scholarly journals AB0533 COMBINATION OF METHOTREXATE AND LEFLUNOMIDE IS SAFE AND HAS GOOD DRUG RETENTION AMONG PATIENTS WITH PSORIATIC ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1298.1-1298
Author(s):  
M. Haroon ◽  
S. Batool ◽  
S. Asif ◽  
F. Hashmi ◽  
S. Ullah
Keyword(s):  
Psoriatic Arthritis ◽  
Combination Therapy ◽  
Treatment Option ◽  
Retention Time ◽  
Median Number ◽  
First Line ◽  
Effective Treatment Option ◽  
Drug Retention ◽  
Synthetic Dmards

Background:Among patients with psoriatic arthritis (PsA), there remains a considerable confusion regarding the effectiveness of conventional synthetic DMARDs (csDMARDs), especially methotrexate (MTX). The availability of biologic DMARDs and targeted synthetic DMARDs have revolutionised the management of psoriatic disease; however, it comes with a significant cost burden. We believe that combination of DMARDs, especially combining MTX and Leflunomide (LEF) provides a valuable low-cost treatment option for patients with PsA after failure of MTX monotherapy. Hence, in our practice, we are inclined to use combination of potent DMARDs after MTX failure, prior to considering biologic therapies. Little is known about the combination use of LEF and MTX in PsA, especially in the context of drug retention time and tolerability.Objectives:We aimed to review our PsA cohort data especially examining the drug retention of first-line csDMARD monotherapy and combination csDMARDs.Methods:In our centre, MTX is a preferred first line csDMARD, unless contraindicated, and patients are followed up with a protocol on 4-6 weekly basis unless complete remission is achieved. MTX if needed is escalated to the maximum tolerated dose (up to 25mg/week), and if PsA is still active then preferably LEF is added (usual starting dose for add-on therapy is 10mg a day and if needed escalated to 20mg a day, without any loading dose). Other csDMARDs, such as sulphasalazine are used, if needed. For this study, after written-informed consent, only those adult patients were included who had a follow up of at least 6 months with our rheumatology services, and were fulfilling CASPAR criteria. Moreover, only patients who were DMARD-naïve (no prior DMARD therapy for any cause, including psoriasis), and initiated DMARD as monotherapy after 1 April 2018 were included. If any patient had already been on any DMARDs prior to attending our rheumatology services was excluded.Results:A total of 81 PsA patients [mean age 45.6±6 years; 52% male; mean PsA disease duration=9±4 years; 35% with dactylitis, 42% with enthesitis, 17% with sacroiliitis, median current PASI=2.6, median number of swollen joints=8.0, median number of tender joints= 11.0] fulfilled the inclusion and exclusion criteria. As regards first-line csDMARD monotherapy, 88% (n=71) of patients were commenced on MTX. In total, 79% (n=56 out of 71) of patients who were started on MTX as their first-line csDMARD therapy failed this monotherapy during follow-up (51=ineffective, 5=intolerance). After a median follow-up of 22 months, MTX median drug retention among all MTX monotherapy users (n=71) was only 7 months (IQR 5-7); and among MTX failures (n=56), MTX monotherapy median drug retention was 6.0 months (IQR 4-8). Eighty percent (n=45 out of 56) of the MTX monotherapy failure cohort was started on combination therapy of MTX and LEF (combo MTX+LEF); among them, only 7 patients needed escalation of therapy to bDMARDs, and the rest are still using combo MTX+LEF. It was noted that to date median drug retention time of combo MTX+LEF has been 8 months (IQR 7-11), and 84% (n=38 out of 45) of these patients are still using this combo therapy. Significantly more patients managed to continue the combo MTX+LEF therapy compared to MTX monotherapy (84% vs. 21%, p<0.001)Conclusion:Among csDMARD naïve PsA patients, 79% of patients failed MTX monotherapy with median drug retention time of only 6 months. Combination of MTX and LEF was well tolerated and had good drug retention time, with 84% of patients having ongoing treatment to date. Our data provides initial evidence that MTX and LEF combination therapy could be an effective treatment option for PsADisclosure of Interests:Muhammad Haroon Speakers bureau: Roche, Novartis, Grant/research support from: Abbvie, Pfizer, Shabnam Batool: None declared., Sadia Asif: None declared., Farzana Hashmi: None declared., Saadat Ullah: None declared.

scholarly journals POS0663 SAFETY AND EFFICACY OF COMBINING METHOTREXATE AND LEFLUNOMIDE AMONG PATIENTS WITH INFLAMMATORY ARTHROPATHIES: FINDINGS FROM THE PRIME REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 574.1-574
Author(s):  
M. Haroon ◽  
A. Ashraf ◽  
H. J. Shaheen ◽  
S. Asif ◽  
S. Batool ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Adverse Events ◽  
Disease Activity ◽  
Treatment Option ◽  
Low Income ◽  
Low Income Countries ◽  
Real World Data ◽  
Effective Treatment Option ◽  
Upper Limit ◽  
Drug Retention

Background:Currently, conventional synthetic DMARDs (csDMARDs) are the most commonly prescribed drugs as first-line treatment for peripheral arthritis. In resource-constrained settings where biologic agents are not widely available, there are limited therapeutic options for patients with rheumatoid arthritis (RA) and seronegative inflammatory arthropathies refractory to other csDMARD therapies. Hence, in our practice, we are inclined to use combination of potent DMARDs after MTX failure, prior to considering biologic therapies. We believe that combination of DMARDs, especially combining MTX and Leflunomide (LEF) provides a potent and valuable low-cost treatment option. Efficacy of MTX and LEF is very well established, but there have been lot of concern as regards their combination use due to potential risk of hepatotoxicity.Objectives:We aimed to review our inflammatory arthropathies cohort data especially examining the safety, efficacy and drug retention of the combination usage of MTX and Leflunomide. We addressed this question using real-world data from the PRIME registry.Methods:This was a cross-sectional study conducted using data collected at the time of patient enrolment in the PRIME registry. The PRIME Registry is a large, independent, prospective, observational cohort initiated in October 2019 that comprises patients diagnosed with RA, SLE, PsA or AS by a rheumatologist, and is being actively followed up. IRB approval and informed consent was obtained. A number of clinical variables were recorded. Detailed history was gathered from every patient regarding their present and past medications usage. Questions were asked directly about the usage or otherwise of all available DMARDs and biologics. The duration of usage, any adverse events, or the reasons for discontinuation were recorded. Evaluation of disease activity and severity was made as per internationally agreed definitions.Results:The data of 766 inflammatory arthritis patients (RA=663, PsA=103) was reviewed. Among them, 241 patients (RA=196, PsA=45) were using combination therapy of MTX and LEF (combo MTX+LEF) with mean age 42.3±6 years; 42% male]. These patients had failed MTX or LEF monotherapy. Among these 241 patients, 49 patients were also on concomitant hydroxychloroquine therapy. It was noted that median drug retention of combo MTX+LEF therapy has been 9.5 months (IQR 6-16). Regarding any adverse events of combo MTX+LEF therapy, hepatotoxicity (ALT ≤3 times the upper limit of normal) was noted among 15 (6.2%) patients, hepatotoxicity (ALT ≥3 times the upper limit of normal) was noted among 8 (3.3%) patients, and troublesome gastrointestinal upset (nausea, or vomiting, or diarrhoea) in 3 (1.2%). Overall, only 13 (5.4%) patients had to discontinue this combo MTX+LEF therapy due to adverse events. Disease activity among combo MTX+LEF users was as follows: 64% (n=29) of PsA patients had achieved MDA; 42% (n=83) of RA cohort were in DAS28 remission, 46% (n=91) of RA patients were having DAS low disease activity.Conclusion:Combination of MTX and LEF was well tolerated and had good drug retention time, with 94.6% of patients having ongoing treatment to date. In low-income countries, where bDMARD availability is limited, financial arguments significantly influence decision making process, and our data provides initial evidence that MTX and LEF combination therapy could be an effective treatment option.Disclosure of Interests:Muhammad Haroon Speakers bureau: Roche, Novartis, Grant/research support from: Abbvie, Pfizer, Arfa Ashraf: None declared, Hafiza Javeria Shaheen: None declared, Sadia Asif: None declared, Shabnam Batool: None declared, Farzana Hashmi: None declared, Saadat Ullah: None declared

scholarly journals Sialendoscopy With Intraductal Steroid Irrigation in Patients With Sialadenitis Without Sialoliths

2019 ◽  
Vol 98 (5) ◽  
pp. 291-294 ◽  
Author(s):  
Saudamini J. Lele ◽  
Mickie Hamiter ◽  
Torrey Louise Fourrier ◽  
Cherie-Ann Nathan
Keyword(s):  
Treatment Option ◽  
Case Series ◽  
Complete Response ◽  
Definitive Treatment ◽  
Invasive Technique ◽  
Effective Treatment Option ◽  
Patient Reported ◽  
History Of ◽  
The Mean

Sialendoscopy has emerged as a safe, effective and minimally invasive technique for management of obstructive and inflammatory salivary gland disease. The aim of our study was to analyze outcomes of sialendoscopy and steroid irrigation in patients with sialadenitis without sialoliths. We performed a retrospective analysis of patients who underwent interventional sialendoscopy with steroid irrigation from 2013 to 2016, for the treatment of sialadenitis without sialolithiasis. Twenty-two patients underwent interventional sialendoscopy with ductal dilation and steroid irrigation for the treatment of sialadenitis without any evidence of sialolithiasis. Conservative measures had failed in all. Eleven patients had symptoms arising from the parotid gland, 4 patients had symptoms arising from the submandibular gland, while 6 patients had symptoms in both parotid and submandibular glands. One patient complained of only xerostomia without glandular symptoms. The mean age of the study group which included 1 male and 21 females was 44.6 years (range: 3-86 years). Four patients had autoimmune disease, while 7 patients had a history of radioactive iodine therapy. No identifiable cause for sialadenitis was found in the remaining 11 patients. The mean follow-up period was 378.9 days (range: 16-1143 days). All patients underwent sialendoscopy with ductal dilation and steroid irrigation. Twelve patients showed a complete response and 9 patients had a partial response, while 1 patient reported no response. Only 3 patients required repeat sialendoscopy. The combination of sialendoscopy with ductal dilation and steroid irrigation is a safe and effective treatment option for patients with sialadenitis without sialoliths refractory to conservative measures. Prospective studies with a larger case series are needed to establish its role as a definitive treatment option.

Republished: Delayed relapse in pseudotumor cerebri due to new stenosis after transverse sinus stenting

2015 ◽  
Vol 8 (10) ◽  
pp. e41-e41 ◽  
Author(s):  
Hugh Stephen Winters ◽  
Geoff Parker ◽  
Gabor Michael Halmagyi ◽  
Ankur Mehta ◽  
Thomas Atkins
Keyword(s):  
Intracranial Hypertension ◽  
Effective Treatment ◽  
Treatment Option ◽  
Small Proportion ◽  
Severe Disease ◽  
Pseudotumor Cerebri ◽  
Transverse Sinus ◽  
Effective Treatment Option ◽  
Risk Of Recurrence

A patient presented with recurrent severe pseudotumor cerebri (PTC). Transverse sinus stenting is a very effective treatment option, however stenosis and intracranial hypertension can recur. In our patient, stenting initially resulted in resolution of papilloedema. However, after 5 years, a new stenosis developed which required further stenting. This case highlights the fact that, in patients with PTC who undergo transverse sinus stenting, a small proportion require repeat treatment due to formation of a new stenosis, usually adjacent to the existing stent. Patients with severe disease, such as ours, may be at higher risk of recurrence. Regardless of the severity, all patients who undergo stenting should have regular ocular follow-up.

scholarly journals Durability and Long-Term Clinical Outcomes of Fecal Microbiota Transplant (FMT) Treatment in Patients with Recurrent C. difficile Infection

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S384-S385 ◽  
Author(s):  
Yafet Mamo ◽  
Michael Woodworth ◽  
Kaitlin Sitchenko ◽  
Tanvi Dhere ◽  
Colleen Kraft
Keyword(s):  
Clinical Outcomes ◽  
Medical Condition ◽  
Antibiotic Use ◽  
Median Number ◽  
Fecal Microbiota ◽  
Medical Conditions ◽  
Effective Treatment Option ◽  
Fecal Microbiota Transplant

Abstract Background Fecal microbiota transplant (FMT) has been shown to be safe and effective for treatment of recurrent C. difficile infection (RCDI). The aim of this study is to determine factors impacting the durability of FMT and assess patient long-term clinical outcomes and satisfaction with the procedure. Methods Eligible patients who had received FMT for RCDI at Emory Hospital between July 1, 2012 and December 31, 2016 were contacted via telephone for a follow up survey. Of 232 patients who received FMT, 27 were deceased and 15 were unable to be reached with listed phone number. Of the remaining 190 eligible patients, 137 patients completed the survey. Results The median time-period between FMT and follow up was 22 months. Median number of failed antibiotic courses for RCDI before FMT was 4. Overall, 82% (113/137) of patients experienced resolution of RCDI post-FMT (non-RCDI group) while 18% (24/137) of patients had recurrence of CDI post-FMT (RCDI group). In the RCDI and non-RCDI groups, antibiotic use post-FMT for non- C. difficile-related infections was 75% and 38% (P = 0.0004), respectively. PPI use post-FMT was 38% and 31% (P = 0.28), and probiotic use post-FMT was 63% and 41% (P = 0.026) in the RCDI and non-RCDI groups, respectively. There were 18 hospitalizations in the RCDI group and 9 were related to C. difficile complications; of the 36 hospitalizations in the non-RCDI group, only 1 was related to chronic complication of a previous C. difficile infection. Overall, 11% of patients reported improvement or resolution of medical conditions not related to CDI post-FMT while 33% reported diagnosis of a new medical condition or development of new symptoms; none of the new medical conditions or symptoms were attributable to the procedure. In all, 95% of patients indicated willingness to undergo FMT in the future if they experience another bout of C. difficile infection. Conclusion The findings show that FMT is a highly effective treatment option for RCDI with a cure rate, defined as resolution of RCDI post-FMT or recurrence attributable to antibiotic use post-FMT, of 96% (131/137) in the study group. Furthermore, clinical outcomes and patient satisfaction post-FMT indicate the safety of the procedure. Disclosures All authors: No reported disclosures.

Characterization of unresectable cholangiocarcinoma patients treated with or without chemoradiation.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 403-403
Author(s):  
Jane Elizabeth Rogers ◽  
Van Nguyen ◽  
Graciela M. Nogueras-Gonzalez ◽  
Christopher H. Crane ◽  
Prajnan Das ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Median Number ◽  
Primary Objective ◽  
First Line ◽  
Dismal Prognosis ◽  
History Of ◽  
Mixed Histology

403 Background: Curative treatment for cholangiocarcinoma (CC) is surgical resection. Unfortunately, most CC patients (pts) present with unresectable disease in which gemcitabine plus platinum (GEM-P) chemotherapy is the mainstay of treatment (tx). Advanced CC has a dismal prognosis with 5-year survival reported at 5-10 %. Data regarding chemoradiation (CRT) in pts with unresectable CC (uCC) remains limited. Methods: We retrospectively reviewed uCC pts from 1/1/2009 to 7/31/2013. Primary objective: to evaluate the percentage of pts treated with CRT and the median number of chemotherapy cycles given prior to CRT. Secondary objectives: response to first-line tx, progression free survival (PFS) with or without CRT, overall survival (OS) with or without CRT, and duration of CRT control. Inclusion criteria: uCC diagnosis, received tx, and had follow-up at our institution. Exclusion criteria: pts who received liver-directed therapy other than CRT, mixed histology tumors, and a history of other malignancies. Results: 114 pts were included with 62% having intrahepatic CC. Disease control (DC) (response + stable disease) with first-line tx was 75% with 71% receiving GEM-P +/- erlotinib first-line. 65% of pts received CRT with a median of 6 chemotherapy cycles given prior to CRT. DC after CRT was 62% with a median duration of radiation control of 6.4 mths. Median PFS and OS for all pts were 13.4 mths and 27.8 mths, respectively. Median PFS in the CRT group was 14.5 mths versus 11.4 mths in the no CRT group (p = 0.105). Median OS in the CRT cohort was 29.4 mths, while median OS without CRT was 22.4 mths (p = 0.005). Median OS and PFS after CRT for pts with DC on first-line tx were 32.0 months (95% CI = 24-44 mths) and 15.7 mths (95% CI =13.5-18.8 mths), respectively. Pts who progressed on first-line tx and received CRT had a median OS of 23.8 mths (95% CI = 7-30 months) and median PFS of 4.2 mths (95% CI = 2.3-9 mths). Conclusions: Our retrospective review reveals a significant improvement in median OS with CRT in uCC pts. Those with DC on first-line tx showed improvement in PFS and OS with CRT. Patient selection is key with the benefit being highest in pts with DC with first-line tx. Our results warrant further investigation of the role of CRT in uCC.

scholarly journals DOP54 Real-world effectiveness of thiopurine monotherapy in Crohn’s Disease: Is there still a place for thiopurines in the biological era?

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S089-S090
Author(s):  
A Rezazadeh Ardabili ◽  
S F G Jeuring ◽  
Z Mujagic ◽  
M J L Romberg-Camps ◽  
A A van Bodegraven ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Maintenance Therapy ◽  
Treatment Option ◽  
Real World ◽  
Population Based ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Abstract Background In current guidelines, thiopurines are still recommended as first-line maintenance therapy for patients with Crohn’s disease (CD). Due to their lack of immunogenicity, oral administration route and low costs, thiopurines are an attractive first-line treatment option. However, in recent studies the position of thiopurine monotherapy in CD has been questioned as a result of relatively lower overall effectiveness rates compared to ulcerative colitis. Real-world long-term effectiveness data substantiating the use and position of thiopurines in CD management remain sparse. We assessed long-term effectiveness of thiopurine monotherapy in CD using the population-based IBD South-Limburg (IBDSL) cohort. Methods All CD patients in the IBDSL cohort starting thiopurine monotherapy as first-line maintenance therapy between 1991–2014 were included. Thiopurine monotherapy was defined effective if either: (1) no escalation to biological treatment, (2) no course of corticosteroids, (3) no resective surgery or, (4) no hospitalization for active disease was required whilst on thiopurine treatment. Patients with early treatment discontinuation (i.e. &lt;3 months) were identified, including reason of discontinuation. Long-term effectiveness was assessed adjusting for differences in follow-up between patients using Kaplan-Meier analysis. Potential risk factors for therapy failure were identified using Cox regression. Results In total, 643/1162 (55.3%) CD patients (median follow-up: 8.5 years IQR 5.0–13.2) received first-line thiopurine monotherapy after a median of 9.7 months (IQR 3.2–31.3) after diagnosis. Therapy was discontinued within three months in 164 patients (25.5%), mainly due to adverse events [Figure 1]. Thiopurine monotherapy was effective for the duration of treatment in 229/479 (35.6%) patients, corresponding to estimated effectiveness rates of 62.9%, 43.9% and 31.2% after 1, 5 and 10 years, respectively [Figure 1–2]. No significant difference in effectiveness was observed after stratifying for era of thiopurine initiation (pre-biological (1991–1998) vs. biological (&gt;1999) era, p=0.84). Factors associated with thiopurine failure were stricturing disease (aHR 1.41, 95%CI 1.01–1.96) and upper GI involvement (aHR 1.52, 95%CI 1.02–2.28) at diagnosis. During follow-up, 40/229 patients with a durable response discontinued treatment due to quiescent disease. Of these, 35 patients (87.5%) remained without treatment 24 months after discontinuation. Conclusion Real-world data from this population-based study demonstrate that thiopurine monotherapy remains an effective and durable first-line treatment option for CD, even in the biological era. These results should be considered in the ongoing discussion regarding the position of thiopurine therapy.

scholarly journals Efficacy Differences of First-line EGFR-TKIs Alone vs. in Combination with Chemotherapy in Advanced Lung Adenocarcinoma Patients with Sensitive EGFR Mutation and Concomitant Non-EGFR Genetic Alteration(s)

2021 ◽  
Author(s):  
Guowei Zhang ◽  
Ruirui Cheng ◽  
Yuanyuan Niu ◽  
Huijuan Wang ◽  
Xiangtao Yan ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Lung Adenocarcinoma ◽  
Survival Data ◽  
Egfr Mutation ◽  
Objective Response ◽  
Genetic Alterations ◽  
Monotherapy Group ◽  
First Line ◽  
Egfr Tki

Abstract Objective: To explore whether EGFR-TKI combined with chemotherapy would benefit patients with advanced lung adenocarcinoma with both sensitive EGFR mutation and concomitant non-EGFR genetic alterations. Materials and Methods: Cases of advanced lung adenocarcinoma with EGFR mutation combined with concomitant non-EGFR genetic alterations were retrospectively collected. And the patients were required to receive first-line EGFR-TKI and chemotherapy combination or EGFR-TKI monotherapy. Demographic, clinical and pathological data were collected, and the electronic imaging data were retrieved to evaluate the efficacy and time of disease progression. Survival data were obtained through face-to-face or telephone follow-up. The differences between the two groups in objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) were investigated. Results: 107 patients were included, including 63 in the combination therapy group and 44 in the monotherapy group. The ORR were 78% and 50% (P =0.003), and DCR were 97% and 77% (P =0.002), respectively. At a median follow-up of 13.7 months, a PFS event occurred in 38.1% and 81.8% of patients in the two groups, with median PFS of 18.8 and 5.3 months, respectively (P <0.0001). Median OS was unreached in the combination group, and 27.8 months in the monotherapy group (P =0.31). According to the Cox multivariate regression analysis, combination therapy was an independent prognostic factor of PFS. Conclusion: In patients with EGFR-mutant advanced lung adenocarcinoma with concomitant non-EGFR genetic alterations, combination of TKI and chemotherapy was significantly superior to EGFR-TKI monotherapy, which should be the preferred treatment option.

scholarly journals Real-World Healthcare Resource Utilization in Patients with Indolent Non-Hodgkin's Lymphoma: Differences between Patients Treated First-Line with Ibrutinib or Bendamustine + Rituximab

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3549-3549
Author(s):  
Debra Irwin ◽  
Lu Zhang ◽  
Kathleen Wilson ◽  
Gerard Hoehn ◽  
Erika Szabo ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Healthcare Utilization ◽  
Resource Utilization ◽  
Real World ◽  
Index Date ◽  
Healthcare Resource ◽  
Healthcare Resource Utilization ◽  
Hodgkin's Lymphoma ◽  
First Line

Abstract OBJECTIVES: The purpose of this study was to examine real-world differences in healthcare resource utilization of indolent non-Hodgkin's Lymphoma (iNHL) patients treated with first-line ibrutinib monotherapy (IM) or first-line bendamustine + rituximab (BR) combination therapy using U.S. administrative claims data. METHODS: The MarketScan® Research Databases were used to identify patients aged 18 years or older with commercial or Medicare supplemental insurance plans based on their first prescription (index date) of either IM or BR therapy between 02/01/2014 and 08/30/2017. Patients were required to be diagnosed with iNHL and be treatment naïve, as well as be continuously enrolled (CE) for 6 months prior to and at least 30 days following the index date. All-cause and iNHL-related healthcare resource utilization (e.g., inpatient admission (IP) and emergency room (ER) visits) were evaluated during a 12-month follow-up period from the index date among the subset of patients with 12 months of continuous enrollment and reported per-patient per-month (PPPM). Statistical differences in the distribution of IP and ER visits between the IM versus BR therapy groups were estimated using chi-squared test for categorical variables and t-test for continuous variables. RESULTS: A total of 1,544 iNHL patients were identified, with 207 patients in the IM cohort and 1,337 patients in the BR cohort. The IM cohort was significantly older (mean = 68.3 years; SD = 11.8) then the BR cohort (mean age = 62.1 years; SD = 11.1). The proportion of females was significantly (p<.05) lower in the IM cohort (36%) relative to the BR cohort (49%). The two cohorts did not differ in comorbidity as assessed by National Cancer Institute Comorbidity Index score (IM=0.7 vs. BR=0.8, p=0.40). The results of the comparisons between the two groups with 12 months of follow-up (IM = 110; BR = 745) are provided in Table 1. For all-cause healthcare utilization, the proportion of IM patients experiencing at least one IP admission was significantly higher than the BR cohort as were the PPPM number of admissions. The proportion of patients with at least one ER visit was similar in the IM and BR cohorts. However, the average PPPM number of ER visits was significantly higher in the IM cohort relative to the BR cohort. A similar pattern was found for the iNHL-related healthcare utilization variables with one exception. The proportion of patients with at least one iNHL-related ER visit was significantly higher in the IM relative to the BR cohort. Conclusions: The current study examined differences in healthcare utilization among iNHL-patients treated in a front-line setting with either ibrutinib or BR combination therapy. Results indicated that not only did more ibrutinib patients experience an IP admission and ER visits, including both all-cause and iNHL-related, but they also experienced more repeat admissions and ER visits. These real-world findings highlight the importance of considering the healthcare resource utilization of iNHL patients which may be associated with their first-line therapy. Disclosures Irwin: Teva: Consultancy. Zhang:Teva: Consultancy. Wilson:Teva: Consultancy. Hoehn:Teva: Employment. Szabo:Teva: Employment. Tang:Teva: Employment.

scholarly journals Patterns of treatment with everolimus exemestane in hormone receptor-positive HER2-negative metastatic breast cancer in the era of targeted therapy

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Mariya Rozenblit ◽  
Sophia Mun ◽  
Pamela Soulos ◽  
Kerin Adelson ◽  
Lajos Pusztai ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Treatment Option ◽  
Metastatic Breast ◽  
Prior Treatment ◽  
Second Line ◽  
First Line ◽  
Effective Treatment Option ◽  
Third Line ◽  
Line Following

Abstract Background There is currently no clinical trial data regarding the efficacy of everolimus exemestane (EE) following prior treatment with CDK4/6 inhibitors (CDK4/6i). This study assesses the use and efficacy of everolimus exemestane in patients with metastatic HR+ HER2− breast cancer previously treated with endocrine therapy (ET) or endocrine therapy + CDK4/6i. Methods Retrospective analysis of electronic health record-derived data for HR+ HER2− metastatic breast cancer from 2012 to 2018. The proportion of patients receiving EE first-line, second-line, or third-line, and the median duration of EE prior to next line of treatment (TTNT) by line of therapy was calculated. OS for patients receiving EE first-line, second-line, or third-line, indexed to the date of first-line therapy initiation and stratified by prior treatment received, was calculated with Kaplan-Meier method with multivariable Cox proportional hazards regression analysis. Results Six hundred twenty-two patients received EE first-line (n = 104, 16.7%), second-line (n = 273, 43.9%) or third-line (n = 245, 39.4%). Median TTNT was 8.3 months, 5.5 months, and 4.8 months respectively. Median TTNT of EE second-line was longer following prior ET alone compared to prior ET + CDK4/6i (6.2 months (95% CI 5.2, 7.3) vs 4.3 months (95% CI 3.2, 5.7) respectively, p = 0.03). Similarly, EE third-line following ET alone vs ET + CDK4/6i in first- or second-line resulted in median TTNT 5.6 months (95% CI 4.4, 6.9) vs 4.1 months (95% CI 3.6, 6.1) respectively, although this was not statistically significant (p = 0.08). Median OS was longer for patients who received EE following prior ET + CDK4/6i. EE second-line following ET + CDK 4/6i vs ET alone resulted in median OS 37.7 months vs. 32.7 months (p = 0.449). EE third-line following ET + CDK4/6i vs prior ET alone resulted in median OS 59.2 months vs. 40.8 months (p < 0.010). This difference in OS was not statistically significant when indexed to the start of EE therapy. Conclusion This study suggests that EE remains an effective treatment option after prior ET or ET + CDK4/6i use. Median TTNT of EE was longer for patients who received prior ET, whereas median OS was longer for patients who received prior ET + CDK4/6i. However, this improvement in OS was not statistically significant when indexed to the start of EE therapy suggesting that OS benefit is primarily driven by prior CDK4/6i use. EE remains an effective treatment option regardless of prior treatment option.

Effect of oxaliplatin-capecitabine first-line chemotherapy and tumor response on serum proteomic profiles in advanced colorectal cancer and identification of diagnostic biomarkers

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3603-3603
Author(s):  
H. H. Helgason ◽  
J. Y. Engwegen ◽  
A. Cats ◽  
H. Boot ◽  
H. G. Bonfrer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Median Number ◽  
Healthy Controls ◽  
First Line ◽  
Diagnostic Biomarkers ◽  
Standardized Protocol ◽  
Apolipoprotein A ◽  
Potential Biomarker ◽  
Healthy Control

3603 Background: Colorectal cancer (CRC) is the third most common cause of cancer related death. Prognosis is highly dependent on stage at diagnosis making early diagnosis mandatory. Previously we identified serum biomarkers for CRC, by comparing serum from CRC patients and healthy controls, using SELDI-TOF mass spectrometry. Methods: We validated our identified biomarkers and assessed the effect of first-line oxaliplatin (130 mg/m2 day 1, q21)-capecitabine (1000 mg/m2 d1–14, q21) therapy by prospective standardized serum sampling at < 2 weeks prior to start of chemotherapy and serially before each chemotherapy cycle in patients with advanced CRC. Samples were drawn according to standardized protocol, centrifuged within 1 hour and stored at -30°C. After thawing they were analyzed with SELDI-TOF MS on CM10 chips at pH 5. Healthy control subjects were matched according to age, gender and time of serum collection. For serial analysis the time points T: 0, 6, 12 and 18 - 24 weeks were used. All patients had given written consent, had WHO PS ≤ 2 and measurable disease, according to RECIST criteria, and/or were evaluable by CEA. Results: In total 42 patients (mean age: 57 years; range: 37 - 73; male 62%), were treated between 06/2003 and 09/2005. All patients were previously untreated except 8 patients who had received radiation or chemo-radiation for rectal carcinoma (all > 6 months). Median follow up was 45 weeks and median number of courses was 5.5 (range: 1 -10). Response rate was 46%; PR in 19, SD in 12 and PD in 10 patients, respectively (1 not evaluable) and median overall survival was 10.5 months. We identified 6 peptides/proteins (m/z: 31948, 8078, 28101 (apolipoprotein A-I), 7970, 5912 and 12861 Da, respectively (in order of significance) discriminating between CRC and healthy controls (p < 0.001). In a serial analysis of the patients a peptide, with m/z: 5.9-kDa (most likely fibrinogen split product) declined, during chemotherapy in some responsive patients, but apolipoprotein A-I appeared not to change. Conclusions: We confirmed our previous identification of apolipoprotein A-I (m/z: 28-kDa) as a potential biomarker for CRC and suggest a peptide with m/z: 5.9-kDa as a potential biomarker of response. No significant financial relationships to disclose.

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