Usefulness of bone turnover markers as predictors of mortality risk, disease progression and skeletal-related events appearance in patients with prostate cancer with bone metastases following treatment with zoledronic acid: TUGAMO study

Owing to the limited validity of clinical data on the treatment of prostate cancer (PCa) and bone metastases, biochemical markers are a promising tool for predicting survival, disease progression and skeletal-related events (SREs) in these patients. The aim of this study was to evaluate the predictive capacity of biochemical markers of bone turnover for mortality risk, disease progression and SREs in patients with PCa and bone metastases undergoing treatment with zoledronic acid (ZA). Methods: This was an observational, prospective and multicenter study in which ninety-eight patients were included. Patients were treated with ZA (4mg every 4 weeks for 18 months). Data were collected at baseline and 3, 6, 9, 12, 15 and 18 months after the beginning of treatment. Serum levels of bone alkaline phosphtase (BALP), aminoterminal propeptide of procollagen type I (P1NP) and beta-isomer of carboxiterminal telopeptide of collagen I (b-CTX) were analysed at all points in the study. Data on disease progression, SREs development and survival were recorded. Results: Cox regression models with clinical data and bone markers showed that the levels of the three markers studied were predictive of survival time, with b-CTX being especially powerful, in which a lack of normalisation in visit 1 (3 months after the beginning of treatment) showed a 6.3-times more risk for death than in normalised patients. Levels of these markers were also predictive for SREs, although in this case BALP and P1NP proved to be better predictors. We did not find any relationship between bone markers and disease progression. Conclusion: In patients with PCa and bone metastases treated with ZA, b-CTX and P1NP can be considered suitable predictors for mortality risk, while BALP and P1NP are appropriate for SREs. The levels of these biomarkers 3 months after the beginning of treatment are especially importantThis study was supported by Novartis Oncology Spai

Evaluación del tratamiento del dolor crónico en pacientes oncológicos con buprenorfina transdérmica

Introduction. The concern with chronic severe pain in cancer patients is growing as antineoplastic therapeutic advances are procuring prolonged survival in many patients. This necessitates the development of new effective and safe analgesic treatments. For this purpose, the comparison of therapeutic outcomes with that obtained in non-cancer patients may be helpful. Methods. A prospective, uncontrolled observational study that included a 3 month follow-up of patients starting transdermal buprenorphine was performed. Information was collected systematically on pain relief, quality of life (EuroQol-5D questionnaire), comfort of patch use and adverse events. Missing data were imputed by carrying forward former observations. This article refers to the comparative results of a subgroup of 207 cáncer patients with that of 968 non-cancer patients that participated in the same study. Results and conclusions. 30% of cáncer patients switched to transdermal buprenorphine from other opioid drug. Dose increases were required by 44% of patients, and most occurred in the first month; this proportion being significantly greater (p<0.001) than among non-cancer patients (18.8%). More than two third achieved satisfactory pain relief, regardless of the origin of pain. There was a significant increase of quality of life score that was, nevertheless, lower among cáncer patients (by an average of 12.2 mm in a visual analogue scale) than among non-cancer patients (17.1 mm); that was mainly attributed to pain improvement. The proportion of patients with adverse events was significantly lower among cáncer (42.0%) than non-cancer patients (49.1%), p=0.010. This was true also for related adverse events and withdrawals because of adverse events. Conversely, more cáncer patients had serious adverse events or died during follow-up; although in none case these were related to buprenorphine treatment. Conclusions. Within the opioid class, the transdermal formulation of buprenorphine is effective and safe for the treatment of modérate to severe chronic pain in non-terminal cáncer patients.Introducción. El dolor crónico severo en el paciente oncológico no terminal es un problema creciente porque los avances de los tratamientos antineoplásicos están aumentando la supervivencia de los pacientes. Es necesario, pues, el desarrollo de nuevos tratamientos analgésicos eficaces y seguros para estos pacientes. Para ello, la comparación con los resultados terapéuticos en pacientes no oncológicos con dolor crónico resulta de interés. Material y métodos. Se realizó un estudio de post-autorización observacional prospectivo no controlado en el que se siguió durante tres meses a pacientes que comenzaron tratamiento con buprenorfina transdérmica. Se recogió información sistemática sobre el grado de alivio del dolor, la calidad de vida (cuestionario EuroQol-5D), el manejo del parche y los acontecimientos adversos. Los datos ausentes se cubrieron arrastrando valores anteriores válidos. Se presentan comparativamente los resultados obtenidos en un subgrupo de 207 pacientes oncológicos con los de 968 pacientes no oncológicos que participaron en el mismo estudio. Resultados. El 30% de los pacientes oncológicos tenían un tratamiento previo con opioides. El 44'1% precisó de un aumento de dosis, en su mayoría durante el primer mes de tratamiento; proporción significativamente mayor (p<0'001) que entre los no oncológicos (18'8%). Más de dos tercios obtuvieron alivio satisfactorio con independencia del origen del dolor. Se produjo un aumento significativo de la calidad de vida, que fue menor entre los oncológicos (12'2 mm en promedio en una escala analógica visual) que entre los no oncológicos (17'1 mm); y que un análisis ajustado atribuyó principalmente a la mejoría del dolor. La proporción de pacientes que presentaron acontecimientos adversos fue menor entre los oncológicos (42'0%) que entre los no oncológicos (49'1%), p=0'010. Ello mismo ocurrió con los acontecimientos adversos relacionados o los que motivaron el abandono. Por el contrario, fue mayor entre los oncológicos la proporción de acontecimientos adversos graves y de fallecimientos, si bien ninguno de ellos se relacionó con el tratamiento de buprenorfina transdérmica. Conclusiones. Entre los fármacos opioides, la presentación transdérmica de buprenorfina demostró ser efectiva y segura para el tratamiento del dolor crónico de moderado a severo en pacientes oncológicos no terminales

Dos nuevos yacimientos con cerámica tipo Penha en el Valle del Miño

[ES] Se analizan los materiales recuperados de forma casual en dos yacimientos emplazados en el tramo inferior del valle del Miño. La industria lítica y la cerámica que ambos proporcionaron permite encuadrarlos en el calcolitico precampaniforme del Noroeste, estando presentes varios vasos decorados según el conocido estilo Penha, en tanto que en uno de los asentamientos (Chan da Carrola) se hallaron fragmentos de cobre con fuerte contenido en arsénico. En los dos casos el emplazamiento no responde tan sólo a motivaciones económicas sino también a las necesidades de control del territorio o de ciertos lugares de paso.[EN] TWO new settlements with Venha ware at the Miño valley. In this paper a couple of open-air settlements, casually found in the lower tract of the river Miño, are studied. The material culture thus recovered is characteristic of the NW Iberian Chalcolithic: concave arrowheads, Penha pottery and arsenical copper. Moreover, the actual placing of these sites seems to be linked not just to the exploitation of the inmediate resources but also to strategic concerns