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Las Palmas de Gran Canaria, Spain

Salmeron J.,CIBER ISCIII | Salmeron J.,Complejo Hospitalario Universitario Of Granada | Salmeron J.,University of Granada | Vinaixa C.,CIBER ISCIII | And 75 more authors.
World Journal of Gastroenterology

AIM: To evaluates the effectiveness and safety of the first generation, NS3/4A protease inhibitors (PIs) in clinical practice against chronic C virus, especially in patients with advanced fibrosis. METHODS: Prospective study and non-experimental analysis of a multicentre cohort of 38 Spanish hospitals that includes patients with chronic hepatitis C genotype 1, treatment-naïve (TN) or treatment-experienced (TE), who underwent triple therapy with the first generation NS3/4A protease inhibitors, boceprevir (BOC) and telaprevir (TVR), in combination with pegylated interferon and ribavirin. The patients were treatment in routine practice settings. Data on the study population and on adverse clinical and virologic effects were compiled during the treatment period and during follow up. RESULTS: One thousand and fifty seven patients were included, 405 (38%) were treated with BOC and 652 (62%) with TVR. Of this total, 30% (n = 319) were TN and the remaining were TE: 28% (n = 298) relapsers, 12% (n = 123) partial responders (PR), 25% (n = 260) null-responders (NR) and for 5% (n = 57) with prior response unknown. The rate of sustained virologic response (SVR) by intention-to-treatment (ITT) was greater in those treated with TVR (65%) than in those treated with BOC (52%) (P < 0.0001), whereas by modified intention-to-treatment (mITT) no were found significant differences. By degree of fibrosis, 56% of patients were F4 and the highest SVR rates were recorded in the non-F4 patients, both TN and TE. In the analysis by groups, the TN patients treated with TVR by ITT showed a higher SVR (P = 0.005). However, by mITT there were no significant differences between BOC and TVR. In the multivariate analysis by mITT, the significant SVR factors were relapsers, IL28B CC and non-F4; the type of treatment (BOC or TVR) was not significant. The lowest SVR values were presented by the F4-NR patients, treated with BOC (46%) or with TVR (45%). 28% of the patients interrupted the treatment, mainly by non-viral response (51%): this outcome was more frequent in the TE than in the TN patients (57% vs 40%, P = 0.01). With respect to severe haematological disorders, neutropaenia was more likely to affect the patients treated with BOC (33% vs 20%, P ≤ 0.0001), and thrombocytopaenia and anaemia, the F4 patients (P = 0.000, P = 0.025, respectively). CONCLUSION: In a real clinical practice setting with a high proportion of patients with advanced fibrosis, effectiveness of first-generation PIs was high except for NR patients, with similar SVR rates being achieved by BOC and TVR. © The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved. Source

Clavo B.,Dr Negrin University Hospital | Clavo B.,ICIC Canary Islands Institute for Cancer Research | Robaina F.,Dr Negrin University Hospital | Robaina F.,ICIC Canary Islands Institute for Cancer Research | And 9 more authors.
Integrative Cancer Therapies

Aims. Relapsed high-grade gliomas (HGGs) have poor prognoses and there is no standard treatment. HGGs have ischemia/hypoxia associated and, as such, drugs and oxygen have low access, with increased resistance to chemotherapy and radiotherapy. Tumor hypoxia modification can improve outcomes and overall survival in some patients with these tumors. In previous works, we have described that cervical spinal cord stimulation can modify tumor microenvironment in HGG by increasing tumor blood flow, oxygenation, and metabolism. The aim of this current, preliminary, nonrandomized, study was to assess the clinical effect of spinal cord stimulation during brain reirradiation and chemotherapy deployed for the treatment of recurrent HGG; the hypothesis being that an improvement in oxygenated blood supply would facilitate enhanced delivery of the scheduled therapy. Materials and methods. Seven patients had spinal cord stimulation applied during the scheduled reirradiation and chemotherapy for the treatment of recurrent HGG (6 anaplastic gliomas and 1 glioblastoma). Median dose of previous irradiation was 60 Gy (range = 56-72 Gy) and median dose of reirradiation was 46 Gy (range = 40-46 Gy). Primary end point of the study was overall survival (OS) following confirmation of HGG relapse. Results. From the time of diagnosis of last tumor relapse before reirradiation, median OS was 39 months (95% CI = 0-93) for the overall study group: 39 months (95% CI = 9-69) for those with anaplastic gliomas and 16 months for the patient with glioblastoma. Posttreatment, doses of corticosteroids was significantly decreased (P =.026) and performance status significantly improved (P =.046). Conclusions. Spinal cord stimulation during reirradiation and chemotherapy is feasible and well tolerated. In our study, spinal cord stimulation was associated with clinical improvement and longer survival than previously reported in recurrent anaplastic gliomas. Spinal cord stimulation as adjuvant during chemotherapy and reirradiation in relapsed HGGs merits further research. © The Author(s) 2014. Source

Clavo B.,Dr Negrin University Hospital | Clavo B.,Canary Islands Institute for Cancer Research ICIC | Ceballos D.,Dr Negrin University Hospital | Gutierrez D.,Dr Negrin University Hospital | And 15 more authors.
Journal of Pain and Symptom Management

Context: Persistent or severe hemorrhagic radiation proctitis (HRP) has limited therapeutic options. Objectives: To describe our experience with ozone therapy (O3T) in the management of refractory HRP. Methods: Patients (n = 17; median age 69 years [range 42-80 years]) previously irradiated for prostate or uterine cancer and suffering persistent or severe HRP without response to conventional treatment were enrolled to receive an O 3/O2 gas mixture via rectal insufflations and topical application of ozonized oil. Most of the patients (83%) had Grade 3 or Grade 4 toxicity. Median follow-up post-O3T was 40 months (range 3-56 months). Results: Endoscopic treatments required were: 43 (median 1; range 0-10) pre-O3T; 17 (median 0; range 0-8; P = 0.063) during O3T; and five (median 0; range 0-2; P = 0.008) during follow-up. Hemoglobin levels were 10.35 g/dL (7-14 g/dL) pre-O3T and 13 g/dL (9-15 g/dL) (P = 0.001) post-O3T. Median toxicity grades were 3 (range 2-4) pre-O 3T, 1 (range 0-2; P < 0.001) at the end of O3T, and 0 (range 0-1; P < 0.001) at the last follow-up. Conclusion: Persistent advanced HRP was significantly improved with O3T. The addition of O 3T can be useful as a complementary treatment in the long-term management of HRP and, as such, merits further evaluation. © 2013 U.S. Cancer Pain Relief Committee.Published by Elsevier Inc. All rights reserved. Source

Clavo B.,Dr Negrin University Hospital | Clavo B.,Canary Islands Institute for Cancer Research ICIC | Clavo B.,Spanish Group for Clinical Research in Radiation Oncology GICOR | Santana-Rodriguez N.,Dr Negrin University Hospital | And 14 more authors.
Evidence-based Complementary and Alternative Medicine

Introduction. Persistent radiation-induced proctitis and rectal bleeding are debilitating complications with limited therapeutic options. We present our experience with ozone therapy in the management of such refractory rectal bleeding. Methods. Patients (n=12) previously irradiated for prostate cancer with persistent or severe rectal bleeding without response to conventional treatment were enrolled to receive ozone therapy via rectal insufflations and/or topical application of ozonized-oil. Ten (83%) patients had Grade 3 or Grade 4 toxicity. Median follow-up after ozone therapy was 104 months (range: 52-119). Results. Following ozone therapy, the median grade of toxicity improved from 3 to 1 (p<0.001) and the number of endoscopy treatments from 37 to 4 (p=0.032). Hemoglobin levels changed from 11.1 (7-14) g/dL to 13 (10-15) g/dL, before and after ozone therapy, respectively (p=0.008). Ozone therapy was well tolerated and no adverse effects were noted, except soft and temporary flatulence for some hours after each session. Conclusions. Ozone therapy was effective in radiation-induced rectal bleeding in prostate cancer patients without serious adverse events. It proved useful in the management of rectal bleeding and merits further evaluation. © 2015 Bernardino Clavo et al. Source

Clavo B.,Dr Negrin University Hospital | Clavo B.,ICIC Canary Islands Institute for Cancer Research | Robaina F.,ICIC Canary Islands Institute for Cancer Research | Robaina F.,Dr Negrin University Hospital | And 11 more authors.
Journal of Neuro-Oncology

The effectiveness of radiotherapy and chemotherapy in high grade gliomas (HGG) depends on tumor micro-environment. We summarize our experience of the influence of spinal cord stimulation (SCS) on this micro-environment. Patients with HGG (n = 26) were assessed pre- and post-SCS, using: (1) Doppler in middle cerebral arteries (MCA) and (2) in common carotid arteries (CCA); (3) tumor blood-flow using single photon emission computed tomography (SPECT); (4) tumor-pO 2 (mmHg) using polarographic probes (eight tumor areas from five patients); and (5) tumor glucose metabolism using 18F-fluoro-2- deoxyglucose ( 18FDG) positron emission tomography ( 18FDG-PET). Pre-SCS: tumor blood-flow was lower (P < 0.001) than peri-tumor areas and healthy contra-lateral areas. Tumor-pO 2 was lower (P < 0.042) than healthy tissue. Tumor glucose metabolism was higher than peri-tumor areas (P = 0.017) and healthy contra-lateral areas (P = 0.048). Post-SCS: there were increases in: MCA blood-flow (P ≤ 0.002), CCA blood-flow (P ≤ 0.013), tumor blood-flow (P = 0.033), tumor glucose metabolism (P = 0.027) and tumor-pO 2 (P = 0.022). The percentage of hypoxic values decreased (P = 0.007). SCS can modify tumor micro-environment. The potential usefulness of SCS in improving the effectiveness of radio-chemotherapy in HGG needs to be evaluated. © 2011 Springer Science+Business Media, LLC. Source

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