11 results on '"Castellano, D."'
Search Results
2. Pneumatosis intestinalis in a radioactive iodine-refractory metastasic thyroid papillary carcinoma with BRAFV600E mutation treated with dabrafenib-trametinib: a case report.
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Martín-Soberón, M. C., Ruiz, S., De Velasco, G., Yarza, R., Carretero, A., Castellano, D., and Sepúlveda-Sánchez, J. M.
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PAPILLARY carcinoma ,THYROID cancer ,SMALL intestine ,POSITRON emission tomography ,DIAGNOSIS ,INTESTINAL tumors - Abstract
Background: Pneumatosis intestinalis (PI) is a rare entity which refers to the presence of gas within the wall of the small bowel or colon which is a radiographic sign. The etiology and clinical presentation are variable. Patients with PI may present either with chronic mild non-specific symptoms or with acute abdominal pain with peritonitis. Some cases of intestinal pneumatosis have been reported as adverse events of new oncological treatments such as targeted therapies that are widely used in multiple tumors.Case Presentation: A 59-year-old caucasian female with radioactive iodine-refractory metastatic thyroid papillary carcinoma with BRAFV600E mutation was treated with dabrafenib and trametinib as a compassionate use. After 4 months treatment, positron emission tomography-computed tomography (PET-CT) showed PI. At the time of diagnosis, the patient was asymptomatic without signs of peritonitis. The initial treatment was conservative and no specific treatment for PI was needed. Unfortunately, after dabrafenib-trametinib withdrawal, the patient developed tumor progression with significant clinical worsening.Conclusions: This case report is, in our knowledge, the first description of PI in a patient treated with dabrafenib-trametinib. Conservative treatment is feasible if there are no abdominal symptoms. [ABSTRACT FROM AUTHOR]- Published
- 2021
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3. Ibrutinib combination therapy for advanced gastrointestinal and genitourinary tumours: results from a phase 1b/2 study.
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Oh DY, Maqueda MA, Quinn DI, O'Dwyer PJ, Chau I, Kim SY, Duran I, Castellano D, Berlin J, Mellado B, Williamson SK, Lee KW, Marti F, Mathew P, Saif MW, Wang D, Chong E, Hilger-Rolfe J, Dean JP, and Arkenau HT
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- Humans, Piperidines, Adenine, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Renal Cell, Kidney Neoplasms
- Abstract
Background: Ibrutinib, a first-in-class inhibitor of Bruton's tyrosine kinase, is approved for the treatment of various B-cell malignancies and chronic graft-versus-host disease. Based on encouraging preclinical data, safety and efficacy of ibrutinib combined with companion drugs for advanced renal cell carcinoma (RCC), gastric/gastroesophageal junctional adenocarcinoma (GC), and colorectal adenocarcinoma (CRC) were evaluated., Methods: Ibrutinib 560 mg or 840 mg once daily was administered with standard doses of everolimus for RCC, docetaxel for GC, and cetuximab for CRC. Endpoints included determination of the recommended phase 2 dose (RP2D) of ibrutinib in phase 1b and efficacy (overall response rate [ORR] for GC and CRC; progression-free survival [PFS] for CRC) in phase 2., Results: A total of 39 (RCC), 46 (GC), and 50 (RCC) patients were enrolled and received the RP2D. Safety profiles were consistent with the individual agents used in the study. Confirmed ORRs were 3% (RCC), 21% (GC), and 19% (CRC). Median (90% CI) PFS was 5.6 (3.9-7.5) months in RCC, 4.0 (2.7-4.2) months in GC, and 5.4 (4.1-5.8) months in CRC., Conclusions: Clinically meaningful increases in efficacy were not observed compared to historical controls; however, the data may warrant further evaluation of ibrutinib combinations in other solid tumours., Trial Registration: ClinicalTrials.gov, NCT02599324., (© 2023. The Author(s).)
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- 2023
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4. Type 2 diabetes is associated with decreased PGC1α expression in epicardial adipose tissue of patients with coronary artery disease.
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Moreno-Santos I, Pérez-Belmonte LM, Macías-González M, Mataró MJ, Castellano D, López-Garrido M, Porras-Martín C, Sánchez-Fernández PL, Gómez-Doblas JJ, Cardona F, de Teresa-Galván E, and Jiménez-Navarro M
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- Coronary Artery Disease pathology, DNA-Binding Proteins genetics, DNA-Binding Proteins metabolism, Diabetes Mellitus, Type 2 pathology, Female, Gene Expression Regulation, Humans, Logistic Models, Male, Middle Aged, Pericardium pathology, Peroxisome Proliferator-Activated Receptor Gamma Coactivator 1-alpha metabolism, RNA, Messenger genetics, RNA, Messenger metabolism, Subcutaneous Fat metabolism, Thermogenesis genetics, Transcription Factors genetics, Transcription Factors metabolism, Uncoupling Protein 1 genetics, Uncoupling Protein 1 metabolism, Adipose Tissue metabolism, Coronary Artery Disease complications, Coronary Artery Disease genetics, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 genetics, Pericardium metabolism, Peroxisome Proliferator-Activated Receptor Gamma Coactivator 1-alpha genetics
- Abstract
Background: Although recent studies indicate that epicardial adipose tissue expresses brown fat-like genes, such as PGC1α, UCP1 and PRDM16, the association of these genes with type 2 diabetes mellitus (DM2) in coronary artery disease (CAD) remains unknown., Methods: PGC1α, UCP1, and PRDM16 mRNAs expression levels were measured by real-time PCR in epicardial and thoracic subcutaneous adipose tissue from 44 CAD patients (22 with DM2 [CAD-DM2] and 22 without DM2 [CAD-NDM2]) and 23 non-CAD patients (NCAD)., Results: The CAD-DM2 patients had significantly lower PGC1α and UCP1 expression in epicardial adipose tissue than the CAD-NDM2 and NCAD patients. However, PGC1α and UCP1 mRNA trended upward in subcutaneous adipose tissue from CAD-DM2 patients. At multiple regression analysis, age, body mass index, left ventricular ejection fraction, UCP1 expression of epicardial adipose tissue and diabetes came out to be independent predictors of PGC1α levels. Epicardial adipose tissue PGC1α expression was dependent on the number of injured coronary arteries and logistic regression analysis showed that PGC1α expression in epicardial adipose tissue could exert a protective effect against coronary lesions., Conclusions: DM2 is associated with decreased expression of PGC1α and UCP1 mRNA in epicardial adipose tissue of patients with CAD, likely reflecting a loss of brown-like fat features. Decreased expression of PGC1α in human epicardial adipose tissue is associated with higher prevalence of coronary lesions.
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- 2016
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5. Impact on clinical practice of the implementation of guidelines for the toxicity management of targeted therapies in kidney cancer. The protect-2 study.
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Lainez N, García-Donas J, Esteban E, Puente J, Sáez MI, Gallardo E, Pinto-Marín Á, Vázquez-Estévez S, León L, García-Carbonero I, Suárez-Rodríguez C, Molins C, Climent-Duran MA, Lázaro-Quintela M, González Del Alba A, Méndez-Vidal MJ, Chirivella I, Afonso FJ, López-Brea M, Sala-González N, Domenech M, Basterretxea L, Santander-Lobera C, Gil-Arnáiz I, Fernández O, Caballero-Díaz C, Mellado B, Marrupe D, García-Sánchez J, Sánchez-Escribano R, Fernández Parra E, Villa Guzmán JC, Martínez-Ortega E, Belén González M, Morán M, Suarez-Paniagua B, Lecumberri MJ, and Castellano D
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- Aged, Antineoplastic Agents therapeutic use, Female, Guideline Adherence statistics & numerical data, Humans, Male, Middle Aged, Molecular Targeted Therapy adverse effects, Neoplasm Metastasis, Practice Guidelines as Topic, Spain, Antineoplastic Agents adverse effects, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms drug therapy
- Abstract
Background: The impact of such recommendations after their implementation of guidelines has not usually been evaluated. Herein, we assessed the impact and compliance with the Spanish Oncology Genitourinary Group (SOGUG) Guidelines for toxicity management of targeted therapies in metastatic renal cell carcinoma (mRCC) in daily clinical practice., Methods: Data on 407 mRCC patients who initiated first-line targeted therapy during the year before and the year after publication and implementation of the SOGUG guideline program were available from 34 Spanish Hospitals. Adherence to SOGUG Guidelines was assessed in every cycle., Results: Adverse event (AE) management was consistent with the Guidelines as a whole for 28.7% out of 966 post-implementation cycles compared with 23.1% out of 892 pre-implementation cycles (p = 0.006). Analysis of adherence by AE in non-compliant cycles showed significant changes in appropriate management of hypertension (33% pre-implementation vs. 44.5% post-implementation cycles; p < 0.0001), diarrhea (74.0% vs. 80.5%; p = 0.011) and dyslipemia (25.0% vs. 44.6%; p < 0.001)., Conclusions: Slight but significant improvements in AE management were detected following the implementation of SOGUG recommendations. However, room for improvement in the management of AEs due to targeted agents still remains and could be the focus for further programs in this direction.
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- 2016
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6. A comparison of the brief international cognitive assessment for multiple sclerosis and the brief repeatable battery in multiple sclerosis patients.
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Niccolai C, Portaccio E, Goretti B, Hakiki B, Giannini M, Pastò L, Righini I, Falautano M, Minacapelli E, Martinelli V, Incerti C, Nocentini U, Fenu G, Cocco E, Marrosu MG, Garofalo E, Ambra FI, Maddestra M, Consalvo M, Viterbo RG, Trojano M, Losignore NA, Zimatore GB, Pietrolongo E, Lugaresi A, Pippolo L, Roscio M, Ghezzi A, Castellano D, Stecchi S, and Amato MP
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- Adult, Cognition Disorders etiology, Female, Humans, Male, Middle Aged, Multiple Sclerosis complications, Cognition Disorders diagnosis, Multiple Sclerosis diagnosis, Neuropsychological Tests standards, Psychometrics instrumentation
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Background: Recently, a Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) has been developed as an international and standardized brief cognitive test, which is easily performed in everyday clinical practice for neuropsychological assessment in multiple sclerosis (MS). However, we need to gather more information about this tool compared to other neuropsychological batteries. The aim of our study is to compare the performance of BICAMS and Brief Repeatable Battery (BRB) in MS subjects., Methods: Tests of the BRB and BICAMS were administered to MS patients recruited from 11 Italian MS centres. Cognitive impairment (CI) was defined as the failure on at least two tests (scores below the fifth percentile) on the BRB and as the failure on at least one test of the BICAMS. The agreement between the performances on the two batteries was assessed through Cohen's K statistic. Finally we calculated the effects sizes for each test of the two batteries using Cohen's d., Results: The two batteries were administered to 192 MS patients (142 women, 50 men; mean age 41.4 ± 10.8 years, mean education 12.3 ± 3.5 years). Mean scores of patients were lower compared to those of healthy subjects in all the cognitive measures examined. Forty-six MS patients were identified as impaired and 48 as unimpaired on both of the batteries, when the Symbol Digit Modalities Test (SDMT) was included in the analysis. Cohen's K statistic was 0.46 which corresponds to a moderate accord. If the SDMT was excluded from the BRB, 37 MS patients were identified as impaired and 57 as unimpaired on both of the batteries. Cohen's K statistic was 0.3 which corresponds to a poor accord. The SDMT, the Paced Auditory Serial Addition Test (PASAT) 3 and 2 yielded higher d values (SDMT 0.83, PASAT 3 0.65, PASAT 2 0.84)., Conclusions: This study confirms the feasibility of BICAMS in everyday clinical practice for the identification of CI and highlights the good psychometric properties of the SDMT.
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- 2015
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7. Evaluation of the efficacy and safety of lanreotide in combination with targeted therapies in patients with neuroendocrine tumours in clinical practice: a retrospective cross-sectional analysis.
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Capdevila J, Sevilla I, Alonso V, Antón Aparicio L, Jiménez Fonseca P, Grande E, Reina JJ, Manzano JL, Alonso Lájara JD, Barriuso J, Castellano D, Medina J, López C, Segura Á, Carrera S, Crespo G, Fuster J, Munarriz J, and García Alfonso P
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- Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Agents administration & dosage, Antineoplastic Combined Chemotherapy Protocols, Cross-Sectional Studies, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neuroendocrine Tumors mortality, Peptides, Cyclic administration & dosage, Retrospective Studies, Somatostatin administration & dosage, Somatostatin adverse effects, Somatostatin therapeutic use, Young Adult, Antineoplastic Agents adverse effects, Antineoplastic Agents therapeutic use, Neuroendocrine Tumors drug therapy, Peptides, Cyclic adverse effects, Peptides, Cyclic therapeutic use, Somatostatin analogs & derivatives
- Abstract
Background: Based on the mechanism of action, combining somatostatin analogues (SSAs) with mTOR inhibitors or antiangiogenic agents may provide synergistic effects for the treatment of patients with neuroendocrine tumours (NETs). Herein, we investigate the use of these treatment combinations in clinical practice., Methods: This retrospective cross-sectional analysis of patients with NETs treated with the SSA lanreotide and targeted therapies at 35 Spanish hospitals evaluated the efficacy and safety of lanreotide treatment combinations in clinical practice. The data of 159 treatment combinations with lanreotide in 133 patients was retrospectively collected., Results: Of the 133 patients, with a median age of 59.4 (16-83) years, 70 (52.6%) patients were male, 64 (48.1%) had pancreatic NET, 23 (17.3%) had ECOG PS ≥ 2, 41 (30.8%) had functioning tumours, 63 (47.7%) underwent surgery of the primary tumour, 45 (33.8%) had received prior chemotherapy, and 115 (86.5%) had received prior SSAs. 115 patients received 1 lanreotide treatment combination and 18 patients received between 2 and 5 combinations. Lanreotide was mainly administered in combination with everolimus (73 combinations) or sunitinib (61 combinations). The probability of being progression-free was 78.5% (6 months), 68.6% (12 months) and 57.0% (18 months) for patients who only received everolimus plus lanreotide (n = 57) and 89.3% (6 months), 73.0% (12 months), and 67.4% (18 months) for patients who only received sunitinib and lanreotide (n = 50). In patients who only received everolimus plus lanreotide the median time-to-progression from the initiation of lanreotide combination treatment was 25.8 months (95% CI, 11.3, 40.3) and it had not yet been reached among the subgroup of patients only receiving sunitinib plus lanreotide. The safety profile of the combination treatment was comparable to that of the targeted agent alone., Conclusions: The combination of lanreotide and targeted therapies, mainly everolimus and sunitinib, is widely used in clinical practice without unexpected toxicities and suggests efficacy that should be explored in randomized prospective clinical trials.
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- 2015
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8. Controversies in the treatment of invasive urothelial carcinoma: a case report and review of the literature.
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Guillem V, Climent MA, Cassinello J, Esteban E, Castellano D, González-Larriba JL, Maroto P, and Camps C
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- Antineoplastic Combined Chemotherapy Protocols administration & dosage, Biopsy, Needle, Carcinoma, Transitional Cell pathology, Chemotherapy, Adjuvant, Follow-Up Studies, Humans, Immunohistochemistry, Lung Neoplasms diagnostic imaging, Male, Middle Aged, Neoplasm Invasiveness pathology, Neoplasm Recurrence, Local diagnosis, Neoplasm Staging, Radiography, Risk Assessment, Time Factors, Treatment Outcome, Carcinoma, Transitional Cell secondary, Carcinoma, Transitional Cell surgery, Cystectomy methods, Lung Neoplasms secondary, Lung Neoplasms surgery, Neoplasm Recurrence, Local drug therapy
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Background: More than 429,000 patients worldwide are diagnosed with bladder cancer each year and muscle-invasive bladder cancer has an especially poor outcome. The median age at diagnosis is over 70 years, and many patients also have a substantial number of age-associated impairments that need to be considered when planning therapeutic interventions., Case Presentation: Here, we report the case of a 63-year-old man with a cT3b urothelial carcinoma which was surgically removed. No neoadjuvant or adjuvant chemotherapy was administered. After 18 months a lung metastasis was confirmed and resected but no chemotherapy was given after surgery. Twelve months later, the patient relapsed and was treated with a combination of gemcitabine and cisplatin and after a decline in renal function the treatment was changed to a combination of carboplatin and gemcitabine which resulted in a partial response which lasted 8 months. Following this vinflunine was administered as a second line treatment. Here we review the evidence available in the literature regarding the suitability of different treatment options for managing muscle-invasive bladder cancer at each step of the case presentation., Conclusion: Bladder cancer treatment requires a multidisciplinary approach. Although, depending on the clinical characteristics of the patient, there are some controversial points in the management of this pathology we hope that the scientific data and the clinical trials reviewed in this case report, can help to guide physicians to make more rational decisions regarding the management of these patients.
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- 2015
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9. Safety and effectiveness of vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract after failure of one platinum-based systemic therapy in clinical practice.
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Castellano D, Puente J, de Velasco G, Chirivella I, López-Criado P, Mohedano N, Fernández O, García-Carbonero I, González MB, and Grande E
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- Aged, Aged, 80 and over, Antineoplastic Agents pharmacology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Transitional Cell mortality, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Retreatment, Survival Analysis, Treatment Failure, Treatment Outcome, Urinary Bladder Neoplasms mortality, Vinblastine pharmacology, Vinblastine therapeutic use, Antineoplastic Agents therapeutic use, Carcinoma, Transitional Cell drug therapy, Carcinoma, Transitional Cell pathology, Urinary Bladder Neoplasms drug therapy, Urinary Bladder Neoplasms pathology, Vinblastine analogs & derivatives
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Background: Patients with transitional cell carcinoma of the urothelial tract (TCCU) who fail initial platinum-based chemotherapy for advanced disease represent a challenge in daily clinical practice. Vinflunine is approved by the European Medicine Agency (EMA) but, up to now, limited experience has been reported outside clinical trials., Methods: We assessed the efficacy and safety of vinflunine in an unselected group of 102 consecutive patients with metastatic TCCU., Results: The median age was 67 years (range 45-83). Among the most common comorbidities that patients presented at baseline were hypertension (50.5%) and diabetes (20.7%).Distant metastases were present in retroperitoneal nodes (58%), lung (29.3%), and bone (20.2%). The ECOG 0, 1 and 2 performance status at the start of vinflunine were 31.3%, 60.6% and 8.1%, respectively. The most commonly reported adverse events of any grade were constipation 70.6% (5.9% grade 3-4), vomiting 49.1% (2% grade 3-4), neutropenia 48.1% (12.8% grade 3-4) and abdominal pain 34.3% (4.9% grade 3-4). A median of 4 cycles of vinflunine was administered per patient (range 1-18). Median progression free and overall survival for all patients (N = 102) were 3.9 months (2.3-5.5) and 10 months (7.3-12.8), respectively. Time to tumor progression was 4.3 months (2.6-5.9). Two patients (2%) achieved CR, 23 (22.5%) patients had PR, and 42 (41.2%) presented SD as best response. The clinical benefit rate with vinflunine was 65.7%., Conclusions: Our results show that the behavior of vinflunine in routine clinical practice resembles that of the pivotal phase III randomized study.
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- 2014
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10. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study.
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Martín-Richard M, Massutí B, Pineda E, Alonso V, Marmol M, Castellano D, Fonseca E, Galán A, Llanos M, Sala MA, Pericay C, Rivera F, Sastre J, Segura A, Quindós M, and Maisonobe P
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- Adult, Aged, Antineoplastic Agents pharmacology, Cell Proliferation drug effects, Combined Modality Therapy, Disease Progression, Female, Humans, Male, Middle Aged, Neoplasm Grading, Neuroendocrine Tumors mortality, Neuroendocrine Tumors therapy, Peptides, Cyclic pharmacology, Somatostatin pharmacology, Somatostatin therapeutic use, Spain, Treatment Outcome, Antineoplastic Agents therapeutic use, Neuroendocrine Tumors drug therapy, Neuroendocrine Tumors pathology, Peptides, Cyclic therapeutic use, Somatostatin analogs & derivatives
- Abstract
Background: Somatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs., Methods: This was a multicentre, open-label, phase II trial conducted in 17 Spanish specialist centres. Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, tumour biomarkers, symptom control, quality of life (QoL), and safety. Radiographic imaging was assessed by a blinded central radiologist., Results: Of 30 patients included in the efficacy and safety analyses, 40% had midgut tumours and 27% pancreatic tumours; 63% of tumours were functioning. Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%). No deterioration in QoL was observed. Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe., Conclusion: Lanreotide Autogel provided effective tumour stabilisation and PFS >12 months in patients with progressive NETs ineligible for surgery or chemotherapy, with a safety profile consistent with the pharmacology of the class., Trial Registration: ClinicalTrials.gov Identifier NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18.
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- 2013
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11. A randomized multi-center phase II trial of the angiogenesis inhibitor Cilengitide (EMD 121974) and gemcitabine compared with gemcitabine alone in advanced unresectable pancreatic cancer.
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Friess H, Langrehr JM, Oettle H, Raedle J, Niedergethmann M, Dittrich C, Hossfeld DK, Stöger H, Neyns B, Herzog P, Piedbois P, Dobrowolski F, Scheithauer W, Hawkins R, Katz F, Balcke P, Vermorken J, van Belle S, Davidson N, Esteve AA, Castellano D, Kleeff J, Tempia-Caliera AA, Kovar A, and Nippgen J
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- Adult, Angiogenesis Inhibitors toxicity, Antimetabolites, Antineoplastic therapeutic use, Antimetabolites, Antineoplastic toxicity, Cell Division drug effects, Deoxycytidine therapeutic use, Deoxycytidine toxicity, Humans, Pancreatic Neoplasms blood supply, Pancreatic Neoplasms mortality, Pancreatic Neoplasms pathology, Quality of Life, Snake Venoms toxicity, Surveys and Questionnaires, Survival Rate, Gemcitabine, Angiogenesis Inhibitors therapeutic use, Deoxycytidine analogs & derivatives, Pancreatic Neoplasms drug therapy, Snake Venoms therapeutic use
- Abstract
Background: Anti-angiogenic treatment is believed to have at least cystostatic effects in highly vascularized tumours like pancreatic cancer. In this study, the treatment effects of the angiogenesis inhibitor Cilengitide and gemcitabine were compared with gemcitabine alone in patients with advanced unresectable pancreatic cancer., Methods: A multi-national, open-label, controlled, randomized, parallel-group, phase II pilot study was conducted in 20 centers in 7 countries. Cilengitide was administered at 600 mg/m2 twice weekly for 4 weeks per cycle and gemcitabine at 1000 mg/m2 for 3 weeks followed by a week of rest per cycle. The planned treatment period was 6 four-week cycles. The primary endpoint of the study was overall survival and the secondary endpoints were progression-free survival (PFS), response rate, quality of life (QoL), effects on biological markers of disease (CA 19.9) and angiogenesis (vascular endothelial growth factor and basic fibroblast growth factor), and safety. An ancillary study investigated the pharmacokinetics of both drugs in a subset of patients., Results: Eighty-nine patients were randomized. The median overall survival was 6.7 months for Cilengitide and gemcitabine and 7.7 months for gemcitabine alone. The median PFS times were 3.6 months and 3.8 months, respectively. The overall response rates were 17% and 14%, and the tumor growth control rates were 54% and 56%, respectively. Changes in the levels of CA 19.9 went in line with the clinical course of the disease, but no apparent relationships were seen with the biological markers of angiogenesis. QoL and safety evaluations were comparable between treatment groups. Pharmacokinetic studies showed no influence of gemcitabine on the pharmacokinetic parameters of Cilengitide and vice versa., Conclusion: There were no clinically important differences observed regarding efficacy, safety and QoL between the groups. The observations lay in the range of other clinical studies in this setting. The combination regimen was well tolerated with no adverse effects on the safety, tolerability and pharmacokinetics of either agent.
- Published
- 2006
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