Gemcitabine plus sirolimus for relapsed and progressing osteosarcoma patients after standard chemotherapy: a multicenter, single-arm phase II trial of Spanish Group for Research on Sarcoma (GEIS).

BACKGROUND: Patients with relapsed unresectable osteosarcoma represents an unmet need, so active and safe systemic treatments are required. Fas cell surface death receptor and mammalian target of rapamycin pathways are implicated in progressing osteosarcoma, and we had preclinical and clinical experience with a scheme that targets both pathways. Therefore, we designed a phase II trial with gemcitabine plus rapamycin, to determine the efficacy and safety, in this subset of patients. PATIENTS AND METHODS: A multicenter, single-arm phase II trial was sponsored by the Spanish Group for Research on Sarcoma. Osteosarcoma patients, relapsed or progressing after standard chemotherapy and unsuitable for metastasectomy received gemcitabine and rapamycin p.o. 5 mg/day except for the same day of gemcitabine administration, and the day before. The main end point was 4-month progression-free survival rate (PFSR), with the assumption that rates higher than 40% would be considered as an active regimen. Translational research aimed to correlate biomarkers with the clinical outcome. RESULTS: Thirty-five patients were enrolled and received at least one cycle. PFSR at 4 months was 44%, and after central radiologic assessment, 2 partial responses and 14 stabilizations (48.5%) were reported from 33 assessable patients. The most frequent grade 3-4 adverse events were: neutropenia (37%), thrombocytopenia (20%), anemia (23%), and fatigue (15%); however, only three patients had febrile neutropenia. Positive protein expression of RRM1 significantly correlated with worse PFS and overall survival, while positivity of P-ERK1/2 was correlated with significant better overall survival. CONCLUSION: Gemcitabine plus sirolimus exhibits satisfactory antitumor activity and safety in this osteosarcoma population, exceeding the prespecified 40% of 4-month PFSR. The significant correlation of biomarkers with clinical outcome encourages further prospective investigation.

Análisis de técnica anestésica para aspiración folicular transvaginal en Embriovid Centro de Reproducción Asistida / Technical analysis for anesthesia in vacuum follicular transvaginal Embriovid center of assisted reproduction

OBJETIVO: Analizar las técnicas anestésicas utilizadas en el centro de reproducción asistida avanzada Embriovid para la aspiración folicular transvaginal guiada por ecografía (AFT) con el propósito de estandarizar las dosis de anestésicos ,revisar sus complicaciones y el perfil de recuperación en pacientes donantes y en tratamiento de fertilidad. DISEÑO METODOLÓGICO: Serie de casos. Población y temporalidad: pacientes sometidas a AFT bajo anestesia en el centro de alta especialidad de reproducción asistida Embriovid en la ciudad de La Paz- Bolivia en el periodo de Septiembre 2015 a Abril 2016. MATERIAL Y MÉTODO: Se revisaron los expedientes clínicos de pacientes sometidas a anestesia para AFT y se registraron variables biodemograficas, los datos de recuperación y complicaciones. Las pacientes recibieron anestesia total intravenosa TIVA en bolos con propofol y fentanil o en su defecto sedación consiente con fentanil y midazolam o dosis bajas de propofol. Se registraron los datos de la hoja anestésica con dosis totales, tiempos quirúrgicos y anestésicos, y medicamentos no anestésicos administrados. RESULTADOS: Se incluyeron 209 procedimientos divididos en dos grupos de registro, grupo 1 de donantes con 91 aspiraciones (43.5%) y grupo 2 con 118 aspiraciones (56.5%) de pacientes en tratamiento de fertilidad (óvulos propios). 199 pacientes (94.7%) recibieron anestesia TIVA en bolos y 10 pacientes sedación consiente (5.3%). La técnica TIVA combino fentanil con propofol en bolos. La dosis de fentanil fue similar en ambos grupos (promedio 0.1mg) mientras que la dosis de propofol fue mayor en el grupo 1(200mg vs. 180mg) .La técnica TIVA presento periodos de apnea cortos que no requirió maniobras invasivas. El dolor postoperatorio fue frecuente pero de baja intensidad. El tiempo de estadía de las pacientes conservo su carácter ambulatorio. CONCLUSIONES: La técnica TIVA en bolos que combina propofol con fentanil parece ser una técnica anestésica segura en manos de un anestesiólogo y adecuada para la aspiración transvaginal de folículos ováricos.

OBJECTIVE: To analyze the anesthetic techniques used in the center of advanced assisted reproduction Embriovid for transvaginal follicular aspiration guided by ultrasound (TFA) in order to standardize the dose of anesthetic, review it's complications and recovery profile in donor patients in fertility treatment. METHODOLOGICAL DESIGN: Case series. Population and temporality: Patients under anesthesia for TFA in the center of highly specialized assisted reproduction "Embriovid" in the city of La Paz, Bolivia in the period September 2015 to April 2016. MATERIAL AND METHODS: Clinical records of patients undergoing anesthesia for TFA, their biodemographic variables, data of recovery and complications were recorded and reviewed. Patients received total intravenous anesthesia (TIVA) with with bolus of propofol and fentanyl or conscious sedation with fentanyl and midazolam or low doses of propofol. We record the anesthetic dose, surgical and anesthesia times, and no anesthetic drugs administered. RESULTS: 209 procedures divided into two groups registration, group 1 donors aspirations 91 (43.5%) and Group 2 with 118 aspirations (56.5%) of patients in fertility treatment (own oocytes) were included. 199 patients (94.7%) received bolus TIVA anesthesia and conscious sedation in 10 patients (5.3%). TIVA technique combine with propofol bolus fentanyl. The dose of fentanyl was similar in both (average 0.1mg) groups while propofol dose was higher in Group 1 TIVA (200mg vs. 180mg). The TIVA technique shows periods of apnea not requiring invasive procedures. Postoperative pain was frequent but low intensity. The length of stay of patients retained its outpatient basis. CONCLUSIONS: TIVA bowling technique combining propofol with fentanyl appears to be a safe anesthetic technique in the hands of an anesthesiologist and suitable for transvaginal aspiration of ovarian follicles.

Linfoma primario del nervio ciático / Primary Linfoma of the sciatic nerve

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