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PubMed | Instituto Oncologico, University Cattolica Sacro Cuore, San Paolo Hospital, Irccs Instituto Of Ricerche Farmacologiche Mario Negri and 2 more.
Type: Journal Article | Journal: Journal of geriatric oncology | Year: 2015

Some parameters of the Comprehensive Geriatric Assessment (CGA) are predictive of chemotherapy toxicity. The Vulnerable Elders Survey-13 (VES-13) is a short instrument that has been tested as a means of identifying patients who need a full CGA, but its ability to predict chemotherapy toxicity is still unclear. We performed a pooled analysis of four published clinical trials studying VES-13 as a means of diagnosing vulnerability, in order to evaluate its accuracy in predicting the risk of grade 3/4 toxicity in older patients undergoing chemotherapy.The study involved patients aged 66 years with a diagnosis of solid or hematological cancer, all of whom were administered VES-13. The number of medications taken by each patient, their comorbidities, their Cumulative Illness Rating Scale for Geriatrics (CIRS-G) score and index, the type of chemotherapy and treatment line, and their Mini Mental State Evaluation (MMSE), and Mini Nutritional Assessment (MNA) scores were recorded. Information was available concerning the grades 3-4 hematological and non-hematological toxicities experienced by each patient.The study involved 648 patients aged 66 years (mean age 76.24.5, range 66-90) of whom 336 (51.9%) were female. VES-13 identified 287 patients (44.3%) as vulnerable. Grades 3-4 hematological and non-hematological toxicities were more prevalent in the vulnerable subjects (35.2% vs 20.8%, p<0.0001, and 18.5% vs 10.8%, p=0.0055), who were also at higher risk of both (adjusted ORs 2.15, 95% CI 1.46-3.17, p<0.001); and 1.66 (95% CI 1.02-2.72, p=0.043).VES-13 could be considered to be a good candidate for future prospective studies to assess older patients with cancer at risk of toxicity.


Quintero E.,Hospital Universitario Of Canarias | Bujanda L.,University of the Basque Country | Cubiella J.,Complexo Hospitalario Universitario Of Ourense | Salas D.,Colorectal Cancer Screening Program | And 32 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: Colonoscopy and fecal immunochemical testing (FIT) are accepted strategies for colorectal-cancer screening in the average-risk population. METHODS: In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, we compared one-time colonoscopy in 26,703 subjects with FIT every 2 years in 26,599 subjects. The primary outcome was the rate of death from colorectal cancer at 10 years. This interim report describes rates of participation, diagnostic findings, and occurrence of major complications at completion of the baseline screening. Study outcomes were analyzed in both intention-to-screen and as-screened populations. RESULTS: The rate of participation was higher in the FIT group than in the colonoscopy group (34.2% vs. 24.6%, P<0.001). Colorectal cancer was found in 30 subjects (0.1%) in the colonoscopy group and 33 subjects (0.1%) in the FIT group (odds ratio, 0.99; 95% confidence interval [CI], 0.61 to 1.64; P=0.99). Advanced adenomas were detected in 514 subjects (1.9%) in the colonoscopy group and 231 subjects (0.9%) in the FIT group (odds ratio, 2.30; 95% CI, 1.97 to 2.69; P<0.001), and nonadvanced adenomas were detected in 1109 subjects (4.2%) in the colonoscopy group and 119 subjects (0.4%) in the FIT group (odds ratio, 9.80; 95% CI, 8.10 to 11.85; P<0.001). CONCLUSIONS: Subjects in the FIT group were more likely to participate in screening than were those in the colonoscopy group. On the baseline screening examination, the numbers of subjects in whom colorectal cancer was detected were similar in the two study groups, but more adenomas were identified in the colonoscopy group. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT00906997.) Copyright © 2012 Massachusetts Medical Society. All rights reserved.


Bediaga N.G.,University of the Basque Country | Acha-Sagredo A.,University of the Basque Country | Guerra I.,Hospital Txagorritxu | Viguri A.,Hospital Txagorritxu | And 12 more authors.
Breast Cancer Research | Year: 2010

Introduction: Identification of gene expression-based breast cancer subtypes is considered a critical means of prognostication. Genetic mutations along with epigenetic alterations contribute to gene-expression changes occurring in breast cancer. So far, these epigenetic contributions to sporadic breast cancer subtypes have not been well characterized, and only a limited understanding exists of the epigenetic mechanisms affected in those particular breast cancer subtypes. The present study was undertaken to dissect the breast cancer methylome and to deliver specific epigenotypes associated with particular breast cancer subtypes.Methods: By using a microarray approach, we analyzed DNA methylation in regulatory regions of 806 cancer-related genes in 28 breast cancer paired samples. We subsequently performed substantial technical and biologic validation by pyrosequencing, investigating the top qualifying 19 CpG regions in independent cohorts encompassing 47 basal-like, 44 ERBB2+ overexpressing, 48 luminal A, and 48 luminal B paired breast cancer/adjacent tissues. With the all-subset selection method, we identified the most subtype-predictive methylation profiles in multivariable logistic regression analysis.Results: The approach efficiently recognized 15 individual CpG loci differentially methylated in breast cancer tumor subtypes. We further identified novel subtype-specific epigenotypes that clearly demonstrate the differences in the methylation profiles of basal-like and human epidermal growth factor 2 (HER2)-overexpressing tumors.Conclusions: Our results provide evidence that well-defined DNA methylation profiles enable breast cancer subtype prediction and support the utilization of this biomarker for prognostication and therapeutic stratification of patients with breast cancer. © 2010 de Pancorbo et al.; licensee BioMed Central Ltd.


Etxano J.,University of Navarra | Insausti L.P.,University of Navarra | Elizalde A.,University of Navarra | Lopez Vega J.M.,Hospital Universitario Marques Of Valdecilla | And 2 more authors.
Acta Radiologica | Year: 2015

Background Antiangiogenic drugs are being used in the treatment of locally advanced breast cancer. The effect of these drugs can be monitorized using high temporal resolution dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Purpose To evaluate changes in tumor microvasculature induced by bevacizumab and the usefulness of these changes predicting response to further neoadjuvant therapy. Material and Methods Seventy patients with locally advanced breast cancers were treated with one cycle of bevacizumab followed by neoadjuvant therapy, combining bevacizumab and cytotoxic chemotherapy. Two DCE-MRI were performed before and after bevacizumab. Changes in tumoral volume, pharmacodynamic curves, and pharmacokinetic variables (Ktrans, Kep, Ve, AUC90) in a ROI (ROI 1) encompassing the entire tumor and in another ROI (ROI 2) in the area of higher values of Ktrans were analyzed. Correlations with pathological response were made: parametrical and non-parametrical statistical analysis and ROC curves were used; a P < 0.05 was considered significant. Results Significant changes in tumoral volume (-4%), pharmacodynamic curves, and pharmacokinetic variables in ROI 1 Ktrans (-45%), Kep (-38%), Ve (-11%), and AUC90 (-44%) and ROI 2 Ktrans (-43%), Kep (-39%), Ve (-5%), and AUC90 (-45%) were observed after bevacizumab (P < 0.05). The effect of bevacizumab was not different between responders and non-responders (P > 0.05), and these changes could not predict response to further neoadjuvant therapy. Conclusion Bevacizumab induces remarkable tumoral volume, pharmacodynamics, and pharmacokinetic changes. However, these changes could not be used as early predictors for response to further neoadjuvant therapy. © The Foundation Acta Radiologica 2014.


Gebbia V.,University of Palermo | Maiello E.,IRCCS | Giuliani F.,Instituto Oncologico | Borsellino N.,Ospedale Buccheri la Ferla | And 2 more authors.
American Journal of Clinical Oncology: Cancer Clinical Trials | Year: 2010

Background: Patients with advanced pancreatic cancer failing gemcitabine- based first-line chemotherapy are still in relatively good clinical conditions and may still require second-line chemotherapy, which is frequently administered in daily clinical practice given to without solid scientific support. Patients and Methods: A retrospective survey was carried out including 40 patients with stage III or IV gemcitabine-refractory pancreatic carcinoma. Patients received standard FOLFIRI regimen biweekly until progression or unacceptable toxicity. Response evaluation criteria in solid tumors and National Cancer Institute common toxicity criteria were employed respectively for response and toxicity assessment. Results: Six partial responses (15%) and 14 stabilizations of disease (35%) were recorded for a tumor growth control rate of 50%. The median time to progression was 3.7 (range, 1-6.5 months), and median overall survival was 6 months (range, 2-8.2 months). A stabilization of performance status and a subjective improvement of cancer-related symptoms were recorded in 21 patients (52.5%). No correlation has been found between length of time to progression during first-line chemotherapy and length of that reported in the second-line setting or objective response. Grade 3-4 diarrhea and mucositis was observed in 15% and 10% of cases, respectively. Conclusions: Data presented in this article demonstrate that the second-line FOLFIRI regimen are able to induce an objective response in a relatively small fraction of patients with gemcitabine-refractory adenocarcinoma of the pancreas. The use of second-line chemotherapy should be carefully proposed to patients with good performance status or those who had a good response to first-line therapy. Copyright © 2010 by Lippincott Williams & Wilkins.


Numico G.,Science Oncologia | Silvestris N.,Instituto Oncologico | Russi E.G.,Science Radioterapia Oncologica
Frontiers in Bioscience - Scholar | Year: 2011

Initial research showed that EGFR targeting through known single agents, both monoclonal antibodies and small-molecule tyrosine-kinase inhibitors, applied to patients with refractory head and neck cancer, resulted in low response rates and short median survival times. However, the combination of Cetuximab with radiotherapy in patients with locally advanced disease and with a combination of platinum and fluorouracil in the setting of relapsed and/or metastatic disease resulted in a sharp improvement compared to standard therapy. Cetuximab entered clinical practice in both indications. Other anti- EGFR drugs, although showing activity, have not demonstrated an improvement of the results of standard therapy. Unfortunately, no molecular parameter emerged as a useful tool in predicting activity, thus impairing clinical applications. Only skin rash was repeatedly shown to be related with drug activity. Although generally well tolerated, class and drug specific toxicities can be troublesome and require knowledge and expertise for an optimal management. Further research is needed in order to find the best ways of integrating the anti-EGFR strategy with current standards of care.


Gonzalez Domingo M.,Instituto Oncologico | Gonzalez San Segundo C.,Hospital General Universitario Gregorio Maranon
Archivos Espanoles de Urologia | Year: 2011

Penile cancer is a radiocurable disease. The different types of radiotherapy (RT)-brachytherapy, plesiotherapy, external beam radiation therapy-have proven valid in the treatment of the primary tumor allowing preservation of the penis and sexual function. RT is even an option in candidates for surgery who reject surgery for clinical or personal reasons. A high nodal recurrence rate has been observed after inguinal lymphadenectomy, specially in patients at high risk of relapse. Technological advances in the field of RT, new imaging techniques, and more modern equipment enable RT to enhance local control and improve survival in patients with this condition. Palliative RT can exercise a decompressive effect that makes possible tumor size reduction in cases of inguinal-pelvic recurrence in patients with lymphedema and thus improve quality of life. In this article, we review the current role of RT in the treatment of penile cancer. We also present two cases that illustrate the main indications.


Chiarion-Sileni V.,Instituto Oncologico Veneto IOV | Guida M.,Instituto Oncologico | Ridolfi L.,Instituto Scientif Ico Romagnolo per Lo Studio | Romanini A.,S Chiara Hospital | And 6 more authors.
British Journal of Cancer | Year: 2011

Background:This study compared the central nervous system (CNS) metastasis incidence between a temozolomide- and a dacarbazine-based regimen in untreated stage IV melanoma patients.Methods:A total of 150 patients were randomly assigned to receive either oral temozolomide (200 mg m 2 per day; days 1-5) or intravenous dacarbazine (800 mg m 2; day 1), in combination with intravenous cisplatin (75 mg m 2; day 1) and subcutaneous interleukin-2 (3 MU twice daily; days 9-18), every 28 days (CTI and CDI).Results:A total of 149 patients were eligible for an intention-to-treat analysis (CTI: n74, CDI: n75). The 1-year cumulative CNS incidence failure was 20.6% for CTI and 31.1% for CDI (P0.22). In all 24 patients in CTI (32%) and 34 (45%) in CDI developed CNS metastases; 31 patients died of early systemic progression, before CNS evaluation. Median survival time was 8.4 months in the CTI and 8.7 in the CDI arm; in patients with CNS metastases the median survival time was 13.5 months in the CTI and 11.5 in the CDI arm. No difference in toxicity was observed between the two arms.Conclusion:The incidence of CNS failures in metastatic melanoma was not significantly reduced and the clinical course was not modified substituting a dacarbazine-based regimen with a temozolomide-based regimen. Patients who developed CNS metastases did not have a worse prognosis than patients progressing in other sites and should not be excluded from new investigational studies. © 2011 Cancer Research UK All rights reserved.


Gonzalez M.E.,Instituto Oncologico | Giannini O.H.,Instituto Oncologico | Gonzalez P.,Instituto Oncologico | Gonzalez P.,University of Valparaíso | Saldana B.,Instituto Oncologico
Clinical and Translational Oncology | Year: 2011

Purpose To analyse results of combined treatment of adjuvant radio-chemotherapy (RT-CT) in patients diagnosed with gallbladder cancer (GBC) after complete resection. Methods and material From June 1993 until July 2006, 67 patients with a diagnosis of GBC who underwent R0 surgical resection and were staged as T1b-2-3N0-1M0 received adjuvant RT-CT. Radiotherapy consisted of whole abdominal irradiation (20 Gy at 100 cGy daily) plus a boost to the tumour bed for a total of 45-59.4 Gy. Concomitant chemotherapy (fluoropyrimidines) was given. Overall survival (OS) and median survival were analysed in relation to different prognostic factors. Results With a median follow-up of 90 months, 5-year OS was 41%, in the group who underwent extended cholecystectomy it reached 57% and it was only 27% in those who underwent simple cholecystectomy (p=0.005). Median survival was 42 months for the whole population, not yet reached for the extended cholecystectomy subgroup and 23 months for the simple cholecystectomy subgroup. When analysing for histological grade, median survival was 23 months for those graded as high grade (III or IV) and 57 months for those of low-unknown grade (p=0.029). In multivariate analysis, a statistically significant OS benefit was found for those who underwent extended cholecystectomy (p=0.003). Conclusions In the absence of randomised studies, these data support the use of extended cholecystectomy followed by adjuvant RT-CT in patients diagnosed as stages T1b-2- 3N0-1M0 GBC after R0 resection.


PubMed | Hospital Of Basurto, University of Navarra, Instituto Oncologico and Hospital Universitario Marques Of Valdecilla
Type: Clinical Trial | Journal: Acta radiologica (Stockholm, Sweden : 1987) | Year: 2015

Antiangiogenic drugs are being used in the treatment of locally advanced breast cancer. The effect of these drugs can be monitorized using high temporal resolution dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).To evaluate changes in tumor microvasculature induced by bevacizumab and the usefulness of these changes predicting response to further neoadjuvant therapy.Seventy patients with locally advanced breast cancers were treated with one cycle of bevacizumab followed by neoadjuvant therapy, combining bevacizumab and cytotoxic chemotherapy. Two DCE-MRI were performed before and after bevacizumab. Changes in tumoral volume, pharmacodynamic curves, and pharmacokinetic variables (K(trans), Kep, Ve, AUC90) in a ROI (ROI 1) encompassing the entire tumor and in another ROI (ROI 2) in the area of higher values of K(trans) were analyzed. Correlations with pathological response were made: parametrical and non-parametrical statistical analysis and ROC curves were used; a P<0.05 was considered significant.Significant changes in tumoral volume (-4%), pharmacodynamic curves, and pharmacokinetic variables in ROI 1 K(trans) (-45%), Kep (-38%), Ve (-11%), and AUC90 (-44%) and ROI 2 K(trans) (-43%), Kep (-39%), Ve (-5%), and AUC90 (-45%) were observed after bevacizumab (P<0.05). The effect of bevacizumab was not different between responders and non-responders (P>0.05), and these changes could not predict response to further neoadjuvant therapy.Bevacizumab induces remarkable tumoral volume, pharmacodynamics, and pharmacokinetic changes. However, these changes could not be used as early predictors for response to further neoadjuvant therapy.

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