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2. The reorganization of healthcare services from the perspective of appropriateness: The experience of the University Hospital 'San Giovanni di Dio e Ruggi d'Aragona' in the management of Diagnosis-Related Group no. 127 - Heart failure and shock|La riorganizzazione delle prestazioni sanitarie in ottica di appropriatezza: L'esperienza dell'AOU 'San Giovanni di Dio e Ruggi d'Aragona' nella gestione del DRG 127 - Insufficienza cardiaca e shock

Author

Soriente, L, Cigolari, S, Gigantino, A, Aliberti, C, Ardovino, P, Adinolfi, P, and Palumbo, R

Subjects
Process Improvement, BPI, Quality, Settore SECS-P/10
Published
2020

6. 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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7. Phase II study of sequential hormonal therapy with anastrozole/exemestane in advanced and metastatic breast cancer

Author

IAFFAIOLI RV, FORMATO R, TORTORIELLO A, DEL PRETE S, PAPPAGALLO G, PISANO A, GEBBIA V, FANELLI F, IANNIELLO G, CIGOLARI S, PIZZA C, MARANO O, PEZZELLA G, PEDICINI T, FEBBRARO A, INCORONATO P, MANZIONE L, FERRARI E, MARZANO N, QUATTRIN S, PISCONTI S, NASTI G, GIOTTA G, COLUCCI G, SOUTHERN ITALY ONCOLOGY GROUP, CARAGLIA, Michele, Iaffaioli, Rv, Formato, R, Tortoriello, A, DEL PRETE, S, Caraglia, Michele, Pappagallo, G, Pisano, A, Gebbia, V, Fanelli, F, Ianniello, G, Cigolari, S, Pizza, C, Marano, O, Pezzella, G, Pedicini, T, Febbraro, A, Incoronato, P, Manzione, L, Ferrari, E, Marzano, N, Quattrin, S, Pisconti, S, Nasti, G, Giotta, G, Colucci, G, and SOUTHERN ITALY ONCOLOGY, Group

Published
2005

8. 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

9. 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

10. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial

Author

GRIDELLI C, PERRONE F, CIGOLARI S, ROSSI A, PIANTEDOSI F, BARBERA S, FERRAU F, PIAZZA E, ROSETTI F, CLERICI M, BERTETTO O, ROBBIATI SF, FRONTINI L, SACCO C, CASTIGLIONE F, FAVARETTO A, NOVELLO S, MIGLIORINO MR, GASPARINI G, GALETTA D, IAFFAIOLI RV, GEBBIA V, MILES INVESTIGATORS, GALLO, Ciro, Gridelli, C, Perrone, F, Gallo, Ciro, Cigolari, S, Rossi, A, Piantedosi, F, Barbera, S, Ferrau, F, Piazza, E, Rosetti, F, Clerici, M, Bertetto, O, Robbiati, Sf, Frontini, L, Sacco, C, Castiglione, F, Favaretto, A, Novello, S, Migliorino, Mr, Gasparini, G, Galetta, D, Iaffaioli, Rv, Gebbia, V, and Miles, Investigators

Published
2003

11. Activity and toxicity of gemcitabine and gemcitabine plus vinorelbine in advanced non-small-cell lung cancer elderly patients. Phase II data from the MILES (Multicenter Italian Lung cancer in the Elderly Study) randomized trial

Author

GRIDELLI C, CIGOLARI S, MANZIONE L, IANNIELLO GP, FRONTINI L, FERRAÙ F, ROBBIATI SF, ADAMO V, GASPARINI G, NOVELLO S, PERRONE F., GALLO, Ciro, Gridelli, C, Cigolari, S, Gallo, Ciro, Manzione, L, Ianniello, Gp, Frontini, L, Ferraù, F, Robbiati, Sf, Adamo, V, Gasparini, G, Novello, S, and Perrone, F.

Published
2001

13. Carboplatin plus Vinorelbine, a new well tolerated and active regimen for the treatment of extensive-stage small-cell lung cancer: a phase II study

Author

GRIDELLI C, PERRONE F, IANNIELLO GP, BRANCACCIO L, IAFFAIOLI RV, CURCIO C, D'APRILE M, CIOFFI R, CIGOLARI S, ROSSI A, PALAZZOLO G, VELTRI E, PERGOLA M, DE PLACIDO S, MONFARDINI S, BIANCO AR, GALLO, Ciro, Gridelli, C, Perrone, F, Ianniello, Gp, Brancaccio, L, Iaffaioli, Rv, Curcio, C, D'Aprile, M, Cioffi, R, Cigolari, S, Rossi, A, Palazzolo, G, Veltri, E, Pergola, M, DE PLACIDO, S, Gallo, Ciro, Monfardini, S, and Bianco, Ar

Published
1998

14. 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

15. 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

18. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer

Author

Gridelli, C, Perrone, F, Gallo, C, Rossi, A, Scognamiglio, F, Monfardini, S, Ianniello, Gp, Tinessa, V, Caprio, Mg, Santoro, A, Maiorino, L, Santoro, M, Brancaccio, L, Crispino, C, Cigolari, S, DI LANNO, M, Angelini, V, Manzione, L, Bilancia, D, Dinota, A, Failla, G, Aiello, Ra, Tralongo, P, Figoli, F, Zuccarino, L, Pedicini, T, Febbraro, A, Zollo, C, Frontini, L, Zonato, S, Azzarello, G, Vinante, O, Castiglione, F, Porcile, G, Bearz, A, Sorio, R, Tonato, M, Darwish, S, Veltri, E, D'Aprile, M, Curcio, C, Vasta, M, Clerici, M, Luporini, G, Farris, A, Alicicco, Mg, Bretti, S, Bumma, C, Ionta, Mt, Massidda, B, Adamo, Vincenzo, Altavilla, Giuseppe, Stefani, M, Michetti, G, Iaffaioli, Rv, Marzano, N, Favaretto, A, Murtas, S, Nascimbene, C, Nistico, C, Robbiati, Sf, Strada, Mr, Belli, M, Loizzi, M, Bandera, M, Bochicchio, Am, Piazza, E, Foladore, S, Giura, R, Gualtieri, G, Barni, S, Cariello, A, Mattioli, R, Pazzola, A, Gioga, G, Puxeddu, G, Bartolucci, R, Graiff, C, DEL CONTE, G, Farriniello, Ga, Mauri, F, Corradini, Gm, Capuano, Ma, Carrozza, F, and Gianni, W.

Published
1999

19. Cisplatin, fotemustine and whole-brain radiotherapy in non-small cell lung cancer patients with asymptomatic brain metastases: A multicenter phase II study of the Gruppo Oncologico Italia Meridionale (GOIM 2603)

Author

Galetta, D., primary, Gebbia, V., additional, Silvestris, N., additional, Ferraù, F., additional, Carrozza, F., additional, Cigolari, S., additional, Russo, P., additional, Calista, F., additional, Adamo, V., additional, and Colucci, G., additional

Published
2011
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21. Activity and tolerability of cisplatin (CDDP) and fotemustine (FTM) in non-small cell lung cancer (NSCLC) patients (PTS) with brain metastases (BM): A multicentric phase II study of the Gruppo Oncologico dell’Italia Meridionale (GOIM)

Author

Galetta, D., primary, Gebbia, V., additional, Ferraù, F., additional, Carrozza, F., additional, Cigolari, S., additional, Russo, P., additional, Calista, F., additional, Adamo, V., additional, and Colucci, G., additional

Published
2009
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22. Activity and tolerability of Cisplatin (CDDP) and Fotemustine (FTM) combination in the treatment of patients with non-small cell lung cancer (NSCLC) with brain metastases (BM): A multicentric phase II study of the Gruppo Oncologico dell’Italia Meridionale (GOIM)

Author

Galetta, D., primary, Gebbia, V., additional, Romito, S., additional, Ferraù, F., additional, De Marinis, F., additional, Cigolari, S., additional, Adamo, S., additional, and Colucci, G., additional

Published
2008
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24. Supportive care in patients with advanced non-small-cell lung cancer

Author

Di Maio, M, primary, Perrone, F, additional, Gallo, C, additional, Iaffaioli, R V, additional, Manzione, L, additional, Piantedosi, F V, additional, Cigolari, S, additional, Illiano, A, additional, Barbera, S, additional, Robbiati, S F, additional, Piazza, E, additional, Ianniello, G P, additional, Frontini, L, additional, Veltri, E, additional, Castiglione, F, additional, Rosetti, F, additional, De Maio, E, additional, Maione, P, additional, and Gridelli, C, additional

Published
2003
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25. Chemotherapy for Elderly Patients With Advanced Non-Small-Cell Lung Cancer: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) Phase III Randomized Trial

Author

Gridelli, C., primary, Perrone, F., additional, Gallo, C., additional, Cigolari, S., additional, Rossi, A., additional, Piantedosi, F., additional, Barbera, S., additional, Ferrau, F., additional, Piazza, E., additional, Rosetti, F., additional, Clerici, M., additional, Bertetto, O., additional, Robbiati, S. F., additional, Frontini, L., additional, Sacco, C., additional, Castiglione, F., additional, Favaretto, A., additional, Novello, S., additional, Migliorino, M. R., additional, Gasparini, G., additional, Galetta, D., additional, Iaffaioli, R. V., additional, and Gebbia, V., additional

Published
2003
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27. Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: a phase II study of three different doses

Author

Gridelli, C, primary, Frontini, L, additional, Perrone, F, additional, Gallo, C, additional, Gulisano, M, additional, Cigolari, S, additional, Castiglione, F, additional, Robbiati, S F, additional, Gasparini, G, additional, Ianniello, G P, additional, Farris, A, additional, Locatelli, M C, additional, Felletti, R, additional, and Piazza, E, additional

Published
2000
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28. Amifostine plus cisplatin plus vinorelbine in the treatment of advanced non small cell lung cancer: a multicenter phase II study

Author

Gridelli, C, primary, Cigolari, S, additional, Maiorino, A, additional, Ianniello, G.P, additional, Brancaccio, L, additional, Rossi, A, additional, De Cataldis, G, additional, Pedicini, T, additional, Maiorino, L, additional, Barletta, E, additional, Di Lanno, M, additional, Bilancia, D, additional, Crispino, C, additional, Barzelloni, M.L, additional, Masullo, P, additional, D’Aniello, R, additional, and Manzione, L, additional

Published
2000
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30. Carboplatin plus vinorelbine, a new well-tolerated and active regimen for the treatment of extensive-stage small-cell lung cancer: a phase II study. Gruppo Oncologico Centro-Sud-Isole.

Author

Gridelli, C, primary, Perrone, F, additional, Ianniello, G P, additional, Brancaccio, L, additional, Iaffaioli, R V, additional, Curcio, C, additional, D'Aprile, M, additional, Cioffi, R, additional, Cigolari, S, additional, Rossi, A, additional, Palazzolo, G, additional, Veltri, E, additional, Pergola, M, additional, De Placido, S, additional, Gallo, C, additional, Monfardini, S, additional, and Bianco, A R, additional

Published
1998
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31. Carboplatin plus vinorelbine: A new active regimen in extensive small cell lung cancer. Results of a multicenter phase II study

Author

Gridelli, C., primary, lanniello, G., additional, Brancaccio, L., additional, Perrone, F., additional, laffaioli, R.V., additional, Curcio, C., additional, D’Aprile, M., additional, Cioffi, R., additional, Cigolari, S., additional, Rossi, A., additional, Rinaldi, L., additional, Palazzolo, G., additional, Garcia, M., additional, Guida, C., additional, Bianco, A.R., additional, Pergola, M., additional, and Monfardini, S., additional

Published
1997
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34. 212 Carboplatin plus vinorelbine: A new active regimen in extensive small cell lung cancer. Results of a multicenter phase II study

Author

Gridelli, C., primary, Ianniello, G., additional, Brancaccio, L., additional, Perrone, F., additional, Iaffaioli, R.V., additional, Curcio, C., additional, D'Aprile, M., additional, Cioffi, R., additional, Cigolari, S., additional, Rossi, A., additional, Rinaldi, L., additional, Veltri, E., additional, Palazzolo, G., additional, Leo, L., additional, Bianco, A.R., additional, Pergola, M., additional, and Monfardini, S., additional

Published
1997
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35. 39 Six year follow up of the European Multicentre Randomised Study comparing Navelbine (NVB) alone vs NVB + Cisplatin (CDDP) vs Vindesine (VDS) + CDDP in 612 patients (pts) with advanced non-small cell lung cancer (NSCLC)

Author

Le Chevalier, T., primary, Pujol, J.L., additional, Douilard, J.Y., additional, Alberola, V., additional, Monnier, A., additional, Rivière, A., additional, Cigolari, S., additional, Ruffié, P., additional, Panizo, A., additional, Guillem, V., additional, Besson, P.F., additional, Danel, P., additional, Brisgand, D., additional, Berthaud, P., additional, Larriba, J.L.G., additional, and Martinez, A., additional

Published
1997
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36. Vinorelbine is well tolerated and active in the treatment of elderly patients with advanced non-small cell lung cancer. A two-stage phase II study

Author

Gridelli, C., primary, Perrone, F., additional, Gallo, C., additional, De Marinis, F., additional, Ianniello, G., additional, Cigolari, S., additional, Cariello, S., additional, Di Costanzo, F., additional, D'Aprile, M., additional, Rossi, A., additional, Migliorino, R., additional, Bartolucci, R., additional, Bianco, A.R., additional, Pergola, M., additional, and Monfardini, S., additional

Published
1997
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37. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients.

Author

Le Chevalier, T, primary, Brisgand, D, additional, Douillard, J Y, additional, Pujol, J L, additional, Alberola, V, additional, Monnier, A, additional, Riviere, A, additional, Lianes, P, additional, Chomy, P, additional, and Cigolari, S, additional

Published
1994
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41. Phase II study of sequential hormonal therapy with anastrozole/exemestane in advanced and metastatic breast cancer.

Author

Iaffaioli, R. V., Formato, R., Tortoriello, A., del Prete, S., Caraglia, M., Pappagallo, G., Pisano, A., Fanelli, F., Ianniello, G., Cigolari, S., Pizza, C., Marano, O., Pezzella, G., Pedicini, T., Febbraro, A., Incoronato, P., Manzione, L., Ferrari, E., Marzano, N., and Quattrin, S.

Subjects
BREAST cancer, HORMONE therapy, CANCER patients, MEDICAL care, CYTOCHROME P-450, MEDICAL research
Abstract

Hormonal therapy is the preferred systemic treatment for recurrent or metastatic, post-menopausal hormone-receptor-positive breast cancer. Previous studies have shown that there is no cross-resistance between exemestane and reversible aromatase inhibitors. Exposure to hormonal therapy does not hamper later response to chemotherapy. Patients with locally advanced or metastatic, hormonal receptor positive or unknown, breast cancer were treated with oral anastrozole, until disease progression, followed by oral exemestane until new evidence of disease progression. The primary end point of the study was clinical benefit, defined as the sum of complete responses (CR), partial responses (PR) and > 24 weeks stable disease (SD). In all, 100 patients were enrolled in the study. Anastrozole produced eight CR and 19 PR for an overall response rate of 27% (95% CI: 18.6-36.8%). An additional 46 patients had long-term (> 24 weeks) SD for an overall clinical benefit of 73% (95% CI: 63.2-81.4). Median time to progression (TTP) was 11 months (95% CI: 10-12). A total of 50 patients were evaluated for the second-line treatment: exemestane produced one CR and three PR; 25 patients had SD which lasted > or = 6 months in 18 patients. Median TTP was 5 months. Toxicity of treatment was low. Our study confirms that treatment with sequential hormonal agents can extend the period of time during which endocrine therapy can be used, thereby deferring the decision to use chemotherapy. [ABSTRACT FROM AUTHOR]

Published
2005
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42. Adjuvant Systemic Therapies in Patients with Colorectal Cancer: An Audit on Clinical Practice in Italy

Author

Roila, Fausto, Ruggeri, Benedetta, Ballatori, Enzo, Patoia, Lucio, Palazzo, Salvatore, Colucci, Giuseppe, Di Costanzo, Francesco, Cascinu, Stefano, Labianca, Roberto, Sobrero, Alberto, Cortesi, E., Bressi, C., Ferraldeschi, R., Mazzoli, M., Evangelista, M.L., Di Fonzo, C., Cigolari, S., Angelini, V., Cioffi, A., Guardasole, V., Zarra, E., Tonato, M., Betti, M., Marrocolo, F., Bon-ciarelli, V., Cetto, G., Silingardi, V., Cognetti, F., Beretta, G., Pessi, A., Mosconi, S., Milesi, L., Bertetto, O., Malacarne, P., Marzola, M., Margutti, G., Modenesi, C., Manente, P., Comandone, A., Oliva, C., Berniolo, P., Cutin, S. Chiadò, Luporini, G., Colucci, G., Recaldin, E., Nicodemo, M., Picece, V., Turaz-za, M., Ferrazzi, E., Solina, G., Rosati, G., Rossi, A., Manzione, L., Sozzi, P., Fornarini, G., Lavarello, A., Catalano, G., Giordani, P., Alessandroni, P., Troccoli, G., Ramus, G. Vietti, Tonda, L., Sirgiovanni, M.P., Iannello, G. P., Tinessa, V., Ruggiero, A, Palazzo, S., Barni, S., Mandalà, M., Cremonesi, M., Porcile, G., Destefanis, M., Testore, F., Carteni, G., Daniele, B., Volta, C., Ferraù, F., Zaniboni, A., Marchetti, P., Citone, G., Cefaro, G. Ausili, Iacono, C., Musi, M., Mozzicafreddo, A., Imperiale, F. Nigro, Filippelli, G., Sciacca, V., D'Aprile, M., Isa, L., Recchia, F., Spada, S., Cascinu, S., Carroccio, R., Mustacchi, G., Ceccherini, R., Chetrì, M., Rizzo, P., Botturi, M., Marchei, P., Bretti, S., Montalbetti, L., Reguzzoni, G., Massidda, B., Ionta, M.T., Cruciani, G., Prosperi, A., Mantovani, G., Sidoti, V., Peta, A., Greco, E., Cicero, G., Sobrero, A., Marsilio, P., Vigevani, E., Rimondi, G., Gebbia, V., Nuzzo, A., Biondi, E., Caroti, C., D'Amico, M., Tuveri, G., Pieri, G., Enrici, R. Maurizi, Tonini, G., Santini, D., Iannone, T., Pizza, C., Belli, M., Del Prete, S., Pizza, C., Trevisonne, R., Serlenga, M., Laricchiuta, R., Lacava, V., Bumma, C., Roselli, M., Verderame, F., Mascia, V., Perrone, D., Prantera, T., Venuta, S., Nastasi, G., Bortolussi, V., and Lembo, A.

Abstract

Aims and Background Rarely are conclusions from clinical trials summarized in international consensus conferences and promptly transferred to patient care. The adjuvant therapy for colorectal cancer used in daily clinical practice in Italy is described and compared with the recommendations of the 1990 NIH Consensus Conference.Patients and Methods We audited prescriptions of adjuvant systemic therapies for Italian colorectal cancer patients in 82 centers during a fixed one-week period.Results Among 434 patients receiving adjuvant chemotherapy there were 139 (42.5%) colon cancer patients with N- and 169 (51.7%) with N+ regional nodal involvement. Treatment at academic centers, a young age, T4 and a low total number of lymph nodes removed at surgery were the factors potentially justifying the decision for adjuvant chemotherapy in stage II colon cancer patients. The most common chemotherapy used was a bolus of 5-fluorouracil/folinic acid for 6 months (75.8%). Adjuvant radiotherapy was not administered to 37 (38.5%) of 96 patients with stage II and III rectal cancer.Conclusions The study shows that a substantial proportion of patients on adjuvant treatment at a certain time point in a large enough sample of Italian centers are stage II (potential over-treatment) and that an under-treatment of stage II and III rectal cancer patients (lack of radiotherapy) occurs too often in daily clinical practice in this country.

Published
2005
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43. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: The multicenter Italian lung cancer in the elderly study (MILES) phase III randomized trial

Author

Gridelli, C., Perrone, F., Gallo, C., Cigolari, S., Rossi, A., Piantedosi, F., Barbera, S., Ferraù, F., Piazza, E., Rosetti, F., Clerici, M., Bertetto, O., Robbiati, S. F., Frontini, L., Sacco, C., Castiglione, F., Adolfo Favaretto, Novello, S., Migliorino, M. R., Gasparini, G., Galetta, D., Iaffaioli, R. V., Gebbia, V., Celano, A., Schiavon, S., Illiano, A., Raucci, C. A., Caruso, M., Foa, P., Tonini, G., Curcio, C., and Cazzaniga, M.

46. Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of three randomised trials

Author

Lesley Seymour, S. Cigolari, Santi Barbera, Frances A. Shepherd, Ciro Gallo, Francesco Perrone, Franco Vito Piantedosi, Giovanni Pietro Ianniello, Paolo Chiodini, Luigi Manzione, Massimo Di Maio, Alfonso Illiano, Federico Castiglione, Sergio Federico Robbiati, E. Piazza, Enzo Veltri, Francesco Rosetti, Luciano Frontini, Cesare Gridelli, Vittorio Gebbia, DI MAIO M, GRIDELLI C, GALLO C, SHEPHERD F, PIANTEDOSI FV, CIGOLARI S, MANZIONE L, ILLIANO A, BARBERA S, ROBBIATI SF, FRONTINI L, PIAZZA E, IANNIELLO, GP, VELTRI E, CASTIGLIONE F, ROSETTI F, GEBBIA V, SEYMOUR L, CHIODINI P, PERRONE, DI MAIO, M., Gridelli, C., Gallo, Ciro, Shepherd, F., Piantedosi, F., Cigolari, S., Manzione, L., Illiano, A., Barbera, S., Robbiati, S., Frontini, L., Piazza, E., Ianniello, G., Veltri, E., Castiglione, F., Rosetti, F., Gebbia, V., Seymour, L., Chiodini, Paolo, and Perrone, F.

Subjects
Adult, Male, Oncology, medicine.medical_specialty, Lung Neoplasms, Neutropenia, medicine.medical_treatment, Antineoplastic Agents, Vinorelbine, Severity of Illness Index, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, Lung cancer, Survival rate, Aged, Proportional Hazards Models, Randomized Controlled Trials as Topic, Aged, 80 and over, Chemotherapy, Dose-Response Relationship, Drug, business.industry, Standard treatment, Hazard ratio, Middle Aged, randomized clinical trial, medicine.disease, Gemcitabine, Surgery, Survival Rate, landmark analysis, non-small-cell lung cancer, Italy, chemotherapy-induced neutropenia, Female, Drug Monitoring, business, Biomarkers, medicine.drug
Abstract

Summary Background Chemotherapy is the standard treatment for advanced non-small-cell lung cancer, and myelosuppression is a common side-effect. We aimed to assess whether haematological toxic effects could be a biological measure of drug activity and a marker of efficacy. Methods We analysed data for 1265 patients who received chemotherapy (vinorelbine, gemcitabine, gemcitabine and vinorelbine, cisplatin and vinorelbine, or cisplatin and gemcitabine) within three randomised trials. Primary landmark analyses were restricted to 436 patients who received all six planned chemotherapy cycles and who were alive 180 days after randomisation. Neutropenia was categorised on the basis of worst WHO grade during chemotherapy: absent (grade 0), mild (grade 1–2), or severe (grade 3–4). All statistical analyses were stratified by treatment allocation. Analyses were repeated in the out-of-landmark group (829 patients), stratifying by treatment allocation and number of chemotherapy cycles. The primary endpoint was overall survival. Findings In the landmark group, hazard ratios of death were 0·65 (0·46–0·93) for patients with severe neutropenia and 0·74 (0·56–0·98) for those with mild neutropenia. Median survival after the landmark time of 180 days was 31·4 weeks (95% CI 25·7–39·6) for patients without neutropenia compared with 42·0 weeks (32·7–59·7) for patients with severe neutropenia, and with 43·7 weeks (36·6–66·0) for those with mild neutropenia (severe vs mild vs no neutropenia p=0·0118). Findings were much the same for the out-of-landmark group. Interpretation Neutropenia during chemotherapy is associated with increased survival of patients with advanced non-small-cell lung cancer, and its absence might be a result of underdosing. Prospective trials are needed to assess whether drug dosing guided by the occurrence of toxic effects could improve efficacy of standard regimens.

Published
2005

47. Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of three randomised trials.

Author

Di Maio M, Gridelli C, Gallo C, Shepherd F, Piantedosi F, Cigolari S, Manzione L, Illiano A, Barbera S, Robbiati SF, Frontini L, Piazza E, Ianniello GP, Veltri E, Catiglione F, Rosetti F, Gebbia V, Seymour L, Chiodini P, and Perrone F

Abstract

BACKGROUND: Chemotherapy is the standard treatment for advanced non-small-cell lung cancer, and myelosuppression is a common side-effect. We aimed to assess whether haematological toxic effects could be a biological measure of drug activity and a marker of efficacy. METHODS: We analysed data for 1265 patients who received chemotherapy (vinorelbine, gemcitabine, gemcitabine and vinorelbine, cisplatin and vinorelbine, or cisplatin and gemcitabine) within three randomised trials. Primary landmark analyses were restricted to 436 patients who received all six planned chemotherapy cycles and who were alive 180 days after randomisation. Neutropenia was categorised on the basis of worst WHO grade during chemotherapy: absent (grade 0), mild (grade 1-2), or severe (grade 3-4). All statistical analyses were stratified by treatment allocation. Analyses were repeated in the out-of-landmark group (829 patients), stratifying by treatment allocation and number of chemotherapy cycles. The primary endpoint was overall survival. FINDINGS: In the landmark group, hazard ratios of death were 0.65 (0.46-0.93) for patients with severe neutropenia and 0.74 (0.56-0.98) for those with mild neutropenia. Median survival after the landmark time of 180 days was 31.4 weeks (95% CI 25.7-39.6) for patients without neutropenia compared with 42.0 weeks (32.7-59.7) for patients with severe neutropenia, and with 43.7 weeks (36.6-66.0) for those with mild neutropenia (severe vs mild vs no neutropenia p=0.0118). Findings were much the same for the out-of-landmark group. INTERPRETATION: Neutropenia during chemotherapy is associated with increased survival of patients with advanced non-small-cell lung cancer, and its absence might be a result of underdosing. Prospective trials are needed to assess whether drug dosing guided by the occurrence of toxic effects could improve efficacy of standard regimens. [ABSTRACT FROM AUTHOR]

Published
2005
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48. Vinorelbine is well tolerated and active in the treatment of elderly patients with advanced non-small cell lung cancer. A two-stage phase II study

Author

Alessandra Rossi, C. Gridelli, M. D'Aprile, R. Migliorino, S. Cigolari, Ciro Gallo, S. Cariello, Ar Bianco, F. De Marinis, F. Di Costanzo, R. Bartolucci, Silvio Monfardini, M. Pergola, F. Perrone, G P Ianniello, Gridelli, C, Perrone, F, Gallo, Ciro, DE MARINIS, F, Ianniello, G, Cigolari, S, Cariello, S, DI COSTANZO, F, D'Aprile, M, Rossi, A, Migliorino, R, Bartolucci, R, Bianco, Ar, Pergola, M, and Monfardini, S.

Subjects
Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Phases of clinical research, ECOG Performance Status, Vinblastine, Vinorelbine, Drug Administration Schedule, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, Lung cancer, Aged, Aged, 80 and over, Chemotherapy, Performance status, business.industry, Age Factors, medicine.disease, Antineoplastic Agents, Phytogenic, Surgery, Survival Rate, Clinical trial, Oncology, Tolerability, Female, business, medicine.drug
Abstract

More than 30% of lung cancers arise in patients aged 70 years or more; however, because elderly patients are not considered to tolerate chemotherapy, they are generally excluded from clinical trials and are not considered eligible for aggressive cisplatin-based chemotherapy in clinical practice. The aims of the present study were to test tolerability and activity of weekly vinorelbine in advanced non-small cell lung cancer (NSCLC) patients aged 70 years or more, and to define whether minimum conditions existed for a randomised comparison with best supportive care. The study was designed as a multicentre two-stage phase II trial according to Simon's optimal design: 8 or more responses out of 43 treated patients were expected at the end of the trial. Patients aged 70 years or more were eligible if they had a cytological or histological diagnosis of NSCLC at stage IIIb–IV and a performance status less than or equal to two according to the ECOG scale. Vinorelbine was given intravenously (i.v.) at a dose of 30 mg/m 2 every week for 12 doses. As planned, 43 patients entered the study; median age was 73 years (range 70–80); 11 patients were older than 75 years. Median dose-intensity (mg/m 2 /week) of vinorelbine was 21.2 (range 7.5–30) and was not affected by age of patients. Toxicity was generally mild, mainly haematological and never life-threatening. ECOG performance status improved in 26% of patients; cough and pain improved in more than 40% of patients symptomatic at entry, while dyspnoea improved in 28%; approximately half the patients had a stabilisation of their symptoms. 10 patients (23–95% exact confidence interval (CI): 12–39%) obtained a partial response. Median time to progression was 11 weeks (95% CI 8–30) and median survival 36 weeks (95% CI 28–53). One-year estimated progression-free and overall survival rates are 16% and 36%, respectively. In conclusion, vinorelbine was well tolerated and active in the treatment of elderly NSCLC patients. A phase III trial (ELVIS—Elderly Lung Cancer Vinorelbine Italian Study) comparing best supportive care versus best supportive care plus vinorelbine is now ongoing.

Published
1997
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49. Prognostic impact of education level of patients with advanced non-small cell lung cancer enrolled in clinical trials

Author

E. Piazza, Cesare Gridelli, Vittorio Gebbia, Claudia Sandomenico, Ciro Gallo, Francovito Piantedosi, Alfonso Illiano, Anna Ceribelli, Bruno Daniele, Francesco Perrone, Gennaro Daniele, Pasqualina Giordano, Domenico Bilancia, Adolfo Favaretto, Raffaele Costanzo, Francesco Carrozza, Gaetano Rocco, Simona Signoriello, Antonio Rossi, Paolo Maione, Santi Barbera, Alessandro Morabito, Sergio Federico Robbiati, S. Cigolari, Maria Carmela Piccirillo, Massimo Di Maio, Di Maio, M, Signoriello, Simona, Morabito, A, Rossi, A, Maione, P, Piantedosi, F, Bilancia, D, Cigolari, S, Barbera, S, Gebbia, V, Daniele, B, Robbiati, Sf, Illiano, A, Ceribelli, A, Carrozza, F, Favaretto, A, Piazza, E, Piccirillo, Mc, Daniele, G, Giordano, P, Costanzo, R, Sandomenico, C, Rocco, G, Gallo, Ciro, Perrone, F, and Gridelli, C.

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, Cancer Research, medicine.medical_specialty, Lung Neoplasms, ECOG Performance Status, law.invention, Randomized controlled trial, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, Malignant pleural effusion, Lung cancer, Socioeconomic status, Aged, Neoplasm Staging, Randomized Controlled Trials as Topic, Aged, 80 and over, business.industry, Hazard ratio, Cancer, Middle Aged, Prognosis, medicine.disease, Surgery, Clinical trial, Oncology, Educational Status, Female, business
Abstract

Background Socioeconomic status can potentially affect prognosis of cancer patients. Our aim was to describe potential differences in demographic and clinical characteristics, treatment, and survival by education level in patients with advanced non-small cell lung cancer (NSCLC) enrolled in clinical trials of first-line treatment. Methods Individual data of Italian patients with advanced NSCLC (stage IV, or IIIB with supraclavicular nodes or malignant pleural effusion), ECOG performance status (PS) 0–2, enrolled in four phase III randomized trials conducted between 1996 and 2005 were pooled. Information about education was available for 1680 of 1709 patients (98.3%). Patients were divided in two groups according to education level: high (patients with at least high school diploma) or low (those with less than high school diploma). Survival analyses were stratified by treatment arm within trial. Results There were 312 (19%) and 1368 (81%) patients with high and low education, respectively. Education level was significantly different among birth cohorts, with a time-trend toward higher education level. Patients with high education were significantly younger (median age 65 vs. 70), were less frequently unfit at diagnosis (ECOG PS2 5% vs. 16%), and their tumor type was more frequently adenocarcinoma (47% vs. 37%). Number of treatment cycles received was not significantly different between education groups. Median survival was 9.4 and 7.6 months in high and low education, respectively (p = 0.012). At multivariable analysis, female sex, better PS and high education level (Hazard Ratio 0.85, 95%CI 0.73–0.99, p = 0.03) were independently associated with longer survival. Conclusions In Italian patients enrolled in four randomized trials of first-line chemotherapy for advanced NSCLC, high education was significantly more frequent among younger patients, and was associated with lower proportion of PS2 patients. Education level did not significantly affect number of chemotherapy cycles received. Overall survival was longer in patients with high education, after adjustment for PS and other prognostic factors. The exact underlying mechanisms of the independent prognostic role of education level are substantially unknown, but lead-time bias (anticipation in diagnosis and time to inclusion in the trial), differences in adherence to care outside the trial procedures, differences in comorbidities and life-style factors may all contribute.

Published
2012

50. Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer: a phase III trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group

Author

Frances A. Shepherd, Sergio Federico Robbiati, Giampietro Gasparini, S. Cigolari, Luigi Manzione, B. Findlay, Francovito Piantedosi, Lesley Seymour, Sergio Fava, Alfonso Illiano, Enzo Veltri, Andrea Bezjak, Francesco Perrone, Vera Hirsh, Robert P. Myers, Luciano Frontini, Cesare Gridelli, Vittorio Gebbia, Santi Barbera, Giovanni Pietro Ianniello, Ciro Gallo, Gridelli, C, Gallo, Ciro, Shepherd, Fa, Illiano, A, Piantedosi, F, Robbiati, Sf, Manzione, L, Barbera, S, Frontini, L, Veltri, E, Findlay, B, Cigolari, S, Myers, R, Ianniello, Gp, Gebbia, V, Gasparini, G, Fava, S, Hirsh, V, Bezjak, A, Seymour, L, and Perrone, F.

Subjects
Adult, Male, Oncology, Canada, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Vinblastine, Vinorelbine, Deoxycytidine, Quality of life, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, Aged, Chemotherapy, business.industry, Standard treatment, Cancer, Middle Aged, medicine.disease, Survival Analysis, Gemcitabine, Surgery, Clinical trial, Italy, Quality of Life, Female, Cisplatin, business, medicine.drug
Abstract

Purpose: Platinum-containing chemotherapy regimens are the standard treatment for patients with advanced non–small-cell lung cancer (NSCLC), although toxicity is common and may significantly affect the patient’s quality of life (QoL). This trial aimed to assess whether a combination of gemcitabine and vinorelbine had benefits in terms of QoL, without influencing negatively on survival, compared with cisplatin-containing regimens. Patients and Methods: Patients with stage IIIB (effusion and supraclavicular nodes) or IV documented NSCLC who were younger than 70 years of age were randomly assigned gemcitabine plus vinorelbine (GemVin) or either gemcitabine plus cisplatin or vinorelbine plus cisplatin (cisplatin-based). European Organization for Research and Treatment of Cancer scales were used for QoL analysis. Results: Five hundred one patients were randomly assigned to treatment. The median age was 62 years. There were no significant differences in global QoL scores between the two arms after 2 months of treatment. However, worsening scores for appetite, vomiting, and alopecia were significantly more common in the cisplatin-based arm. Median survival was 38 v 32 weeks and median progression-free survival was 23 v 17 weeks in the cisplatin-based versus GemVin arms, respectively. For the GemVin arm the hazard ratio for death was 1.15 (90% confidence interval [CI], 0.96 to 1.37) and the hazard ratio for progression was 1.29 (90% CI, 1.10 to 1.52). Grade 3 or 4 myelosuppression, vomiting, alopecia, and ototoxicity were significantly more frequent with cisplatin-based treatment. Conclusion: Global QoL is not improved with GemVin, although advantages in some components of QoL were apparent. GemVin is less toxic than standard cisplatin-based chemotherapy. There is a nonsignificant slight survival advantage with cisplatin-based chemotherapy. GemVin could be offered to advanced NSCLC patients who express concern about toxicity.

Published
2003

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