Corrigendum to: Impact of lymphopenia on survival for elderly patients with glioblastoma: A secondary analysis of the CCTG CE.6 (EORTC 26062-22061, TROG 08.02) randomized clinical trial.

[This corrects the article DOI: 10.1093/noajnl/vdab153.].

Impact of lymphopenia on survival for elderly patients with glioblastoma: A secondary analysis of the CCTG CE.6 (EORTC 26062-22061, TROG03.01) randomized clinical trial.

Background: Lymphopenia may lead to worse outcomes for glioblastoma patients. This study is a secondary analysis of the CCTG CE.6 trial evaluating the impact of chemotherapy and radiation on lymphopenia, and effects of lymphopenia on overall survival (OS).

Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma.

Background: Glioblastoma is associated with a poor prognosis in the elderly. Survival has been shown to increase among patients 70 years of age or younger when temozolomide chemotherapy is added to standard radiotherapy (60 Gy over a period of 6 weeks). In elderly patients, more convenient shorter courses of radiotherapy are commonly used, but the benefit of adding temozolomide to a shorter course of radiotherapy is unknown.

Examining the relationships among health-related quality-of-life indicators in cancer patients participating in clinical trials: a pooled study of baseline EORTC QLQ-C30 data.

Aims: Cancer patients experience multiple and concurrent health-related problems and symptoms due to their illness and therapies. The first objective of this analysis was to identify how health-related quality-of-life (HRQoL) indicators cluster among cancer patients and how possible clusters change across patients with different sociodemographic and clinical characteristics. The second objective of this study was to identify which HRQoL indicators are linked to patients' perception of overall quality of life.

Health-related quality of life and cancer clinical trials.

The measurement of patient-reported outcomes, including health-related quality of life, is a new initiative which has emerged and grown over the past four decades. Following the development of reliable and valid self-report questionnaires, health-related quality of life has been assessed in tens of thousands of patients and a wide variety of cancers. This review is based on a selection of data published in the last decade and is intended primarily for healthcare professionals.

Meta-analysis provides evidence-based interpretation guidelines for the clinical significance of mean differences for the FACT-G, a cancer-specific quality of life questionnaire.

Our aim was to develop evidence-based interpretation guidelines for the Functional Assessment of Cancer Therapy-General (FACT-G), a cancer-specific health-related quality of life (HRQOL) instrument, from a range of clinically relevant anchors, incorporating expert judgment about clinical significance. Three clinicians with many years' experience managing cancer patients and using HRQOL outcomes in clinical research reviewed 71 papers. Blinded to the FACT-G results, they considered the clinical anchors associated with each FACT-G mean difference, predicted which dimensions of HRQOL would be affected, and whether the effects would be trivial, small, moderate, or large.

An international validation study of the EORTC brain cancer module (EORTC QLQ-BN20) for assessing health-related quality of life and symptoms in brain cancer patients.

Aims: The psychometric properties of the EORTC QLQ-BN20, a brain cancer-specific HRQOL questionnaire, have been previously determined in an English-speaking sample of patients. This study examined the validity and reliability of the questionnaire in a multi-national, multi-lingual study.

Methods: QLQ-BN20 data were selected from two completed phase III EORTC/NCIC clinical trials in brain cancer (N=891), including 12 languages.

Meta-analysis provides evidence-based effect sizes for a cancer-specific quality-of-life questionnaire, the FACT-G.

Objective: To compare Cohen's guidelines for small (0.2), medium (0.5), and large (0.

Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials.

Background: Although individual studies show that baseline health-related quality of life (HRQOL) is a prognostic factor for survival, contradictory results have been published and very few meta-analyses have confirmed the finding. We examined whether HRQOL scores are associated with survival when pooled across a large sample of patients with different disease sites.

Methods: We selected 30 randomised controlled trials from the European Organisation for Research and Treatment of Cancer (EORTC) started between 1986 and 2004, which included survival data for 10 108 patients with 11 different cancer sites.

Evaluating health-related quality of life in cancer clinical trials: the National Cancer Institute of Canada Clinical Trials Group experience.

Introduction: The National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) Quality of Life (QOL) Committee was initiated in 1986.

Purpose: The purpose of this review is to describe the evolution of the Committee's work and to highlight key developments such as the formulation of a policy regarding health-related quality-of-life (HRQOL) assessment, the provision of guidelines to ensure completion of HRQOL data within the protocol requirements, the rationale behind the choice of HRQOL instruments, the timing of assessments and the development of data analytic methods. These developments are illustrated with examples from CTG studies.

Lessons learned in the assessment of health-related quality of life: selected examples from the National Cancer Institute of Canada Clinical Trials Group.

In this article, we provide a brief historical review of the development of patient-reported outcome measurement, analysis, and reporting in clinical trials of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). In doing so, we examine selected lessons learned in furthering the quality of these data and their application to clinical practice. We conclude that sequential institution of key policies within the NCIC CTG and the development of a collective philosophy within the group has enabled the routine incorporation of health-related quality of life into clinical trial protocols according to robust scientific principles; that collection of quality data is possible in a variety of circumstances (although not universally so); that patient-reported data on subjective experiences is likely to be more reliable and valid than conventional toxicity information; and that simple analyses that report group trends as well as individual patient response rates are preferred.

Translating the science of patient-reported outcomes assessment into clinical practice.

Patient-reported outcomes (PROs) are based on direct reporting by patients without the intervention of an observer. They include the self-assessment of functional status, symptoms, and other concerns such as needs and satisfaction with care. Health-related quality of life (HRQOL) assessment is a form of PRO and often includes both functional status and symptoms.

Are chemotherapy patients' HRQoL importance weights consistent with linear scoring rules? A stated-choice approach.

Objective: To compare a linear scoring rule with the subjective importance of different domain and symptom levels of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) among patients undergoing chemotherapy.

Methods: Using a stated-choice or choice-format conjoint analysis survey instrument, we elicited patient preferences for varying levels of physical, role, social, emotional, and cognitive function along with chemotherapy-related side effects and financial difficulties. A total of 375 patients completed the questionnaire: 159 breast cancer, 117 colorectal cancer, 99 non-small-cell lung cancer; and 21 with unknown tumor type.

Stated preferences of patients with cancer for health-related quality-of-life (HRQOL) domains during treatment.

Objectives: It is postulated that patients with different cancer diagnoses, stages of disease and treatments will exhibit different individual preferences for health-related quality-of-life (HRQOL) functional domains and symptoms.

Methods: A stated-preference (SP) instrument incorporating all functional domains and symptoms of the EORTC Quality of Life Questionnaire (QLQ-C30) was administered to 400 patients with either breast (n = 150); colorectal (n = 150) or non-small cell lung cancer (n = 100) who had previously experienced chemotherapy. The SP survey asked patients to make choices between a series of hypothetical functional/symptom pairs defined by combinations of HRQOL attributes, and depicted by levels of functioning and symptomatology.

Health-related quality of life in patients with glioblastoma: a randomised controlled trial.

Background: A randomised controlled trial of radiotherapy alone versus radiotherapy with concomitant and adjuvant temozolomide for patients with glioblastoma showed that survival was higher for patients assigned combination treatment compared with those assigned standard radiotherapy alone. This paper reports the health-related quality of life (HRQOL) of the patients in this trial.

Methods: 573 patients with newly diagnosed glioblastoma were randomly allocated either radiotherapy alone or radiotherapy and temozolomide.

Use of liposomal anthracyclines in Kaposi's sarcoma.

Conventional chemotherapy regimens for the treatment of advanced Kaposi's sarcoma (KS) show limited efficacy and considerable toxicity. Liposomal anthracyclines with potential utility in KS include pegylated liposomal doxorubicin (Doxil/Caelyx [PLD]), daunorubicin citrate liposome (DaunoXome [DNX]), and nonpegylated liposomal doxorubicin (Myocet [NPLD]). Preclinical data showed that pegylated liposomes accumulate preferentially in highly vascularized KS lesions.

Emesis induced by low or minimal emetic risk chemotherapy.

For patients treated with low or minimally emetogenic chemotherapy there is little evidence from clinical trials supporting the choice of a given antiemetic therapy or of any treatment at all. The panel recognized the necessity of considering the introduction into clinical practice of new agents in these categories, particularly oral cytotoxic agents and targeted biological agents and also the possibility of over-treatment with antiemetics. There was consensus among panel members regarding the recommended treatment for patients receiving chemotherapy agents with low and minimal emetic risk.

Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group.

Clinicians are being confronted with increasing amounts of health-related quality of life (HRQOL) data. Thus, there is a need for a greater understanding of the analysis and interpretation of HRQOL so that the data can be reported in an appropriate manner. The approach of the Clinical Trials Group of the National Cancer Institute of Canada emphasises the clinical meaning of the results, while avoiding complex statistical modelling.

Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--an update.

Development of effective antiemetic therapy depends upon an understanding of both the antiemetic agents and the emetogenic challenges these agents are designed to address. New potential antiemetic agents should be studied in an orderly manner, proceeding from phase I to phase II open-label trials and then to randomized double-blind phase III trials comparing new agents and regimens to best standard therapy. Use of placebos in place of antiemetic therapy against highly or moderately emetogenic chemotherapy is unacceptable.

Quality of life in ovarian cancer patients: comparison of paclitaxel plus cisplatin, with cyclophosphamide plus cisplatin in a randomized study.

Purpose: Formal quality-of-life (QOL) assessments may contribute important information on patient symptoms. Despite many trials of systemic chemotherapy in ovarian cancer, reports of its effect on QOL are few.

Patients And Methods: QOL was assessed in an Intergroup randomized trial comparing paclitaxel plus cisplatin to cyclophosphamide plus cisplatin in women with advanced ovarian cancer.