Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada

PG Kluetz, DJ O'Connor, K Soltys - The Lancet Oncology, 2018 - thelancet.com
The clinical development of cancer therapeutics is a global undertaking, and incorporation
of the patient experience into the clinical decision-making process is of increasing interest to …

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies

G Thanarajasingam, LM Minasian, F Baron… - The Lancet …, 2018 - thelancet.com
Tremendous progress in treatment and outcomes has been achieved across the whole
range of haematological malignancies in the past two decades. Although cure rates for …

Gastrointestinal toxicity of immune checkpoint inhibitors: from mechanisms to management

MA Samaan, P Pavlidis, S Papa, N Powell… - Nature Reviews …, 2018 - nature.com
Immune checkpoint inhibitor therapies are a novel group of monoclonal antibodies with
proven effectiveness in a wide range of malignancies, including melanoma, renal cell …

The HOPE pilot study: harnessing patient-reported outcomes and biometric data to enhance cancer care

AA Wright, N Raman, P Staples… - JCO clinical cancer …, 2018 - ascopubs.org
Purpose Integrating patient-reported outcomes (PROs) into clinical practice is an
increasingly promising strategy for improving patients' symptoms, communication, and …

[HTML][HTML] Health-related quality of life in lower-risk MDS patients compared with age-and sex-matched reference populations: a European LeukemiaNet study

R Stauder, G Yu, KA Koinig, T Bagguley, P Fenaux… - Leukemia, 2018 - nature.com
In myelodysplastic syndromes (MDS), health-related quality of life (HRQoL) represents a
relevant patient-reported outcome, which is essential in individualized therapy planning …

Revisiting the dose constraints for head and neck OARs in the current era of IMRT

NP Brodin, WA Tomé - Oral oncology, 2018 - Elsevier
Head and neck cancer poses a particular challenge in radiation therapy, whilst being an
effective treatment modality it requires very high doses of radiation to provide effective …

Bowel morbidity following radiochemotherapy and image-guided adaptive brachytherapy for cervical cancer: physician-and patient reported outcome from the …

NBK Jensen, R Pötter, K Kirchheiner, L Fokdal… - Radiotherapy and …, 2018 - Elsevier
Abstract Background/Purpose This study describes late bowel morbidity prospectively
assessed in the multi-institutional EMBRACE study on MRI-guided adaptive brachytherapy …

[HTML][HTML] Feasibility of implementing the patient-reported outcomes version of the common terminology criteria for adverse events in a multicenter trial: NCCTG N1048

E Basch, AC Dueck, LJ Rogak, SA Mitchell… - Journal of Clinical …, 2018 - ncbi.nlm.nih.gov
Purpose The US National Cancer Institute (NCI) Patient-Reported Outcomes version of the
Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to enable …

Systematic review of normal tissue complication models relevant to standard fractionation radiation therapy of the head and neck region published after the QUANTEC …

NP Brodin, R Kabarriti, MK Garg, C Guha… - International Journal of …, 2018 - Elsevier
There has recently been an increasing interest in model-based evaluation and comparison
of different treatment options in radiation oncology studies. This is partly driven by the …

A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus

R Fish, C Sanders, R Adams, J Brewer… - The lancet …, 2018 - thelancet.com
Chemoradiotherapy is the primary treatment for patients with squamous cell carcinoma of
the anus, but variations in the reported outcomes have restricted between-study …