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2. Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Author

De Giorgi, U, Carteni, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, Cn, Procopio, G, Falcone, A, Roila, F, Cascinu, S, Tirelli, U, Giustini, L, Sobrero, A, Cappuzzo, F, Tortora, G, Tassinari, D, Passalacqua, R, Pazzola, A, Surico, G, Maio, M, Benedetti, G, Barone, C, Adamo, V, Ricevuto, E, De Censi, A, Spada, M, Tonini, G, Pinto, C, Ciuffreda, L, Ruggeri, Em, Bengala, C, Scotti, V, Fagnani, D, Bonetti, A, Mitterer, M, Castiglione, F, Bidoli, P, Ferrau, F, Crino, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Favaretto, A, Di Costanzo, F, Fasola, G, Merlano, M, Artioli, F, Di Leo, A, Romito, S, Maestri, A, Giorgio, Cg, Ionta, Mt, Verderame, F, Zampa, G, Numico, G, Minelli, M, Tagliaferri, P, Foa, P, Palmiotti, G, De Placido, S, Mattioli, R, Iuliano, F, Defraia, E, Siena, S, Clerico, M, Salvagno, L, Ceresoli, Gl, Bernardo, A, Di Lieto, M, Moroni, M, Maisano, M, Scartozzi, M, Scagliotti, G, Soraru, M, Pepe, S, Scaltriti, A, Gebbia, V, Testa, E, Lorusso, V, Bordonaro, R, De Signoribus, G, Tedde, N, Santoro, A, Francini, G, Aondio, G, De Giorgi, U., Carteni, G., Giannarelli, D., Basso, U., Galli, L., Cortesi, E., Caserta, C., Pignata, S., Sabbatini, R., Bearz, A., Buti, S., Lo Re, G., Berruti, A., Bracarda, S., Cognetti, F., Rastelli, F., Fornarini, G., Porta, C., Turci, D., Sternberg, C. N., Procopio, G., Falcone, A., Roila, F., Cascinu, S., Tirelli, U., Giustini, L., Sobrero, A., Cappuzzo, F., Tassinari, D., Passalacqua, R., Pazzola, A., Surico, G., Maio, M., Benedetti, G., Barone, C., Adamo, V., Ricevuto, E., De Censi, A., Spada, M., Tonini, G., Pinto, C., Ciuffreda, L., Ruggeri, E. M., Bengala, C., Scotti, V., Fagnani, D., Bonetti, A., Mitterer, M., Castiglione, F., Bidoli, P., Ferrau, F., Crino, L., Frassoldati, A., Marchetti, P., Mini, E., Scoppola, A., Verusio, C., Favaretto, A., Di Costanzo, F., Fasola, G., Merlano, M., Artioli, F., Di Leo, A., Romito, S., Maestri, A., Giannitto Giorgio, C., Ionta, M. T., Verderame, F., Zampa, G., Numico, G., Minelli, M., Tagliaferri, P., Foa, P., Palmiotti, G., De Placido, S., Mattioli, R., Iuliano, F., Defraia, E., Siena, S., Clerico, M., Salvagno, L., Ceresoli, G. L., Bernardo, A., Di Lieto, M., Moroni, M., Maisano, M., Scartozzi, M., Scagliotti, G., Soraru, M., Pepe, S., Scaltriti, A., Gebbia, V., Testa, E., Lorusso, V., Bordonaro, R., De Signoribus, G., Tedde, N., Santoro, A., Francini, G., Aondio, G., De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, and Bidoli, P

Subjects
0301 basic medicine, Male, expanded access programme, nivolumab, real-world experience, renal cell cancer, Antineoplastic Agent, 0302 clinical medicine, Antineoplastic Agents, Immunological, 80 and over, Sunitinib, Medicine, Urology, Aged, 80 and over, Sulfonamides, Brain Neoplasms, Kidney Neoplasm, Common Terminology Criteria for Adverse Events, Middle Aged, Kidney Neoplasms, Progression-Free Survival, Survival Rate, Everolimu, Immunological, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Retreatment, Female, Nivolumab, medicine.drug, Human, Adult, medicine.medical_specialty, Indazoles, metastatic renal cancer, Response Evaluation Criteria in Solid Tumor, Antineoplastic Agents, Bone Neoplasms, Bone Neoplasm, expanded access programme, nivolumab, real-world experience, renal cell cancer, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Agents, Immunological, Bone Neoplasms, Brain Neoplasms, Carcinoma, Renal Cell, Everolimus, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Nivolumab, Progression-Free Survival, Pyrimidines, Response Evaluation Criteria in Solid Tumors, Retreatment, Sulfonamides, Sunitinib, Survival Rate, Sulfonamide, Pazopanib, Brain Neoplasm, 03 medical and health sciences, Aged, Carcinoma, Renal Cell, Everolimus, Humans, Pyrimidines, Internal medicine, Progression-free survival, Survival rate, business.industry, Carcinoma, Renal Cell, 030104 developmental biology, Pyrimidine, Expanded access, business
Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Published
2019

3. Long-term outcome of pemetrexed maintenance for advanced nonsquamous non-small-cell lung cancer: A real-world observational cohort study [Risultati a lungo termine della terapia di mantenimento con pemetrexed nei pazienti affetti da tumore polmonare non a piccole cellule in stadio avanzato e istologia non squamosa: Uno studio osservazionale di coorte condotto nella pratica clinica del mondo reale]

Author

Nelli, F., Fabbri, M. A, Moscetti, L., Sperduti, I., Gamucci, T., Mansueto, G., Signorelli, C., Cortesi, E., Martelli, O., Natoli, C., Angelini, F., Ruggeri, E. M., Nelli, F., Fabbri, M. A, Moscetti, L., Sperduti, I., Gamucci, T., Mansueto, G., Signorelli, C., Cortesi, E., Martelli, O., Natoli, C., Angelini, F., and Ruggeri, E. M.

Published
2020
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5. Clinical utility of circulating tumor cell counting through CellSearch®: the dilemma of a concept suspended in Limbo

Author

Raimondi C, Gradilone A, Naso G, Cortesi E, and Gazzaniga P

Subjects
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282
Abstract

Cristina Raimondi,1 Angela Gradilone,1 Giuseppe Naso,2 Enrico Cortesi,2 Paola Gazzaniga1 1Dipartimento Medicina Molecolare, Sapienza Università di Roma, Rome, Italy; 2Dipartimento di Scienze Radiologiche, Oncologiche e Anatomopatologiche, Sapienza Università di Roma, Rome, Italy Abstract: To date, 10 years after the first demonstration of circulating tumor cells (CTCs), prognostic significance in metastatic breast cancer using the US Food and Drug Administration–cleared system CellSearch®, the potential utility of CTCs in early clinical development of drugs, their role as a surrogate marker of response to therapy, and their molecular analysis for patient stratification for targeted therapies are still major unsolved questions. Great expectations are pinned on the ongoing interventional trials aimed to demonstrate that CTCs might be of value for guiding treatment of patients and predicting cancer progression. To fill the gap between theory and practice with regard to the clinical utility of CTCs, a bridge is needed, taking into account innovative design for clinical trials, a revised definition of traditional CTCs, next-generation CTC technology, the potential clinical application of CTC analysis in non-validated settings of disease, and finally, expanding the number of patients enrolled in the studies. In this regard, the results of the first European pooled analysis definitely validated the independent prognostic value of CTC counting in metastatic breast cancer patients. Keywords: CTC, clinical trials, prognosis

Published
2014

8. Clinical significance of epithelial-to-mesenchymal transition in laryngeal carcinoma: Its role in the different subsites

Author

Mezi, S, Chiappetta, C, Carletti, R, Nardini, A, Cortesi, E, Orsi, E, Piesco, G, and Di Gioia, C.

Subjects
Male, Epithelial-Mesenchymal Transition, laryngeal carcinoma, Caveolin 1, E-chaderin, Kaplan-Meier Estimate, Risk Assessment, Disease-Free Survival, Sampling Studies, Predictive Value of Tests, Biomarkers, Tumor, Humans, Vimentin, Laryngeal Neoplasms, beta Catenin, Aged, Aged, 80 and over, Tissue Embedding, Biopsy, Needle, EMT, beta-catenin, Middle Aged, Cadherins, Prognosis, Immunohistochemistry, Survival Analysis, N-chaderin, Disease Progression, Female, Neoplasm Recurrence, Local
Abstract

During epithelial-to-mesenchymal transition, cancer cells lose adhesion capacity gaining migratory properties. The role of the process on prognosis has been evaluated in 50 cases of laryngeal carcinoma.E-cadherin, N-cadherin, β-catenin, α-catenin, γ-catenin, caveolin-1, and vimentin immunohistochemical expression were evaluated using a double score based on staining intensity and cellular localization.Cytoplasmic E-cadherin and α/γ catenin staining were associated with a decrease in survival, cytoplasmic β-catenin was associated with advanced stage, and N-cadherin and vimentin expression were associated with poor differentiation and tumor relapse. On the basis of cancer cells, epithelial or mesenchymal morphological and immunophenotypic similarity we identified 4 main subgroups correlated with a transition to a more undifferentiated phenotype, which have a different pattern of relapse and survival.The negative prognostic role of epithelial-to-mesenchymal transition has been confirmed and a predictive role in glottic tumors has been suggested, leading us to propose epithelial-to-mesenchymal transition as an additional adverse feature in laryngeal carcinoma.

Published
2016

9. Pre-treatment neutrophil to lymphocyte ratio as an independent prognostic factor in patients with treated with everolimus for metastatic renal cell carcinoma

Author

Santoni M, De Giorgi U, Iacovelli R, Conti A, Burattini L, Rossi L, Luca Burgio S, Berardi R, Muzzonigro G, Cortesi E, Amadori D, CASCINU, Stefano, Santoni, M, De Giorgi, U, Iacovelli, R, Conti, A, Burattini, L, Rossi, L, Luca Burgio, S, Berardi, R, Muzzonigro, G, Cortesi, E, Amadori, D, and Cascinu, Stefano

Abstract

BACKGROUND: Everolimus is a mammalian target of rapamycin inhibitor approved for the treatment of metastatic renal cell carcinoma (mRCC). We aimed to assess the association between pre-treatment neutrophil-to-lymphocyte ratio (NLR) and the outcome of patients treated with everolimus for mRCC.METHODS: Ninety-seven patients with mRCC were treated with everolimus till April 2013 in our institutions. Patients were stratified in two groups with NLR >3 (Group A) vs

Published
2013

10. 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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13. Communicating cancer diagnosis and prognosis: when the target is the elderly patient-a GIOGer study

Author

Repetto, L., Pierluca Piselli, Raffaele, M., Locatelli, C., GIOGER, Collaborators Aiello, R., Alabiso, O., Airoldi, M., Barberis, G., Belloni, P., Biganzoli, L., Boccardo, F., Brunetti, C., Butera, A., Calcagno, A., Carpano, S., Castagneto, B., Cicero, G., Colangelo, M., Cortesi, E., Di Caprio, G., Di Costanzo, F., Di Seri, M., Esani, G., Farris, A., Fioretto, L., Forti, G., Gambardella, A., Giuffrida, D., Greco, E., Iacono, C., Ielapi, T., La Ricchiuta, R., Leopaldi, L., Liguori, V., Madaio, R., Maggi, L., Mencoboni, M., MILIA AG, Neri, B., Nuzzo, A., Olgiati, A., Pagliarulo, C., Porcile, G., Pronzato, P., Said, K., Susi, M., Tralongo, P., Travaglini, C., Valenza, R., Zagonel, V., Repetto, L, Piselli, P, Raffaele, M, Locatelli, C, Gioger, COLLABORATORS AIELLO, R, Alabiso, O, Airoldi, M, Barberis, G, Belloni, P, Biganzoli, L, Boccardo, F, Brunetti, C, Butera, A, Calcagno, A, Carpano, S, Castagneto, B, Cicero, G, Colangelo, M, Cortesi, E, DI CAPRIO, G, DI COSTANZO, F, DI SERI, M, Esani, G, Farris, A, Fioretto, L, Forti, G, Gambardella, Antonio, Giuffrida, D, Greco, E, Iacono, C, Ielapi, T, LA RICCHIUTA, R, Leopaldi, L, Liguori, V, Madaio, R, Maggi, L, Mencoboni, M, Milia, Ag, Neri, B, Nuzzo, A, Olgiati, A, Pagliarulo, C, Porcile, G, Pronzato, P, Said, K, Susi, M, Tralongo, P, Travaglini, C, Valenza, R, and Zagonel, V.

Published
2009

14. Surgical Resection Does Not Improve Survival in Patients with Renal Metastases to the Pancreas in the Era of Tyrosine Kinase Inhibitors

Author

Santoni, M, Conti, A, Partelli, S, Porta, C, Sternberg, Cn, Procopio, G, Bracarda, S, Basso, U, De Giorgi, U, Derosa, L, Rizzo, M, Ortega, C, Massari, F, Iacovelli, Roberto, Milella, M, Di Lorenzo, G, Buti, S, Cerbone, L, Burattini, L, Montironi, R, Santini, D, Falconi, M, Cascinu, S, Iacovelli, R, Albiges, L, Loriot, Y, Massard, C, Fizazi, K, Escudier, B, Pietrantonio, F, Di Bartolomeo, M, de Braud, F, Verzoni, E, Braud, Fd, Testa, I, Grassi, P, Galli, G, De Braud, F, Saravia, D, Salvioni, R, Farcomeni, Alessio, Maggi, C, Palazzo, A, Ricchini, F, Porcu, L, Torri, V, Masini, C, Atzori, F, Pagano, M, De Vivo, R, Mosca, A, Rossi, M, Paglino, C, Muzzonigro, G, Fanetti, G, Deraco, M, Perrone, F, Baratti, D, Kusamura, S, Tamborini, E, Castano, A, Consonni, Pv, Bossi, I, Gavazzi, C, Milione, M, Pelosi, G, Orlando, V, Cortesi, E, Biondani, P, Garanzini, E, Facciorusso, Mg, Testi, A, Miceli, R, Leone, G, de Braud, F., Santoni, Matteo, Conti, Alessandro, Porta, Camillo, Sternberg Cora, N., Procopio, Giuseppe, Bracarda, Sergio, Basso, Umberto, De Giorgi, Ugo, Derosa, Lisa, Rizzo, Mimma, Ortega, Cinzia, Massari, Francesco, Iacovelli, Roberto, Milella, Michele, Di Lorenzo, Giuseppe, Buti, Sebastiano, Cerbone, Linda, Burattini, Luciano, Montironi, Rodolfo, Santini, Daniele, Falconi, Massimo, Cascinu, Stefano, and Partelli, Stefano

Subjects
Oncology, Male, medicine.medical_treatment, urologic and male genital diseases, Gastroenterology, Nephrectomy, Metastasis, Surgical oncology, Renal cell carcinoma, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Medicine, Aged, 80 and over, Middle Aged, Protein-Tyrosine Kinases, Prognosis, Combined Modality Therapy, female genital diseases and pregnancy complications, Kidney Neoplasms, Survival Rate, Local, Lymphatic Metastasis, Female, Adult, medicine.medical_specialty, Internal medicine, Carcinoma, Humans, Neoplasm Invasiveness, Survival rate, Carcinoma, Renal Cell, Protein Kinase Inhibitors, Aged, Neoplasm Staging, Retrospective Studies, business.industry, Renal Cell, Cancer, medicine.disease, not applicable, Pancreatic Neoplasms, Neoplasm Recurrence, Concomitant, Surgery, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

The aim of this study was to compare survival of resected and unresected patients in a large cohort of patients with metastases to the pancreas from renal cell carcinoma (PM-RCC). Data from 16 Italian centers involved in the treatment of metastatic RCC were retrospectively collected. The Kaplan–Meier and log-rank test methods were used to evaluate overall survival (OS). Clinical variables considered were sex, age, concomitant metastasis to other sites, surgical resection of PM-RCC, and time to PM-RCC occurrence. Overall, 103 consecutive patients with radically resected primary tumors were enrolled in the analysis. PM-RCCs were synchronous in only three patients (3 %). In 56 patients (54 %), the pancreas was the only metastatic site, whereas in the other 47 patients, lung (57 %), lymph nodes (28 %), and liver (21 %) were the most common concomitant metastatic sites. Median time for PM-RCC occurrence was 9.6 years (range 0–24 years) after nephrectomy. Surgical resection of PM-RCC was performed in 44 patients (median OS 103 months), while 59 patients were treated with tyrosine kinase inhibitors (TKIs; median OS 86 months) (p = 0.201). At multivariate analysis, Memorial Sloan Kettering Cancer Center risk group was the only independent prognostic factor. None of the other clinical variables, such as age, sex, pancreatic surgery, or the presence of concomitant metastases, were significantly associated with outcome in PM-RCC patients. The presence of PM-RCC is associated with a long survival, and surgical resection does not improve survival in comparison with TKI therapy. However, surgical resection leads to a percentage of disease-free PM-RCC patients.

Published
2014

15. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial

Author

Rosell, R, Carcereny, E, Gervais, R, Vergnenegre, A, Massuti, B, Felip, E, Palmero, R, Garcia Gomez, R, Pallares, C, Sanchez, Jm, Porta, R, Cobo, M, Garrido, P, Longo, F, Moran, T, Insa, A, De Marinis, F, Corre, R, Bover, I, Illiano, A, Dansin, E, de Castro, J, Milella, M, Reguart, N, Altavilla, Giuseppe, Jimenez, U, Provencio, M, Moreno, Ma, Terrasa, J, Muñoz Langa, J, Valdivia, J, Isla, D, Domine, M, Molinier, O, Mazieres, J, Baize, N, Garcia Campelo, R, Robinet, G, Rodriguez Abreu, D, Lopez Vivanco, G, Gebbia, V, Ferrera Delgado, L, Bombaron, P, Bernabe, R, Bearz, A, Artal, A, Cortesi, E, Rolfo, C, Sanchez Ronco, M, Drozdowskyj, A, Queralt, C, de Aguirre, I, Ramirez, Jl, Sanchez, Jj, Molina, Ma, Taron, M, Paz Ares, L, on behalf of the Spanish Lung Cancer Group in collaboration with the Groupe Français de Pneumo Cancérologie, and the Associazione Italiana Oncologia Toracica

Subjects
Male, Oncology, Lung Neoplasms, Time Factors, Administration, Oral, Docetaxel, Kaplan-Meier Estimate, NSCLC, Deoxycytidine, Carboplatin, chemistry.chemical_compound, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Molecular Targeted Therapy, Prospective Studies, Rociletinib, Precision Medicine, Erlotinib Hydrochloride, Exons, Middle Aged, ErbB Receptors, Europe, Treatment Outcome, Erlotinib, Female, Taxoids, medicine.drug, medicine.medical_specialty, Disease-Free Survival, Drug Administration Schedule, Gefitinib, Internal medicine, medicine, Humans, Protein Kinase Inhibitors, Erlotinib, NSCLC, EGFR mutations, Aged, Proportional Hazards Models, Chi-Square Distribution, business.industry, Patient Selection, Gemcitabine, EGFR mutations, Surgery, chemistry, Mutation, Icotinib, Quinazolines, Cisplatin, business
Abstract

Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations. We aimed to assess the safety and efficacy of erlotinib compared with standard chemotherapy for first-line treatment of European patients with advanced EGFR-mutation positive NSCLC.We undertook the open-label, randomised phase 3 EURTAC trial at 42 hospitals in France, Italy, and Spain. Eligible participants were adults (18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ≥ 6 months before study entry was allowed). We randomly allocated participants (1:1) according to a computer-generated allocation schedule to receive oral erlotinib 150 mg per day or 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m(2) on day 1 plus docetaxel (75 mg/m(2) on day 1) or gemcitabine (1250 mg/m(2) on days 1 and 8). Carboplatin (AUC 6 with docetaxel 75 mg/m(2) or AUC 5 with gemcitabine 1000 mg/m(2)) was allowed in patients unable to have cisplatin. Patients were stratified by EGFR mutation type and Eastern Cooperative Oncology Group performance status (0 vs 1 vs 2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed safety in all patients who received study drug (≥ 1 dose). This study is registered with ClinicalTrials.gov, number NCT00446225.Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5-5·8) in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25-0·54; p0·0001). Main grade 3 or 4 toxicities were rash (11 [13%] of 84 patients given erlotinib vs none of 82 patients in the chemotherapy group), neutropenia (none vs 18 [22%]), anaemia (one [1%] vs three [4%]), and increased amino-transferase concentrations (two [2%] vs 0). Five (6%) patients on erlotinib had treatment-related severe adverse events compared with 16 patients (20%) on chemotherapy. One patient in the erlotinib group and two in the standard chemotherapy group died from treatment-related causes.Our findings strengthen the rationale for routine baseline tissue-based assessment of EGFR mutations in patients with NSCLC and for treatment of mutation-positive patients with EGFR tyrosine-kinase inhibitors.Spanish Lung Cancer Group, Roche Farma, Hoffmann-La Roche, and Red Temática de Investigacion Cooperativa en Cancer.

Published
2012

16. Circulating tumor cells and 'suspicious objects' evaluated through CellSearch® in metastatic renal cell carcinoma

Author

Gradilone, A., Roberto Iacovelli, Cortesi, E., Raimondi, C., Gianni, W., Nicolazzo, C., Petracca, A., Palazzo, A., Longo, F., Frati, L., and Gazzaniga, P.

Subjects
Keratin-19, Keratin-18, Keratin-8, Cytological Techniques, Reproducibility of Results, Middle Aged, Medical Oncology, Neoplastic Cells, Circulating, Kidney Neoplasms, Gene Expression Regulation, Neoplastic, renal cell carcinoma, cellsearch, cytokeratins, cd44, circulating tumor cells, Hyaluronan Receptors, Humans, Neoplasm Metastasis, Carcinoma, Renal Cell, Aged
Abstract

Recent evidence supports the hypothesis that the CellSearch assay, used in the enumeration of circulating tumor cells (CTCs), may underestimate the number of CTCs, especially in tumors, such as renal cell carcinoma, frequently lacking cytokeratin expression. According to the CellSearch guidelines, all objects with no clear cytokeratin staining are defined as "suspicious objects", and are not counted as CTCs. The aim of this study was to investigate the presence of CTCs and "suspicious objects" in 25 patients affected by metastatic renal cell carcinoma (mRCC).Twenty-five patients were enrolled in the study, all with a diagnosis of metastatic clear cell RCC. The CellSearch™ system was used to count the CTC in 7.5 mL of whole blood. A further 10 ml blood obtained from each patient was used to isolate CTCs through CELLection™ Dynabeads®. The expression of cytokeratin (CK) 8, 18, 19 and CD44 were evaluated by RT-PCR.Standard CTCs and suspicious objects were found in 16% and 60% of the patients, respectively. CK-8/18/19 transcripts were found in 15% and CD44 in 68% of the 19 patients with evidence of classical CTC or "suspicious objects" as assessed by Cellsearch.The low number of CTCs detected through CellSearch in renal cell carcinoma may be due to the presence of a CTC population with atypical characteristics and a peculiar gene expression profile, characterized by lack of cytokeratin expression and gain of CD44.

Published
2011

17. Intermittent versus continuous chemotherapy in advanced colorectal cancer: a randomised 'GISCAD' trial

Author

Labianca, R, Sobrero, A, Isa, L, Cortesi, E, Barni, S, Nicolella, D, Aglietta, M, Lonardi, S, Corsi, D, Turci, D, Beretta, Gd, Fornarini, G, Dapretto, E, Floriani, I, Zaniboni, A, Pessi, A, Mosconi, S, Aitini, E, Carlo, Ao, Astorre, P, Cabiddu, M, Mandala', M, Petrelli, F, Cassata, A, Ucci, G, Catalano, V, Clerico, M, D'Andrea, M, Gambi, A, Frontini, L, Gardani, G, Vaghi, M, Gridelli, C, Gottardi, O, Jirillo, A, Martignoni, G, Piazza, E, Tabiadon, D, Zagonel, V, Meriggi, F, Bolzoni, P, and Naso, G. Italian Group for the Study of Gastrointestinal Cancer-GISCAD.

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, metastatic colorectal cancer, intermittent chemotherapy, folfiri, colorectal cancer, FOLFIRI, Kaplan-Meier Estimate, Irinotecan, Gastroenterology, Disease-Free Survival, Bolus (medicine), Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Aged, Chemotherapy, Levoleucovorin, business.industry, Hazard ratio, Hematology, Drug holiday, Middle Aged, Oxaliplatin, Surgery, Regimen, Treatment Outcome, Oncology, Toxicity, Camptothecin, Female, Fluorouracil, business, Colorectal Neoplasms, medicine.drug
Abstract

In advanced colorectal cancer, chemotherapy is usually administered without pauses and until progression but patients can experience cumulative toxicity and cannot tolerate a heavy therapeutic charge.The aim of the present trial was to evaluate whether an intermittent chemotherapy with levo-leucovorin + 5-fluorouracil (5-FU) + irinotecan (CPT-11) was at least as effective as the same regimen given continuously, both administered until progression, in patients affected with advanced colorectal cancer and not previously exposed to chemotherapy for metastatic disease.A total of 337 patients from 27 institutions were randomised between levo-leucovorin, 100/mg/m(2) i.v. + 5-FU; 400 mg/m(2) i.v. bolus + 5-FU; 600 mg/m(2) 22-h continuous infusion, days 1 and 2 + CPT-11; 180 mg/m(2) day 1, administered every 2 weeks 2 months on and 2 months off (arm A) and the same regimen administered continuously (arm B), until progression in both arms. The main end point was overall survival (OS), the secondary progression-free survival (PFS) and toxicity.At a median follow-up of 41 months, OS was 18 months in arm A and 17 months in arm B [hazard ratio (HR), 0.88]. Also PFS was comparable in the two groups (6 months in both, with HR, 1.03), and even grades 3-4 toxicity (mainly myelosuppression, fever and diarrhoea) was similar. Second-line oxaliplatin-based treatment was administered in a similar percentage (66%) in the two arms. The median chemotherapy-free period (drug holiday) in arm A was 3.5 months.Reducing the charge of therapy in this population did not diminish the efficacy of treatment. Further studies with this strategy, including biologicals, are warranted.

Published
2011

18. Dermatomyositis as first clinical appearance for a thymic epidermoid cell carcinoma

Author

Iacovelli, R., Palazzo, A., Conte, D., Maria Agnese Fabbri, Vitolo, D., and Cortesi, E.

Subjects
Thymoma, Humans, Female, Thymus Neoplasms, Middle Aged, paraneoplastic syndrome, thymic carcinoma, dermatomyositis, Dermatomyositis
Abstract

Primary thymic carcinoma is a rare and heterogeneous group of tumours of the anterior mediastinum that includes different histological types. Frequently, it first comes to clinical attention through paraneoplastic syndromes such as dermatomyositis. We report the case of a 54-year-old woman with several episodes of fever and chest pain in the previous 5 months. The patient was admitted to the Rheumatology Department with a peri-ungual erythema and papular lesions on both sides of each hand and alteration at biochemistry tests. A left deltoid muscle biopsy specimen showed a histological pattern compatible with the diagnosis of dermatomyositis. A computed tomography of the chest, abdomen and pelvis, showed a solid mass in the upper anterior mediastinal area and a mediastinoscopy with mass-biopsy was performed. Only the immunohistochemical staining technique allowed a definitive histological diagnosis. We report the diagnostic challenge and the therapeutic approach of thymic neoplasia.

Published
2010

21. La valutazione della qualità di vita in oncologia: razionale ed obiettivi della prima fase del progetto QV-ONC

Author

Costantini M., Mencaglia E., Di Giulio P., Cortesi E., Roila F., Ballatori E., Tamburini M., Casali P., Licitra L., Massidda B., Luzzani M., Campora E., Palmeri S., Martignetti A., DE PLACIDO, SABINO, Costantini, M., Mencaglia, E., Di Giulio, P., Cortesi, E., Roila, F., Ballatori, E., Tamburini, M., Casali, P., Licitra, L., Massidda, B., Luzzani, M., Campora, E., DE PLACIDO, Sabino, Palmeri, S., and Martignetti, A.

Published
1997

24. Phase III Trial of infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) compared with infusional Fluorouracil,Leucovorin, and Irinotecan (FOLFIRI) as first-line treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest(G.O.N.O.)

Author

Alfredo Falcone, Ricci, S., Brunetti, I., Pfanner, E., Allegrini, G., Barbara, C., Crin, L., Benedetti, G., Evangelista, W., Fanchini, L., Cortesi, E., Picone, V., Vitello, S., Chiara, S., Granetto, C., Porcile, G., Fioretto, L., Orlandini, C., Andreuccetti, M., and GIANLUCA MASI

Published
2007

27. 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

30. 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

31. Randomized, double-blind, dose-finding study of dexamethasone in preventing acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide (vol 22, pg 725, 2004)

Author

Roila, F, Ballatori, E, Bosnjak, S, Tonato, M, Basurto, C, Betti, M, Bonciarelli, V, Cianchetti, M, Susnjar, S, Neskovic-Konstantinovic, Z, Stamotovic, L, Marinkovic, Z, Rosati, G, Manzione, L, Rossi, A, Germano, D, Romano, R, Nuzzo, A, Laudadio, L, D'Ostilio, N, Forciniti, S, Buzzi, F, Bartolucci, R, Fumi, G, Catanzani, S, Gamucci, T, Ferraresi, V, Trombetta, G, Vaccaro, A, Contu, A, Olmeo, N, Baldino, G, Campora, E, Venturino, A, Addamo, G, Silva, Rr, Giuliodori, L, Bisonni, R, Dazzi, C, Cariello, A, Zumaglini, F, Tonini, G, Santini, D, Vincenzi, B, Fava, S, Grimi, E, Luoni, M, Picece, V, Nicodemo, M, Recaldin, E, Donati, D, Margutti, G, Cortesi, E, D'Auria, G, Lalli, A, Di Giandomenico, F, Massidda, B, Ionta, Mt, Alessandroni, P, Baldelli, Am, Pinaglia, D, Sassi, M, Sabbatini, R, Maur, M, di Castello, C, Porrozzi, S, Bravi, S, Eugenio, S, Antimi, M, Gridelli, C, and Verusio, C

Published
2004

32. Hepatic arterial infusion (HAI) of cisplatin and systemic fluorouracil in the treatment of unresectable colorectal liver metastases

Author

Raffaello Mancini, Tedesco, M., Garufi, C., Filippini, A., Arcieri, S., Caterino, M., Pizzi, G., Cortesi, E., Spila, A., Sperduti, I., and Cosimelli, M.

Subjects
hai, Dose-Response Relationship, Drug, Liver Neoplasms, colorectal cancer, Infusion Pumps, Implantable, regional chemotherapy, Combined Modality Therapy, liver metastases, cisplatin, Drug Administration Schedule, Catheterization, Hepatic Artery, Antineoplastic Combined Chemotherapy Protocols, Humans, Infusions, Intra-Arterial, Fluorouracil, Cisplatin, Colorectal Neoplasms
Abstract

Only 5-10% of colorectal cancer patients (pts) with liver metastases are eligible for surgical resection. Regional and systemic chemotherapy represents the best therapeutic options for unresectable metastases.In a randomized phase II trial 123 pts were enrolled with a minimum follow-up of 3 years. In Arm A 58 pts were submitted to intraarterial continuous infusion of cisplatin (CDDP), 24 mg/m2/day, while the other 65 were included in Arm B (bolus of CDDP, 24 mg/m2/day). All the pts were also given i.v. escalating doses of fluorouracil. Response was evaluated after a minimum of 3 cycles.Toxicityor = G3 was lower in Arm B. The objective response rate was 52% in all the series, the complete responses being 17.3% (17.6% vs. 17% in Arms A and B, respectively). The overall median survival was 18 months rising to 28 months in the responders.CDDP HAI provided similar results as FUdR in terms of response to treatment. Moreover, long-term survivors were unexpectedly observed.

Published
2003

33. 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

37. Patient compliance with quality of life questionnaires

Author

Roila, F, Ballatori, E, Mattei, Antonella, Cortesi, E, Tamburini, M, Casali, P, Licitra, L, Mencaglia, E, Costantini, M, Massidda, B, and on behalf of Italian Group for Evaluation of Outcomes in Oncology

Published
1999

41. Preoperative chemotherapy and immunochemotherapy for locally advanced stage IIIA and IIIB non small cell lung cancer. Preliminary results

Author

Ciriaco P, I. Flaishman, Costante Ricci, Carlo D. Baroni, Federico Venuta, Erino A. Rendina, Cortesi E, Della Rocca G, Bonsignore G, and De Giacomo T

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Mitomycin, Vinblastine, Pneumonectomy, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Thoracotomy, Lung cancer, Survival rate, Etoposide, Aged, Neoplasm Staging, Chemotherapy, business.industry, Mitomycin C, Remission Induction, General Medicine, Middle Aged, medicine.disease, Combined Modality Therapy, Surgery, Survival Rate, Multivariate Analysis, Female, Interferons, Cisplatin, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract

From January 1991 to November 1993, 110 patients with histologically confirmed stage IIIA and IIIB non-small cell lung cancer (NSCLC), were seen at our Institution. Our study was designed to evaluate whether redirection to surgery of otherwise unresectable patients may be obtained by preoperative therapy. Forty-nine patients were considered eligible for neoadjuvant treatment. Thirty-two (Group I) were treated with two or three cycles of cisplatin, vinblastine and mitomycin C and 17 (Group II) received two cycles of cisplatin, VP16, alpha 1 timosine and interferon. The overall response rate was 81.2% for Group I and 88.7% for Group II. Downstaging was predictive of resectability (P < 0.05). Forty-one patients (83.6%) underwent thoracotomy with 37 (75.5%) radical resections. Conservative techniques (bronchovascular reconstruction) (22 cases) were preferred over pneumonectomy (2 cases). The resectability rate was 84% for Group I and 87% for Group II (P = NS). Treatment-related complications were minor, with no deaths. Postoperative complications occurred in two cases in each group (7.4% and 14.3%). There was no histologic evidence of tumor in three patients. Two-year survival was 75% for Group I and 55% for Group II (P = NS). To date 35 patients who had complete resection are alive, and free of disease. We conclude that preoperative chemotherapy produces high response and resectability rates in both stage IIIA and IIIB unresectable NSCLC; radical resection using a conservative technique is possible in patients who are otherwise unresectable; no local recurrence occurred after radical resection; no significant differences were demonstrated between the two protocols.

Published
1995

43. [Clinical use of a totally implantable and programmable pump for the infusion of drugs]

Author

Balletto, N., Cavallini, Marco, Cortesi, E., Decian, F., Arnone, G. B., and Civalleri, D.

Subjects
implantable, infusion pumps, administration /&/ dosage, antineoplastic agents, colorectal neoplasms, drug therapy, floxuridine, humans, kidney neoplasms, Humans, Antineoplastic Agents, Infusion Pumps, Implantable, Colorectal Neoplasms, Floxuridine, Kidney Neoplasms
Abstract

Totally implantable programmable systems allow preordained complex continuous infusion of drugs. Sixteen totally programmable implantable pumps (Medtronic DAD) have been implanted in fifteen advanced colorectal and renal cancer patients for continuous ia and iv sinusoidal Fudr infusion. Median duration of pump function was 125 days (range 46-468), there was observed only one case of malfunction device which required the implant of a new device, and three complications of pump pocket (seroma, hematoma and infection) without interrumption of chemotherapy for clinical causes. The use of totally implantable programmable systems provides and important clinical improvement in controlled long-term drugs administration improving quality of life and duration of chemotherapy.

Published
1992

45. Oncologia Clinica

Author

Marchetti, P, Ficorella, Corrado, Mazzei, N, Cortesi, E, and Pellegrini, A.

Published
1990

48. Medical treatment of loco-regional recurrence of colo-rectal tumors

Author

Marchetti P, Ficorella C, Cortesi E, Mazzei N, Domenico MASCAGNI, Corbellini L, Pellegrini P, and Pellegrini A

Subjects
Humans, Infusions, Intra-Arterial, Antineoplastic Agents, Infusions, Parenteral, Neoplasm Recurrence, Local, Colorectal Neoplasms
Published
1988

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