scholarly journals Real-World Utilization of Midostaurin Among Patients with Systemic Mastocytosis (SM)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5378-5378
Author(s):  
Ajeet Gajra ◽  
Andrew J Klink ◽  
Dhruv Chopra ◽  
Bruce Feinberg
Keyword(s):  
Mast Cells ◽  
Median Duration ◽  
Real World ◽  
Systemic Mastocytosis ◽  
Recommended Dose ◽  
Study Cohort ◽  
Cell Transplant ◽  
First Line ◽  
Line Setting

Introduction: Systemic Mastocytosis (SM) is a rare neoplasm of myeloid origin characterized by an accumulation of abnormal mast cells in the bone marrow, liver, spleen, and skin and has a molecular signature of the KITD816V mutation, detectable in >90% of patients. Clinical findings include cytopenias, liver-function abnormalities, hypoalbuminemia, weight loss, ascites, and osteolytic bone lesions due to infiltration of various organs by the malignant mast cells. The indolent and smoldering subtypes of SM can have a long natural history but aggressive systemic mastocytosis (aSM), SM with associated hematological neoplasm (SMHN), and mast cell leukemia (MCL) subtypes are associated with poor prognosis at a median survival of 3.5 years, 2 years and 6 months respectively. In April 2017, the FDA approved midostaurin, a multitargeted kinase inhibitor for the treatment of adults with aSM, SMHN and MCL at a dose of 100mg twice daily based on achievement of response rate endpoint noted in an open label trial of midostaurin (Gotlib et al, NEJM 2016). Pre-midostaurin, the treatment options for aSM, SMHN and MCL were imatinib, cladribine, interferon or allogeneic stem cell transplant (ASCT). The objective of this retrospective study was to assess the uptake and utilization of midostaurin in patients with aSM, SMHN and MCL. Methods: Patients with at least 1 claim for midostaurin (index date) between April 1, 2017 and October 31, 2018 and who had at least 1 claim with a diagnosis of SM (ICD 10 code C96.2x or C94.3x) in the 6-month pre-index period were identified from Symphony Health's Integrated Dataverse (IDV), a large US claims database containing linked longitudinal prescription, medical, and hospital claims. The IDV contains claims for 280 million active unique patients representing over 73% of specialty prescriptions, 58% of medical claims, and 30% of hospital claims volume in the US. Patients included in the study cohort had a 6-month pre-index period with no claims with a diagnosis of SM, were at least 18 years old at initiation of midostaurin, and no evidence of participation in a clinical trial. Patient characteristics and treatment patterns were summarized using descriptive statistics. Median and 95% confidence interval (CI) for duration of midostaurin were calculated using Kaplan-Meier estimates. Results: Of the 38 patients with SM treated with midostaurin, 33 had a diagnosis of aSM and 5 had a diagnosis of MCL. The majority were female (61%) with a median age of 63 years (range 27-79) at diagnosis; 42% of these patients were 65 years or older (Table). The majority (66%) of patients had commercial insurance, and patients resided in all 4 US regions (34% South, 34% West, 18% Midwest, 11% Northeast). Nearly two-thirds (63%) of midostaurin use was in the first line setting, 32% was given in second line, and 5% was given in third line. Among the 14 patients with therapy prior to midostaurin, cladribine was most common (n=4, 29%), followed by hydroxyurea, interferon alfa-2b, brentuximab vedotin, and others (each n=2, 14%). Over two-thirds (68%) had an average daily dose of 200mg on the first fill, 5% treated at 100mg daily, and 26% with average daily doses <100mg. Two thirds (22 of 33) patients with aSM and 4 of 5 with MCL were prescribed the 200mg/day recommended dose. With a median follow-up of 13.4 months from midostaurin initiation, the median duration of midostaurin 2.4 months (95% CI 1.1-4.6). Conclusions: In this retrospective claims based study, there is evidence of early uptake of midostaurin use in SM. Midostaurin was used in the first line setting in the majority of patients. The median duration of midostaurin treatment was short at 2.4 months especially when compared to a median treatment duration of 11.5 months in the pivotal trial. It is noteworthy that almost a third of patients were started on a lower than recommended dose which may compromise efficacy. The relatively short follow up may be another reason for the observed duration of response. Potential barriers to the appropriate use of midostaurin in SM such as lack of awareness, access, cost or delay in diagnosis due to its rarity will need further exploration. While the current claims-based dataset does not provide us the information, early, accurate diagnosis of SM is essential to timely utilization of midostaurin in the real-world setting. Further research and education may be needed to optimize the use of novel therapeutics in such orphan diseases. Disclosures Gajra: Cardinal Health: Employment. Klink:Cardinal Health: Employment. Chopra:Cardinal Health: Employment. Feinberg:Cardinal Health: Employment.

Tivozanib as first-line treatment of metastatic renal cell carcinoma: A real-world outcome review in North-West of England, United Kingdom.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 638-638 ◽  
Author(s):  
Sam Wong ◽  
Kellati Prasad ◽  
Tom Waddell ◽  
Natalie Charnley ◽  
Helen Wong ◽  
...  
Keyword(s):  
Real World ◽  
Kinase Inhibitor ◽  
P Value ◽  
Risk Category ◽  
First Line ◽  
North West ◽  
Low Incidence ◽  
Line Setting ◽  
Treatment Tolerance

638 Background: Tivozanib is a selective tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor and has been shown to offer PFS and tolerance advantage compared to sorafenib among patients with mRCC. In this retrospective review, we aim to investigate the real world efficacy and tolerance of tivozanib delivered in four cancer hospital in the Northwest of England. Methods: mRCC patients started tivozanib in first line setting were identified and reviewed. Primary outcomes of interest include overall response rate (ORR), survival (OS, PFS where possible) and treatment tolerance. Results: A total of 113 patients were identified between March 2017 and May 2019. Median follow up was 200 days (15-792). 26% were switched from other prior TKI due to intolerance. 28%, 48% and 24% had Favourable (F), Intermediate (I) and Poor(P) IMDC risk category respectively. ORR was 29% (CR 0%, PR29%, SD38%, PD26%, NE 7%). Median PFS (after 53 events) was 9 months (F = NR, I = 7 months, P = 3 months p value < 0.0001) with estimated 6 and 12 months OS of 80% and 67 % respectively. At cut-off, 26/32 with F IMDC risk remaining on treatment c.f. 24/54 (I) and 6/27 (P). Median treatment received was 5 cycles and 65% still on full dose at end of observation. Dose reduction was necessary in 31% while treatment was stopped in 15% due to toxicity. 46% received subsequent therapy post- progression. The commonest adverse events were fatigue (32%, G3 0%), diarrhoea (15%, G3 1.7%), mucositis (15%, G3 < 1%), and anorexia (7%, G3 1.7%). Conclusions: Preliminary findings from this review suggests similar clinical efficacy of tivozanib compared to agents such as pazopanib or sunitinib in real-world setting particularly among patient with Favourable IMDC category however longer follow up is required to fully evaluate this. Treatment is well tolerated with low incidence of severe grade toxicities and may be a good monotherapy option in patient of Favourable IMDC category unsuitable for combination therapies.

Aleukemic Mast Cell Leukemia (aMCL) - Clinical Characteristics and Outcomes

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4255-4255 ◽  
Author(s):  
Preetesh Jain ◽  
Sa Wang ◽  
Hagop M. Kantarjian ◽  
Nawid Sarwari ◽  
Keyur P. Patel ◽  
...  
Keyword(s):  
Overall Survival ◽  
Mast Cell ◽  
Mast Cells ◽  
Research Funding ◽  
Median Overall Survival ◽  
Systemic Mastocytosis ◽  
Cell Transplant ◽  
Cell Leukemia ◽  
Mast Cell Leukemia

Abstract ABSTRACT Introduction: Systemic mastocytosis (SM) is a complex and rare disease of clonal mast cells. Mast cell leukemia (MCL) is a very rare form of SM seen in <1% patients. We describe here our experience with MCL patients treated at our institution. Methods: We reviewed the medical records of 218 patients with mastocytosis who presented to our institution between 1994 and 2016. The survival of patients was calculated from the date of initial presentation to the date of last follow up. Kaplan-Meier product limit method was used to estimate the median survival. Results: From the 218 patients with mastocytosis, we identified 13 patients with MCL (6.5%). All 13 had aleukemic variant of MCL (aMCL; no presence of mast cells in blood measured by standard CBC technique but with ≥ 20% atypical mast cells in the marrow aspirate). In addition, in 4 of 13 patients, associated hematologic neoplasm (AHN) was present: 2 with myelodysplastic syndrome, 1 with chronic myelomonocytic leukemia and 1 with multiple myeloma. Median age of 13 patients was 62 years (range 24-75 years). Baseline features are summarized in Table-1. During their initial clinical presentation, 85% had constitutional symptoms, 54% had skin rash and other cutaneous symptoms, 31% gastrointestinal symptoms and 23% had joint pains. Imaging studies were performed in 6 patients: 5/6 had enlarged liver and/or spleen, 3 patients had nodal involvement, 2 had sclerotic bony lesions and 1 pt had adrenal involvement. Serum tryptase was >200 ng/ml in all the patients. Testing for c-KITD816V mutation was performed in 9 patients using mutation-specific quantitative (real-time) PCR, of which mutation was undetectable in 6 and detected in 3 patients. The sensitivity of detection was approximately 1 in 1000 mutation-bearing cells. None had FIP1L1-PDGFRA mutations. Treatments given were heterogeneous. Two patients each received imatinib with no response, 2 received dasatinib (one [positive for KITD816V mutation] had significant improvement in hepatosplenomegaly and pruritus but progressed after 1 year of dasatinib therapy), 2 cladribine based therapy with no response, and 2 with stem cell transplant and progression after it. Overall, median follow up was 111 months (1.4-131); 3 patients were alive and 9 died at the time of last follow up. Interestingly, among our 13 aMCL patients, those 4 with AHN appear to have had worse outcome: Figure-1A, shows the median overall survival (OS) of aMCL vs aMCL-AHN (32 vs 25 months; p=0.22). Overall, the median overall survival (OS) of aMCL without AHN was significantly inferior compared to aggressive systemic mastocytosis (ASM) and indolent systemic mastocytosis (ISM) without AHN: 31 months and not reached respectively (Figure-1B; p<0.001). Conclusions: In this analysis, we have shown that aMCL is very rare and these patients have very poor outcome. Based on the recent data from Gotlib et al NEJM 2016, role of midostaurin in the treatment of MCL should be explored. Further studies to characterize the genomic profile of patients with MCL are needed to identify potential therapeutic targets and disease resistance pathways. Table Survival of patients with aleukemic mast cell leukemia (aMCL) with/without AHN (A) and survival comparison of aMCL to other types of systemic mastocytosis, all without AHN (B) Table. Survival of patients with aleukemic mast cell leukemia (aMCL) with/without AHN (A) and survival comparison of aMCL to other types of systemic mastocytosis, all without AHN (B) Figure Figure. Disclosures Daver: Sunesis: Consultancy, Research Funding; Kiromic: Research Funding; Ariad: Research Funding; Pfizer: Consultancy, Research Funding; Otsuka: Consultancy, Honoraria; Karyopharm: Honoraria, Research Funding; BMS: Research Funding. Cortes:ARIAD: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Teva: Research Funding. Verstovsek:Celgene: Research Funding; Bristol-Myers Squibb: Research Funding; AstraZeneca: Research Funding; Incyte Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding; Galena BioPharma: Research Funding; Gilead: Research Funding; CTI BioPharma Corp: Research Funding; Lilly Oncology: Research Funding; NS Pharma: Research Funding; Geron: Research Funding; Promedior: Research Funding; Seattle Genetics: Research Funding; Roche: Research Funding; Pfizer: Research Funding; Genentech: Research Funding.

Outcomes of Patients (pts) with Myelodysplatic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML) Post Clofarabine Failure

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1722-1722
Author(s):  
Hady Ghanem ◽  
Guillermo Garcia Manero ◽  
Stefan Faderl ◽  
Koichi Takahashi ◽  
Farhad Ravandi ◽  
...  
Keyword(s):  
Median Duration ◽  
Salvage Therapy ◽  
Single Agent ◽  
Myelogenous Leukemia ◽  
High Dose ◽  
Cell Transplant ◽  
First Line ◽  
Platelet Recovery ◽  
Duration Of Response

Abstract Abstract 1722 Introduction: Clofarabine is a nucleoside analogue that has shown activity in pts with myeloid disorders. The outcome of pts with MDS and CMML post clofarabine is unknown. Aims: To evaluate the outcome of pts with MDS or CMML treated and failed clofarabine based chemotherapy as a first line or salvage regimen. Methods: We reviewed data of 89 pts with MDS and 21 patients with CMML treated with a clofarabine based chemotherapy at MDACC between 6/2001 and 5/2012. Thirty-nine pts (36%) received clofarabine as first line therapy and 71 pts (64%) received clofarabine as salvage therapy. Ninety-six pts (87%) received single agent clofarabine and 14 pts (13%) received a clofarabine containing combination. Response assessment followed standard criteria. Overall survival (OS) was measured from the time of therapy till the time of death or last follow-up. Results: One hundred and ten pts with a median age of 68 years (range, 42–88) were assessed. Sixty-five percent of the pts were older than 65 years. At the time of MDS diagnosis, 68 (61%) had a high or intermediate-2 risk International Prognostic System Score (IPSS). Thirty-one pts (27%) had complex cytogenetics. Sixty-one pts (55%) had failed therapy with a hypomethylating agent (HMA) before initiation of a clofarabine containing salvage therapy. Of the pts who received frontline clofarabine treatment, 15 (23%) achieved complete remission (CR) and 2 (3%) CR with incomplete platelet recovery (CRp), for an overall response rate (ORR) of 26%. Of the pts who received salvage clofarabine treatment, 4 (9%) achieved CR and 5 (11%) CRp, for an ORR of 20%. The median duration of response to clofarabine was 6 months. ORR was 14% among the 61 patients who had received a prior HMA. At time of clofarabine failure, 20 (18%) had progressed to acute myelogenous leukemia (AML). Fifty-eight patients received salvage therapy after clofarabine failure. Among these, 13 patients received allogeneic stem cell transplant, 17 patients received a high dose Ara-C containing regimen and 25 patients received only investigational treatments. Only 8 (14%) responded (median duration of response not reached) (range, 0–40 months). Within a median follow-up of 3 months from clofarabine failure, 13 pts (14%) remained alive. The median OS post clofarabine failure was 5.1 months and the 1-year survival rate of 25% (figure 1). Conclusion: Outcome of patients with MDS post clofarabine failure is poor, with a median survival of 5.1 months. These patients should be offered investigational strategies. Disclosures: Off Label Use: Use of clofarabine is investigational in MDS.

scholarly journals Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2− metastatic breast cancer in US real-world clinical practice

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Angela DeMichele ◽  
Massimo Cristofanilli ◽  
Adam Brufsky ◽  
Xianchen Liu ◽  
Jack Mardekian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Clinical Practice ◽  
Real World ◽  
Metastatic Breast ◽  
Routine Clinical Practice ◽  
Survival Outcomes ◽  
First Line ◽  
Line Setting

Abstract Background Findings from randomized clinical trials may have limited generalizability to patients treated in routine clinical practice. This study examined the effectiveness of first-line palbociclib plus letrozole versus letrozole alone on survival outcomes in patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor–negative (HER2−) metastatic breast cancer (MBC) treated in routine clinical practice in the USA. Patients and methods This was a retrospective observational analysis of electronic health records within the Flatiron Health Analytic Database. A total of 1430 patients with ≥ 3 months of follow-up received palbociclib plus letrozole or letrozole alone in the first-line setting between February 3, 2015, and February 28, 2019. Stabilized inverse probability treatment weighting (sIPTW) was used to balance baseline demographic and clinical characteristics. Real-world progression-free survival (rwPFS) and overall survival (OS) were analyzed. Results After sIPTW adjustment, median follow-up was 24.2 months (interquartile range [IQR], 14.2–34.9) in the palbociclib group and 23.3 months (IQR, 12.7–34.3) in those taking letrozole alone. Palbociclib combination treatment was associated with significantly longer median rwPFS compared to letrozole alone (20.0 vs 11.9 months; hazard ratio [HR], 0.58; 95% CI, 0.49–0.69; P < 0.0001). Median OS was not reached in the palbociclib group and was 43.1 months with letrozole alone (HR, 0.66; 95% CI, 0.53–0.82; P = 0.0002). The 2-year OS rate was 78.3% in the palbociclib group and 68.0% with letrozole alone. A propensity score matching analysis showed similar results. Conclusions In this “real-world” population of patients with HR+/HER2− MBC, palbociclib in combination with endocrine therapy was associated with improved survival outcomes compared with patients treated with letrozole alone in the first-line setting. Trial registration Clinicaltrials.gov; NCT04176354

scholarly journals Health Resource Utilization and Costs Associated with the Use of Obinutuzumab-Based Regimens Are Similar to Rituximab-Based Regimens for the First-Line Treatment of Follicular Lymphoma

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4721-4721
Author(s):  
Tu My To ◽  
Keith L. Dawson ◽  
Anthony S Masaquel ◽  
Arpamas Seetasith
Keyword(s):  
Drug Treatment ◽  
Follicular Lymphoma ◽  
Real World ◽  
Specific Drug ◽  
First Line ◽  
Employment Equity ◽  
Total Cost ◽  
Claims Database ◽  
Equity Ownership

Introduction: Obinutuzumab (GA101; G), a fully humanized, glycoengineered, type II anti-CD20 monoclonal antibody, is approved in the US for the first-line (1L) treatment of follicular lymphoma (FL). Despite the superior efficacy of G plus chemotherapy (G-chemo) versus rituximab (R) plus chemotherapy (R-chemo) in patients with previously untreated FL demonstrated in the Phase III, randomized GALLIUM study (NCT01332968; Marcus et al. N Engl J Med 2017), information on healthcare resource use (HRU) and real-world costs with G in previously untreated FL patients is limited. The aim of this retrospective cohort study was to examine HRU and costs for G-based and R-based therapies for the 1L treatment of FL using a US claims database. Methods: The data source for this study was the PharMetrics Plus Commercial Claims database. Adult patients (≥18 years) diagnosed with FL between February 1, 2015 and September 30, 2018 and who began any treatment for FL between February 1, 2016 and September 30, 2018 were included. The first FL treatment date within this selection window was denoted the index date. Patients were required to have ≥12 months of pre-index and ≥3 months of post-index continuous study enrolment, and to have at least one FL diagnosis on or during the 12-month pre-index period. Patients with FL treatment during the 12-month pre-index period were excluded in order to select only previously untreated patients. HRU and cost data during the 1L treatment period were descriptive and categorized by HRU category. Costs are in 2018 US dollars ($) and standardized as per patient per month (PPPM) costs. FL treatment determination was based on National Comprehensive Cancer Network guidelines. Results: A total of 1584 FL patients with ≥3 months follow up were analyzed. Overall, 26 patients received G-chemo (any combination) as their 1L treatment, 208 patients received R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), 391 patients received R-Benda (bendamustine) and 17 patients received R-CVP (cyclophosphamide, vincristine, prednisone); the remaining 942 patients received other regimens (predominantly other R combinations). Data are reported for those patients who received G-chemo, R-CHOP, R-Benda or R-CVP as 1L therapy (n=642; 281 females, 361 males). Baseline patient characteristics were similar for most variables across treatment groups. Mean (standard deviation [SD]) age was 56.9 (9.7) years and all patients had a Charlson Comorbidity Index (CCI) of ≥2 (mean [SD]: 2.9 [1.9]). Mean (SD) patient follow-up was 14.1 (8.0) months and mean (SD) duration of 1L treatment was 7.0 (5.1) months. A summary of all-cause HRU in patients receiving 1L treatment is provided by treatment category (Figure 1A). The proportion of patients with at least one hospitalization was highest with R-CHOP (23.6%). The proportion of patients with at least one emergency room (ER) visit was highest with R-Benda (29.4%). Mean (SD) total all-cause healthcare costs PPPM during 1L treatment were comparable among G-chemo, R-CHOP and R-Benda (Figure 1B) and lowest with R-CVP ($17,874 [$13,465]). Medical costs (mean [SD]) were highest for R-Benda ($27,716 [$19,610] PPPM) and lowest for R-CVP ($17,373 [$12,908] PPPM). G-chemo was associated with the lowest pharmacy costs ($76 [$107] PPPM) (Figure 1B). Mean (SD) total cost of FL drug treatment PPPM was $16,028 ($9,942) for G-chemo, $11,684 ($6,122) for R-CHOP and $12,108 ($8,794) for R-CVP. Mean (SD) total cost of FL drug treatment PPPM was highest with R-Benda ($21,263 [$15,328]). G-specific drug costs PPPM ($9,643 [$6,071]) were similar to R-specific drug costs ($9,992 [$5,234] R-CHOP; $9,083 [$5,859] R-Benda; and $10,702 [$7,717] R-CVP). Conclusions: Our results depict real-world HRU and costs associated with G and commonly used 1L regimens for FL. In this setting, HRU and costs associated with G-chemo were comparable with R-chemo, supporting the use of G-chemo as a treatment option for patients with previously untreated FL. The study findings are limited by the small sample size of the G-chemo patient cohort (n=26) and short follow-up; to address this, an updated analysis incorporating a larger number of patients is planned. Disclosures To: Genentech, Inc.: Employment, Equity Ownership. Dawson:Roche/Genentech: Equity Ownership; Genentech: Employment. Masaquel:Genentech: Employment; Roche: Equity Ownership. Seetasith:Genentech: Employment, Equity Ownership.

Real-world starting dose and outcomes of palbociclib plus an aromatase inhibitor for metastatic breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13021-e13021
Author(s):  
Debra A. Patt ◽  
Xianchen Liu ◽  
Benjamin Li ◽  
Lynn McRoy ◽  
Rachel M. Layman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Aromatase Inhibitor ◽  
Real World ◽  
Metastatic Breast ◽  
Routine Practice ◽  
First Line ◽  
Starting Dose ◽  
The Us

e13021 Background: Palbociclib (PA) has been approved for HR+/HER2–advanced/metastatic breast cancer (mBC) in combination with an aromatase inhibitor (AI) or fulvestrant for more than 6 years. Regardless of the labeled recommended starting dose of 125mg/day, some patients initiate palbociclib at lower doses in routine practice. This study described real-world starting dose, patient characteristics, and effectiveness outcomes of first line PA+ AI for mBC in the US clinical setting. Methods: We conducted a retrospective analysis of Flatiron Health’s nationwide longitudinal electronic health records, which came from over 280 cancer clinics representing more than 2.2 million actively treated cancer patients in the US. Between February 2015 and September 2018, 813 HR+/HER2– mBC women initiated PA+AI as first-line therapy and had ≥ 3 months of potential follow-up. Patients were followed from start of PA+AI to December 2018, death, or last visit, whichever came first. Real-world progression-free survival (rwPFS) was defined as the time from the start of PA+AI to death or disease progression. Real-world tumor response (rwTR) was assessed based on the treating clinician’s assessment of radiologic evidence for change in burden of disease over the course of treatment. Multivariate analyses were performed to adjust for demographic and clinical characteristics. Results: Of 813 eligible patients, 68.3% were white, median age was 65.0 years, and 42.9% had visceral disease (lung and/or liver). Median duration of follow-up was 21.0 months. 805 patients had records of PA starting dose, with 125mg and 75/100mg/day being 86.5% and 13.5%, respectively. Patients who started at 75/100mg/day were more likely to be ≥75 years than those who started at 125mg/day (38.5% vs 17.1%). Other baseline and disease characteristics were generally evenly distributed. Patients who started at 125mg/day had longer median rwPFS (27.8 vs 18.6 months, adjusted HR=0.74, 95%CI=0.52-1.05) and higher rwTR (54.0% vs. 40.4%) than those patients who started 100/75mg/day (adjusted OR=1.76, 95%CI=1.13-2.74). Table presents results in detail. Conclusions: Most patients in this study initiated palbociclib at 125mg/day and dose adjustment was similar regardless of starting dose. These real-world findings may support initiation of palbociclib at a dose of 125mg/day in combination with AI for the first-line treatment of HR+/HER2- mBC. [Table: see text]

Healthcare utilization and costs associated with first-line treatment with obinutuzumab- and rituximab-based regimens for follicular lymphoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19536-e19536
Author(s):  
Jamie T. Ta ◽  
Tu My To ◽  
Cheryl Sud ◽  
Sheila Shapouri ◽  
Arpamas Seetasith
Keyword(s):  
Follicular Lymphoma ◽  
Healthcare Utilization ◽  
Real World ◽  
Healthcare Costs ◽  
Trial Participation ◽  
Administrative Claims ◽  
Cell Transplant ◽  
First Line ◽  
Real World Data ◽  
Eligibility Criteria

e19536 Background: Current real-world data on healthcare utilization (HCU) and costs of common first-line (1L) follicular lymphoma (FL) regimens, including obinutuzumab (G), remain limited. The aim of this study was to examine real-world HCU and costs for the most common National Comprehensive Cancer Network (NCCN)-recommended 1L FL treatments. Methods: This was a retrospective cohort study using administrative claims data from the IQVIA PharMetrics Plus and IBM MarketScan Commercial and Medicare Supplemental databases. We identified patients (pts) ≥18 years, who had ≥1 inpatient claim or ≥2 outpatient claims, with a diagnosis of FL from February 1, 2015 to March 31, 2020, and had received 1L FL treatment (per NCCN guidelines) between February 1, 2016 and September 30, 2019. The first claim for FL treatment was the index date. All pts had ≥12 months of pre- and ≥6 months of post-index continuous enrollment in medical and pharmacy benefits. Pts with other primary cancers, FL treatment, or stem cell transplant during the pre-index period, and clinical trial participation or end-stage renal disease during the study period were excluded. All-cause HCU and costs (2020 USD) per pt during the 6-month post-index period were reported for the five most common 1L FL regimens (only complete NCCN regimens were considered). Results: Overall, 1991 pts met the eligibility criteria, and 53% were male. The mean (standard deviation [SD]) age and Charlson Comorbidity Index at index were 58 (10.4) years, and 1.7 (1.0), respectively. The most common 1L regimens were rituximab-bendamustine (R-benda; n=818 [41.1%]), R-monotherapy (R-mono; n=592 [29.7%]), R-CHOP (n=461 [23.2%]), G-benda (n=86 [4.3%]), and R-CVP (n=34 [1.7%]). The proportion of pts who had ≥1 hospitalization or an emergency room visit was highest with R-CHOP (26.7% and 33.6%, respectively) and lowest with R-mono (11.3% and 18.1%, respectively). Mean (SD) all-cause total healthcare costs were highest with R-benda and G-benda, followed by R-CHOP, R-CVP, and R-mono (Table). Mean (SD) all-cause medical and FL treatment costs (drug and administration) were highest for R-benda ($174,407 [$110,520]; $135,520 [$96,492]) and lowest for R-mono ($87,368 [$83,910]; $54,271 [$40,433]). Conclusions: This real-world study provides an update on HCU and costs among pts initiating current NCCN-recommended 1L treatment for FL. Unadjusted 6-month total healthcare costs were highest with R-benda, followed by G-benda, while the lowest costs were seen with R-CVP and R-mono. Future studies with adjustment for pt characteristics are needed to compare HCU and costs between FL regimens.[Table: see text]

scholarly journals Is There Still a Role for Endocrine Therapy Alone in HR+/HER2– Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies

Breast Care ◽  
2019 ◽  
Vol 15 (1) ◽  
pp. 30-37
Author(s):  
Marina Elena Cazzaniga ◽  
Claudio Verusio ◽  
Mariangela Ciccarese ◽  
Alberto Fumagalli ◽  
Donata Sartori ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Median Duration ◽  
Real World ◽  
Advanced Breast ◽  
Data Sets ◽  
First Line ◽  
First Line Therapy ◽  
Real World Setting ◽  
Line Therapy

Background: Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting. Methods: For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies). Results: Eighty-one and 91 patients have been identified from the two data sets. The median age was 63 years (range 35–82) for the EVA and 57.8 years (range 35.0–82.3) for the AMBRA patients. ORRs were 23.5 and 24.3% in the whole population, 26.9% in the patients with bone only, and 21.8 and 21.4% in those with visceral metastases. The median duration of HD-FUL was 11.6 months (range 1–48) and 12.4 months (range 2.9–70.0) in the two data sets, respectively. Conclusion: These data suggest that HD-FUL should still continue to play a significant role as first-line therapy in HR+ ABC patients.

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