Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment

Purpose The objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer. Methods Randomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint: grade 3–4 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints: SOM duration and grade 2–4 OM or Ulcerative Oral Mucositis (UOM) incidence and duration. Results Eighty-four patients were included in the study. Concurrent systemic treatments were cisplatin (n = 54; 64%) or cetuximab (n = 30; 36%). Compared with the placebo arm, RTOG-defined SOM incidence was numerically lower in the 3% melatonin oral gel arm (53 vs. 64%, P = 0.36). In patients treated with cisplatin, assessed by the RTOG-NCI composite scale, both SOM incidence (44 vs. 78%; P = 0.02) and median SOM duration (0 vs. 22 days; P = 0.022) were significantly reduced in the melatonin arm. Median UOM duration assessed by the RTOG-NCI scale was also significantly shorter in the melatonin arm (49 vs. 73 days; P = 0.014). Rate of adverse events and overall response rate were similar between the two arms. Conclusions Treatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial (AU)

Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment.

PURPOSE: The objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer. METHODS: Randomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint: grade 3-4 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints: SOM duration and grade 2-4 OM or Ulcerative Oral Mucositis (UOM) incidence and duration. RESULTS: Eighty-four patients were included in the study. Concurrent systemic treatments were cisplatin (n = 54; 64%) or cetuximab (n = 30; 36%). Compared with the placebo arm, RTOG-defined SOM incidence was numerically lower in the 3% melatonin oral gel arm (53 vs. 64%, P = 0.36). In patients treated with cisplatin, assessed by the RTOG-NCI composite scale, both SOM incidence (44 vs. 78%; P = 0.02) and median SOM duration (0 vs. 22 days; P = 0.022) were significantly reduced in the melatonin arm. Median UOM duration assessed by the RTOG-NCI scale was also significantly shorter in the melatonin arm (49 vs. 73 days; P = 0.014). Rate of adverse events and overall response rate were similar between the two arms. CONCLUSIONS: Treatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial.

Nasopharyngeal carcinoma: 30-year experience of a single institution in a non-endemic area

Purpose. Over the past years, radiotherapy techniques have changed significantly. The impact of these changes in the management of nasopharyngeal carcinoma (NPC) has not been fully evaluated. Methods/patients. Between 1984 and 2014, 223 NPC were diagnosed in our hospital. Prior to 2000, patients were treated with 2D treatment plan (RT2D) that evolved to 3D schemes thereafter (RT3D). Results. Tumors in the RT3D period showed significantly lower stages than those in the RT2D period. 5-year cause-specific survival improved from 55.7% (95% CI: 46.7-64.7%) in the RT2D period to 78.7% (95% CI: 68.7-88.7%) in the RT3D period (P = 0.006). This difference was greater for non-keratinizing NPC, where specific survival went from 63.2% (95% CI: 52.2-74.2%) to 84.4% (95% CI: 74.4-94.4%) (P = 0.014). Conclusion. Recent changes in treatment strategies including concurrent chemoradiation and 3D radiotherapy may have impacted in better survival for NPC. Improved imaging techniques may have contributed by earlier detection and better treatment planning (AU)

No disponible

Nasopharyngeal carcinoma: 30-year experience of a single institution in a non-endemic area.

PURPOSE: Over the past years, radiotherapy techniques have changed significantly. The impact of these changes in the management of nasopharyngeal carcinoma (NPC) has not been fully evaluated. METHODS/PATIENTS: Between 1984 and 2014, 223 NPC were diagnosed in our hospital. Prior to 2000, patients were treated with 2D treatment plan (RT2D) that evolved to 3D schemes thereafter (RT3D). RESULTS: Tumors in the RT3D period showed significantly lower stages than those in the RT2D period. 5-year cause-specific survival improved from 55.7% (95% CI: 46.7-64.7%) in the RT2D period to 78.7% (95% CI: 68.7-88.7%) in the RT3D period (P = 0.006). This difference was greater for non-keratinizing NPC, where specific survival went from 63.2% (95% CI: 52.2-74.2%) to 84.4% (95% CI: 74.4-94.4%) (P = 0.014). CONCLUSION: Recent changes in treatment strategies including concurrent chemoradiation and 3D radiotherapy may have impacted in better survival for NPC. Improved imaging techniques may have contributed by earlier detection and better treatment planning.

Trasplante renal de donante vivo en paciente VIH positivo / Living donor kidney transplatation in a HIV patient

La infección por el virus de la inmunodeficiencia humana (VIH) ha dejado de ser una contraindicación absoluta para el trasplante renal desde la introducción del tratamiento antirretroviral de gran actividad (TARGA). Se han establecido unos criterios consensuados para seleccionar a los pacientes VIH positivo candidatos a un trasplante: no haber sufrido enfermedades definitorias de SIDA (criptosporidiosis intestinal, leuco encefalopatía multifocal progresiva o sarcoma de Kaposi sistémico), tener una cifra de linfocitos CD4 mayor de 200 células/ µL, tener una carga viral indetectable y estar con tratamiento antirretroviral de gran actividad. Cumpliendo estos criterios, individualizando el tratamiento antirretroviral y con una pauta inmunosupresora óptima, la supervivencia del injerto renal al año es comparable a la de los pacientes VIH negativo. Presentamos el primer trasplante renal de donante vivo en un paciente VIH realizado en la Fundación Puigvert (AU)

Since the introduction of highly active antiretroviral therapy (HAART), human immunodeficiency virus (HIV) infection is no longer an absolute contraindication for renal transplantation. Selection criteria have been established for selecting HIV patients as a candidates for a transplant: not having suffered AIDS-defining disease (intestinal cryptosporidiosis, progressive multifocal leukoencephalopathy or systemic Kaposi sarcoma), to have a CD4 T-cell count greater than 200 cells/mL, undetectable viral load and being under treatment with highly active antiretroviral therapy. Fulfilling these criteria, individualizing antiretroviral therapy and with optimal immunosuppressive regimen, graft survival rates are similar to those reported for patients without HIV. We present the first Kidney transplantation from living donor in HIV patient performed at Fundació Puigvert (AU)

Induction chemotherapy with paclitaxel plus carboplatin followed by paclitaxel with concurrent radiotherapy in stage IIIB non-small-cell lung cancer (NSCLC) patients: a phase II trial.

PURPOSE: We conducted a prospective phase II trial to evaluate the efficacy and toxicity of induction chemotherapy with paclitaxel plus carboplatin followed by concurrent radiotherapy with weekly paclitaxel in stage IIIB non-small-cell lung cancer (NSCLC) patients. PATIENTS AND METHODS: Patients with stage IIIB NSCLC received two 3-week cycles of paclitaxel 200mg/m(2) combined with carboplatin (target area under the plasma concentration curve (AUC) of 6 mg/ml) followed by weekly paclitaxel 50mg/m(2) concurrently with radiotherapy consisted of 2 Gy daily, 5 days per week (60 Gy total dose in 6 weeks). The median follow-up period was 5 years. RESULTS: Between March 1999 and January 2002, 21 patients were enrolled and analyzed. Ninety percent of patients completed the planned treatment schedule. The overall response rate was 76% (24% complete response and 52% partial response). The median overall survival time was 15 months and the 1-year, 2-year and 5-year overall survival rates were 57, 33 and 24%, respectively. The disease progression rate at 1 year was 43% and the median progression-free survival was 8 months. During the chemoradiation period, grade 3-4 oesophagitis and pneumonitis were observed in 24 and 14% of patients, respectively. CONCLUSIONS: Induction chemotherapy with carboplatin and paclitaxel followed by weekly paclitaxel with concurrent radiotherapy was found to be active and tolerable in selected stage IIIB NSCLC patients. Further studies are needed to improve the safety profile and outcome in this setting.

[Drug prescriptions in Catalonia following the Decree of Selective Financing of Drugs]. / La prescripción farmacéutica en Cataluña tras el Decreto de Financiación Selectiva de Medicamentos.

OBJECTIVES: To assess the consequences of the Selective Financial Decree for prescription drugs in Catalonia. METHODS: Observational longitudinal study of the registry of prescribed pharmaceutical specialties that were charged to the Catalan Service of Health, from august 1991 to July 1994. 243.8 million of prescriptions were analyzed. RESULTS: Between the 12 months prior to the Decree and the 12 months following, the number of drug prescriptions was reduced by 10%. As a whole, the drugs included in the decree were loosing sales before the Decree; 38% of then were not been prescribed at all during the period studied. The main groups affected by the Decree were, vitamins associations, stimulants an associations with cough suppressants, mainly with a low therapeutic value. There has only been and important and clear substitution effect in antianemic and cough suppressants associations. CONCLUSION: In general, substitutions between pharmaceutical groups were few and positive.