BackgroundPanitumumab is a fully human monoclonal antibody Ig G2 whose target is the epidermal growth factor receptor (EGFR). It is indicated as monotherapy to treat patients with metastatic colorectal cancer (mCRC) that show EGFR with wild-type KRAS, after failure of chemotherapy regimens containing fluoropyrimidine, oxaliplatin and/or irinotecan.PurposeThe purpose of this study was to evaluate the effectiveness and safety of panitumumab monotherapy in patients with mCRC.Material and methodsThis was a retrospective observational study of patients with mCRC treated with panitumumab as monotherapy from June 2008 to September 2015. Demographic, clinical and pharmacotherapeutic information was collected from the computerised medical records. The main effectiveness variables were: type of response to treatment (following RECIST criteria), progression free survival (PFS) and overall survival (OS). Frequency of adverse effects and severity (according to CTCAE V.4.0) established the safety profile of the treatment.Results30 patients were included: 73% men (n=22), average age 65.4 years (SD=10.7), 56.6% (n=17) ECOG PS 2 at the beginning of treatment and 46.7% (n=14) stage IV diagnosed. Panitumumab was used as a second-(n=10), third- (n=11) and fourth-line (n=9) treatment. Median number of cycles was 6 (IQR 4–10) and the average treatment period was 3.9 months (SD=2.6). Objective response rate was 10% (n=3), all being partial responses. 10% (n=3) showed stabilisation of disease and 63.3% (n=19) progression. In 5 patients the response was not evaluable (2 treatment cycles until death). The SLP median was 3 months (95% CI 1.7–4.2) and the SG median was 8 months (95% CI 3.6–12.3). Dermatologic toxicities occurred in 70% (n=21) of patients, and were severe (grade 3 and higher) in 15% of patients receiving panitumumab monotherapy. It was necessary to reduce the drug dose in 3 patients (due to dermal toxicity), with an average reduction of 26% (SD=11.5, range 20–40).ConclusionPanitumumab as monotherapy showed adequate effectiveness (SLP median 3 months and SG median 8 months) in patients with mCRC: pretreated, KRAS wild-type and poor performance status. It should be noted that dermal toxicity was observed in 70% of patients, characteristic of the EGFR inhibitor family. Future guidelines for mCRC treatment will have to establish the optimum sequence of use of the available therapies with the aim of achieving the greatest clinical benefit in patients.References and/or acknowledgementsI want to thank Beatriz Sánchez Castellanos for her support and time.No conflict of interest
Conclusion SI makes it difficult to manage medicines at the pharmacy service and consumes a significant amount of resources so that they do not affect the patient. Shortages usually increase treatment costs. Considering that most of the supply problems are essential drugs, these problems can compromise the quality of healthcare and patient safety.
El Enterococcuss faecalis es un coco grampositivo, anaerobio facultativo. El reservorio más importante es el hombre dado que forma parte de la microbiota normal. Raramente es agente causal de artritis séptica debido a su baja afinidad por los tejidos osteoarticulares. Presentamos un caso de un paciente de 81 años, con una uropatía obstructiva baja y sonda vesical que presenta artritis séptica sobre articulación nativa.
BackgroundBosentan, an orphan drug, is a dual endothelin receptor antagonist indicated in pulmonary hypertension and in the prevention of new digital ulcers (DU) in patients with systemic sclerosis and ongoing digital ulcer disease.PurposeTo evaluate the effectiveness and safety of bosentan in the treatment of clinical manifestations associated with underlying autoimmune disease (Raynaud’s phenomenon (RP), DU and other location skin ulcers (SU)), all of them considered rare diseases.Material and methodsRetrospective observational study including patients treated with bosentan from January 2012 to September 2014, on compassionate use.Variables collected were: sex, age, underlying disease, indication, previous treatments, dose and follow-up time.Effectiveness was evaluated as: absence of new ulcers, improvement of the basal ulcers and decrease in the number of RP episodes.The safety profile was determined according to the adverse reactions.Results14 patients were included; follow up (median, range): 22 (2–55) months; sex: 10 (71%) female; age: 52 (25–81) years.All of them had previously been treated with first-line treatment until resistance or intolerance had developed.In 11 cases bosentan was indicated to treat RP and prevent/treat DU (4 systemic sclerosis, 3 pre-systemic sclerosis, 2 systemic lupus erythematosus (SLE), 1 dermatomyositis and 1 Buerger´s disease. Getting the next results: 63.6% effective (7), 18.2% ineffective (2) and 18.2% could not be evaluated.In the other 3 cases, bosentan was used to treat other location SUs (1 polyarteritis nodosa,1 SLE and 1 necrobiosis lipoidica) with 100% effectiveness.The treatment was discontinued in two cases due to digestive intolerance. In another two cases, the dose was adjusted as a consequence of an initial increase in the hepatic enzymes.ConclusionBosentan may be considered an appropriate alternative in these diseases which have been refractory to conventional treatment. The number of patients is limited due to the low prevalence of these diseases and to the off-label use of the drug. Therefore, it could be said that value of research lies in the possibility of opening new therapeutic perspectives with this drug.References and/or AcknowledgementsNo conflict of interest.
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