FRESC: French Real world Extensive stage SCLC Cohorts: A retrospective study on patient characteristics and treatment strategy based on KBP-2010.

OBJECTIVES: FRESC reanalyzed extensive-stage small-cell lung cancer (ES-SCLC) patient data from the French KBP-2010 cohort to describe the characteristics and therapeutic management of ES-SCLC and provide real-world estimates of survival. METHODS: A target population of first line (1L) ES-SCLC was identified at initial diagnosis in KBP-2010 (KBP population, N = 796). A KBP-2010 subpopulation was defined as patients who also met the IMpower133 clinicaltrial PS ≤ 1 inclusion criteria (KBP-PS_0/1 population, N = 394). Subgroups were defined according to the 1L ES-SCLC chemotherapy regimens: carboplatin or cisplatin with etoposide (Carb-E or Cisp-E subgroups). RESULTS: The vast majority of KBP populations exhibited stage IV ES-SCLC (84.9%) at initial diagnosis. Median age was 66 years; patients were mostly male and smokers. Patients receiving Cisp + Eto were younger (median age 61 years [55.0-67.0]) and fitter (25.5% had PS ≥ 2) than those receiving Carb + Eto (71 years [62.5-77.5]; 44.1%had PS ≥ 2). Median overall survival (OS) of chemotherapy-treated 1L ES-SCLC patients varied from 7.0 months [95% CI, 6.1; 7.8] in the KBPCarb-Esubgroups to 9.6 months [95% CI, 8.4;10.8] in the KBP Cisp-E subgroup. KBP-PS_0/1 population showed better median OS, especially for the Cisp-E subgroup (10 months [95% CI, 8.7; 11.3]). CONCLUSION: In the KBP-PS_0/1 population, median OS was close to the one that was found in the IMpower133 control arm. Although this needs to be confirmed by further research, it suggests the transposability of the IMpower133 results to real-life conditions.

Application of clinical trial inclusion criteria to clinical practice patients to quantify the burden of CNS metastases on health-related quality of life and healthcare resource use in patients with NSCLC.

OBJECTIVES: Quantify the burden of central nervous system (CNS) metastases on health-related quality of life (HRQoL) and healthcare resource use (HRU) in patients with advanced non-small-cell lung cancer (NSCLC) from a prospective European study in clinical practice, utilising clinical trial inclusion criteria. MATERIALS AND METHODS: Patients ≥18 years, with metastatic NSCLC, Eastern Oncology C0operative Group (ECOG) performance status 0-2 and life expectancy ≥12 weeks were enrolled in two cohorts by baseline CNS metastases status. Demographics, clinical characteristics, NSCLC management data, HRQoL and HRU were collected at baseline and two follow-up visits (Visits 2 and 3, 6 weeks apart). HRQoL was assessed using validated questionnaires. RESULTS: 162 patients were enrolled (n = 80 CNS cohort, n = 82 non-CNS cohort). Baseline characteristics were balanced, but CNS patients were younger (mean ±â€¯standard deviation age: 62.1 ±â€¯9.6 vs 65.6 ±â€¯9.7 years, p =  0.021) with a lower body mass index (13.8 % underweight [<18.5kg/m2] vs 3.7 %, p =  0.049). Mean HRQoL scores were similar between cohorts at all visits. Cancer pharmacotherapy, procedures and concomitant treatment were comparable across cohorts, with some exceptions. More CNS patients were hospitalised at baseline (10.3 % vs 2.2 %) for longer (mean 7.2 vs 4.6 days; p <  0.001). By Visit 2, more CNS patients were hospitalised (50.0 % vs 29.3 %; p = 0.009) with emergency room visits (11.8 % vs 2.7 %; p =  0.032). At baseline, more CNS versus non-CNS patients had Magnetic Resonance Imaging (MRI) scans (80.0 % vs 31.7 %; p <  0.001), but fewer had fluorodeoxyglucose (FDG)-positron emission tomography (PET)-computed tomography (CT) scans (10.0 % vs 28.0 %; p = 0.004). CONCLUSION: These data from clinical practice show minor differences in HRQoL/HRU between patients with advanced NSCLC with/without CNS metastases when applying selected clinical trial criteria. Although follow-up was short, HRQoL scores were similar between cohorts at all visits, supporting the wider inclusion of selected patients with CNS disease into clinical trials.

Tocilizumab Effectiveness After Switching from Intravenous to Subcutaneous Route in Patients with Rheumatoid Arthritis: The RoSwitch Study.

INTRODUCTION: The main objective of this work was to assess the maintenance of effectiveness of subcutaneous tocilizumab 6 months after switching from intravenous to subcutaneous formulation in patients with rheumatoid arthritis (RA) in a real-world setting. Secondary objectives aimed to describe the characteristics of patients and disease, the effectiveness at 12 months after switching, the therapeutic maintenance, and to search for predictive factors of switching. METHODS: We analyzed all the RA patients of the shared medical file "RIC Nord de France", treated with tocilizumab, switching or not from intravenous to subcutaneous tocilizumab, between April 2015 and January 2016. The primary effectiveness endpoint was the proportion of patients remaining in their DAS28-ESR category remission/low disease activity (LDA) or moving to an inferior DAS28-ESR category at 6 months. Since RoSwitch was an observational study, without randomization, a propensity score was built in a sensitivity analysis to balance on RA and patients' characteristics at inclusion between switching and no-switching groups. RESULTS: An improvement of initial DAS28-ESR category or maintenance in DAS28-ESR remission/LDA at 6 months was shown in 203 of the 285 patients with an evaluation for the primary criterion (71.2%, 95% CI [65.6-76.4%]) without differences between groups (73.3%, 95% CI [63.0-82.1%] vs. 70.3%, 95% CI [63.3-76.6%]). The RoSwitch study showed the maintenance of effectiveness at 6 and 12 months. Similar therapeutic maintenance rates were observed for switch and no-switch patients. No clinical factor was associated with the switch in patients in remission/LDA at inclusion. CONCLUSIONS: The RoSwitch study showed the maintenance of effectiveness at 6 months in RA patients switching from intravenous (IV) to subcutaneous (SC) tocilizumab. FUNDING: Roche SAS and Chugai Pharma France.