Gemcitabine plus capecitabine (Gem-Cape) biweekly in chemorefractory metastatic colorectal cancer.

PURPOSE: A proportion of patients with metastatic colorectal cancer (mCRC) are still able to continue with active therapy after their progression to fluoropyrimidines, oxaliplatin, and irinotecan regimens. Studies suggest that gemcitabine and fluoropyrimidines are synergic antimetabolites. The purpose was to evaluate gemcitabine-capecitabine (Gem-Cape) in heavily pretreated mCRC and to thus assess possible predictive factors for progression-free survival (PFS) and overall survival (OS). PATIENTS AND METHODS: This analysis was performed on 119 evaluable patients pretreated with fluoropyrimidines, oxaliplatin, irinotecan, and biological agents between June 2001 and July 2011. Patients received gemcitabine 1,000 mg/m(2) day 1 and capecitabine 1,000 mg/m(2) bid for 7 days every 2 weeks. RESULTS: The general characteristics were ECOG 0-1, 89 %; male, 68 %, and median age 63 years. In total, 61 % had received two chemotherapy lines, while 39 % had received three or more. Objective response rates and stable disease rates at 3 months were 6.72 and 37.81 %, equalling a clinical benefit of 44.53 %. The median PFS and OS were 2.87 months [95 % confidence interval (CI) 2.53-3.17 months] and 6.53 months (95 % CI 5.33-8.77), respectively. The most frequent toxicities were grades 1-2, anemia (22 %), thrombocytopenia (10 %), and hand-foot syndrome (9 %); grade ≥3, diarrhea (2 %), with no treatment-related discontinuations. No treatment-related deaths were reported. Statistical significance was obtained by subgroups, assessing clinical benefits and objective responses for PFS and OS. Moreover, patients under 65 tended to have a better PFS. CONCLUSION: These data suggest that Gem-Cape is a tolerable and feasible regimen, associated with clinical benefit in non-selected, heavily pretreated, mCRC patients.

[Infectious spondylodiscitis in a health area of Galicia (Spain) from 1983-2003]. / Espondilodiscitis infecciosas en un área sanitaria gallega, 1983-2003.

OBJECTIVE: To study the clinical-epidemiological characteristics of infectious spondylodiscitis (IS) in adults of our health area in the late 20 years. MATERIAL AND METHODS: We performed a retrospective analysis of the medical records of adult patients with a diagnosis of both, tuberculous (TS) and non tuberculous spondylodiscitis (NTS), between January 1983 and December 2003. The diagnosis was made when compatible clinical-radiological picture were present in association with at least two positive blood cultures and/or micro-organism recovery from vertebral samples. Additionally, TS was diagnosed when biopsy showed typical caseating granulomas from vertebral or extra-vertebral lesions. RESULTS: 17 TS and 22 NTS were identified. The mean age was lower in patients with TS than in NTS (43.5 +/- 24.6 vs 52.0 +/- 15.2 years; mean +/- SD). Patients were predominantly males in both, TS (57%) and NTS (82%; p < 0001). The time between the onset of symptoms and diagnosis was longer in TS (16.4 +/- 15.2 weeks) than in NTS (3.9 +/- 3.2 weeks), p= 0.005. Seven (41%) of the 17 patients with TS had active extra-vertebral tuberculosis. A source of infection was presumed in 20 NTS (90%), mainly surgical spinal procedures (9/22.41%). In three TS and four NTS one o more predisposing factors were observed. The patients with NTS presented a higher prevalence of fever (41 vs 24%; p= 0.0003) and leucocytosis (41 vs 12%; p < 0.001), but less neurological impairment (9 vs 21% p= 0,01). None patient with NTS presented mixed infection and Staphylococcus aureus was the main pathogen (14/22.64%) follows by Streptococcus sp (6/22.27%). Klebsiella pneumoniae and Proteus mirabilis were the remain causative agents. Spinal cord decompression and surgical drainage of abscess were performed in five patients (24%) with TS and four patients with NTS (18%), p= 0.0027). Neurological sequels were more common in the patients with TS (24 vs 14%, p= 0.008). The global incidence of IS was 2.2 cases/105 inhabitants/year, which 1.73 cases are NTS. CONCLUSIONS: The IS are a unusual disease what occurs predominantly in male patients. In the last 10 years, a increasing prevalence of NTS was observed, with high contribution (41%) of post-surgical cases. Diagnostic delay is greater in patients with TS and this condition was associated with more neurological sequels.

Espondilodiscitis infecciosas en un área sanitaria gallega, 1983-2003 / Infectious spondylodiscitis in a health area of Galicia (Spain) from 1983-2003

Objetivo: Estudiar las características clínicas y epidemiológicas de las espondilodiscitis infecciosas (EI) diagnosticadas en nuestra área sanitaria durante los últimos 20 años. Material y métodos: Análisis retrospectivo de las historias de los pacientes adultos con EI tuberculosas (EIT) y de otra etiología (EINT) cuyo diagnóstico se realizó entre el 1 de enero de 1983 y el 31 de diciembre de 2003. Se incluyeron aquellos casos con cuadro clínico y radiológico compatible asociado a la recuperación del microorganismo en dos o más hemocultivos y / o del material obtenido del foco de EI. También se consideró probado el diagnóstico de EIT si existían granulomas caseificantes típicos en las biopsias vertebrales o de focos extravertebrales concomitantes. Resultados: Se recogieron 17 EIT y 22 EINT. La edad de los pacientes fue inferior en las EIT (43,5 ± 24,6 vs 52,0 ± 15,2 años; media ± desviación estándar). Los varones predominaron en ambos grupos, sobre todo en las EINT (82 por ciento vs 57 por ciento, p< 0,0001). El intervalo entre el inicio de los síntomas y el diagnóstico fue más corto en las EINT (3,9 ± 3,2 vs 16,4 ± 15,2 semanas, p= 0,005). En siete (41 por ciento) de los pacientes con EIT existían otros focos tuberculosos activos. En el 90 por ciento de las EINT se identificaron potenciales puertas de entrada para los microorganismos, destacando las intervenciones en la columna vertebral (9/22,41 por ciento). Se registraron factores predisponentes generales en 3 EIT y 4 EINT. En las EINT fueron más frecuentes la leucocitosis (41 por ciento vs 12 por ciento, p < 0,001) y la fiebre (41 por ciento vs 24 por ciento, p= 0,0003), mientras los déficit neurológicos en el momento del diagnóstico predominaron en las EIT (24 por ciento vs 9 por ciento, p= 0,01). Todas las EINT fueron monobacterianas, destacando Staphylococcus aureus (14/22,64 por ciento), seguido del género Streptococcus (6/22,27 por ciento). Klebsiella pneumoniae y Proteus mirabilis causaron las dos EINT restantes. Las EIT requirieron más intervenciones para descompresión mielorradicular y / o drenaje de abscesos paravertebrales (29 por ciento vs 18 por ciento; p= 0,0027) y presentaron más secuelas neurológicas (24 por ciento vs 14 por ciento; p= 0,008). La incidencia global estimada de EI en nuestro sector sanitario fue de 2,2 casos /105 habitantes / año, de los que 1,73 corresponderían a EINT. Conclusiones: Las EI son poco frecuentes y predominan en varones. Durante la última década se ha producido un notable incremento de las EINT, con participación significativa (41 por ciento) de las postquirúrgicas. Las EIT sufren una mayor demora en el diagnóstico y ello se asocia a mayor prevalencia de secuelas (AU)