Epirubicin Plus Cyclophosphamide Followed by Docetaxel Versus Epirubicin Plus Docetaxel Followed by Capecitabine As Adjuvant Therapy for Node-Positive Early Breast Cancer: Results From the GEICAM/2003-10 Study.

PURPOSE: Capecitabine is an active drug in metastatic breast cancer (BC). GEICAM/2003-10 is an adjuvant trial to investigate the integration of capecitabine into a regimen of epirubicin and docetaxel for node-positive early BC. PATIENTS AND METHODS: Patients with operable node-positive BC (T1-3/N1-3) were eligible. After surgery, 1,384 patients were randomly assigned to receive epirubicin plus cyclophosphamide (EC; 90 and 600 mg/m(2), respectively, × four cycles), followed by docetaxel (100 mg/m(2) × four cycles; EC-T) or epirubicin plus docetaxel (ET; 90 and 75 mg/m(2), respectively, × four cycles), followed by capecitabine (1,250 mg/m(2) twice a day on days 1 to 14, × four cycles; ET-X); all regimens were given every 3 weeks. The primary end point was invasive disease-free survival. Secondary end points included safety (with an alopecia-specific study) and overall survival (OS). RESULTS: After a median follow-up of 6.6 years and 297 events, 86% of patients who received EC-T and 82% of those who received ET-X were invasive disease free at 5 years (hazard ratio, 1.30; 95% CI, 1.03 to 1.64; log-rank P = .03). The OS difference between arms was not statistically significant (hazard ratio, 1.13; 95% CI, 0.82 to 1.55; log-rank P = .46). The most frequent grade 3 to 4 adverse events in the EC-T versus ET-X arms were neutropenia (19% v 10%), with 7% febrile neutropenia across arms; fatigue (13% v 11%); diarrhea (3% v 11%); hand-foot syndrome (2% v 20%); mucositis (6% v 5%); vomiting (both, 5%); and myalgia (4.5% v 1%). Incomplete scalp hair recovery was more frequent in the EC-T than ET-X arm (30% v 14%), and patients who received EC-T wore wigs significantly longer than those who received ET-X (8.35 v 6.03 months). CONCLUSION: Invasive disease-free survival, but not OS, was significantly superior for patients with node-positive early BC who received the adjuvant standard schedule EC-T than for those who received the experimental ET-X regimen. Toxicity profiles differed substantially across arms.

Inmunoterapia alérgica desde Atención Primaria de Salud / Allergen immunotherapy from Primary Health Care

La vacuna o inmunoterapia es el único tratamiento etiológico y específico de las enfermedades alérgicas capaz de modificar su curso natural.El objetivo de este artículo es mostrar una actualización en la administración de la inmunoterapia alérgica (subcutánea y sublingual) en el ámbito de la Atención Primaria de Salud, así como en las recomendaciones generales para el paciente con alergia. Para ello se llevó a cabo una revisión de la literatura.No se han encontrado diferencias sobre la modificación de pautas y la actuación en caso de reacciones adversas. Además se ha de valorar la inmunoterapia sublingual, la cual se está posicionando como forma segura y eficaz en el tratamiento de la enfermedad alérgica. Esta vía de administración presenta una buena tolerancia, comodidad de administración y escasez de efectos secundarios en los pacientes alérgicos (AU)

Vaccines or immunotherapy is the only causal and specific treatment of allergic diseases able to modify the natural course of allergic disease.The aim of this paper is to show an update on the administration of allergenim munotherapy (subcutaneous and sublingual) in the field of PrimaryHealth Care, as well as general recommendations for patients with allergy. To this end a review of the literature was carried out.No differences were found on the modification of regimen patterns or actions to be taken in adverse reactions. In addition, sublingual immunotherapy has to be assessed, which is positioning it self as a safe and effective method in the treatment of allergic disease. This route of administration affords a good tolerance, ease of administration and lack of side effects in allergic patients (AU)

Phase II study of gemcitabine and cisplatin in chemonaive patients with advanced epithelial ovarian cancer.

This phase II study evaluated the activity of gemcitabine (Gemzar) plus cisplatin (Platinol) as first-line treatment of advanced epithelial ovarian cancer. Forty-two chemonaive patients with advanced (stage III and IV) epithelial ovarian cancer received gemcitabine 1,250 mg/m(2) on days 1 and 8 and cisplatin 100 mg/m(2) on day 1, every 3 weeks, up to eight cycles. The median number of cycles completed was 5 (range 2-8). Of the 41 patients evaluable for tumor response, 20 had a partial response and nine had a complete response, for an overall clinical and pathologic response rate of 70.7% (95% CI 56.8-84.6%). Median overall survival for all 42 patients was 23.4 months (95% CI 15.9-29.9 months) and the median progression-free survival time was 10.4 months (95% CI 9.4-13.5 months). The combination was generally manageable. Hematologic toxicity (grade 3/4 neutropenia: 31.0/21.4%; grade 3/4 thrombocytopenia: 9.5/4.8%; grade 3/4 anemia: 11.9/0%) and nausea and vomiting (grade 3/4: 35.7/31.0%) were the most common toxicities. There was one toxic death (septic shock due to hematologic toxicity-induced infection). We conclude that gemcitabine plus cisplatin is active and feasible as first-line treatment of advanced epithelial ovarian cancer. Further clinical trials with the addition of gemcitabine to first-line treatment appear warranted.

Tamoxifen therapy for ovarian cancer in the adjuvant and advanced settings: systematic review of the literature and implications for future research.

BACKGROUND: Ovarian neoplasms frequently express hormonal receptors and are sensitive to hormonal manipulations, as shown by preclinical and clinical studies. However, despite the outstanding relevance of hormonal adjuvant therapy in breast cancer and the importance of receptor status as a predictive factor, few trials have addressed these issues in ovarian cancer. METHODS: Computerized and manual searches were performed to identify preclinical and clinical studies evaluating single-agent tamoxifen activity in ovarian cancer or any kind of hormonal therapy employed as adjuvant therapy for ovarian cancer. RESULTS: In advanced tumors, none of the trials was performed exclusively in chemonaive patients, but those including less heavily pretreated patients showed greater response rates. Some studies found a correlation between receptor status and activity (although differences were not significant), whereas other trials did not. Nevertheless, none were specifically designed to answer this question. Few randomized trials comparing hormonal treatment and chemotherapy versus chemotherapy alone were identified. Although their results were negative, all were small, and none was designed with the rigor that allowed adjuvant hormonal therapy to become successfully established in breast cancer. CONCLUSION: The activity of tamoxifen in advanced ovarian cancer has not been adequately evaluated and its role may have been underestimated. Furthermore, the relevance of adjuvant hormonal therapy in ovarian cancer and the predictive value of hormonal receptors have never been studied in well-designed trials. Additional studies to clarify the role of tamoxifen for this indication are warranted.