in Expert Review of Anticancer Therapy, 2018
Felix Hilpert, Andreas Du Bois
The meaning of ‘treatment toxicity’ in ovarian cancer requires greater insight. For example, what does it mean for a patient to have a low-grade toxicity (e.g. abdominal pain, nausea) throughout the course of treatment? Whereas current focus continues to be on peak toxicities, it is possible that ongoing low-grade toxicities may be of greater relevance to patients. Patients can be queried about their symptoms using PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE), which were developed by the National Cancer Institute and are available and validated in different languages. Patients are asked questions such as: Over the past 7 days, what was the severity of your mouth or throat sores at their worst – none, mild, moderate, severe, very severe? How much did mouth or throat sores interfere with your usual or daily activities – not at all, a little bit, somewhat, quite a bit, very much?