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2. Gut microbiota signatures are associated with toxicity to combined CTLA-4 and PD-1 blockade

Author

Andrews, Miles C., Duong, Connie P. M., Gopalakrishnan, Vancheswaran, Iebba, Valerio, Chen, Wei-Shen, Derosa, Lisa, Khan, Md Abdul Wadud, Cogdill, Alexandria P., White, Michael G., Wong, Matthew C., Ferrere, Gladys, Fluckiger, Aurélie, Roberti, Maria P., Opolon, Paule, Alou, Maryam Tidjani, Yonekura, Satoru, Roh, Whijae, Spencer, Christine N., Curbelo, Irina Fernandez, Vence, Luis, Reuben, Alexandre, Johnson, Sarah, Arora, Reetakshi, Morad, Golnaz, Lastrapes, Matthew, Baruch, Erez N., Little, Latasha, Gumbs, Curtis, Cooper, Zachary A., Prieto, Peter A., Wani, Khalida, Lazar, Alexander J., Tetzlaff, Michael T., Hudgens, Courtney W., Callahan, Margaret K., Adamow, Matthew, Postow, Michael A., Ariyan, Charlotte E., Gaudreau, Pierre-Olivier, Nezi, Luigi, Raoult, Didier, Mihalcioiu, Catalin, Elkrief, Arielle, Pezo, Rossanna C., Haydu, Lauren E., Simon, Julie M., Tawbi, Hussein A., McQuade, Jennifer, Hwu, Patrick, Hwu, Wen-Jen, Amaria, Rodabe N., Burton, Elizabeth M., Woodman, Scott E., Watowich, Stephanie, Diab, Adi, Patel, Sapna P., Glitza, Isabella C., Wong, Michael K., Zhao, Li, Zhang, Jianhua, Ajami, Nadim J., Petrosino, Joseph, Jenq, Robert R., Davies, Michael A., Gershenwald, Jeffrey E., Futreal, P. Andrew, Sharma, Padmanee, Allison, James P., Routy, Bertrand, Zitvogel, Laurence, and Wargo, Jennifer A.

Published
2021
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4. Long-term safety of pembrolizumab monotherapy and relationship with clinical outcome: A landmark analysis in patients with advanced melanoma

Author

Robert, Caroline, Hwu, Wen-Jen, Hamid, Omid, Ribas, Antoni, Weber, Jeffrey S., Daud, Adil I., Hodi, F. Stephen, Wolchok, Jedd D., Mitchell, Tara C., Hersey, Peter, Dronca, Roxana, Joseph, Richard W., Boutros, Celine, Min, Le, Long, Georgina V., Schachter, Jacob, Puzanov, Igor, Dummer, Reinhard, Lin, Jianxin, Ibrahim, Nageatte, Diede, Scott J., Carlino, Matteo S., and Joshua, Anthony M.

Published
2021
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5. Telomerase Reverse Transcriptase Protein Expression Is More Frequent in Acral Lentiginous Melanoma Than in Other Types of Cutaneous Melanoma

Author

Cho, Woo Cheal, Wang, Wei-Lien, Milton, Denai R., Ingram, Davis R., Nagarajan, Priyadharsini, Curry, Jonathan L., Ivan, Doina, Lazar, Alexander J., Hwu, Wen-Jen, Prieto, Victor G., Torres-Cabala, Carlos A., and Aung, Phyu P.

Subjects
Oncology, Experimental, Gene mutations -- Research, Gene expression -- Research, Promoters (Genetics) -- Structure -- Health aspects, Telomerase -- Structure -- Health aspects, Cancer -- Research, Melanoma -- Diagnosis -- Genetic aspects, Health
Abstract

* Context.--Molecularly distinct from cutaneous melanomas arising from sun-exposed sites, acral lentiginous melanomas (ALMs) typically lack ultraviolet-signature mutations, such as telomerase reverse transcriptase (TERT) promoter mutations. Instead, ALMs show a high degree of copy number alterations, often with multiple amplifications of TERT, which are associated with adverse prognosis. The prognostic value of TERT protein expression in acral melanomas, however, is not established. Objective.--To evaluate the frequency and pattern of TERT immunoreactivity and assess the potential utility of TERT expression as a prognostic indicator in ALMs. Design.--TERT expression by immunohistochemistry was analyzed in a series of 57 acral and nonacral melanocytic lesions, including 24 primary and 6 metastatic ALMs. Clinical outcome in patients with ALMs by TERT expression was assessed. Results.--TERT expression was more frequent in ALMs than in nonlentiginous acral melanomas and nonacral cutaneous melanomas, and was absent in acral nevi (P =.01). When present, TERT expression in ALMs was cytoplasmic and more intense than TERT expression in other melanocytic lesions (P =.05) with a higher H-score (P =.01). There was a trend toward decreased overall survival in patients with ALMs with TERT immunoreactivity, but it did not reach statistical significance. Furthermore, no correlation was found between TERT expression and disease-specific survival in patients with ALMs. Conclusions.--Although TERT protein expression was frequently detected in both primary and metastatic ALMs, TERT immunoreactivity in ALMs did not correlate with survival in our study. Further studies with larger cohorts are needed to elucidate the prognostic value of TERT expression in ALMs. (Arch Pathol Lab Med. 2021;145:842-850; doi: 10.5858/arpa.2020-0330-OA), Telomeres are regions of repetitive nucleotide sequences located at the ends of chromosomes that play a key role in the maintenance of genomic integrity and stability in cells. (1) In [...]

Published
2021
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9. Neoadjuvant plus adjuvant dabrafenib and trametinib versus standard of care in patients with high-risk, surgically resectable melanoma: a single-centre, open-label, randomised, phase 2 trial

Author

Amaria, Rodabe N, Prieto, Peter A, Tetzlaff, Michael T, Reuben, Alexandre, Andrews, Miles C, Ross, Merrick I, Glitza, Isabella C, Cormier, Janice, Hwu, Wen-Jen, Tawbi, Hussein A, Patel, Sapna P, Lee, Jeffrey E, Gershenwald, Jeffrey E, Spencer, Christine N, Gopalakrishnan, Vancheswaran, Bassett, Roland, Simpson, Lauren, Mouton, Rosalind, Hudgens, Courtney W, Zhao, Li, Zhu, Haifeng, Cooper, Zachary A, Wani, Khalida, Lazar, Alexander, Hwu, Patrick, Diab, Adi, Wong, Michael K, McQuade, Jennifer L, Royal, Richard, Lucci, Anthony, Burton, Elizabeth M, Reddy, Sangeetha, Sharma, Padmanee, Allison, James, Futreal, Phillip A, Woodman, Scott E, Davies, Michael A, and Wargo, Jennifer A

Published
2018
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12. Tumor and Microenvironment Evolution during Immunotherapy with Nivolumab

Author

Riaz, Nadeem, Havel, Jonathan J., Makarov, Vladimir, Desrichard, Alexis, Urba, Walter J., Sims, Jennifer S., Hodi, F. Stephen, Martín-Algarra, Salvador, Mandal, Rajarsi, Sharfman, William H., Bhatia, Shailender, Hwu, Wen-Jen, Gajewski, Thomas F., Slingluff, Craig L., Jr., Chowell, Diego, Kendall, Sviatoslav M., Chang, Han, Shah, Rachna, Kuo, Fengshen, Morris, Luc G.T., Sidhom, John-William, Schneck, Jonathan P., Horak, Christine E., Weinhold, Nils, and Chan, Timothy A.

Published
2017
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13. Standard-dose pembrolizumab in combination with reduced-dose ipilimumab for patients with advanced melanoma (KEYNOTE-029): an open-label, phase 1b trial

Author

Long, Georgina V, Atkinson, Victoria, Cebon, Jonathan S, Jameson, Michael B, Fitzharris, Bernie M, McNeil, Catriona M, Hill, Andrew G, Ribas, Antoni, Atkins, Michael B, Thompson, John A, Hwu, Wen-Jen, Hodi, F Stephen, Menzies, Alexander M, Guminski, Alexander D, Kefford, Richard, Kong, Benjamin Y, Tamjid, Babak, Srivastava, Archana, Lomax, Anna J, Islam, Mohammed, Shu, Xinxin, Ebbinghaus, Scot, Ibrahim, Nageatte, and Carlino, Matteo S

Published
2017
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14. Spatially resolved analyses link genomic and immune diversity and reveal unfavorable neutrophil activation in melanoma

Author

Mitra, Akash, Andrews, Miles C., Roh, Whijae, De Macedo, Marianna Petaccia, Hudgens, Courtney W., Carapeto, Fernando, Singh, Shailbala, Reuben, Alexandre, Wang, Feng, Mao, Xizeng, Song, Xingzhi, Wani, Khalida, Tippen, Samantha, Ng, Kwok-Shing, Schalck, Aislyn, Sakellariou-Thompson, Donald A., Chen, Eveline, Reddy, Sangeetha M., Spencer, Christine N., Wiesnoski, Diana, Little, Latasha D., Gumbs, Curtis, Cooper, Zachary A., Burton, Elizabeth M., Hwu, Patrick, Davies, Michael A., Zhang, Jianhua, Bernatchez, Chantale, Navin, Nicholas, Sharma, Padmanee, Allison, James P., Wargo, Jennifer A., Yee, Cassian, Tetzlaff, Michael T., Hwu, Wen-Jen, Lazar, Alexander J., and Futreal, P. Andrew

Published
2020
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15. Neoadjuvant immune checkpoint blockade in high-risk resectable melanoma

Author

Amaria, Rodabe N., Reddy, Sangeetha M., Tawbi, Hussein A., Davies, Michael A., Ross, Merrick I., Glitza, Isabella C., Cormier, Janice N., Lewis, Carol, Hwu, Wen-Jen, Hanna, Ehab, Diab, Adi, Wong, Michael K., Royal, Richard, Gross, Neil, Weber, Randal, Lai, Stephen Y., Ehlers, Richard, Blando, Jorge, Milton, Denái R., Woodman, Scott, Kageyama, Robin, Wells, Daniel K., Hwu, Patrick, Patel, Sapna P., Lucci, Anthony, Hessel, Amy, Lee, Jeffrey E., Gershenwald, Jeffrey, Simpson, Lauren, Burton, Elizabeth M., Posada, Liberty, Haydu, Lauren, Wang, Linghua, Zhang, Shaojun, Lazar, Alexander J., Hudgens, Courtney W., Gopalakrishnan, Vancheswaran, Reuben, Alexandre, Andrews, Miles C., Spencer, Christine N., Prieto, Victor, Sharma, Padmanee, Allison, James, Tetzlaff, Michael T., and Wargo, Jennifer A.

Published
2018
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17. Utility of BRAF V600E Immunohistochemistry Expression Pattern as a Surrogate of BRAF Mutation Status in 154 Patients with Advanced Melanoma

Author

Tetzlaff, Michael T., Pattanaprichakul, Penvadee, Wargo, Jennifer, Fox, Patricia S., Patel, Keyur P., Estrella, Jeannelyn S., Broaddus, Russell R., Williams, Michelle D., Davies, Michael A., Routbort, Mark J., Lazar, Alexander J., Woodman, Scott E., Hwu, Wen-Jen, Gershenwald, Jeffrey E., Prieto, Victor G., Torres-Cabala, Carlos A., and Curry, Jonathan L.

Published
2015
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19. 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

Published
2014
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20. Integrated molecular analysis of tumor biopsies on sequential CTLA-4 and PD-1 blockade reveals markers of response and resistance

Author

Roh, Whijae, Chen, Pei-Ling, Reuben, Alexandre, Spencer, Christine N., Prieto, Peter A., Miller, John P., Gopalakrishnan, Vancheswaran, Wang, Feng, Cooper, Zachary A., Reddy, Sangeetha M., Gumbs, Curtis, Little, Latasha, Chang, Qing, Chen, Wei-Shen, Wani, Khalida, De Macedo, Mariana Petaccia, Chen, Eveline, Austin-Breneman, Jacob L., Jiang, Hong, Roszik, Jason, Tetzlaff, Michael T., Davies, Michael A., Gershenwald, Jeffrey E., Tawbi, Hussein, Lazar, Alexander J., Hwu, Patrick, Hwu, Wen-Jen, Diab, Adi, Glitza, Isabella C., Patel, Sapna P., Woodman, Scott E., Amaria, Rodabe N., Prieto, Victor G., Hu, Jianhua, Sharma, Padmanee, Allison, James P., Chin, Lynda, Zhang, Jianhua, Wargo, Jennifer A., and Futreal, P. Andrew

Published
2017
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24. Infliximab associated with faster symptom resolution compared with corticosteroids alone for the management of immune-related enterocolitis

Author

Johnson, Daniel H, Zobniw, Chrystia M, Trinh, Van A, Ma, Junsheng, Bassett, Jr, Roland L, Abdel-Wahab, Noha, Anderson, Jaime, Davis, Jennifer E, Joseph, Jocelyn, Uemura, Marc, Noman, Ali, Abu-Sbeih, Hamzah, Yee, Cassian, Amaria, Rodabe, Patel, Sapna, Tawbi, Hussein, Glitza, Isabella C, Davies, Michael A, Wong, Michael K, Woodman, Scott, Hwu, Wen-Jen, Hwu, Patrick, Wang, Yinghong, and Diab, Adi

Published
2018
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28. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: Final results of a randomised phase III study (EORTC 18032)

Author

Patel, Poulam M., Suciu, Stefan, Mortier, Laurent, Kruit, Wim H., Robert, Caroline, Schadendorf, Dirk, Trefzer, Uwe, Punt, Cornelis J.A., Dummer, Reinhard, Davidson, Neville, Becker, Juergen, Conry, Robert, Thompson, John A., Hwu, Wen-Jen, Engelen, Kristel, Agarwala, Sanjiv S., Keilholz, Ulrich, Eggermont, Alexander M.M., and Spatz, Alain

Published
2011
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32. High response rate to PD-1 blockade in desmoplastic melanomas

Author

Eroglu, Zeynep, Zaretsky, Jesse M., Hu-Lieskovan, Siwen, Kim, Dae Won, Algazi, Alain, Johnson, Douglas B., Liniker, Elizabeth, Ben Kong, Munhoz, Rodrigo, Rapisuwon, Suthee, Gherardini, Pier Federico, Chmielowski, Bartosz, Wang, Xiaoyan, Shintaku, I. Peter, Wei, Cody, Sosman, Jeffrey A., Joseph, Richard W., Postow, Michael A., Carlino, Matteo S., Hwu, Wen-Jen, Scolyer, Richard A., Messina, Jane, Cochran, Alistair J., Long, Georgina V., and Ribas, Antoni

Subjects
Melanoma -- Physiological aspects, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Author(s): Zeynep Eroglu [1, 2]; Jesse M. Zaretsky [1]; Siwen Hu-Lieskovan (corresponding author) [1]; Dae Won Kim [2, 3]; Alain Algazi [4]; Douglas B. Johnson [5]; Elizabeth Liniker [6]; Ben [...]

Published
2018
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33. 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

Published
2013
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35. Safety and Activity of Anti–PD-L1 Antibody in Patients with Advanced Cancer

Author

Brahmer, Julie R., Tykodi, Scott S., Chow, Laura Q.M., Hwu, Wen-Jen, Topalian, Suzanne L., Hwu, Patrick, Drake, Charles G., Camacho, Luis H., Kauh, John, Odunsi, Kunle, Pitot, Henry C., Hamid, Omid, Bhatia, Shailender, Martins, Renato, Eaton, Keith, Chen, Shuming, Salay, Theresa M., Alaparthy, Suresh, Grosso, Joseph F., Korman, Alan J., Parker, Susan M., Agrawal, Shruti, Goldberg, Stacie M., Pardoll, Drew M., Gupta, Ashok, and Wigginton, Jon M.

Published
2012
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45. Incidence, patterns of progression, and outcomes of preexisting and newly discovered brain metastases during treatment with anti-PD-1 in patients with metastatic melanoma.

Author

Schvartsman, Gustavo, Ma, Junsheng, Bassett, Roland L., Haydu, Lauren E., Amaria, Rodabe Navroze, Hwu, Patrick, Wong, Michael K., Hwu, Wen‐Jen, Diab, Adi, Patel, Sapna Pradyuman, Davies, Michael A., Hamerschlak, Nelson, Tawbi, Hussein Abdul‐Hassan, Glitza Oliva, Isabella C., Bassett, Roland L Jr, Hwu, Wen-Jen, and Tawbi, Hussein Abdul-Hassan

Subjects
BRAIN metastasis, CENTRAL nervous system diseases, STEREOTACTIC radiosurgery, BRAIN tumors, IMMUNOTHERAPY, MELANOMA, METASTASIS, TREATMENT effectiveness, DISEASE incidence, DISEASE progression, DISEASE complications
Abstract

Background: Melanoma brain metastases (MBM) occur in up to 50% of patients with metastatic melanoma (MM) and represent a frequent site of systemic treatment failure for targeted therapies. However, to the authors' knowledge, little is known regarding the incidence, patterns of disease progression, and outcomes of MBM in patients treated with anti-PD-1 immunotherapy.Methods: A total of 320 patients with MM who were treated with anti-PD-1 at The University of Texas MD Anderson Cancer Center in Houston were reviewed. Analyses were performed to identify factors associated with brain metastasis-free survival and overall survival (OS) using Cox regression models.Results: The median age of the patients was 63.3 years. OS from the initiation of anti-PD-1 therapy was not significantly different between patients without MBM prior to anti-PD-1 compared with patients with prior MBM (P = .359). Among patients without prior MBM, 21 patients (8.6%) developed MBM during anti-PD-1 therapy, 12 of whom (4.9%) presented with disease progression in the central nervous system (CNS) only. Developing MBM during or after therapy with anti-PD-1 (hazard ratio, 4.70; 95% CI, 3.18-6.93) was associated with shorter OS. Among patients with MBM prior to anti-PD-1 treatment, 15 (20.0%) progressed in the CNS only and 19 (25.3%) progressed both intracranially and extracranially; at the time of the last data cutoff, 27 patients (36.0%) had not developed disease progression. Radiation necrosis occurred in 11.3% of patients (7 of 62 patients) in the group with a prior MBM who received stereotactic radiosurgery.Conclusions: Anti-PD-1 therapy may change the natural history of patients with preexisting MBM. However, CNS failure during treatment with anti-PD-1 is predictive of a worse prognosis compared with extracranial progression. The results of the current study support the activity of anti-PD-1 in patients with MBM, although routine CNS imaging during therapy is warranted. [ABSTRACT FROM AUTHOR]

Published
2019
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49. Phase 1 study of the combination of vemurafenib, carboplatin, and paclitaxel in patients with BRAF-mutated melanoma and other advanced malignancies.

Author

Bhatty, Minny, Kato, Shumei, Piha‐Paul, Sarina A., Naing, Aung, Subbiah, Vivek, Huang, Helen J., Karp, Daniel D., Tsimberidou, Apostolia M., Zinner, Ralph G., Hwu, Wen‐Jen, Javle, Milind, Patel, Sapna P., Hu, Mimi I., Varadhachary, Gauri R., Conley, Anthony P., Ramzanali, Nishma M., Holley, Veronica R., Kurzrock, Razelle, Meric‐Bernstam, Funda, and Kwang Chae, Young

Subjects
MELANOMA treatment, CARBOPLATIN, PACLITAXEL, ANTINEOPLASTIC agents, SKIN cancer
Abstract

Background: BRAF inhibitors are effective against selected BRAFV600 -mutated tumors. Preclinical data suggest that BRAF inhibition in conjunction with chemotherapy has increased therapeutic activity.Methods: Patients with advanced cancers and BRAF mutations were enrolled into a dose-escalation study (3+3 design) to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs).Results: Nineteen patients with advanced cancers and BRAF mutations were enrolled and received vemurafenib (480-720 mg orally twice a day), carboplatin (area under the curve [AUC] 5-6 intravenously every 3 weeks), and paclitaxel (100-135 mg/m2 intravenously every 3 weeks). The MTD was not reached, and vemurafenib at 720 mg twice a day, carboplatin at AUC 5, and paclitaxel at 135 mg/m2 were the last safe dose levels. DLTs included a persistent grade 2 creatinine elevation (n = 1), grade 3 transaminitis (n = 1), and grade 4 thrombocytopenia (n = 1). Non-dose-limiting toxicities that were grade 3 or higher and occurred in more than 2 patients included grade 3/4 neutropenia (n = 5), grade 3/4 thrombocytopenia (n = 5), grade 3 fatigue (n = 4), and grade 3 anemia (n = 3). Of the 19 patients, 5 (26%; all with melanoma) had a partial response (PR; n = 4) or complete response (CR; n = 1); these responses were mostly durable and lasted 3.1 to 54.1 months. Of the 13 patients previously treated with BRAF and/or mitogen-activated protein kinase kinase (MEK) inhibitors, 4 (31%) had a CR (n = 1) or PR (n = 3). Patients not treated with prior platinum therapy had a higher response rate than those who did (45% vs 0%; P = .045).Conclusions: The combination of vemurafenib, carboplatin, and paclitaxel is well tolerated and demonstrates encouraging activity, predominantly in patients with advanced melanoma and BRAFV600 mutations, regardless of prior treatment with BRAF and/or MEK inhibitors. [ABSTRACT FROM AUTHOR]

Published
2019
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