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Aim: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assesses the health-related quality of life of patients in cancer trials. There are currently no minimally important difference (MID) guidelines for the EORTC QLQ-C30 for colorectal cancer (CRC). This study aims to estimate MIDs for the EORTC QLQ-C30 scales in patients with advanced CRC treated with chemotherapy and enrolled in clinical trials. Method: The data were obtained from three published EORTC trials that treated CRC patients using chemotherapy. Potential anchors were selected from clinical variables based on their correlation with EORTC QLQ-C30 scales. Anchor-based MIDs for within-group change and between-group change were estimated via the mean change method and linear regression, respectively, and summarized using weighted correlation. Distribution-based MIDs were also examined. Results: Anchor-based MIDs were determined for deterioration in 8 of the 14 EORTC QLQ-C30 scales and in 9 scales for improvement, and varied by scale, direction of change and anchor. MIDs for improvement (deterioration) ranged from 6 to 18 (−11 to −5) points for within-group change and 5 to 15 (−10 to −4) for between-group change. Summarized MIDs (in absolute values) per scale mostly ranged from 5 to 10 points. Conclusions: These findings have clinical relevance for the interpretation of treatment efficacy and the design of clinical trials by informing sample size requirements.

BACKGROUND: The aim was to carry out phase 4 international field-testing of the European Organisation for Research and Treatment of Cancer (EORTC) breast reconstruction (BRECON) module. The primary objective was finalization of its scale structure. Secondary objectives were evaluation of its reliability, validity, responsiveness, acceptability and interpretability in patients with breast cancer undergoing mastectomy and reconstruction. METHODS: The EORTC module development guidelines were followed. Patients were recruited from 28 centres in seven countries. A prospective cohort completed the QLQ-BRECON15 before mastectomy and the QLQ-BRECON24 at 4-8 months after reconstruction. The cross-sectional cohort completed the QLQ-BRECON24 at 1-5 years after reconstruction, and repeated this 2-8 weeks later (test-retest reliability). All participants completed debriefing questionnaires. RESULTS: A total of 438 patients were recruited, 234 in the prospective cohort and 204 in the cross-sectional cohort. A total of 414 reconstructions were immediate, with a comparable number of implants (176) and donor-site flaps (166). Control groups comprised patients who underwent two-stage implant procedures (72, 75 per cent) or delayed reconstruction (24, 25 per cent). Psychometric scale validity was supported by moderate to high item-own scale and item-total correlations (over 0·5). Questionnaire validity was confirmed by good scale-to-sample targeting, and computable scale scores exceeding 50 per cent, except nipple cosmesis (over 40 per cent). In known-group comparisons, QLQ-BRECON24 scales and items differentiated between patient groups defined by clinical criteria, such as type and timing of reconstruction, postmastectomy radiotherapy and surgical complications, with moderate effect sizes. Prospectively, sexuality and surgical side-effects scales showed significant responsiveness over time (P < 0·001). Scale reliability was supported by high Cronbach's α coefficients (over 0·7) an

Background: Health related quality of life (HRQOL) was a secondary endpoint in AGO-OVAR 16, which randomized 940 patients with EOC after first-line chemotherapy to maintenance pazopanib (PZ) or placebo (P). Additional post hoc analyses were carried out to investigate additional patient centered endpoints. Patients and Methods: HRQOL was measured with EORTC-QLQ-C30, QLQ-OV28 and EQ-5D-3L. Pre-specified endpoints included mean differences in HRQOL between treatment arms. Exploratory analyses included quality-adjusted progression-free survival (QAPFS), impact of specific symptoms and progressive disease (PD) on HRQOL and time to second-line chemotherapy. The objective was to provide clinical perspective to the significant median PFS gain of 5.6 months with PZ. Results: There were statistically significant differences between PZ and P in QLQ-C30 global health status (GHC) (5.5 points; 95%CI, 0.7 to 10.4, P=0.024) from baseline to 25 months, but not EQ-5D-3L (0.018 points; 95%CI, -0.033 to 0.069, P=0.485). The impact of diarrhea was captured in QLQ-OV28 Abdominal/GI-Symptoms scale (8.1 points; 95% CI, 3.6 to 12.5, P = 0.001). QAPFS was 386 days (95%CI, 366 to 404 days) with PZ vs 359 days (95%CI, 338 to 379 days) with placebo (P=0.052). PD was associated with a decline in HRQOL (P<0.0001). Median time to second-line chemotherapy was 19.7 months with PZ and 15.0 months with P (HR 0.72, 95%CI 0.69 to 0.86, P=0.0001). Conclusions: There were small to no significant mean score differences in global HRQOL and EQ5D-3L between PZ and placebo respectively despite the increased toxicity of PZ. Exploratory endpoints including QAPFS, impact of specific symptoms on HRQOL during treatment and at PD help place the PFS gain with PZ in context and interpret the results. Additional patient centered endpoints should be considered in trials of maintenance therapy in EOC beyond mean differences in HRQOL scores alone, to support the benefit to patients of prolongation of PFS.