Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program.

BACKGROUND: The programmed death (PD-1) inhibitor pembrolizumab has been recently approved for the treatment of advanced melanoma. We evaluated the clinical activity of pembrolizumab in melanoma patients treated under the Spanish Expanded Access Program. METHODS: Advanced melanoma patients who failed to previous treatment lines were treated with pembrolizumab 2 mg/kg every three weeks. Patients with brain metastases were not excluded if they were asymptomatic. Data were retrospectively collected from 21 centers in the Spanish Melanoma Group. RESULTS: Sixty-seven advanced melanoma patients were analyzed. Most patients were stage M1c (73.1%), had high LDH levels (55.2%) and had ECOG PS 1 or higher (59.7%). For cutaneous melanoma patients, median overall survival was 14.0 months; the 18-month overall survival rate was 47.1%. Overall response rate was 27%, including three patients with complete responses (6.5%). Median response duration was not reached, with 83.3% of responses ongoing (3.5 m+ to 20.4 m+). From ten patients included with brain metastases, four (40%) had an objective response, two (20%) of them achieved a complete response. Significant prognostic factors for overall survival were LDH level, ECOG PS and objective response. There were no serious adverse events. CONCLUSION: Although this was a heavily pretreated cohort, pembrolizumab activity at the approved dose and schedule was confirmed in the clinical setting with long-term responders, also including patients with brain metastases.

[Impact of the new smoke-free legislation (law 42/2010) on levels of second-hand smoke in hospitality venues]. / Impacto de la nueva legislación sobre tabaquismo (Ley 42/2010) en los niveles de humo ambiental de tabaco en locales de hostelería.

OBJECTIVE: To evaluate pollution by second-hand smoke in a sample of hospitality venues before and after the implementation of smoke-free legislation. METHODS: A cross sectional, before-after study was conducted in 2008 and 2011 after the total ban. A SidePack Aerosol monitor was used both inside and outside the hospitality venues to measure fine breathable particles (PM2.5). A total of 43 places with pre- and post-legislation measurements were included. RESULTS: The median indoor pollution in hospitality venues was 204.2µg/m(3) in 2008 and 18.82µg/m(3) in 2011; the average outdoor PM2.5 concentration was 47.04µg/m(3) in 2008 and 18.82µg/m(3) in 2011. Pollution was higher in bars and cafeterias, followed by pubs and discos. Before the law was implemented, pollution was 4.34 times higher indoors than outdoors; in 2011 the average indoor PM2.5 concentration decreased by 90.88%. CONCLUSIONS: Only a complete ban is able to protect workers and customers against the health risks of second-hand smoke exposure.