Résultats du premier essai randomisé de phase III évaluant la survie de patients atteints de cancer du poumon via un suivi médié par une web-application comparé au suivi standard

Bulletin de l'Académie Nationale de Médecine(2016)

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Abstract
Background: Symptoms monitoring of cancer patients may improve survival. We developed a web-application for an early detection of symptomatic relapses or complications between screening visits, allowing early supportive care in high-risk lung cancer patients. An algorithmic surveillance of the weekly self-reported symptoms automatically triggered visits to the oncologist. Methods: We performed a multi-institutional phase III randomized study to compare survival between i) a web-application follow-up (experimental arm) for which patient's self-scored symptoms were weekly sent (between planned visits) to the oncologist and ii) a clinical routine assessment with a CT-scan (every 3-6 months or at investigator's discretion - standard arm). High-risk lung cancer patients without progression after an initial treatment were included. Internet access was required. Maintenance chemotherapy or TKI therapy were allowed. In the experimental arm, an email alert was sent to the oncologist when some predefined clinical criteria were fulfilled: an imaging check was then quickly prescribed. Early supportive cares were provided if adequate. Secondary outcomes were quality of life (QOL), performance status at relapse and cost-effectiveness assessed by Incremental Cost-Effectiveness Ratio of Life-Year (ICER-LY) and Quality-Adjusted Life Year (ICER QALY). Results: 133 patients were randomized and 121 patients were included in the intent-to-treat analysis (96 % stage IIIIIV): 60 in the experimental arm and 61 in standard arm. Median follow-up was 9 months. Median overall survival was 19 months vs 12 in favor of experimental arm (p=0.0014 - hazard ratio, 0.325 95 % CI 0.157 to 0.672 ; p=0.0025) and the performance status at the first relapse was 0-1 for 82 % of the patients in the experimental and 35 % in standard arm (p < .001). One-year survival was 75 % versus 49 % in experimental and standard arms respectively (p=0.0025). QOL was improved in experimental arm ( FACT-L, FACT-L TOI, FACT-G, p=0.02, p=0.01, p=0.04 respectively) and the annual cost of the follow-up was reduced by 37 %. Conclusions: This trial shows a significant survival and QOL improvement using symptom self-reporting follow-up by this web-application that allowed better performance status at relapse, earlier supportive care and limited cost.
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Key words
Tumeurs du poumon,Surveillance sentinelle,Survie,Qualité de vie,Coûts et analyse des coûts
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