Rates Of Early Discontinuation Research Articles

Magnitude and associated factors of early Implanon discontinuation among rural women in public health facilities of central Ethiopia: a community-based cross-sectional study

BackgroundAdvocating for and promoting contraception use is critical in reducing mother and child morbidity and mortality. Early Implanon discontinuation may result in unwanted pregnancies and induced abortions. Although there has been research in Ethiopia on long-acting reversible contraceptives, there has been none on early Implanon removal among rural women who have used and removed it. Hence, this study aimed to investigate the magnitude of Implanon discontinuation and related characteristics among women who had the Implanon removed in central Ethiopian public health facilities.MethodsA community-based cross-sectional study was conducted among all women of the reproductive age group who had removed Implanon after using it. A simple random sampling technique was used to select 373 women after proportional allocation to each health facility. Data were collected using a pretested semi-structured interviewer-administered questionnaire adapted from previous studies. Data were entered using EpiInfo and exported to SPSS version 21 for analysis. A binary logistic regression model was used to determine the association between the outcome variable and independent variables. A p-value less than 0.25 was used as a cutoff point to select candidate variables for the final model. Then, a p value less than 0.05, AOR, and a 95% confidence level were used to declare statistical significance.ResultA total of 360 participants responded to the questionnaires, making a response rate of 96.5%. In this study, the early discontinuation rate was 42% (95% CI 36.9–47.7). No formal education (AOR = 0.53 [95% CI 0.3–0.94], having medium monthly income (AOR = 3.02 [95% CI 1.38–6.6]), inadequate pre-insertion counseling (AOR = 0.55 [95% CI 0.31–0.98]), lack of appointment for follow up (AOR = 0.16 [95% CI 0.05–0.54]), didn`t satisfy with service provided (AOR = 0.067 [95% CI 0.015–0.29] and developed side effect (AOR) = 4.45 [95% CI 2.37–8.36] were significantly associated with Implanon discontinuation.ConclusionThe discontinuation rate of Implanon among those who removed it after using it in this study was high. Lack of formal education, having a medium-income, inadequate pre-insertion counseling, lack of appointments for the follow-up, poor satisfaction, and problems with side effects were the factors associated with early discontinuation rate. Hence, quality family planning service provision is essential to reduce the discontinuation rate.

Beyond Response: Aiming for Quality Remission in Depression.

To define treatment response in depression as at least a 50% reduction in total symptom severity is to accept that up to half of patients will continue to have residual symptoms, most commonly low mood/loss of interest, cognitive problems, lack of energy, and difficulty sleeping. In fact, patients’ goals for treatment are to return to premorbid levels of functioning. This highlights the importance of assessing both functional outcomes and symptom improvement when evaluating the efficacy of antidepressant medication. Not all patients who achieve symptomatic response/remission will achieve a functional response/remission. In two studies (one with agomelatine and one with escitalopram), 54% of patients receiving agomelatine and 47% of those receiving escitalopram achieved a symptomatic response, and 53% of patients in each study achieved a functional response. However, 42% of patients receiving agomelatine and 35% of those receiving escitalopram had both a symptomatic and a functional response. The four symptoms of depression with the most marked effect on function are sad mood, impaired concentration, fatigue, and loss of interest. Low energy is particularly associated with poor occupational functioning, highlighting the importance of ongoing assessment of patients with depression, focusing particular attention on the symptoms that affect their ability to function, such as fatigue. Depending on the type of residual symptoms, some patients may benefit from combination therapy, such as adding dopamine modulator therapy. Antidepressant therapy is only effective if patients continue to take their medication, and high rates of early discontinuation have been reported. Therefore, when selecting treatment for depression, physicians can maximize the likelihood of adherence and persistence by taking into account both the antidepressant efficacy of treatment, its adverse effects and acceptability to patients.

Reasons and Associated Factors of Early Discontinuation of Implanon: A Follow-up Study from Lahore, Pakistan

Background: Family planning is needed at this time when the world population is rapidly increasing. Etonogestrel sub-dermal implant is a highly effective long-acting and reversible sub-dermal contraceptive implant. Despite its success and enhancement in usage, it is stopped by a proportion of users prior to its expiration date. Objective: To ascertain the frequency of discontinuation of Implanon during one year period and uncover its reasons and associated factors among women consulting obstetrics and gynecological clinics for contraception methods and opting for Implanon among the available options. Methodology: This prospective observational study was conducted in Services Hospital, Lahore. All of the women who underwent Implanon insertion from July to December 2020 were enrolled in the study. The outcome variable is early discontinuation of the inserted implant within one year of its insertion. Results: 350 women receiving sub-dermal Implanon for contraception purposes were included in this study. Their median age and BMI were 28(IQR= 25.8-31) years and 24.3 (IQR=23.6-25) Kg/m2 respectively. The early discontinuation rate was 49.1%. Reasons for removal were menstrual problems (100%), headache (19%), weight gain (12%), pain in the arm (5%), desire to conceive (1.7%) and spouse death (0.3%). Younger age, increasing body mass index, rural residence and shorter marriage duration were found to be significantly associated with early removal. Conclusion: This study found a high early discontinuation rate. Premature removal was most commonly caused by menstrual issues. Early removal was independently predicted by an early age, length of the marriage, rising BMI, and residence in a rural location. An awareness campaign should be created specifically for rural areas to address their concerns and reduce the early discontinuation rate. Further research should be conducted to understand the menstrual problems in women undergoing implanon insertion.

Early discontinuation of biological therapy among inflammatory bowel disease patients in Bahrain: Real world experience.

Background:Despite the effectiveness of several biological agents in the treatment of inflammatory bowel disease (IBD), some patients respond better than others. Such discrepancies are often evident early in the treatment course. The aim of this study is to identify the risks and assess the rate of early biological discontinuation (BD) among IBD patients.Methods:In this retrospective cohort study conducted in Bahrain all IBD patients who were administered biological agents between June 2009 and June 2019 were included. Medical records were reviewed to collect study data and confirm IBD diagnoses. Early discontinuation of biological agents was defined by discontinuation of a biological agent (within 6 months from administration). Montreal classification was used to classify Crohn's disease and ulcerative colitis (UC) according to location and extension, respectively.Results:Ineffectiveness was the most common reason for early BD. Early BD was not related to the type of IBD, biological agent used, or to most patient-related factors (such as gender and family history). Patient age at index biological initiation was the only independent significant predictor of early BD (P = 0.045, adjusted odds ratios (95% CI): 1.06 (1.001–1.116)] even after correction of two significant factors: comorbid diabetes and marked weight loss at diagnosis.Conclusion:The older the IBD patient at the time of biological therapy initiation, the higher the incidence of early BD. Therefore, caution and close follow-up are required for biological therapy among elderly patients to assess effectiveness and adverse drug reactions.

Addition of Isatuximab to Lenalidomide, Bortezomib and Dexamethasone As Induction Therapy for Newly-Diagnosed, Transplant-Eligible Multiple Myeloma Patients: The Phase III GMMG-HD7 Trial

Addition of Isatuximab to Lenalidomide, Bortezomib and Dexamethasone As Induction Therapy for Newly-Diagnosed, Transplant-Eligible Multiple Myeloma Patients: The Phase III GMMG-HD7 Trial

HIV PrEP is more than ART-lite: Longitudinal study of real-world PrEP services data identifies missing measures meaningful to HIV prevention programming.

IntroductionEvidence indicates HIV oral pre‐exposure prophylaxis (PrEP) is highly efficacious and effective. Substantial early discontinuation rates are reported by many programs, which may be misconstrued as program failure. However, PrEP use may be non‐continuous and still effective, since HIV risk fluctuates. Real‐world PrEP use phenomena, like restarting and cyclical use, and the temporal characteristics of these use patterns are not well described. The objective of our study was to characterize and identify predictors of use patterns observed in large PrEP scale‐up programs in Africa.MethodsWe analysed demographic and clinical data routinely collected during client visits between 2017 and 2019 in three Jhpiego‐supported programs in Kenya, Lesotho and Tanzania. We characterized duration on/off PrEP and, using ordinal regression, modelled the likelihood of spending additional time off and identified factors associated with increasing cycle number. The Andersen‐Gill model was used to identify predictors of time to PrEP discontinuation. To analyse factors associated with a client's first return following initiation, we used a two‐step Heckman probit.ResultsAmong 47,532 clients initiating PrEP, approximately half returned for follow‐up. With each increase in cycle number, time off PrEP between use cycles decreased. The Heckman first‐step model showed an increased probability of returning versus not by older age groups and among key and vulnerable population groups versus the general population; in the second‐step model older age groups and key and vulnerable populations were less likely in Kenya, but more likely in Lesotho, to return on‐time (refill) versus delayed (restarting).ConclusionsPrEP users frequently cycle on and off PrEP. Early discontinuation and delays in obtaining additional prescriptions were common, with broad predictive variability noted. Time off PrEP decreased with cycle number in all countries, suggesting normalization of use with experience. More nuanced measures of use are needed than exist for HIV treatment if effective use of PrEP is to be meaningfully measured. Providers should be equipped with measures and counselling messages that recognize non‐continuous and cyclical use patterns so that clients are supported to align fluctuating risk and use, and can readily restart PrEP after stopping, in effect empowering them further to make their own prevention choices.

The use of all-oral direct-acting antivirals in hepatitis C virus-infected patients with substance use disorders.

BACKGROUND: There is evidence that barriers exist for the initiation of direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) for those with substance use disorders (SUDs). However, real world clinical evidence of DAA treatment initiation following receipt of a prescription and continuation among those with SUDs and HCV is lacking. OBJECTIVES: To (1) compare HCV treatment initiation (prescription fill) rates and early discontinuation rates between HCV-infected patients with and without SUDs in the DAA era, and (2) identify patient-level factors associated with HCV treatment initiation and early discontinuation in patients with SUDs. METHODS: A retrospective cohort analysis of the MarketScan databases (January 2012-December 2018) was conducted for newly diagnosed treatment naïve HCV-infected patients (age ≥ 18) with and without SUDs. We used multivariable Cox regression to estimate adjusted hazard ratios (aHRs) with 95% confidence intervals of treatment initiation and early discontinuation in those with SUDs versus those without. RESULTS: We identified a total of 29,228 newly diagnosed HCV-infected patients (6,385 with SUDs and 22,843 without SUDs). Overall, DAA treatment initiation for patients with SUDs was significantly lower than that for those without SUDs (24% vs 34%; P < 0.01). After adjusting for demographics and clinical characteristics, patients with SUDs were less likely to initiate DAA treatments than those without SUDs (aHR, 0.87 [0.82-0.92]). There was no difference in discontinuation of DAA treatment between those with and without SUDs (4% vs 3%: aHR, 1.13 [0.81-1.60]). Among patients with SUDs (n = 6,385), lower rates of initiating DAA treatment was associated with younger age, and comorbidities including alcoholic liver disease (ALD; aHR, 0.44 [0.33-0.57), chronic kidney disease (CKD) (aHR, 0.52 [0.36-0.75]), and hepatitis B virus (HBV; aHR, 0.64 [0.44-0.92]). DAA treatment discontinuation was associated with younger age, ribavirin (RBV) therapy (aHR, 3.78 [2.21-6.47]), and cirrhosis diagnosis (aHR, 2.42 [1.21-4.84]) but not SUD treatment (aHR, 0.68 [0.34-1.34]). CONCLUSIONS: HCV-infected patients with SUDs had significantly lower treatment initiation rates, especially in young females and those with ALD, CKD, and HBV. No difference was found in DAA discontinuation. However, younger patients with RBV treatment and/or cirrhosis were more likely to stop treatment. Interventions directed towards these groups are needed to enhance DAA initiation and treatment maintenance among HCV-infected patients with SUDs. DISCLOSURES: Research reported in this publication was supported in part by the National Institute on Drug Abuse of the National Institutes of Health under award number K01DA045618 (to Park). The other authors have nothing to disclose that may present a potential conflict of interest.

Racial/ethnic disparities in the use of medications for opioid use disorder (MOUD) and their effects on residential drug treatment outcomes in the US

BackgroundThis study examines racial/ethnic disparities in the use of medications for opioid use disorder (MOUD) in residential treatment and the influence of race/ethnicity on the association between MOUD use and treatment retention and completion. MethodsData were extracted from SAMHSA’s 2015–2017 Treatment Episode Dataset-Discharge (TEDS-D) datasets for adult opioid admissions/discharges to short-term (ST) (30 days or less) (N = 83,032) or long-term (LT) (> 30 days) residential treatment settings (N=61,626). Logistic regression estimated the likelihood of MOUD use among racial/ethnic groups and the moderation of race/ethnicity on the probability of treatment completion and retention, controlling for background factors. ResultsAfter adjusting for covariates, compared to Whites, MOUD use was less likely for Blacks in ST (OR = 0.728) and LT settings (OR = 0.725) and slightly less likely for Hispanics in ST settings (OR = 0.859) but slightly more likely for Hispanics in LT settings (OR = 1.107). In ST settings, compared to Whites, the positive effect of MOUD on retention was enhanced for Blacks (OR = 1.191) and Hispanics (OR = 1.234), and the positive effect on treatment completion was enhanced for Hispanics (OR = 1.144). In LT settings, the negative association between MOUD and treatment completion was enhanced for Hispanics (OR = 0.776). ConclusionsAccess to medications for opioid use disorder in short term residential treatment is particularly beneficial for Blacks and Hispanics, though adjusted models indicate they are less likely to receive it compared to Whites. Results are mixed for long-term residential treatment. Residential addiction treatment may represent an important setting for mitigating low rates of medication initiation and early discontinuation for minority patients.

Veterans self-reported reasons for non-attendance in psychotherapy for posttraumatic stress disorder.

This study explored rates of non-attendance (i.e., non-initiation, inconsistent attendance, early discontinuation) in cognitive processing therapy (CPT) and other posttraumatic stress disorder (PTSD) focused individual and group psychotherapies (i.e., interventions with at least some PTSD and/or trauma-related content) and characterized veterans' self-reported reasons for non-attendance in these treatments. Baseline and 6-month follow-up data from the Telemedicine Outreach for PTSD study, a pragmatic randomized effectiveness trial conducted in 11 Veterans Health Administration community-based outpatient clinics, was examined (N = 265 veterans). Over 90% of veterans with a scheduled psychotherapy appointment attended at least one appointment by 6-month follow-up. Self-reported treatment completion was higher for veterans attending individual CPT (25%) than for those attending PTSD-focused individual (4.4%) and group psychotherapy (15.5%). However, rates of inconsistent attendance (13.3%) and early discontinuation (18.3%) were also higher in veterans attending CPT when compared to other forms of PTSD-focused psychotherapy (inconsistent attendance-individual: 2.2%, group: 6.9%; early discontinuation-individual: 14.6%; group: 10.3%). Issues with scheduling appointments was one of the most frequently reported reasons for non-attendance across treatments (> 20%). Logistical barriers, including transportation (CPT), therapy taking too much time (PTSD-focused individual psychotherapy) and not being able to afford counseling (PTSD-focused group psychotherapy), were also commonly cited (i.e., > 15%). Those scheduled to attend CPT (26%) or PTSD-focused individual psychotherapy (11%) also cited treatment efficacy concerns as a reason for non-attendance. Findings suggest logistical barriers, particularly scheduling convenient appointments, and beliefs about treatment may be important to address when engaging veterans in psychotherapy for PTSD. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Breast cancer patients' insurance status and residence zip code correlate with early discontinuation of endocrine therapy: An analysis of the ECOG-ACRIN TAILORx trial.

Early discontinuation is a substantial barrier to the delivery of endocrine therapies (ETs) and may influence recurrence and survival. The authors investigated the association between early discontinuation of ET and social determinants of health, including insurance coverage and the neighborhood deprivation index (NDI), which was measured on the basis of patients' zip codes, in breast cancer. In this retrospective analysis of a prospective randomized clinical trial (Trial Assigning Individualized Options for Treatment), women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who started ET within a year of study entry were included. Early discontinuation was calculated as stopping ET within 4 years of its start for reasons other than distant recurrence or death via Kaplan-Meier estimates. A Cox proportional hazards joint model was used to analyze the association between early discontinuation of ET and factors such as the study-entry insurance and NDI, with adjustments made for other variables. Of the included 9475 women (mean age, 55.6 years; White race, 84%), 58.0% had private insurance, whereas 11.7% had Medicare, 5.8% had Medicaid, 3.8% were self-pay, and 19.1% were treated at international sites. The early discontinuation rate was 12.3%. Compared with those with private insurance, patients with Medicaid (hazard ratio [HR], 1.53; 95% confidence interval [CI], 1.23-1.92) and self-pay patients (HR, 1.65; 95% CI, 1.25-2.17) had higher early discontinuation. Participants with a first-quartile NDI (highest deprivation) had a higher probability of discontinuation than those with a fourth-quartile NDI (lowest deprivation; HR, 1.34; 95% CI, 1.11-1.62). Patients' insurance and zip code at study entry play roles in adherence to ET, with uninsured and underinsured patients having a high rate of treatment nonadherence. Early identification of patients at risk may improve adherence to therapy. In this retrospective analysis of 9475 women with breast cancer participating in a clinical trial (Trial Assigning Individualized Options for Treatment), Medicaid and self-pay patients (compared with those with private insurance) and those in the highest quartile of neighborhood deprivation scores (compared with those in the lowest quartile) had a higher probability of early discontinuation of endocrine therapy. These social determinants of health assume larger importance with the expected increase in unemployment rates and loss of insurance coverage in the aftermath of the coronavirus disease 2019 pandemic. Early identification of patients at risk and enrollment in insurance optimization programs may improve the persistence of therapy.

13. Contraceptive Implant-associated Abnormal Uterine Bleeding in Adolescents and Young Adults: Predictors, Management, and Rates of Continuation

<h3>Background</h3> Abnormal uterine bleeding (AUB) is commonly experienced by adolescents and young adults (AYA) following contraceptive implant placement. We assessed for predictors of AUB, factors contributing to AUB management, and differences in implant continuation rates by AUB management approach. <h3>Methods</h3> We analyzed data from a long-acting reversible contraception database from 3 AYA sites in tertiary care institutions. We included patients with the contraceptive implant placed from 7/1/2014-12/31/2018 and follow-up data through 12/31/2019. We excluded patients with ≥3 years since insertion without follow-up. Variables included age at insertion, comorbid conditions, menstrual history, prior contraceptive use, patient-reported AUB after implant placement, AUB evaluation and management, and implant discontinuation. We included data from insertion, follow-up, and removal visits. We assessed AUB predictors with logistic regression. Descriptive statistics, chi-square, and t-tests compared patient demographic and clinical variables by AUB status. Survival analysis examined predictors of time to discontinuation. This study was IRB approved. <h3>Results</h3> Our sample included 609 patients, average age was 19 years (SD=2.5). Prior to implant placement 37% reported irregular menses, and after insertion 25% reported AUB. In those with AUB, 67% had evaluation and management including laboratory studies (32%), pelvic ultrasound (4%), or medication therapy (86%). Medication initiation occurred at first AUB report for the majority of patients. Of those prescribed a medication, 60% received a combined oral contraceptive or progestin-only pill. AUB was associated with polycystic ovary syndrome (PCOS) in bivariate analysis (p-value=0.006), 57% of patients with PCOS (n=14) reported AUB after implant insertion. This association persisted after adjusting for age, medical comorbidities, menstrual history, and prior contraceptive use. Bivariate analyses did not identify any predictors for AUB evaluation and management. Implant discontinuation was low: 16% at 1 year, 27% at 2 years, and 35% at 3 years. Early discontinuation was significantly different between patients with and without AUB: 21% vs. 14% at 1 year (p-value=0.047), 38% vs. 23% at 2 years (p-value=0.000), 44% vs. 31% at 3 years (p-value=0.007). Medication for AUB management did not impact rates of or time to early discontinuation. <h3>Conclusions</h3> In this large cohort of AYA, PCOS was the only significant predictor of implant-associated AUB. There were no relationships between AUB and comorbid medical conditions or prior contraceptive use. There were no significant predictors of AUB evaluation and management following implant insertion, and such evaluation and management did not impact rates of early discontinuation.

Real-world retrospective observational study exploring the effectiveness and safety of antifibrotics in idiopathic pulmonary fibrosis

BackgroundPirfenidone and nintedanib are the only disease-modifying treatments available for idiopathic pulmonary fibrosis (IPF). Our aim was to test their effectiveness and safety in clinical practice.MethodsThis is a single-centre retrospective...

Momelotinib's Spleen, Symptom and Anemia Efficacy Is Maintained in Intermediate/High Risk Myelofibrosis Patients with Thrombocytopenia

Momelotinib's Spleen, Symptom and Anemia Efficacy Is Maintained in Intermediate/High Risk Myelofibrosis Patients with Thrombocytopenia

Prevalence and factors associated with early discontinuation rate of Implanon utilization among women who ever used Implanon in Kucha District Gamo Gofa Zone, Southern Ethiopia

BackgroundThe promotion of contraception in countries with high birth rates has the potential to reduce poverty, hunger, maternal, and childhood deaths. Every year in sub-Saharan Africa approximately 14 million unintended pregnancies occurred and a sizeable proportion was due to poor use of short-term hormonal methods. Contraceptive hormonal implants are highly effective and suitable for almost all women at any stage of their reproductive lives. On the other hand, early discontinuation of the Implanon contraceptive method utilization is one of the foremost problems amid the family planning program. Early discontinuation of the Implanon contraceptive method and reasons for such discontinuation lingers the most significant anxiety for family planning programs. In unindustrialized countries, contraceptive discontinuation due to health concerns is generally higher; these complaints are often related to service quality. Hence, this study aimed to assess the prevalence and factors associated with early discontinuation of Implanon among women who ever used Implanon in Kucha district, Gamo Gofa Zone, Southern Ethiopia.MethodsImplanon contraceptive device users were selected from the Kucha district using a cross-sectional community-based survey from January to March 2018. A total of 430 women were selected and data were collected through face-to-face interviews by using a pre-tested structured questionnaire. Data were cleaned, coded, and entered into Epi-Info version 7statistical software. Factors that showed association in a bivariate analysis that has a p value of less than 0.25 were entered into multiple logistic regression models for controlling confounding factors. The strength of statistical association was measured by adjusted odds ratio, at 95% confidence intervals, and p value < 0.05 were considered as statistically significant variables.ResultThe result of this study revealed that the overall discontinuation rate of Implanon in the study was 34%. Variables having statistically significant association with Implanon discontinuation were women who never use a contraceptive method other than Implanon (AOR = 2.96, 95% CI 1.53–5.74), women who didn’t make discussion with a partner (AOR = 3.32, 95% CI 1.57–7.04), poor counseling and follow up (AOR = 9.23, 95% CI 4.7–18.13), fear of side effects (AOR = 0.12, 95% CI 0.058- 0.24) and poor satisfaction of service (AOR = 5.2, 95% CI 2.77- 9.76)ConclusionThe overall early discontinuation rate of Implanon in the study area was high. The main factors associated with early discontinuation of Implanon were contraceptive ever use, discussion with partner, poor follow-up of counseling, fear of side effects, and un-satisfaction by the services given during the insertion rate of Implanon.

Pharmacotherapy of migraine prevention based on the assessment of headache

Migraine as a recurrent, relapsing, and chronic disease is one of the most disabling disorders globally. Most patients are women in their reproductive age and their migraines are classified as episodic migraine. Although less than half of the episodic and most chronic migraineurs require preventive intervention, early discontinuation rates are high, owing to poor tolerability and insufficient awareness about migraine. This article aims to review the recent update of migraine prevention based on the practice guidelines for the prevention of episodic migraine published by the Korea Headache Society and the position statement of the American Headache Society in 2019. The goal of migraine prevention is to reduce migraine attack frequency by at least 50 %, the number of migraine days, and the attack severity to ultimately improve quality of life. The guidelines recommend considering the initiation of preventive medication when recurring migraines significantly interfere with daily life or when acute treatment is contraindicated or inappropriate. Preventive medications should be determined based on various qualified assessments. Pharmacologic treatments are recommended for migraine prophylaxis include antidepressant (amitriptyline), anti-epileptic drugs (topiramate, divalproex sodium), beta-blockers (propranolol, metoprolol), calcium channel blocker (flunarizine), and intramuscular injection of onabotulinumtoxin A. Furthermore subcutaneous or intravenous injection of calcitonin gene-related peptide monoclonal antibodies was recently approved as a new therapy for migraine prevention. Migraine is a chronic debilitating disorder. The initiation of evidence-based preventive management is necessary and management methods should be individually selected to improve quality of life.

Induction chemotherapy in nonlaryngeal human papilloma virus-negative high-risk head and neck cancer: a real-world experience.

The role of induction chemotherapy in the multidisciplinary treatment of locally advanced, nonlaryngeal high-risk human papilloma virus (HPV)-negative head and neck squamous cells carcinoma (HNSCC) is uncertain in terms of overall survival (OS). The primary objective of this study was to identify possible predictive factors of survival and outcome in patients with HNSCC who were treated with induction chemotherapy. Fifty-nine patients with stage IVa/b HPV-negative non-laryngeal HNSCC (mostly originating from the oral cavity) who underwent induction chemotherapy at Policlinico Umberto I were reviewed. Treatment outcomes in term of objective response rate (ORR), progression-free survival (PFS), OS and toxicities were analyzed. A significant association between nodal status, ORR, ongoing smoking use, toxicities and OS was demonstrated. ORR (obtained in 61% of patients) was associated with a reduction in mortality of 80% (P< 0.0001). Early discontinuation after just one cycle of induction chemotherapy was associated to a significantly shorter OS. In oral cavity radical surgery with negative margins was obtained in 15/16 patients. In 42% of patients G3-G4 toxicity occurred. Toxicity requiring hospitalization occurred in 42% and 21% of patients with oropharyngeal and oral cavity carcinoma, respectively. Five patients died of treatment-related causes. No treatment-related mortality occurred in oral cavity patients. G5 toxicities were different according to the sub-sites of disease (P = 0.05). Induction chemotherapy in non-laryngeal high-risk HNSCC is an active strategy, most importantly in oral cavity cancer, even though burdened with a high (G ≥ 3) toxicity and early discontinuation rate. These data will however need to be confirmed in further and larger studies.

Postoperative Thoracic Epidural Analgesia: Adverse Events from a Single-Center Series of 3126 Patients.

PurposeThoracic epidural analgesia (TEA) has been shown to reduce postsurgical morbidity and mortality; nevertheless, major and minor complications can occur. We report our 10-year experience with TEA and incidence of complications.Patients and MethodsPatients received continuous infusion TEA (0.2% ropivacaine and 2 µg ml−1 fentanyl) to control postoperative pain. Every 8 hours, the acute pain service recorded the analgesia regimen and occurrence of side effects. The initial infusion rate was tapered daily in response to improvement in pain symptoms or occurrence of side effects.ResultsA total of 3126 patients received TEA. The median age was 65 years (range, 18–94) and the duration of catheter placement was 3.5 days (range, 2–8). Three major complications were identified (1:1042): two subarachnoid blocks and one epidural abscess which led to permanent sequela (1:3126). Minor complications were hypotension (4.8%), pruritus (4.4%), accidental catheter removal (3.7%), insertion site inflammation (2.5%), motor weakness (2.0%), postoperative nausea and vomiting (1.8%), catheter disconnection (1.9%), catheter occlusion (0.3%), post-dural puncture headache (0.5%), and catheter fragment retention (0.06%), which were the reasons for a 7.4% rate of early discontinuation of epidural analgesia. No occurrence of epidural hematoma, local anesthetic systemic toxicity, and cardiovascular/respiratory depression was recorded.ConclusionPostoperative TEA is an advanced technique that poses certain difficulties that can subvert its great potential. While serious complications were rare, minor complications occurred more often and affected the postoperative course negatively. A risk/benefit evaluation of each patient should be done before employing the technique.

Breast cancer patients’ insurance status correlates with their adherence to endocrine therapy: Analysis of ECOG-ACRIN TAILORx trial.

7041 Background: Cancer patients spend substantial amounts on their healthcare services, and are at high risk for financial toxicity, a patient-reported outcome shown to be associated with care non-adherence. Even with insurance, cancer patients often face unpredictable or unmanageable costs. In women with breast cancer enrolled in TAILORx trial, we investigated the association between study entry insurance status and adherence to endocrine therapy (ET). Methods: Women with hormone-receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative breast cancer enrolled in TAILORx clinical trial who started ET within a year of study entry were included. Early discontinuation was defined as stopping ET within 4 years of start for reasons other than distant recurrence or death, and the rate was calculated using Kaplan-Meier estimates. Cox proportional hazards model was used to analyze association between the patients’ insurance status at study entry and early discontinuation of ET incorporating patients’ treatment, age, race and Recurrence Score in the model. Results: A total of 9,475 patients were included (mean age: 55.6; 84% white; 9% Hispanic). A total of 58.0% had private insurance, while 11.7% had Medicare; 5.8% had Medicaid; 0.98% had military/VA insurance; 3.8% were self-pay, and 19.1% were patient recruited from international sites. The rates of 4-year early discontinuation were highest among self-pay (18.7%) and Medicaid patients (18%) and lowest among patients with military/VA insurance (8.6%) and international sites (9.8%). In multivariable analysis, compared to private insurance patients with Medicaid (HR 1.6; 95% CI 1.3-2.0) and self-pay (HR 1.6; 95% CI 1.3-2.1) had higher probability of discontinuing ET within 4 years of start and those at international sites had lower probability of early discontinuation (HR 0.8; 95% CI 0.7-0.9) (All p values &lt; 0.05). Conclusions: Patients’ insurance status plays an important role in adherence to ET with uninsured and underinsured having a high rate of treatment non-adherence. Early identification of patients at risk and enrollment in insurance optimization programs may improve adherence to therapy. Clinical trial information: NCT00310180 .

Prognostic model based on the geriatric nutritional risk index and sarcopenia in patients with diffuse large B-cell lymphoma

BackgroundSystemic inflammation and cachexia are associated with adverse clinical outcomes in diffuse large B-cell lymphoma (DLBCL). The Geriatric Nutritional Risk Index (GNRI) is one of the main parameters used to assess these conditions, but its efficacy in DLBCL is inconclusive.MethodsWe retrospectively reviewed 228 DLBCL patients who were treated with R-CHOP immunochemotherapy (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone). The patients were stratified according to GNRI score (> 98, 92 to 98, 82 to < 92, and < 82) as defined in previous studies. Additionally, the extent of sarcopenia was categorized as sarcopenia-both, sarcopenia-L3/PM alone, and non-sarcopenia-both according to skeletal muscle index.ResultsSurvival curves plotted against a combination of GNRI and sarcopenia scores revealed two clear groups as follows: high cachexia risk (HCR) group (GNRI < 82, sarcopenia-both, or GNRI 82–92 with sarcopenia-L3/PM alone) and low cachexia risk (LCR) group (others). The HCR group had a lower complete response rate (46.5% vs. 86.6%) and higher frequency of treatment-related mortality (19.7% vs. 3.8%) and early treatment discontinuation (43.7% vs. 8.3%) compared with the LCR group. The median progression-free survival (PFS) (not reached vs. 10.3 months, p < 0.001) and overall survival (OS) (not reached vs. 12.9 months, p < 0.001) were much shorter in the HCR group than in the LCR group. On multivariable analyses, the HCR group was shown to be an independent negative prognostic factor for PFS and OS after adjusting the National Comprehensive Cancer Network-International Prognostic Index (NCCN-IPI).ConclusionsA combined model of GNRI and sarcopenia may provide prognostic information independently of the NCCN-IPI in DLBCL.

Abstract PD10-10: Factors associated with decreased relative dose intensity in older adults with early-stage breast cancer receiving chemotherapy

Abstract Background: Older adults with breast cancer receiving neo/adjuvant chemotherapy are at increased risk for toxicity and dose reductions, often leading to decreased relative dose intensity (dRDI &amp;lt; 85%) and potentially compromised chemotherapy benefits. Identifying which older patients are projected to have dRDI with standard regimens could help to optimize systemic treatment delivery and completion. Methods: We prospectively enrolled patients aged ≥ 65 who were starting neo/adjuvant chemotherapy for HER2-negative, stage I-III breast cancer. Geriatric assessment and clinical variables were captured at baseline. Chemotherapy regimen, dosing, and treatment-related modifications (reductions, delays, discontinuation) were also captured. RDI was calculated as the ratio of actual dose delivered to intended dose. Our primary outcome was dRDI, which we defined as RDI &amp;lt; 85% (associated with poorer survival, Bonadonna et al. NEJM 1995). Bivariate logistic regression for dRDI was performed to elucidate the relationship with baseline factors. Stepwise regression was used to identify the significant factors that are independently associated with dRDI. Results: Of 323 patients (median age 69, range 65-86), 216 had HR+/HER2- breast cancer and 107 had triple negative breast cancer (TNBC). Patients were treated with taxotere and cyclophosphamide [TC] (47%), anthracycline-based regimens (46%), and cyclophosphamide, methotrexate, and 5-fluorouracil [CMF] (7%). Overall, the mean RDI was 90.1% (median 100%, range 16.7%-100%), and 69 patients (21%) had dRDI (i.e. RDI &amp;lt;85%). HR+/HER2- and TNBC had similar RDI (p = 0.74). In bivariate analysis, older age &amp;gt; 70, higher stage (II/III), use of non-TC regimens (anthracycline-based or CMF), abnormal liver function, KPS &amp;lt; 90, poor physical function, lack of social support, and cardiac conditions were associated with reduced RDI. Multivariate stepwise regression identified that anthracycline-based or CMF regimens (28% dRDI, OR=3.34, 95% CI 1.77-6.29), age &amp;gt;70 (27% dRDI, OR = 2.01, 95% CI 1.11-3.63), abnormal liver function (41% dRDI, OR = 2.50, 95% CI 1.10-5.66), and KPS &amp;lt; 90 (48% dRDI, OR = 4.31, 95% CI 2.06-9.03) were significantly associated with dRDI. dRDI was significantly associated with grade 3 or higher toxicities, hospitalization, dose reduction, dose delay, and early discontinuation of chemotherapy (all p &amp;lt; 0.001). Conclusion: Among older patients receiving neo/adjuvant chemotherapy for HER2-negative early-stage breast cancer, those aged &amp;gt; 70, treated with anthracycline or CMF regimens, with abnormal liver functions, and KPS &amp;lt; 90 were at substantially higher risk for reduced RDI (actual/planned dose) likely due to increased rates of toxicities, hospitalizations, dose modifications, and/or early treatment discontinuation. Future targeted supportive care interventions and/or alternative treatment regimens are needed to improve the delivery of chemotherapy in older patients who are predicted to have dRDI and better understand whether dRDI impacts outcomes in this population. Citation Format: Mina S Sedrak, Can-Lan Sun, Allison Magnuson, Hyman Muss, Rachel Freedman, Cary P Gross, William P Tew, Heidi Klepin, Tanya M Wildes, Efrat Dotan, Tracey O'Connor, Harvey J Cohen, Heeyoung Kim, Vani Katheria, Reena Jayani, Anait Arsenyan, Abrahm Levi, Kemeberly Charles, Arti Hurria, William Dale. Factors associated with decreased relative dose intensity in older adults with early-stage breast cancer receiving chemotherapy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD10-10.