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1. Safety and efficacy of talacotuzumab plus decitabine or decitabine alone in patients with acute myeloid leukemia not eligible for chemotherapy: results from a multicenter, randomized, phase 2/3 study

Author

Montesinos, Pau, Roboz, Gail J., Bulabois, Claude-Eric, Subklewe, Marion, Platzbecker, Uwe, Ofran, Yishai, Papayannidis, Cristina, Wierzbowska, Agnieszka, Shin, Ho Jin, Doronin, Vadim, Deneberg, Stefan, Yeh, Su-Peng, Ozcan, Mehmet Ali, Knapper, Steven, Cortes, Jorge, Pollyea, Daniel A., Ossenkoppele, Gert, Giralt, Sergio, Döhner, Hartmut, Heuser, Michael, Xiu, Liang, Singh, Indrajeet, Huang, Fei, Larsen, Julie S., and Wei, Andrew H.

Published
2021
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2. Prostate-specific antigen (PSA) decline with apalutamide therapy is associated with longer survival and improved outcomes in individuals with metastatic prostate cancer: a plain language summary of the TITAN study

Author

Chowdhury, Simon, primary, Bjartell, Anders, additional, Agarwal, Neeraj, additional, Chung, Byung H, additional, Given, Robert W, additional, Pereira de Santana Gomes, Andrea J, additional, Merseburger, Axel S, additional, Özgüroğlu, Mustafa, additional, Soto, Álvaro Juárez, additional, Uemura, Hirotsugu, additional, Ye, Ding-Wei, additional, Brookman-May, Sabine D, additional, Londhe, Anil, additional, Bhaumik, Amitabha, additional, Mundle, Suneel D, additional, Larsen, Julie S, additional, McCarthy, Sharon A, additional, and Chi, Kim N, additional

Published
2023
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3. PD34-11 PROSTATE-SPECIFIC ANTIGEN KINETICS IN PATIENTS WITH ADVANCED PROSTATE CANCER TREATED WITH APALUTAMIDE: RESULTS FROM THE TITAN AND SPARTAN STUDIES

Author

Chi, Kim N., primary, Saad, Fred, additional, Chowdhury, Simon, additional, Graff, Julie N., additional, Agarwal, Neeraj, additional, Oudard, Stéphane, additional, Li, Gang, additional, Lopez-Gitlitz, Angela, additional, Larsen, Julie S., additional, McCarthy, Sharon A., additional, Mundle, Suneel D., additional, Smith, Matthew R., additional, and Small, Eric J., additional

Published
2021
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4. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study

Author

Chi, Kim N., primary, Chowdhury, Simon, additional, Bjartell, Anders, additional, Chung, Byung Ha, additional, Pereira de Santana Gomes, Andrea J., additional, Given, Robert, additional, Juárez, Alvaro, additional, Merseburger, Axel S., additional, Özgüroğlu, Mustafa, additional, Uemura, Hirotsugu, additional, Ye, Dingwei, additional, Brookman-May, Sabine, additional, Mundle, Suneel D., additional, McCarthy, Sharon A., additional, Larsen, Julie S., additional, Sun, Weili, additional, Bevans, Katherine B., additional, Zhang, Ke, additional, Bandyopadhyay, Nibedita, additional, and Agarwal, Neeraj, additional

Published
2021
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5. Apalutamide for metastatic, castration‐sensitive prostate cancer in the Japanese population: A subgroup analysis of the randomized, double‐blind, placebo‐controlled phase 3 TITAN study

Author

Uemura, Hirotsugu, primary, Arai, Gaku, additional, Uemura, Hiroji, additional, Suzuki, Hiroyoshi, additional, Iijima, Kazuyoshi, additional, Nishimura, Kazuo, additional, Fujii, Koji, additional, Hatayama, Tomoyoshi, additional, Aoyama, Junya, additional, Deprince, Kris, additional, Lopez‐Gitlitz, Angela, additional, McCarthy, Sharon, additional, Larsen, Julie S, additional, Li, Jinhui, additional, and Chi, Kim N, additional

Published
2020
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6. Abstract 776: Androgen receptor (AR) and non-AR aberrations associated with outcomes in metastatic castration-sensitive prostate cancer (mCSPC) treated with apalutamide (APA) plus androgen deprivation therapy (ADT) in TITAN

Author

Chi, Kim N., primary, Thomas, Shibu, additional, Gormley, Michael, additional, Shen, Dong, additional, Agarwal, Neeraj, additional, Feng, Felix, additional, Attard, Gerhardt, additional, Wyatt, Alex, additional, Ricci, Deborah S., additional, Lopez-Gitlitz, Angela, additional, Larsen, Julie S., additional, Miladinovic, Branko, additional, and Chowdhury, Simon, additional

Published
2020
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7. Molecular determinants of outcome for metastatic castration-sensitive prostate cancer (mCSPC) with addition of apalutamide (APA) or placebo (PBO) to androgen deprivation therapy (ADT) in TITAN.

Author

Feng, Felix Y, primary, Thomas, Shibu, additional, Aguilar-Bonavides, Clemente, additional, Gormley, Michael, additional, Agarwal, Neeraj, additional, Attard, Gerhardt, additional, Wyatt, Alexander William, additional, Davicioni, Elai, additional, Ricci, Deborah S., additional, Lopez-Gitlitz, Angela, additional, Larsen, Julie S., additional, Chowdhury, Simon, additional, and Chi, Kim N., additional

Published
2020
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8. Prostate-specific antigen (PSA) kinetics in patients (pts) with advanced prostate cancer treated with apalutamide: Results from the TITAN and SPARTAN studies.

Author

Chi, Kim N., primary, Saad, Fred, additional, Chowdhury, Simon, additional, Graff, Julie N, additional, Agarwal, Neeraj, additional, Oudard, Stephane, additional, Li, Gang, additional, Lopez-Gitlitz, Angela, additional, Larsen, Julie S., additional, McCarthy, Sharon Anne, additional, Mundle, Suneel, additional, Smith, Matthew Raymond, additional, and Small, Eric Jay, additional

Published
2020
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9. PD10-11 APALUTAMIDE FOR METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER IN TITAN: PROGNOSTIC IMPORTANCE OF PROSTATE-SPECIFIC ANTIGEN RESPONSES

Author

Chowdhury*, Simon, primary, Bjartell, Anders, additional, Agarwal, Neeraj, additional, Chung, Byung Ha, additional, Given, Robert W., additional, Pereira de Santana Gomes, Andrea J., additional, Merseburger, Axel S., additional, Özgüroğlu, Mustafa, additional, Juárez Soto, Alvaro, additional, Uemura, Hirotsugu, additional, Ye, Dingwei, additional, Lopez-Gitlitz, Angela, additional, Londhe, Anil, additional, Mundle, Suneel, additional, Larsen, Julie S., additional, McCarthy, Sharon, additional, and Chi, Kim N., additional

Published
2020
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10. Safety and efficacy of talacotuzumab plus decitabine or decitabine alone in patients with acute myeloid leukemia not eligible for chemotherapy: results from a multicenter, randomized, phase 2/3 study

Author

Montesinos, Pau, primary, Roboz, Gail J., additional, Bulabois, Claude-Eric, additional, Subklewe, Marion, additional, Platzbecker, Uwe, additional, Ofran, Yishai, additional, Papayannidis, Cristina, additional, Wierzbowska, Agnieszka, additional, Shin, Ho Jin, additional, Doronin, Vadim, additional, Deneberg, Stefan, additional, Yeh, Su-Peng, additional, Ozcan, Mehmet Ali, additional, Knapper, Steven, additional, Cortes, Jorge, additional, Pollyea, Daniel A., additional, Ossenkoppele, Gert, additional, Giralt, Sergio, additional, Döhner, Hartmut, additional, Heuser, Michael, additional, Xiu, Liang, additional, Singh, Indrajeet, additional, Huang, Fei, additional, Larsen, Julie S., additional, and Wei, Andrew H., additional

Published
2020
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11. Apalutamide (APA) for metastatic castration-sensitive prostate cancer (mCSPC) in TITAN: Outcomes in patients (pts) with low- and high-risk disease.

Author

Ozguroglu, Mustafa, primary, Chowdhury, Simon, additional, Bjartell, Anders, additional, Uemura, Hirotsugu, additional, Chung, Byung Ha, additional, Agarwal, Neeraj, additional, Merseburger, Axel Stuart, additional, Juárez Soto, Álvaro, additional, Lopez-Gitlitz, Angela, additional, Bhaumik, Amitabha, additional, Larsen, Julie S., additional, McCarthy, Sharon Anne, additional, and Chi, Kim N., additional

Published
2020
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12. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer

Author

Chi, Kim N, Agarwal, Neeraj, Bjartell, Anders, Chung, Byung Ha, Pereira de Santana Gomes, Andrea J, Given, Robert, Juárez Soto, Álvaro, Merseburger, Axel S, Özgüroğlu, Mustafa, Uemura, Hirotsugu, Dingwei, Ye, Deprince, Kris, Naini, Vahid, Jinhui, Li, Cheng, Shinta, Margaret K, Yu, Zhang, Ke, Larsen, Julie S, Mccarthy, Sharon, Chowdhury, Simon, Titan, Investigators, Sciarra, Alessandro, and İÜC, Cerrahpaşa Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Urology, Kaplan-Meier Estimate, Adenocarcinoma, 030204 cardiovascular system & hematology, Placebo, 03 medical and health sciences, chemistry.chemical_compound, Prostate cancer, 0302 clinical medicine, Double-Blind Method, Antineoplastic Combined Chemotherapy Protocols, Androgen Receptor Antagonists, medicine, Humans, 030212 general & internal medicine, Progression-free survival, apalutamide, Aged, Aged, 80 and over, hormone therapy, Prostatectomy, business.industry, Apalutamide, Hazard ratio, prostate cancer, Prostatic Neoplasms, Androgen Antagonists, General Medicine, Exanthema, Middle Aged, medicine.disease, Interim analysis, Progression-Free Survival, Radiography, Thiohydantoins, Docetaxel, chemistry, Quality of Life, Neoplasm Grading, business, medicine.drug
Abstract

MUSTAFA, OZGUROGLU/0000-0002-8417-8628; CARCANO, FLAVIO M/0000-0002-0002-3507; Smirnov, Alexey/0000-0001-5361-8232; Sciarra, Alessandro/0000-0002-7899-8056; Chung, Byung Ha/0000-0001-9817-3660; Mosca, Alessandra/0000-0003-2538-8411 WOS:000474094900008 PubMed ID: 31150574 Background Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression-free survival and overall survival as compared with placebo plus ADT among patients with metastatic, castration-sensitive prostate cancer has not been determined. Methods In this double-blind, phase 3 trial, we randomly assigned patients with metastatic, castration-sensitive prostate cancer to receive apalutamide (240 mg per day) or placebo, added to ADT. Previous treatment for localized disease and previous docetaxel therapy were allowed. The primary end points were radiographic progression-free survival and overall survival. Results A total of 525 patients were assigned to receive apalutamide plus ADT and 527 to receive placebo plus ADT. The median age was 68 years. A total of 16.4% of the patients had undergone prostatectomy or received radiotherapy for localized disease, and 10.7% had received previous docetaxel therapy; 62.7% had high-volume disease, and 37.3% had low-volume disease. At the first interim analysis, with a median of 22.7 months of follow-up, the percentage of patients with radiographic progression-free survival at 24 months was 68.2% in the apalutamide group and 47.5% in the placebo group (hazard ratio for radiographic progression or death, 0.48; 95% confidence interval [CI], 0.39 to 0.60; P

Published
2019

13. Prostate-specific antigen (PSA) decline with apalutamide therapy is associated with longer survival and improved outcomes in individuals with metastatic prostate cancer: a plain language summary of the TITAN study.

Author

Chowdhury, Simon, Bjartell, Anders, Agarwal, Neeraj, Chung, Byung H, Given, Robert W, Pereira de Santana Gomes, Andrea J, Merseburger, Axel S, Özgüroğlu, Mustafa, Soto, Álvaro Juárez, Uemura, Hirotsugu, Ye, Ding-Wei, Brookman-May, Sabine D, Londhe, Anil, Bhaumik, Amitabha, Mundle, Suneel D, Larsen, Julie S, McCarthy, Sharon A, and Chi, Kim N

Abstract

This summary describes the results from an additional (or post hoc) analysis of the TITAN study. The TITAN study looked at whether the prostate cancer treatment apalutamide could be used to treat individuals with metastatic castration-sensitive prostate cancer (or mCSPC). A total of 1052 participants with mCSPC were included in the TITAN study. Treatment with apalutamide was compared with treatment with placebo. All participants received androgen deprivation therapy (or ADT), which is a type of hormone therapy that has been part of the main treatment for mCSPC for many years. The results showed that apalutamide plus ADT increased the length of time that participants remained alive compared with placebo plus ADT. Apalutamide plus ADT also controlled the growth of the cancer for a longer length of time compared with placebo plus ADT. Additionally, participants who received apalutamide plus ADT experienced a greater reduction in the blood levels of prostate-specific antigen (or PSA), called a deep PSA decline, compared with those who received placebo plus ADT. An additional (or post hoc) analysis was carried out to understand whether a decrease in blood PSA levels, in response to treatment, was associated with improved outcomes, including longer survival time. In participants who received apalutamide plus ADT, a deep PSA decline in response to treatment was associated with longer survival time and improved outcomes. These results demonstrate that individuals with mCSPC can benefit from treatment with apalutamide plus ADT. The association seen between deep PSA decline and the longer survival time and improved outcomes highlights how PSA measurements can be used to help monitor cancer disease evolution in response to treatment. Monitoring PSA levels will assist doctors and other healthcare professionals to understand how effectively a treatment is working for a patient and to tailor their treatment approach to improve PSA decline. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer

Author

Chi, Kim N., primary, Agarwal, Neeraj, additional, Bjartell, Anders, additional, Chung, Byung Ha, additional, Pereira de Santana Gomes, Andrea J., additional, Given, Robert, additional, Juárez Soto, Álvaro, additional, Merseburger, Axel S., additional, Özgüroğlu, Mustafa, additional, Uemura, Hirotsugu, additional, Ye, Dingwei, additional, Deprince, Kris, additional, Naini, Vahid, additional, Li, Jinhui, additional, Cheng, Shinta, additional, Yu, Margaret K., additional, Zhang, Ke, additional, Larsen, Julie S., additional, McCarthy, Sharon, additional, and Chowdhury, Simon, additional

Published
2019
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15. First results from TITAN: A phase III double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT).

Author

Chi, Kim N., primary, Agarwal, Neeraj, additional, Bjartell, Anders, additional, Chung, Byung Ha, additional, Pereira de Santana Gomes, Andrea Juliana, additional, Given, Robert W., additional, Juárez Soto, Álvaro, additional, Merseburger, Axel Stuart, additional, Ozguroglu, Mustafa, additional, Uemura, Hirotsugu, additional, Ye, Dingwei, additional, Deprince, Kris, additional, Naini, Vahid, additional, Li, Jinhui, additional, Cheng, Shinta, additional, Yu, Margaret K., additional, Zhang, Ke, additional, Larsen, Julie S., additional, McCarthy, Sharon Anne, additional, and Chowdhury, Simon, additional

Published
2019
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16. Apalutamide for metastatic, castration‐sensitive prostate cancer in the Japanese population: A subgroup analysis of the randomized, double‐blind, placebo‐controlled phase 3 TITAN study.

Author

Uemura, Hirotsugu, Arai, Gaku, Uemura, Hiroji, Suzuki, Hiroyoshi, Iijima, Kazuyoshi, Nishimura, Kazuo, Fujii, Koji, Hatayama, Tomoyoshi, Aoyama, Junya, Deprince, Kris, Lopez‐Gitlitz, Angela, McCarthy, Sharon, Larsen, Julie S, Li, Jinhui, and Chi, Kim N

Subjects
CASTRATION-resistant prostate cancer, JAPANESE people, ANDROGEN deprivation therapy, PROSTATE cancer, DRUG efficacy, SUBGROUP analysis (Experimental design)
Abstract

Objective: To evaluate the efficacy and safety of apalutamide + androgen deprivation therapy versus androgen deprivation therapy alone in Japanese patients with metastatic castration‐sensitive prostate cancer from the phase 3, randomized, global TITAN study. Methods: Men with metastatic castration‐sensitive prostate cancer randomly (1:1) received 240 mg apalutamide + androgen deprivation therapy or matching placebo + androgen deprivation therapy. The primary efficacy endpoints were radiographic progression‐free survival and overall survival. Secondary efficacy endpoints were time to cytotoxic chemotherapy, pain progression, chronic opioid use, and skeletal‐related events. Safety was also assessed. Results: Of the 1052 patients included in the TITAN study, 51 (4.85%) were Japanese (apalutamide group, n = 28; placebo group, n = 23). In all, 81.8% of patients in the apalutamide and 71.8% in the placebo group did not experience radiographic progression or death, and the hazard ratio for radiographic progression‐free survival favored treatment with apalutamide (hazard ratio 0.712, 95% confidence interval 0.205–2.466; P = 0.59). At 24 months, 85.7% of patients in the apalutamide group and 81.5% in the placebo group were alive, and the hazard ratio for overall survival favored apalutamide (hazard ratio 0.840, 95% confidence interval 0.210–3.361; P = 0.805). In the interim analysis, the median radiographic progression‐free survival and overall survival were not reached in the apalutamide group and time to cytotoxic chemotherapy was delayed following apalutamide treatment. The safety profile of apalutamide in the Japanese subpopulation was comparable with that of the global population, except for skin rash. Conclusions: The results of the present analyses suggest that apalutamide + androgen deprivation therapy in Japanese patients had favorable efficacy compared with androgen deprivation therapy alone, and these findings are comparable to those in the overall population. Apalutamide + androgen deprivation therapy can be considered as one of the therapeutic options for a broad spectrum of metastatic castration‐sensitive prostate cancer regardless of prior treatment and disease extent in Japanese patients. [ABSTRACT FROM AUTHOR]

Published
2021
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18. Asthma control in pregnancy

Author

Larsen, Julie S. and Grose, Loree

Subjects
Pregnant women -- Health aspects, Asthma -- Care and treatment, Pharmaceutical industry -- Product information
Abstract

M.K., a 24-year-old woman diagnosed with moderate, persistent asthma, has attended your hospital's classes on asthma management. Her asthma has been adequately controlled with fluticasone (inhalation aerosol), 440 mcg twice [...]

Published
2002

19. A phase III study of ibrutinib in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously treated follicular lymphoma or marginal zone lymphoma.

Author

Fowler, Nathan Hale, primary, Hiddemann, Wolfgang, additional, Leonard, John, additional, Larsen, Julie S., additional, Rose, Esther, additional, Zhuang, Sen Hong, additional, Vermeulen, Jessica, additional, Sun, Steven, additional, Mentzer, Lisa, additional, Yeh, Tzu-Min, additional, and Salles, Gilles A., additional

Published
2015
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20. A phase 3 study of ibrutinib in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously treated follicular lymphoma or marginal zone lymphoma.

Author

Fowler, Nathan Hale, primary, Hiddemann, Wolfgang, additional, Leonard, John, additional, Rose, Esther, additional, Ahmadi, Tahamtan, additional, Vermeulen, Jessica, additional, Larsen, Julie S., additional, Sun, Steven, additional, Mentzer, Lisa, additional, Wang, Shean-Sheng, additional, Yeh, Tzu-Min, additional, and Salles, Gilles A., additional

Published
2014
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21. Randomized double-blind, comparative study of abiraterone acetate (AA) plus low-dose prednisone (P) plus androgen deprivation therapy (ADT) versus ADT alone in newly diagnosed, high-risk, metastatic hormone-naive prostate cancer (mHNPC).

Author

Fizazi, Karim, primary, Larsen, Julie S., additional, Matheny, Shannon, additional, Molina, Arturo, additional, Li, Jinhui, additional, Todd, Mary Beth, additional, Yu, Margaret K., additional, Kheoh, Thian San, additional, and Tran, Namphuong, additional

Published
2013
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23. Multicenter Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Myelodysplastic Syndromes: The Alternative Dosing for Outpatient Treatment (ADOPT) Trial

Author

Steensma, David P., primary, Baer, Maria R., additional, Slack, James L., additional, Buckstein, Rena, additional, Godley, Lucy A., additional, Garcia-Manero, Guillermo, additional, Albitar, Maher, additional, Larsen, Julie S., additional, Arora, Sujata, additional, Cullen, Michael T., additional, and Kantarjian, Hagop, additional

Published
2009
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