European Organization For Research And Treatment Of Cancer Guidelines Research Articles

Comparative dosimetric study of radiotherapy in high-grade gliomas based on the guidelines of EORTC and NRG-2019 target delineation.

Radiotherapy is one of the most important treatments for high-grade glioma (HGG), but the best way to delineate the target areas for radiotherapy remains controversial, so our aim was to compare the dosimetric differences in radiation treatment plans generated based on the European Organization for Research and Treatment of Cancer (EORTC) and National Research Group (NRG) consensus to provide evidence for optimal target delineation for HGG. We prospectively enrolled 13 patients with a confirmed HGG from our hospital and assessed dosimetric differences in radiotherapy treatment plans generated according to the EORTC and NRG-2019 guidelines. For each patient, two treatment plans were generated. Dosimetric parameters were compared by dose-volume histograms for each plan. The median volume for planning target volume (PTV) of EORTC plans, PTV1 of NRG-2019 plans, and PTV2 of NRG-2019 plans were 336.6 cm3 (range, 161.1-511.5 cm3), 365.3 cm3 (range, 123.4-535.0 cm3), and 263.2 cm3 (range, 116.8-497.7 cm3), respectively. Both treatment plans were found to have similar efficiency and evaluated as acceptable for patient treatment. Both treatment plans showed well conformal index and homogeneity index and were not statistically significantly different (P = 0.397 and P = 0.427, respectively). There was no significant difference in the volume percent of brain irradiated to 30, 46, and 60 Gy according to different target delineations (P = 0.397, P = 0.590, and P = 0.739, respectively). These two plans also showed no significant differences in the doses to the brain stem, optic chiasm, left and right optic nerves, left and right lens, left and right eyes, pituitary, and left and right temporal lobes (P = 0.858, P = 0.858, P = 0.701 and P = 0.794, P = 0.701 and P = 0.427, P = 0.489 and P = 0.898, P = 0.626, and P = 0.942 and P = 0.161, respectively). The NRG-2019 project did not increase the dose of organs at risk (OARs) radiation. This is a significant finding that further lays the groundwork for the application of the NRG-2019 consensus in the treatment of patients with HGGs. The effect of radiotherapy target area and glial fibrillary acidic protein (GFAP) on the prognosis of high-grade glioma and its mechanism, number ChiCTR2100046667. Registered 26 May 2021.

A Randomized Trial of Comparative Dosimetric Study of Radiotherapy in High Grade Gliomas Based on the Guidelines of 2019-NRG and EORTC Target Delineation

<h3>Purpose/Objective(s)</h3> Postoperative radiotherapy is important for high-grade glioma (WHO Grade 3-4), but the optimal way for contouring the target area for radiotherapy is still unclear. The purpose of this randomized trial was to compare the dosimetric differences in radiation treatment plans (TPS) generated based on the European Organization for Research and Treatment of Cancer (EORTC) and NRG consensus (NRG-2019) guidelines to provide evidence for optimal target delineation for high-grade glioma. <h3>Materials/Methods</h3> Patients with diagnosis of high-grade glioma were randomly assigned (1:1) to receive postoperative radiotherapy based on either EORTC guideline or NRG-2019 guideline. We report the result of dosimetric comparison first. In 13 high grade glioma patients, both EORTC and NRG-2019 radiation treatment plans were generated for dosimetric comparison. For EORTC group, the prescription dose was 95% PTV 60 Gy in 30 fractions. The gross tumor volume (GTV) including resection cavity and residual tumor encompassed the T1-weighted images (T1WI) and T2 FLAIR contrast-enhancing lesion. For NRG-2019group, GTV involved the T1-weighted images (T1WI) and T2 FLAIR contrast-enhancing foci and peritumoral edema on the preoperative CT or MRI. The prescription dose of PTV1 was 46 Gy in 23 fractions. The areas were then diminished to contain merely the contrast enhancing foci with a 2.5 cm margin as CTV2, and PTV2 was equal the CTV2 plus 0.3 cm margin for additional prescription dose was 14 Gy in 7 fractions. It should be noted that CTV1 and CTV2 were trimmed according to the anatomical barriers, falx, ventricles, etc. This trial is registered with chictr.org.cn, number ChiCTR2100046667. <h3>Results</h3> The median volume for PTV of EORTC plans, PTV1 of NRG-2019 plans, PTV2 of NRG-2019 plans were 336.6 cm³ (range 161.1-511.5 cm³), 365.3 cm³ (range 123.4-535.0 cm³), and 263.2 cm³ (range 116.8-497.7 cm³), respectively. Both treatment plans were found to have similar efficiency and evaluated as acceptable for patient treatment. Both treatment plans showed well conformal index and homogeneity index and were not statistically significantly different. There was no significant difference in the volume percent of brain irradiated to 30 Gy, 46 Gy, and 60 Gy according to different target delineations (P = 0.397, P = 0.590 and P = 0.739, respectively). These two plans also showed no significant differences in the doses to the brainstem, optic chiasm, optic nerve, lens, eyes, pituitary, and temporal lobes (P = 0.858, P = 0.858, 0.701, P = 0.794, P = 0.701, P = 0.427, P = 0.489, P = 0.898, P = 0.626, P = 0.942 and P = 0.161, respectively). <h3>Conclusion</h3> Compared with EORTC guidelines for postoperative radiotherapy for high-grade glioma, the NRG-2019 target area delineation guidelines were able to include peritumor edema in the CTV without increasing the radiation dose to organs at risk (OARs). This study further provides a foundation for the application of the NRG-2019 consensus in radiotherapy for patients with high-grade gliomas.

Translation and Pilot Validation of the EORTC QLQ-NHL-HG29 Module in Indian Languages (Hindi and Marathi) for Use in Indian Patients with Non-Hodgkin's Lymphoma

Background Cancer and its related treatments have a huge impact on a patient's quality of life (QOL). To measure such QOL in cancer patients, the European Organization for Research and Treatment of Cancer (EORTC) has introduced various scales/questionnaires for various cancers. In the present study, we aimed to translate and validate high-grade Non-Hodgkin's lymphoma (NHL-HG) English questionnaire (EORTC QLQ-NHL-HG29) into Hindi and Marathi (two of the most popular Indian language) to make it available for patients and the scientific community. Materials and methods The EORTC QLQ-NHL-HG29 was translated into Hindi and Marathi languages as per EORTC guidelines. The translated questionnaire was pilot-tested in a sample of 20 patients (10 for each translation) with NHL-HG. Results After procuring required approvals from EORTC, the existing QLQ-NHL-HG29 English questionnaire was translated (forward and backward) into vernacular languages (Hindi and Marathi). Later, the translations were sent to EORTC for evaluation and all the queries raised by EORTC toward translations were discussed and included in the final questionnaires as per EORTC guidelines. On receiving approval from EORTC translation coordinator, pilot study was conducted in 20 patients. In the pilot study, 10 patients were given the Hindi questionnaire and other 10 patients were given the Marathi questionnaire. Based on the pilot testing interpretations or suggestions from the patients, all the necessary modifications were incorporated in the questionnaires and sent to EORTC for validation and approval. Conclusion Both the translations (Hindi and Marathi) submitted to the EORTC have now been approved (QLQ-NHL-HG29) by the EORTC-QOL unit and after procuring necessary permissions from the EORTC both of these translations can be used reliably in clinical practice and clinical trials to assess QOL in patients suffering from NHL-HG.

Marathi Translation and Linguistic Validation of an Updated European Organization for Research and Treatment of Cancer Quality of Life Module for Head and Neck.

Aim This study was aimed to translate an updated European Organization for Research and Treatment of Cancer (EORTC) quality of life module for head and neck (EORTC QLQ-H&N43) in grammatically and conceptually acceptable Marathi language and its linguistic validation. Materials and Methods Approval was obtained from the Institutional Ethics Committee. The permission for translation was obtained from the EORTC translation unit (TU). The EORTC guidelines for the translation were followed to form a translation for pilot testing which was administered to 10 Marathi speaking head and neck squamous cell cancer (HNSCC) patients who gave informed written consent for the participation in the study. Patients were interviewed personally. The final Marathi translation was prepared and sent to EORTC TU for approval. Statistical analysis was performed using SYSTAT version 12 by Cranes software, Bengaluru, Karnataka, India. Results After getting permission, the translation files were received from EORTC TU, including Marathi EORTC QLQ-H&N35 for reference. Two forward translations, reconciled translation, back translations, first interim translation, translation for proof editing, and second interim translation (SIT) were prepared. This SIT was pilot tested in 10 Marathi-speaking HNSCC patients. Each patient was interviewed regarding difficulty in answering, confusing or offensive word, and reframing sentence. The questionnaire was well understood by patients reflecting its linguistic validity. After incorporating the changes as per the patient’s interview, updated translation was prepared and sent to EORTC TU which was accepted and approved by EORTC. The psychometric analysis of pilot testing showed that the questionnaire is acceptable. Conclusion Marathi translation of EORTC QLQ-H&N43 is well accepted and understandable. It can be used for future studies.

An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 was one of the first disease-specific questionnaires developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996 major changes in BC treatment have occurred, requiring an update of the EORTC BC module. This study presents the results of the phase I-III update of the QLQ-BR23 questionnaire. The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items. The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale. Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.

Comparison of expected treatment outcomes, obtained using risk models and international guidelines, with observed treatment outcomes in a Dutch cohort of patients with non-muscle-invasive bladder cancer treated with intravesical chemotherapy

To compare the risks according to the American Urological Association (AUA), EAU, European Organization for Research and Treatment of Cancer (EORTC) and Club Urológico Español de Tratamiento Oncologico (CUETO) classifications with real outcomes in a cohort of patients in the Netherlands, and to confirm that patients who were undertreated according to these risk models have worse outcomes than adequately treated patients. Patients treated with complete transurethral resection of bladder tumour and intravesical chemotherapy were included. Not all patients would have received intravesical chemotherapy had they been treated to current standards, and thus comparison of the observed outcomes in our Dutch cohort vs expected outcomes based on the EORTC risk tables and CUETO scoring model was possible. The cohort was reclassified according to the definitions of five index patients (IPs), as defined by the AUA guidelines, and three risk groups, defined according to the EAU guidelines, to compare the outcomes of undertreated patients with those of adequately treated patients. A total of 1001 patients were available for comparison with the AUA definitions and 728 patients were available for comparison with the EORTC and CUETO models. There was a large overlap between the observed outcomes and expected recurrence and progression probabilities when comparison was made using the EORTC risk tables. The observed recurrence outcomes were in general higher than the expected probabilities according to the CUETO risk classification, especially in the long term. No differences in progression were found when comparing these two models to the Dutch cohort. Patients who were undertreated according to the guidelines showed, in general, a higher risk of developing recurrence and progression. Limitations are i.a. its retrospective nature and the differences in grading system. Comparisons between the observed outcomes in our Dutch cohort and the expected outcomes based on EAU and CUETO risk models and the EORTC and AUA guidelines showed that lack of adherence to existing guidelines translates into worse outcomes.

International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24

Health-related quality of life (HRQOL) is a key aspect for chronic myeloid leukemia (CML) patients. The aim of this study was to develop a disease-specific HRQOL questionnaire for patients with CML to supplement the European Organization for Research and Treatment of Cancer (EORTC)-QLQ C30. The process followed a predefined and systematic stepwise iterative process as defined by the EORTC guidelines for questionnaire development. The process was divided into 3 phases: (1) generation of relevant HRQOL issues, (2) operationalization of the HRQOL issues into a set of items, and (3) pretesting the questionnaire for relevance and acceptability. Descriptive statistics and psychometric analyses were also performed. Overall, 655 CML patients were enrolled in 10 countries including the USA and countries in Europe and Asia. Interviews with health-care professionals experienced in CML (n=59) were also conducted. Results from the interviews, clinical experiences, and statistical analyses were used to develop the EORTC QLQ-CML24. The final module consists of 24 items assessing the following aspects: symptom burden, impact on daily life and on worry/mood, body image problems, and satisfaction with care and with social life. Internal consistency, assessed with Cronbach's alpha coefficients, ranged from 0.73 to 0.83 for the proposed scales. The EORTC QLQ-CML24 is an internationally developed HRQOL questionnaire for CML patients, and its implementation in clinical research and practice can provide important information to facilitate clinical decision-making.

Validation of the Polish version of the EORTC QLQ-BM22 module for the assessment of health-related quality of life in patients with bone metastases

The aim of our study was to undertake a prospective validation study of the Polish version of the European Organization for Research and Treatment of Cancer (EORTC) bone metastases (QLQ-BM22) module used alongside the EORTC core measure. The translated module was pilot-tested according to the established EORTC guidelines. Patients with histological confirmation of malignancy and bone metastases, diagnosed by imaging studies, were eligible for the study. All patients filled out the Polish version of the QLQ-BM22 module in addition to QLQ-C30 and a demographic questionnaire. Standard validity and reliability analyses were performed. One hundred and fifty-five patients were enrolled into the study, including 94 women (60.7 %) and 61 men (mean age ± SD; 59.1 ± 12.1). Cronbach's alpha coefficients, range 0.68-0.93, showed positive internal consistency. Re-test was undertaken with fifty patients (32.3 %). Interclass correlations for the EORTC QLQ-BM22 ranged from 0.91 to 0.93 and proved sufficient test-retest reliability. Satisfactory convergent and discriminant validity in multi-trait scaling analyses was seen. Our study provides new and robust evidence which shows that the Polish version of the QLQ-BM22 module is a valid and reliable instrument for measuring health-related quality of life in patients with bone metastases. It is suitable for use in clinical trials and in research.

Validation of the Polish Version of the EORTC QLQ-C30 and the QLQ-OG25 for the Assessment of Health-Related Quality of Life in Patients with Esophagi-Gastric Cancer

The aim of this study was to validate the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Core 30 (QLQ-C30) and its esophagi-gastric module (QLQ-OG25) in their Polish language versions. Translation of the QLQ-OG25 was done according to EORTC guidelines. Each of the 98 patients filled out the two EORTC questionnaires and a personal questionnaire. Reliability and validity test were performed and patients’ comments were analyzed. The Polish version of the EORTC QLQ-C30 and the QLQ-OG25 are reliable and valid tools for measuring health-related quality of life in patients with esophagi-gastric cancer.

Translation and validation of the Polish version of the EORTC QLQ-OPT30 module for the assessment of health-related quality of life in patients with uveal melanoma

The purpose of this study was to translate into Polish and validate the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Ophthalmic Module (QLQ-OPT30). The QLQ-OPT30 was translated and pilot-tested according to EORTC guidelines. Patients were qualified based on the histological or ophthalmoscopic and ultrasonographic diagnosis of uveal melanoma. Each patient filled out the Polish version of the EORTC Quality of Life Questionnaire (EORTC QLQ-C30), the QLQ-OPT30 module and a personal questionnaire. Patients were divided into three groups according to treatment type, melanoma localisation and possible negative outcomes of the disease or treatment. Reliability and validity test were performed and patients' comments were analysed. Our study included 94 patients--50 women (53.2%) and 44 men (46.8%) in the mean age of 58.4 (±13) years. Treatment type and melanoma location did not influence the health-related quality of life. The QLQ-OPT30, apart from two scales, showed positive internal consistency (Cronbach's alpha coefficients range: 0.70-0.88). We found the Polish version of the EORTC QLQ-OPT30 module a useful tool for measuring health-related quality of life in uveal melanoma patients. Although its discriminative validity is somewhat limited it still can be recommended for clinical use in the Polish population.

Validation of the Mexican-Spanish version of the EORTC QLQ-C30 and BR23 questionnaires to assess health-related quality of life in Mexican women with breast cancer

The aim of this study was to validate the Mexican-Spanish version of The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 questionnaire. The translation procedure followed EORTC guidelines. QLQ-C30 and QLQ-BR23 instruments were completed by Mexican women with breast cancer, attending a teaching referral cancer centre from February 2009 to January 2010. Patients were divided in two groups: (1) Patients with early stage of breast cancer; and (2) Patients with locally advanced breast cancer (LABC). Reliability and validity tests were performed, and validity over time (responsiveness) was conducted in a subset of patients. Two hundred and thirty-four women (mean age, 52.3 years) completed both questionnaires. Convergent and divergent validity was adequate. Cronbach's alpha of all multi-item scales showed values ≥0.7 except for Cognitive and Breast symptoms scales (0.52 and 0.65 respectively). Patients with early stages (n= 77) showed better functional scores and lower symptoms scores than patients with LABC (n= 157). Score means variation after responsiveness analysis demonstrated high sensitivity to change after breast cancer surgery. The Mexican-Spanish version of the EORTC QLQ-BR23 questionnaire is a valid and suitable instrument to estimate HRQL in patients with breast cancer.

Re: Personalized Medicine and Cancer Supportive Care: Appropriate Use of Colony-Stimulating Factor Support of Chemotherapy

Re: Personalized Medicine and Cancer Supportive Care: Appropriate Use of Colony-Stimulating Factor Support of Chemotherapy

Delineation of the Postprostatectomy Prostate Bed Using Computed Tomography: Interobserver Variability Following the EORTC Delineation Guidelines

The present study aims to assess the interobserver agreement of prostate bed delineation after radical prostatectomy using CT alone as proposed by the European Organization for Research and Treatment of Cancer (EORTC) guidelines. Six observers delineated the postoperative prostate bed (PB) and the original seminal vesicle position or remnants (SV) of 10 patients according to the EORTC guidelines. Contours were then compared for agreement between observers (the apparent volume overlap and generalized kappa statistics). Standard deviations were also calculated to measure the variability of the position of the outer margins. The mean volume of 100% agreement (±1 standard deviation, SD) was only 5.0 (±3.3) ml for the PB and 0.9 (±1.5) ml for the SV, whereas the mean union of all contours (±1 SD) was 41.1 (±11.8) ml and 25.3 (±13.4) ml, respectively. The mean overall agreement corrected for chance was moderate for both the PB (mean kappa, 0.49; range, 0.35-0.62) and SV (mean kappa, 0.42; range, 0.22-0.59). The overall SD of the outer margins of the PB ranged from 4.6 to 7.0 mm The delineation of the postprostatectomy bed using CT shows only a moderate observer agreement when following the EORTC guidelines.

Validation of the Mexican Spanish Version of the EORTC C30 and STO22 Questionnaires for the Evaluation of Health-Related Quality of Life in Patients with Gastric Cancer

Health-related quality of life (HRQL) is a fundamental outcome in surgical oncology and culturally valid tools are essential for this purpose. Our aim was to validate the Mexican-Spanish versions of the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire QLQ-C30 and the QLQ-STO22 disease-specific questionnaire module in Mexican patients with gastric cancer (GC). The translation procedure followed EORTC guidelines. Both instruments were completed by patients with GC and analyses were performed within three clinically distinct groups: (1) patients undergoing palliative treatment, (2) patients undergoing treatment with curative intent, and (3) GC survivors. Tests for reliability and validity were performed. One hundred and fifty patients (mean age 54.2 years) completed both questionnaires. Sixty-seven, 55, and 28 patients were allocated to groups 1, 2, and 3, respectively. Compliance rates were high, and questionnaires were well-accepted. Survivors of treatment for GC reported better functional HRQL scores and lower symptom scores than patients in group 2 who were currently undergoing treatment. Patients selected for potentially curative treatment had better HRQL than group 1 (palliative treatments). Scales in the QLQ-C30 and QLQ-STO22 distinguished between other clinically distinct groups of patients. Cronbach's alpha coefficients of 14 scales of both questionnaires were >0.7. Multitrait scaling analysis demonstrated good convergent and discriminant validity. Test-retest scores were consistent. We conclude that the Mexican-Spanish versions of EORTC QLQ-C30 and QLQ-C22 questionnaires are reliable and valid for HRQL measurement in patients with GC and are therefore recommended for use in clinical trials of Mexican community.

Assessing adherence to the European Organization for Research and Treatment of Cancer (EORTC) guidelines for the use of erythropoiesis-stimulating agents in cancer patients

20696 Background: Anemia is a common symptom in cancer patients and has a considerable impact on patient quality of life (QoL). According to the European Cancer Anemia Survey, anemia was treated in only 38.9% of patients. Erythropoiesis-stimulating agents (ESAs) are widely used for the treatment of the chemotherapy-induced anemia (CIA). The European Organization for Research and Treatment of Cancer (EORTC) recently published guidelines for the use of ESAs in cancer patients, but actual adherence to these guidelines in clinical practice is unknown. Methods: Between March and July 2007, 16 working sessions were held and 179 Spanish oncologists were consulted to assess their adherence to the EORTC guidelines (update 2006)for the use of ESAs. In all sessions, a preliminary presentation about these guidelines was given, followed by a structured discussion that was facilitated by a moderator using an organized, brain storming work method (Metaplan). Results: Over 90% of oncologists agreed that the two major goals of ESA therapy are improvement of QoL and prevention of transfusions; 70% consider that CIA treatment with ESA should be initiated at a hemoglobin (Hb) level of 10–11g/dL. ESAs are administered every week (59%) or every three weeks (33%). In the opinion of 64% of respondents, the target Hb concentration should be 12–13 g/dL. Altogether 45% of oncologists use ESA in anemic patients with an Hb level of <11.9 g/dL to prevent a further decline in Hb. All participants agreed with the use of fixed doses of ESAs. Intravenous iron supplementation is low (5%). Conclusions: These study results show good adherence to the current EORTC guidelines in Spain, but action to increase adherence may improve patient outcomes. The main discrepancies are the use of intravenous iron and ESA in patients with Hb <11.9 g/dL. This study was supported by Amgen S.A. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Amgen Amgen

September 2007 Update on EORTC Guidelines and Anemia Management with Erythropoiesis-Stimulating Agents

Anemia is frequently experienced by cancer patients receiving chemotherapy and can negatively impact the patient's prognosis. Blood transfusions, iron supplementation (in absolute or functionally iron-deficient anemias), and erythropoiesis-stimulating agents (ESAs) are among the treatment options for anemia. Treatment options for anemia management should be selected based on the best benefit-to-risk ratio for each individual patient. In September 2007, the working party of the European Organization for Research and Treatment of Cancer (EORTC) updated their guidelines on the use of ESAs, which are summarized in this paper. ESAs reduce the number of transfusions required and significantly improve quality of life in patients with chemotherapy-induced anemia. A sustained hemoglobin level of about 12 g/dl should be the target for treatment with ESAs. ESAs should be used according to the EORTC guidelines and within label with carefully considered exceptions.

The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: The QLQ-CIPN20

Chemotherapy-induced peripheral neuropathy (CIPN) is a common phenomenon, often resulting in serious limitations in daily functioning and comprosised quality of life. Currently available toxicity grading systems typically use a combination of clinical and paraclinical parameters and relies on the judgment of clinicians and/or nurses. However, because many of the symptoms of CIPN are subjective in nature, it is only logical that an assessment of CIPN be based, at least in part, on patient self-report data. We report on the development of a patient self-report questionnaire, the CIPN20, intended to supplement the core quality of life questionnaire of the European Organization for Research and Treatment of Cancer (EORTC). Following EORTC guidelines, relevant CIPN-related issues were identified from a literature survey and interviews with health professionals ( n = 15) and patients ( n = 112). The resulting 20-item questionnaire was pre-tested in three languages and four countries and is currently being examined in a large, international clinical trial. The EORTC CIPN20 should provide valuable information on CIPN-related symptoms and functional limitations of patients exposed to potentially neurotoxic chemotherapeutic and/or neuroprotective agents.

Measurement of quality of life in carcinoid/neuroendocrine tumours.

Quality of life is multi-dimensional, including issues relating to symptoms from the disease but also social, emotional, functional and financial domains. Debate remains on the true definition of quality of life and its measurement. Quality of life measurements are best done by patients themselves, although, in some situations a proxy such as carer or relative can be substituted. Healthcare workers can over- or underestimate overall quality of life. Currently used devices for measuring quality of life in cancer include the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, which is a generic tool for all cancers and which requires the use of add-on modules for specific cancers. We are developing a separate module for carcinoid/neuroendocrine tumours, in accordance with the EORTC guidelines on module development, which will be translated into five languages and will be available for use throughout Europe.

The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38)

The objectives of the current study were to construct a colorectal cancer-specific quality of life (QL) questionnaire module to be used in conjunction with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and to test its reliability and validity in The Netherlands. Module construction took place following the EORTC guidelines for module development. The module—the QLQ-CR38—consists of 38 items covering symptoms and side-effects related to different treatment modalities, body image, sexuality and future perspective. This module was tested among 117 colorectal cancer patients on several occasions. The timing was prior to treatment with radiotherapy or chemotherapy, during treatment and 3 months following the second assessment. For purposes of test–retest reliability, a subsample of patients completed the QLQ-CR38 1 week following the third assessment. Multitrait scaling analysis confirmed the hypothesised scale structure of the function scales but not of the symptom scales. Cronbach’s alpha coefficients for seven of the nine scales exceeded the 0.70 criterion at one or both assessments. The test–retest reliability for all scales and one single item was 0.78 or higher. The stability of the two remaining single items was lower. On the basis of known-groups comparisons, selective scales distinguished clearly between patients differing in disease stage, initial and on-treatment performance status and the presence of a stoma. Additionally, selective scales detected change over time as a function of change in performance status and treatment-induced change. These results lend support to the clinical validity of the QLQ-CR38 as a supplementary questionnaire for assessing specific QL issues relevant to patients with colorectal cancer. Additional efforts to test the module’s cross-cultural validity are needed.

The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study.

To construct a breast cancer-specific quality-of-life questionnaire (QLQ) module to be used in conjunction with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and to test its reliability and validity cross-culturally. Module construction took place after the EORTC guidelines for module development. The module--the QLQ-BR23--consists of 23 items covering symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. This module was tested in 170 Dutch, 168 Spanish, and 158 American cancer patients at two points in time. The timing for the Dutch and Spanish patients was before and during treatment with radiotherapy or chemotherapy. For the American patients, the questionnaire was administered at admission at the breast clinic and 3 months after the first assessment. Multitrait scaling analysis confirmed the hypothesized structure of four of the five scales. Cronbach's alpha coefficients were, in general, lowest in Spain (range; .46 to .94) and highest in the United States (range; .70 to .91). On the basis of known-groups comparisons, selective scales distinguished clearly between patients differing in disease stage, previous surgery, performance status, and treatment modality, according to expectation. Additionally, selective scales detected change over time as a function of changes in performance status and treatment-induced change. These results lend support to the clinical and cross-cultural validity of the QLQ-BR23 as a supplementary questionnaire for assessing specific quality-of-life issues relevant to patients with breast cancer.