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5. EPIRUBICIN vs EPIRUBICIN + CISPLATIN vs EPIRUBICIN + LONIDAMINE vs EPIRUBICIN + CISPLATIN + LONIDAMINE AS FIRST LINE TREATMENT IN ADVANCED BREAST CANCER (BC) PATIENTS. A RANDOMIZED MULTICENTER PHASE III TRIAL WITH A FACTORIAL DESIGN.

Author

Dogliotti, L, Berruti, A, Bitossi, R, Gorzegno, G, Bottini, A, Alquati, P, De Matteis, A, Nuzzo, F, Giardina, B, Danese, S, De Lena, M, Lorusso, V, Farris, A, Sarobba, M G, DeFabiani, E, Spanu, G, Bonazzi, G, Castiglione, F, Bumma, C, Moro, G, and Galletto, L

Published
2000

8. 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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9. Combined Tamoxifen and Luteinizing Hormone-Releasing Hormone (LHRH) Agonist Versus LHRH Agonist Alone in Premenopausal Advanced Breast Cancer: A Meta-Analysis of Four Randomized Trials

Author

Klijn, J. G. M., Blamey, R. W., Boccardo, F., Tominaga, T., Duchateau, L., Sylvester, R., Beex, L. V. A. M., Mauriac, L., Zijl, J. A., Veyret, C., Wildiers, J., Jassem, J., Piccart, M., Burghouts, J., Becqaert, D., Seynaeve, C., Mignolet, F., Namer, M., Julien, J. P., Garcia Conde, J., Dunser, M., Margreiter, R., Tjabbes, T., Roozendaal, K. J., Velden, P. C., Nortier, J. W. R., Blamey, R., Howell, A., Forbes, J., Kaufmann, M., Nordenskjold, B., Kvinnsland, S., Wilson, R. G., Jonat, W., Kleeberg, U. R., Eiermann, W., Hilfrich, J., Weitzel, H. K., Glas, U., Rutqvist, L. E., Rudenstam, C., Sander, S., Ryden, S., Honsson, P., Lonning, P. E., Loven, L., Russell, I. S., Olweny, C., Byrne, J. J., Snyder, R. D., Coates, A. S., Lowenthal, R. M., Jeal, P. N., Dalley, D. N., Janicke, F., Kleine, W., Michel, R. Th, Canobbio, L., Amoroso, D., Rubagotti, A., Bumma, C., D Aprile, M., Matteis, A., Di Carlo, A., Francini, G., Petrioli, R., Folco, U., Calligioni, E., Gallotti, P., Lopez, M., Mesiti, M., Pacini, P., Sassi, M., Sismondi, P., Paolo Zola, Ogita, M., Okazaki, M., Watanabe, T., Satomi, T., Hatazawa, C., Okuyama, N., Koyama, T., Kobayashi, M., Shimizu, T., Tabei, T., Sano, M., Makino, H., Ando, J., Kimura, M., Takeuchi, T., Aoyama, H., Koyama, H., Shin, E., Chou, G., and Medical Oncology

Subjects
Agonist, Oncology, endocrine system, Cancer Research, medicine.medical_specialty, Neoplasms, Hormone-Dependent, Antineoplastic Agents, Hormonal, medicine.drug_class, medicine.medical_treatment, Antineoplastic Agents, Breast Neoplasms, Buserelin, Gonadotropin-Releasing Hormone, Drug Therapy, SDG 3 - Good Health and Well-being, Neoplasms, Internal medicine, medicine, Humans, Neoplasm Metastasis, Hormone-Dependent, Randomized Controlled Trials as Topic, Hormonal, business.industry, Standard treatment, Goserelin, Oophorectomy, Cancer, Antiestrogen, medicine.disease, Survival Analysis, Drug Therapy, Combination, Female, Premenopause, Tamoxifen, Endocrinology, Combination, business, hormones, hormone substitutes, and hormone antagonists, medicine.drug
Abstract

PURPOSE: The logic behind the application of luteinizing hormone-releasing hormone (LHRH) agonists in combination with tamoxifen in premenopausal women is that LHRH agonists on the one hand suppress the tamoxifen-induced stimulation of the pituitary-ovarian function and, on the other hand, seem as effective as surgical castration. This meta-analysis combines all randomized evidence to compare the combined treatment with LHRH agonist alone with respect to overall survival, progression-free survival, and objective response in premenopausal women with advanced breast cancer. PATIENTS AND METHODS: Four clinical trials randomizing a total of 506 premenopausal women with advanced breast cancer to LHRH agonist alone or to the combined treatment of LHRH agonist plus tamoxifen were identified. Meta-analytic techniques were used to analyze individual patient data from these trials. RESULTS: With a median follow-up of 6.8 years, there was a significant survival benefit (stratified log-rank test, P = .02; hazards ratio [HR] = 0.78) and progression-free survival benefit (stratified log-rank test, P = .0003; HR = 0.70) in favor of the combined treatment. The overall response rate was significantly higher on combined endocrine treatment (stratified Mantel Haenszel test, P = .03; odds ratio = 0.67). CONCLUSION: The combination of LHRH agonist plus tamoxifen is superior to LHRH agonist alone in premenopausal women with advanced breast cancer. Therefore, if a premenopausal woman with advanced breast cancer is thought to be suitable for endocrine treatment, it is proposed that the combination of a LHRH agonist plus tamoxifen be considered as the new standard treatment.

Published
2001
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10. 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

13. 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

14. 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

15. Vinorelbine treatment of recurrent salivary gland carcinomas

Author

Airoldi, M., Bumma, C., Bertetto, O., Pietro Gabriele, Succo, G., and Pedani, F.

Subjects
Adult, Male, Carcinoma, Adenoma, Pleomorphic, Vinorelbine, Salivary gland tumors, Adenocarcinoma, Middle Aged, chemotherapy, Salivary Gland Neoplasms, Vinblastine, Antineoplastic Agents, Phytogenic, Carcinoma, Adenoid Cystic, vinorelbine, Humans, Female, Neoplasm Recurrence, Local, Aged
Abstract

Twenty patients (13 males, 7 females, median age 61 years, range 27-74) with recurrent adenocarcinoma-like tumors of major (10 patients) and minor (10 patients) salivary gland origin (13 adenoid cystic carcinoma, 5 adenocarcinoma, 1 malignant mixed tumor, 1 undifferentiated carcinoma) were treated with vinorelbine at the dose of 30 mg/m2 i.v. weekly. Sixteen patients had been previously treated with surgery + radiation, 3 with surgery + radiotherapy + Novantrone and 1 with radiotherapy alone. Nine patients had local recurrence, 2 local relapse + metastasis and 9 metastasis alone. Site of metastases are: lung (7), bone (1), lung + bone (2), lung + bone + lymph-node + skin (1). Overall 174 courses were given (median 9, range 6-19). Responses were: PR in 4 patients (20%) with a median duration of 6 months (3-9), 9 NC (45%) with a median duration of 3.5 months and 7 PD (35%). The median survival time was 10 months for PR/NC patients, 4 months for non-responders. Median overall survival was 7 months. Vinorelbine has a moderate activity in these very advanced cases.

Published
1998

16. Epirubicina

Author

Cattel, Luigi, Brusa, Paola, Recalenda, V., Tagini, V., Airoldi, M., and Bumma, C.

Published
1998

33. Neo-adjuvant chemo-(immuno-) therapy of advanced head and neck squamous cell carcinoma (HNSCC): A multicenter phase III randomized study comparing cisplatin (CDDP) + 5-FU with CDDP + 5-FU + recombinant interleukin 2 (rIL 2): Preliminary results

Author

Mantovani, G., primary, Airoldi, M., additional, Bianchi, A., additional, Ghiani, M., additional, Succu, G., additional, Massa, D., additional, Curreli, L., additional, Lampis, B., additional, Lai, P., additional, Cadeddu, G., additional, and Bumma, C., additional

Published
1997
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46. 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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47. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. Italian Multicentre Breast Study with Epirubicin

Author

Ambrosini G, Palazzotto G, Becchi G, Fornasiero A, Fiorentino M, Calabresi F, Viaro D, Grignani F, Farris A, Foggi Cm, Pastorino G, Rausa L, Bonciarelli G, Fila G, Cartei G, Jirillo A, Bumma C, Di Costanzo F, Capodicasa E, Giuseppe Altavilla, Secondo, Giusto M, Adamo, Lopez M, Lacroix F, Sartori S, Speranza Gb, Palmeri S, Gallo L, Di Lauro L, Minotti, Sacchetti G, Spinelli I, Demicheli R, Maurizio Tonato, Marsilio P, Vici P, Buzzi F, Brugia M, d'Aquino S, Papaldo P, Fosser, Blasina B, Puccetti C, Gambi A, Camilluzzi E, Ardia A, Falchi Am, De Micheli P, Marenco G, Natali M, Cusimano Mp, Zingali G, Daniele O, Poggio R, Moro G, Saccani F, Garusi G, Balli M, D'Alessandro N, Schieppati G, Ciambellotti E, Gebbia N, De Maria D, Padalino D, Bonanni F, Di Carlo A, Bruscagnin G, Bertoncelli P, Chiesa G, Tagliagambe A, Intini C, and Folco U

Subjects
Cancer Research, medicine.medical_specialty, Cardiotoxicity, Leukopenia, Cyclophosphamide, Performance status, business.industry, Nausea, Gastroenterology, Oncology, Fluorouracil, Internal medicine, medicine, Doxorubicin, medicine.symptom, business, medicine.drug, Epirubicin
Abstract

From February 1983 to January 1985, 497 patients with advanced breast cancer were randomly allocated to receive either epirubicin or doxorubicin in the following combination chemotherapy regimen: fluorouracil (5-FU) 500 mg/m2 intravenous (IV) on days 1 and 8; epirubicin or doxorubicin 50 mg/m2 IV on day 1; cyclophosphamide 500 mg/m2 IV on day 1 (FEC or FAC). Cycles were repeated every 21 days until progression or to cumulative doses of 700 mg/m2 for epirubicin and 550 mg/m2 for doxorubicin. Dose reductions were applied according to the standard criteria. Activity was evaluated in 443 patients (222 in the FEC arm and 221 in the FAC arm). The two experimental groups were comparable in age, performance status, menopausal status, histology, previous treatments, and site of the disease. The overall response rate (complete response and partial response [CR + PR]) was not significantly different: 53.6% for FEC and 56.5% for FAC. The median time to progression was 273 days for FEC and 314 days for FAC; the median survival time was 591 and 613 days, respectively. Leukopenia, anemia, nausea, and vomiting were significantly lower in patients treated with FEC. As for cardiotoxicity, four cases of congestive heart failure (CHF) were recorded among patients treated with FAC while only one was observed in the FEC group. These results indicate that epirubicin in a combination chemotherapy regimen is as active as doxorubicin and is significantly less toxic.

Published
1988
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