Background.
The Trastuzumab for Gastric Cancer phase III trial demonstrated that combining trastuzumab with chemotherapy significantly improved overall survival compared with chemotherapy alone in HER2‐positive advanced gastric or gastroesophageal junction cancer. We report health‐related quality of life (HRQoL) and quality‐adjusted time without symptoms of disease or toxicity (Q‐TWiST) results from this trial.
Patients and Methods.
Patients were randomized to receive six cycles of chemotherapy given every 3 weeks (capecitabine or fluorouracil, plus cisplatin) either alone or combined with administration of trastuzumab every 3 weeks until disease progression. At each clinical visit, HRQoL was assessed using two European Organization for Research and Treatment of Cancer quality of life questionnaires, QLQ‐C30 and QLQ‐STO22. Q‐TWiST methodology was applied retrospectively using the clinical data and utility coefficients.
Results.
Trastuzumab plus chemotherapy prolonged time to 10% definitive deterioration in all QLQ‐C30 and QLQ‐STO22 scores, including QLQ‐C30 global health status versus chemotherapy alone, from 6.4 months to 10.2 months. In addition, trastuzumab plus chemotherapy extended Q‐TWiST by 2.42 months compared with chemotherapy alone.
Conclusion.
Compared with chemotherapy alone, trastuzumab plus chemotherapy prolongs time to deterioration of HRQoL and increases quality‐adjusted survival in patients with HER2‐positive gastric or gastroesophageal junction cancer.
OBJECTIVES:The Washington Panel on Cost Effectiveness argued that '. . .the best articulation of society's preferences for a particular state would be gathered from a representative sample of fully informed members of the community'. In the UK, NICE currently recommends generic preference-based health-related quality of life questionnaires, namely, the EQ-5D, for use in cost effectiveness analysis. The EQ-5D UK value set was obtained from an uninformed general public sample. Our aim is to investigate what effect information had on valuations of health states. We compared public valuations of health states, which were a) uninformed b) informed with labeling c) informed about the condition d) informed about adaptation to the condition. METHODS: Generic preference-based questionnaires (EQ-5D and SF-6D), the visual analogue scale (VAS) and the time trade-off (TTO) valuation techniques were administered to a sample of patients with age-related macular degeneration (Nϭ60). A general public pilot sample (Nϭ40) were randomised to groups with different types of information about the condition before being presented with patient EQ-5D health states and being asked to value the health states using the TTO. RESULTS: Comparisons were made between public valuations of health states with different types of information about the condition using multiple regression. Public valuations differed across information conditions (pϽ0.05). Groups provided with labeling or disease information value health states more severely while groups provided with information on adaptation valued health states less severely compared to no information. However these effects did not reach statistical significance. CONCLUSIONS: This is the first study to compare the impact of condition-specific information, labeling and adaptation information on health state valuations within the same population. Early results suggest that framing of information leads the public to different valuations, although a larger study is required to confirm this.
498 Background: A systematic review was conducted to identify RCTs of adjuvant chemotherapy regimens for early-stage colon cancer and a network meta-analysis performed to compare efficacy of oxaliplatin/fluoropyrimidine regimens. Methods: A systematic review identified RCTs recruiting adult patients with early-stage (adjuvant) stage II/III colon cancer. Outcome measures included hazard ratios for DFS and OS. Only publications in English were considered. Study quality was assessed using the Cochrane Collaboration “risk of bias” assessment tool. A single reviewer screened abstracts/titles using predefined selection criteria, with critical appraisal and data extraction conducted independently by two reviewers. A Bayesian network meta-analysis was used to estimate comparative efficacy of adjuvant chemotherapy across RCTs. Results: 56 articles describing 40 trials were selected, of which six reported data on regimens accepted as current standard of care (capecitabine/X-ACT, XELOX/NO16968, FOLFOX/MOSAIC, FLOX/C-07) or common comparators: bolus 5FU/LV and LV5FU2 (C-96-1, PETACC-2). Statistical assessment of heterogeneity was not possible due to the limited study network. Baseline characteristics were similar across trials with the exception of three trials recruiting only stage III patients; sub-group analysis on these trials was not possible due to lack of common comparators. There was no significant difference in DFS at a median follow-up of 3-years (or closest reported analysis) for XELOX vs. FLOX (HR=0.99, 95% CI 0.80–1.22) or FOLFOX (HR=1.00, 95% CI 0.72–1.41). There was also no significant difference in OS at a median follow-up of at least 5 years. Taken as a class, oxaliplatin-containing regimens (XELOX, FOLFOX, FLOX) improved DFS vs. non-oxaliplatin-containing regimens (HR=0.80, 95% CI 0.73–0.87). This result was confirmed for OS. Conclusions: Despite the limited number of available trials, the results of these analyses demonstrate a clear benefit of incorporating oxaliplatin into combination regimens for early-stage colon cancer. XELOX, FOLFOX and FLOX appear to be equivalent in terms of efficacy in this setting. [Table: see text]
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