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1. Liver Metastasis and Treatment Outcome with Anti-PD-1 Monoclonal Antibody in Patients with Melanoma and NSCLC

Author: Tumeh, Paul C, Hellmann, Matthew D, Hamid, Omid, Tsai, Katy K, Loo, Kimberly L, Gubens, Matthew A, Rosenblum, Michael, Harview, Christina L, Taube, Janis M, Handley, Nathan, Khurana, Neharika, Nosrati, Adi, Krummel, Matthew F, Tucker, Andrew, Sosa, Eduardo V, Sanchez, Phillip J, Banayan, Nooriel, Osorio, Juan C, Nguyen-Kim, Dan L, Chang, Jeremy, Shintaku, I Peter, Boasberg, Peter D, Taylor, Emma J, Munster, Pamela N, Algazi, Alain P, Chmielowski, Bartosz, Dummer, Reinhard, Grogan, Tristan R, Elashoff, David, Hwang, Jimmy, Goldinger, Simone M, Garon, Edward B, Pierce, Robert H, and Daud, Adil
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Women's Health, Lung Cancer, Digestive Diseases, Clinical Research, Lung, Liver Disease, Cancer, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, CD8-Positive T-Lymphocytes, Carcinoma, Non-Small-Cell Lung, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Liver Neoplasms, Lung Neoplasms, Lymphocytes, Tumor-Infiltrating, Male, Melanoma, Middle Aged, Programmed Cell Death 1 Receptor, Treatment Outcome, Young Adult, Pharmacology and Pharmaceutical Sciences, Oncology and carcinogenesis
Abstract: We explored the association between liver metastases, tumor CD8+ T-cell count, and response in patients with melanoma or lung cancer treated with the anti-PD-1 antibody, pembrolizumab. The melanoma discovery cohort was drawn from the phase I Keynote 001 trial, whereas the melanoma validation cohort was drawn from Keynote 002, 006, and EAP trials and the non-small cell lung cancer (NSCLC) cohort from Keynote 001. Liver metastasis was associated with reduced response and shortened progression-free survival [PFS; objective response rate (ORR), 30.6%; median PFS, 5.1 months] compared with patients without liver metastasis (ORR, 56.3%; median PFS, 20.1 months) P ≤ 0.0001, and confirmed in the validation cohort (P = 0.0006). The presence of liver metastasis significantly increased the likelihood of progression (OR, 1.852; P < 0.0001). In a subset of biopsied patients (n = 62), liver metastasis was associated with reduced CD8+ T-cell density at the invasive tumor margin (liver metastasis+ group, n = 547 ± 164.8; liver metastasis- group, n = 1,441 ± 250.7; P < 0.016). A reduced response rate and shortened PFS was also observed in NSCLC patients with liver metastasis [median PFS, 1.8 months; 95% confidence interval (CI), 1.4-2.0], compared with those without liver metastasis (n = 119, median PFS, 4.0 months; 95% CI, 2.1-5.1), P = 0.0094. Thus, liver metastatic patients with melanoma or NSCLC that had been treated with pembrolizumab were associated with reduced responses and PFS, and liver metastases were associated with reduced marginal CD8+ T-cell infiltration, providing a potential mechanism for this outcome. Cancer Immunol Res; 5(5); 417-24. ©2017 AACR.
Published: 2017

2. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma.

Author: Hamid, Omid, Robert, Caroline, Daud, Adil, Hodi, F Stephen, Hwu, Wen-Jen, Kefford, Richard, Wolchok, Jedd D, Hersey, Peter, Joseph, Richard W, Weber, Jeffrey S, Dronca, Roxana, Gangadhar, Tara C, Patnaik, Amita, Zarour, Hassane, Joshua, Anthony M, Gergich, Kevin, Elassaiss-Schaap, Jeroen, Algazi, Alain, Mateus, Christine, Boasberg, Peter, Tumeh, Paul C, Chmielowski, Bartosz, Ebbinghaus, Scot W, Li, Xiaoyun Nicole, Kang, S Peter, and Ribas, Antoni
Subjects: Humans, Melanoma, Brain Neoplasms, Skin Neoplasms, Antineoplastic Agents, Antibodies, Monoclonal, Drug Administration Schedule, Dose-Response Relationship, Drug, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Antibodies, Monoclonal, Humanized, Programmed Cell Death 1 Receptor, Human Genome, Genetics, Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Cancer, Medical and Health Sciences, General & Internal Medicine
Abstract: BackgroundThe programmed death 1 (PD-1) receptor is a negative regulator of T-cell effector mechanisms that limits immune responses against cancer. We tested the anti-PD-1 antibody lambrolizumab (previously known as MK-3475) in patients with advanced melanoma.MethodsWe administered lambrolizumab intravenously at a dose of 10 mg per kilogram of body weight every 2 or 3 weeks or 2 mg per kilogram every 3 weeks in patients with advanced melanoma, both those who had received prior treatment with the immune checkpoint inhibitor ipilimumab and those who had not. Tumor responses were assessed every 12 weeks.ResultsA total of 135 patients with advanced melanoma were treated. Common adverse events attributed to treatment were fatigue, rash, pruritus, and diarrhea; most of the adverse events were low grade. The confirmed response rate across all dose cohorts, evaluated by central radiologic review according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was 38% (95% confidence interval [CI], 25 to 44), with the highest confirmed response rate observed in the cohort that received 10 mg per kilogram every 2 weeks (52%; 95% CI, 38 to 66). The response rate did not differ significantly between patients who had received prior ipilimumab treatment and those who had not (confirmed response rate, 38% [95% CI, 23 to 55] and 37% [95% CI, 26 to 49], respectively). Responses were durable in the majority of patients (median follow-up, 11 months among patients who had a response); 81% of the patients who had a response (42 of 52) were still receiving treatment at the time of analysis in March 2013. The overall median progression-free survival among the 135 patients was longer than 7 months.ConclusionsIn patients with advanced melanoma, including those who had had disease progression while they had been receiving ipilimumab, treatment with lambrolizumab resulted in a high rate of sustained tumor regression, with mainly grade 1 or 2 toxic effects. (Funded by Merck Sharp and Dohme; ClinicalTrials.gov number, NCT01295827.).
Published: 2013

3. A phase I study of the investigational NEDD8-activating enzyme inhibitor pevonedistat (TAK-924/MLN4924) in patients with metastatic melanoma

Author: Bhatia, Shailender, Pavlick, Anna C., Boasberg, Peter, Thompson, John A., Mulligan, George, Pickard, Michael D., Faessel, Hélène, Dezube, Bruce J., and Hamid, Omid
Published: 2016
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4. Pilot study of PD-0325901 in previously treated patients with advanced melanoma, breast cancer, and colon cancer

Author: Boasberg, Peter D., Redfern, Charles H., Daniels, Gregory A., Bodkin, David, Garrett, Chris R., and Ricart, Alejandro D.
Published: 2011
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5. Animal and Human Studies with Oral Mitomycin C(6): A Preliminary Report

Author: Boasberg, P. D., Hall, T. C., Odujinrin, O. O., Benjamin, R. S., Lowitz, B. B., Nevinny, H. B., Maddock, Charlotte L., Hellmann, K., editor, and Connors, T. A., editor
Published: 1976
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6. Chemohormonal Therapy of Breast Cancer — A Pilot Phase I–II Study

Author: Odujinrin, O. O., Benjamin, R. J., Hardy, R. E., Boasberg, P. D., Hall, T. C., Hellmann, K., editor, and Connors, T. A., editor
Published: 1976
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7. Integrative Tumor Board: Advanced Breast Cancer

Author: Kut, Timothy C. Birdsall, Block Ki, He B, C. S. Cheung, Rogers M, Chen K, Boasberg P, Stephen M. Sagar, Rey S, Martin J, Wicke Rw, Dreher H, Hovi Ma, McCray P, and Miller S
Subjects: Complementary Therapies, Oncology, medicine.medical_specialty, Specialty board, Advanced breast, MEDLINE, Bone Neoplasms, Breast Neoplasms, Specialty Boards, Internal medicine, Radiation oncology, medicine, Carcinoma, Humans, Tumor board, Medical nutrition therapy, Delivery of Health Care, Integrated, business.industry, Cancer, Middle Aged, medicine.disease, United States, Carcinoma, Lobular, Complementary and alternative medicine, Radiation Oncology, Female, Nutrition Therapy, business
Published: 2002
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8. 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

9. 511 Updated results from a phase 1/2 study of epacadostat (INCB024360) in combination with ipilimumab in patients with metastatic melanoma

Author: Gibney, G., primary, Hamid, O., additional, Lutzky, J., additional, Olszanski, A., additional, Gangadhar, T., additional, Gajewski, T., additional, Chmielowski, B., additional, Hanks, B., additional, Boasberg, P., additional, Zhao, Y., additional, Newton, R., additional, Bowman, J., additional, Maleski, J., additional, Leopold, L., additional, and Weber, J.S., additional
Published: 2015
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10. BM-05 * IPILUMUMAB THERAPY FOR MELANOMA BRAIN METASTASES IS ASSOCIATED WITH INCREASED RADIATION NECROSIS

Author: Barkhoudarian, G., primary, Deutsch, G., additional, Yost, S., additional, Duong, H., additional, Chaloner, C., additional, Eisenberg, A., additional, Boasberg, P., additional, Faries, M., additional, Hamid, O., additional, and Kelly, D., additional
Published: 2014
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11. NEUROSURGICAL TREATMENTS

Author: Nanney, A. D., primary, Adel, J. G., additional, Smith, T. R., additional, Chandler, J. P., additional, Kimmell, K. T., additional, Walter, K., additional, Zacharia, B. E., additional, Deibert, C., additional, Malone, H. R., additional, Sonabend, A. M., additional, Neugut, A. I., additional, Spencer, B., additional, Bruce, J. N., additional, Wang, Y., additional, Li, S., additional, Zhang, Z., additional, Chen, X., additional, You, G., additional, Yang, P., additional, Yan, W., additional, Bao, Z., additional, Yao, K., additional, Liu, Y., additional, Wang, L., additional, Jiang, T., additional, Farhoud, M. K., additional, Ruge, M. I., additional, Brandes, A. A., additional, Ermani, M., additional, Fioravanti, A., additional, Andreoli, A., additional, Pozzati, E., additional, Bacci, A., additional, Bartolini, S., additional, Poggi, R., additional, Crisi, G., additional, Franceschi, E., additional, Recinos, P. F., additional, Grabowski, M. M., additional, Nowacki, A. S., additional, Thompson, N., additional, Vogelbaum, M. A., additional, Sun, P., additional, Krueger, D., additional, Liu, Z., additional, Kohrman, M., additional, Dagens, A. B., additional, Rachinger, W., additional, Kunz, M., additional, Eigenbrod, S., additional, Lutz, J., additional, Tonn, J.-C., additional, Kreth, F.-W., additional, Duong, H. T., additional, Chaloner, C., additional, Bordo, G., additional, Eisenberg, A., additional, Rosenthal, K., additional, Sim, M.-S., additional, Boasberg, P., additional, Faries, M. B., additional, Hamid, O., additional, Kelly, D. F., additional, Thon, N., additional, Simon, M., additional, Westphal, M., additional, Schackert, G., additional, Nikkhah, G., additional, Hentschel, B., additional, Pietsch, T., additional, Reifenberger, G., additional, Weller, M., additional, Ironside, S., additional, Perry, J., additional, Tsao, M., additional, Mainprize, T., additional, Keith, J., additional, Laperrierre, N., additional, Paszat, L., additional, Sahgal, A., additional, Hoover, J. M., additional, Nwojo, M., additional, Puffer, R., additional, Parney, I. F., additional, Tanaka, S., additional, Nakada, M., additional, Hayashi, Y., additional, Hamada, J.-i., additional, Lee, I. Y., additional, Ekram, T., additional, Jain, R., additional, Scarpace, L., additional, Omodon, M., additional, Rock, J., additional, Rosenblum, M., additional, Kalkanis, S., additional, Amankulor, N. M., additional, Kim, J.-H., additional, Tabar, V., additional, Peck, K. K., additional, Holodny, A. I., additional, Gutin, P. H., additional, Kim, C.-Y., additional, Kim, Y.-H., additional, Kim, T., additional, Kim, I. K., additional, Kim, J. W., additional, Kim, Y. H., additional, Han, J. H., additional, Park, C.-K., additional, Kim, D. G., additional, Jung, H.-W., additional, Nonaka, M., additional, Bamba, Y., additional, Kanemura, Y., additional, and Nakajima, S., additional
Published: 2012
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12. Phase II trial of nab-paclitaxel and bevacizumab as first-line therapy in patients with unresectable melanoma.

Author: Boasberg, P. D., primary, Weber, R. W., additional, Cruickshank, S., additional, Hamid, O., additional, O'Day, S., additional, and Spitler, L. E., additional
Published: 2011
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13. Frequent dosing and GPNMB expression with CDX-011 (CR011-vcMMAE), an antibody-drug conjugate (ADC), in patients with advanced melanoma.

Author: Hamid, O., primary, Sznol, M., additional, Pavlick, A. C., additional, Kluger, H. M., additional, Kim, K. B., additional, Boasberg, P. D., additional, Simantov, R., additional, Davis, T. A., additional, Crowley, E., additional, and Hwu, P., additional
Published: 2010
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14. Prognostic factors in metastatic melanoma patients treated with biochemotherapy and maintenance immunotherapy

Author: Minor, D. R., primary, Kashani-Sabet, M., additional, Moore, D., additional, Kim, C., additional, Venna, S. S., additional, Wang, W., additional, Boasberg, P. D., additional, and O'Day, S., additional
Published: 2009
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15. A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate (ADC) targeting glycoprotein NMB (GPNMB) in patients (pts) with advanced melanoma

Author: Hwu, P., primary, Sznol, M., additional, Pavlick, A., additional, Kluger, H., additional, Kim, K. B., additional, Boasberg, P., additional, Sanders, D., additional, Simantov, R., additional, Crowley, E., additional, and Hamid, O., additional
Published: 2009
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16. Nab-paclitaxel and bevacizumab as first-line therapy in patients with unresectable stage III and IV melanoma

Author: Boasberg, P., primary, Cruickshank, S., additional, Hamid, O., additional, O'Day, S., additional, Weber, R., additional, and Spitler, L., additional
Published: 2009
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17. A phase I/II study of CR011-vcMMAE, an antibody toxin conjugate drug, in patients with unresectable stage III/IV melanoma

Author: Hwu, P., primary, Sznol, M., additional, Kluger, H., additional, Rink, L., additional, Kim, K. B., additional, Papadopoulos, N. E., additional, Sanders, D., additional, Boasberg, P., additional, Ooi, C. E., additional, and Hamid, O., additional
Published: 2008
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18. Prophylatic cranial irradiation (PCI) in patients (Pts) with stage IV metastatic melanoma (MM) receiving concurrent biochemotherapy (cBCT) and maintenance biotherapy (MBT)

Author: Boasberg, P., primary, Minor, D. R., additional, Hamid, O., additional, Weber, J. S., additional, Wollman, R., additional, Anderson, C. M., additional, and O’Day, S. J., additional
Published: 2008
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19. A phase II multi-center trial of maintenance biotherapy (MBT) after induction concurrent biochemotherapy (BCT) for patients (Pts) with metastatic melanoma (MM)

Author: O’Day, S., primary, Atkins, M., additional, Weber, J., additional, Thompson, J., additional, Anderson, C., additional, Gonzalez, R., additional, Lutzky, J., additional, Amatruda, T., additional, Hersh, E., additional, and Boasberg, P., additional
Published: 2005
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20. Phase 1–2a dose ranging study of TLK286 (a novel glutathione analog) in combination with docetaxel in platinum-resistant non-small cell lung cancer (NSCLC)

Author: Papadimitrakopoulou, V., primary, Boasberg, P., additional, Figlin, R., additional, Zinner, R., additional, Blumenschein, G., additional, King, L., additional, Truong, M., additional, Patel, K., additional, Brown, G. L., additional, and Hanna, N., additional
Published: 2004
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21. Immune gene polymorphisms predict overall survival for stage IV melanoma patients treated with biochemotherapy

Author: Liu, D., primary, O'Day, S. J., additional, Yang, D., additional, Boasberg, P., additional, Milford, R., additional, Kristedja, T., additional, Groshen, S., additional, and Weber, J. S., additional
Published: 2004
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22. Circulating DNA Microsatellites: Molecular Determinants of Response to Biochemotherapy in Patients With Metastatic Melanoma

Author: Taback, B., primary, O'Day, S. J., additional, Boasberg, P. D., additional, Shu, S., additional, Fournier, P., additional, Elashoff, R., additional, Wang, H.-J., additional, and Hoon, D. S. B., additional
Published: 2004
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23. Phase I/II Study of the Antibody-Drug Conjugate Glembatumumab Vedotin in Patients With Advanced Melanoma.

Author: Ott, Patrick A., Hamid, Omid, Pavlick, Anna C., Kluger, Harriet, Kim, Kevin B., Boasberg, Peter D., Simantov, Ronit, Crowley, Elizabeth, Green, Jennifer A., Hawthorne, Thomas, Davis, Thomas A., Sznol, Mario, and Hwu, Patrick
Published: 2014
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24. Phase II Study of Nab-Paclitaxel and Bevacizumab as First-line Therapy for Patients with Unresectable Stage III and IV Melanoma

Author: Spitler, Lynn E., Boasberg, Peter, Day, Steven O’, Hamid, Omid, Cruickshank, Scott, Mesko, Shane, and Weber, Robert W.
Published: 2015
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25. High-dose tamoxifen added to concurrent biochemotherapy with decrescendo interleukin-2 in patients with metastatic melanoma.

Author: O'Day, Steven J., Boasberg, Peter D., Kristedja, Tim S., Martin, Maureen, Wang, He-Jing, Fournier, Patricia, Cabot, Myles, DeGregorio, Michael W., Gammon, Guy, O'Day, S J, Boasberg, P D, Kristedja, T S, Martin, M, Wang, H J, Fournier, P, Cabot, M, DeGregorio, M W, and Gammon, G
Published: 2001
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26. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial

Author: Robert, Caroline, Ribas, Antoni, Wolchok, Jedd D, Hodi, F Stephen, Hamid, Omid, Kefford, Richard, Weber, Jeffrey S, Joshua, Anthony M, Hwu, Wen-Jen, Gangadhar, Tara C, Patnaik, Amita, Dronca, Roxana, Zarour, Hassane, Joseph, Richard W, Boasberg, Peter, Chmielowski, Bartosz, Mateus, Christine, Postow, Michael A, Gergich, Kevin, Elassaiss-Schaap, Jeroen, Li, Xiaoyun Nicole, Iannone, Robert, Ebbinghaus, Scot W, Kang, S Peter, and Daud, Adil
Abstract: The anti-programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma.
Published: 2014
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27. Melanoma and immunotherapy bridge 2015: Naples, Italy. 1–5 December 2015

Author: Nanda, Vashisht G. Y., Peng, Weiyi, Hwu, Patrick, Davies, Michael A., Ciliberto, Gennaro, Fattore, Luigi, Malpicci, Debora, Aurisicchio, Luigi, Ascierto, Paolo Antonio, Croce, Carlo M., Mancini, Rita, Spranger, Stefani, Gajewski, Thomas F., Wang, Yangyang, Ferrone, Soldano, Vanpouille-Box, Claire, Wennerberg, Erik, Pilones, Karsten A., Formenti, Silvia C., Demaria, Sandra, Tang, Haidong, Wang, Yang, Fu, Yang-Xin, Dummer, Reinhard, Puzanov, Igor, Tarhini, Ahmad, Chauvin, Joe-Marc, Pagliano, Ornella, Fourcade, Julien, Sun, Zhaojun, Wang, Hong, Sanders, Cindy, Kirkwood, John M., Chen, Tseng-hui Timothy, Maurer, Mark, Korman, Alan J., Zarour, Hassane M., Stroncek, David F., Huber, Veronica, Rivoltini, Licia, Thurin, Magdalena, Rau, Tilman, Lugli, Alessandro, Pagès, Franck, Camarero, Jorge, Sancho, Arantxa, Jommi, Claudio, de Coaña, Yago Pico, Wolodarski, Maria, Yoshimoto, Yuya, Gentilcore, Giusy, Poschke, Isabel, Masucci, Giuseppe V., Hansson, Johan, Kiessling, Rolf, Scognamiglio, Giosuè, Sabbatino, Francesco, Marino, Federica Zito, Anniciello, Anna Maria, Cantile, Monica, Cerrone, Margherita, Scala, Stefania, D’alterio, Crescenzo, Ianaro, Angela, Cirin, Giuseppe, Liguori, Giuseppina, Bott, Gerardo, Chapman, Paul B., Robert, Caroline, Larkin, James, Haanen, John B., Ribas, Antoni, Hogg, David, Hamid, Omid, Testori, Alessandro, Lorigan, Paul, Sosman, Jeffrey A., Flaherty, Keith T., Yue, Huibin, Coleman, Shelley, Caro, Ivor, Hauschild, Axel, McArthur, Grant A., Sznol, Mario, Callahan, Margaret K., Kluger, Harriet, Postow, Michael A., Gordan, RuthAnn, Segal, Neil H., Rizvi, Naiyer A., Lesokhin, Alexander, Atkins, Michael B., Burke, Matthew M., Ralabate, Amanda, Rivera, Angel, Kronenberg, Stephanie A., Agunwamba, Blessing, Ruisi, Mary, Horak, Christine, Jiang, Joel, Wolchok, Jedd, Ascierto, Paolo A., Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stoyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Atkinson, Victoria, Dutriaux, Caroline, Garbe, Claus, Wongchenko, Matthew, Chang, Ilsung, Koralek, Daniel O., Rooney, Isabelle, Yan, Yibing, Dréno, Brigitte, Sullivan, Ryan, Patel, Manish, Hodi, Stephen, Amaria, Rodabe, Boasberg, Peter, Wallin, Jeffrey, He, Xian, Cha, Edward, Richie, Nicole, Ballinger, Marcus, Smith, David C., Bauer, Todd M., Wasser, Jeffrey S., Luke, Jason J., Balmanoukian, Ani S., Kaufman, David R., Zhao, Yufan, Maleski, Janet, Leopold, Lance, Gangadhar, Tara C., Long, Georgina V., Michielin, Olivier, VanderWalde, Ari, Andtbacka, Robert H. I., Cebon, Jonathan, Fernandez, Eugenio, Malvehy, Josep, Olszanski, Anthony J., Gause, Christine, Chen, Lisa, Chou, Jeffrey, Stephen Hodi, F., Brady, Benjamin, Mortier, Laurent, Hassel, Jessica C., Rutkowski, Piotr, McNeil, Catriona, Kalinka-Warzocha, Ewa, Lebbé, Celeste, Ny, Lars, Chacon, Matias, Queirolo, Paola, Loquai, Carmen, Cheema, Parneet, Berrocal, Alfonso, Eizmendi, Karmele Mujika, Bar-Sela, Gil, Hardy, Helene, Weber, Jeffrey S., Grob, Jean-Jacques, Marquez-Rodas, Ivan, Schmidt, Henrik, Briscoe, Karen, Baurain, Jean-François, Wolchok, Jedd D., Pinto, Rosamaria, De Summa, Simona, Garrisi, Vito Michele, Strippoli, Sabino, Azzariti, Amalia, Guida, Gabriella, Guida, Michele, Tommasi, Stefania, Jacquelot, Nicolas, Enot, David, Flament, Caroline, Pitt, Jonathan M., Vimond, Nadège, Blattner, Carolin, Yamazaki, Takahiro, Roberti, Maria-Paula, Vetizou, Marie, Daillere, Romain, Poirier-Colame, Vichnou, la Semeraro, Michaë, Caignard, Anne, Slingluff, Craig L, Sallusto, Federica, Rusakiewicz, Sylvie, Weide, Benjamin, Marabelle, Aurélien, Kohrt, Holbrook, Dalle, Stéphane, Cavalcanti, Andréa, Kroemer, Guido, Di Giacomo, Anna Maria, Maio, Michaele, Wong, Phillip, Yuan, Jianda, Umansky, Viktor, Eggermont, Alexander, Zitvogel, Laurence, Anna, Passarelli, Marco, Tucci, Stefania, Stucci, Francesco, Mannavola, Mariaelena, Capone, Gabriele, Madonna, Antonio, Ascierto Paolo, Franco, Silvestris, Roberti, María Paula, Enot, David P., Semeraro, Michaela, Jégou, Sarah, Flores, Camila, Kwon, Byoung S., Anderson, Ana Carrizossa, Borg, Christophe, Aubin, François, Ayyoub, Maha, De Presbiteris, Anna Lisa, Cordaro, Fabiola Gilda, Camerlingo, Rosa, Fratangelo, Federica, Mozzillo, Nicola, Pirozzi, Giuseppe, Patriarca, Eduardo J., Caputo, Emilia, Motti, Maria Letizia, Falcon, Rosaria, Miceli, Roberta, Capone, Mariaelena, Madonna, Gabriele, Mallardo, Domenico, Carrier, Maria Vincenza, Panza, Elisabetta, De Cicco, Paola, Armogida, Chiara, Ercolano, Giuseppe, Botti, Gerardo, Cirino, Giuseppe, Sandru, Angela, Blank, Miri, Balatoni, Timea, Olasz, Judit, Farkas, Emil, Szollar, Andras, Savolt, Akos, Godeny, Maria, Csuka, Orsolya, Horvath, Szabolcs, Eles, Klara, Shoenfeld, Yehuda, Kasler, Miklos, Costantini, Susan, Capone, Francesca, Moradi, Farnaz, Berglund, Pontus, Leandersson, Karin, Linnskog, Rickard, Andersson, Tommy, Prasad, Chandra Prakash, Nigro, Cristiana Lo, Lattanzio, Laura, Wang, Hexiao, Proby, Charlotte, Syed, Nelofer, Occelli, Marcella, Cauchi, Carolina, Merlano, Marco, Harwood, Catherine, Thompson, Alastair, Crook, Tim, Bifulco, Katia, Ingangi, Vincenzo, Minopoli, Michele, Ragone, Concetta, Pessi, Antonello, Mannavola, Francesco, D’Oronzo, Stella, Felici, Claudia, Tucci, Marco, Doronzo, Antonio, Silvestris, Franco, Ferretta, Anna, Guida, Stefania, Maida, Imma, Cocco, Tiziana, Passarelli, Anna, Quaresmini, Davide, Franzese, Ornella, Palermo, Belinda, Di Donna, Cosmo, Sperduti, Isabella, Foddai, MariaLaura, Stabile, Helena, Gismondi, Angela, Santoni, Angela, Nisticò, Paola, Sponghini, Andrea P., Platini, Francesca, Marra, Elena, Rondonotti, David, Alabiso, Oscar, Fierro, Maria T., Savoia, Paola, Stratica, Florian, Quaglino, Pietro, Di Monta, Gianluca, Corrado, Caracò, Di Marzo, Massimiliano, Ugo, Marone, Di Cecilia, Maria Luisa, Nicola, Mozzillo, Fusciello, Celeste, Marra, Antonio, Guarrasi, Rosario, Baldi, Carlo, Russo, Rosa, Di Giulio, Giovanni, Faiola, Vincenzo, Zeppa, Pio, Pepe, Stefano, Gambale, Elisabetta, Carella, Consiglia, Di Paolo, Alessandra, De Tursi, Michele, Marra, Laura, De Murtas, Fara, Sorrentino, Valeria, Voinea, Silviu, Panaitescu, Eugenia, Bolovan, Madalina, Stanciu, Adina, Cinca, Sabin, Botti, Chiara, Aquino, Gabriella, Anniciello, Annamaria, Fortes, Cristina, Mastroeni, Simona, Caggiati, Alessio, Passarelli, Francesca, Zappalà, Alba, Capuano, Maria, Bono, Riccardo, Nudo, Maurizio, Marino, Claudia, Michelozzi, Paola, De Biasio, Valeria, Battarra, Vincenzo C., Formenti, Silvia, Ascierto, Maria Libera, McMiller, Tracee L., Berger, Alan E., Danilova, Ludmila, Anders, Robert A., Netto, George J., Xu, Haiying, Pritchard, Theresa S., Fan, Jinshui, Cheadle, Chris, Cope, Leslie, Drake, Charles G., Pardoll, Drew M., Taube, Janis M., Topalian, Suzanne L., Gnjatic, Sacha, Nataraj, Sarah, Imai, Naoko, Rahman, Adeeb, Jungbluth, Achim A., Pan, Linda, Venhaus, Ralph, Park, Andrew, Lehmann, Frédéric F., Lendvai, Nikoletta, Cohen, Adam D., Cho, Hearn J., Daniel, Speiser, and Hirsh, Vera
Abstract: Table of contents 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 immunoscore task force: an update K15 The immunoscore in colorectal cancer highlights the importance of digital scoring systems in surgical pathology Tilman Rau, Alessandro Lugli K16 The immunoscore: toward an integrated immunomonitoring from the diagnosis to the follow up of cancer’s patients Franck Pagès Economic sustainability of melanoma treatments: regulatory, health technology assessment and market access issues K17 Nivolumab, the regulatory experience in immunotherapy Jorge Camarero, Arantxa Sancho K18 Evidence to optimize access for immunotherapies Claudio Jommi ORAL PRESENTATIONS Molecular and immuno-advances O1 Ipilimumab treatment results in CD4 T cell activation that is concomitant with a reduction in Tregs and MDSCs Yago Pico de Coaña, Maria Wolodarski, Yuya Yoshimoto, Giusy Gentilcore, Isabel Poschke, Giuseppe V. Masucci, Johan Hansson, Rolf Kiessling O2 Evaluation of prognostic and therapeutic potential of COX-2 and PD-L1 in primary and metastatic melanoma Giosuè Scognamiglio, Francesco Sabbatino, Federica Zito Marino, Anna Maria Anniciello, Monica Cantile, Margherita Cerrone, Stefania Scala, Crescenzo D’alterio, Angela Ianaro, Giuseppe Cirino, Paolo Antonio Ascierto, Giuseppina Liguori, Gerardo Botti O3 Vemurafenib in patients with BRAFV600 mutation–positive metastatic melanoma: final overall survival results of the BRIM-3 study Paul B. Chapman, Caroline Robert, James Larkin, John B. Haanen, Antoni Ribas, David Hogg, Omid Hamid, Paolo Antonio Ascierto, Alessandro Testori, Paul Lorigan, Reinhard Dummer, Jeffrey A. Sosman, Keith T. Flaherty, Huibin Yue, Shelley Coleman, Ivor Caro, Axel Hauschild, Grant A. McArthur O4 Updated survival, response and safety data in a phase 1 dose-finding study (CA209-004) of concurrent nivolumab (NIVO) and ipilimumab (IPI) in advanced melanoma Mario Sznol, Margaret K. Callahan, Harriet Kluger, Michael A. Postow, RuthAnn Gordan, Neil H. Segal, Naiyer A. Rizvi, Alexander Lesokhin, Michael B. Atkins, John M. Kirkwood, Matthew M. Burke, Amanda Ralabate, Angel Rivera, Stephanie A. Kronenberg, Blessing Agunwamba, Mary Ruisi, Christine Horak, Joel Jiang, Jedd Wolchok Combination therapies O5 Efficacy and correlative biomarker analysis of the coBRIM study comparing cobimetinib (COBI) + vemurafenib (VEM) vs placebo (PBO) + VEM in advanced BRAF-mutated melanoma patients (pts) Paolo A. Ascierto, Grant A. McArthur, James Larkin, Gabriella Liszkay, Michele Maio, Mario Mandalà, Lev Demidov, Daniil Stoyakovskiy, Luc Thomas, Luis de la Cruz-Merino, Victoria Atkinson, Caroline Dutriaux, Claus Garbe, Matthew Wongchenko, Ilsung Chang, Daniel O. Koralek, Isabelle Rooney, Yibing Yan, Antoni Ribas, Brigitte Dréno O6 Preliminary clinical safety, tolerability and activity results from a Phase Ib study of atezolizumab (anti-PDL1) combined with vemurafenib in BRAFV600-mutant metastatic melanoma Ryan Sullivan, Omid Hamid, Manish Patel, Stephen Hodi, Rodabe Amaria, Peter Boasberg, Jeffrey Wallin, Xian He, Edward Cha, Nicole Richie, Marcus Ballinger, Patrick Hwu O7 Preliminary safety and efficacy data from a phase 1/2 study of epacadostat (INCB024360) in combination with pembrolizumab in patients with advanced/metastatic melanoma Thomas F. Gajewski, Omid Hamid, David C. Smith, Todd M. Bauer, Jeffrey S. Wasser, Jason J. Luke, Ani S. Balmanoukian, David R. Kaufman, Yufan Zhao, Janet Maleski, Lance Leopold, Tara C. Gangadhar O8 Primary analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma Reinhard Dummer, Georgina V. Long, Antoni Ribas, Igor Puzanov, Olivier Michielin, Ari VanderWalde, Robert H.I. Andtbacka, Jonathan Cebon, Eugenio Fernandez, Josep Malvehy, Anthony J. Olszanski, Thomas F. Gajewski, John M. Kirkwood, Christine Gause, Lisa Chen, David R. Kaufman, Jeffrey Chou, F. Stephen Hodi News in immunotherapy O9 Two-year survival and safety update in patients (pts) with treatment-naïve advanced melanoma (MEL) receiving nivolumab (NIVO) or dacarbazine (DTIC) in CheckMate 066 Victoria Atkinson, Paolo A. Ascierto, Georgina V. Long, Benjamin Brady, Caroline Dutriaux, Michele Maio, Laurent Mortier, Jessica C. Hassel, Piotr Rutkowski, Catriona McNeil, Ewa Kalinka-Warzocha, Celeste Lebbé, Lars Ny, Matias Chacon, Paola Queirolo, Carmen Loquai, Parneet Cheema, Alfonso Berrocal, Karmele Mujika Eizmendi, Luis De La Cruz-Merino, Gil Bar-Sela, Christine Horak, Joel Jiang, Helene Hardy, Caroline Robert O10 Efficacy and safety of nivolumab (NIVO) in patients (pts) with advanced melanoma (MEL) who were treated beyond progression in CheckMate 066/067 Georgina V. Long, Jeffrey S. Weber, James Larkin, Victoria Atkinson, Jean-Jacques Grob, Reinhard Dummer, Caroline Robert, Ivan Marquez-Rodas, Catriona McNeil, Henrik Schmidt, Karen Briscoe, Jean-François Baurain, F. Stephen Hodi, Jedd D. Wolchok Tumor microenvironment and biomarkers O11 New biomarkers for response/resistance to BRAF inhibitor therapy in metastatic melanoma Rosamaria Pinto, Simona De Summa, Vito Michele Garrisi, Sabino Strippoli, Amalia Azzariti, Gabriella Guida, Michele Guida, Stefania Tommasi O12 Chemokine receptor patterns in lymphocytes mirror metastatic spreading in melanoma and response to ipilimumab Nicolas Jacquelot, David Enot, Caroline Flament, Jonathan M. Pitt, Nadège Vimond, Carolin Blattner, Takahiro Yamazaki, Maria-Paula Roberti, Marie Vetizou, Romain Daillere, Vichnou Poirier-Colame, Michaëla Semeraro, Anne Caignard, Craig L Slingluff Jr, Federica Sallusto, Sylvie Rusakiewicz, Benjamin Weide, Aurélien Marabelle, Holbrook Kohrt, Stéphane Dalle, Andréa Cavalcanti, Guido Kroemer, Anna Maria Di Giacomo, Michaele Maio, Phillip Wong, Jianda Yuan, Jedd Wolchok, Viktor Umansky, Alexander Eggermont, Laurence Zitvogel O13 Serum levels of PD1- and CD28-positive exosomes before Ipilimumab correlate with therapeutic response in metastatic melanoma patients Passarelli Anna, Tucci Marco, Stucci Stefania, Mannavola Francesco, Capone Mariaelena, Madonna Gabriele, Ascierto Paolo Antonio, Silvestris Franco O14 Immunological prognostic factors in stage III melanomas María Paula Roberti, Nicolas Jacquelot, David P Enot, Sylvie Rusakiewicz, Michaela Semeraro, Sarah Jégou, Camila Flores, Lieping Chen, Byoung S. Kwon, Ana Carrizossa Anderson, Caroline Robert, Christophe Borg, Benjamin Weide, François Aubin, Stéphane Dalle, Michele Maio, Jedd D. Wolchok, Holbrook Kohrt, Maha Ayyoub, Guido Kroemer, Aurélien Marabelle, Andréa Cavalcanti, Alexander Eggermont, Laurence Zitvogel POSTER PRESENTATIONS Molecular and immuno-advances P1 Human melanoma cells resistant to B-RAF and MEK inhibition exhibit mesenchymal-like features Anna Lisa De Presbiteris, Fabiola Gilda Cordaro, Rosa Camerlingo, Federica Fratangelo, Nicola Mozzillo, Giuseppe Pirozzi, Eduardo J. Patriarca, Paolo A. Ascierto, Emilia Caputo P2 Anti-proliferative and pro-apoptotic effect of ABT888 on melanoma cell lines and its potential role in the treatment of melanoma resistant to B-RAF inhibitors Federica Fratangelo, Rosa Camerlingo, Emilia Caputo, Maria Letizia Motti, Rosaria Falcone, Roberta Miceli, Mariaelena Capone, Gabriele Madonna, Domenico Mallardo, Maria Vincenza Carriero, Giuseppe Pirozzi and Paolo Antonio Ascierto P3 Involvement of the L-cysteine/CSE/H2S pathway in human melanoma progression Elisabetta Panza, Paola De Cicco, Chiara Armogida, Giuseppe Ercolano, Rosa Camerlingo, Giuseppe Pirozzi, Giosuè Scognamiglio, Gerardo Botti, Giuseppe Cirino, Angela Ianaro P4 Cancer stem cell antigen revealing pattern of antibody variable region genes were defined by immunoglobulin repertoire analysis in patients with malignant melanoma Beatrix Kotlan, Gabriella Liszkay, Miri Blank, Timea Balatoni, Judit Olasz, Emil Farkas, Andras Szollar, Akos Savolt, Maria Godeny, Orsolya Csuka, Szabolcs Horvath, Klara Eles, Yehuda Shoenfeld and Miklos Kasler P5 Upregulation of Neuregulin-1 expression is a hallmark of adaptive response to BRAF/MEK inhibitors in melanoma Debora Malpicci, Luigi Fattore, Susan Costantini, Francesca Capone, Paolo Antonio Ascierto, Rita Mancini, Gennaro Ciliberto P6 HuR positively regulates migration of HTB63 melanoma cells Farnaz Moradi, Pontus Berglund, Karin Leandersson, Rickard Linnskog, Tommy Andersson, Chandra Prakash Prasad P7 Prolyl 4- (C-P4H) hydroxylases have opposing effects in malignant melanoma: implication in prognosis and therapy Cristiana Lo Nigro, Laura Lattanzio, Hexiao Wang, Charlotte Proby, Nelofer Syed, Marcella Occelli, Carolina Cauchi, Marco Merlano, Catherine Harwood, Alastair Thompson, Tim Crook P8 Urokinase receptor antagonists: novel agents for the treatment of melanoma Maria Letizia Motti, Katia Bifulco, Vincenzo Ingangi, Michele Minopoli, Concetta Ragone, Federica Fratangelo, Antonello Pessi, Gennaro Ciliberto, Paolo Antonio Ascierto, Maria Vincenza Carriero P9 Exosomes released by melanoma cell lines enhance chemotaxis of primary tumor cells Francesco Mannavola, Stella D’Oronzo, Claudia Felici, Marco Tucci, Antonio Doronzo, Franco Silvestris P10 New insights in mitochondrial metabolic reprogramming in melanoma Anna Ferretta, Gabriella Guida, Stefania Guida, Imma Maida, Tiziana Cocco, Sabino Strippoli, Stefania Tommasi, Amalia Azzariti, Michele Guida P11 Lenalidomide restrains the proliferation in melanoma cells through a negative regulation of their cell cycle Stella D’Oronzo, Anna Passarelli, Claudia Felici, Marco Tucci, Davide Quaresmini, Franco Silvestris Combination therapies P12 Chemoimmunotherapy elicits polyfunctional anti-tumor CD8 + T cells depending on the activation of an AKT pathway sustained by ICOS Ornella Franzese, Belinda Palermo, Cosmo Di Donna, Isabella Sperduti, MariaLaura Foddai, Helena Stabile, Angela Gismondi, Angela Santoni, Paola Nisticò P13 Favourable toxicity profile of combined BRAF and MEK inhibitors in metastatic melanoma patients Andrea P. Sponghini, Francesca Platini, Elena Marra, David Rondonotti, Oscar Alabiso, Maria T. Fierro, Paola Savoia, Florian Stratica, Pietro Quaglino P14 Electrothermal bipolar vessel sealing system dissection reduces seroma output or time to drain removal following axillary and ilio-inguinal node dissection in melanoma patients: a pilot study Di Monta Gianluca, Caracò Corrado, Di Marzo Massimiliano, Marone Ugo, Di Cecilia Maria Luisa, Mozzillo Nicola News in immunotherapy P15 Clinical and immunological response to ipilimumab in a metastatic melanoma patient with HIV infection Francesco Sabbatino, Celeste Fusciello1, Antonio Marra, Rosario Guarrasi, Carlo Baldi, Rosa Russo, Di Giulio Giovanni, Vincenzo Faiola, Pio Zeppa, Stefano Pepe P16 Immunotherapy and hypophysitis: a case report Elisabetta Gambale, Consiglia Carella, Alessandra Di Paolo, Michele De Tursi Tumor microenvironment and biomarkers P17 New immuno- histochemical markers for the differential diagnosis of atypical melanocytic lesions with uncertain malignant potential Laura Marra, Giosuè Scognamiglio, Monica Cantile, Margherita Cerrone, Fara De Murtas, Valeria Sorrentino, Anna Maria Anniciello, Gerardo Botti P18 Utility of simultaneous measurement of three serum tumor markers in melanoma patients Angela Sandru, Silviu Voinea, Eugenia Panaitescu, Madalina Bolovan, Adina Stanciu, Sabin Cinca P19 The significance of various cut-off levels of melanoma inhibitory activity in evaluation of cutaneous melanoma patients Angela Sandru, Silviu Voinea, Eugenia Panaitescu, Madalina Bolovan, Adina Stanciu, Sabin Cinca P20 The long noncoding RNA HOTAIR is associated to metastatic progression of melanoma and it can be identified in the blood of patients with advanced disease Chiara Botti, Giosuè Scognamiglio, Laura Marra, Gabriella Aquino, Rosaria Falcone, Annamaria Anniciello, Paolo Antonio Ascierto, Gerardo Botti, Monica Cantile Other P21 The effect of Sentinel Lymph Node Biopsy in melanoma mortality: timing of dissection Cristina Fortes, Simona Mastroeni, Alessio Caggiati, Francesca Passarelli, Alba Zappalà, Maria Capuano, Riccardo Bono, Maurizio Nudo, Claudia Marino, Paola Michelozzi P22 Epidemiological survey on related psychopathology in melanoma Valeria De Biasio, Vincenzo C. Battarra IMMUNOTHERAPY BRIDGE KEYNOTE SPEAKER PRESENTATIONS Immunotherapy beyond melanoma K19 Predictor of response to radiation and immunotherapy Silvia Formenti K20 Response and resistance to PD-1 pathway blockade: clues from the tumor microenvironment Maria Libera Ascierto, Tracee L. McMiller, Alan E. Berger, Ludmila Danilova, Robert A. Anders, George J. Netto, Haiying Xu, Theresa S. Pritchard, Jinshui Fan, Chris Cheadle, Leslie Cope, Charles G. Drake, Drew M. Pardoll, Janis M. Taube and Suzanne L. Topalian K21 Combination immunotherapy with autologous stem cell transplantation, protein immunization, and PBMC reinfusion in myeloma patients Sacha Gnjatic, Sarah Nataraj, Naoko Imai, Adeeb Rahman, Achim A. Jungbluth, Linda Pan, Ralph Venhaus, Andrew Park, Frédéric F. Lehmann, Nikoletta Lendvai, Adam D. Cohen, and Hearn J. Cho K22 Anti-cancer immunity despite T cell “exhaustion” Speiser Daniel Immunotherapy in oncology (I-O): data from clinical trial K23 The Checkpoint Inhibitors for the Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC) Vera Hirsh
Published: 2016
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28. BRAF-Targeted Therapy to Treat Superior Vena Cava Syndrome in a Patient With Metastatic Cancer.

Author: Mesko, Shane M., Rosenthal, Katherine J., Boasberg, Peter D., and Hamid, Omid
Published: 2015
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29. Ipilimumab: Unleashing the Power of the Immune System Through CTLA-4 Blockade

Author: Boasberg, Peter, Hamid, Omid, and O’Day, Steven
Abstract: Malignant melanoma is rising faster in incidence than any other malignancy. Long-term remission or “cure” is rare and is almost exclusively limited to therapies that stimulate an immune antitumor response. Ipilimumab is a novel targeted human immunostimulatory monoclonal antibody that blocks cytotoxic T-lymphocyte antigen4 (CTLA-4), an immune-inhibitory site expressed on activated T cells. Ipilimumab is well tolerated as an outpatient infusion therapy. Multiple studies have confirmed significant antimelanoma activity. A randomized trial has documented a survival benefit when ipilimumab was compared to a gp-100 vaccine only arm. The unique mechanism of action of ipilimumab makes assessment of response by conventional criteria difficult. Benefit from ipilimumab can occur after what would be considered progression with World Health Oganization (WHO) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria. New immune response criteria have been proposed. Therapeutic responses peak between 12 and 24 weeks, with slow responses continuing up to and beyond 12 months. The major drug- related adverse side effects (10%–15% grade 3 or above) are immune-related and consist most commonly of rash, colitis, hypophysitis, thyroiditis, and hepatitis. Colonic perforation can occur and patients with diarrhea have to be monitored carefully with strict adherence to treatment algorithms. Algorithms for the treatment of other adverse side effects have been developed. The treatment of immune-related side effects with immunosuppressive agents, such as corticosteroids, does not appear to impair antitumor response. With proper monitoring and management of side effects, ipilimumab is an extremely safe drug to administer. The benefits of ipilimumab will most certainly extend to other malignancies in the near future.
Published: 2010
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30. PET Scanning in Breast Cancer: A Clinician’s Perspective

Author: Boasberg, Peter
Abstract: Breast cancer is the most common cancer among women excluding nonmelanotic skin cancers, and is the second leading cause of cancer deaths in women. In 2005, it is estimated there will be over 200,000 women diagnosed with breast cancer and approximately 40,000 deaths from the disease. Although the incidence of breast cancer remains high, the rate of death from breast cancer has recently been estimated to have diminished by 25% to 38% through the contribution of screening mammography and adjuvant therapy. Despite these advances, breast cancer continues to remain a major personal and public health issue. Oncologists are continually seeking tools to aid the treatment decisions for patients with breast cancer. At every stage of a patient’s disease, accurate information is required to assess the extent of disease, the pattern of spread, and the response to therapy. The purpose of this paper is to review the existing data regarding the potential role of fluorodeoxyglucose positron emission topography (FDG-PET) scanning in the mangement of breast cancer patients from a clinician’s viewpoint.
Published: 2006
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31. Paraneoplastic chorea associated with CRMP‐5 neuronal antibody and lung carcinoma

Author: Vernino, Steven, Tuite, Paul, Adler, Charles H., Meschia, James F., Boeve, Bradley F., Boasberg, Peter, Parisi, Joseph E., and Lennon, Vanda A.
Abstract: Paraneoplastic chorea is described in 16 patients: 11 with limited small‐cell carcinoma, 2 with lung cancer revealed by imaging, 1 with renal cell carcinoma, and 1 with lymphoma. All had CRMP‐5‐IgG; 6 also had ANNA‐1 (anti‐Hu), including 1 without evident cancer. Chorea was the initial and most prominent symptom in 11 patients, asymmetric or unilateral in 5 patients, and part of a multifocal syndrome in 14 patients. Basal ganglia abnormalities were revealed by magnetic resonance imaging and at autopsy (as perivascular inflammation and microglial activation). Four patients improved with chemotherapy, and 2 improved with intravenous methylprednisolone.
Published: 2002
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32. Pursuing In-Person Learning in the Time of Coronavirus.

Author: Boasberg, Tom
Subjects: COVID-19 pandemic, TRAVELERS, HIGH school students
Published: 2020

33. Medical Oncology Analysis

Author: Boasberg, Peter
Published: 2002
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34. Impact of gene polymorphisms on clinical outcome for stage IV melanoma patients treated with biochemotherapy: An exploratory study

Author: Liu, D., O Day, S. J., Dongyun Yang, Boasberg, P., Milford, R., Kristedja, T., Groshen, S., and Weber, J.
Subjects: Adult, Male, Cancer Research, Adolescent, Genotype, Pilot Projects, Vinblastine, Interferon-gamma, Gene Frequency, Antineoplastic Combined Chemotherapy Protocols, Humans, Melanoma, Aged, Neoplasm Staging, Xeroderma Pigmentosum Group D Protein, Polymorphism, Genetic, DNA Helicases, Interferon-alpha, Middle Aged, Endonucleases, Survival Analysis, Interleukin-10, DNA-Binding Proteins, Dacarbazine, Treatment Outcome, X-ray Repair Cross Complementing Protein 1, Oncology, Interleukin-2, Female, Cisplatin, Transcription Factors
Abstract: Purpose: Biochemotherapy can achieve high response rates in advanced melanoma, but the factors that influence regression and survival remain unknown. The present exploratory study tested the hypothesis that cytokine gene polymorphisms predict clinical outcome in stage IV melanoma patients treated with biochemotherapy.Experimental Design: Ninety patients with stage IV melanoma were treated with biochemotherapy, including cisplatin, vinblastine, and dacarbazine combined with interleukin (IL)-2 and IFN-α either with or without tamoxifen. Cytokine gene polymorphisms for IFN-γ (+874A→T) and IL-10 (−1082G→A) were assessed. X-ray repair cross-complementing gene 1 (XRCC1; Arg399Gln), xeroderma pigmentosum complementary group D (XPD; Lys751Gln), and excision repair cross-complementing gene 1 (ERCC1; codon 118) DNA repair polymorphisms were also determined.Results: IFN-γ (+874A→T) gene polymorphism was statistically significantly associated with response (P = 0.001), progression-free survival (P = 0.0012), and overall survival (P < 0.001), whereas the IL-10 polymorphism was marginally associated with response (P = 0.03) and overall survival (P = 0.065). Multivariate analysis revealed that IFN-γ (+874A→T) independently predicted overall survival (P = 0.003). The ERCC1 polymorphism was weakly associated with overall survival (P = 0.045). Combining polymorphisms for IFN-γ, IL-10, and ERCC1 stratified patients into four distinct groups with significantly different clinical outcome (P < 0.001), so that patients with more “favorable” polymorphisms had a better outcome.Conclusions: Cytokine gene polymorphisms predicted clinical outcome for advanced melanoma patients who received biochemotherapy. The combined effects of multiple genetic polymorphisms may provide more accurate prognostic information. Additional independent studies are needed to confirm these pilot findings.

35. Experiencing Futures as Apprentices in Denver.

Author: BOASBERG, TOM
Subjects: APPRENTICES, JUNIOR high schools
Abstract: the article focuses on high school student Juan Carlos applied for the Denver Public Schools apprenticeship program as a way to try out college courses while gaining work experience in advanced manufacturing. It mentions Employers participate for two primary reasons as they need to fill a position and apprentices are a cost-effective means to develop the talent in-house. It also mentions CareerResidency has helped to break down financial barriers.
Published: 2019

36. Experiencing Futures as Apprentices in Denver.

Author: BOASBERG, TOM
Subjects: APPRENTICESHIP programs, HIGH school seniors, VOCATIONAL guidance, WORK experience (Employment)
Abstract: The article discusses the apprenticeship programs in Denver Public Schools. The apprenticeship program provides an alternative path for non-college-going students to try out college courses and gain work experience at a metal-cutting company. It refers to the circumstances and challenges of the CareerResidency program, which include scheduling, commuting, and mindsets.
Published: 2018

37. Colon carcinoma and the cancer family syndrome.

Author: Arndt, R D, Kositchek, R J, and Boasberg, P D
Published: 1977
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38. Lymphocyte transfusion therapy for cancer patients [letter]

Author: Boasberg, PD, Tokita, KM, Terasaki, PI, and Wang, X
Published: 1996
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39. "Hired Gun".

Author: Boasberg, Tersh
Abstract: A letter to the editor discussing Ron Shibley in the article "The New Preservationists" that appeared in the May/June 1986 issue is presented.
Published: 1986

40. Estrogen-induced hypercalcemia.

Author: Boasberg, P
Published: 1973
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41. Tumor Mutational Burden Guides Therapy in a Treatment Refractory POLE- Mutant Uterine Carcinosarcoma.

Author: Bhangoo MS, Boasberg P, Mehta P, Elvin JA, Ali SM, Wu W, and Klempner SJ
Subjects: Carcinosarcoma pathology, Female, Humans, Mutation, Uterine Neoplasms pathology, Carcinosarcoma therapy, Tumor Burden genetics, Uterine Neoplasms therapy
Abstract: Gynecologic carcinosarcomas, previously known as malignant mixed Müllerian tumors, are uncommon malignancies that demonstrate an aggressive biology and lack a standard therapeutic approach. Molecular analyses have revealed recurrent alterations in chromatin remodeling genes, but clinical support for therapeutic significance is lacking. We prospectively identified a patient with refractory uterine carcinosarcoma whose tumor was subject to molecular profiling at diagnosis and again at radiographic progression. Initial molecular testing did not assess tumor mutational burden, DNA polymerase ɛ ( POLE ), or microsatellite status. After the failure of several lines of chemotherapy, comprehensive genomic profiling of a repeat biopsy identified two missense mutations of the exonuclease domain of POLE (P286R and T323A). Tumor mutational burden was elevated (169 mutations per DNA megabase), consistent with an ultramutator phenotype. As seen in previously reported POLE -endometrioid cases, our patient harbored alterations in PIK3CA , ARID1A , and PTEN and was microsatellite stable, with appreciable tumor-infiltrating lymphocytes. She achieved an ongoing durable response with pembrolizumab. This is the first report of programmed cell death protein 1 response in uterine carcinosarcoma., Key Points: Uterine carcinosarcoma is an uncommon and aggressive histologic variant of endometrial carcinoma with a poor prognosis.Inactivating DNA polymerase ɛ ( POLE ) mutations have been associated with high tumor mutational burden (TMB) and response to immune checkpoint inhibition.To the authors' knowledge, this is the first report of response to immune checkpoint inhibitor therapy in a patient with uterine carcinosarcoma.This case further supports expanding genomic profiling to include assessment of tumor mutational burden across tumor types, given the potential for immune checkpoint inhibitor therapy in TMB-high tumors., Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article., (© AlphaMed Press 2018.)
Published: 2018
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42. Clinical Remission of Cutaneous Squamous Cell Carcinoma of the Auricle with Cetuximab and Nivolumab.

Author: Chen A, Ali N, Boasberg P, and Ho AS
Abstract: Cutaneous squamous cell carcinomas (SCC) affecting the regions of the head and neck can be challenging to resect surgically and refractory to chemotherapy or radiation therapy. Consequently; the treatment of squamous cell carcinomas of the skin is a focus of current research. One such advancement is immunotherapy. Herein we describe clinical remission of invasive, poorly differentiated squamous cell carcinoma of the pre-auricular region with external auditory canal involvement using cetuximab, an epidermal growth factor receptor (EGFR) antibody; and nivolumab, a programmed death receptor-1 (PD-1) antibody. Such durable and comprehensive disease resolution demonstrates the therapeutic potential of cetuximab and nivolumab in surgically challenging, treatment-resistant cutaneous squamous cell carcinoma., Competing Interests: The authors declare no conflict of interest.
Published: 2018
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43. Combination of vemurafenib and cobimetinib in patients with advanced BRAF(V600)-mutated melanoma: a phase 1b study.

Author: Ribas A, Gonzalez R, Pavlick A, Hamid O, Gajewski TF, Daud A, Flaherty L, Logan T, Chmielowski B, Lewis K, Kee D, Boasberg P, Yin M, Chan I, Musib L, Choong N, Puzanov I, and McArthur GA
Subjects: Adult, Aged, Azetidines adverse effects, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Indoles adverse effects, Infusions, Intravenous, Male, Maximum Tolerated Dose, Melanoma genetics, Melanoma mortality, Melanoma pathology, Middle Aged, Mutation, Neoplasm Invasiveness pathology, Neoplasm Staging, Patient Selection, Piperidines adverse effects, Prospective Studies, Protein Kinase Inhibitors administration & dosage, Protein Kinase Inhibitors adverse effects, Proto-Oncogene Proteins B-raf genetics, Risk Assessment, Skin Neoplasms genetics, Skin Neoplasms mortality, Skin Neoplasms pathology, Sulfonamides adverse effects, Survival Rate, Treatment Outcome, Vemurafenib, Azetidines administration & dosage, Indoles administration & dosage, Melanoma drug therapy, Piperidines administration & dosage, Proto-Oncogene Proteins B-raf drug effects, Skin Neoplasms drug therapy, Sulfonamides administration & dosage
Abstract: Background: Addition of a MEK inhibitor to a BRAF inhibitor enhances tumour growth inhibition, delays acquired resistance, and abrogates paradoxical activation of the MAPK pathway in preclinical models of BRAF-mutated melanoma. We assessed the safety and efficacy of combined BRAF inhibition with vemurafenib and MEK inhibition with cobimetinib in patients with advanced BRAF-mutated melanoma., Methods: We undertook a phase 1b study in patients with advanced BRAF(V600)-mutated melanoma. We included individuals who had either recently progressed on vemurafenib or never received a BRAF inhibitor. In the dose-escalation phase of our study, patients received vemurafenib 720 mg or 960 mg twice a day continuously and cobimetinib 60 mg, 80 mg, or 100 mg once a day for either 14 days on and 14 days off (14/14), 21 days on and 7 days off (21/7), or continuously (28/0). The primary endpoint was safety of the drug combination and to identify dose-limiting toxic effects and the maximum tolerated dose. Efficacy was a key secondary endpoint. All patients treated with vemurafenib and cobimetinib were included in safety and efficacy analyses (intention-to-treat). The study completed accrual and all analyses are final. This study is registered with ClinicalTrials.gov, number NCT01271803., Findings: 129 patients were treated at ten dosing regimens combining vemurafenib and cobimetinib: 66 had recently progressed on vemurafenib and 63 had never received a BRAF inhibitor. Dose-limiting toxic effects arose in four patients. One patient on a schedule of vemurafenib 960 mg twice a day and cobimetinib 80 mg once a day 14/14 had grade 3 fatigue for more than 7 days; one patient on a schedule of vemurafenib 960 mg twice a day and cobimetinib 60 mg once a day 21/7 had a grade 3 prolongation of QTc; and two patients on a schedule of vemurafenib 960 mg twice a day and cobimetinib 60 mg 28/0 had dose-limiting toxic effects-one developed grade 3 stomatitis and fatigue and one developed arthralgia and myalgia. The maximum tolerated dose was established as vemurafenib 960 mg twice a day in combination with cobimetinib 60 mg 21/7. Across all dosing regimens, the most common adverse events were diarrhoea (83 patients, 64%), non-acneiform rash (77 patients, 60%), liver enzyme abnormalities (64 patients, 50%), fatigue (62 patients, 48%), nausea (58 patients, 45%), and photosensitivity (52 patients, 40%). Most adverse events were mild-to-moderate in severity. The most common grade 3 or 4 adverse events were cutaneous squamous-cell carcinoma (12 patients, 9%; all grade 3), raised amounts of alkaline phosphatase (11 patients, 9%]), and anaemia (nine patients, 7%). Confirmed objective responses were recorded in ten (15%) of 66 patients who had recently progressed on vemurafenib, with a median progression-free survival of 2·8 months (95% CI 2·6-3·4). Confirmed objective responses were noted in 55 (87%) of 63 patients who had never received a BRAF inhibitor, including six (10%) who had a complete response; median progression-free survival was 13·7 months (95% CI 10·1-17·5)., Interpretation: The combination of vemurafenib and cobimetinib was safe and tolerable when administered at the respective maximum tolerated doses. The combination has promising antitumour activity and further clinical development is warranted in patients with advanced BRAF(V600)-mutated melanoma, particularly in those who have never received a BRAF inhibitor; confirmatory clinical testing is ongoing., Funding: F Hoffmann-La Roche/Genentech., (Copyright © 2014 Elsevier Ltd. All rights reserved.)
Published: 2014
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44. Serial monitoring of circulating tumor cells predicts outcome of induction biochemotherapy plus maintenance biotherapy for metastatic melanoma.

Author: Koyanagi K, O'Day SJ, Boasberg P, Atkins MB, Wang HJ, Gonzalez R, Lewis K, Thompson JA, Anderson CM, Lutzky J, Amatruda TT, Hersh E, Richards J, Weber JS, and Hoon DS
Subjects: Adolescent, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biomarkers, Tumor metabolism, Clinical Trials, Phase II as Topic, Female, Humans, Male, Melanoma blood, Melanoma pathology, Middle Aged, Multicenter Studies as Topic, Prospective Studies, RNA, Messenger genetics, RNA, Messenger metabolism, Remission Induction, Reverse Transcriptase Polymerase Chain Reaction, Skin Neoplasms blood, Skin Neoplasms pathology, Survival Rate, Treatment Outcome, Young Adult, Biomarkers, Tumor genetics, Melanoma drug therapy, Neoplastic Cells, Circulating pathology, RNA, Neoplasm genetics, Skin Neoplasms drug therapy
Abstract: Purpose: Molecular biomarkers in blood are promising for assessment of tumor progression and treatment response. We hypothesized that serial monitoring of circulating tumor cells (CTC) with the use of multimarker quantitative real-time reverse transcriptase-PCR assays could be a surrogate predictor of outcome for melanoma patients enrolled in a multicenter phase II clinical trial of biochemotherapy (BCT) combined with maintenance biotherapy (mBT)., Experimental Design: Blood specimens were collected from 87 patients before and during induction BCT and mBT for stage IV melanoma. Expression of five melanoma-associated CTC biomarkers (MART-1, GalNAc-T, PAX-3, MAGE-A3, and Mitf) was assessed by quantitative real-time reverse transcriptase-PCR, and correlated with treatment response and disease outcome., Results: The number of positive CTC biomarkers decreased overall during induction BCT (P < 0.0001). CTC biomarker detection after two cycles of BCT was correlated with treatment response (P = 0.005) and overall survival (P = 0.001): an increase in the number of CTC biomarkers was associated with poor response (P = 0.006) and overall survival (P < 0.0001). Multivariate analyses with the use of a Cox proportional hazards model identified the change in CTC biomarkers after two cycles of BCT as an independent prognostic factor for disease progression (risk ratio, 12.6; 95% confidence interval, 4.78-33.4; P < 0.0001) and overall survival (risk ratio, 6.11; 95% confidence interval, 2.37-15.7; P = 0.0005)., Conclusion: Serial monitoring of CTC during induction BCT may be useful for predicting therapeutic efficacy and disease outcome in patients receiving BCT and mBT for stage IV melanoma.
Published: 2010
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45. Phase II multicenter trial of maintenance biotherapy after induction concurrent Biochemotherapy for patients with metastatic melanoma.

Author: O'Day SJ, Atkins MB, Boasberg P, Wang HJ, Thompson JA, Anderson CM, Gonzalez R, Lutzky J, Amatruda T, Hersh EM, and Weber JS
Subjects: Adolescent, Adult, Aged, Cisplatin administration & dosage, Dacarbazine administration & dosage, Disease-Free Survival, Drug Administration Schedule, Female, Granulocyte-Macrophage Colony-Stimulating Factor administration & dosage, Humans, Interleukin-2 administration & dosage, Male, Melanoma pathology, Melanoma secondary, Middle Aged, Neoplasm Metastasis, Remission Induction, Skin Neoplasms pathology, Skin Neoplasms secondary, Survival Analysis, Vinblastine administration & dosage, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Melanoma drug therapy, Skin Neoplasms drug therapy
Abstract: Purpose: Biochemotherapy improves responses in metastatic melanoma, but not overall survival, in randomized trials. We developed a maintenance biotherapy regimen after induction biochemotherapy in an attempt to improve durability of responses and overall survival., Patients and Methods: One hundred thirty-three chemotherapy-naïve patients with metastatic melanoma without CNS metastases were treated at 10 melanoma centers. The biochemotherapy induction regimen included cisplatin, vinblastine, dacarbazine, decrescendo interleukin-2 (IL-2), and interferon alfa-2b with granulocyte-macrophage colony-stimulating factor (GM-CSF) cytokine support. Patients not experiencing disease progression were eligible for maintenance biotherapy with low-dose IL-2 and GM-CSF followed by intermittent pulses of decrescendo IL-2 over 12 months. Patients were observed for response, progression-free survival, toxicity, and overall survival., Results: The response rate to induction biochemotherapy was 44% (95% CI, 35% to 52%; complete response, 8%; partial response, 36%; stable disease, 29%). The median number of biochemotherapy cycles was four, and the median number of maintenance biotherapy cycles was five. The median progression-free survival was 9 months, and the median survival was 13.5 months. The 12-month and 24-month survival rates were 57% and 23%, respectively. Twenty percent of patients remain alive (12 without disease), with median follow-up of 30 months (95% CI, 25+ to 45+ months). Thirty-nine percent of patients developed CNS metastases. The median times to CNS progression and death were 8 months and 5 months, respectively., Conclusion: Maintenance biotherapy after induction biochemotherapy seems to prolong progression-free survival and improve overall survival compared with recent multicenter trials of biochemotherapy or chemotherapy. The regimen should be studied in a randomized clinical trial in patients with advanced metastatic melanoma. CNS progression remains a formidable challenge.
Published: 2009
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46. Prognostic factors in metastatic melanoma patients treated with biochemotherapy and maintenance immunotherapy.

Author: Minor DR, Moore D, Kim C, Kashani-Sabet M, Venna SS, Wang W, Boasberg P, and O'Day S
Subjects: Adolescent, Adult, Aged, Analysis of Variance, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biomarkers, Tumor blood, Disease Progression, Disease-Free Survival, Female, Humans, Interleukin-2 therapeutic use, Male, Melanoma blood, Melanoma mortality, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Prognosis, Proportional Hazards Models, Retrospective Studies, Skin Neoplasms blood, Skin Neoplasms mortality, Survival Rate, Young Adult, Antineoplastic Agents administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Immunotherapy, L-Lactate Dehydrogenase blood, Melanoma therapy, Skin Neoplasms therapy
Abstract: Background: With no U.S. Food and Drug Administration-approved standard therapy other than high-dose interleukin-2 and dacarbazine for metastatic melanoma, biochemotherapy has shown promise, with long-term survival in selected patients. We felt that the study of prognostic factors would determine which patients might benefit from this intensive therapy., Methods: One hundred thirty-five consecutive patients with metastatic melanoma treated with decrescendo biochemotherapy followed by maintenance immunotherapy over 5 years were retrospectively studied to determine the most important prognostic factors for both overall survival and progression-free survival., Results: The median overall survival (OS) time was 16.6 months, with 1-year and 5-year survival rates of 70% and 28%, respectively. The median progression-free survival (PFS) time was 7.6 months, with 15% of patients progression free at 5 years. PFS curves showed no relapses after 30 months, so remissions were durable. For OS, a performance status score of zero, normal lactate dehydrogenase (LDH) level, stage M1a, and nonvisceral sites of metastasis were favorable factors. The group with normal LDH levels and skin or nodes as one of their metastatic sites had a relatively good prognosis, with median survival time of 44 months and an estimated 5-year survival rate of 38%. Conversely, patients with an elevated LDH level without any skin or nodal metastases had a poor prognosis, with no long-term survivors., Conclusions: Metastatic melanoma patients treated with biochemotherapy and maintenance immunotherapy who have either a normal LDH level or skin or nodes as one of their metastatic sites may have durable remissions of their disease, and this therapy should be studied further in these groups.
Published: 2009
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47. Management of metastatic melanoma 2005.

Author: O'Day S and Boasberg P
Subjects: Humans, Immunologic Factors therapeutic use, Melanoma pathology, Melanoma surgery, Neoplasm Metastasis immunology, Neoplasm Metastasis pathology, Neoplasm Staging, Skin Neoplasms pathology, Skin Neoplasms surgery, Antineoplastic Agents therapeutic use, Immunotherapy, Melanoma drug therapy, Neoplasm Metastasis drug therapy, Skin Neoplasms drug therapy
Abstract: The management of metastatic melanoma in 2005 remains a major clinical challenge. Multidisciplinary treatment planning and careful attention to sites of metastases, tumor biology, and comorbid conditions are critical to making the best clinical decisions for individual patients. No standard of care exists because no systemic therapies have yet shown efficacy in phase III trials. Single-agent or combination chemotherapy has not impacted over-all survival, and response rates are of short duration. High-dose IL-2 produces durable responses in a small subset (7%) of highly selected patients and has considerable toxicity and quality-of-life trade-offs. Biochemotherapy results in overall higher responses, but its impact on overall survival has been disappointing and its toxicity and expense are considerable. Re-searchers are further investigating biochemotherapy modifications with maintenance biotherapy and CNS consolidation in effort to increase durability of responses and prevent or delay the devastating sequela of CNS metastases. Despite a disappointing past, the advancement of science and a better understanding of critical cellular targets and pathways make the future of melanoma research encouraging. Clinical trials are actively studying novel immune potentiators, cytotoxics, and targeted therapies. Combinations of these new agents will likely be necessary to advance the treatment of the dis-ease. All patients should be encouraged to participate in clinical trials.
Published: 2006
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48. Impact of gene polymorphisms on clinical outcome for stage IV melanoma patients treated with biochemotherapy: an exploratory study.

Author: Liu D, O'Day SJ, Yang D, Boasberg P, Milford R, Kristedja T, Groshen S, and Weber J
Subjects: Adolescent, Adult, Aged, Cisplatin administration & dosage, DNA Helicases genetics, DNA-Binding Proteins genetics, Dacarbazine administration & dosage, Endonucleases genetics, Female, Gene Frequency, Genotype, Humans, Interferon-alpha administration & dosage, Interferon-gamma genetics, Interleukin-10 genetics, Interleukin-2 administration & dosage, Male, Melanoma drug therapy, Melanoma pathology, Middle Aged, Neoplasm Staging, Pilot Projects, Survival Analysis, Transcription Factors genetics, Treatment Outcome, Vinblastine administration & dosage, X-ray Repair Cross Complementing Protein 1, Xeroderma Pigmentosum Group D Protein, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Melanoma genetics, Polymorphism, Genetic
Abstract: Purpose: Biochemotherapy can achieve high response rates in advanced melanoma, but the factors that influence regression and survival remain unknown. The present exploratory study tested the hypothesis that cytokine gene polymorphisms predict clinical outcome in stage IV melanoma patients treated with biochemotherapy., Experimental Design: Ninety patients with stage IV melanoma were treated with biochemotherapy, including cisplatin, vinblastine, and dacarbazine combined with interleukin (IL)-2 and IFN-alpha either with or without tamoxifen. Cytokine gene polymorphisms for IFN-gamma (+874A-->T) and IL-10 (-1082G-->A) were assessed. X-ray repair cross-complementing gene 1 (XRCC1; Arg399Gln), xeroderma pigmentosum complementary group D (XPD; Lys751Gln), and excision repair cross-complementing gene 1 (ERCC1; codon 118) DNA repair polymorphisms were also determined., Results: IFN-gamma (+874A-->T) gene polymorphism was statistically significantly associated with response (P = 0.001), progression-free survival (P = 0.0012), and overall survival (P < 0.001), whereas the IL-10 polymorphism was marginally associated with response (P = 0.03) and overall survival (P = 0.065). Multivariate analysis revealed that IFN-gamma (+874A-->T) independently predicted overall survival (P = 0.003). The ERCC1 polymorphism was weakly associated with overall survival (P = 0.045). Combining polymorphisms for IFN-gamma, IL-10, and ERCC1 stratified patients into four distinct groups with significantly different clinical outcome (P < 0.001), so that patients with more "favorable" polymorphisms had a better outcome., Conclusions: Cytokine gene polymorphisms predicted clinical outcome for advanced melanoma patients who received biochemotherapy. The combined effects of multiple genetic polymorphisms may provide more accurate prognostic information. Additional independent studies are needed to confirm these pilot findings.
Published: 2005

49. Screening-detected breast cancer in a man with BRCA2 mutation: case report.

Author: Brenner RJ, Weitzel JN, Hansen N, and Boasberg P
Subjects: Aged, Biopsy, Needle, Breast pathology, Breast Neoplasms, Male diagnostic imaging, Breast Neoplasms, Male pathology, Breast Neoplasms, Male therapy, Carcinoma, Ductal, Breast diagnostic imaging, Carcinoma, Ductal, Breast pathology, Carcinoma, Ductal, Breast therapy, Carcinoma, Lobular diagnostic imaging, Carcinoma, Lobular pathology, Carcinoma, Lobular therapy, Follow-Up Studies, Humans, Male, Mastectomy, Neoplasm Staging, Neoplasms, Hormone-Dependent diagnostic imaging, Neoplasms, Hormone-Dependent genetics, Neoplasms, Hormone-Dependent pathology, Neoplasms, Hormone-Dependent therapy, Neoplasms, Multiple Primary diagnostic imaging, Neoplasms, Multiple Primary pathology, Neoplasms, Multiple Primary therapy, Radiography, Receptors, Estrogen analysis, Receptors, Progesterone analysis, Reoperation, Sentinel Lymph Node Biopsy, BRCA2 Protein genetics, Breast Neoplasms, Male genetics, Carcinoma, Ductal, Breast genetics, Carcinoma, Lobular genetics, Germ-Line Mutation, Mass Screening, Neoplasms, Multiple Primary genetics
Abstract: Current indications for breast cancer screening in the male population are lacking, although family history of breast cancer may be such an indication. The authors describe a man with a history of clinically diagnosed right breast cancer who subsequently tested positive for the breast cancer susceptibility gene BRCA2 and received a diagnosis of mammographically detected left breast cancer at screening. The authors discuss the clinical implications of this approach to detecting male breast cancer., (Copyright RSNA, 2004)
Published: 2004
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50. Advantages of concurrent biochemotherapy modified by decrescendo interleukin-2, granulocyte colony-stimulating factor, and tamoxifen for patients with metastatic melanoma.

Author: O'Day SJ, Gammon G, Boasberg PD, Martin MA, Kristedja TS, Guo M, Stern S, Edwards S, Fournier P, Weisberg M, Cannon M, Fawzy NW, Johnson TD, Essner R, Foshag LJ, and Morton DL
Subjects: Adult, Aged, Cisplatin administration & dosage, Cisplatin adverse effects, Dacarbazine administration & dosage, Dacarbazine adverse effects, Disease-Free Survival, Drug Therapy, Combination, Female, Granulocyte Colony-Stimulating Factor adverse effects, Humans, Interleukin-2 adverse effects, Male, Melanoma pathology, Middle Aged, Pilot Projects, Skin Diseases chemically induced, Skin Neoplasms pathology, Tamoxifen administration & dosage, Tamoxifen adverse effects, Vinblastine administration & dosage, Vinblastine adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Granulocyte Colony-Stimulating Factor administration & dosage, Interleukin-2 administration & dosage, Melanoma drug therapy, Skin Neoplasms drug therapy
Abstract: Purpose: Concurrent biochemotherapy results in high response rates but also significant toxicity in patients with metastatic melanoma. We attempted to improve its efficacy and decrease its toxicity by using decrescendo dosing of interleukin-2 (IL-2), posttreatment granulocyte colony-stimulating factor (G-CSF), and low-dose tamoxifen., Patients and Methods: Forty-five patients with poor prognosis metastatic melanoma were treated at a community hospital inpatient oncology unit affiliated with the John Wayne Cancer Institute (Santa Monica, CA) between July 1995 and September 1997. A 5-day modified concurrent biochemotherapy regimen of dacarbazine, vinblastine, cisplatin, decrescendo IL-2, interferon alfa-2b, and tamoxifen was repeated at 21-day intervals. G-CSF was administered beginning on day 6 for 7 to 10 days., Results: The overall response rate was 57% (95% confidence interval, 42% to 72%), the complete response rate was 23%, and the partial response rate was 34%. Complete remissions were achieved in an additional 11% of patients by surgical resection of residual disease after biochemotherapy. The median time to progression was 6.3 months and the median duration of survival was 11.4 months. At a maximum follow-up of 36 months (range, 10 to 36 months), 32% of patients are alive and 14% remain free of disease. Decrescendo IL-2 dosing and administration of G-CSF seemed to reduce toxicity, length of hospital stay, and readmission rates. No patient required intensive care unit monitoring, and there were no treatment-related deaths., Conclusion: The data from this study indicate that the modified concurrent biochemotherapy regimen reduces the toxicity of concurrent biochemotherapy with no apparent decrease in response rate in patients with poor prognosis metastatic melanoma.
Published: 1999
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