Purpose: Muscle wasting deteriorates life quality after critical illness and increases mortality. Wasting starts upon admission to intensive care unit (ICU). We aimed to determine whether bÀhydroxy-bÀmethylbutyrate (HMB), a metabolite of leucine, can attenuate this process.Methods: Prospective randomized, placebo-controlled double blind trial. Inclusion criteria: ICU patients depending on mechanical ventilation on day 3 having a functional gastrointestinal tract. They were randomized to HMB (3 g/day) or placebo (maltodextrin) from day 4 on for 30 days. Primary outcome: magnitude of loss of skeletal muscle area (SMA) of the quadriceps femoris measured by ultrasound at days 4 and 15. Secondary outcomes: body composition, change in protein metabolism assessed by amino acids tracer pulse, and global health at 60 days. Data are mean [95% CI]. Statistics by ANCOVA with correction for confounders sex, age and/or BMI. Results: Thirty patients completed the trial, aged 65 [59, 71] years, SAPS2 score 48 [43, 52] and SOFA 8.5 [7.4, 9.7]. The loss of total SMA was 11% between days 4 and 15 (p < 0.001), but not different between the groups (p ¼ 0.86). In the HMB group, net protein breakdown (D Estimate HMB-Placebo: À153 [-242, À63]; p ¼ 0.0021) and production of several amino acid was significantly reduced, while phase angle increased more (0.66 [0.09, 1.24]; p ¼ 0.0247), and SF-12 global health improved more 53.19], p ¼ 0.04). Conclusion: HMB treatment did not significantly reduce muscle wasting over 10 days of observation (primary endpoint), but resulted in significantly improved amino acid metabolism, reduced net protein breakdown, a higher phase angle and better global health. Clinicaltrials.gov identifier: NCT03628365.
Our economic analysis shows that although the costs of the two trastuzumab plus taxane regimens are similar, they may contribute to the on-going debate about the availability and use of innovative chemotherapy drugs, in particular in human epidermal growth factor receptor 2-positive metastatic breast cancer with new therapies such as trastuzumab-DM1 and pertuzumab.
BackgroundOne of the main measures of the French national cancer plan is to encourage physicians to work collectively, and to minimize territorial inequities in access to care by rethinking the geographical distribution of oncologists. For this reason, cancer care services are currently being reorganized at national level. A new infrastructure for multidisciplinary cancer care delivery has been put in place in our region. Patients can receive multidisciplinary health care services nearer their homes, thanks to a mobile team of oncologists. The objective of our study was to assess, using a quality approach, the impact on medical management and on the costs of treating early breast cancer, of the new regional structure for cancer care delivery.MethodsBefore-and-after study performed from 2007 to 2010, including patients treated for early breast cancer in three hospitals in the region of Franche-Comté in Eastern France. The main outcome measures were quality criteria, namely delayed treatment (>12 weeks), dose-intensity and assessment of adjuvant chemotherapy. Other outcomes were 24-month progression-free survival (PFS) and economic evaluation.ResultsThis study included 667 patients. The rate of chemotherapy tended to decrease, but not significantly (49.3% before versus 42.2% after, p=0.07), while the use of taxanes increased by 38% across all centres (59.6% before versus 98.0% after, p < 0.0001). There was a non-significant reduction in the time between surgery and adjuvant chemotherapy (6.0 ± 3.0 weeks before versus 5.6 ± 3.6 weeks after, p=0.11). Dose-dense chemotherapy improved slightly, albeit non significantly (86.3% versus 91.1% p=0.22) and time to treatment tended to decrease. The new regional infrastructure did not change 24-month PFS, which remained at about 96%. The average cost of treatment was estimated at €7000, with no difference between the two periods.ConclusionsDespite a shortage of oncologists, the new organization put in place in our region for the provision of care for early breast cancer makes it possible to maintain local community-based treatment, without negative economic consequences. This new structure for cancer care delivery offers cancer services of similar quality with no modification of 24-month PFS in early breast cancer.
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