Treatment patterns among newly diagnosed women with cervical cancer in the United States.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18019-e18019
Author(s):  
Anuj Shah ◽  
Nehemiah Kebede ◽  
Ruchit Shah ◽  
Shelby Corman ◽  
Chizoba Nwankwo

e18019 Background: To address the gap in US-based real-world data, this analysis described the real-world treatment patterns among newly diagnosed cervical cancer patients. Methods: Women newly diagnosed with cervical cancer between Jan 2015 – June 2018, with a confirmatory diagnosis or treatment within 2 months, and continuous enrollment for 12 months prior and 6 months post diagnosis were identified in the Optum Clinformatics DataMart database. Surgeries (hysterectomy, conization, lymphadenectomy and trachelectomy), radiation (external beam radiotherapy [EBRT]/brachytherapy) and systemic therapies (chemotherapy/immunotherapy) received after diagnosis were described by line of therapy (LOT). The start of the first LOT was the date of the first treatment. All treatments initiated within 90 days of a surgery or the end of radiotherapy, and all systemic treatment started within 28 days of any previous treatment were a part of the same LOT. Most frequently received treatments in LOT1 and 2 and time to treatment initiation were described. Results: Out of 1,004 newly diagnosed women, 655 (65.2%) received at least LOT1 and 162 (16.14%) received LOT2. Median time to first LOT was 1.5 (1.4 – 1.7) months from diagnosis. Surgery was the most common treatment in LOT1 (58.0%). Among patients receiving radiation, the majority received a combination of EBRT and brachytherapy (LOT1: 66.9%, LOT2: 58.0%). The use of chemotherapy increased with subsequent LOTs (LOT1: 53.3%, LOT2: 61.1%). Treatments received in LOT1 and LOT2 are described in the table. Conclusions: This analysis shows that newly diagnosed cervical cancer patients are primarily receiving guideline recommended treatment with surgery or chemoradiation as primary treatment. Radiation therapy includes EBRT and brachytherapy. Counts ≤ 10 are not reported (NR). [Table: see text]

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17020-e17020
Author(s):  
Shelby Corman ◽  
Chizoba Nwankwo ◽  
Youngmin Kwon ◽  
Ruchit Shah

e17020 Background: Treatment options for cervical cancer include surgery, radiation therapy, chemotherapy, and immunotherapy depending upon the disease stage. There is limited real-world evidence providing us with a clinical profile for a treated cervical cancer patient. The objective of this study was to compare cervical cancer patients who were currently receiving treatment versus those not receiving treatment. Methods: This was a retrospective, cross-sectional analysis of Medical Expenditure Panel Survey (MEPS) data (2006-2015). Cervical cancer cases were identified using ICD-9 CM code 180 or clinical classification software code 26. Patients receiving only chemotherapy, radiation therapy, undergoing surgery, or a combination of these treatments in a given year were regarded as “currently receiving treatment”. The comparator cohort included patients “not currently receiving treatment”. The two cohorts were compared in terms of patient clinical characteristics using bivariate analyses. Results: The analytic cohort consisted of 275,246 cervical cancer cases (mean age: 42 years, Caucasian: 88.0%, having private insurance: 55.3%) of which 115,639 (42.01%) were “currently receiving treatment”. The most common treatment option was undergoing surgery only (88.21%), followed by combination therapy (6.82%), chemotherapy only (3.84%), and radiation therapy only (1.12%). The “currently receiving treatment” cohort had a significantly higher proportion of patients having a history of myocardial infarction (4.21% vs 3.50%), congestive heart failure (2.73% vs 1.42%), chronic obstructive pulmonary disorder (29.5% vs 23.2%), connective tissue disease (20.5% vs 11.6%), renal disease (2.49% vs 0.48%), and diabetes (17.7% vs 11.7%) compared to those “not currently receiving treatment”. The latter cohort had a higher proportion of patients with moderate/severe liver disease (0.46% vs 5.32%). Conclusions: The observed real-world patient characteristics and treatment patterns were indicative of a cohort of largely early stage cervical cancer patients. Patients receiving treatment appeared to have a higher comorbidity burden which may subsequently result in poorer quality of life and activity limitations.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4163-4163
Author(s):  
Jeff Sharman ◽  
Shaum Kabadi ◽  
Jamyia Clark ◽  
E Susan Amirian ◽  
David J. Andorsky

Abstract Introduction Ibrutinib, a Bruton's tyrosine kinase inhibitor, was approved in the U.S. for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in November of 2013. However, real-world data on ibrutinib use for the treatment of MCL is limited. The purpose of this study was to examine ibrutinib use, dosages, and reasons for treatment discontinuation among MCL patients treated in a community oncology practice setting. Methods The study population consisted of adult (≥18 year old) MCL patients treated with ibrutinib between November 1, 2013 and October 31, 2016, who were not enrolled in a clinical trial and had at least 2 visits to a US Oncology Network (USON) clinic. Patients with other primary cancers were excluded. Patient data were sourced from the USON's electronic health records system, iKnowMed (iKM)™. The structured iKM database provided information on demographics and clinical and treatment characteristics. Manual chart review was used to confirm ibrutinib treatment patterns. Duration of ibrutinib therapy (DOT), overall survival (OS), and progression-free survival (PFS) from systemic treatment initiation were estimated using Kaplan-Meier methods. Events were defined as death in the OS analysis, and progression or death in the PFS analysis. Patients were censored if their treatment was ongoing for DOT. Censors for OS and PFS were patients lost to follow up or those who did not experience a failure event within the study period. Results 159 eligible MCL patients were identified through iKM. The majority of patients were Caucasian (n=141, 88.7%), male (n=121, 76.1%), and diagnosed with Stage IV disease (n=117, 73.6%). Median follow-up for the population was 16.1 months. Approximately 7.5% (n=12) of patients received ibrutinib as first-line therapy (1L), compared to 54.1% (n=86) in 2L and 38.4% (n=61) in 3L or beyond. Median ibrutinib dose at initiation was 560mg (range: 140-700). During ibrutinib treatment, 16.4% (n=26) of patients experienced a dose reduction. Dose holds occurred in 30.2% (n=48), 66.7% (n=32) due toxicities. The overall discontinuation rate was 83.6% The primary reason for discontinuation was disease progression (n=46, 34.6%) followed by toxicities (n=34, 25.6%). Median DOT was higher for patients initiating treatment in 3L+ (14.9: 95% CI 8.8-17.1) compared to other lines. Median PFS was 19.6 (95% CI: 16.5-24.3) for the overall population and median OS was 25.8 months (95% CI: 19.9-not reached). Conclusions Our real-world findings on survival are consistent with those from clinical trials on ibrutinib in relapsed/refractory MCL, although our observed discontinuation rate (~84%) was higher than that of the trial (~58%), which had a similar median follow-up time (16.1 months vs. 15.3 months, respectively). Our findings provide additional data on MCL treatment patterns and patient outcomes in clinical practice. Disclosures Sharman: Acerta: Consultancy, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding. Kabadi:AstraZeneca: Employment. Clark:McKesson Specialty Health: Employment, Equity Ownership. Amirian:McKesson Specialty Health: Employment. Andorsky:Celgene: Research Funding; CTI BioPharma: Consultancy, Research Funding; AstraZeneca: Consultancy; Genentech: Consultancy.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2142-2142
Author(s):  
Maneesha Mehra ◽  
Sarah Cote ◽  
Tobias Kampfenkel ◽  
Sandhya Nair

Introduction: For patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem-cell transplantation (ASCT), two standard of care (SoC) induction regimens are bortezomib/cyclophosphamide/dexamethasone (VCd) and bortezomib/thalidomide/dexamethasone (VTd), each followed by ASCT. While VCd and VTd are both treatment options according to international guidelines, treatment selection varies by country. Additionally, while some clinical studies have evaluated the efficacy and safety of these therapies, direct comparisons have been limited to response endpoints post-induction and post-transplant (Moreau P, et al. Blood. 2016;127[21]2569-2574; Cavo M, et al. Blood. 2014;124[21]197; Cavo M, et al. Leukemia. 2015;29[12]2429-31). Herein we describe real-world treatment patterns in the United States for patients with NDMM who are transplant-eligible, and report results from a matched adjusted comparison to evaluate real-world long-term efficacy (overall survival, OS) for VCd +ASCT versus VTd +ASCT. Methods: Data for the VCd and VTd real-world evidence (RWE) cohorts were identified from 3 US data sources collectively covering the period January 2000 to March 2017: the OPTUM™ Commercial Claims database, the OPTUM™ Integrated (CLAIMS+EMR) database, and the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked database. RWE data were from patients with an index MM diagnosis on or after 1 January 2007, medical prescription coverage in place at diagnosis, no prior malignancies in the 1-year period prior to index diagnosis, a 1-year look-back period prior to index diagnosis, received ≥1 line of therapy, and received stem cell transplantation with induction as frontline treatment. The Kaplan-Meier method and Cox proportional hazard model compared outcomes with and without adjustments for baseline characteristics (age, sex, renal impairment, and anemia) and induction treatment duration; comparisons were also conducted with inverse probability of treatment weighting (IPTW). Results: Analysis of RWE from the United States demonstrated that bortezomib (V)-based regimens were the most common induction treatment (together accounting for approximately 75% of therapies), with bortezomib/lenalidomide/dexamethasone (VRd) being the most common (31%). Use of VCd (13%) and VTd (5%) was limited. Comparisons were conducted for VCd (n = 135) and VTd (n = 51). Baseline characteristics were generally similar between groups, except for fewer male patients in the VCd group than the VTd group (57% vs 65%), and lower rates of renal impairment in the VCd group than the VTd group (29% vs 43%; Table 1). The naïve and adjusted comparisons of OS for VCd versus VTd therapy showed these treatments were not statistically different (adjusted hazard ratio, 1.180 [95%: 0.468-2.972]; P = 0.7260; Figure 1). The IPTW method generated similar results. Conclusions: Real-world data from the United States show that V-based induction regimens are the most commonly used for treatment of patients with NDMM who are transplant-eligible. Results from the naïve, adjusted, and IPTW comparisons all showed that OS was not significantly different for VCd + ASCT versus VTd + ASCT. Survival data for VTd from RWE are generally consistent with VTd data reported in the recent phase 3 CASSIOPEIA study, although OS data from CASSIOPEIA remain immature (Moreau P, et al. Lancet. 2019;394[10192]:29-38). Disclosures Cote: Janssen: Employment, Equity Ownership. Kampfenkel:Janssen: Employment, Equity Ownership. Nair:Janssen: Employment, Equity Ownership.


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