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Garrido Lopez P.,Hospital Universitario Ramon y Cajal | Felip Font E.,Hospital General Universitario Vall dHebron | Isla Casado D.,Hospital Clinico Universitario Lozano Blesa
Clinical and Translational Oncology | Year: 2010

The purpose of this article is to provide updated recommendations for the diagnosis and treatment of patients non-small-cell lung cancer (NSCLC). The staging system for lung cancer has recently been revised by the International Association for Study of Lung Cancer and patients with NSCLC shall now be staged according to the UICC system 7th edition. Recommendations for treatment were based on treatment strategies that improve overall survival. In functionally fit patients with stage I-II disease surgical resection is recommended. Four cycles of adjuvant cisplatin-based chemotherapy is recommended in patients with pathologic stage II-III. For patients with stage IIIA and non-bulky mediastinal lymph node survival was significantly improved with induction chemotherapy plus surgical resection. Patients with unresectable or bulky stage IIIA and those with stage IIIB, should be treated with platinum-based chemotherapy and thoracic radiotherapy. For patients with metastatic disease and performance status of 0 or 1, a platinum-based two-drug combination of cytotoxic drugs is recommended. Nonplatinum cytotoxic doublets are acceptable for patients with contraindications to platinum therapy. For elderly patients and those with performance status of 2, a single cytotoxic drug is sufficient. Stop first-line cytotoxic chemotherapy at disease progression or after four cycles in patients who are not responding to treatment. Stop two-drug cytotoxic chemotherapy at six cycles even in patients who are responding to therapy. The first-line use of gefitinib may be recommended for patients with known epidermal growth factor receptor (EGFR) mutation; for negative or unknown EGFR mutation status, cytotoxic chemotherapy is preferred. Bevacizumab is recommended with platinum-based chemotherapy, except for patients with certain clinical characteristics. Maintenance therapy with pemetrexed or erlotinib increases survival in patients who did not progress after 4 cycles of a platinum based chemotherapy. Docetaxel, erlotinib, gefitinib, or pemetrexed is recommended as second-line therapy. Erlotinib is recommended as third-line therapy for patients who have not received prior erlotinib or gefitinib. Data are insufficient to recommend the routine third-line use of cytotoxic drugs. © 2010 Feseo. Source

Mateos M.-V.,University of Salamanca | Hernandez M.-T.,Hospital Universitario Of Canarias | Giraldo P.,Hospital Universitario Miguel Servet | De La Rubia J.,San Vicente Martir Catholic University of Valencia | And 14 more authors.
New England Journal of Medicine | Year: 2013

BACKGROUND: For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention. METHODS: In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with high-risk smoldering myeloma to treatment or observation. Patients in the treatment group received an induction regimen (lenalidomide at a dose of 25 mg per day on days 1 to 21, plus dexamethasone at a dose of 20 mg per day on days 1 to 4 and days 12 to 15, at 4-week intervals for nine cycles), followed by a maintenance regimen (lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years). The primary end point was time to progression to symptomatic disease. Secondary end points were response rate, overall survival, and safety. RESULTS: After a median follow-up of 40 months, the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P = 0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase. Toxic effects were mainly grade 2 or lower. CONCLUSIONS: Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival. Copyright © 2013 Massachusetts Medical Society. Source

Summary. Epilepsy is one of the most common neurological diseases. In recent years an important number of drugs have been added to the therapeutic options we have available to us. With the aim of ofering an optimal clinical efectiveness, the mechanisms of action or chemical structures of the antiepileptic drugs recently introduced onto the market have been modifed with respect to the frst, so-called classical or conventional, antiepileptics. Eslicarbazepine acetate belongs to this group of recently incorporated pharmaceuticals and is a novel single daily dose voltage-gated sodium channel blocker, which acts selectively in groups of rapid-activation neurons. It has been approved for indication in associated therapy in adults with partial onset seizures, with or without secondary generalisation. It is widely metabolised to eslicarbazepine and, to a lesser extent, to R-licarbazepine and oxcarbazepine. In 800 mg and 1200 mg doses it has been shown to bring about a signifcant reduction in a high percentage of patients with refractory epilepsy in simultaneous treatment with up to three antiepileptic drugs, and this efectiveness is maintained in open follow-up studies lasting up to a year. It is generally speaking well-tolerated; most of the adverse side-efects range in intensity from mild to moderate, and the percentage of patients who withdraw from treatment for this reason is low. Eslicarbazepine acetate is an alternative treatment in associated therapy in patients with partial epilepsy who do not respond adequately to treatment in monotherapy. Source

Gomollon F.,Hospital Clinico Universitario Lozano Blesa | Gisbert J.P.,Hospital Universitario La Paz
Current Opinion in Gastroenterology | Year: 2013

Purpose of review: Anemia and iron deficiency are the most common extraintestinal complications of inflammatory bowel diseases (IBDs) and are often undertreated. We review the evidence on intravenous (i.v.) iron overcoming the limitations of oral iron in IBD. RECENT FINDINGS: Recent reports demonstrate that i.v. iron is at least as effective, quicker, and better tolerated than oral iron. Moreover, experimental data confirm that oral and parenteral iron have divergent effects on intestinal mucosa: oral iron severely increasing inflammation. Observational and randomized studies prove that i.v. iron is not only effective but also well tolerated with no negative influence in the activity of IBD. A new formulation, iron carboxymaltose, which permits higher individual doses, has been shown more effective and less costly than standard iron sucrose. Another formulation, iron isomaltoside, shows promising in in-vitro and small clinical studies, but data from large trials are not available yet. SUMMARY: Oral iron is not an ideal option for treating anemia and iron deficiency in IBD. i.v. iron should be preferred at least in five scenarios: intolerance to oral iron, severe anemia, failure of oral therapy, need for a quick recovery, and use of erythropoietin. Direct evidence in IBD patients not only confirms the effectiveness of i.v. iron, but also demonstrates that new, more convenient preparations probably will become the standard in the near future. Copyright © Lippincott Williams & Wilkins. Source

Gomollon F.,Hospital Clinico Universitario Lozano Blesa
Digestive Diseases | Year: 2014

Biologics have revolutionized several areas of medical therapeutics, and dozens of them are used by millions of patients. Monoclonal antibodies are only one type of biologics, but more than 900 are now in different phases of development. These drugs are complex to make and not cheap. The market is constantly increasing, and several biosimilars (copies of biologics) are being used, while many are still waiting to become available to the public. Biosimilars are more complex than generics, and regulatory agencies have very stringent criteria for approval. In the IBD field, the biosimilar infliximab (Inflectra®, Remsima®) has been recently approved by the EMA, but not by Canadian authorities. The EMA has considered that 'high similarity' in preclinical studies together with clinical data from two trials in ankylosing spondylitis and rheumatoid arthritis warrant the 'extrapolation' for all approved indications for original infliximab (Remicade®), specifically Crohn's disease and ulcerative colitis. Canadian authorities have not accepted extrapolation, based on differences in glycosylation (fucosylation) that could be related to properties important in Crohn's disease. Most scientific societies do support the idea of asking for specific clinical trials before approval, although they acknowledge that following EMA, FDA, and WHO guidelines warrant safe products. Practical issues such as interchangeability and substitution remain unsolved, and it is very likely that there will be different solutions at the national level. Pharmacovigilance plans will be key for obtaining reliable data. Biosimilars are not better drugs, but can be clearly cheaper and may facilitate access to new treatments in many populations. © 2014 S. Karger AG, Basel. Source

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