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3. Melanoma and immunotherapy bridge 2015 : Naples, Italy. 1-5 December 2015.

Author

Nanda, VGY, Peng, W, Hwu, P, Davies, MA, Ciliberto, G, Fattore, L, Malpicci, D, Aurisicchio, L, Ascierto, PA, Croce, CM, Mancini, R, Spranger, S, Gajewski, TF, Wang, Y, Ferrone, S, Vanpouille-Box, C, Wennerberg, E, Pilones, KA, Formenti, SC, Demaria, S, Tang, H, Fu, Y-X, Dummer, R, Puzanov, I, Tarhini, A, Chauvin, J-M, Pagliano, O, Fourcade, J, Sun, Z, Wang, H, Sanders, C, Kirkwood, JM, Chen, T-HT, Maurer, M, Korman, AJ, Zarour, HM, Stroncek, DF, Huber, V, Rivoltini, L, Thurin, M, Rau, T, Lugli, A, Pagès, F, Camarero, J, Sancho, A, Jommi, C, de Coaña, YP, Wolodarski, M, Yoshimoto, Y, Gentilcore, G, Poschke, I, Masucci, GV, Hansson, J, Kiessling, R, Scognamiglio, G, Sabbatino, F, Marino, FZ, Anniciello, AM, Cantile, M, Cerrone, M, Scala, S, D’alterio, C, Ianaro, A, Cirin, G, Liguori, G, Bott, G, Chapman, PB, Robert, C, Larkin, J, Haanen, JB, Ribas, A, Hogg, D, Hamid, O, Testori, A, Lorigan, P, Sosman, JA, Flaherty, KT, Yue, H, Coleman, S, Caro, I, Hauschild, A, McArthur, GA, Sznol, M, Callahan, MK, Kluger, H, Postow, MA, Gordan, R, Segal, NH, Rizvi, NA, Lesokhin, A, Atkins, MB, Burke, MM, Ralabate, A, Rivera, A, Kronenberg, SA, Agunwamba, B, Ruisi, M, Horak, C, Jiang, J, Wolchok, J, Liszkay, G, Maio, M, Mandalà, M, Demidov, L, Stoyakovskiy, D, Thomas, L, de la Cruz-Merino, L, Atkinson, V, Dutriaux, C, Garbe, C, Wongchenko, M, Chang, I, Koralek, DO, Rooney, I, Yan, Y, Dréno, B, Sullivan, R, Patel, M, Hodi, S, Amaria, R, Boasberg, P, Wallin, J, He, X, Cha, E, Richie, N, Ballinger, M, Smith, DC, Bauer, TM, Wasser, JS, Luke, JJ, Balmanoukian, AS, Kaufman, DR, Zhao, Y, Maleski, J, Leopold, L, Gangadhar, TC, Long, GV, Michielin, O, VanderWalde, A, Andtbacka, RHI, Cebon, J, Fernandez, E, Malvehy, J, Olszanski, AJ, Gause, C, Chen, L, Chou, J, Stephen Hodi, F, Brady, B, Mortier, L, Hassel, JC, Rutkowski, P, McNeil, C, Kalinka-Warzocha, E, Lebbé, C, Ny, L, Chacon, M, Queirolo, P, Loquai, C, Cheema, P, Berrocal, A, Eizmendi, KM, Bar-Sela, G, Hardy, H, Weber, JS, Grob, J-J, Marquez-Rodas, I, Schmidt, H, Briscoe, K, Baurain, J-F, Wolchok, JD, Pinto, R, De Summa, S, Garrisi, VM, Strippoli, S, Azzariti, A, Guida, G, Guida, M, Tommasi, S, Jacquelot, N, Enot, D, Flament, C, Pitt, JM, Vimond, N, Blattner, C, Yamazaki, T, Roberti, M-P, Vetizou, M, Daillere, R, Poirier-Colame, V, la Semeraro, M, Caignard, A, Slingluff, CL, Sallusto, F, Rusakiewicz, S, Weide, B, Marabelle, A, Kohrt, H, Dalle, S, Cavalcanti, A, Kroemer, G, Di Giacomo, AM, Wong, P, Yuan, J, Umansky, V, Eggermont, A, Zitvogel, L, Anna, P, Marco, T, Stefania, S, Francesco, M, Mariaelena, C, Gabriele, M, Antonio, AP, Franco, S, Roberti, MP, Enot, DP, Semeraro, M, Jégou, S, Flores, C, Kwon, BS, Anderson, AC, Borg, C, Aubin, F, Ayyoub, M, De Presbiteris, AL, Cordaro, FG, Camerlingo, R, Fratangelo, F, Mozzillo, N, Pirozzi, G, Patriarca, EJ, Caputo, E, Motti, ML, Falcon, R, Miceli, R, Capone, M, Madonna, G, Mallardo, D, Carrier, MV, Panza, E, De Cicco, P, Armogida, C, Ercolano, G, Botti, G, Cirino, G, Sandru, A, Blank, M, Balatoni, T, Olasz, J, Farkas, E, Szollar, A, Savolt, A, Godeny, M, Csuka, O, Horvath, S, Eles, K, Shoenfeld, Y, Kasler, M, Costantini, S, Capone, F, Moradi, F, Berglund, P, Leandersson, K, Linnskog, R, Andersson, T, Prasad, CP, Nigro, CL, Lattanzio, L, Proby, C, Syed, N, Occelli, M, Cauchi, C, Merlano, M, Harwood, C, Thompson, A, Crook, T, Bifulco, K, Ingangi, V, Minopoli, M, Ragone, C, Pessi, A, Mannavola, F, D’Oronzo, S, Felici, C, Tucci, M, Doronzo, A, Silvestris, F, Ferretta, A, Guida, S, Maida, I, Cocco, T, Passarelli, A, Quaresmini, D, Franzese, O, Palermo, B, Di Donna, C, Sperduti, I, Foddai, M, Stabile, H, Gismondi, A, Santoni, A, Nisticò, P, Sponghini, AP, Platini, F, Marra, E, Rondonotti, D, Alabiso, O, Fierro, MT, Savoia, P, Stratica, F, Quaglino, P, Di Monta, G, Corrado, C, Di Marzo, M, Ugo, M, Di Cecilia, ML, Nicola, M, Fusciello, C, Marra, A, Guarrasi, R, Baldi, C, Russo, R, Di Giulio, G, Faiola, V, Zeppa, P, Pepe, S, Gambale, E, Carella, C, Di Paolo, A, De Tursi, M, Marra, L, De Murtas, F, Sorrentino, V, Voinea, S, Panaitescu, E, Bolovan, M, Stanciu, A, Cinca, S, Botti, C, Aquino, G, Anniciello, A, Fortes, C, Mastroeni, S, Caggiati, A, Passarelli, F, Zappalà, A, Capuano, M, Bono, R, Nudo, M, Marino, C, Michelozzi, P, De Biasio, V, Battarra, VC, Formenti, S, Ascierto, ML, McMiller, TL, Berger, AE, Danilova, L, Anders, RA, Netto, GJ, Xu, H, Pritchard, TS, Fan, J, Cheadle, C, Cope, L, Drake, CG, Pardoll, DM, Taube, JM, Topalian, SL, Gnjatic, S, Nataraj, S, Imai, N, Rahman, A, Jungbluth, AA, Pan, L, Venhaus, R, Park, A, Lehmann, FF, Lendvai, N, Cohen, AD, Cho, HJ, Daniel, S, Hirsh, V, Nanda, VGY, Peng, W, Hwu, P, Davies, MA, Ciliberto, G, Fattore, L, Malpicci, D, Aurisicchio, L, Ascierto, PA, Croce, CM, Mancini, R, Spranger, S, Gajewski, TF, Wang, Y, Ferrone, S, Vanpouille-Box, C, Wennerberg, E, Pilones, KA, Formenti, SC, Demaria, S, Tang, H, Fu, Y-X, Dummer, R, Puzanov, I, Tarhini, A, Chauvin, J-M, Pagliano, O, Fourcade, J, Sun, Z, Wang, H, Sanders, C, Kirkwood, JM, Chen, T-HT, Maurer, M, Korman, AJ, Zarour, HM, Stroncek, DF, Huber, V, Rivoltini, L, Thurin, M, Rau, T, Lugli, A, Pagès, F, Camarero, J, Sancho, A, Jommi, C, de Coaña, YP, Wolodarski, M, Yoshimoto, Y, Gentilcore, G, Poschke, I, Masucci, GV, Hansson, J, Kiessling, R, Scognamiglio, G, Sabbatino, F, Marino, FZ, Anniciello, AM, Cantile, M, Cerrone, M, Scala, S, D’alterio, C, Ianaro, A, Cirin, G, Liguori, G, Bott, G, Chapman, PB, Robert, C, Larkin, J, Haanen, JB, Ribas, A, Hogg, D, Hamid, O, Testori, A, Lorigan, P, Sosman, JA, Flaherty, KT, Yue, H, Coleman, S, Caro, I, Hauschild, A, McArthur, GA, Sznol, M, Callahan, MK, Kluger, H, Postow, MA, Gordan, R, Segal, NH, Rizvi, NA, Lesokhin, A, Atkins, MB, Burke, MM, Ralabate, A, Rivera, A, Kronenberg, SA, Agunwamba, B, Ruisi, M, Horak, C, Jiang, J, Wolchok, J, Liszkay, G, Maio, M, Mandalà, M, Demidov, L, Stoyakovskiy, D, Thomas, L, de la Cruz-Merino, L, Atkinson, V, Dutriaux, C, Garbe, C, Wongchenko, M, Chang, I, Koralek, DO, Rooney, I, Yan, Y, Dréno, B, Sullivan, R, Patel, M, Hodi, S, Amaria, R, Boasberg, P, Wallin, J, He, X, Cha, E, Richie, N, Ballinger, M, Smith, DC, Bauer, TM, Wasser, JS, Luke, JJ, Balmanoukian, AS, Kaufman, DR, Zhao, Y, Maleski, J, Leopold, L, Gangadhar, TC, Long, GV, Michielin, O, VanderWalde, A, Andtbacka, RHI, Cebon, J, Fernandez, E, Malvehy, J, Olszanski, AJ, Gause, C, Chen, L, Chou, J, Stephen Hodi, F, Brady, B, Mortier, L, Hassel, JC, Rutkowski, P, McNeil, C, Kalinka-Warzocha, E, Lebbé, C, Ny, L, Chacon, M, Queirolo, P, Loquai, C, Cheema, P, Berrocal, A, Eizmendi, KM, Bar-Sela, G, Hardy, H, Weber, JS, Grob, J-J, Marquez-Rodas, I, Schmidt, H, Briscoe, K, Baurain, J-F, Wolchok, JD, Pinto, R, De Summa, S, Garrisi, VM, Strippoli, S, Azzariti, A, Guida, G, Guida, M, Tommasi, S, Jacquelot, N, Enot, D, Flament, C, Pitt, JM, Vimond, N, Blattner, C, Yamazaki, T, Roberti, M-P, Vetizou, M, Daillere, R, Poirier-Colame, V, la Semeraro, M, Caignard, A, Slingluff, CL, Sallusto, F, Rusakiewicz, S, Weide, B, Marabelle, A, Kohrt, H, Dalle, S, Cavalcanti, A, Kroemer, G, Di Giacomo, AM, Wong, P, Yuan, J, Umansky, V, Eggermont, A, Zitvogel, L, Anna, P, Marco, T, Stefania, S, Francesco, M, Mariaelena, C, Gabriele, M, Antonio, AP, Franco, S, Roberti, MP, Enot, DP, Semeraro, M, Jégou, S, Flores, C, Kwon, BS, Anderson, AC, Borg, C, Aubin, F, Ayyoub, M, De Presbiteris, AL, Cordaro, FG, Camerlingo, R, Fratangelo, F, Mozzillo, N, Pirozzi, G, Patriarca, EJ, Caputo, E, Motti, ML, Falcon, R, Miceli, R, Capone, M, Madonna, G, Mallardo, D, Carrier, MV, Panza, E, De Cicco, P, Armogida, C, Ercolano, G, Botti, G, Cirino, G, Sandru, A, Blank, M, Balatoni, T, Olasz, J, Farkas, E, Szollar, A, Savolt, A, Godeny, M, Csuka, O, Horvath, S, Eles, K, Shoenfeld, Y, Kasler, M, Costantini, S, Capone, F, Moradi, F, Berglund, P, Leandersson, K, Linnskog, R, Andersson, T, Prasad, CP, Nigro, CL, Lattanzio, L, Proby, C, Syed, N, Occelli, M, Cauchi, C, Merlano, M, Harwood, C, Thompson, A, Crook, T, Bifulco, K, Ingangi, V, Minopoli, M, Ragone, C, Pessi, A, Mannavola, F, D’Oronzo, S, Felici, C, Tucci, M, Doronzo, A, Silvestris, F, Ferretta, A, Guida, S, Maida, I, Cocco, T, Passarelli, A, Quaresmini, D, Franzese, O, Palermo, B, Di Donna, C, Sperduti, I, Foddai, M, Stabile, H, Gismondi, A, Santoni, A, Nisticò, P, Sponghini, AP, Platini, F, Marra, E, Rondonotti, D, Alabiso, O, Fierro, MT, Savoia, P, Stratica, F, Quaglino, P, Di Monta, G, Corrado, C, Di Marzo, M, Ugo, M, Di Cecilia, ML, Nicola, M, Fusciello, C, Marra, A, Guarrasi, R, Baldi, C, Russo, R, Di Giulio, G, Faiola, V, Zeppa, P, Pepe, S, Gambale, E, Carella, C, Di Paolo, A, De Tursi, M, Marra, L, De Murtas, F, Sorrentino, V, Voinea, S, Panaitescu, E, Bolovan, M, Stanciu, A, Cinca, S, Botti, C, Aquino, G, Anniciello, A, Fortes, C, Mastroeni, S, Caggiati, A, Passarelli, F, Zappalà, A, Capuano, M, Bono, R, Nudo, M, Marino, C, Michelozzi, P, De Biasio, V, Battarra, VC, Formenti, S, Ascierto, ML, McMiller, TL, Berger, AE, Danilova, L, Anders, RA, Netto, GJ, Xu, H, Pritchard, TS, Fan, J, Cheadle, C, Cope, L, Drake, CG, Pardoll, DM, Taube, JM, Topalian, SL, Gnjatic, S, Nataraj, S, Imai, N, Rahman, A, Jungbluth, AA, Pan, L, Venhaus, R, Park, A, Lehmann, FF, Lendvai, N, Cohen, AD, Cho, HJ, Daniel, S, and Hirsh, V

Abstract

MELANOMA BRIDGE 2015 KEYNOTE SPEAKER PRESENTATIONS Molecular and immuno-advances K1 Immunologic and metabolic consequences of PI3K/AKT/mTOR activation in melanoma Vashisht G. Y. Nanda, Weiyi Peng, Patrick Hwu, Michael A. Davies K2 Non-mutational adaptive changes in melanoma cells exposed to BRAF and MEK inhibitors help the establishment of drug resistance Gennaro Ciliberto, Luigi Fattore, Debora Malpicci, Luigi Aurisicchio, Paolo Antonio Ascierto, Carlo M. Croce, Rita Mancini K3 Tumor-intrinsic beta-catenin signaling mediates tumor-immune avoidance Stefani Spranger, Thomas F. Gajewski K4 Intracellular tumor antigens as a source of targets of antibody-based immunotherapy of melanoma Yangyang Wang, Soldano Ferrone Combination therapies K5 Harnessing radiotherapy to improve responses to immunotherapy in cancer Claire Vanpouille-Box, Erik Wennerberg, Karsten A. Pilones, Silvia C. Formenti, Sandra Demaria K6 Creating a T cell-inflamed tumor microenvironment overcomes resistance to checkpoint blockade Haidong Tang, Yang Wang, Yang-Xin Fu K7 Biomarkers for treatment decisions? Reinhard Dummer K8 Combining oncolytic therapies in the era of checkpoint inhibitors Igor Puzanov K9 Immune checkpoint blockade for melanoma: should we combine or sequence ipilimumab and PD-1 antibody therapy? Michael A. Postow News in immunotherapy K10 An update on adjuvant and neoadjuvant therapy for melanom Ahmad Tarhini K11 Targeting multiple inhibitory receptors in melanoma Joe-Marc Chauvin, Ornella Pagliano, Julien Fourcade, Zhaojun Sun, Hong Wang, Cindy Sanders, John M. Kirkwood, Tseng-hui Timothy Chen, Mark Maurer, Alan J. Korman, Hassane M. Zarour K12 Improving adoptive immune therapy using genetically engineered T cells David F. Stroncek Tumor microenvironment and biomarkers K13 Myeloid cells and tumor exosomes: a crosstalk for assessing immunosuppression? Veronica Huber, Licia Rivoltini K14 Update on the SITC biomarker taskforce: progress and challenges Magdalena Thurin World-wide immunosc

Published
2016

4. ledronic acid in the treatment of bone metastases by hepatocellular carcinoma: a case series

Author

Montella L, Addeo R, Caraglia M, Cennamo G, Vincenzi B, Guarrasi R, Mamone R, Faiola V, Frega N, Capasso E, Maiorino L, Leopardo D, Pizza C, Montesarchio V, Del Prete S., PALMIERI, GIOVANNELLA, Montella, L, Addeo, R, Palmieri, Giovannella, Caraglia, M, Cennamo, G, Vincenzi, B, Guarrasi, R, Mamone, R, Faiola, V, Frega, N, Capasso, E, Maiorino, L, Leopardo, D, Pizza, C, Montesarchio, V, and Del Prete, S.

Subjects
ledronic acid, hepatocellular carcinoma, bone metastase
Published
2009

6. Phase I clinical study with 8-Chloro-cAMP and evaluation of immunological effects in cancer patients

Author

Giampaolo Tortora, Ciardiello F, Pepe S, Tagliaferri P, Ruggiero A, Bianco C, Guarrasi R, Miki K, Ar, Bianco, Tortora, Giampaolo, Ciardiello, F., Pepe, Stefano, Tagliaferri, P., Ruggiero, A., Bianco, C., Guarrasi, R., Miki, K., Bianco, A. R., Tortora, G, Ciardiello, Fortunato, Pepe, S, Tagliaferri, P, Ruggiero, A, Bianco, C, Guarrasi, R, Miki, K, and Bianco, Ar

Subjects
Clinical trial, 8-Chloro-cAMP, immunological effcts
Abstract

The site-selective cyclic AMP analogue 8-chloro-cAMP (8-Cl-cAMP) is able to inhibit the growth of a wide variety of cancer cell lines in vitro and in vivo. 8-Cl-cAMP has been extensively investigated as a new potential anticancer agent and, more recently, preclinical Phase I studies have been conducted in animal models to study its toxicity. We have conducted the first Phase I trial with 8-Cl-cAMP to define the maximum tolerated dose, toxicity, plasma drug levels, and immunological effects in patients with cancers refractory to standard treatments. We have administered 36 courses of 8-Cl-cAMP to 17 patients by continous i.v. infusion of the drug for 5 days/week for 2 weeks followed by a 1-week rest period. Six increasing dose levels, from 0.01 to 0.25 mg/kg/h, were explored. Drug plasma levels were determined and the expression of interleukin 2 receptor alpha amount of natural killer cells, and cytolytic activity against K562 cells were measured in peripheral blood lymphocytes. A grade 4 and a grade 3 increase in serum creatinine and a grade 2 increase in blood urea nitrogen observed in two patients were the dose-limiting toxicity. The maximum tolerated dose (0.2 mg/kg/h) determined a grade 1 increase in serum creatinine. An increase in calcium levels was observed in several patients. The 8-Cl-cAMP plasma concentrations obtained at the steady state were in the range previously shown to be effective for cancer cell growth inhibition in vitro. Interleukin 2 receptor alpha expression, natural killer cell number, and cytolytic activity from peripheral blood lymphocytes were markedly increased after 8-Cl-cAMP administration at all dose levels. In conclusion, at doses below the maximum tolerated dose, 8-Cl-cAMP was not toxic but reached plasma concentrations in the potential therapeutic range for growth inhibition. Moreover, 8-Cl-cAMP determined a marked biomodulatory effect and showed antitumor activity.

Published
1995

7. Phase I clinical trial of high dose recombinant interleukin-2/veparimil combination in advancer cancer

Author

Tagliaferri, P., Correale, P., Mottola, M., DE SIMONE, G., Montesarchio, V., Matano, E., Rea, A., Morabito, A., Famiani, M., Ciardiello, F., Tortora, Giampaolo, Caraglia, M., Guarrasi, R., Barile, C., Palmieri, G., Bianco, A. R., Tagliaferri, P., Correale, P., Mottola, Michele, DE SIMONE, Giovanni, Montesarchio, V., Matano, Elide, Rea, A., Morabito, A., Famiani, M., Ciardiello, F., Tortora, Giampaolo, Caraglia, M., Guarrasi, R., Barile, C., Palmieri, Giovannella, and Bianco, A. R.

Subjects
Clinical trial, IL-2, veparimil
Published
1996

8. Differential sensitivity to non-MHC-restricted rIL-2 activated lymphocyte killing of human mammary epithelial MCF-10A cells overexpressing oncogenes or PKA subunits

Author

Tagliaferri, P., Tortora, G., Guarrasi, R., Damiano, V., Ruggiero, A., Morelli, D., Caraglia, M., Bianco, R., DI ISERNIA, G., Pepe, Stefano, Arteaga, C. L., LANGTON WEBSTER, B. C., Bianco, A. R., Ciardiello, F., Tagliaferri, P., Tortora, Giampaolo, Guarrasi, R., Damiano, Vincenzo, Ruggiero, A., Morelli, D., Caraglia, M., Bianco, Roberto, di Isernia, G., Pepe, Stefano, Arteaga, C. L., Langton Webster, B. C., Bianco, A. R., and Ciardiello, F.

Subjects
immune system, PKA, lymphocyte killing
Published
1996

11. 785 SORAFENIB PLUS OCTREOTIDE IN ADVANCED HEPATOCELLULAR CARCINOMA: UPDATED RESULTS OF A MULTICENTER STUDY

Author

Del Prete, S., primary, Addeo, R., additional, Caraglia, M., additional, Maiorino, L., additional, Montesarchio, V., additional, Cennamo, G., additional, Guarrasi, R., additional, Faiola, V., additional, Leo, L., additional, Febbraro, A., additional, Vincenzi, B., additional, Savastano, C., additional, Tarantino, L., additional, Sabia, A., additional, Capasso, E., additional, Palmieri, G., additional, Giorgio, A., additional, Bianco, M., additional, and Montella, L., additional

Published
2009
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12. Sorafenib plus long-acting octreotide in advanced hepatocellular carcinoma. Preliminary results of a multicenter ongoing study

Author

Del Prete, S., primary, Addeo, R., additional, Maiorino, L., additional, Cennamo, G., additional, Montesarchio, V., additional, Leo, L., additional, Faiola, V., additional, Guarrasi, R., additional, Tarantino, L., additional, Vascone, A., additional, D’Agostino, A., additional, Palmieri, G., additional, Bianco, M., additional, Caraglia, M., additional, Pizza, C., additional, Mamone, R., additional, and Montella, L., additional

Published
2008
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23. Management of pain in elderly patients receiving infusion of zoledronic acid for bone metastasis: a single-institution report.

Author

Addeo R, Nocera V, Faiola V, Vincenzi B, Ferraro G, Montella L, Guarrasi R, Rossi E, Cennamo G, Tonini G, Capasso E, Santini D, Caraglia M, Del Prete S, Addeo, Raffaele, Nocera, Vincenzo, Faiola, Vincenzo, Vincenzi, Bruno, Ferraro, Gabriella, and Montella, Liliana

Abstract

Goals Of Work: Bone metastases are a common cause of morbidity in elderly patients with solid tumors and myeloma. We studied the safety and the effect of a new bisphosphonate, zoledronic acid (ZA), on pain and on quality of life (QoL) in elderly patients with bone metastases.Materials and Methods: From January 2004 to December 2005, we have enrolled elderly patients with bone metastasis for receiving ZA administration. Visual analog scale (VAS) and Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire were used to assess potential benefits of ZA therapy.Results: Eighty-six patients were included; the median age was 75.5 years. Before starting treatment, the mean VAS was 6.8 (+/-0.24), after three infusions 5.4 (+/-0.3), and after six courses 4.5 (+/-0.3) with a significant improvement of bone pain. Moreover, we found a statistically significant improvement of QoL measured by FACT-G questionnaire after six courses (p = 0.010). Median baseline and final value of serum creatinine were 0.73 and 0.72 mg/dl, respectively (p = 0.11); creatinine clearance was also normal for most patients. Osteonecrosis of the jaw was diagnosed in one patient who received a prolonged ZA treatment.Conclusions: These data confirm the benefits of ZA on pain and QoL also in elderly patients with bone metastasis from solid tumors. [ABSTRACT FROM AUTHOR]

Published
2008
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25. Differential sensitivity to non-major histocompatibility complex-restricted recombinant interleukin 2-activated lymphocyte killing of human mammary epithelial MCF-10A cells overexpressing oncogenes or protein kinase A subunits

Author

Tagliaferri, P., Tortora, G., Guarrasi, R., Damiano, V., Ruggiero, A., Morelli, D., Caraglia, M., Bianco, R., Di Isernia, G., Pepe, S., Arteaga, C. L., Langten-Webster, B. C., Bianco, A. R., Fortunato Ciardiello, Tagliaferri, P, Tortora, G, Guarrasi, R, Damiano, V, Ruggiero, A, Morelli, D, Caraglia, Michele, Bianco, R, DI ISERNIA, G, Pepe, S, Arteaga, Cl, LANGTON WEBSTER, Bc, Bianco, Ar, and Ciardiello, Fortunato

Subjects
Cytotoxicity, Immunologic, Histocompatibility Antigens Class I, Breast Neoplasms, Genes, erbB-2, Intercellular Adhesion Molecule-1, Cyclic AMP-Dependent Protein Kinases, Recombinant Proteins, Mice, Transforming Growth Factor beta, Tumor Cells, Cultured, Animals, Humans, Interleukin-2, Female, Lymphocytes, Killer Cells, Lymphokine-Activated
Abstract

The sensitivity of human tumor cells to activated lymphocytes is considered to play an essential role in the antitumor activity of recombinant interleukin-2 (rIL-2)-based immunotherapy. We have investigated the effects of several genes involved in the regulation of cell growth and transformation on the sensitivity of human mammary epithelial MCF-10A cells to non-MHC-restricted, rIL-2-activated lymphocytes. Therefore, the lysability of MCF-10A cells overexpressing activated oncogenes (Ha-ras, erbB-2, and a mutated p53), growth factors [transforming growth factor alpha (TGFalpha)], or cAMP-dependent protein kinase A subunits (RIalpha, RIIbeta, and Calpha) was evaluated comparatively at different effector:target ratios by a 51Cr release assay. Parental MCF-10A, MCF-10A p53-mutated, and MCF-10A RIIbeta cells showed an intermediate sensitivity. Lysability was increased significantly in MCF-10A Ha-ras, MCF-10A TGFalpha, and MCF-10A RIalpha cells, reduced in MCF-10A Calpha cells, and completely abrogated in MCF-10A erbB-2 cells. These differences could not be explained by simple changes in the cell surface expression of MHC class I and intercellular adhesion molecule-1 proteins or by secretion of TGFbeta. Treatment with TAb 250, a mouse anti-p185(erbB-2) monoclonal antibody, or down-regulation of p185(erbB-2) expression resulted in circumvention of MCF-10A erbB-2 cell resistance. We conclude that molecular changes at the single-gene level resulting in alterations of intracellular signaling and/or cell transformation modulate sensitivity of human mammary epithelial cells to non-MHC-restricted, rIL-2-induced cytotoxicity, regardless of MHC class I and/or intercellular adhesion molecule-1 expression or TGFbeta secretion. Furthermore, anti-p185(erbB-2) monoclonal antibodies may be useful as adjuncts to rIL-2 treatment in patients with erbB-2-overexpressing tumors.

28. Zoledronic acid in metastatic chondrosarcoma and advanced sacrum chordoma: two case reports

Author

Capasso Elena, Guarrasi Rosario, Cennamo Gregorio, Faiola Vincenzo, Addeo Raffaele, Montella Liliana, Mamone Rosanna, Michele Caraglia, and Del Prete Salvatore

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

Abstract Introduction Chondrosarcomas and chordomas are usually chemoresistant bone tumors and may have a poor prognosis when advanced. They are usually associated with worsening pain difficult to control. Patients and Methods Zoledronic acid was used in a 63-year-old man with metastatic chondrosarcoma and in a 66-year-old woman with a diagnosis of sacrum chordoma both reporting severe pain related to tumor. Results In the first case, zoledronic acid was able to maintain pain control despite disease progression following chemotherapy, in the other case, zoledronic acid only produced significant clinical benefit. Conclusion Control of pain associated with bone tumors such as chondrosarcoma and chondroma may significantly improve from use of zoledronic acid, independently from tumor response to other treatments. Evaluation on larger series are needed to confirm the clinical effect of this bisphosphonate on such tumors.

Published
2009
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29. Concomitant treatment of brain metastasis with Whole Brain Radiotherapy [WBRT] and Temozolomide [TMZ] is active and improves Quality of Life

Author

Montella Liliana, Vincenzi Bruno, Capasso Elena, Faiola Vincenzo, Caraglia Michele, Addeo Raffaele, Guarrasi Rosario, Caserta Luigi, and Del Prete Salvatore

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

Abstract Background Brain metastases (BM) represent one of the most frequent complications related to cancer, and their treatment continues to evolve. We have evaluated the activity, toxicity and the impact on Quality of Life (QoL) of a concomitant treatment with whole brain radiotherapy (WBRT) and Temozolomide (TMZ) in patients with brain metastases from solid tumors in a prospective Simon two stage study. Methods Fifty-nine patients were enrolled and received 30 Gy WBRT with concomitant TMZ (75 mg/m2/day) for ten days, and subsequently TMZ (150 mg/m2/day) for up to six cycles. The primary end points were clinical symptoms and radiologic response. Results Five patients had a complete response, 21 patients had a partial response, while 18 patients had stable disease. The overall response rate (45%) exceeded the target activity per study design. The median time to progression was 9 months. Median overall survival was 13 months. The most frequent toxicities included grade 3 neutropenia (15%) and anemia (13%), and only one patient developed a grade 4 thrombocytopenia. Age, Karnofsky performance status, presence of extracranial metastases and the recursive partitioning analysis (RPA) were found to be predictive factors for response in patients. Overall survival (OS) and progression-free survival (PFS) were dependent on age and on the RPA class. Conclusion We conclude that this treatment is well tolerated, with an encouraging objective response rate, and a significant improvement in quality of life (p < 0.0001) demonstrated by FACT-G analysis. All patients answered the questionnaires and described themselves as 'independent' and able to act on their own initiatives. Our study found a high level of satisfaction for QoL, this provides useful information to share with patients in discussions regarding chemotherapy treatment of these lesions.

Published
2007
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30. Interleukin-2 and Lanreotide in the Treatment of Medullary Thyroid Cancer: In Vitro and In Vivo Studies

Author

Michele Caraglia, Salvatore Del Prete, Germano Gaudenzi, Gaetano Facchini, Raffaele Addeo, Alessandra Dicitore, Maria Castellano, Rosario Guarrasi, Annamaria Colao, Giovanni Vitale, Giovanni Lupoli, Gabriella Misso, Vitale, G, Lupoli, G, Guarrasi, R, Colao, A, Dicitore, A, Gaudenzi, G, Misso, Gabriella, Castellano, M, Addeo, R, Facchini, G, Del Prete, S, Caraglia, Michele, Lupoli, Giovanni, Colao, Annamaria, Misso, G, Del prete, S, and Caraglia, M.

Subjects
Medullary Thyroid Carcinoma (MTC), Adult, Male, Interleukin 2, medicine.medical_specialty, Drug Administration Route, Endocrinology, Diabetes and Metabolism, Clinical Biochemistry, Antineoplastic Agents, Context (language use), Lanreotide, Peptides, Cyclic, Biochemistry, Peripheral blood mononuclear cell, Antineoplastic Agent, chemistry.chemical_compound, Endocrinology, In vivo, Aldesleukin, Cell Line, Tumor, Internal medicine, medicine, Carcinoma, Humans, Thyroid Neoplasms, Thyroid Neoplasm, Cell Proliferation, business.industry, Drug Administration Routes, Biochemistry (medical), Medullary thyroid cancer, Middle Aged, medicine.disease, Carcinoma, Neuroendocrine, Treatment Outcome, chemistry, Carcinoma, Medullary, Leukocytes, Mononuclear, Interleukin-2, Drug Therapy, Combination, Female, Somatostatin, business, Human, medicine.drug
Abstract

"Context: To date no efficacious treatments are available for advanced medullary thyroid carcinoma (MTC). Objective: We investigated in vitro and in vivo a new strategy for the therapy of MTC, combining human recombinant IL-2 with lanreotide (LAN), a somatostatin analog. Methods: The in vitro effects of LAN on the sensitivity of TT cells, a MTC cell line, to IL-2-stimulated human peripheral blood mononuclear cells were determined by a lactate dehydrogenase release assay. In addition, we evaluated the toxicity, the effects on quality of life, and the antitumor activity of sc low-dose IL-2 in combination with LAN (90 mg every 28 days) in a series of 6 patients with symptomatic and advanced MTC. Results: The cytotoxicity of IL-2-activated peripheral blood mononuclear cells was significantly increased in TT cells treated with LAN or LAN plus IL-2 compared with that in TT cells without treatment. The therapy was well tolerated, and a statistically significant improvement of quality of life was observed in patients treated with the combination of LAN and IL-2. After 6 months of therapy, partial response and stable disease have been recorded in 2 and 3 patients, respectively, with a significant decrease in calcitonin levels in 3 patients. Conclusions: Both in vitro and in vivo evidence suggests that the combination of LAN and IL-2 may have a role in the management of advanced and symptomatic MTC. However, these preliminary data require further validation in larger randomized trials. . . " Context: To date no efficacious treatments are available for advanced medullary thyroid carcinoma (MTC). Objective: We investigated in vitro and in vivo a new strategy for the therapy of MTC, combining human recombinant IL-2 with lanreotide (LAN), a somatostatin analog. Methods: The in vitro effects of LAN on the sensitivity of TT cells, a MTC cell line, to IL-2-stimulated human peripheral blood mononuclear cells were determined by a lactate dehydrogenase release assay. In addition, we evaluated the toxicity, the effects on quality of life, and the antitumor activity of sc low-dose IL-2 in combination with LAN (90 mg every 28 days) in a series of 6 patients with symptomatic and advanced MTC. Results: The cytotoxicity of IL-2-activated peripheral blood mononuclear cells was significantly increased in TT cells treated with LAN or LAN plus IL-2 compared with that in TT cells without treatment. The therapy was well tolerated, and a statistically significant improvement of quality of life was observed in patients treated with the combination of LAN and IL-2. After 6 months of therapy, partial response and stable disease have been recorded in 2 and 3 patients, respectively, with a significant decrease in calcitonin levels in 3 patients. Conclusions: Both in vitro and in vivo evidence suggests that the combination of LAN and IL-2 may have a role in the management of advanced and symptomatic MTC. However, these preliminary data require further validation in larger randomized trials. Copyright © 2013 by The Endocrine Society.

Published
2013

31. Randomized Phase III Trial on Gemcitabine Versus Mytomicin in Recurrent Superficial Bladder Cancer: Evaluation of Efficacy and Tolerance

Author

Salvatore Del Prete, Sergio Bellini, Rosario Guarrasi, Vincenzo Faiola, Antonio Miragliuolo, Michele Lanna, Liliana Montella, Gregorio Cennamo, Alberto Abbruzzese, Raffaele Addeo, Bruno Vincenzi, Michele Caraglia, Addeo, R, Caraglia, Michele, Bellini, S, Abbruzzese, A, Vincenzi, B, Montella, L, Miragliuolo, A, Guarrasi, R, Lanna, M, Cennamo, G, Faiola, V, and DEL PRETE, S.

Subjects
Male, Antimetabolites, Antineoplastic, Cancer Research, medicine.medical_specialty, Maximum Tolerated Dose, endocrine system diseases, Mitomycin, medicine.medical_treatment, Urology, Deoxycytidine, Maintenance therapy, medicine, Carcinoma, Humans, Survival rate, Aged, Neoplasm Staging, Carcinoma, Transitional Cell, Chemotherapy, Antibiotics, Antineoplastic, business.industry, Cancer, Prognosis, medicine.disease, Gemcitabine, Surgery, Survival Rate, Treatment Outcome, Urinary Bladder Neoplasms, Oncology, Female, Neoplasm Recurrence, Local, business, Progressive disease, medicine.drug, Epirubicin
Abstract

Purpose Approximately 30% to 40% patients with a superficial bladder cancer treated with Bacille Calmette-Guerin (BCG) or epirubicin do not respond; of the initial responders, 35% have a relapse within 5 years. We compare the therapeutic efficacy and toxicity of intravescical infusions of gemcitabine (GEM) with mitomycin (MMC) in patients with a recurrent superficial bladder cancer. Patients and Methods Patients with a history of a previously treated, recurrent Ta-T1, G1-G3 bladder transitional cell carcinoma were enrolled in the study. The patients received a 6-week course of GEM infusions or 4-week course of MMC. In both arms, for the initial responders who remained free of recurrences, maintenance therapy consisted of 10 monthly treatments during the first year. Results A total of 120 patients were enrolled and randomly assigned to either the MMC or GEM treatment arm. At the end of the study, 109 patients (55 in MMC and 54 in GEM) were assessable. The median duration of follow-up was 36 months for either arm. In the GEM arm, 39 (72%) of 54 patients remained free of recurrence versus 33 (61%) of 55 in MMC arm. Among patients with recurrences, 10 in the MMC arm and six in the GEM arm also had a progressive disease by stage. The incidence of chemical cystitis in the MMC arm was statistically higher than in the GEM arm (P = .012). Conclusion This study demonstrates that GEM has better efficacy and lower toxicity than MMC; therefore, GEM appears as a logical candidate for intrabladder therapy in patients with refractory transitional cancer.

Published
2010

32. Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study

Author

Antonio Febbraro, Agata Pisano, Elena Capasso, Raffaele Addeo, Vincenzo Faiola, Rosanna Mamone, M. Bianco, Alberto D’Agostino, Vincenzo Montesarchio, Clementina Savastano, Luciano Tarantino, Michele Caraglia, Salvatore Del Prete, Antonietta Sabia, Gregorio Cennamo, Giovannella Palmieri, Luigi Maiorino, Guido Piai, Rosario Guarrasi, Liliana Montella, Bruno Vincenzi, Prete, Sd, Montella, Liliana, Caraglia, M, Maiorino, L, Cennamo, G, Montesarchio, V, Piai, G, Febbraro, A, Tarantino, L, Capasso, E, Palmieri, Giovannella, Guarrasi, R, Bianco, M, Mamone, R, Savastano, C, Pisano, A, Vincenzi, B, Sabia, A, D'Agostino, A, Faiola, V, Addeo, R., DEL PRETE, Sd, Montella, L, Caraglia, Michele, and Palmieri, G

Subjects
Diarrhea, Male, Niacinamide, Sorafenib, Cancer Research, medicine.medical_specialty, Carcinoma, Hepatocellular, Survival, Pyridines, medicine.drug_class, Population, Octreotide, Toxicology, Gastroenterology, Tyrosine-kinase inhibitor, Multikinase inhibitor, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Pharmacology (medical), education, Aged, Aged, 80 and over, Pharmacology, education.field_of_study, business.industry, Phenylurea Compounds, Benzenesulfonates, Liver Neoplasms, Cancer, hepatocellular carcinoma, Middle Aged, medicine.disease, digestive system diseases, Surgery, Treatment Outcome, Oncology, Hepatocellular carcinoma, Hypertension, Disease Progression, Female, Liver cancer, business, octreotide, medicine.drug
Abstract

PURPOSE: Advanced hepatocellular carcinoma (HCC) not eligible for local therapies has limited chances of cure. Sorafenib is a multikinase inhibitor with proven activity in advanced HCC. Octreotide is used in this setting with conflicting results. Treatment with sorafenib and long-acting octreotide was tested in advanced HCC to evaluate safety and activity. METHODS: Fifty patients with advanced HCC, Child-Pugh A or B, received sorafenib at a dosage of 800 mg/day for 28 days with a following week of rest and long-acting octreotide at a dose of 40 mg, administered every 28 days. RESULTS: All patients were assessable for safety and efficacy. Sixteen patients out of 50 (34%) were naïve from other therapies, while all the others were previously treated with local and/or systemic treatments. We achieved 5 partial responses (10%), 33 stable diseases (66%) and 12 progressions of disease (24%). Median time to progression was 7.0 months (95% CI, 3.0-10.9 months), and median overall survival was 12 months (95% CI, 6.3-17.4 months). Treatment was well tolerated. Diarrhoea (6%) and hypertension (4%) were the most frequent grade 3 toxicities. CONCLUSIONS: Our data suggest that the combination between sorafenib and long-acting octreotide is active and well tolerated in patients with advanced HCC and could represent another efficacious chance for the management of this population.

Published
2009

33. Atypical Cutaneous Lymphoid Hyperplasia Induced by Chemotherapy in a Patient with Advanced Colon Carcinoma

Author

Gregorio Cennamo, Rosario Guarrasi, Raffaele Addeo, Alfonso Baldi, Michele Caraglia, Liliana Montella, Salvatore Del Prete, Vincenzo Faiola, Addeo, R, Montella, L, Baldi, Alfonso, Cennamo, G, Guarrasi, R, Faiola, V, Caraglia, Michele, and DEL PRETE, S.

Subjects
Male, Oncology, medicine.medical_specialty, Organoplatinum Compounds, Colorectal cancer, 5-Fluorouracil, medicine.medical_treatment, Leucovorin, Irinotecan, Gastroenterology, Immunophenotyping, Skin lesion, FOLFOX, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Pseudolymphoma, Humans, Leucovorin Oxaliplatin, Lymphatic Diseases, Aged, Chemotherapy, business.industry, fungi, food and beverages, medicine.disease, Chemotherapy regimen, Oxaliplatin, Angiotensin-converting enzyme inhibitor, Colonic Neoplasms, Cutaneous lymphoid hyperplasia, Drug Eruptions, Fluorouracil, business, medicine.drug
Abstract

Some conditions are predisposed to excessive lymphocyte responses, which can progress to a benign condition, ie, atypical cutaneous lymphoid hyperplasia (ACLH), or a malignant lymphoma. Clinical diagnosis of drug-associated pseudolymphoma can be based on a temporal association between drug ingestion and lesion onset followed by resolution without recurrence after discontinuation of drug administration. Herein, we report the case of a 66- year-old man with advanced colon carcinoma with ACLH developed while receiving chemotherapy regimen with oxaliplatin/5-fl uorouracil/leucovorin. The authors postulate that chemotherapy can promote an aberrant immune response to an antigen that can be the drug itself or other self-antigens.

Published
2007

34. α-interferon potentiates epidermal growth factor receptor-mediated effects on human epidermoid carcinoma KB cells

Author

Pierosandro Tagliaferri, Alfredo Budillon, Rosario Guarrasi, Angelo Raffaele Bianco, Michele Caraglia, Stefania Corradino, Annalisa Leardi, Fortunato Ciardiello, Caraglia, Michele, Leardi, A, Corradino, S, Ciardiello, Fortunato, Budillon, A, Guarrasi, R, Bianco, Ar, and Tagliaferri, P.

Subjects
Cancer Research, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Alpha interferon, Interferon alpha-2, Biology, KB Cells, Growth factor receptor, Epidermal growth factor, Internal medicine, medicine, Humans, Cytotoxic T cell, Epidermal growth factor receptor, Interferon alfa, Epidermal Growth Factor, Growth factor, Antibodies, Monoclonal, Interferon-alpha, Molecular biology, Recombinant Proteins, Up-Regulation, ErbB Receptors, Molecular Weight, Kinetics, Endocrinology, Oncology, Epidermoid carcinoma, Carcinoma, Squamous Cell, biology.protein, Cell Division, hormones, hormone substitutes, and hormone antagonists, medicine.drug
Abstract

The molecular mechanisms underlying the growth inhibition of human tumor cells induced by recombinant interferon-alpha (IFN alpha) are mostly unknown. It has been proposed that this effect could be related to down-regulation and/or impaired function of peptide growth factor receptors (PGF-Rs) in tumor cells exposed to IFN alpha. However, we have previously described that IFN alpha-induced growth inhibition of human epidermoid carcinoma cells is paralleled by up-regulation of epidermal growth factor receptor (EGF-R). Here we report that an increase in EGF-R synthesis is detectable after 3 hr of exposure to cytostatic concentration of IFN alpha in epidermoid KB tumor cells. In these experimental conditions IFN alpha does not depress and even potentiates EGF-R function. IFN alpha-treated KB cells retain sensitivity to the cytotoxic activity of the anti-EGF-R 225 monoclonal antibody (MAb), which acts through receptor blockade, and are sensitized to the growth-promoting effect of EGF. EGF-induced tyrosine (tyr) phosphorylation both of total cellular protein extracts and of the immunoprecipitated EGF-R is increased in IFN alpha-treated cells. We conclude that a cross-talk between IFN alpha and EGF occurs in KB cells since IFN alpha, at cytostatic concentration, potentiates the effects mediated by the EGF-R.

Published
1995

35. Once-per-cycle pegfilgrastim in breast cancer patients treated with docetaxel/epidoxorubicin/cyclophosphamide

Author

Michele Caraglia, S. Del Prete, Liliana Montella, Vincenzo Faiola, R. Addeo, Rosario Guarrasi, Gregorio Cennamo, Elena Capasso, Montella, L, Addeo, R, Guarrasi, R, Cennamo, G, Faiola, V, Capasso, E, Caraglia, Michele, and Prete, Sd

Subjects
Oncology, Adult, medicine.medical_specialty, Neutropenia, Cyclophosphamide, Filgrastim, medicine.medical_treatment, Breast Neoplasms, Docetaxel, Drug Administration Schedule, Polyethylene Glycols, Breast cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Aged, Epirubicin, Chemotherapy, Dose-Response Relationship, Drug, business.industry, Combination chemotherapy, Middle Aged, medicine.disease, Recombinant Proteins, Treatment Outcome, Female, Taxoids, business, Febrile neutropenia, Pegfilgrastim, medicine.drug, Blood sampling
Abstract

The incidence of neutropenia following combination chemotherapy is significant in breast cancer and impairs patients' quality of life. Colony-stimulating factors significantly decrease the risk of febrile neutropenia (FN). Aim of the present study was to assess the efficacy and safety profile of once-per-cycle pegfilgrastim in reducing FN in breast cancer patients treated with docetaxel (75 mg/m(2)), epidoxorubicin (75 mg/m(2)), cyclophosphamide (500 mg/m(2)) administered every 3 weeks. Thirty-five breast cancer patients were enrolled. Chemotherapy was administered in adjuvant, neoadjuvant and metastatic setting respectively in 26, 4 and 5 patients. Toxicity was monitored with programmed clinical evaluation and blood sampling. All patients completed the therapeutic programme consisting of six cycles for overall 210 cycles. The FN appeared in 6 out of 35 patients (17%), requiring dose reduction in 3 patients. Hypertransaminasemia was registered in two patients. In one patient pegfilgrastim administration was stopped because of skin hypersensitivity reaction. In conclusion, pegfilgrastim was able to maintain doses and timing of docetaxel/epidoxorubicin/cyclophosphamide in almost all breast cancer patients treated in this series. The reduced need for daily administration of colony-stimulating factors, blood sampling, antibiotic therapy and hospitalization has a significant impact in terms of both quality of life and pharmaco-economic evaluations.

Published
2009

36. ZOLEDRONIC ACID IN THE TREATMENT OF BONE METASTASES BY HEPATOCELLULAR CARCINOMA: A CASE SERIES

Author

Vincenzo Faiola, Bruno Vincenzi, Rosario Guarrasi, Raffaele Addeo, Luigi Maiorino, Liliana Montella, Davide Leopardo, Vincenzo Montesarchio, C. Pizza, Salvatore Del Prete, Rosanna Mamone, Giovannella Palmieri, Michele Caraglia, Nicola Frega, Elena Capasso, Gregorio Cennamo, Montella, L, Addeo, R, Palmieri, G, Caraglia, Michele, Cennamo, G, Vincenzi, B, Guarrasi, R, Mamone, R, Faiola, V, Frega, N, Capasso, E, Maiorino, L, Leopardo, D, Pizza, C, Montesarchio, V, and DEL PRETE, S.

Subjects
Male, Cancer Research, medicine.medical_specialty, Carcinoma, Hepatocellular, medicine.medical_treatment, Bone Neoplasms, Kaplan-Meier Estimate, Toxicology, Gastroenterology, Zoledronic Acid, Internal medicine, medicine, Carcinoma, Humans, Pharmacology (medical), Survival rate, Aged, Pharmacology, Aged, 80 and over, Bone Density Conservation Agents, Diphosphonates, business.industry, Liver Neoplasms, Imidazoles, Bone metastasis, Bisphosphonate, Middle Aged, medicine.disease, Surgery, Survival Rate, Zoledronic acid, Treatment Outcome, Oncology, Hepatocellular carcinoma, Concomitant, Female, Liver cancer, business, medicine.drug, Follow-Up Studies
Abstract

The survival of patients with hepatocellular carcinoma (HCC) has improved with advancements in various diagnostic tools and treatment modalities. Consequently, bone metastases from HCC are diagnosed more frequently. The aims of the present study was to describe the clinical features and treatment of HCC patients presenting with bone metastases. In particular, we evaluated the role of zoledronic acid in these patients especially with regard to pain reduction, analgesic drug consumption and safety.Between December 2006 and July 2008, we recruited 17 (male:female, 12:5, median age, 68 years; age range, 62-85 years) consecutive patients. Spinal metastases were present in 11 patients (64.7%). Zoledronic acid was administered in all patients (total number of administrations, 107; mean number of administrations, 6.29).A total of 15 patients received at least three administrations of zoledronic acid and reported clinical benefit with pain reduction and tapering of analgesic drugs. Before starting treatment, the mean VAS for patients who received at least three administrations (15/17 patients) of zoledronic acid was 7.1 (+/-0.24), and after 3 months 5.3 (+/-0.20). This improvement was independent of the sex, the extent of metastasis and the concomitant anticancer treatment. No significant side effects were registered in this series of patients. Median survival was 10 months (CI 6,353-13,647).Zoledronic acid may be helpful in treating bone metastases in HCC patients. Patients regularly receiving zoledronic acid showed significant pain relief.

Published
2009

37. Phase 2 trial of temozolomide using protracted low-dose and whole-brain radiotherapy for nonsmall cell lung cancer and breast cancer patients with brain metastases

Author

Luigi Leo, Salvatore Del Prete, Gregorio Cennamo, Michele Caraglia, Raffaele Addeo, Rosario Guarrasi, Carmine De Rosa, Vincenzo Faiola, Liliana Montella, Bruno Vincenzi, Addeo, R, DE ROSA, C, Faiola, V, Leo, L, Cennamo, G, Montella, L, Guarrasi, R, Vincenzi, B, Caraglia, Michele, and DEL PRETE, S.

Subjects
Oncology, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Breast Neoplasms, Breast cancer, Bone Marrow, Internal medicine, Carcinoma, Non-Small-Cell Lung, medicine, Temozolomide, Humans, Lung cancer, Antineoplastic Agents, Alkylating, Aged, business.industry, Brain Neoplasms, Liver Neoplasms, Remission Induction, Cancer, Middle Aged, medicine.disease, Prognosis, Combined Modality Therapy, Surgery, Radiation therapy, Dacarbazine, Survival Rate, Regimen, Concomitant, Female, Cranial Irradiation, business, medicine.drug, Brain metastasis
Abstract

BACKGROUND. Temozolomide (TMZ), an oral methylating imidazotetrazinone, has antitumor activity against gliomas, malignant melanomas, and brain metastasis and is presently administered as a 5-day oral schedule every 4 weeks. METHODS. A single-institution phase 2 clinical trial was conducted to determine the efficacy and the safety profile of a new regimen based on a dose-intensified, protracted course of TMZ after whole-brain radiotherapy (WBRT). Patients were eligible if they had at least 1 bidimensionally measurable brain metastasis from breast cancer and nonsmall cell lung cancer (NSCLC). Twenty-seven patients were treated with 30 grays (Gy) of WBRT with concomitant TMZ (75 mg/m2/day) for 10 days, and subsequent TMZ at a dose of 75 mg/m2 per day for 21 days every 4 weeks, for up to 12 cycles. RESULTS. Two complete responses (7.4%) and 11 partial responses (40.7%) were achieved. The schedule appeared to be well tolerated, with grade 3 toxicity (graded according to National Cancer Institute Common Toxicity Criteria) observed in only 2 patients. The overall median survival was 8.8 months and the median progression-free survival was 6 months. CONCLUSIONS. The concomitant use of WBRT and protracted low-dose TMZ appears to be an active, well-tolerated regimen. The observed antitumor activity suggests the need for further investigation of this schedule in combination with other anticancer agents for the concomitant treatment of brain metastases and primary cancers. Cancer 2008. © 2008 American Cancer Society.

Published
2008

38. Vascular endothelial growth factor monitoring in advanced hepatocellular carcinoma patients treated with radiofrequency ablation plus octreotide: a single center experience

Author

M Ariete, Liliana Montella, Bruno Vincenzi, Elena Capasso, Luciano Tarantino, Michele Caraglia, Vincenzo Faiola, Rosario Guarrasi, S. Del Prete, R. Addeo, V. Nocera, A Martorelli, A. Palmeri, Montella, L, Addeo, R, Caraglia, Michele, Faiola, V, Guarrasi, R, Vincenzi, B, Palmeri, A, Capasso, E, Nocera, V, Tarantino, L, Ariete, M, Martorelli, A, and DEL PRETE, S.

Subjects
Liver Cirrhosis, Male, Vascular Endothelial Growth Factor A, Cancer Research, medicine.medical_specialty, Carcinoma, Hepatocellular, Cirrhosis, Antineoplastic Agents, Hormonal, Radiofrequency ablation, Octreotide, Single Center, Gastroenterology, Disease-Free Survival, law.invention, law, Internal medicine, Biomarkers, Tumor, medicine, Carcinoma, Humans, Prospective Studies, Survival rate, Aged, Neoplasm Staging, Aged, 80 and over, business.industry, Liver Neoplasms, General Medicine, Middle Aged, Prognosis, medicine.disease, Combined Modality Therapy, Surgery, Survival Rate, Treatment Outcome, Oncology, Hepatocellular carcinoma, Catheter Ablation, Female, Neoplasm Recurrence, Local, Liver cancer, business, medicine.drug
Abstract

Local therapies such as radiofrequency ablation (RFA) represent a valuable choice in limited hepatocellular carcinoma (HCC) and are increasingly used also in advanced tumors. Medical treatments generally gave frustrating results in advanced HCC especially if comorbidities exist. Several biologic non-chemotherapeutic drugs are currently tested in HCC and, among them, octreotide was evaluated in single series of HCC patients reporting conflicting results. We have treated a series of 35 patients affected by advanced HCC (26 M and 9 F; age range: 55-85 years, median: 73 years) with RFA followed by octreotide to primarily evaluate the safety of combined treatment and to give preliminary evaluation on its activity. We have also evaluated serum VEGF changes during the study. Child A and Child B represented 60% and about 34% of the cases, respectively. Only two patients with Child C compensated cirrhosis were included in this study. All patients have multiple liver HCC nodules and one had bone metastases. Two complete responses, 3 partial responses and 23 disease stabilization for at least three months were obtained (overall response rate, 14,2%; clinical benefit, 80%). Mean overall survival was 31.4 months. The combined treatment was well tolerated. Statistically significant correlation was found between serum VEGF and tumor progression. In conclusion, the combination of RFA and octreotide was active in advanced HCC, however, confirmation in a larger series is required.

Published
2008

39. Management of pain in elderly patients receiving infusion of zoledronic acid for bone metastasis: a single-institution report

Author

Raffaele Addeo, Vincenzo Faiola, Gregorio Cennamo, Salvatore Del Prete, Elena Capasso, Rosario Guarrasi, Gabriella Ferraro, Bruno Vincenzi, Giuseppe Tonini, Michele Caraglia, Liliana Montella, Eugenio Rossi, Vincenzo Nocera, Daniele Santini, Addeo, R, Nocera, V, Faiola, V, Vincenzi, B, Ferraro, G, Montella, L, Guarrasi, R, Rossi, E, Cennamo, G, Tonini, G, Capasso, E, Santini, D, Caraglia, Michele, and DEL PRETE, S.

Subjects
Male, medicine.medical_specialty, Visual analogue scale, medicine.medical_treatment, Renal function, Pain, Bone Neoplasms, Zoledronic Acid, Quality of life, Surveys and Questionnaires, medicine, Humans, Bone pain, Aged, Pain Measurement, Aged, 80 and over, Diphosphonates, business.industry, Imidazoles, Bone metastasis, Bisphosphonate, medicine.disease, Surgery, Zoledronic acid, Treatment Outcome, Oncology, Quality of Life, Female, medicine.symptom, Osteonecrosis of the jaw, business, medicine.drug
Abstract

Bone metastases are a common cause of morbidity in elderly patients with solid tumors and myeloma. We studied the safety and the effect of a new bisphosphonate, zoledronic acid (ZA), on pain and on quality of life (QoL) in elderly patients with bone metastases.From January 2004 to December 2005, we have enrolled elderly patients with bone metastasis for receiving ZA administration. Visual analog scale (VAS) and Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire were used to assess potential benefits of ZA therapy.Eighty-six patients were included; the median age was 75.5 years. Before starting treatment, the mean VAS was 6.8 (+/-0.24), after three infusions 5.4 (+/-0.3), and after six courses 4.5 (+/-0.3) with a significant improvement of bone pain. Moreover, we found a statistically significant improvement of QoL measured by FACT-G questionnaire after six courses (p = 0.010). Median baseline and final value of serum creatinine were 0.73 and 0.72 mg/dl, respectively (p = 0.11); creatinine clearance was also normal for most patients. Osteonecrosis of the jaw was diagnosed in one patient who received a prolonged ZA treatment.These data confirm the benefits of ZA on pain and QoL also in elderly patients with bone metastasis from solid tumors.

Published
2007

40. Concomitant treatment of brain metastasis with Whole Brain Radiotherapy [WBRT] and Temozolomide [TMZ] is active and improves Quality of Life

Author

Salvatore Del Prete, Michele Caraglia, Bruno Vincenzi, Luigi Caserta, Vincenzo Faiola, Elena Capasso, Liliana Montella, Rosario Guarrasi, Raffaele Addeo, Addeo, R, Caraglia, Michele, Faiola, V, Capasso, E, Vincenzi, B, Montella, L, Guarrasi, R, Caserta, L, and DEL PRETE, S.

Subjects
Male, Oncology, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, Neutropenia, lcsh:RC254-282, Quality of life, Internal medicine, Temozolomide, Genetics, medicine, Humans, Prospective Studies, Prospective cohort study, Survival rate, Aged, Chemotherapy, Brain Neoplasms, business.industry, Brain, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Combined Modality Therapy, Surgery, Dacarbazine, Survival Rate, Concomitant, Quality of Life, Female, Cranial Irradiation, business, Research Article, medicine.drug, Brain metastasis
Abstract

Background Brain metastases (BM) represent one of the most frequent complications related to cancer, and their treatment continues to evolve. We have evaluated the activity, toxicity and the impact on Quality of Life (QoL) of a concomitant treatment with whole brain radiotherapy (WBRT) and Temozolomide (TMZ) in patients with brain metastases from solid tumors in a prospective Simon two stage study. Methods Fifty-nine patients were enrolled and received 30 Gy WBRT with concomitant TMZ (75 mg/m2/day) for ten days, and subsequently TMZ (150 mg/m2/day) for up to six cycles. The primary end points were clinical symptoms and radiologic response. Results Five patients had a complete response, 21 patients had a partial response, while 18 patients had stable disease. The overall response rate (45%) exceeded the target activity per study design. The median time to progression was 9 months. Median overall survival was 13 months. The most frequent toxicities included grade 3 neutropenia (15%) and anemia (13%), and only one patient developed a grade 4 thrombocytopenia. Age, Karnofsky performance status, presence of extracranial metastases and the recursive partitioning analysis (RPA) were found to be predictive factors for response in patients. Overall survival (OS) and progression-free survival (PFS) were dependent on age and on the RPA class. Conclusion We conclude that this treatment is well tolerated, with an encouraging objective response rate, and a significant improvement in quality of life (p < 0.0001) demonstrated by FACT-G analysis. All patients answered the questionnaires and described themselves as 'independent' and able to act on their own initiatives. Our study found a high level of satisfaction for QoL, this provides useful information to share with patients in discussions regarding chemotherapy treatment of these lesions.

Published
2007

41. Daily low-dose subcutaneous recombinant interleukin-2 by alternate weekly administration: antitumor activity and immunomodulatory effects

Author

Giovannella Palmieri, Rosario Guarrasi, Giuseppe Catalano, B Ricciardi, M T Librera, D Morelli, M. Famiani, Elide Matano, A Martignetti, C. Barile, Pierpaolo Correale, A Della Vecchia, Ar Bianco, Michele Caraglia, Pierosandro Tagliaferri, Tagliaferri, P, Barile, C, Caraglia, Michele, Guarrasi, R, Morelli, D, Ricciardi, B, Martignetti, A, Librera, Mt, Matano, E, DELLA VECCHIA, A, Catalano, G, Famiani, M, Palmieri, G, Correale, P, Bianco, Ar, Caraglia, M, Matano, Elide, Della Vecchia, A, Palmieri, Giovannella, and Bianco, A. R.

Subjects
Interleukin 2, Adult, Cancer Research, medicine.medical_specialty, Colorectal cancer, medicine.medical_treatment, Injections, Subcutaneous, Antineoplastic Agents, Peripheral blood mononuclear cell, Gastroenterology, Drug Administration Schedule, Renal cell carcinoma, Internal medicine, Carcinoma, medicine, Humans, Immunologic Factors, Carcinoma, Renal Cell, Melanoma, Aged, business.industry, Immunotherapy, Middle Aged, medicine.disease, Kidney Neoplasms, Recombinant Proteins, Oncology, Toxicity, Immunology, Cytokines, Interleukin-2, business, Colorectal Neoplasms, medicine.drug
Abstract

A phase II clinical trial of subcutaneous recombinant Interleukin 2 (rIL-2) given by 5 days pulses followed by a 9 days rest has been performed in patients affected by renal cell carcinoma, malignant melanoma and colorectal cancer. A total of 25 patients entered the study, completed at least six courses of treatment, and were evaluable for toxicity and response to treatment. This schedule of subcutaneous rIL-2 was well tolerated and no World Health Organization grade 3 side effects were observed. A 33.3% response rate was recorded in patients affected by renal cell carcinoma, although no major responses were achieved in patients with malignant melanoma and colorectal cancer. A durable increase of natural killer activity retained by poeripheral blood mononuclear cells was demonstrated in these patients and was paralleled by increased serum levels of interferon gamma and tumor necrosis factor a without changes of circulating interleukin-1d. It is concluded that this schedule of pulse administration of subcutaneous rIL-2 has antitumor activity in renal cell carcinoma and produces durable biomodulatory effects.

Published
1998

42. Extracellular adenosine 5' triphosphate involvement in the death of LAK-engaged human tumor cells via P2X-receptor activation

Author

Rosario Guarrasi, Antonio Procopio, Maria Rita Marinetti, Pierosandro Tagliaferri, Angelo Raffaele Bianco, Mariateresa Giuliano, Michele Caraglia, Pierpaolo Correale, Correale, P, Tagliaferri, P, Guarrasi, R, Caraglia, Michele, Giuliano, Mariateresa, Marinetti, Mr, Bianco, Ar, and Procopio, A.

Subjects
Cytotoxicity, Immunologic, Immunology, chemical and pharmacologic phenomena, Biology, Cell Line, chemistry.chemical_compound, Adenosine Triphosphate, Extracellular, Tumor Cells, Cultured, Immunology and Allergy, Cytotoxic T cell, Humans, Cytotoxicity, Killer Cells, Lymphokine-Activated, Adenosine Triphosphatases, Lymphokine-activated killer cell, Cell Death, Apyrase, Receptors, Purinergic P2, Purinergic receptor, hemic and immune systems, Thionucleotides, Calcium Channel Blockers, Molecular biology, Adenosine Diphosphate, Cell killing, chemistry, Verapamil, Colonic Neoplasms, Phorbol, Tetradecanoylphorbol Acetate
Abstract

This study reports that extracellular ATP is a critical factor involved in LAK cell-mediated cytotoxicity. Human colon carcinoma LoVo cells were resistant to LAK cells as well as to ATP, while their multidrug resistant (MDR-1+) derivative, LoVo-Dx cells, were sensitive to both LAK and ATP. LoVo-Dx cells, became resistant to LAK cells and ATP after 48 h pretreatment with Phorbol 12-Myristate-13-Acetate (PMA), while 48 h pretreatment with verapamil in parallel sensitized LoVo cells to LAK cells and to ATP as well. The sensitivity to ATP and LAK cells was not related to the expression of extracellular ecto-ATPase activity on cell targets membranes. Conversely, apyrase, an enzyme with powerful ecto-ATPase activity, abolished the LAK- and ATP-mediated cytotoxicity. Furthermore, ADP-β-S, an antagonist of ATP, abolished both LAK and ATP-mediated cell killing. Purine binding sites have been detected by radioreceptor assays with ADP-β[35S] on the cell surface of ATP and LAK-sensitive LoVo-Dx cells. By contrast, no nucleotide receptor was found on the ATP and LAK-resistant cells. Such a putative cytotoxic purinoreceptor has been categorized as P2x purinergic receptor by a panel of synthetic nucleotides. These results demonstrate that extracellular ATP is needed for an efficient LAK cell-mediated killing of tumor cells. We propose that ATP acts as a natural amplifier of physical, or immune cytotoxic damages since it may be released in large amounts from target cells injured by several cytotoxic mediators secreted by LAK effectors.

Published
1997

43. Bryostatin 1 enhances lymphokine activated killer sensitivity and modulates the beta 1 integrin profile of cultured human tumor cells

Author

Gianni Marone, Antonio Pinto, Stefano Pepe, Pierpaolo Correale, Angelo Raffaele Bianco, Rosario Guarrasi, Pierosandro Tagliaferri, Michele Caraglia, Vincenzo Patella, Antonietta Fabbrocini, Correale, P, Caraglia, Michele, Fabbrocini, A, Guarrasi, R, Pepe, S, Patella, V, Marone, G, Pinto, A, Bianco, Ar, Tagliaferri, P., P., Correale, M., Caraglia, Fabbrocini, Antonietta, R., Guarrasi, Pepe, Stefano, V., Patella, Marone, Gianni, A., Pinto, Bianco, ANGELO RAFFAELE, and P. T. a. g. l. i. a. f. e. r. r., I.

Subjects
Cancer Research, Integrins, Bryostatin 1, Tumor cells, Antineoplastic Agents, cytotoxic T lymphocyte, tumor cells, Lactones, Adjuvants, Immunologic, Tumor Cells, Cultured, cell growth, Cytotoxic T cell, Humans, Pharmacology (medical), Killer Cells, Lymphokine-Activated, Protein kinase C, Pharmacology, Lymphokine-activated killer cell, Chemistry, Integrin beta1, PKC signaling, Lymphokine, differentiation, Natural killer T cell, Bryostatins, Human tumor, Oncology, Immunology, Cancer research, Macrolides
Abstract

Bryostatin 1 interferes with protein kinase C (PKC) signaling which is involved in the activation of human and murine cytotoxic T lymphocytes, and in the growth and differentiation of tumor cells. Bryostatin 1 has immunomodulating and antitumor properties as demonstrated by preclinical and clinical studies. Here we report that bryostatin 1 increases the susceptibility to lymphokine activated killers and modifies the pattern of beta 1 integrin expression of human tumor cells. On the basis of these results the use of bryostatin 1 in combination with immunostimulating cytokines such as interleukin-2 in the treatment of human cancer is suggested.

Published
1995

44. Zoledronic acid in metastatic chondrosarcoma and advanced sacrum chordoma: two case reports

Author

Elena Capasso, Rosario Guarrasi, Raffaele Addeo, Gregorio Cennamo, Michele Caraglia, Liliana Montella, Rosanna Mamone, Salvatore Del Prete, Vincenzo Faiola, Montella, L, Addeo, R, Faiola, V, Cennamo, G, Guarrasi, R, Capasso, E, Mamone, R, Caraglia, Michele, and DEL PRETE, S.

Subjects
Male, musculoskeletal diseases, Cancer Research, medicine.medical_specialty, Poor prognosis, Sacrum, Chondrosarcoma, Antineoplastic Agents, Case Report, Zoledronic Acid, lcsh:RC254-282, X ray computed, medicine, Humans, Aged, Neoplasm Staging, Metastatic Chondrosarcoma, Spinal Neoplasms, Diphosphonates, business.industry, Imidazoles, Middle Aged, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Zoledronic acid, Oncology, Female, Chordoma, Radiology, business, Tomography, X-Ray Computed, Chondroma, medicine.drug
Abstract

Introduction Chondrosarcomas and chordomas are usually chemoresistant bone tumors and may have a poor prognosis when advanced. They are usually associated with worsening pain difficult to control. Patients and Methods Zoledronic acid was used in a 63-year-old man with metastatic chondrosarcoma and in a 66-year-old woman with a diagnosis of sacrum chordoma both reporting severe pain related to tumor. Results In the first case, zoledronic acid was able to maintain pain control despite disease progression following chemotherapy, in the other case, zoledronic acid only produced significant clinical benefit. Conclusion Control of pain associated with bone tumors such as chondrosarcoma and chondroma may significantly improve from use of zoledronic acid, independently from tumor response to other treatments. Evaluation on larger series are needed to confirm the clinical effect of this bisphosphonate on such tumors.

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45. Interleukin-2 and lanreotide in the treatment of medullary thyroid cancer: in vitro and in vivo studies.

Author

Vitale G, Lupoli G, Guarrasi R, Colao A, Dicitore A, Gaudenzi G, Misso G, Castellano M, Addeo R, Facchini G, Del Prete S, and Caraglia M

Subjects
Adult, Antineoplastic Agents pharmacology, Carcinoma, Medullary pathology, Carcinoma, Neuroendocrine, Cell Line, Tumor, Cell Proliferation drug effects, Drug Administration Routes, Drug Therapy, Combination, Female, Humans, Interleukin-2 pharmacology, Leukocytes, Mononuclear drug effects, Leukocytes, Mononuclear pathology, Male, Middle Aged, Peptides, Cyclic pharmacology, Somatostatin pharmacology, Somatostatin therapeutic use, Thyroid Neoplasms pathology, Treatment Outcome, Antineoplastic Agents therapeutic use, Carcinoma, Medullary drug therapy, Interleukin-2 therapeutic use, Peptides, Cyclic therapeutic use, Somatostatin analogs & derivatives, Thyroid Neoplasms drug therapy
Abstract

Context: To date no efficacious treatments are available for advanced medullary thyroid carcinoma (MTC)., Objective: We investigated in vitro and in vivo a new strategy for the therapy of MTC, combining human recombinant IL-2 with lanreotide (LAN), a somatostatin analog., Methods: The in vitro effects of LAN on the sensitivity of TT cells, a MTC cell line, to IL-2-stimulated human peripheral blood mononuclear cells were determined by a lactate dehydrogenase release assay. In addition, we evaluated the toxicity, the effects on quality of life, and the antitumor activity of sc low-dose IL-2 in combination with LAN (90 mg every 28 days) in a series of 6 patients with symptomatic and advanced MTC., Results: The cytotoxicity of IL-2-activated peripheral blood mononuclear cells was significantly increased in TT cells treated with LAN or LAN plus IL-2 compared with that in TT cells without treatment. The therapy was well tolerated, and a statistically significant improvement of quality of life was observed in patients treated with the combination of LAN and IL-2. After 6 months of therapy, partial response and stable disease have been recorded in 2 and 3 patients, respectively, with a significant decrease in calcitonin levels in 3 patients., Conclusions: Both in vitro and in vivo evidence suggests that the combination of LAN and IL-2 may have a role in the management of advanced and symptomatic MTC. However, these preliminary data require further validation in larger randomized trials.

Published
2013
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46. Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study.

Author

Prete SD, Montella L, Caraglia M, Maiorino L, Cennamo G, Montesarchio V, Piai G, Febbraro A, Tarantino L, Capasso E, Palmieri G, Guarrasi R, Bianco M, Mamone R, Savastano C, Pisano A, Vincenzi B, Sabia A, D'Agostino A, Faiola V, and Addeo R

Subjects
Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Benzenesulfonates administration & dosage, Carcinoma, Hepatocellular physiopathology, Diarrhea chemically induced, Disease Progression, Female, Humans, Hypertension chemically induced, Liver Neoplasms physiopathology, Male, Middle Aged, Niacinamide analogs & derivatives, Octreotide administration & dosage, Phenylurea Compounds, Pyridines administration & dosage, Sorafenib, Survival, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Hepatocellular drug therapy, Liver Neoplasms drug therapy
Abstract

Purpose: Advanced hepatocellular carcinoma (HCC) not eligible for local therapies has limited chances of cure. Sorafenib is a multikinase inhibitor with proven activity in advanced HCC. Octreotide is used in this setting with conflicting results. Treatment with sorafenib and long-acting octreotide was tested in advanced HCC to evaluate safety and activity., Methods: Fifty patients with advanced HCC, Child-Pugh A or B, received sorafenib at a dosage of 800 mg/day for 28 days with a following week of rest and long-acting octreotide at a dose of 40 mg, administered every 28 days., Results: All patients were assessable for safety and efficacy. Sixteen patients out of 50 (34%) were naïve from other therapies, while all the others were previously treated with local and/or systemic treatments. We achieved 5 partial responses (10%), 33 stable diseases (66%) and 12 progressions of disease (24%). Median time to progression was 7.0 months (95% CI, 3.0-10.9 months), and median overall survival was 12 months (95% CI, 6.3-17.4 months). Treatment was well tolerated. Diarrhoea (6%) and hypertension (4%) were the most frequent grade 3 toxicities., Conclusions: Our data suggest that the combination between sorafenib and long-acting octreotide is active and well tolerated in patients with advanced HCC and could represent another efficacious chance for the management of this population.

Published
2010
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47. Zoledronic acid in the treatment of bone metastases by hepatocellular carcinoma: a case series.

Author

Montella L, Addeo R, Palmieri G, Caraglia M, Cennamo G, Vincenzi B, Guarrasi R, Mamone R, Faiola V, Frega N, Capasso E, Maiorino L, Leopardo D, Pizza C, Montesarchio V, and Del Prete S

Subjects
Aged, Aged, 80 and over, Bone Density Conservation Agents therapeutic use, Bone Neoplasms mortality, Bone Neoplasms secondary, Carcinoma, Hepatocellular pathology, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Liver Neoplasms pathology, Male, Middle Aged, Survival Rate, Treatment Outcome, Zoledronic Acid, Bone Neoplasms drug therapy, Carcinoma, Hepatocellular drug therapy, Diphosphonates therapeutic use, Imidazoles therapeutic use, Liver Neoplasms drug therapy
Abstract

Purpose: The survival of patients with hepatocellular carcinoma (HCC) has improved with advancements in various diagnostic tools and treatment modalities. Consequently, bone metastases from HCC are diagnosed more frequently. The aims of the present study was to describe the clinical features and treatment of HCC patients presenting with bone metastases. In particular, we evaluated the role of zoledronic acid in these patients especially with regard to pain reduction, analgesic drug consumption and safety., Methods: Between December 2006 and July 2008, we recruited 17 (male:female, 12:5, median age, 68 years; age range, 62-85 years) consecutive patients. Spinal metastases were present in 11 patients (64.7%). Zoledronic acid was administered in all patients (total number of administrations, 107; mean number of administrations, 6.29)., Results: A total of 15 patients received at least three administrations of zoledronic acid and reported clinical benefit with pain reduction and tapering of analgesic drugs. Before starting treatment, the mean VAS for patients who received at least three administrations (15/17 patients) of zoledronic acid was 7.1 (+/-0.24), and after 3 months 5.3 (+/-0.20). This improvement was independent of the sex, the extent of metastasis and the concomitant anticancer treatment. No significant side effects were registered in this series of patients. Median survival was 10 months (CI 6,353-13,647)., Conclusions: Zoledronic acid may be helpful in treating bone metastases in HCC patients. Patients regularly receiving zoledronic acid showed significant pain relief.

Published
2010
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48. Randomized phase III trial on gemcitabine versus mytomicin in recurrent superficial bladder cancer: evaluation of efficacy and tolerance.

Author

Addeo R, Caraglia M, Bellini S, Abbruzzese A, Vincenzi B, Montella L, Miragliuolo A, Guarrasi R, Lanna M, Cennamo G, Faiola V, and Del Prete S

Subjects
Aged, Carcinoma, Transitional Cell pathology, Deoxycytidine therapeutic use, Female, Humans, Male, Maximum Tolerated Dose, Neoplasm Recurrence, Local pathology, Neoplasm Staging, Prognosis, Survival Rate, Treatment Outcome, Urinary Bladder Neoplasms pathology, Gemcitabine, Antibiotics, Antineoplastic therapeutic use, Antimetabolites, Antineoplastic therapeutic use, Carcinoma, Transitional Cell drug therapy, Deoxycytidine analogs & derivatives, Mitomycin therapeutic use, Neoplasm Recurrence, Local drug therapy, Urinary Bladder Neoplasms drug therapy
Abstract

Purpose: Approximately 30% to 40% patients with a superficial bladder cancer treated with Bacille Calmette-Guerin (BCG) or epirubicin do not respond; of the initial responders, 35% have a relapse within 5 years. We compare the therapeutic efficacy and toxicity of intravescical infusions of gemcitabine (GEM) with mitomycin (MMC) in patients with a recurrent superficial bladder cancer., Patients and Methods: Patients with a history of a previously treated, recurrent Ta-T1, G1-G3 bladder transitional cell carcinoma were enrolled in the study. The patients received a 6-week course of GEM infusions or 4-week course of MMC. In both arms, for the initial responders who remained free of recurrences, maintenance therapy consisted of 10 monthly treatments during the first year., Results: A total of 120 patients were enrolled and randomly assigned to either the MMC or GEM treatment arm. At the end of the study, 109 patients (55 in MMC and 54 in GEM) were assessable. The median duration of follow-up was 36 months for either arm. In the GEM arm, 39 (72%) of 54 patients remained free of recurrence versus 33 (61%) of 55 in MMC arm. Among patients with recurrences, 10 in the MMC arm and six in the GEM arm also had a progressive disease by stage. The incidence of chemical cystitis in the MMC arm was statistically higher than in the GEM arm (P = .012)., Conclusion: This study demonstrates that GEM has better efficacy and lower toxicity than MMC; therefore, GEM appears as a logical candidate for intrabladder therapy in patients with refractory transitional cancer.

Published
2010
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49. Zoledronic acid in metastatic chondrosarcoma and advanced sacrum chordoma: two case reports.

Author

Montella L, Addeo R, Faiola V, Cennamo G, Guarrasi R, Capasso E, Mamone R, Caraglia M, and Del Prete S

Subjects
Aged, Chondroma diagnostic imaging, Chondroma pathology, Chondrosarcoma diagnostic imaging, Female, Humans, Male, Middle Aged, Neoplasm Staging, Sacrum diagnostic imaging, Spinal Neoplasms diagnostic imaging, Spinal Neoplasms pathology, Tomography, X-Ray Computed, Zoledronic Acid, Antineoplastic Agents therapeutic use, Chondroma drug therapy, Chondrosarcoma drug therapy, Chondrosarcoma secondary, Diphosphonates therapeutic use, Imidazoles therapeutic use, Sacrum pathology, Spinal Neoplasms drug therapy
Abstract

Introduction: Chondrosarcomas and chordomas are usually chemoresistant bone tumors and may have a poor prognosis when advanced. They are usually associated with worsening pain difficult to control., Patients and Methods: Zoledronic acid was used in a 63-year-old man with metastatic chondrosarcoma and in a 66-year-old woman with a diagnosis of sacrum chordoma both reporting severe pain related to tumor., Results: In the first case, zoledronic acid was able to maintain pain control despite disease progression following chemotherapy, in the other case, zoledronic acid only produced significant clinical benefit., Conclusion: Control of pain associated with bone tumors such as chondrosarcoma and chondroma may significantly improve from use of zoledronic acid, independently from tumor response to other treatments. Evaluation on larger series are needed to confirm the clinical effect of this bisphosphonate on such tumors.

Published
2009
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50. Phase 2 trial of temozolomide using protracted low-dose and whole-brain radiotherapy for nonsmall cell lung cancer and breast cancer patients with brain metastases.

Author

Addeo R, De Rosa C, Faiola V, Leo L, Cennamo G, Montella L, Guarrasi R, Vincenzi B, Caraglia M, and Del Prete S

Subjects
Aged, Bone Marrow drug effects, Bone Marrow radiation effects, Brain Neoplasms drug therapy, Brain Neoplasms radiotherapy, Brain Neoplasms secondary, Breast Neoplasms drug therapy, Breast Neoplasms pathology, Breast Neoplasms radiotherapy, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung radiotherapy, Carcinoma, Non-Small-Cell Lung secondary, Combined Modality Therapy, Dacarbazine therapeutic use, Female, Humans, Liver Neoplasms drug therapy, Liver Neoplasms radiotherapy, Liver Neoplasms secondary, Liver Neoplasms therapy, Lung Neoplasms drug therapy, Lung Neoplasms radiotherapy, Lung Neoplasms secondary, Lung Neoplasms therapy, Male, Middle Aged, Prognosis, Remission Induction, Survival Rate, Temozolomide, Antineoplastic Agents, Alkylating therapeutic use, Brain Neoplasms therapy, Breast Neoplasms therapy, Carcinoma, Non-Small-Cell Lung therapy, Cranial Irradiation, Dacarbazine analogs & derivatives
Abstract

Background: Temozolomide (TMZ), an oral methylating imidazotetrazinone, has antitumor activity against gliomas, malignant melanomas, and brain metastasis and is presently administered as a 5-day oral schedule every 4 weeks., Methods: A single-institution phase 2 clinical trial was conducted to determine the efficacy and the safety profile of a new regimen based on a dose-intensified, protracted course of TMZ after whole-brain radiotherapy (WBRT). Patients were eligible if they had at least 1 bidimensionally measurable brain metastasis from breast cancer and nonsmall cell lung cancer (NSCLC). Twenty-seven patients were treated with 30 grays (Gy) of WBRT with concomitant TMZ (75 mg/m(2)/day) for 10 days, and subsequent TMZ at a dose of 75 mg/m(2) per day for 21 days every 4 weeks, for up to 12 cycles., Results: Two complete responses (7.4%) and 11 partial responses (40.7%) were achieved. The schedule appeared to be well tolerated, with grade 3 toxicity (graded according to National Cancer Institute Common Toxicity Criteria) observed in only 2 patients. The overall median survival was 8.8 months and the median progression-free survival was 6 months., Conclusions: The concomitant use of WBRT and protracted low-dose TMZ appears to be an active, well-tolerated regimen. The observed antitumor activity suggests the need for further investigation of this schedule in combination with other anticancer agents for the concomitant treatment of brain metastases and primary cancers.

Published
2008
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