tbuckley/cabot-search huggingface dataset:
PI3 Kinase Pathway Mutations in Human Cancers
Authors: Joe W. Gray
Journal: JAMA Oncology (2016)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Oncology HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Oncology journal
O<scp>pening the</scp> D<scp>ebate on the</scp> N<scp>ew</scp> S<scp>epsis</scp> D<scp>efinition</scp>Change Is Not Necessarily Progress: Revision of the Sepsis Definition Should Be Based on New Scientific Insights
Authors: Irene Cortés-Puch, Christiane S. Hartog
Journal: American Journal of Respiratory and Critical Care Medicine (2016)
PILLAR-2: A randomized, double-blind, placebo-controlled, phase III study of adjuvant everolimus (EVE) in patients (pts) with poor-risk diffuse large B-cell lymphoma (DLBCL).
Authors: Thomas E. Witzig, Kensei Tobinai, Luigi Rigacci, Tongyu Lin, Takashi Ikeda, Anna Vanazzi, Masayuki Hino, Yuankai Shi, Jiri Mayer, Luciano J Costa, Carlos DANIEL Bermudez, Jun Zhu, David Belada, Kamal Bouabdallah, Joseph Gergi Kattan, Cassandra Wu, Jenna Fan, Anne-Laure Louveau, Maurizio Voi, Franco Cavalli
Journal: Journal of Clinical Oncology (2016)

7506 Background: The goal of PILLAR-2 (NCT00790036) was to reduce DLBCL relapse by providing 1 year of adjuvant EVE to poor-risk (International Prognostic Index [IPI] ≥3) pts who had achieved a CR with R-chemo. Methods: PILLAR-2 was a multicenter double-blind, placebo (PBO)-controlled, phase 3 study. Pts with histologically confirmed stage III/IV poor-risk (IPI ≥3) DLBLC who had a PET/CT-confirmed CR to first-line R-chemo were randomized 1:1 to EVE 10 mg/day or PBO for 1 year or until disease relapse, unacceptable toxicity, or death. The primary endpoint was disease-free survival (DFS) by local assessment using revised IWRC; secondary endpoints were overall survival (OS), lymphoma-specific survival (LSS), and safety. Results: Median study follow-up was 50.4 months (range, 24.0–76.9 months). Of the 742 pts randomized, 177 (48%) pts in the EVE and 249 (67%) in the PBO arms completed the study treatment as per protocol. Overall, 47% pts were ≥65 years, 50% were male and 42% had an IPI of 4+5. Adjuvant EVE did not improve DFS vs. PBO (Log-rank p = 0.276) (Table). The 2-yr DFS rates (95% CI) were 78% (73-82%) in EVE vs 77% (72-81%) in PBO. However, trends favoring EVE were observed for OS and LSS, and for exploratory analyses of DFS and OS in males and those with IPI 4+5. Common grade 3/4 AEs with > 3% difference for EVE vs PBO included neutropenia, stomatitis, CD4 lymphocytes decreased, lymphopenia and anemia. Conclusions: In poor-risk DLBCL patients with a CR after R-chemo,adjuvant EVE for 1 year did not improve DFS. A trend favoring EVE for OS and LSS, overall and for DFS in selected patient subgroups suggests that everolimus may provide anti-lymphoma activity in high-risk DLBCL, and warrant further investigation. Clinical trial information: NCT00790036. EVE vs PBO Hazard ratio (95% confidence interval) DFS* Overall (n = 742) 0.92 (0.69–1.22)† IPI 4+5 (n = 313) 0.65 (0.42–1.01) Male (n = 372) 0.68 (0.45–1.05) OS* Overall (n = 742) 0.75 (0.51–1.10) IPI 4+5 (n = 313) 0.63 (0.37–1.07) Male (n = 372) 0.55 (0.32–0.94) LSS* (n = 742) 0.64 (0.39–1.04) * Median duration not evaluable. †Log-Rank p = 0.276
Overexpression Of Mir-125a In Bone Marrow CD34+ cells Of Patients With Myelodysplastic Syndrome Is Correlated To a Poor Prognosis and May Contribute To The Pathogenesis Of The Disease Through The Modulation Of NF-Kb Activation and Enhancement Of Differentiation Arrest
Authors: Irene Ganan-Gomez, Yue Wei, Hui Yang, Maria Carmen Boyano-Adánez, Guillermo Garcia-Manero
Journal: Blood (2013)
Genomic Analysis of Immune Cell Infiltrates Across 11 Tumor Types
Authors: Michael D. Iglesia, Joel S. Parker, Katherine A. Hoadley, Jonathan S. Serody, Charles M. Perou, Benjamin G. Vincent
Journal: JNCI Journal of the National Cancer Institute (2016)

Background: Immune infiltration of the tumor microenvironment has been associated with improved survival for some patients with solid tumors. The precise makeup and prognostic relevance of immune infiltrates across a broad spectrum of tumors remain unclear. Methods: Using mRNA sequencing data from The Cancer Genome Atlas (TCGA) from 11 tumor types representing 3485 tumors, we evaluated lymphocyte and macrophage gene expression by tissue type and by genomic subtypes defined within and across tumor tissue of origin (Cox proportional hazards, Pearson correlation). We investigated clonal diversity of B-cell infiltrates through calculating B-cell receptor (BCR) repertoire sequence diversity. All statistical tests were two-sided. Results: High expression of T-cell and B-cell signatures predicted improved overall survival across many tumor types including breast, lung, and melanoma (breast CD8_T_Cells hazard ratio [HR] = 0.36, 95% confidence interval [CI] = 0.16 to 0.81, P = .01; lung adenocarcinoma B_Cell_60gene HR = 0.71, 95% CI = 0.58 to 0.87, P = 7.80E-04; melanoma LCK HR = 0.86, 95% CI = 0.79 to 0.94, P = 6.75E-04). Macrophage signatures predicted worse survival in GBM, as did B-cell signatures in renal tumors (Glioblastoma Multiforme [GBM]: macrophages HR = 1.62, 95% CI = 1.17 to 2.26, P = .004; renal: B_Cell_60gene HR = 1.17, 95% CI = 1.04 to 1.32, P = .009). BCR diversity was associated with survival beyond gene segment expression in melanoma (HR = 2.67, 95% CI = 1.32 to 5.40, P = .02) and renal cell carcinoma (HR = 0.36, 95% CI = 0.15 to 0.87, P = .006). Conclusions: These data support existing studies suggesting that in diverse tissue types, heterogeneous immune infiltrates are present and typically portend an improved prognosis. In some tumor types, BCR diversity was also associated with survival. Quantitative genomic signatures of immune cells warrant further testing as prognostic markers and potential biomarkers of response to cancer immunotherapy.
Prognostic Significance Of EVI1 expression In Acute Myeloid Leukemia Patients With Intermediate and Adverse Cytogenetic Risk Undergoing Allogeneic Hematopoietic Cell Transplantation With Reduced-Intensity Conditioning
Authors: Marius Bill, Madlen Jentzsch, Thoralf Lange, Laura Kloss, Rainer Krahl, Georg Franke, Stephan Fricke, Vladan Vucinic, Wolfram Poenisch, Haifa Kathrin Al-Ali, Gerhard Behre, Michael Cross, Dietger Niederwieser, Sebastian Schwind
Journal: Blood (2013)
A phase I/II study of the selective phosphatidylinositol 3-kinase-delta (PI3Kδ) inhibitor, GS-1101 (CAL-101), with ofatumumab in patients with previously treated chronic lymphocytic leukemia (CLL).
Authors: Richard R. Furman, Jacqueline Claudia Barrientos, Jeff Porter Sharman, Sven De Vos, John Leonard, Steven E. Coutre, Marshall T. Schreeder, Nina D. Wagner-Johnston, Thomas E. Boyd, Nathan Hale Fowler, Ian W. Flinn, Ralph V. Boccia, Leanne Holes, Brian Joseph Lannutti, Dave Johnson, Thomas Michael Jahn, Langdon L. Miller
Journal: Journal of Clinical Oncology (2012)

6518^ Background: PI3Kδ is expressed in cells of hematopoietic origin where it regulates the survival and proliferation of malignant B-cells. GS-1101 is an orally bioavailable, small-molecule inhibitor that selectively targets PI3Kδ and is highly active in patients with hematologic malignancies. Methods: This Phase 1/2 study evaluated repeated 28-day cycles of GS‑1101 in combination with ofatumumab. GS-1101 (150mg BID) was co-administered with a total of 12 infusions of ofatumumab over 24 weeks (300mg initial dose either on Day 1 or Day 2 (relative to the first dose of GS-1101), followed 1 week later by 1,000mg weekly for 7 doses, followed 4 weeks later by 1,000mg every 4 weeks for 4 doses). Thereafter, each subjects received single-agent GS‑1101 as long as the subject was benefitting. Results: Accrual is complete with 21 subjects enrolled and 11 evaluable. Six subjects started ofatumumab treatment on Day 1 and 5 on Day 2. Median [range] age was 63 [54‑76] years. The majority (9/11; 82%) of patients had bulky adenopathy. The median [range] number of prior therapies was 3 [1‑6], including prior exposure to alkylating agents (10/11; 90%), rituximab (9/11; 82%), purine analogs (8/11; 72%), alemtuzumab (3/11; 28%) and/or ofatumumab (2/11;18%). At the data cutoff, the median [range] treatment duration was 5 [0‑7] cycles. Almost all subjects (9/11;82%) experienced marked and rapid reductions in lymphadenopathy within the first 2 cycles. The lymphocyte mobilization that is expected with PI3Kδ inhibition was significantly reduced in magnitude and duration and persisted past Cycle 1 in only 1 patient. Early follow up data support a favorable safety profile and confirm a lack of clinically significant myelosuppression. Elevated baseline levels of CCL3, CCL4, CXCL13, and TNFa were significantly reduced after 28 days of treatment. Conclusions: GS-1101/ofatumumab offers a well-tolerated noncytotoxic combination regimen with substantial activity in previously treated patient with bulky adenopathy. Data on the complete cohort of 21 subjects will be presented.
A single arm, single stage phase II trial of trametinib (GSK1120212) and GSK2141795 in persistent or recurrent cervical cancer.
Authors: Ursula Matulonis, Alexi A. Wright, Siobhan A Collins, Susana M. Campos, Panagiotis Konstantinopoulos, Kimberley MacNeill, Stephanie Morrissey, Victoria Patterson, Christin Whalen, Joyce Liu
Journal: Journal of Clinical Oncology (2015)

TPS5618 Background: In the US, invasive cervical cancer (CC) will affect 12,710 women/year with ~4290 deaths; global deaths from CC are ~275,000 women per yr. Though treatment options for recurrent/metastatic (met) CC have improved by adding bevacizumab to chemotherapy, pts with met CC will eventually have cancer progression (Tewari et al ,NEJM 2014), and effective therapies are few. Data from our own institution (Wright et al, Cancer 2013) found PIK3CA mutations in 32% of adenocarcinomas of the cervix (ACC) and in 35% of squamous cell cancers of the cervix (SCC). KRAS mutations were present in 17% of AC’s and 0% of SCC. Thus, therapies targeting the PIK3CA and RAS-ERK pathways have rationale for treating met CC; this phase II study is testing a MEK and an AKT inhibitor combination. Pre-clinical studies support dual PI3Ki and MEKi given pathway redundancy and negative feedback loops. Methods: Trametinib (GSK1120212) is a reversible/selective inhibitor of MEK1/MEK2. GSK2141795 is an AKT1-3 inhibitor. Objectives of this study: RECIST 1.1 activity of trametinib and GSK2141795 in pts with recurrent CC; other objectives include assess PFS and OS duration, toxicities, mutation and co-mutation rates of PI3K and RAS-ERK signaling pathway genes using high throughput mutational analysis on FFPE samples, and mutational status with clinical benefit from trametinib and GSK2141795. Eligibility: recurrent or met CC (any histology eligible), receipt of 1 prior chemotherapy, and up to 1 add’l regimen, no prior use of PI3K or RAS-ERK pathway inhibitor, ECOG PS 0-2, normal organ function, and availability of FFPE tissue. The treatment regimen is as follows: trametinib 1.5 mg and GSK2141795 50 mg, both given PO and daily. Cycle length is 28 days and pts are assessed for RR every 2 cycles. The study opened in 10/2013, and as of 2/2015, 12 pts have been enrolled. Target accrual is 35 pts; there is a 91% power to detect an improvement in RR from 0.07 to 0.22 using a one-sided 0.09-level exact binomial test. The null hypothesis will be rejected if 5 or more pts respond to trametinib and GSK2141795; the null hypothesis of 0.07 is based on a weighted average of the observed RR from the 11 cohorts enrolled to GOG 127 and 227 series. Clinical trial information: NCT01958112.
A Perspective on Hospice Reform and Additional Caregiver Support—Reply
Authors: Shaida Talebreza, Eric Widera
Journal: JAMA Internal Medicine (2016)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Internal Medicine HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Internal Medicine journal
Carboplatin and etoposide (CE) chemotherapy in patients with recurrent or progressive oligodendroglial tumors
Authors: L. Scopece, G. Cavallo, E. Palmerini, E. Franceschi, A. Paioli, F. Spagnolli, S. Rimondini, R. Conforti, R. Degli Esposti, L. Crino
Journal: Journal of Clinical Oncology (2004)

1562 Background: Oligodendroglial tumors are chemosensitive diseases, and the response rate (RR) with first line chemotherapy is in the range of 40 to 70%. Second line chemotherapy with temozolomide showed a RR of 40–60%. However TTP with these therapies cannot be considered satisfactory and other active treatments are necessary. Etoposide (VP-16) is a topoisomerase IIα inhibitor which penetrates the CNS and has activity against a variety of CNS tumors, showing a synergistic effect with cisplatin or carboplatin, either in vitro and in vivo. Methods: In this phase II trial primary endpoint was to evaluate the RR following first and second line Carboplatin and Etoposide (CE) regimen in patients with recurrent/progressive oligodendroglioma (O2), anaplastic oligodendroglioma (O3), oligoastrocytoma (OA2) and anaplastic oligoastrocytoma (OA3). PFS, TTP, overall survival and toxicity were evaluated as secondary endpoints. Patients were treated with first or second line carboplatin AUC 5 on day 1 and etoposide 120 mg/m2 on days 1 to 3 every 28 days. Results: 18 pts were included in the study (median age 45.5 yrs, range 28–65 y; median KPS 90, range 70–100; 1 O2, 1 OA2, 8 O3 and 8 OA3). Twelve patients were treated with first line CE, and in 6 pts the treatment was given as a second line. All pts were evaluable for response: 1 CR (5.6%) and 5 PR (27.8%) were obtained with a RR of 33.4%. Eight pts (44.4%) were stable for more than two months. At the time of analysis 14 patients had progression while 4 patients were progression free. The median TTP was 8 months. The PFS at 6 and 12 months were 70.5% and 37.5% respectively; in responders these percentages were 100% and 80%, respectively. A total of 78 cycles of CE were administered (median 4, range 1–7). When given in first line, CE regimen showed a RR of 41.1% (1CR and 4PR). Toxicity was mainly hematological, with grade 3–4 neutropenia in 2 (11.1%) pts. Mild nausea and vomiting were common. Conclusions: In this trial the CE regimen has shown activity and a good toxicity profile. Further studies with biological correlations with LOH of 1p and 19q are warranted. No significant financial relationships to disclose.
PD6-1-2: ERCC1 and TOPOIIa mRNA levels predict response to platinum/etoposide chemotherapy and survival of small-cell lung cancer patients.
Authors: Giovanni Selvaggi, Paolo Ceppi, Matteo Giai Levra, Silvia Novello, Marina Longo, Susanna Cappia, Mauro Papotti, Marco Volante, Giorgio V. Scagliotti
Journal: Journal of Thoracic Oncology (2007)
Fish Intake During Pregnancy and Offspring Adiposity
Authors: Wei Bao
Journal: JAMA Pediatrics (2016)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Pediatrics HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Pediatrics journal
Resilience: Mediated by not one but many appraisal mechanisms
Authors: Patrik N. Juslin
Journal: Behavioral and Brain Sciences (2015)

Kalisch et al. discuss the causal process underlying stress in terms of a multidimensional goal-appraisal process, but there are several mechanisms at various levels of the brain that use different types of information to guide behavior. Depending on the mechanism, the characteristics of the process are different. Hence, both research and prevention must deal with appraisal in mechanism-specific ways.
Continuous Dose-Response Association Between Sedentary Time and Risk for Cardiovascular Disease
Authors: Ambarish Pandey, Usman Salahuddin, Sushil Garg, Colby Ayers, Jacquelyn Kulinski, Vidhu Anand, Helen Mayo, Dharam J. Kumbhani, James de Lemos, Jarett D. Berry
Journal: JAMA Cardiology (2016)

Prior studies suggest that higher sedentary time is associated with a greater risk for cardiovascular disease (CVD). However, the quantitative, dose-response association between sedentary time and CVD risk is not known.To determine the categorical and quantitative dose-response association between sedentary time and CVD risk.Two independent investigators searched the MEDLINE and EMBASE databases for all studies published before July 6, 2015, that evaluated the association between sedentary time and incident CVD.Prospective cohort studies with participants 18 years or older that reported the association between sedentary time and incident CVD were included.Two independent investigators performed the data extraction and collection using a standardized form. The study quality was assessed using the Newcastle-Ottawa Scale. The categorical dose-response association was evaluated by comparing the pooled hazard ratio (HR) for incident CVD associated with different levels of sedentary time (vs lowest sedentary time) across studies. The continuous dose-response association was assessed using random-effects generalized least squares spline models. Data were collected from April 5 to July 6, 2015.Incident CVD (coronary heart disease, including nonfatal myocardial infarction, stroke, and cardiovascular mortality).Nine prospective cohort studies with 720 425 unique participants (57.1% women; 42.9% men; mean age, 54.5 years) and 25 769 unique cardiovascular events and a median follow-up of 11 years were included. In categorical analyses, compared with the lowest sedentary time category (median, 2.5 h/d), participants in the highest sedentary time category (median, 12.5 h/d) had an increased risk for CVD (HR, 1.14; 95% CI, 1.09-1.19). However, no apparent risk associated with intermediate levels of sedentary time (HR for 7.5 h/d, 1.02; 95% CI, 0.96-1.08) was found. In continuous analyses, a nonlinear association between sedentary time and incident CVD was found (P for nonlinearity < .001), with an increased risk observed for more than 10 hours of sedentary time per day (pooled HR, 1.08; 95% CI, 1.00-1.14).The association between sedentary time and the risk for CVD is nonlinear with an increased risk only at very high levels. These findings could have implications for guideline recommendations regarding the risks related to sedentary behavior.
P-052 Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer
Authors: H. Osumi, E. Shinozaki, M. Suenaga, S. Matsusaka, I. Nakayama, T. Wakatsuki, M. Ogura, M. Ozaka, I. Takashi, D. Takahari, K. Chin, N. Mizunuma, K. Yamaguchi
Journal: Annals of Oncology (2016)
Degarelix/bicalutamide combination versus degarelix alone as initial androgen-deprivation therapy
Authors: Masahiro Nozawa, Koichi Sugimoto, Yasuharu Nagai, Takahide Sugiyama, Yuji Hatanaka, Takashi Oki, Hideo Tahara, Hisao Matsuda, Yutaka Yamamoto, Hirotsugu Uemura
Journal: Journal of Clinical Oncology (2016)

183 Background: Antiandrogens have been used to prevent symptoms due to testosterone surge in the early phase of treatment with gonadotropin-releasing hormone (GnRH) agonist as well as to add antitumor efficacy. Degarelix, an antagonist of GnRH does not introduce testosterone surge, however, the combination of degarelix and antiandrogen can exert a stronger antitumor effect than degarelix alone. We conducted a phase II study to investigate the early-phase efficacy and safety of combination of degarelix and bicalutamide compared with degarelix alone in patients with prostate cancer (PCa). Methods: Patients with histologically proven adenocarcinoma in the prostate indicated for androgen-deprivation therapy (ADT) were randomly assigned to a treatment group with either combination of degarelix and bicalutamide or degarelix alone. Degarelix was administered subcutaneously with an initial dose of 240 mg followed by 80 mg thereafter every four weeks. Bicalutamide was taken 80 mg every day. The primary endpoint was the percentage of patients whose serum prostate-specific antigen (PSA) declined with greater than 90% of the baseline at Day 28. Secondary endpoints were the transition of serum PSA and testosterone during treatment of 12 weeks, safety, and quality of life. Results: A total of 93 patients were evaluable in this final analysis. Median age was 75 years. Median baseline serum PSA was 10.2ng/ml. Baseline patient characteristics were well-balanced in both arms. The percentage of patients with serum PSA declines greater than 90% from baseline was 34% and 27% in the combination group and the degarelix monotherapy group, respectively (P= 0.503). The transition of serum PSA and testosterone levels were similar in both groups. No grade 3 or greater adverse event was observed in both groups. Conclusions: Adding bicalutamide on degarelix as initial ADT does not produce a greater impact on serum PSA decline in the early-treatment phase compared to degarelix alone. Clinical trial information: UMIN000011506.