EBNEO Commentary: Safety of early discontinuation of anti‐seizure medication in neonates

2021 ◽  
Author(s):  
Natasha Keerthika Russell ◽  
Gopakumar Hariharan
Keyword(s):  
Early Discontinuation

scholarly journals Flare phenomenon in prostate cancer: recent evidence on new drugs and next generation imaging

2021 ◽  
Vol 13 ◽  
pp. 175883592098765
Author(s):  
Vincenza Conteduca ◽  
Giulia Poti ◽  
Paola Caroli ◽  
Sabino Russi ◽  
Nicole Brighi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Response Assessment ◽  
New Drugs ◽  
Biological Mechanisms ◽  
Early Discontinuation ◽  
Flare Phenomenon ◽  
Discontinuation Of Treatment ◽  
Different Types ◽  
Treatment Response Assessment ◽  
New Evidence

Over the years, an increasing proportion of metastatic prostate cancer patients has been found to experience an initial bone flare phenomenon under both standard therapies (androgen deprivation therapy, chemotherapy, radiotherapy, abiraterone, enzalutamide) and novel agents (immunotherapy, bone-targeting radioisotopes). The underlying biological mechanisms of the flare phenomenon are still elusive and need further clarification, particularly in relation to different types of treatment and their treatment response assessment. Flare phenomenon is often underestimated and, in some cases, can negatively affect clinical outcome. In cases with suspected bone flare, the treatment should be continued for a minimum of 12 more weeks before further decisions about efficacy can be taken. Physicians and patients should be aware of this effect to avoid unwarranted anxiety and inadequate early discontinuation of treatment. This review aims at highlighting new evidence on flare phenomenon arising after the introduction of new drugs extending across the biochemical, radiographic and clinical spectrum of the disease.

Provider Practices of Phenobarbital Discontinuation in Neonatal Seizures

2017 ◽  
Vol 33 (2) ◽  
pp. 153-157 ◽  
Author(s):  
Niranjana Natarajan ◽  
Christopher W. Beatty ◽  
Juliane Gust ◽  
Lorie Hamiwka
Keyword(s):  
Seizure Control ◽  
Prolonged Treatment ◽  
Published Data ◽  
Neonatal Seizures ◽  
Early Discontinuation ◽  
Treatment Length ◽  
Provider Practices ◽  
Factors Influencing ◽  
Symptomatic Seizures ◽  
Infectious Etiology

Neonatal seizures are treated with phenobarbital and prolonged treatment does not prevent postneonatal epilepsy. The authors documented factors influencing phenobarbital use and determined whether published data changed practice. A total of 83 neonates with symptomatic seizures, clinical or electrographic, were evaluated for treatment, incidence of postneonatal epilepsy, and associated factors. Median phenobarbital treatment was 81 days. Nineteen children (23%) developed postneonatal epilepsy. Longer duration of seizures and an infectious etiology were associated with postneonatal epilepsy suggesting no impact on duration of phenobarbital treatment. Treatment duration was associated with duration of seizures and use of a second antiseizure medication. This study supports early discontinuation of phenobarbital and suggests providers utilize factors such as use of a second antiseizure medication and time to seizure control to determine phenobarbital duration, despite prior studies suggesting no impact of treatment length.

scholarly journals Factors Related to Breastfeeding Discontinuation Between Hospital Discharge and 2 Weeks Postpartum

2011 ◽  
Vol 20 (1) ◽  
pp. 36-44 ◽  
Author(s):  
Elizabeth Brand ◽  
Catherine Kothari ◽  
Mary Ann Stark
Keyword(s):  
Longitudinal Study ◽  
Hospital Discharge ◽  
Secondary Analysis ◽  
Perceived Support ◽  
Breastfeeding Initiation ◽  
New Mothers ◽  
Early Discontinuation ◽  
Problem Solving Skills ◽  
Study Support ◽  
Duration Of Breastfeeding

Although breastfeeding is known to be beneficial to both mother and infant, many women encounter barriers to breastfeeding, even after successful breastfeeding initiation, which may put them at greater risk for early cessation of breastfeeding. The objectives of this study were to conduct a secondary analysis of data from a longitudinal study of postpartum depression to (a) examine factors related to very early discontinuation of breastfeeding (at 2 weeks postpartum) following hospital discharge and (b) identify women’s reasons for very early cessation of breastfeeding. The results of this study support findings from previous research. Having a perceived support system, whether it is personal or professional, may have an effect on both the initiation and duration of breastfeeding. Educating expectant and new mothers, especially women who encounter multiple barriers and are at risk for very early cessation of breastfeeding, of the benefits of breastfeeding and supporting them in developing efficient techniques and problem-solving skills can help increase the duration of breastfeeding.

scholarly journals Early Discontinuation and Nonadherence to Adjuvant Hormonal Therapy in a Cohort of 8,769 Early-Stage Breast Cancer Patients

2010 ◽  
Vol 28 (27) ◽  
pp. 4120-4128 ◽  
Author(s):  
Dawn L. Hershman ◽  
Lawrence H. Kushi ◽  
Theresa Shao ◽  
Donna Buono ◽  
Aaron Kershenbaum ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormonal Therapy ◽  
Early Stage ◽  
Optimal Schedule ◽  
Medication Possession Ratio ◽  
Adjuvant Hormonal Therapy ◽  
Breast Cancer Patients ◽  
Early Discontinuation ◽  
Younger Women ◽  
Hormone Sensitive

Purpose While studies have found that adjuvant hormonal therapy for hormone-sensitive breast cancer (BC) dramatically reduces recurrence and mortality, adherence to medications is suboptimal. We investigated the rates and predictors of early discontinuation and nonadherence to hormonal therapy in patients enrolled in Kaiser Permanente of Northern California health system. Patients and Methods We identified women diagnosed with hormone-sensitive stage I-III BC from 1996 to 2007 and used automated pharmacy records to identify hormonal therapy prescriptions and dates of refill. We used Cox proportional hazards regression models to analyze factors associated with early discontinuation and nonadherence (medication possession ratio < 80%) of hormonal therapy. Results We identified 8,769 patients with BC who met our eligibility criteria and who filled at least one prescription for tamoxifen (43%), aromatase inhibitors (26%), or both (30%) within 1 year of diagnosis. Younger or older age, lumpectomy (v mastectomy), and comorbidities were associated with earlier discontinuation, while Asian race, being married, earlier year at diagnosis, receipt of chemotherapy or radiotherapy, and longer prescription refill interval were associated with completion of 4.5 years of therapy. Of those who continued therapy, similar factors were associated with full adherence. Women age younger than 40 years had the highest risk of discontinuation (hazard ratio, 1.51; 95% CI, 1.23 to 1.85). By 4.5 years, 32% discontinued therapy, and of those who continued, 72% were fully adherent. Conclusion Only 49% of patients with BC took adjuvant hormonal therapy for the full duration at the optimal schedule. Younger women are at high risk of nonadherence. Interventions to improve adherence and continuation of hormonal therapy are needed, especially for younger women.

Feasibility of an adapted schedule of carboplatin plus paclitaxel in elderly women with advanced ovarian cancer: A retrospective cohort.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5546-5546
Author(s):  
Benjamin Nicaise ◽  
Soraya Mebarki ◽  
Mathilde Gisselbrecht ◽  
Elisabeth Ashton ◽  
Henri Azais ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Progressive Disease ◽  
Elderly Women ◽  
Advanced Ovarian Cancer ◽  
Early Discontinuation ◽  
Grade 3 ◽  
Vulnerable Elderly ◽  
Dose Delay ◽  
Dose Reductions ◽  
Unacceptable Toxicity

5546 Background: The EWOC-1 trial compared Carboplatin monotherapy (C mono) to two different Carboplatin + Paclitaxel (CP) regimens (weekly or 3-weekly) in vulnerable elderly patients treated for advanced ovarian cancers (OC). This study was closed prematurely because of a worse outcome in the C mono group. Both CP regimens were equivalent in terms of feasibility and efficacy with different toxicity profiles. Optimal CP regimen in elderly patient is still unknown. Here we propose a study of another adapted regimen of CP (aCP) performed in elderly patients in our institution. Methods: We retrospectively analyzed OC patients ≥ 70 years who received a Carboplatin AUC 4-5 d1q3week + Paclitaxel 80 mg/m² d1-d8 q3week regimen between 2015 and 2019. Primary endpoint was treatment feasibility according to the EWOC-1 standard: completion of 6 courses of chemotherapy without early stopping for disease progression, death or unacceptable toxicity (adverse event (AE) related to chemotherapy or treatment procedure leading either to early treatment stopping, to an unplanned hospital admission or to death or to a dose delay lasting more than 14 days or more than 2 dose reductions). Results: We identified 36 pts with a median age of 79 years (table). All patient but one had an ONCODAGE-G8 score ≤ 14, 30.6% of patients had a comorbidity Charlson’s index > 4 and 52.5% had an albumin rate < 35 g/L. The feasibility endpoint was met in 58.3% of patients (IC95% = [25.6; 57.8]). Main causes of treatment failure (TF) were early discontinuation because of toxicity in 6 patients (16.7%) and progressive disease in 3 patients (8.33%). Median PFS was 35.3 months (IC95% = [22.7; NR]) and median OS was 62.1 months (IC95% = [31.4.0; NR]). The most frequent AE were asthenia (all grades = 94.4%, grade 3-4 = 13.9%), anemia (all grades = 94.4%, grade 3-4 = 27.8%), neutropenia (all grades = 66.7%, grade 3-4 = 38.9%) and neuropathy sensory (all grades = 61.1%, no grade 3-4). Non high-grade-serous histological type and a poor Charlson’s score were associated with a higher rate of TF (100% and 63.6%, respectively). Conclusions: These results are consistent with the findings of the EWOC-1 trial in both CP regimens and suggest that aCP could be non-inferior with an acceptable toxicity profile. Further prospective and comparative studies are mandatory to confirm this trend and to better identify predictive factors of TF in OC elderly patients.[Table: see text]

Preliminary analysis of a U.S. phase II study of the safety and tolerability of proxalutamide (GT0918) in subjects with mCRPC who had progressed on either abiraterone (Abi) or enzalutamide (Enza).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 99-99
Author(s):  
Nicholas J. Vogelzang ◽  
Richard Levin ◽  
Arash Rezazadeh ◽  
Chandler H. Park ◽  
Britt Haley Bolemon ◽  
...  
Keyword(s):  
Phase Ii ◽  
Lipid Lowering ◽  
Early Discontinuation ◽  
Once Daily ◽  
Experimental Therapies ◽  
Daily Dose ◽  
Grade 3 ◽  
Good Treatment Option ◽  
Recommended Phase Ii Dose ◽  
Clinical Trial Information

99 Background: GT0918, an androgen receptor (AR) antagonist, is a new chemical entity with reduced drug accumulation in the CNS. In a phase I dose escalation trial (NCT02826772), GT0918 was well tolerated with some durable responses in mCRPC patients (pts) who had progressed on ≥2 lines of standard and experimental therapies. This Phase 2 was designed to study the safety and efficacy of GT0918 400 mg vs. 500 mg oral daily in mCRPC pts who had progressed on either Abi or Enza with or without prior docetaxel. Methods: Pts with histologically confirmed mCRPC who had progressed on either Abi or Enza with or without prior docetaxel were eligible and randomized to 400 mg or 500 mg of GT0918 administered once daily orally. Pts continued treatment with GT0918 at their assigned dose until disease progression, intolerable toxicities or withdrawal of consent. PSA and labs were checked monthly. Imaging scans (CT/MRI and bone scan), circulating tumor cells and cf-DNA/RNA were performed every 3 months. Results: 61 pts were enrolled at 9 US sites and randomized 1:1 to 400 mg (n = 31) or 500 mg (n = 30) daily dose. All pts had progressed on either Abi (n = 34) or Enza (n = 27). Most of the reported AEs related to GT0918 were grade 1 or 2 as per CTCAE v4.03, but 22 AEs (5.3%) were reported as grade ≥ 3, such as fatigue, increase ALT/AST, rhabdomyolysis, or muscle weakness. Some AEs were due to drug-drug interaction with lipid-lowering medications leading to early discontinuation (26.2%). As of 5 October 2020, twelve pts finished 6 cycles. Among them, three finished 12 cycles and remained on the treatment. Treatment duration showed more pts in the 400 mg cohort with stable disease (SD) on imaging (9/31 finished 6 cycles) compared to the 500 mg cohort (3/30 finished 6 cycles). Further, all three pts who finished 12 cycles had progressed on Abi indicating that GT0918 might be a good treatment option for pts who had progressed on Abi. Conclusions: Proxalutamide (GT0918) administrated orally once a day is well tolerated and resulted in SD in pts who had progressed on either Abi or Enza. The 400 mg/day will be considered as the recommended phase II dose for further clinical trials. GT0918 is warranted for pts failed either Abi or Enza. Clinical trial information: NCT03899467.

The surgical oncology clinical trial landscape: A cross-sectional analysis of ClinicalTrials.gov from 2008-2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1561-1561
Author(s):  
Nirosha D. Perera ◽  
Brandon E. Turner ◽  
Jolie Z. Shen ◽  
Bonnie O. Wong ◽  
Henry K. Litt ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cox Regression ◽  
Surgical Oncology ◽  
Treatment Modalities ◽  
Early Discontinuation ◽  
Cross Sectional ◽  
Surgical Interventions ◽  
Funding Sources ◽  
Oncology Clinical Trials ◽  
Results Reporting

1561 Background: Surgical interventions are studied less often than medical or radiation interventions in oncology clinical trials. We characterized surgical oncology trials registered on ClinicalTrials.gov, analyzed funding sources and identified features associated with early discontinuation and results reporting. Methods: We employed a cross-sectional study design with descriptive, logistic regression, cox regression, time series and survival analyses. We downloaded all 270,172 studies registered on the Aggregate Analysis of the ClinicalTrials.gov database from October 1, 2008 to March 9, 2020. After excluding non-interventional trials, applying cancer/oncology specific Medical Subject Heading terms to the remaining trials and excluding phase 1 trials, 27,915 trials were identified for manual review. Primary exposure variables were trial focus: neoplasia site and treatment modality (surgical interventions included investigations of outcomes from surgical resection or intra-operative/peri-operative changes), and funding: industry, U.S. government, academic. Results: 26,815 trials were found to have true oncology content; 1,661 (6.2%) involved surgical oncology, representing 311,789 patients. Funding sources were: 82.7% by academic institutions, 10.9% by industry, and 6.2% by U.S. government. The most studied neoplasia sites were colorectal (17.4% of trials), breast (10.7%), gastric (10.5%), hepatic (8.6%), lung (7.5%), brain/CNS (6.7%) and cervical (6.6%). U.S. government funded surgical oncology trials had the lowest risk of early discontinuation (adjusted HR 0.65, 95% CI: 0.58-0.73, p<0.001) and the highest odds of results reporting (adjusted OR 1.35, 95% CI: 1.08-1.68, p=0.008) (Table). Conclusions: There is a paucity of surgical oncology clinical trials compared to other treatment modalities, especially in context of surgery’s role in overall cancer care. From 2008-2020 only 6.2% of trials focused on surgical oncology, and U.S. government funded trials displayed the lowest hazard of early discontinuation and highest odds of results reporting. Stakeholders should look to government funded trials as models of improvement, but must increase representation and results dissemination of surgical oncology trials to guide treatment recommendations. Surgical oncology trial features and associated early discontinuation/results reporting.[Table: see text]

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