4 research outputs found
Endocrine-based targeted combination versus endocrine therapy alone as first-line treatment in elderly patients with hormone receptor-positive advanced breast cancer: Meta-analysis of phase II and III randomized clinical trials.
Background: Combined endocrine approaches have been widely investigated as 1st-line treatment in hormone receptors
positive metastatic breast cancer. In particular, multiple randomized trials showed that the addiction of CDK (cyclindependent
kinase) 4/6 inhibitors to endocrine therapy (ET) increase progression free survival (PFS). Elderly patients (aged ≥
65 years) are under represented in most of the clinical studies. Moreover, due to the multi-morbidity and the major toxicity
associated with the targeted agents, the combination strategy in that subgroup is widely discussed. The present metaanalysis
aimed to understand the role of the new endocrine approaches in women aged ≥65 years. Methods: This metaanalysis
included first line phase II/III randomized published trials comparing (ET) to the experimental strategy. Trials with no
data about hazard ratios (HR) for PFS in the subgroup of patients aged ≥ 65 years were excluded. The heterogeneity of the
data was evaluated by Chi-square Q test and I2 statistic. Results: 8 studies were included in the analysis. 4 trials
(Paloma1/TRIO-18, Paloma2, Monaleesa2, Monarch3) investigated the role of CDK 4/6 inhibitors, 2 trials (SWOG and
FACT) analysed the combination of Fulvestrant plus Aromatase Inhibitors, while other two trials explored the association of
ET with Bevacizumab (LEA) and Temsirolimus (HORIZON), respectively. Overall, the meta-analysis showed a PFS
advantage for the experimental arms [HR 0.77, p 0.016] with a significant high/moderate heterogeneity [I2 65.46%, p 0.005].
The 4 studies adding CDK4/6 inhibitors to ET showed a significant improvement in PFS compared to ET alone. No
significant advantages for the addition of anti-angiogenic agents or Fulvestrant to ET have been found in elderly population
subgroup. Conclusions: The novel experimental combo-strategies in the first line setting showed an improvement in PFS in
the subgroup of elderly patients. Adding CDK4/6 inhibitors to ET significantly prolongs PFS as compared to ET alone. The
magnitude of PFS benefit due to addition of CDK4/6 inhibitors to ET is age-independent
Current treatment practice of Guillain-Barré syndrome
Objective: To define the current treatment practice of Guillain-Barré syndrome (GBS).
Methods: The study was based on prospective observational data from the first 1,300 patients included in the International GBS Outcome Study. We described the treatment practice of GBS in general, and for (1) severe forms (unable to walk independently), (2) no recovery after initial treatment, (3) treatment-related fluctuations, (4) mild forms (able to walk independently), and (5) variant forms including Miller Fisher syndrome, taking patient characteristics and hospital type into account.
Results: We excluded 88 (7%) patients because of missing data, protocol violation, or alternative diagnosis. Patients from Bangladesh (n = 189, 15%) were described separately because 83% were not treated. IV immunoglobulin (IVIg), plasma exchange (PE), or other immunotherapy was provided in 941 (92%) of the remaining 1,023 patients, including patients with severe GBS (724/743, 97%), mild GBS (126/168, 75%), Miller Fisher syndrome (53/70, 76%), and other variants (33/40, 83%). Of 235 (32%) patients who did not improve after their initial treatment, 82 (35%) received a second immune modulatory treatment. A treatment-related fluctuation was observed in 53 (5%) of 1,023 patients, of whom 36 (68%) were re-treated with IVIg or PE.
Conclusions: In current practice, patients with mild and variant forms of GBS, or with treatment-related fluctuations and treatment failures, are frequently treated, even in absence of trial data to support this choice. The variability in treatment practice can be explained in part by the lack of evidence and guidelines for effective treatment in these situations
Second IVIg course in Guillain-Barré syndrome with poor prognosis. The non-randomised ISID study
Objective To compare disease course in patients with Guillain-Barré syndrome (GBS) with a poor prognosis who were treated with one or with two intravenous immunoglobulin (IVIg) courses. Methods From the International GBS Outcome Study, we selected patients whose modified Erasmus GBS Outcome Score at week 1 predicted a poor prognosis. We compared those treated with one IVIg course to those treated with two IVIg courses. The primary endpoint, the GBS disability scale at 4 weeks, was assessed with multivariable ordinal regression. Results Of 237 eligible patients, 199 patients received a single IVIg course. Twenty patients received an α early' second IVIg course (1-2 weeks after start of the first IVIg course) and 18 patients a α late' second IVIg course (2-4 weeks after start of IVIg). At baseline and 1 week, those receiving two IVIg courses were more disabled than those receiving one course. Compared with the one course group, the adjusted OR for a better GBS disability score at 4 weeks was 0.70 (95%CI 0.16 to 3.04) for the early group and 0.66 (95%CI 0.18 to 2.50) for the late group. The secondary endpoints were not in favour of a second IVIg course. Conclusions This observational study did not show better outcomes after a second IVIg course in GBS with poor prognosis. The study was limited by small numbers and baseline imbalances. Lack of improvement was likely an incentive to start a second IVIg course. A prospective randomised trial is needed to evaluate whether a second IVIg course improves outcome in GBS