Retrospective Review on the Safety and Efficacy of Nitrofurantoin for the Treatment of Cystitis in the Veteran Population With or Without Renal Insufficiency

Abstract Background The emergence of antimicrobial resistance in uropathogens has generated interest in the use of nitrofurantoin in controversial populations, such as in males and those with renal dysfunction. The purpose of this study was to compare the efficacy and safety of nitrofurantoin for the treatment of cystitis in males and females with variable degrees of renal dysfunction. Methods A retrospective chart review was conducted in adult patients who received nitrofurantoin for acute cystitis in the outpatient setting. The primary outcome was clinical cure compared between males and females and across various renal function groups (creatinine clearances [CrCl] >60 mL/min, 30–60 mL/min, and <30 mL/min) following nitrofurantoin treatment. The secondary outcome was adverse events. Results A total of 446 patients were included, with 278 females and 168 males. The overall clinical cure rate was 86.5% (95% CI, 83.0%–89.4%; n = 386). The clinical cure rate did not vary between genders (odds ratio [OR], 0.6; 95% CI 0.35–1.04; P = .085) or between patients with a CrCl >60 mL/min compared with those with CrCl 30–60 mL/min (OR, 1.01; 95% CI, 0.40–2.44; P = 1). The 1 patient with a CrCl <30 mL/min was not included in the analysis. A history of benign prostatic hyperplasia (OR, 0.5; 95% CI, 0.26–0.99; P = .045) or cirrhosis (OR, 0.21; 95% CI, 0.06–0.82; P = .025) was associated with decreased odds of clinical cure. Adverse events occurred in 2% (n = 9) of patients. Conclusions There was no statistically significant difference in clinical cure with nitrofurantoin between genders or various renal functions.

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1692. Retrospective Review on the Safety and Efficacy of Nitrofurantoin for the Treatment of Cystitis in the Veteran Population With or Without Renal Insufficiency

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1870 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S829-S830

Author(s):

Elwyn W Welch ◽

Shaila Sheth ◽

Chester Ashong ◽

Caroline Pham

Keyword(s):

Renal Function ◽

Renal Dysfunction ◽

Clinical Cure ◽

Clinical Cure Rate ◽

Retrospective Chart Review ◽

Outpatient Setting ◽

Secondary Outcome ◽

Cure Rate ◽

Acute Cystitis ◽

Significant Difference

Abstract Background Nitrofurantoin has been used to treat cystitis in women; however, data supporting its use in men is lacking. In addition, recent retrospective studies have challenged the manufacturer’s recommendation to avoid nitrofurantoin with creatinine clearances (CrCl) less than 60 mL/min. The purpose of this study is to compare the efficacy and safety of nitrofurantoin for the treatment of acute cystitis in male and female veterans with variable degrees of renal dysfunction. Methods A retrospective chart review was conducted in adult patients who received nitrofurantoin for acute cystitis in the outpatient setting between May 1, 2018 and May 1, 2019. The primary outcomes were rates of clinical cure as compared between males and females, and across various renal function groups (CrCl greater than 60 mL/min, 30 to 60 mL/min, and less than 30 mL/min) following treatment with nitrofurantoin. The secondary outcome was adverse event rates. Results A total of 446 patients were included with 278 females and 168 males. Overall clinical cure rate was 86.5% (n=386). Clinical cure rate did not vary between genders (p=0.0851) or CrCl ranges (p=1.0) as shown in the tables. Benign prostatic hyperplasia (BPH) was associated with decreased odds of clinical cure (OR 0.50 [95% CI 0.26-0.97], p=0.0404) in addition to cirrhosis (OR 0.22 [95% CI 0.06-0.91], p=0.0357). Adverse events occurred in 2% of patients and did not vary based on gender or renal function. RATES OF CLINICAL CURE Conclusion There was no statistically significant difference in clinical cure with nitrofurantoin between genders and various renal impairments. However, history of BPH and cirrhosis were associated with decreased efficacy. Subgroup analysis also revealed lower efficacy in males with CrCl greater than 60 mL/min versus females with similar renal function. This study adds to the growing body of literature suggesting that renal dysfunction with CrCl of 30 to 60 mL/min may not carry the risk of treatment failure and adverse effects previously associated with nitrofurantoin, but large randomized trials are needed to confirm these results. Disclosures All Authors: No reported disclosures

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Ceftazidime–Avibactam versus Meropenem for the Treatment of Complicated Intra-Abdominal Infections

Antibiotics ◽

10.3390/antibiotics8040255 ◽

2019 ◽

Vol 8 (4) ◽

pp. 255 ◽

Cited By ~ 3

Author(s):

Che-Kim Tan ◽

Chih-Cheng Lai ◽

Chien-Ming Chao

Keyword(s):

Adverse Events ◽

Clinical Cure ◽

Clinical Cure Rate ◽

Study Drug ◽

Comparable Efficacy ◽

Integrated Analysis ◽

Cure Rate ◽

Serious Adverse Events ◽

Mitt Population ◽

Abdominal Infections

This study reports an integrated analysis of three randomized controlled trials to compare the clinical efficacies and safety of the ceftazidime–avibactam (CAZ–AVI) combination and meropenem in the treatment of adult patients with complicated intra-abdominal infections (cIAIs). Overall, a total of 1677 patients (CAZ–AVI: 835 patients; meropenem: 842 patients) were included in this analysis. CAZ–AVI had a clinical cure rate at test of cure in the clinically evaluable (CE) population similar to that of meropenem (OR, 0.88; 95% CI, 0.58–1.32; I2 = 0%). Similar trends were also observed in the modified intent-to-treat (MITT) population (OR, 0.80; 95% CI, 0.59–1.09; I2 = 0%) and microbiological evaluable (ME) population (OR, 0.73; 95% CI, 0.32–1.68; I2 = 0%). In terms of clinical cure rate at the end of treatment, the efficacy of CAZ–AVI was comparable to that of meropenem in the CE population (OR, 0.77; 95% CI, 0.47–1.25; I2 = 0%), MITT population (OR, 0.70; 95% CI, 0.47–1.06; I2 = 5%), and ME population (OR, 1.26; 95% CI, 0.39–4.08; I2 = 0%). CAZ–AVI had a similar risk of (i) treatment emergent adverse events (TEAEs) (OR, 1.03; 95% CI, 0.79–1.36; I2 = 38%), (ii) any serious adverse events (OR, 0.97; 95% CI, 0.67–1.40; I2 = 0%), (iii) discontinuation of study drug due to TEAE (OR, 2.14; 95% CI, 1.00–4.57), and iv) all-cause mortality (OR, 1.66; 95% CI, 0.78–3.53; I2 = 0%) when compared with meropenem. In conclusion, CAZ–AVI had comparable efficacy and safety profile to those of meropenem in the treatment of cIAI.

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Phase 2 Study of Ceftaroline versus Standard Therapy in Treatment of Complicated Skin and Skin Structure Infections

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.00590-07 ◽

2007 ◽

Vol 51 (10) ◽

pp. 3612-3616 ◽

Cited By ~ 107

Author(s):

George H. Talbot ◽

Dirk Thye ◽

Anita Das ◽

Yigong Ge

Keyword(s):

Success Rate ◽

Standard Therapy ◽

Clinical Cure ◽

Clinical Cure Rate ◽

Tolerability Profile ◽

Clinical Relapse ◽

Cure Rate ◽

Ceftaroline Fosamil ◽

Skin Structure ◽

Complicated Skin

ABSTRACT Ceftaroline, the bioactive metabolite of ceftaroline fosamil (previously PPI-0903, TAK-599), is a broad-spectrum cephalosporin with potent in vitro activity against multidrug-resistant gram-positive aerobic pathogens, including methicillin-resistant Staphylococcus aureus. A randomized, observer-blinded study to evaluate the safety and efficacy of ceftaroline versus standard therapy in treating complicated skin and skin structure infections (cSSSI) was performed. Adults with cSSSI, including at least one systemic marker of inflammation, were randomized (2:1) to receive intravenous (i.v.) ceftaroline (600 mg every 12 h) or i.v. vancomycin (1 g every 12 h) with or without adjunctive i.v. aztreonam (1 g every 8 h) for 7 to 14 days. The primary outcome measure was the clinical cure rate at a test-of-cure (TOC) visit 8 to 14 days after treatment. Secondary outcomes included the microbiological success rate (eradication or presumed eradication) at TOC and the clinical relapse rate 21 to 28 days following treatment. Of 100 subjects enrolled, 88 were clinically evaluable; the clinical cure rate was 96.7% (59/61) for ceftaroline versus 88.9% (24/27) for standard therapy. Among the microbiologically evaluable subjects (i.e., clinically evaluable and having had at least one susceptible pathogen isolated at baseline), the microbiological success rate was 95.2% (40/42) for ceftaroline versus 85.7% (18/21) for standard therapy. Relapse occurred in one subject in each group (ceftaroline, 1.8%; standard therapy, 4.3%). Ceftaroline exhibited a very favorable safety and tolerability profile, consistent with that of marketed cephalosporins. Most adverse events from ceftaroline were mild and not related to treatment. Ceftaroline holds promise as a new therapy for treatment of cSSSI and other serious polymicrobial infections.

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Impact of Colistin Dosing on the Incidence of Nephrotoxicity in a Tertiary Care Hospital in Saudi Arabia

Antibiotics ◽

10.3390/antibiotics9080485 ◽

2020 ◽

Vol 9 (8) ◽

pp. 485 ◽

Cited By ~ 1

Author(s):

Reem Almutairy ◽

Waad Aljrarri ◽

Afnan Noor ◽

Pansy Elsamadisi ◽

Nour Shamas ◽

...

Keyword(s):

Serum Albumin ◽

Clinical Cure ◽

Clinical Cure Rate ◽

Serum Albumin Level ◽

Tertiary Care ◽

Multivariable Analysis ◽

Severity Of Illness ◽

Albumin Level ◽

Care Hospital ◽

Cure Rate

Colistin therapy is associated with the development of nephrotoxicity. We examined the incidence and risk factors of nephrotoxicity associated with colistin dosing. We included adult hospitalized patients who received intravenous (IV) colistin for >72 h between January 2014 and December 2015. The primary endpoint was the incidence of colistin-associated acute kidney injury (AKI). The secondary analyses were predictors of nephrotoxicity, proportions of patients inappropriately dosed with colistin according to the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Garonzik formula and clinical cure rate. We enrolled 198 patients with a mean age of 55.67 ± 19.35 years, 62% were men, and 60% were infected with multidrug-resistant organisms. AKI occurred in 44.4% (95% CI: 37.4–51.7). Multivariable analysis demonstrated that daily colistin dose per body weight (kg) was associated with AKI (OR: 1.57, 95% CI: 1.08–2.30; p = 0.02). Other significant predictors included serum albumin level, body mass index (BMI), and severity of illness. None of the patients received loading doses, however FDA-recommended dosing was achieved in 70.2% and the clinical cure rate was 13%. The incidence of colistin-associated AKI is high. Daily colistin dose, BMI, serum albumin level, and severity of illness are independent predictors of nephrotoxicity.

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The Efficacy and Safety of Eravacycline in the Treatment of Complicated Intra-Abdominal Infections: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

Journal of Clinical Medicine ◽

10.3390/jcm8060866 ◽

2019 ◽

Vol 8 (6) ◽

pp. 866 ◽

Cited By ~ 8

Author(s):

Shao-Huan Lan ◽

Shen-Peng Chang ◽

Chih-Cheng Lai ◽

Li-Chin Lu ◽

Chien-Ming Chao

Keyword(s):

Adverse Event ◽

Clinical Cure ◽

Clinical Cure Rate ◽

Clinical Failure ◽

Efficacy And Safety ◽

Cure Rate ◽

Randomized Controlled ◽

Evaluable Population ◽

Intent To Treat ◽

Treat Population

This study aims to assess the clinical efficacy and safety of eravacycline for treating complicated intra-abdominal infection (cIAI) in adult patients. The PubMed, Web of Science, EBSCO, Cochrane databases, Ovid Medline, Embase, and ClinicalTrials.gov were searched up to May 2019. Only randomized controlled trials (RCTs) that evaluated eravacycline and other comparators for the treatment of cIAI were included. The primary outcome was the clinical cure rate at the test-of-cure visit based on modified intent-to-treat population, microbiological intent-to-treat population, clinically evaluable population, and microbiological evaluable population, and the secondary outcomes were clinical failure rate and the risk of adverse event. Three RCTs were included. Overall, eravacycline had a clinical cure rate (88.7%, 559/630) at test-of-cure in modified intent-to-treat population similar to comparators (90.1%, 492/546) in the treatment of cIAIs (risk ratio (RR), 0.99; 95% confidence interval (CI), 0.95–1.03; I2 = 0%, Figure 3). In the microbiological intent-to-treat, clinically evaluable, and microbiological evaluable populations, no difference was found between eravacycline and comparators in terms of clinical cure rate at test-of-cure (microbiological intent-to-treat population, RR, 0.99; 95% CI, 0.95–1.04; I2 = 0%, clinically evaluable population, RR, 1.00; 95% CI, 0.97–1.03; I2 = 0%, microbiological evaluable population, RR, 0.98; 95% CI, 0.95–1.02; I2 = 0%). In addition, eravacycline had clinical failure rate similar to comparators at test-of-cure in modified intent-to-treat population (RR, 1.01; 95% CI, 0.61–0.69; I2 = 0%), microbiological intent-to-treat population (RR, 1.34; 95% CI, 0.77–2.31; I2 = 16%), clinically evaluable population (RR, 1.03; 95% CI, 0.61–1.76; I2 = 0%), and microbiological evaluable population (RR, 1.32; 95% CI, 0.75–2.32; I2 = 10%). Although eravacycline was associated with higher risk of treatment-emergent adverse event than comparators (RR, 1.34; 95% CI, 1.13–1.58; I2 = 0%), no significant differences were found between eravacycline and comparators for the risk of serious adverse event (RR, 1.04; 95% CI, 0.65–1.65; I2 = 0%), discontinuation of study drug because of adverse event (RR, 0.68; 95% CI, 0.23–1.99; I2 = 13%), and all-cause mortality (RR, 1.09; 95% CI, 0.41–2.9; I2 = 28%). In conclusion, the clinical efficacy of eravacycline is as high as that of the comparator drugs in the treatment of cIAIs and this antibiotic is as well tolerated as the comparators.

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P0341RITUXIMAB IN THE TREATMENT OF PRIMARY MEMBRANOUS NEPHROPATHY - A COMPARATIVE STUDY OF THREE REGIMEN

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa144.p0341 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Harbir Singh Kohli ◽

Raja Ramachandran ◽

Manish Rathi ◽

Ranjana Minz ◽

Ritambhra Nada Duseja

Keyword(s):

Targeted Therapy ◽

Adverse Events ◽

Serum Albumin ◽

Cumulative Dose ◽

Membranous Nephropathy ◽

Response Rate ◽

Secondary Outcome ◽

Therapy Initiation ◽

Significant Difference

Abstract Background and Aims Different rituximab dosing schedules have been used to manage primary membranous nephropathy (PMN). Better response rate and toxicity needs to be balanced to arrive at correct dose. The dosing schedules in PMN as of now are an on the lines of the management of lymphoma or rheumatoid arthritis. In the current study, we report the 1-year outcome of patients treated with three dosing schedules of rituximab in PMN. Method The current report is a study of patient of PMN treated with three different dosing schedules of rituximab treatment. The study included PMN patients with nephrotic syndrome (proteinuria>3.5 g/day and serum albumin of < 3.5 g/dL). Patients with secondary membranous nephropathy and a history of prior exposure of immunosuppressive therapy in the last three months were excluded from the study. The three dosing schedules of rituximab were 1 g (on day 0,15) (regimen 1), 375 mg/m2 (weekly for four weeks) (regimen 2) or CD19 targeted rituximab therapy (375 mg/m2 as the initial dose and additional dose 100 mg, when the CD19 cell count was> 5/ul or >1%, done every month for 12 months) (regimen 3). Serum PLA2R autoantibodies were done before rituximab therapy and at six months of therapy initiation. Primary outcomes: Remission at the end of 12 months of therapy initiation. Secondary outcome: Complete remission (CR) and partial remission (PR), remission with different treatment schedules and adverse events. Definition: CR: reduction of proteinuria to <0.5 g/d and with creatinine clearance of >60 ml/min/1.73m2 and serum albumin > 3.5 g/dl. PR: reduction of proteinuria to 0.5–3.5 g/day and stable serum creatinine. A p-value of <0.05 was considered significant. Results The study included 87 patients of PMN. The mean age of the patients was 33.36±15.38 (range 15-61) years. Thirty-two (36.4%) and 56 (63.6%) patients received rituximab as the first-line therapy and for relapsing/resistant disease, respectively. Forty, 15 and 33 patients received regimen 1, 2 and 3, respectively. The median proteinuria, serum albumin and creatinine at the baseline before rituximab therapy was 5.90 (IQR 4.20,9.75) gm, 2.50 (IQR 2.15,3.25) g/dl and 0.88 (IQR 0.77,1.09) mg/dl, respectively. At the end of 12 months of follow-up, 55 (56.8%) patients received remission. Nineteen (21.6%) and 32 (36.3%) patients achieved CR and PR, respectively. In regimen 1, 12 (30%) and 13 (32.5%) patients achieved CR and PR, respectively. In regimen 2, 2 (13.3%) and 5 (33.3%) patients achieved CR and PR, respectively. In regimen 3, 5 (15.6%) and 14 (43.7%) patients achieved CR and PR, respectively. One patient in the CD19 targeted therapy (regimen 3) was lost to follow-up after the 1st dose; all but one patient in the received regimen three as a second-line treatment. There was a significant association of anti-PLA2R to clinical response (p<0.05). There was no difference in the response rate among the three groups (p>0.05). A total of 7 (7.9%) patients had severe adverse events, there was no difference in the 3 regimens. (p>0.05) The cumulative dose in regimen 3 was significantly less as compared to regimen 1 & 2 (p<0.01) Conclusion Rituximab induces remission in two-thirds of the patients with PMN. There is no significant difference in the remission rates between different rituximab regimens. CD19 targeted therapy is equally effective with lower cumulative dose.

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Cethromycin versus Clarithromycin for Community-Acquired Pneumonia: Comparative Efficacy and Safety Outcomes from Two Double-Blinded, Randomized, Parallel-Group, Multicenter, Multinational Noninferiority Studies

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.05596-11 ◽

2012 ◽

Vol 56 (4) ◽

pp. 2037-2047 ◽

Cited By ~ 16

Author(s):

Marci L. English ◽

Christine E. Fredericks ◽

Nancy A. Milanesio ◽

Nestor Rohowsky ◽

Ze-Qi Xu ◽

...

Keyword(s):

Clinical Cure ◽

Clinical Cure Rate ◽

The United States ◽

Community Acquired Pneumonia ◽

Phase Iii ◽

Efficacy And Safety ◽

Cure Rate ◽

Content Type ◽

Dosing Regimens ◽

Double Blinded

ABSTRACTCommunity-acquired pneumonia (CAP) continues to be a major health challenge in the United States and globally. Factors such as overprescribing of antibiotics and noncompliance with dosing regimens have added to the growing antibacterial resistance problem. In addition, several agents available for the treatment of CAP have been associated with serious side effects. Cethromycin is a new ketolide antibiotic that may provide prescribing physicians with an additional agent to supplement a continually limited armamentarium. Two global phase III noninferiority studies (CL05-001 and CL06-001) to evaluate cethromycin safety and efficacy were designed and conducted in patients with mild to moderate CAP. Study CL05-001 demonstrated an 83.1% clinical cure rate in the cethromycin group compared with 81.1% in the clarithromycin group (95% confidence interval [CI], −4.8%, +8.9%) in the intent to treat (ITT) population and a 94.0% cethromycin clinical cure rate compared with a 93.8% clarithromycin cure rate (95% CI, −4.5%, +5.1%) in the per protocol clinical (PPc) population. Study CL06-001 achieved an 82.9% cethromycin clinical cure rate in the ITT population compared with an 88.5% clarithromycin cure rate (95% CI, −11.9%, +0.6%), whereas the clinical cure rate in the PPc population was 91.5% in cethromycin group compared with 95.9% in clarithromycin group (95% CI, −9.1%, +0.3%). Both studies met the primary endpoints for clinical cure rate based on predefined, sliding-scale noninferiority design. Therefore, in comparison with clarithromycin, these two noninferiority studies demonstrated the efficacy and safety of cethromycin, with encouraging findings of efficacy in subjects withStreptococcus pneumoniaebacteremia. No clinically significant adverse events were observed during the studies. Cethromycin may be a potential oral therapy for the outpatient treatment of CAP.

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Prospective Study of the Wilson Severity-of-Illness Scoring System for Complicated Skin and Skin Structure Infections

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01344-12 ◽

2012 ◽

Vol 57 (1) ◽

pp. 647-650 ◽

Cited By ~ 2

Author(s):

George H. Talbot ◽

Tanya O'Neal ◽

Anita F. Das ◽

Dirk Thye

Keyword(s):

Clinical Cure ◽

Clinical Cure Rate ◽

Severity Of Illness ◽

Cure Rate ◽

Two Phase ◽

Ceftaroline Fosamil ◽

Risk Class ◽

Skin Structure ◽

Complicated Skin ◽

Cure Rates

ABSTRACTWilson et al. (Am. J. Surg.185:369–375, 2003) developed a disease severity classification system for use in complicated skin and skin structure infections (cSSSI). Two phase 3 trials of ceftaroline fosamil in cSSSI provided the opportunity to evaluate the association between Wilson Severity Risk Class and clinical cure rates. Our analyses did not confirm that an association exists between Wilson Severity Risk Class and clinical cure rate and, thus, did not validate its predictive utility.

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Comparing Several Treatments with Antibiotics for CommunityAcquired Pneumonia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Iranian Journal of Public Health ◽

10.18502/ijph.v50i6.6410 ◽

2021 ◽

Author(s):

Fusheng Bai ◽

Xinming Li

Keyword(s):

Randomized Controlled Trials ◽

Subgroup Analysis ◽

Clinical Cure ◽

Clinical Cure Rate ◽

Meta Analysis ◽

Controlled Trials ◽

Clinical Effects ◽

Cure Rate ◽

Ceftaroline Fosamil ◽

Randomized Controlled

Background: We aimed to review relevant randomized controlled trials to assess the relative clinical effects of antibiotic treatment of patients with community-acquired pneumonia (CAP). Methods: In this meta-analysis, we identified relevant studies from PubMed, Cochrane, and Embase using appropriate keywords. Key pertinent sources in the literature were also reviewed and all articles published through Oct 2019 were considered for inclusion. For each study, we assessed the risk ratios (RRs) or mean difference combined with the 95% confidence interval (CI) to assess and synthesize outcomes. Results: Overall, 36 studies were consistent with the meta-analysis, involving 17,076 patients. There was no significant difference in the mortality after subgroup analysis: individualized treatment vs. standard treatment; β-lactams plus macrolides vs. β-lactam and/or fluoroquinolone; ceftaroline fosamil vs. ceftriaxone; combination therapy vs. monotherapy or high-dose vs. low-dose. The drug-related adverse event incidence was significantly higher in the ceftriaxone group than in the other drug groups (P<0.05) and also higher in the tigecyline group than in the levofloxacin group (P<0.05). Compared with ceftriaxone, ceftaroline fosamil significantly increased the clinical cure rate at the test-of-cure (TOC) visit in the clinically evaluable population, modified intent-to-treat efficacy (MITTE) population, microbiologically evaluable (ME) population and the microbiological MITTE (mMITTE) population (all P<0.05). Compared with ceftriaxone, ceftaroline fosamil significantly increased the clinical cure rate at the TOC visit in the mMITTE population of Gram positiveStreptococcus pneumoniae (P<0.05) and multidrug-resistant S. pneumoniae (P<0.05). Conclusion: There was a limited number of included studies in the subgroup analysis, but it will still be necessary to conduct more high-quality randomized controlled trials to confirm the clinical efficacy of different antibiotics used to treat CAP.

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Ophthalmic artery catheterization for retinoblastoma treatment: does reflux affect tumor response?

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2019-015597 ◽

2020 ◽

Vol 12 (9) ◽

pp. 915-920 ◽

Cited By ~ 2

Author(s):

Ahmad Sweid ◽

Batoul Hammoud ◽

Joshua H Weinberg ◽

Pavlos Texakalidis ◽

Vivian Xu ◽

...

Keyword(s):

Adverse Events ◽

Ophthalmic Artery ◽

Tumor Response ◽

Retrospective Chart Review ◽

Primary Treatment ◽

Study Cohort ◽

Significant Difference ◽

Group A ◽

Poor Outcomes ◽

Group B

BackgroundIntra-arterial chemotherapy (IAC) for retinoblastoma (Rb) has been established as a primary treatment for the disease. To determine whether the presence of reflux into the ICA is associated with tumor response or with any other adverse events in pediatric retinoblastoma patients.MethodsA retrospective chart review was performed for patients diagnosed with Rb and managed with ophthalmic artery catheterization (OAC).ResultsThe total study cohort included 205 Rb tumors of 205 eyes in 194 consecutive patients who underwent 624 successful intra-arterial chemotherapy infusions using OAC. Of the 205 eyes, 65 eyes (32.7%) underwent 157 OAC procedures constituted group A (no reflux), 64 eyes (31.2%) underwent 236 OAC procedures constituted group B (variable pattern), and 74 eyes (36.1%) underwent 231 OAC procedures constituted group C (reflux). There was no significant difference in baseline characteristics between the three cohorts. Also, there was no significant difference in tumor characteristics between the three groups, except for genetic status. There was no significant difference between the three groups in terms of tumor response at completion of the treatment regimen. Complete tumor response was achieved at 70.2% in Group A, at 83.3% in Group B, and at 78.5% in group C (P=0.39). Similarly, eye enucleation occurred at 38.5% in group A, 31.8% in group B, and 31.5% in group C. None of the patients in both groups had any neurological adverse events or new onset of seizures.ConclusionsThe presence of reflux, which may complicate the procedure and prolong it, was not associated with poor outcomes in our analysis.

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