Although lidocaine 5% patches decreased the pain's intensity in nearly half of the enrolled patients with an excellent tolerance, the efficacy endpoint was not reached. Further studies should consider a more refined selection of the experimental population to assess the efficacy of lidocaine 5% patches in the pediatric population.

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Background. Better knowledge on caregivers is required to address their needs with dedicated support. The results from the ICE study explored the health-related quality of life (HRQoL) in caregivers of elderly with chronic disabilities, after social intervention or not.Methods. Caregivers of patients (≥60 years) with cancer, neurodegenerative disease, stroke, or age-related macular degeneration were randomized 1:1 in the supportive intervention group (support from social workers and information booklet) or in the control group (information booklet only), and completed questionnaires (short form-36 questionnaire (SF-36), Hospital Anxiety Depression Scale (HADS), and Zarit Burden Interview (ZBI) quarterly (6-monthly for ZBI) during two years. Caregiver characteristics, and caregiver HRQoL assessment through SF-36, HADS, ZBI scores at baseline, at 12 months (M12) and 24 months (M24) on an individual and an aggregate level, were described using paired-t test comparisons, and minimal important difference. Longitudinal assessments of caregiver HRQoL over the two first years were reported.Results. From 2015 to 2019, 179 caregivers supported patients with cancer (n=92, 52%), Alzheimer (n=46, 26%), Parkinson (n=20, 11%) were randomized. No evidence differences in SF-36 PCS and MCS summary scores mean change over time, neither in HADS anxiety and burden ZBI scores were shown. However, HADS depression mean changes showed a clinically significant increase of 1.4 (4.0) at M12, and 1.7 (4.1) at M24 in control group. Conclusion. Appropriate support need to be proposed to improve the global caregiver HRQoL, and reduce depression at 1 and 2 years.Trial registration number: This study was registered retrospectively with ClinicalTrials.gov NCT02626377 on 9th December 2015.

10549 Background: Patients (pts) experiencing a major response under IM treatment seem to have a better outcome than others (Cioffi, ASCO 08). IM interruption in responding patients after 1 and 3 yrs of treatment results in a high risk of rapid progression after a few months. The influence of pattern of response on PFS before IM discontinuation is unknown. Methods: Since June 2002, 415 pts were included in this trial. Fifty-eight, 50 and 12 (ongoing) non progressive pts at 1, 3 and 5 yrs respectively were randomly offered to continue (C arm) or interrupt (I arm) IM. Sixty-four pts were randomized in the I arm, 32, 25 and 7 after 1, 3 and 5 yrs of IM treatment respectively. Time to progression (TTP) of pts achieving a CR or a major PR (residual tumor < 10mm) before IM interruption was compared to outcome of pts experiencing others patterns of response. Results: Twenty-three pts achieving a CR or a major PR (36%) before randomization in the I arm, 9 after 1 yr, 10 after 3 yrs and 4 after 5 yrs of IM treatment. As of December 2008, 15 relapses were observed in the CR group (65%) versus 36 in the other cohort of pts (90%). The median TTP were 10.5 months (IC95%: 9–16 months) for the CR group and 6.1 months (IC95%: 4–9.2 months) for the non CR group (p=0.058). The median TTP were 9.4 months for the CR group vs 6 months for pts randomized after 1 yr of treatment, 12.3 months versus 5.7 months for pts randomized after 3 yrs of treatment respectively. One third of pts achieving a CR before randomization in the I arm was free of disease in December 2008. Conclusions: A CR achieved under IM is not a prerequisite for a prolonged disease-free survival in advanced GIST after 1 or 3 yrs of treatment. Despite a trend for a favourable outcome, prognosis of pts with a CR or a major PR is similar to those achieving a PR or a disease stabilisation. A selected group of advanced GIST pts in CR could be cured with IM alone. New radiological assessments or response critera have to be implemented in order to define a real CR. [Table: see text]