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Sinescu I.,Fundeni Clinical Institute | Geavlete P.,Saint John Clinical Emergency Hospital | Multescu R.,Saint John Clinical Emergency Hospital | Gangu C.,Fundeni Clinical Institute | And 7 more authors.
Urologia Internationalis | Year: 2011

Introduction: The study aimed to evaluate the long-term efficacy of treatment with extract of Serenoa repens (Prostamol Uno) in patients with lower urinary tract symptoms (LUTS) induced by benign prostatic hyperplasia (BPH). Patients and Methods: We studied 120 patients with mild or moderate LUTS induced by BPH, maximal urinary flow (Qmax) <15 ml with a voided volume ≥150 ml, prostate-specific antigen <4 ng/ml, and residual urinary volume <150 ml, treated daily for 24 months with one capsule of 320 mg ethanolic extract of Serenoa repens. Results: Statistically significant improvements in the International Prostate Symptom Score (5.5 points), quality of life (QoL; 1.8 points), Qmax (5.6 ml/s), International Index of Erectile Function (IIEF; 6.4 points) and reduction in residual urinary volume were observed during the study period. The mean prostate volume at 24 months was 36 ml, compared to 39.8 ml at baseline. Conclusions: Long-term treatment with 320 mg ethanolic extract of Serenoa repens proved to be efficient in reducing urinary obstruction, improving symptomatology and QoL of BPH patients. It also had a positive effect on sexual function, demonstrated by the statistically significant increase in the IIEF. Copyright © 2011 S. Karger AG, Basel.

Seicean A.,3rd Medical Clinic University of Medicine and Pharmacy Iuliu Hatieganu | Seicean A.,Regional Institute of Gastroenterology and Hepatology | Cainap C.,Oncological Institute Ion Chiricuta | Gulei I.,Regional Institute of Gastroenterology and Hepatology | And 3 more authors.
Journal of Gastrointestinal and Liver Diseases | Year: 2013

Background: Endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) represents an alternativeapproach to pain palliation in patients with advanced pancreatic cancer.Aim: to evaluate the safety and initial efficacy of EUS-CPN in patients with painful unresectable pancreatic cancer. Methods: Patients with inoperable body-tail pancreatic adenocarcinoma without prior chemotherapy andpain requiring opioid analgesia were included prospectively in this cohort study in a tertiary medical center. Central EUS-CPN was performed and the brief pain inventory and the Functional Assessment of Cancer Therapy measurement were applied before and 2 weeks after the procedure. Results: Thirty-two patients underwent the procedure in one session without complications. Follow-up revealed overall pain relief in 24 patients (75%) and significant improvement in pain scores. Ratings of pain interfering with general activity, walking, work, mood, enjoyment of life, relations with others, and sleep improved significantly. Physical, functional, and emotional well-being improved significantly, except for acceptance of illness and enjoyment of life. Conclusion: Central EUS-CPN was an efficient and safe method for palliative pain management in our patients with inoperable pancreatic body-tail adenocarcinoma. The pain alleviation improved the patients' functional status, sleep, and quality of life, although other variables could also be involved, but acceptance of the illness and enjoyment of life did not change after treatment.

Ramalingam S.S.,Emory University | Goss G.,University of Ottawa | Rosell R.,Catalan Institute of Nanoscience and Nanotechnology | Schmid-Bindert G.,University of Mannheim | And 18 more authors.
Annals of Oncology | Year: 2015

Background: This trial was designed to evaluate the activity and safety of ganetespib in combination with docetaxel in advanced non-small cell lung cancer (NSCLC) and to identify patient populations most likely to benefit from the combination. Patients and methods: Patients with one prior systemic therapy for advanced disease were eligible. Docetaxel (75 mg/m2 on day 1) was administered alone or with ganetespib (150 mg/m2 on days 1 and 15) every 3 weeks. The primary end points were progression-free survival (PFS) in two subgroups of the adenocarcinoma population: patients with elevated lactate dehydrogenase (eLDH) and mutated KRAS (mKRAS). Results: Of 385 patients enrolled, 381 were treated. Early in the trial, increased hemoptysis and lack of efficacy were observed in nonadenocarcinoma patients (n = 71); therefore, only patients with adenocarcinoma histology were subsequently enrolled. Neutropenia was the most common grade ≥3 adverse event: 41% in the combination arm versus 42% in docetaxel alone. There was no improvement in PFS for the combination arm in the eLDH (N = 114, adjusted hazard ratio (HR) = 0.77, P = 0.1134) or mKRAS (N = 89, adjusted HR = 1.11, P = 0.3384) subgroups. In the intent-to-treat adenocarcinoma population, there was a trend in favor of the combination, with PFS (N = 253, adjusted HR = 0.82, P = 0.0784) and overall survival (OS) (adjusted HR = 0.84, P = 0.1139). Exploratory analyses showed significant benefit of the ganetespib combination in the prespecified subgroup of adenocarcinoma patients diagnosed with advanced disease >6 months before study entry (N = 177): PFS (adjusted HR = 0.74, P = 0.0417); OS (adjusted HR = 0.69, P = 0.0191). Conclusion: Advanced lung adenocarcinoma patients treated with ganetespib in combination with docetaxel had an acceptable safety profile. While the study's primary end points were not met, significant prolongation of PFS and OS was observed in patients >6 months from diagnosis of advanced disease, a subgroup chosen as the target population for the phase III study. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Krikelis D.,Aristotle University of Thessaloniki | Pentheroudakis G.,University of Ioannina | Pentheroudakis G.,Hellenic Cooperative Oncology Group | Goussia A.,University of Ioannina | And 13 more authors.
Clinical and Experimental Metastasis | Year: 2012

Cancer of unknown primary (CUP) is a heterogeneous entity, managed on the basis of "one size fits all" therapeutic concepts; insights into the molecular biology of CUP are urgently needed. We retrospectively examined the immunohistochemical (IHC) expression of Notch1, 2, 3, Jagged1, cMET, and pMAPK biomolecules in 100 CUP tumors using tissue microarrays, aiming to study their correlation to clinicopathologic characteristics and prognostic utility for patient outcome. Notch3 and pMAPK were most frequently expressed (97 and 91 %, respectively). A linear correlation of Notch3 and cMET expression was found (p = 0.001), while pMAPK emerged as the major adverse prognostic factor (median overall survival OS 9 vs. 17 months, p = 0.016), carrying also a significantly positive predictive value (p = 0.02). Our study indicated a favorable prognostic impact of cMET expression in CUP, both in univariate (median OS 15 vs. 9 months, p = 0.05) and in multivariate analysis (Relative Risk RR for death 0.48, p = 0.025). cMET and Notch3 expression were found to be statistically more frequent in squamous carcinomas (positive in 90 % of cases), associated with a unique metastatic IHC pattern (cMET-high in soft tissue/lymph node metastases, p < 0.001, Notch3-high in visceral, peritoneal/pleural and soft tissue/lymph node metastases, p < 0.001). Our study points to the MAPK and cMET axes as crucial in defining cancer progression and outcome in CUP patients and, if validated, could justify attempts at their therapeutic modulation. © 2012 Springer Science+Business Media, LLC.

Zanetti R.,Piedmont Cancer Registry | Schmidtmann I.,University Mainz | Sacchetto L.,Piedmont Cancer Registry | Binder-Foucard F.,Registre des Cancers du Bas Rhin | And 12 more authors.
European Journal of Cancer | Year: 2015

Abstract Cancer registries must provide complete and reliable incidence information with the shortest possible delay for use in studies such as comparability, clustering, cancer in the elderly and adequacy of cancer surveillance. Methods of varying complexity are available to registries for monitoring completeness and timeliness. We wished to know which methods are currently in use among cancer registries, and to compare the results of our findings to those of a survey carried out in 2006. Methods In the framework of the EUROCOURSE project, and to prepare cancer registries for participation in the ERA-net scheme, we launched a survey on the methods used to assess completeness, and also on the timeliness and methods of dissemination of results by registries. We sent the questionnaire to all general registries (GCRs) and specialised registries (SCRs) active in Europe and within the European Network of Cancer Registries (ENCR). Results With a response rate of 66% among GCRs and 59% among SCRs, we obtained data for analysis from 116 registries with a population coverage of ∼280 million. The most common methods used were comparison of trends (79%) and mortality/incidence ratios (more than 60%). More complex methods were used less commonly: capture-recapture by 30%, flow method by 18% and death certificate notification (DCN) methods with the Ajiki formula by 9%. The median latency for completion of ascertainment of incidence was 18 months. Additional time required for dissemination was of the order of 3-6 months, depending on the method: print or electronic. One fifth (21%) did not publish results for their own registry but only as a contribution to larger national or international data repositories and publications; this introduced a further delay in the availability of data. Conclusions Cancer registries should improve the practice of measuring their completeness regularly and should move from traditional to more quantitative methods. This could also have implications in the timeliness of data publication. © 2013 Elsevier Ltd.

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