Developing a CTCAEs patient questionnaire for late toxicity after head and neck radiotherapy

Ho, Kean F; Farnell, Damian J. J.; Routledge, Jacqueline A; Burns, Meriel P; Sykes, Andrew J; Slevin, Nicholas J; Davidson, Susan E

doi:10.1016/j.ejca.2009.04.010

Cited by 25 publications

(29 citation statements)

References 21 publications

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“…The questionnaires were revised to collect CTCAEv3 data, which incorporated LENT items, for patients with female [14] and male [15] pelvis cancers and produced for head and neck cancer [16]. The questionnaires were validated to check for reliability, compliance and acceptability and were freely available [17].…”

Section: Questionnaires For Collecting Patientreported Quality Of Lifmentioning

confidence: 99%

The REQUITE Project: Validating Predictive Models and Biomarkers of Radiotherapy Toxicity to Reduce Side-effects and Improve Quality of Life in Cancer Survivors

et al. 2014

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The worldwide number of cancer survivors within 5 years of diagnosis was estimated to be about 28.7 million in 2008 [1]. Many must cope with the long-term effects of treatment, which can affect health-related quality of life [2,3]. These issues need to be addressed in a systematic manner in order to enhance the participation of cancer survivors in society and reduce healthcare costs. Sideeffects and quality of life in long-term survivors after radiotherapy are not well researched and the data are rarely collected in a systematic manner in routine follow-up. Also, studies investigating side-effects can be difficult to compare because of the use of different toxicity reporting systems and a lack of pretreatment data, which is important to ensure that side-effects are related to radiotherapy rather than other underlying health problems [4]. Predictive models of radiotherapy toxicity require cross-centre validation for widespread clinical implementation [5]. Genetics is important, but no biomarker has been validated for clinical use. Predictive model research has the potential to not only improve quality of life, but also to increase survival, for example by using isotoxic strategies [6], and to decrease healthcare costs with a more rational use of expensive medical technology such as proton therapy [7]. The REQUITE ProjectREQUITE is funded by the European Union through its Seventh Framework Programme. The objectives of the project are to: (i) carry out a multicentre, cohort study collecting blood samples, epidemiology and treatment data, longitudinal side-effect and quality of life data (before and after treatment, years 1 and 2); (ii) produce a centralised database and biobank of DNA for 5300 patients; (iii) validate published biomarkers of radiosensitivity; (iv) validate clinical predictors of radiotherapy toxicity and incorporate biomarker data; (v) design interventional trials to reduce long-term side-effects; (vi) provide a resource for dissemination and exploitation to the radiotherapy community. The project focuses on cancers of the breast, lung and prostate.

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Section: Questionnaires For Collecting Patientreported Quality Of Lifmentioning

confidence: 99%

The REQUITE Project: Validating Predictive Models and Biomarkers of Radiotherapy Toxicity to Reduce Side-effects and Improve Quality of Life in Cancer Survivors

et al. 2014

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“…Consequently, damaged salivary glands in surviving head and neck cancer patients have predominantly duct cells remaining, i.e., unable to secrete fluid, and the patients experience significant salivary hypofunction, often termed xerostomia (dry mouth). With a five-year survival rate of ~60%, such patients (Radiation Therapy Oncology Group categories 2 and 3, [68]) suffer from dysphagia, frequent oral infections, poor oral mucosal wound healing and a marked reduction in quality of life [69,70], and there is no adequate conventional therapy available.…”

Section: Adhaqp1 To Correct Radiation-induced Parotid Hypofunctionmentioning

confidence: 99%

Gene delivery in salivary glands: From the bench to the clinic

Samuni

Baum

2011

Biochimica et Biophysica Acta (BBA) - Molecular Basis of Diseas

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In vivo gene delivery has long been seen as providing opportunities for the development of novel treatments for disorders refractory to existing therapies. Over the last two decades, salivary glands have proven to be a useful, if somewhat unconventional, target tissue for studying several potential clinical applications of therapeutic gene delivery. Herein, we follow the progress, address some problems and assess the outlook for clinical applications of salivary gland gene delivery. Our experience with these tissues provides a roadmap for the process of moving an idea from the laboratory bench to patients.

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“…Salivary glands in the radiation field suffer irreversible damage leading to a marked reduction in salivary flow and, as a consequence, xerostomia, dysphagia and oral infections 2,3. Importantly, this irradiation (IR)-induced salivary hypofunction results in a significant diminution in quality of life for surviving oral cancer patients 4,5.…”

Section: Introductionmentioning

confidence: 99%

AAV2-mediated transfer of the human aquaporin-1 cDNA restores fluid secretion from irradiated miniature pig parotid glands

et al. 2010

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Previously (Shan et al, 2005), we reported that adenoviral vector-mediated transfer of the human aquaporin-1 (hAQP1) cDNA to minipig parotid glands following irradiation (IRti) transiently restored salivary flow to near normal levels. This study evaluated a serotype 2, adeno-associated viral (AAV2) vector for extended correction of IR (single dose; 20 Gy)-induced, parotid salivary hypofunction in minipigs. Sixteen weeks following IR, parotid salivary flow decreased by 85-90%. AAV2hAQP1 administration at week 17 transduced only duct cells and resulted in a dose-dependent increase in salivary flow to ∼35% of pre-IR levels (to ∼1ml/10min) after 8 weeks (peak response). Administration of a control AAV2 vector or saline, was without effect. Little change was observed in clinical chemistry and hematology values after AAV2hAQP1 delivery. Vector treated animals generated high anti-AAV2 neutralizing antibody titers by week 4 (∼1:1600) and significant elevations in salivary (∼15%), but not serum, GM-CSF levels. Following vector administration, salivary [Na+] was dramatically increased, from ∼10mM to ∼55 (at 4 weeks) and 39 mM (8 weeks). The findings demonstrate that localized delivery of AAV2hAQP1 to IR-damaged parotid glands leads to increased fluid secretion from surviving duct cells, and may be useful in providing extended relief of salivary hypofunction in previously irradiated patients.

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Developing a CTCAEs patient questionnaire for late toxicity after head and neck radiotherapy

Cited by 25 publications

References 21 publications

The REQUITE Project: Validating Predictive Models and Biomarkers of Radiotherapy Toxicity to Reduce Side-effects and Improve Quality of Life in Cancer Survivors

The REQUITE Project: Validating Predictive Models and Biomarkers of Radiotherapy Toxicity to Reduce Side-effects and Improve Quality of Life in Cancer Survivors

Gene delivery in salivary glands: From the bench to the clinic

AAV2-mediated transfer of the human aquaporin-1 cDNA restores fluid secretion from irradiated miniature pig parotid glands

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