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3. An international expanded-access programme of everolimus: Addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy

Author

Grünwald, V, Karakiewicz, P, Bavbek, S, Miller, K, Machiels, J, Lee, S, Larkin, J, Bono, P, Rha, S, Castellano, D, Blank, C, Knox, J, Hawkins, R, Anak, O, Rosamilia, M, Booth, J, Pirotta, N, Bodrogi, I, Romedi, M, Ferrandini, S, Rondinon, M, Pittman, K, Goldstein, D, Shapiro, J, Troon, S, Yip, D, Mainwaring, P, Zigeuner, R, Loidl, W, Greil, R, Schmidinger, M, De Grève, J, Rottey, S, Vermorken, J, Gil, T, Gennigens, C, Roumeguere, T, Barrios, C, Mathias, C, Assi, H, Hotte, S, Spadafora, S, Wood, L, Zalewski, P, Mackensie, M, Bjarnason, G, Lalancette, A, Chan, A, Higgins, B, North, S, Soulieres, D, Asselah, J, Sperlich, C, Miller, W, Yadav, S, El Maraghi, R, Godoy, J, Prausová, J, Katolicka, J, Petruzelka, L, Kiss, I, Lapela, M, Bergmann, L, Beck, J, Jäger, E, Kindler, M, Overkamp, F, Wirth, M, Hölzer, W, Gschwend, J, Stenzl, A, Gauler, T, Niederwieser, D, Marschner, N, Lück, A, Tessen, H, Eichelberg, C, Steiner, T, Goebell, P, Kettner, E, Bakhshandeh Bath, A, Wilhelm, M, Schmitz, S, Jacob, A, Bierer, S, Kube, U, Staehler, M, Engel, E, Frambach, M, Schellenberger, U, Albers, P, Simon, J, Gleissler, M, Klotz, T, Repp, R, Kröning, H, Westermann, J, Rebmann, U, Brehmer, B, Niederle, N, Grund, C, Verpoort, K, Fonara, P, Rassweiler, J, Bamias, A, Fountzilas, G, Razis, E, Mouratidou, D, Georgoulias, V, Samantas, E, Mangel, L, Szanto, J, Berger, R, Pe'Er, A, Sella, A, Ben Yosef, R, Nechushtan, H, Crinò, L, Bracarda, S, Ciuffreda, L, Graiff, C, Falcone, A, Roselli, M, Sternberg, C, Santoro, A, Ruggeri, E, Bearz, A, Venturini, M, Aglietta, M, Amadori, D, Di Costanzo, F, Bari, M, Gebbia, N, Conte, P, Bonetti, A, Bordonaro, R, Cascinu, S, Contu, A, Cruciani, G, Gasparro, D, Nardi, M, Lelli, G, Lo Re, G, Boccardo, F, Lorusso, V, Maiello, E, Manente, P, Passalacqua, R, Piantedosi, F, Porta, C, Sacco, C, Tondini, C, De Placido, S, Carteni, G, Dogliotto, L, Rosti, G, Milella, M, Roila, F, Amoroso, D, Farina, G, Al Khatib, H, Kim, T, Ahn, J, Lim, H, Chung, I, Kim, J, Chung, J, Ghosn, M, Shameseddine, A, Lugo, R, Cabrera, P, Osanto, S, Groenewegen, G, van den Eertwegh, F, van Herpen, C, Oosting, S, Soetekouw, P, Lilleby, W, Klepp, O, Guren, T, Alcedo, J, Karlov, P, Nosov, D, Roman, L, Rusakov, I, Bazarbashi, S, Toh, C, Mardiak, J, del Muro Solans, F, Ray, J, Mollins, J, Martinez, I, Gonzalez, B, Santasusana, M, Piqueras, M, Fuentes, J, Larriba, J, Caro, R, Garcia, A, Aparicio, L, Lopez, N, Aragon, V, Morales, C, Figueiras, M, Ibanez, J, Billalabeitia, G, Estrada, E, Arranz, J, Sorrosal, J, Lozano, A, de Villena, M, Espinosa, E, Lopez, R, Perez, J, Laurell, A, Stierner, U, Cwikiel, M, Borner, M, Dietrich, P, Rothermundt, C, Pu, Y, Chang, Y, Ou, Y, Chuang, C, Liao, Y, Srimuninnimit, V, Sriuranpong, V, Buyukberber, S, Yalcin, B, Goker, E, Yalcin, S, Geldart, T, Wagstaff, J, Nicholson, S, Chowdhury, S, Bahl, A, Jones, R, Azzabi, A, Chao, D, Fife, K, Mead, G, Nathan, P, Pandha, H, Hajdenberg, J, Gabrail, N, Nimeh, N, Logan, T, Flaig, T, Schraeder, R, Rini, B, O'Rourke, M, Alemany, C, Kessinger, A, Amin, A, Arriaga, M, Rodriguez, J, Gauler, Thomas (Beitragende*r), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, and Laboratory of Molecular and Medical Oncology

Subjects
Nephrology, Oncology, Male, Cancer Research, mTOR inhibitor, Settore MED/06 - Oncologia Medica, Medizin, Advanced kidney cancer, RAD001, REACT, 0302 clinical medicine, Renal cell carcinoma, Receptors, 80 and over, Treatment Failure, Neoplasm Metastasis, Aged, 80 and over, 0303 health sciences, Vascular Endothelial Growth Factor, Sirolimus, Young Adult, Antineoplastic Agents, Humans, Aged, Immunosuppressive Agents, Protein Kinase Inhibitors, Receptors, Vascular Endothelial Growth Factor, Kidney Neoplasms, Adult, Carcinoma, Renal Cell, Middle Aged, Female, 3. Good health, 030220 oncology & carcinogenesis, Safety, medicine.drug, medicine.medical_specialty, SECOND LINE THERPAY, Second-line therapy, Everolimus, 03 medical and health sciences, Internal medicine, medicine, Adverse effect, 030304 developmental biology, business.industry, Carcinoma, Renal Cell, medicine.disease, Surgery, Clinical trial, Expanded access, business, Kidney cancer
Abstract

BACKGROUND AND OBJECTIVES: The RECORD-1 trial established the clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to address an unmet medical need by providing everolimus prior to commercial availability, and also to further assess the safety and efficacy of everolimus in patients with VEGFr-TKI-refractory mRCC. PATIENTS AND METHODS: REACT (Clinicaltrials.gov: NCT00655252) was a global, open-label, expanded-access programme in patients with mRCC who were intolerant of, or who had progressed on or after stopping treatment with, any available VEGFr-TKI therapy. Patients received everolimus 10mg once daily, with dose and schedule modifications allowed for toxicity. Patients were closely monitored for the development of serious and grades 3/4 adverse events (AEs). Response was assessed by RECIST every 3months for the first year and every 6months thereafter. RESULTS: A total of 1367 patients were enroled. Safety findings and tumour responses were consistent with those observed in RECORD-1, with no new safety issues identified. The most commonly reported serious AEs were dyspnoea (5.0%), pneumonia (4.7%) and anaemia (4.1%), and the most commonly reported grades 3/4 AEs were anaemia (13.4%), fatigue (6.7%) and dyspnoea (6.5%). Best overall response was stable disease in 51.6% and partial response in 1.7% of patients. Median everolimus treatment duration was 14weeks. CONCLUSION: Everolimus is well tolerated in patients with mRCC and demonstrates a favourable risk-benefit ratio.

Published
2012

8. Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results

Author

Salvatore Pisconti, Vittorio Gebbia, Michele Aieta, Erica Palesandro, Emanuele Naglieri, Donatello Gasparro, Nicolò Borsellino, Antonio Maestri, Anna Crispo, A. Farnesi, Francesco Grillone, Lucia Bonomi, Gaetano Facchini, Giovanni Re, Giacomo Cartenì, Rocco De Vivo, Sarah Scagliarini, Giuseppe Di Lorenzo, Umberto Basso, Ferdinando De Vita, Enrico Ricevuto, Gelsomina Iovane, Claudio Sini, Maria Giuseppa Vitale, Luca Galli, Carla Cavaliere, Sabrina Rossetti, Carmine D'Aniello, Michele De Tursi, Carlo Buonerba, Chiara Ciccarese, Roberto Iacovelli, Claudio Scavelli, Ugo De Giorgi, Paolo Marchetti, Vincenza Conteduca, Leonardo La Torre, Massimiliano Berretta, Facchini, G., Rossetti, S., Berretta, M., Cavaliere, C., Scagliarini, S., Vitale, M. G., Ciccarese, C., Di Lorenzo, G., Palesandro, E., Conteduca, V., Basso, U., Naglieri, E., Farnesi, A., Aieta, M., Borsellino, N., La Torre, L., Iovane, G., Bonomi, L., Gasparro, D., Ricevuto, E., De Tursi, M., De Vivo, R., Lo Re, G., Grillone, F., Marchetti, P., De Vita, F., Scavelli, C., Sini, C., Pisconti, S., Crispo, A., Gebbia, V., Maestri, A., Galli, L., De Giorgi, U., Iacovelli, R., Buonerba, C., Carteni, G., and D'Aniello, C.

Subjects
Adult, Male, 0301 basic medicine, Oncology, medicine.medical_specialty, Multivariate analysis, Axitinib, Metastatic, Renal cancer, Sunitinib, Treatment, medicine.medical_treatment, Population, lcsh:Medicine, Kaplan-Meier Estimate, Disease-Free Survival, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Humans, Medicine, Neoplasm Metastasis, education, Adverse effect, Metastatic renal cell cancer, Carcinoma, Renal Cell, Aged, Aged, 80 and over, Second-line therapy, education.field_of_study, business.industry, Research, lcsh:R, General Medicine, Middle Aged, Kidney Neoplasms, Nephrectomy, 030104 developmental biology, 030220 oncology & carcinogenesis, Multivariate Analysis, Female, business, medicine.drug
Abstract

Background This multi-institutional retrospective real life study was conducted in 22 Italian Oncology Centers and evaluated the role of Axitinib in second line treatment in not selected mRCC patients. Methods 148 mRCC patients were evaluated. According to Heng score 15.5%, 60.1% and 24.4% of patients were at poor risk, intermediate and favorable risk, respectively. Results PFS, OS, DCR and ORR were 7.14 months, 15.5 months, 70.6% and 16.6%, respectively. The duration of prior sunitinib treatment correlated with a longer significant mPFS, 8.8 vs 6.3 months, respectively. Axitinib therapy was safe, without grade 4 adverse events. The most frequent toxicities of all grades were: fatigue (50%), hypertension (26%), and hypothyroidism (18%). G3 blood pressure elevation significantly correlated with longer mPFS and mOS compared to G1-G2 or no toxicity. Dose titration (DT) to 7 mg and 10 mg bid was feasible in 24% with no statistically significant differences in mPFS and mOS. The sunitinib-axitinib sequence was safe and effective, the mOS was 41.15 months. At multivariate analysis, gender, DCR to axitinib and to previous sunitinib correlated significantly with PFS; whereas DCR to axitinib, nephrectomy and Heng score independently affected overall survival. Conclusions Axitinib was effective and safe in a not selected real life mRCC population. Trial registration INT – Napoli – 11/16 oss. Registered 20 April 2016. http://www.istitutotumori.na.it

Published
2019

9. Comparison of HER2 status in primary and paired metastatic sites of gastric carcinoma

Author

C, Bozzetti, F V, Negri, C A, Lagrasta, P, Crafa, C, Bassano, I, Tamagnini, G, Gardini, R, Nizzoli, F, Leonardi, D, Gasparro, R, Camisa, S, Cavalli, S, Capelli, E M, Silini, A, Ardizzoni, Bozzetti C, Negri FV, Lagrasta CA, Crafa P, Bassano C, Tamagnini I, Gardini G, Nizzoli R, Leonardi F, Gasparro D, Camisa R, Capelli S, Silini EM, and Ardizzoni A

Subjects
Male, Oncology, Pathology, Cancer Research, Skin Neoplasms, Receptor, ErbB-2, Gastric carcinoma, Gastroenterology, Metastasis, Trastuzumab, Ascitic Fluid, Medicine, Stomach cancer, skin and connective tissue diseases, In Situ Hybridization, Fluorescence, Peritoneal Neoplasms, Aged, 80 and over, Clinical Trials as Topic, Liver Neoplasms, Antibodies, Monoclonal, Middle Aged, Immunohistochemistry, Up-Regulation, Gene Expression Regulation, Neoplastic, Lymphatic Metastasis, Adenocarcinoma, Female, Esophagogastric Junction, Corrigendum, HER2, gastric cancer, FISH, immunohistochemistry, medicine.drug, medicine.medical_specialty, Concordance, Antineoplastic Agents, Antibodies, Monoclonal, Humanized, Pancreatic Lymph Node, FISH, Stomach Neoplasms, HER2, Internal medicine, Biomarkers, Tumor, Humans, Aged, business.industry, gastric cancer, Cancer, medicine.disease, Pleural Effusion, Malignant, Clinical Study, business
Abstract

Background: Trastuzumab has recently shown efficacy in the treatment of HER2-positive advanced gastric adenocarcinoma. Although antibody-based therapies target the metastatic disease, HER2 status is usually evaluated in the primary tumour because metastatic sites are rarely biopsied. The aim of this study was to compare HER2 status in primary and paired metastatic sites of gastric adenocarcinoma. Methods: The HER2 status was assessed by fluorescence in situ hybridisation (FISH) and immunohistochemistry (IHC) in 72 secondary lesions of gastric adenocarcinoma and in the corresponding primary tumours. Results: Concordance of FISH results, evaluable in 68 primary and matched metastatic sites, was 98.5%. Concordance of IHC results, available in 39 of the 72 paired cases, was 94.9%. Only one case showed discordance between primary tumour and metastasis, being negative by both IHC and FISH in the primary and showing HER2 overexpression and amplification in the corresponding pancreatic lymph node metastasis. Conclusion: The high concordance observed between HER2 results obtained by both IHC and FISH on primary tumours and corresponding metastases suggests that in gastric cancer HER2 status is maintained in most cases unchanged during the metastatic process. Keywords: HER2, gastric cancer, FISH, immunohistochemistry

Published
2011

10. Comparison between epidermal growth factor receptor (EGFR) gene expression in primary non-small cell lung cancer (NSCLC) and in fine-needle aspirates from distant metastatic sites

Author

Michele Rusca, Francesco Leonardi, Andrea Ardizzoni, Elena Spiritelli, Rita Nizzoli, Vittorio Franciosi, Guido Rindi, Cecilia Bozzetti, Maria Majori, Donatello Gasparro, Annamaria Guazzi, Costanza Lagrasta, Paolo Carbognani, Marcello Tiseo, Bozzetti C, Tiseo M, Lagrasta C, Nizzoli R, Guazzi A, Leonardi F, Gasparro D, Spiritelli E, Rusca M, Carbognani P, Majori M, Franciosi V, Rindi G, and Ardizzoni A

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Lung Neoplasms, EGFR, Biopsy, Fine-Needle, Gene Dosage, non-small cell lung cancer (NSCLC), NSCLC, Gene dosage, Metastasis, Primary tumor, FISH, Carcinoma, Non-Small-Cell Lung, Internal medicine, Cytology, medicine, Humans, Epidermal growth factor receptor, Copy-number variation, Neoplasm Metastasis, In Situ Hybridization, Fluorescence, Aged, Aged, 80 and over, biology, medicine.diagnostic_test, business.industry, Middle Aged, medicine.disease, ErbB Receptors, Carcinoma, Squamous Cell, biology.protein, Feasibility Studies, Female, NSCLC, EGFR, FISH, Primary tumor, Metastasis, business, Fluorescence in situ hybridization
Abstract

Purpose Epidermal growth factor receptor ( EGFR ) gene copy number obtained by fluorescence in situ hybridization (FISH) has been recently found to predict treatment outcome in non-small cell lung cancer (NSCLC) patients receiving EGFR tyrosine kinase inhibitors. However, it is still unknown whether EGFR status differs in metastases compared with primary NSCLC. In all studies FISH have been performed on histologic material. The possibility to perform FISH analysis on cytologic material obtained by fine-needle aspiration from superficial and visceral metastases would allow us to know the real EGFR status avoiding invasive diagnostic procedures. Methods EGFR gene copy number was analyzed by FISH on fine-needle aspirates obtained from 31 patients with metastatic NSCLC and the results were compared with those obtained on corresponding paraffin histologic sections from the primary tumor. Results The feasibility of EGFR FISH on cytology was 90% (28 of 31 patients). EGFR FISH was positive in 61% (17 of 28 patients) of the metastases and in 36% (10 of 28 patients) of the primary tumors. Nine of the 28 cases (32%) were EGFR positive on both primary tumor and metastatic site and 10 (36%) were negative on both primary tumor and metastasis. Nine of the 28 cases (32%) showed discordance of primary tumor versus metastasis (McNemar test; p = 0.041). Conclusions EGFR FISH can be reliably assessed on fine-needle aspirates obtained from NSCLC metastases. We found that EGFR gene copy number is discordant between primary NSCLC and the corresponding distant metastatic sites in a significant proportion of cases. These findings should be considered in future studies designed to elucidate the predictive role of EGFR FISH in NSCLC.

Published
2008

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