RESUMEN
BACKGROUND: In real-world practice, eribulin mesylate provides significant survival benefit, with a manageable safety profile in heavily pretreated patients with metastatic breast cancer (MBC). METHODS: In this prospective, open-label, multicentre, observational study we evaluated the effectiveness and tolerability of eribulin as third-line treatment in a homogeneous population. The primary endpoints were the safety profile and response in metastatic sites; secondary endpoints included the response in different subtypes, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). RESULTS: From 2013 to 2016, 118 women were treated in 21 Sicilian institutions; the median age was 58 years (range 29-79), with 69% of patients under 65. The median cycles of eribulin were 5.5 (range 1-26). The most common adverse event was neutropenia (9.3%, 3 cases of grade 3, 4 of grade 4); only 1 case of QT prolongation was reported. Eribulin was effective in controlling metastatic disease in all sites, and it achieved the highest ORR in brain (16%) and liver (14.9%). Median OS was 31.8 months (95% CI 27.9-34.4) and median PFS 5.5 months (95% CI 4.2-6.6). PFS was 5.2 months (95% CI 2.8-8.4) in patients with triple-negative subtype. Median PFS was longer in patients over 65 years (6.1 months, 95% CI 4.4-8.3). In patients who had visceral metastases PFS was 5.5 months (95% CI 95% 3.5-6.6) and OS 33.9 months (95% CI 29.8-40.8). CONCLUSIONS: Eribulin as third-line treatment shows an acceptable safety profile and a substantial antitumour activity in the treatment of MBC, even in elderly patients and in those with visceral disease.
RESUMEN
To evaluate long-term immunogenicity of a virosomal subunit inactivated influenza vaccine in children with asthma, a prospective study was conducted during 2005-2006 influenza season in six public pediatric clinics in Milan and surroundings, Northern Italy. A single dose (0.5 ml) of a virosomal subunit inactivated influenza vaccine (Inflexal V) was injected in 106 asthmatic children aged 3-9 years. Serum hemagglutinin inhibition antibody titers were determined against the recommended influenza strains A/New Caledonia (H1N1), A/California (H3N2), and B/Shanghai (B), at pre-vaccination and 1 and 6 months after vaccination. Seroconversion rate (95% CI) against the strains A/H1N1, A/H3N2 and B was, respectively, 78% (68.6-85.7), 57% (46.7-66.9) and 66% (55.8-71.2) at 1 month. Seroprotection (titer> or =40) rate for A/H1N1, A/H3N2 and B was, respectively, 87% (77.8-92.2), 82% (72.6-89.7) and 90% (82.6-94.8) at 1 month and 74% (64.3-82.3), 77% (67.5-84.8), and 77% (67.5-84.8) at 6 months. Seroprotection rate was high and persistent (>95%) in children with pre-existing antibodies (titer> or =10) at pre-vaccination for any specific strain. In children without pre-existing antibodies, seroprotection rate for A/H1N1, A/H3N2 and B was, respectively, 67.6%, 66.7% and 74.4% at 1 month, and 35.1%, 56.2% and 41.0% at 6 months after vaccination. Vaccine was well tolerated. These results indicate that in unvaccinated children with asthma vaccination with a single dose of virosomal-adjuvanted influenza vaccine is well tolerated and effective as a whole. However, while immunity response and persistence are excellently high in children with pre-existing antibodies, in children naive for the antigens the immune parameters are lower at 6 months after vaccination.