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

Osoba, David; Bezjak, Andrea; Brundage, Michael; Zee, Benny; Tu, Dongsheng; Pater, Joseph L.

doi:10.1016/j.ejca.2004.10.017

Cited by 258 publications

(209 citation statements)

References 28 publications

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“…A change in score of 10 points from baseline was defined as clinically significant on the basis of previous studies 15, 16 and published NCIC CTG guidelines.…”

Section: Discussionmentioning

confidence: 99%

Quality-of-Life Outcomes for Adjuvant Chemotherapy in Early-Stage Non–Small-Cell Lung Cancer: Results From a Randomized Trial, JBR.10

Bezjak

Lee

Ding

et al. 2008

JCO

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A B S T R A C T PurposeAdjuvant chemotherapy for early stage non-small-cell lung cancer (NSCLC) is now the standard of care, but there is little information regarding its impact on quality of life (QOL). We report the QOL results of JBR.10, a North American, intergroup, randomized trial of adjuvant cisplatin and vinorelbine compared with observation in patients who have completely resected, stages IB to II NSCLC. Patients and MethodsQOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and a trial-specific checklist at baseline and at weeks 5 and 9 for those who received chemotherapy and at follow-up months 3, 6, 9, 12, 18, 24, 30 and 36. A 10-point change in QOL scores from baseline was considered clinically significant. ResultsFour hundred eighty-two patients were randomly assigned on JBR.10. A total of 173 patients (82% of the expected) in the observation arm and 186 (85% of expected) in the chemotherapy arm completed baseline QOL assessments. The two groups were comparable, with low global QOL scores and significant symptom burden, especially pain and fatigue, after thoracotomy. Changes in QOL during chemotherapy were relatively modest; fatigue, nausea, and vomiting worsened, but there was a reduction in pain and no change in global QOL. Patients in the observation arm showed considerable improvements in QOL by 3 months. QOL, except for symptoms of sensory neuropathy and hearing loss, in those treated with chemotherapy returned to baseline by 9 months. ConclusionThe findings of this trial indicate that the negative effects of adjuvant chemotherapy on QOL appear to be temporary, and that improvements (with a return to baseline function) are likely in most patients.

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“…A change in score of 10 points from baseline was defined as clinically significant on the basis of previous studies 15, 16 and published NCIC CTG guidelines.…”

Section: Discussionmentioning

confidence: 99%

Quality-of-Life Outcomes for Adjuvant Chemotherapy in Early-Stage Non–Small-Cell Lung Cancer: Results From a Randomized Trial, JBR.10

Bezjak

Lee

Ding

et al. 2008

JCO

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“…The NCIC CTG recommends a 10% change as the value for clinical significance [25]. In the primary analysis of QoL in the NEJ 002 trial, deterioration was recognized when the score changed from baseline by one in 11 points (9.1%) or more in a direction indicating worse QoL at any timepoint.…”

Section: Time To Deterioration In Qolmentioning

confidence: 99%

“…In addition, we performed a secondary analysis using QoL data according to the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) standard method [25]. During the initial 20 weeks from the start of treatment, we first checked whether or not the scores showed an improvement at any time in a subscale by Ն9.1% (one point or more) from baseline.…”

Section: Statistical Analysesmentioning

confidence: 99%

Quality of Life with Gefitinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer: Quality of Life Analysis of North East Japan Study Group 002 Trial

et al. 2012

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Background. For non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations, first-line gefitinib produced a longer progressionfree survival interval than first-line carboplatin plus paclitaxel but did not show any survival advantage in the North East Japan 002 study. This report describes the quality of life (QoL) analysis of that study.Methods. Chemotherapy-naïve patients with sensitive EGFR-mutated, advanced NSCLC were randomized to receive gefitinib or chemotherapy (carboplatin and paclitaxel). Patient QoL was assessed weekly using the Care Notebook, and the primary endpoint of the QoL analysis

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“…Patients' responses were also classified as improved, stable or worse for all HRQOL items at week 9 according to the NCIC CTG standard QOL analysis framework [24]. Symptom or function items were considered worse if the change from baseline was 10 points towards worse without improvement at any time-point after baseline.…”

Section: Statistical Considerationsmentioning

confidence: 99%

Chemotherapy and quality of life in NSCLC PS 2 patients

et al. 2009

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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

Cited by 258 publications

References 28 publications

Quality-of-Life Outcomes for Adjuvant Chemotherapy in Early-Stage Non–Small-Cell Lung Cancer: Results From a Randomized Trial, JBR.10

Quality-of-Life Outcomes for Adjuvant Chemotherapy in Early-Stage Non–Small-Cell Lung Cancer: Results From a Randomized Trial, JBR.10

Quality of Life with Gefitinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer: Quality of Life Analysis of North East Japan Study Group 002 Trial

Chemotherapy and quality of life in NSCLC PS 2 patients

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