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23. Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STEP trial

Author

Gridelli C., Gallo C., Morabito A., Iaffaioli R. V., Favaretto A., Isa L., Barbera S., Gamucci T., Ceribelli A., Filipazzi V., Maione P., Rossi A., Barletta E., Signoriello S., De Maio E., Piccirillo M. C., Di Maio M., Rocco G., Vecchione A., Perrone F., Cesare Gridelli, Paolo Maione, Antonio Rossi, Ciro Gallo, Giuseppe Signoriello, Paolo Chiodini, Simona Signoriello, Francesco Perrone, Massimo Di Maio, Maria Carmela Piccirillo, Ermelinda De Maio, Jane Bryce, Alessandro Morabito, Raffaele Costanzo, Gaetano Rocco, Rosario Vincenzo Iaffaioli, Emiddio Barletta, Roberta Formato, Aldo Vecchione, Adolfo Favaretto, Giulia Pasello, Cristina Magro, Luciano Isa, Raffaele Venezia, Mario Comandè, Santi Barbera, Francesco Renda, Antonio Volpintesta, Teresa Gamucci, Maria Anna Giampaolo, Giovanni Mansueto, Anna Ceribelli, Ilaria Carbone, Domenica Pellegrini, Virginio Filipazzi, Elena Piazza, Sabrina Ferrario, Vittorina Zagonel, Giuditta di Isernia, Marco Ciaparrone, Francovito Piantedosi, Fabiana Vitiello, Nicolò Borsellino, Maria Elia Vitale, Luigi Brancaccio, Sergio Spina, Maria Rosaria Valerio, Raffaella Felletti, Salvatore Tafuto, Marianna Giampaglia, Rita Migliorino, Francesco Rosetti, Francesco Carrozza, Nestore Rossi, Mario Spatafora, Manlio Mencoboni, Ernest Marshall, Gridelli, C, Gallo, Ciro, Morabito, A, Iaffaioli, Rv, Favaretto, A, Isa, L, Barbera, S, Gamucci, T, Ceribelli, A, Filipazzi, V, Maione, P, Rossi, A, Barletta, E, Signoriello, Simona, De Maio, E, Piccirillo, Mc, Di Maio, M, Rocco, G, Vecchione, A, Perrone, F., Gridelli C., Gallo C., Morabito A., Iaffaioli R.V., Favaretto A., Isa L., Barbera S., Gamucci T., Ceribelli A., Filipazzi V., Maione P., Rossi A., Barletta E., Signoriello S., De Maio E., Piccirillo M.C., Di Maio M., Rocco G., Vecchione A., Perrone F., and Cesare Gridelli, Paolo Maione, Antonio Rossi, Ciro Gallo, Giuseppe Signoriello, Paolo Chiodini, Simona Signoriello, Francesco Perrone, Massimo Di Maio, Maria Carmela Piccirillo, Ermelinda De Maio, Jane Bryce, Alessandro Morabito, Raffaele Costanzo, Gaetano Rocco, Rosario Vincenzo Iaffaioli, Emiddio Barletta, Roberta Formato, Aldo Vecchione, Adolfo Favaretto, Giulia Pasello, Cristina Magro, Luciano Isa, Raffaele Venezia, Mario Comandè, Santi Barbera, Francesco Renda, Antonio Volpintesta, Teresa Gamucci, Maria Anna Giampaolo, Giovanni Mansueto, Anna Ceribelli, Ilaria Carbone, Domenica Pellegrini, Virginio Filipazzi, Elena Piazza, Sabrina Ferrario, Vittorina Zagonel, Giuditta di Isernia, Marco Ciaparrone, Francovito Piantedosi, Fabiana Vitiello, Nicolò Borsellino, Maria Elia Vitale, Luigi Brancaccio, Sergio Spina, Maria Rosaria Valerio, Raffaella Felletti, Salvatore Tafuto, Marianna Giampaglia, Rita Migliorino, Francesco Rosetti, Francesco Carrozza, Nestore Rossi, Mario Spatafora, Manlio Mencoboni, Ernest Marshall

Subjects
Oncology, Male, Lung Neoplasms, Deoxycytidine, Carboplatin, chemistry.chemical_compound, Elderly, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Carcinoma, Small Cell, Multivariate Analysi, Etoposide, Platinum compounds, Aged, 80 and over, Area under the curve, SCLC, Vinorelbine, Prognosis, Gemcitabine, Aged, Cisplatin, Disease-Free Survival, Female, Humans, Multivariate Analysis, Proportional Hazards Models, Quality of Life, Treatment Outcome, Vinblastine, Platinum compound, Toxicity, medicine.drug, Human, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Prognosi, Internal medicine, medicine, Antineoplastic Combined Chemotherapy Protocol, Performance status, business.industry, Carcinoma, Small Cell, Surgery, Lung Neoplasm, chemistry, Proportional Hazards Model, business
Abstract

Introduction: Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence. Methods: Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥60% and unacceptable toxicity ≤25% were required to define a combination worthy of further studies. Results: Median age of 78 eligible patients was 74 years. GemVin produced a 36.7% objective response rate. GemEto and GemCis arms were found not sufficiently active. GemCar produced 16 responses (14 with area under the curve [AUC] 3.5 and 2 with AUC 4.0) in 26 patients (61.5%) and 6 cases of unacceptable toxicity (3 at each Car dose). Conclusions: In elderly patients with extensive SCLC, GemVin, GemEto, and GemCis are not enough active and do not merit further studies. Gem plus Car might deserve further attention. © 2011 by the International Association for the Study of Lung Cancer.

Published
2012

25. Italian Survey on adjuvant treatment of non-small cell lung cancer (ISA)

Author

Banna, G, Di Maio, M, Follador, A, Collovà, E, Menis, J, Novello, S, Bria, E, Airoldi, M, Amoroso, D, Ardizzoia, A, Aurilio, G, Bajetta, E, Ballardini, P, Barbieri, F, Barletta, E, Balzelloni, M, Basso, U, Bernardini, I, Boni, C, Bordin, V, Bretti, S, Bronte, G, Brunetti, C, Buti, S, Capanna, L, Colombo, A, Condemi, G, Cortinovis, D, Dambrosio, M, Di Fonzo, C, Di Lucca, G, Dima, G, Falzetta, A, Favaretto, A, Ferraù, F, Garetto, L, Gebbia, V, Genestreti, G, Gentile, A, Giovanardi, F, Labianca, R, Lorusso, V, Mantovani, G, Martelli, O, Massari, F, Mazzoli, M, Michetti, G, Mordenti, P, Mucciarini, C, Munao, S, Nacci, A, Pogliani, C, Procopio, G, Riccardi, F, Rizzato, S, Rossi, A, Rosti, G, Russo, P, Saladino, T, Salesi, N, Santangelo, D, Sava, T, Savarino, A, Spinnato, F, Tiseo, M, Tomassi, O, Tondulli, L, Tonini, G, Turano, S, Valerio, M, Verderame, F, Zanelli, F, Zanon, E, Banna GL, Di Maio M, Follador A, Collovà E, Menis J, Novello S, Bria E, Airoldi M, Amoroso D, Ardizzoia A, Aurilio G, Bajetta E, Ballardini P, Barbieri F, Barletta E, Balzelloni ML, Basso U, Bernardini I, Boni C, Bordin V, Bretti S, Bronte G, Brunetti C, Buti S, Capanna L, Colombo A, Condemi G, Cortinovis D, Dambrosio M, Di Fonzo C, Di Lucca G, Dima G, Falzetta A, Favaretto A, Ferraù F, Garetto L, Gebbia V, Genestreti G, Gentile AL, Giovanardi F, Labianca R, Lorusso V, Mantovani G, Martelli O, Massari F, Mazzoli M, Michetti G, Mordenti P, Mucciarini C, Munao S, Nacci A, Pogliani C, Procopio G, Riccardi F, Rizzato S, Rossi A, Rosti G, Russo P, Saladino T, Salesi N, Santangelo D, Sava T, Savarino A, Spinnato F, Tiseo M, Tomassi O, Tondulli L, Tonini G, Turano S, Valerio MR, Verderame F, Zanelli F, Zanon E., Banna, G, Di Maio, M, Follador, A, Collovà, E, Menis, J, Novello, S, Bria, E, Airoldi, M, Amoroso, D, Ardizzoia, A, Aurilio, G, Bajetta, E, Ballardini, P, Barbieri, F, Barletta, E, Balzelloni, M, Basso, U, Bernardini, I, Boni, C, Bordin, V, Bretti, S, Bronte, G, Brunetti, C, Buti, S, Capanna, L, Colombo, A, Condemi, G, Cortinovis, D, Dambrosio, M, Di Fonzo, C, Di Lucca, G, Dima, G, Falzetta, A, Favaretto, A, Ferraù, F, Garetto, L, Gebbia, V, Genestreti, G, Gentile, A, Giovanardi, F, Labianca, R, Lorusso, V, Mantovani, G, Martelli, O, Massari, F, Mazzoli, M, Michetti, G, Mordenti, P, Mucciarini, C, Munao, S, Nacci, A, Pogliani, C, Procopio, G, Riccardi, F, Rizzato, S, Rossi, A, Rosti, G, Russo, P, Saladino, T, Salesi, N, Santangelo, D, Sava, T, Savarino, A, Spinnato, F, Tiseo, M, Tomassi, O, Tondulli, L, Tonini, G, Turano, S, Valerio, M, Verderame, F, Zanelli, F, Zanon, E, Banna GL, Di Maio M, Follador A, Collovà E, Menis J, Novello S, Bria E, Airoldi M, Amoroso D, Ardizzoia A, Aurilio G, Bajetta E, Ballardini P, Barbieri F, Barletta E, Balzelloni ML, Basso U, Bernardini I, Boni C, Bordin V, Bretti S, Bronte G, Brunetti C, Buti S, Capanna L, Colombo A, Condemi G, Cortinovis D, Dambrosio M, Di Fonzo C, Di Lucca G, Dima G, Falzetta A, Favaretto A, Ferraù F, Garetto L, Gebbia V, Genestreti G, Gentile AL, Giovanardi F, Labianca R, Lorusso V, Mantovani G, Martelli O, Massari F, Mazzoli M, Michetti G, Mordenti P, Mucciarini C, Munao S, Nacci A, Pogliani C, Procopio G, Riccardi F, Rizzato S, Rossi A, Rosti G, Russo P, Saladino T, Salesi N, Santangelo D, Sava T, Savarino A, Spinnato F, Tiseo M, Tomassi O, Tondulli L, Tonini G, Turano S, Valerio MR, Verderame F, Zanelli F, and Zanon E.

Abstract

Background: A recent pooled analysis of randomized trials indicated significant improvement in overall survival from cisplatin-based adjuvant chemotherapy for non-small cell lung cancer (NSCLC), depending on disease stage (only in stages II and III) and PS (≤1). Post-operative radiotherapy (RT) is optional for pN2 tumours. Patients and methods: To evaluate opinions and daily clinical practice of Italian Oncologists about adjuvant treatment of NSCLC, a 46-item questionnaire was delivered via e-mail. Results: Seventy-eight physicians from 68 Centers (out of 98 contacted) returned their questionnaire. Seventy-four, 86, 94, and 78% of them give the indication for adjuvant chemotherapy for stage IIA, IIB, IIIA, and IIIB disease, respectively and 14% in stage IB disease. Stage, PS, and age are taken into consideration evaluating adjuvant approach by 97, 95 and 73%, respectively. Cisplatin-vinorelbine (64%) and cisplatin-gemcitabine (33%), for 4 cycles (81%), are the preferred regimens, while 32% use different regimens. Ninety-two percent indicate RT in pN2 disease and/or positive resection margins. Real Number of patients Needed to Treat (NNT) is probably not completely known/understood and/or used by physicians. Conclusions: A substantial adherence between clinical daily practice in Italy and scientific progresses is described in this paper, even with some discordances regarding the most appropriate adjuvant chemotherapy regimen.

Published
2011

26. Addition of Either Lonidamine or Granulocyte Colony-Stimulating Factor Does Not Improve Survival in Early Breast Cancer Patients Treated With High-Dose Epirubicin and Cyclophosphamide

Author

Papaldo, P., Lopez, M., Cortesi, Enrico, Cammilluzzi, E., Antimi, M., Terzoli, E., Lepidini, G., Vici, P., Barone, C., Ferretti, G., Di Cosimo, S., Nistico, C., Carlini, P., Conti, F., Di Lauro, L., Botti, C., Vitucci, C., Fabi, A., Giannarelli, D., Marolla, P., Di Maio, M., Perrone, F., Gallo, C., Iaffaioli, R. V., Manzione, L., Piantedosi, F. V., Cigolari, S., Illiano, A., Barbera, S., Robbiati, S. F., Piazza, E., Ianniello, G. P., Frontini, L., Veltri, E., Castiglione, F., Rosetti, F., De Maio, E., Maione, P., Gridelli, C., Rossi, A., Barletta, E., Barzelloni, M. L., Signoriello, G., Bilancia, D., Dinota, A., Rosati, G., Germano, D., Lamberti, A., Pontillo, V., Brancacio, L., Crispino, C., Esposito, M., Battiloro, C., Tufano, G., Cioffi, A., Guardasole, V., Angelini, V., Guidetti, G., Renda, F., Romano, F., Volpintesta, A., Sannicolo, M., Filipazzi, V., Esani, G., Gambaro, A., Ferrario, S., Tinessa, V., Caprio, M. G., Zonato, S., Cabiddu, M., Raina, A., D'Aprile, M., Pistillucci, G., Porcile, G., Ostellino, O., Vinante, O., Azzarello, G., Gebbia, V., Borsellino, N., Testa, A., Gasparini, G., Morabito, A., Gattuso, D., Romito, S., Carrozza, F., Fava, S., Calcagno, A., Grimi, E., Bertetto, O., Ciuffreda, L., Parello, G., Maiorino, L., Santoro, A., Santoro, M., Failla, G., Aiello, R. A., Bearz, A., Sorio, R., Scalone, S., Clerici, M., Bollina, R., Belloni, P., Sacco, C., Sibau, A., Adamo, V., Altavilla, G., Scimone, A., Spatafora, M., Bellia, V., Hopps, M. R., Monfardini, S., Favaretto, A., Stefani, M., Corradini, G. M., Pavia, G., Scagliotti, G., Novello, S., Selvaggi, G., Tonato, M., Darwish, S., Michetti, G., Belometti, M. O., Labianca, R., Quadri, A., De Marinis, F., Migliorino, M. R., Martelli, O., Colucci, G., Galetta, D., Giotta, F., Isa, L., Candido, P., Rossi, N., Calandriello, A., Ferrau, F., Malaponte, E., Barni, S., Cazzaniga, M., Gebbia, N., Valerio, Mr, Belli, M., Colantuoni, G., Capuano, M. A., Angiolillo, M., Sollitto, F., Ardizzoia, A., Luporini, G., Locatelli, M. C., Pari, F., Aitini, E., Pedicini, T., Febbraro, A., Zollo, C., Di Costanzo, F., Bartolucci, R., Gasperoni, S., Gaion, F., Palazzolo, G., Galligioni, E., Caffo, O., Cortesi, E., D'Auria, G., Curcio, C., Vasta, M., Bumma, C., Celano, A., Bretti, S., Nettis, G., Anselmo, A., Mattioli, R., Aschelter, A., and Foa, P.

Subjects
Adult, Cancer Research, medicine.medical_specialty, Indazoles, Filgrastim, Cyclophosphamide, medicine.medical_treatment, Breast Neoplasms, Gastroenterology, Disease-Free Survival, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Survival rate, Aged, Epirubicin, Chemotherapy, business.industry, Lonidamine, Middle Aged, medicine.disease, Metastatic breast cancer, Recombinant Proteins, Granulocyte colony-stimulating factor, Surgery, Survival Rate, Oncology, chemistry, Female, business, Follow-Up Studies, medicine.drug
Abstract

Purpose: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non–G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non–G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). Conclusion: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Published
2003
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27. Tumor heterogeneity affects the activity of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in EGFR mutant non-small cell lung cancer (NSCLC) patients (pts)

Author

Normanno, N., primary, Rachiglio, A.M., additional, Lambiase, M., additional, Fenizia, F., additional, Iannaccone, A., additional, Chicchinelli, N., additional, Morabito, A., additional, Montanino, A., additional, Rocco, G., additional, Galetta, D., additional, Montagna, E.S., additional, Crinò, L., additional, Ludovini, V., additional, Vincenzi, B., additional, Barletta, E., additional, Pinto, C., additional, Ferraù, F., additional, Botti, G., additional, Piccirillo, M.C., additional, and Perrone, F., additional

Published
2016
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28. PACER – A multicentre, single-arm, two-stage, phase 2 study of panitumumab in patients with cetuximab-refractory metastatic colorectal cancer (mCRC)

Author

Daniele, B., primary, Iaffaioli, R.V., additional, Chiara, C., additional, Maiello, E., additional, Rosati, G., additional, Alabiso, O., additional, Nasti, G., additional, De Stefano, A., additional, Latiano, T.P., additional, Bilancia, D., additional, Barletta, E., additional, Ottaiano, A., additional, Romano, C., additional, Silvestro, L., additional, Avallone, A., additional, Lambiase, M., additional, Normanno, N., additional, Daniele, G., additional, Perrone, F., additional, and Piccirillo, M.C., additional

Published
2016
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29. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancer receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the elderly study

Author

Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferraù, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolò, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, V, Altavilla, G, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, Enrico, D'Auria, Giuliana, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, Cazzaniga, M., MAIONE P, PERRONE F, GALLO C, MANZIONE L, PIANTEDOSI F, BARBERA S, CIGOLARI, ROSETTI F, PIAZZA E, ROBBIATI SF, BERTETTO O, NOVELLO S, MIGLIORINO MR, FAVARETTO A, SPATAFORA M, FERRAU F, FRONTINI L, BEARZ A, REPETTO L, GRIDELLI C, BARLETTA E, BARZELLONI ML, IAFFAIOLI RV, DE MAIO E, DI MAIO M, DE FEO G, SIGORIELLO G, CHIODINI P, CIOFFI A, GUARDASOLE V, ANGELINI V, ROSSI A, BILANCIA, GERMANO D, LAMBERTI A, PONTILLO V, BRANCACCIO L, RENDA F, ROMANO F, ESANI G, GAMBARO A, VINANTE O, AZZARELLO G, CLERICI M, BOLLINA R, BELLONI P, SANNICOLO M, CIUFFREDA L, PARELLO G, CABIDDU M, SACCO C, SIBAU A, PORCILE G, CASTIGLIONE F, OSTELLINO O, MONFARDINI S, STEFANI M, SCAGLIOTTI G, SELVAGGI G, DE MARINIS F, MARTELLI O, GASPARINI G, MORABITO A, GATTUSO D, COLUCCI G, GALETTA D, GIOTTA F, GEBBIA V, ET AL, Maione, P, Perrone, F, Gallo, Ciro, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, and Gridelli, C.

Subjects
Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Activities of daily living, Health Status, carcinoma, Vinblastine, Vinorelbine, Deoxycytidine, older people, Quality of life, Instrumental activitie, Carcinoma, Non-Small-Cell Lung, Internal medicine, Activities of Daily Living, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, Aged, Aged, 80 and over, validation, Proportional hazards model, business.industry, QLQ-C30, Age Factors, Cancer, clinical trial, Prognosis, medicine.disease, Gemcitabine, Comorbidity, humanities, comorbidity, Oncology, Quartile, Quality of Life, Physical therapy, impact, Geriatric oncology, Female, business, Randomized-trial, medicine.drug
Abstract

Purpose To study the prognostic value for overall survival of baseline assessment of functional status, comorbidity, and quality of life (QoL) in elderly patients with advanced non—small-cell lung cancer treated with chemotherapy. Patients and Methods Data from 566 patients enrolled onto the phase III randomized Multicenter Italian Lung Cancer in the Elderly Study (MILES) study were analyzed. Functional status was measured as activities of daily living (ADL) and instrumental ADL (IADL). The presence of comorbidity was assessed with a checklist of 33 items; items 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 (EORTC QLQ-C30) were used to estimate QoL. ADL was dichotomized as none versus one or more dependency. For IADL and QoL, three categories were defined using first and third quartiles as cut points. Comorbidity was summarized using the Charlson scale. Analysis was performed by Cox model, and stratified by treatment arm. Results Better values of baseline QoL (P = .0003) and IADL (P = .04) were significantly associated with better prognosis, whereas ADL (P = .44) and Charlson score (P = .66) had no prognostic value. Performance status 2 (P = .006) and a higher number of metastatic sites (P = .02) also predicted shorter overall survival. Conclusions Pretreatment global QoL and IADL scores, but not ADL and comorbidity, have significant prognostic value for survival of elderly patients with advanced non—small-cell lung cancer who were treated with chemotherapy. Using these scores in clinical practice might improve prognostic prediction for treatment planning.

Published
2005

36. EXPRESSION OF CYTOKINES AND CHEMOKINE RECEPTORS IN THE CUTANEOUS LESIONS OF ERYTHEMA MULTIFORME AND STEVENS-JOHNSON SYNDROME/TOXIC EPIDERMAL NECROLYSIS

Author

Caproni, M, Torchia, D, Schincaglia, E, Volpi, W, Frezzolini, A, Schena, D, Marzano, A, Quaglino, Pietro, DE SIMONE, C, Parodi, A, Barletta, E, and Fabbri, P.

Subjects
Adult, Aged, 80 and over, Erythema Multiforme, Male, Receptors, CXCR4, Receptors, CXCR3, Receptors, CCR3, Middle Aged, Th1 Cells, Immunoenzyme Techniques, Th2 Cells, Stevens-Johnson Syndrome, Cytokines, Humans, Female, Receptors, Chemokine, Aged
Abstract

Erythema multiforme (EM) and Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) are caused by a dysregulation of cellular immunity.To evaluate further the potential role of certain cytokines and chemokine receptors in cutaneous lesions of patients affected by EM and SJS/TEN and to establish whether such diseases are polarized preferentially towards a T-helper (Th) 1 or Th2 pattern.Biopsy specimens from eight patients with EM, six with SJS/TEN and three healthy controls were stained for immunohistochemical examination using the alkaline phosphatase-antialkaline phosphatase method. The monoclonal antibodies used included those to tumour necrosis factor (TNF)-alpha, interferon (IFN)-gamma, interleukin (IL)-2, IL-5, IL-13, receptor 3 for C-C chemokines (CCR3), receptor 3 for C-x-C chemokines (CXCR3) and CXCR4.The SJS/TEN specimens showed significantly higher expression of all the cytokines and chemokine receptors (except CXCR3) tested than the EM specimens. Both lesional series showed significantly higher expression of all the receptors tested than the healthy control specimens, with the sole exception of a lower expression of CCR3 in EM specimens. Comparison between molecules associated with a Th1 or Th2 response revealed a predominance of Th1 response in EM and no significant imbalance between Th1 and Th2 in SJS/TEN.We have provided further evidence that TNF-alpha is strongly expressed in SJS/TEN lesions and therefore it may be involved in the epidermal necrosis featured in such diseases. IFN-gamma may play an important role both in EM and SJS/TEN. IL-2, IL-5 and IL-13 may contribute to the cutaneous immunoinflammation in these diseases. Chemokine receptors may be involved strongly in the recruitment of inflammatory cells in lesional skin. In our cases we found a sharp polarization towards a Th1 pattern in EM, while the SJS/TEN lesions showed a mixed Th1/Th2 pattern.

Published
2006

37. Laser ablation-deposited CNx thin films

Author

Fazio E., Barletta E., Barreca F., Mondio G., Neri F., and Trusso S.

Subjects
ELECTRON ENERGY LOSS, SPECTROSCOPY, AMORPHOUS CARBON, STRUCTURAL PROPERTIES, C3N4
Abstract

Amorphous CNx thin films were deposited at room temperature by pulsed laser ablation of graphite targets in a controlled atmosphere using both N-2 and N-2/Ar gas mixtures. The structural and electronic properties of the samples were investigated by means of X-ray photoelectron, reflection electron energy loss and Raman spectroscopy. Nitrogen contents as high as 32% have been estimated. The overall results show a progressive transformation of the C-C sp(3) bonds into sp(2) hybridized C-N ones with the development of SP2 carbon clusters upon increasing the gas pressure values. By means of fast photography measurements, different regimes of the laser-induced plasma expansion dynamics have been evidenced. The results indicate that the electronic and structural properties of the laser ablation-deposited CNx films depend strongly on the regime under which the plasma expansion takes place, not simply on the overall nitrogen content. In this respect the role played by the gas composition and pressure are of fundamental importance.

Published
2006
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38. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancerreceiving chemotherapy: a prognostic analysis of the multicenter Italian lungcancer in the elderly study

Author

Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolo, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, Vincenzo, Altavilla, Giuseppe, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, E, D'Auria, G, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, and Cazzaniga, M.

Published
2005

39. Supportive care in patients with advanced non-small-cell lung cancer

Author

DI MAIO, Massimo, Perrone, F, Gallo, C, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, De Maio, E, Maione, P, Gridelli, C, Rossi, A, Barletta, E, Barzelloni, Ml, Signoriello, G, Bilancia, D, Dinota, A, Rosati, G, Germano, D, Lamberti, A, Pontillo, V, Brancacio, L, Crispino, C, Esposito, M, Battiloro, C, Tufano, G, Cioffi, A, Guardasole, V, Angelini, V, Guidetti, G, Renda, F, Romano, F, Volpintesta, A, Sannicolò, M, Filipazzi, V, Esani, G, Gambaro, A, Ferrario, S, Tinessa, V, Caprio, Mg, Zonato, S, Cabiddu, M, Raina, A, D'Aprile, M, Pistillucci, G, Porcile, G, Ostellino, O, Vinante, O, Azzarello, G, Gebbia, V, Borsellino, N, Testa, A, Gasparini, G, Morabito, A, Gattuso, D, Romito, S, Carrozza, F, Fava, S, Calcagno, A, Grimi, E, Bertetto, O, Ciuffreda, L, Parello, G, Maiorino, L, Santoro, A, Santoro, M, Failla, G, Aiello, Ra, Bearz, A, Sorio, R, Scalone, S, Clerici, M, Bollina, R, Belloni, P, Sacco, C, Sibau, A, Adamo, V, Altavilla, G, Scimone, A, Spatafora, M, Bellia, V, Hopps, Mr, Monfardini, S, Favaretto, A, Stefani, M, Corradini, Gm, Pavia, G, Scagliotti, Giorgio Vittorio, Novello, Silvia, Selvaggi, G, Tonato, M, Darwish, S, Michetti, G, Belometti, Mo, Labianca, R, Quadri, A, De Marinis, F, Migliorino, Mr, Martelli, O, Colucci, G, Galetta, D, Giotta, F, Isa, L, Candido, P, Rossi, N, Calandriello, A, Ferraù, F, Malaponte, E, Barni, S, Cazzaniga, M, Gebbia, N, Valerio, Mr, Belli, M, Colantuoni, G, Capuano, Ma, Angiolillo, M, Sollitto, F, Ardizzoia, A, Luporini, G, Locatelli, Mc, Pari, F, Aitini, E, Pedicini, T, Febbraro, A, Zollo, C, Di Costanzo, F, Bartolucci, R, Gasperoni, S, Gaion, F, Palazzolo, G, Galligioni, E, Caffo, O, Cortesi, E, D'Auria, G, Curcio, C, Vasta, M, Bumma, C, Celano, A, Bretti, S, Nettis, G, Anselmo, A, Mattioli, R, Nisticò, C, Aschelter, A, Foa, P., DI MAIO, M, Perrone, F, Gallo, Ciro, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, DE MAIO, E, Maione, P, and Gridelli, C.

Subjects
Adult, Male, concomitant drugs, Cancer Research, medicine.medical_specialty, Aging, Palliative care, Lung Neoplasms, medicine.medical_treatment, Vinorelbine, Vinblastine, Deoxycytidine, Clinical, Quality of life, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, polypharmacotherapy, medicine, Humans, Lung cancer, Survival rate, Aged, Randomized Controlled Trials as Topic, Aged, 80 and over, Chemotherapy, Performance status, business.industry, Palliative Care, Middle Aged, medicine.disease, Gemcitabine, Surgery, Survival Rate, supportive care, lung cancer, Oncology, Concomitant, Quality of Life, Antiemetics, Female, Cisplatin, business, medicine.drug
Abstract

The present study describes supportive care (SC) in patients with advanced non-small-cell lung cancer (NSCLC), evaluating whether it is affected by concomitant chemotherapy, patient's performance status (PS) and age. Data of patients enrolled in three randomised trials of first-line chemotherapy, conducted between 1996 and 2001, were pooled. The analysis was limited to the first three cycles of treatment. Supportive care data were available for 1185 out of 1312 (90%) enrolled patients. Gastrointestinal drugs (45.7%), corticosteroids (33.4%) and analgesics (23.8%) were the most frequently observed categories. The mean number of drugs per patient was 2.43; 538 patients (45.4%) assumed three or more supportive drugs. Vinorelbine does not produce substantial variations in the SC pattern, while cisplatin-based treatment requires an overall higher number of supportive drugs, with higher use of antiemetics (41 vs 27%) and antianaemics (10 vs 4%). Patients with worse PS are more exposed to corticosteroids (42 vs 30%). Elderly patients require drugs against concomitant diseases significantly more than adults (20 vs 7%) and are less frequently exposed to antiemetics (12 vs 27%). In conclusion, polypharmacotherapy is a relevant issue in patients with advanced NSCLC. Chemotherapy does not remarkably affect the pattern of SC, except for some drugs against side effects. Elderly patients assume more drugs for concomitant diseases and receive less antiemetics than adults.

Published
2004

42. Supportive care in patients with advanced non small cell lung cancer

Author

DI MAIO, M, Perrone, F, Gallo, C, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, DE MAIO, E, Maione, P, Gridelli, C, Rossi, A, Barletta, E, Barzelloni, Ml, Signoriello, G, Bilancia, D, Dinota, A, Rosati, G, Germano, D, Lamberti, A, Pontillo, V, Brancacio, L, Crispino, C, Esposito, M, Battiloro, C, Tufano, G, Cioffi, A, Guardasole, V, Angelini, V, Guidetti, G, Renda, F, Romano, F, Volpintesta, A, Sannicolo, M, Filipazzi, V, Esani, G, Gambaro, A, Ferrario, S, Tinessa, V, Caprio, Mg, Zonato, S, Cabiddu, M, Raina, A, D'Aprile, M, Pistillucci, G, Porcile, G, Ostellino, O, Vinante, O, Azzarello, G, Gebbia, V, Borsellino, N, Testa, A, Gasparini, G, Morabito, A, Gattuso, D, Romito, S, Carrozza, F, Fava, S, Calcagno, A, Grimi, E, Bertetto, O, Ciuffreda, L, Parello, G, Maiorino, L, Santoro, A, Santoro, M, Failla, G, Aiello, Ra, Bearz, A, Sorio, R, Scalone, S, Clerici, M, Bollina, R, Belloni, P, Sacco, C, Sibau, A, Adamo, Vincenzo, Altavilla, Giuseppe, Scimone, A, Spatafora, M, Bellia, V, Hopps, Mr, Monfardini, S, Favaretto, A, Stefani, M, Corradini, Gm, Pavia, G, Scagliotti, G, Novello, S, Selvaggi, G, Tonato, M, Darwish, S, Michetti, G, Belometti, Mo, Labianca, R, Quadri, A, DE MARINIS, F, Migliorino, Mr, Martelli, O, Colucci, G, Galetta, D, Giotta, F, Isa, L, Candido, P, Rossi, N, Calandriello, A, Ferrau, F, Malaponte, E, Barni, S, Cazzaniga, M, Gebbia, N, Valerio, Mr, Belli, M, Colantuoni, G, Capuano, Ma, Angiolillo, M, Sollitto, F, Ardizzoia, A, Luporini, G, Locatelli, Mc, Pari, F, Aitini, E, Pedicini, T, Febbraro, A, Zollo, C, DI COSTANZO, F, Bartolucci, R, Gasperoni, S, Gaion, F, Palazzolo, G, Galligioni, E, Caffo, O, Cortesi, E, D'Auria, G, Curcio, C, Vasta, M, Bumma, C, Celano, A, Bretti, S, Nettis, G, Anselmo, A, Mattioli, R, Nistico, C, Aschelter, A, and Foa, P.

Published
2003

47. Metanalisi degli studi italiani sugli effetti acuti dell'inquinamento atmosferico

Author

Biggeri, Annibale, Bellini, P., Terracini, B., Baccini, M., Barletta, E., Berti, G., Bisanti, L., Cadum, E., Cattani, S., Chellini, E., Chiogna, M., Forastiere, F., Fanu, V., Galassi, C., Lovison, G., Martuzzi, M., Michelozzi, P., Miglio, R., Muggeo, V., Rossi, G., and Vigotti, M.

Subjects
inquinamento atmosferico
Published
2001

48. 1235P - Tumor heterogeneity affects the activity of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in EGFR mutant non-small cell lung cancer (NSCLC) patients (pts)

Author

Normanno, N., Rachiglio, A.M., Lambiase, M., Fenizia, F., Iannaccone, A., Chicchinelli, N., Morabito, A., Montanino, A., Rocco, G., Galetta, D., Montagna, E.S., Crinò, L., Ludovini, V., Vincenzi, B., Barletta, E., Pinto, C., Ferraù, F., Botti, G., Piccirillo, M.C., and Perrone, F.

Published
2016
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50. A03* - Tumor heterogeneity affects the activity of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in EGFR mutant non-small cell lung cancer (NSCLC) patients (pts)

Author

Normanno, N., Rachiglio, A.M., Lambiase, M., Fenizia, F., Iannaccone, A., Chicchinelli, N., Morabito, A., Rocco, G., Galetta, D., Montagna, E.S., Crinò, L., Ludovini, V., Vincenzi, B., Barletta, E., Pinto, C., Ferraù, F., Botti, G., Piccirillo, M.C., and Perrone, F.

Published
2016
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