scholarly journals Non-randomised comparison of efficacy and side effects of bicalutamide compared with LHRH analogues in combination with radiotherapy in the xxxxxx trial.

2022 ◽  
Author(s):  
Alison Tree ◽  
Clare Griffin ◽  
Isabel Syndikus ◽  
Alison Birtle ◽  
Ananya Choudhury ◽  
...  
Keyword(s):  
Side Effects ◽  
Lhrh Analogues

Intergroup study EORTC-1532-gucg: A phase 2 randomized open-label study of oral darolutamide (ODM-201) vs. androgen deprivation therapy (ADT) with LHRH agonists or antagonist in men with hormone naive prostate cancer (PCa).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS406-TPS406 ◽  
Author(s):  
Bertrand F. Tombal ◽  
Silke Gillessen ◽  
Yohann Loriot ◽  
Sandrine Marreaud ◽  
Laurence Collette ◽  
...  
Keyword(s):  
Side Effects ◽  
Androgen Deprivation Therapy ◽  
Competitive Inhibition ◽  
Single Agent ◽  
Objective Response ◽  
Androgen Deprivation ◽  
Total Testosterone ◽  
Disease Extent ◽  
Lhrh Analogues ◽  
Increased Risk

TPS406 Background: Androgen deprivation therapy (ADT) by LHRH analogues aims to lower serum testosterone. ADT is associated with several side effects that include hot flushes, depression, loss of libido, metabolic disturbances leading to an increase risk of cardiovascular disease, increased bone resorption leading to increased risk of osteoporosis and skeletal fracture. AR antagonists may circumvent these side effects by suppressing AR transcription by competitive inhibition of AR, without lowering systemic testosterone. In Europe, first generation AR antagonists bicalutamide 150 mg is registered for the treatment of non-metastatic hormone-naïve PCa. is a novel AR antagonist that is structurally distinct with higher AR-binding affinity compared to bicalutamide, enzalutamide, and apalutamide. The aim of this trial is to investigate the activity, safety and tolerability of darolutamide as single agent, as an alternative to LHRH analogues in men requiring ADT. Methods: EORTC-1532-GUCG (NCT02972060) will randomize 250 men with hormone-naïve PCa 1:1 to 600 mg (2× 300-mg tablets) bid of darolutamide1 or LHRH agonist or antagonist, stratified for type of ADT (agonist vs. antagonist), disease extent (measurable, non-measurable, vs. no metastasis) and age (≥70 vs < 70 years). Key inclusion criteria include histologically confirmed asymptomatic PCa (all stages) for whom continuous ADT is indicated for a minimum period of 24 weeks. Patients with up to 4 confirmed not visceral metastases, are allowed. Baseline total testosterone should be ≥ 8 nmol/L or 230 ng/dL. Primary endpoint is PSA response assessed at 24 weeks, defined as a ≥ 80% decline in PSA at week 24 in the darolutamide study arm. The ADT arm is used as an internal non comparative control. Key secondary endpoints include: Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks (comparison between arms); objective response rate at 24 weeks in patients with measurable disease at baseline, safety according to NCI-CTC version 4.0. Clinical trial information: NCT02972060.

scholarly journals SUN-089 Novel Genetic and Biochemical Findings of DLK1 Deficiency in Children with Central Precocious Puberty - a Collaborative Brazilian-Spanish Study

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Luciana Ribeiro Montenegro ◽  
José Labarta ◽  
Maiara Piovesan ◽  
Ana Pinheiro Machado Canton ◽  
Raquel Corripio Collado ◽  
...  
Keyword(s):  
Transcription Factor ◽  
Side Effects ◽  
Precocious Puberty ◽  
De Novo ◽  
Central Precocious Puberty ◽  
De Novo Mutation ◽  
Enzyme Linked Immunosorbent Assay ◽  
Lhrh Analogues ◽  
Cranial Mri ◽  
Index Cases

Abstract Background: Delta-like 1 homolog (DLK1), also known as pre-adipocyte factor 1 (Pref-1), is part of the Notch signaling pathway that controls many developmental processes. Loss-of-function mutations of DLK1 have been identified in children with central precocious puberty (CPP), as well as in women who had precocious menarche (≤ 9 years) with an unfavorable metabolic profile. Objective: To investigate genetic and biochemical aspects of DLK1 in a cohort of children with CPP. Patients: A large cohort of Spanish children with idiopathic CPP (Spanish PUBERE Registry) was studied. Genomic DNA was obtained from 444 individuals, including 168 index cases with CPP and their close relatives. Automatic sequencing of the coding region (5 exons) of DLK1 was performed in all index cases. Serum DLK1 levels were measured by using a soluble DLK1 enzyme-linked immunosorbent assay (ELISA). Results: A rare allelic deletion (c.401_404 + 8del) of a splice site junction of DLK1 was identified in a girl with sporadic CPP. Pubertal signs appeared at 5.7 years of age with progressive puberty (basal LH: 1.7 mIU/mL, peak LH: 32.77 mIU/mL; basal FSH: 6.32 mIU/mL, peak FSH: 19.89 mIU/mL), BA/CA 1.7 years; normal cranial MRI). She received LHRH analogues (6.3 - 10.1 years of CA) with no side effects. At 14.9 years of age height and BMI are 152.9 cms and 18 kg/m2, respectively, presenting regular menses. Familial segregation analysis showed that the affected child was the only carrier of this deletion characterizing a de novo mutation (biological paternity and maternity were confirmed by microsatellite analysis). Serum DLK1 levels were undetectable (&lt;0.4 ng/mL) in this girl, supporting that the deletion lead to complete lack of DLK1 production. Her father, mother and sister had normal serum DLK1 levels (ranged 6.36 ng/mL to 8.98 ng/mL). Two rare consecutive nucleotide changes in the promoter region of the DLK1 gene (c.-222 C&gt;A and c.-223 G&gt;A) were also identified in an adopted child with CPP. They are located in a transcription factor binding site for SP1 (a zinc finger transcription factor). Pubertal signs appeared at 6.7 years of age with progressive puberty (Basal LH: 0.5 mIU/mL, peak LH: 15.9 mIU/mL, basal FSH: 1.52 mIU/mL, peak FSH: 6.56 mIU/mL, BA/CA 1.4 years; normal cranial MRI). She is under therapy with LHRH analogues with no side effects. Conclusion: Novel DLK1 findings were identified in the Spanish cohort of children with CPP, reinforcing a significant role of this factor in human pubertal timing.

Gastric Ulcers Produced by Cisplatin

1981 ◽  
Vol 39 ◽  
pp. 582-583
Author(s):  
S.K. Aggarwal ◽  
J. San Antonio
Keyword(s):  
Electron Microscopy ◽  
Single Dose ◽  
Side Effects ◽  
Antitumor Agent ◽  
Gastric Ulcers ◽  
Enzyme Cytochemistry ◽  
Intestinal Toxicity ◽  
Ovarian Cancers ◽  
Inner Surface

Cisplatin (cis-dichlorodiammineplatinum(II)) a potent antitumor agent is now available for the treatment of testicular and ovarian cancers. It is however, not free from its serious side effects including nephrotoxicity, gastro intestinal toxicity, myelosuppression, and ototoxicity. Here we now report that the drug produces peculiar bloating of the stomach in rats and induces acute ulceration.Wistar-derived rats weighing 200-250 g were administered cisplatin(9 mg/kg) ip as a single dose in 0.15 M NaCl. After 3 days the animals were sacrificed by decapitation. The stomachs were removed, the contents analyzed for pepsin and acidity. The inner surface was examined with a dissecting microscope after a moderate stretching for ulcers. Affected areas were fixed and processed for routine electron microscopy and enzyme cytochemistry.The drug treated animals kept on food and water consistently showed bloating and lesions (Fig. 1) with a frequency of 6-70 ulcers in the rumen section of the stomachs.

Effects of cisplatin treatment on the rat neurohypophysis

1986 ◽  
Vol 44 ◽  
pp. 122-123
Author(s):  
J.M. Fadool ◽  
P.J. Boyer ◽  
S.K. Aggarwal
Keyword(s):  
Side Effects ◽  
Urine Output ◽  
Morphological Changes ◽  
Limiting Factor ◽  
Antineoplastic Drugs

Cisplatin (CDDP) is currently one of the most valuable antineoplastic drugs available. However, it has severe toxic side effects of which nephrotoxicity is the major dose limiting factor in its use. It induces morphological changes in the kidney with hampered urine output. The present study is an effort to determine the influence of the drug on the neurohypophysis for any antidiuretic effects on the kidney.

Severe Drooling and Treatment With Botulinum Toxin

2012 ◽  
Vol 21 (1) ◽  
pp. 15-21
Author(s):  
Merete Bakke ◽  
Allan Bardow ◽  
Eigild Møller
Keyword(s):  
Botulinum Toxin ◽  
Side Effects ◽  
Health Risk ◽  
Flow Rate ◽  
Clinical Evidence ◽  
Acetylcholine Release ◽  
Psychosocial Problems ◽  
Rate Reduction ◽  
Local Inhibition ◽  
Surgical Treatments

Severe drooling is associated with discomfort and psychosocial problems and may constitute a health risk. A variety of different surgical and non-surgical treatments have been used to diminish drooling, some of them with little or uncertain effect and others more effective but irreversible or with side effects. Based on clinical evidence, injection with botulinum toxin (BTX) into the parotid and submandibular glands is a useful treatment option, because it is local, reversible, and with few side effects, although it has to be repeated. The mechanism of BTX is a local inhibition of acetylcholine release, which diminishes receptor-coupled secretion and results in a flow rate reduction of 25–50% for 2–7 months.

Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial

2001 ◽  
Vol 26 (1) ◽  
pp. 67-71 ◽  
Author(s):  
S. A. Ahmadi-Abhari ◽  
S. Akhondzadeh ◽  
S. M. Assadi ◽  
O. L. Shabestari ◽  
Z. M. Farzanehgan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Controlled Trial ◽  
Double Blind ◽  
Randomized Controlled

Antimicrobials: Use With Care to Avoid Side Effects

2008 ◽  
Vol 42 (12) ◽  
pp. 10
Author(s):  
Diana Mahoney
Keyword(s):  
Side Effects
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