Safety Of Treatment Options Research Articles

The best regimens for chemo-naïve incurable non-squamous non-small cell lung cancer with a programmed death-ligand 1, tumor proportion score 1-49%: a network meta-analysis.

BackgroundNon-small cell lung cancer (NSCLC) is the leading cause of cancer-related death worldwide. There is a rank order of the efficacy and safety of treatment options, including immune checkpoint inhibitors (ICIs), bevacizumab (Bev), and cytotoxic drugs. When patients have low programmed death-ligand 1 (PD-L1) expression, there are multiple options for treatment. In this study, we focused on ICI regimens in patients with non-squamous NSCLC with low PD-L1 expression and no driver alterations and assessed the efficacy of the regimens using network meta-analysis.MethodsRandomized trials for incurable chemo-naïve non-squamous NSCLC were collected through electronic searches. The data were independently extracted and cross-checked by two investigators. The primary outcome of this analysis was overall survival (OS). A frequentist weighted least-squares approach random-model network meta-analysis was applied.ResultsSixty-eight eligible studies and 22,619 patients were identified. Using a platinum + third-generation cytotoxic agent regimen (platinum regimen) as a reference, the platinum regimen + pembrolizumab (Pemb) [hazard ratio (HR) =0.55, 95% confidence interval (CI): 0.34–0.89, P=0.015] showed the best OS, followed by the platinum regimen + nivolumab (Niv) + ipilimumab (Ipi) (HR =0.61, 95% CI: 0.44–0.84, P=0.003) with no heterogeneity (I2=0%, P=0.348).ConclusionsThe addition of Pemb or Niv/Ipi to platinum-based chemotherapy seems to be a good therapeutic option for non-squamous NSCLC with a PD-L1 tumor proportion score (TPS) of 1–49%.

Idiopathic multifocal choroiditis and punctate inner choroidopathy: an evaluation in pregnancy.

PurposeTo evaluate the clinical course of idiopathic multifocal choroiditis (MFC) and punctate inner choroidopathy (PIC) and the efficacy and safety of treatment options during pregnancy.MethodsPatients with MFC or PIC and a pregnancy in 2011–2019 from two academic centres were enrolled. For the most recent pregnancy, data on best‐corrected visual acuity (BCVA) before and after pregnancy, relapse rate in pregnancy and postpartum period and obstetric, maternal and neonatal outcomes were collected. Treatment regimens consisted of a wait‐and‐see regime and an immunosuppressive treatment regime with systemic corticosteroids and/or azathioprine, both combined with intravitreal antivascular endothelial growth factor injections when indicated.ResultsSixteen women (26 affected eyes) were included. Median Snellen BCVA was 20/19 before pregnancy and 20/18 after delivery. In seven pregnancies a wait‐and‐see regime and in nine pregnancies an immunosuppressive treatment regime was carried out. Fourteen intravitreal anti‐VEGF injections were given in six pregnancies. The relapse rate during pregnancy was 44% and in the postpartum period 31%. Maternal/obstetrical and fetal complications occurred in 31% and 13% of the pregnancies, respectively. Fifteen healthy children were born and one pregnancy ended in a stillbirth in a patient with a complicated obstetrical history. One patient treated with azathioprine developed intrahepatic cholestasis of pregnancy (ICP).ConclusionsAmong women with MFC and PIC BCVA remained stable during pregnancy despite a relapse rate of 44% in pregnancy. No major maternal, obstetric and fetal complications occurred in pregnant patients treated with systemic corticosteroids, azathioprine or intravitreal anti‐VEGF injections, though one patient developed ICP while treated with azathioprine.

Retinoblastoma.

Retinoblastoma is a rare cancer of the infant retina that is diagnosed in approximately 8,000 children each year worldwide. It forms when both retinoblastoma gene (RB1) alleles are mutated in a susceptible retinal cell, probably a cone photoreceptor precursor. Loss of the tumour-suppressive functions of the retinoblastoma protein (pRB) leads to uncontrolled cell division and recurrent genomic changes during tumour progression. Although pRB is expressed in almost all tissues, cone precursors have biochemical and molecular features that may sensitize them to RB1 loss and enable tumorigenesis. Patient survival is >95% in high-income countries but <30% globally. However, outcomes are improving owing to increased disease awareness for earlier diagnosis, application of new guidelines and sharing of expertise. Intra-arterial and intravitreal chemotherapy have emerged as promising methods to salvage eyes that with conventional treatment might have been lost. Ongoing international collaborations will replace the multiple different classifications of eye involvement with standardized definitions to consistently assess the eligibility, efficacy and safety of treatment options. Life-long follow-up is warranted, as survivors of heritable retinoblastoma are at risk for developing second cancers. Defining the molecular consequences of RB1 loss in diverse tissues may open new avenues for treatment and prevention of retinoblastoma, as well as second cancers, in patients with germline RB1 mutations.

Patient preferences for a polypill for the prevention of cardiovascular diseases.

Polypill-based strategies have improved patient use of preventive cardiovascular disease (CVD) medications in clinical trials. Continued use in real-world settings relies on patients preferring a polypill over current treatment. Within a clinical trial assessing a CVD polypill-based strategy on patient adherence (Kanyini Guidelines Adherence with the Polypill study [Kanyini GAP]), we used discrete choice experiment (DCE) to assess the influence of polypill-based treatment attributes and patient characteristics on preferences for CVD preventive treatment. A DCE survey was administered to Kanyini GAP participants, involving choices between 2 hypothetical treatment options and no treatment for CVD prevention. Attributes delineating a polypill from current treatment were assessed: out-of-pocket costs, tablet number, administration, and prescriber visit frequency. The odds ratios (ORs) for preferring treatment, trade-off between treatment-related attributes, and willingness to pay against other attributes were estimated. In all, 332 of 487 (68%) participants completed the survey. Active treatment, compared with no treatment, was chosen by 93%. Treatment preference decreased with increasing out-of-pocket cost (OR = 0.04; 95% CI = 0.03-0.05) and tablet number (OR = 0.69; 95% CI = 0.59-0.81). Out-of-pocket cost was the most important attribute. Respondents were willing to pay $3.45 per month for each tablet reduction. Education and household income significantly influenced treatment preference. Assuming equivalent efficacy and safety of treatment options, the treatment-specific attributes that were assessed and influenced patient preference strongly accord with the posited advantages of the cardiovascular polypill. The study provides promising evidence that improvements in treatment adherence observed in CVD polypill trials may translate to the real world and potentially close treatment gaps in CVD prevention.

The Impact of Mood Disorders and Their Treatment on the Pregnant Woman, the Fetus, and the Infant

Treatment of mood disorders in pregnant or nursing women can carry significant risks for the mother and the developing infant. For patients and physicians, it may be difficult to obtain current information to make the proper decisions regarding pharmacologic and alternative treatments. Thus, this paper discusses the risks and benefits of pharmacologic treatment and the risks of not treating depression and bipolar disorder in the pregnant woman. The safety of treatment options is reviewed. Alternative treatment options are also discussed.

Management of cancer-related vertebral compression fracture: Comparison of treatment options: A literature meta-analysis

e20529 Objective: The objective of this review was to compare the efficacy and safety of treatment options for management of vertebral compression fractures (VCF) secondary to multiple myeloma and/or metastatic tumors based on a meta-analysis of the literature. Methods: A search was performed of published literature through November 2008. All articles reporting at least one clinical outcome were included. VAS pain scores and cement extravasation were the most common efficacy and safety outcomes reported in the included studies and were considered for analysis. The mean weighted difference in VAS scores or the effect size was calculated using the number of patients in each study as the weights. The paired t-test was used to assess significance of these differences. A 95% confidence interval (CI) was computed around these differences. The significance of difference (VAS and % cement extravasations) between different modes of treatment was assessed using a two sample t-test. Results: A total of 59 studies met the inclusion criteria and were included in the meta-analysis. The majority of the included studies (56 studies) were case series. No randomized controlled study was identified. The total sample size from the included study was 4,460 patients - 73% of patients had a diagnosis of tumor metastasis to the vertebral column; 18% had a diagnosis of multiple myeloma. Percutaneous vertebroplasty (VP) was described in 57.6% studies; balloon kyphoplasty (BKP) in 20.3%; conservative/combined (CC) therapy in 22%. Results are shown in the Table . Conclusions: This meta-analysis indicates that BKP is more effective than either VP or conservative therapy in relieving pain secondary to cancer-related VCF and that BKP is a safer intervention than VP based on the analysis of the rates of cement extravasation. [Table: see text] No significant financial relationships to disclose.