Efficacy, safety, and cost-effectiveness (CE) analysis of pegfilgrastim (P) and lenograstim (L) in patients (pts) with nonmetastatic breast cancer (nmBC) receiving myelosuppressive chemotherapy (mCT).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19620-e19620
Author(s):  
Anselmo Papa ◽  
Luigi Rossi ◽  
Federica Tomao ◽  
Fabio Ricci ◽  
Erika Giordani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Retrospective Study ◽  
Cost Effectiveness ◽  
Absolute Neutrophil Count ◽  
Neutrophil Count ◽  
Bone Pain ◽  
Single Injection ◽  
Numerical Rate Scale ◽  
Myelosuppressive Chemotherapy ◽  
The Cost

e19620 Background: Neutropenia (N) is common in pts who receive mCT. This retrospective study was conducted to determine efficacy, safety and cost of single injection of P (6 mg) compared with daily L (263 μg), in primary prophilaxis of N in pts affected by nmBC, who received mCT. Methods: 50 women (median age 54 years) underwent to median 6 (range 4–8) CT doses with antracyclines +/- taxanes. At every cycle, 28 pts received daily L (median 5 injections from day 5 to 9), while 22 pts received one dose of P on day 2. Absolute neutrophil count, incidence of G3/G4-N, bone pain (BP: Numerical Rate Scale >7) and CE analysis were evaluated. Results: In overall population (OP) incidence of G3-N and G4-N was 25% and 68%, respectively in L vs 22.7% and 41%, respectively in P; two cases (7%) of febrile N (FN) occurred in pts treated with L and three cases (13.6%) of FN in P. In 19 pts treated with FEC100 (10 pts L vs 9 pts P) we observed 0% of G3-N and 30% of G4-N in L while 33% of G3-N and 44% of G4-N in P. 31 pts received TAC/AC+T (18 pts L vs 13 pts P) with G3-N and G4-N 38.8% and 66.6%, respectively in L vs 15.3% and 30.7%, respectively in P. 18.2% of pts, who received P, had BP vs 35.7% in L. Reduction of CT doses was observed in 35.7% in L vs 41% in P. In Italy the cost of 1 injection of P was about 1489,00 euro compared with about 655,00 euro for 5 injections of L. Conclusions: In our experience, 1 injection of P was more effective and expensive than 5 daily administration of L to control N in OP and in particular in TAC/AC+T, while in FEC100, L was satisfactory with good CE profile. No difference about incidence of NF. Safety of P and L were similar with a lower incidence of BP in P.

scholarly journals Plinabulin and Pegfilgrastim in Combination for the Prevention of Chemotherapy-Induced Neutropenia in Patients with Breast Cancer (PROTECTIVE-2): A Randomized Trial

2022 ◽  
Author(s):  
Douglas Blayney ◽  
Qingyuan Zhang ◽  
Ramon Mohanlal ◽  
Lihua Du ◽  
Ene Ette ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Absolute Neutrophil Count ◽  
Neutrophil Count ◽  
Bone Pain ◽  
Combined Therapy ◽  
Single Agent ◽  
Dose Intensity ◽  
Relative Dose Intensity ◽  
Clinical Trial Registration ◽  
Chemotherapy Induced Neutropenia

Abstract PurposePlinabulin is a non-granulocyte colony-stimulating factor (G-CSF) novel small molecule with both anticancer and myeloprotective effects. Single-agent plinabulin is myeloprotective in the first week of the chemotherapy cycle, and pegfilgrastim in the second week. We assessed the efficacy and safety of the combination of plinabulin and pegfilgrastim for the prevention of chemotherapy-induced neutropenia (CIN) following chemotherapy.MethodsThis randomized, open-label, Phase 2 trial enrolled patients with breast cancer. All received docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2 on Day 1. In the combined therapy cohort, patients received plinabulin 20 mg/m2 on Day 1 and 1.5, 3, or 6 mg pegfilgrastim on Day 2. The primary objective was to establish the recommended Phase 3 dose (RP3D). Secondary endpoints included absolute neutrophil count (ANC) nadir, relative dose intensity (RDI), and incidence of adverse events including neutropenia and bone pain.ResultsIn total, 115 patients were randomized and evaluated. The combination therapy at the RP3D (plinabulin 20 mg/m2 and pegfilgrastim 6 mg) was well-tolerated and had superior CIN prevention in terms of Grade 4 and Grade 3/4 neutropenia frequency, absolute neutrophil count (ANC) nadir, higher relative dose intensity (RDI), less bone pain, and less toxicity burden when compared with pegfilgrastim 6 mg alone.ConclusionPlinabulin combined with pegfilgrastim at the RP3D (plinabulin 20 mg/m2 Day 1 and pegfilgrastim 6 mg Day 2) had more favorable efficacy, safety, and tolerability profiles and lower bone pain incidence than did pegfilgrastim alone.Trial information Clinical Trial Registration: ClinicalTrials.gov NCT04227990Date registered: January 14, 2020 Retrospectively registered

Same day administration of pegfilgrastim with dose dense doxorubicin in early breast cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 671-671
Author(s):  
K. T. Vance ◽  
J. Carpenter
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Absolute Neutrophil Count ◽  
Neutrophil Count ◽  
Bone Pain ◽  
Common Side Effect ◽  
Breast Cancer Patients ◽  
Dose Dense

671 Background: Pegfilgrastim is indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. In licensing studies, patients received a single dose of pegfilgrastim on day 2 of each chemotherapy cycle, which added an extra visit for day 2 administration. We administered pegfilgrastim to a series of early breast cancer patients on the same day of chemotherapy. We reviewed charts retrospectively to assess both efficacy and safety. Methods: Data on blood counts, toxicity and chemotherapy dosing was collected from July 1, 2003 to May 6, 2005 for all patients with early breast cancer who received sequential or combination doxorubicin, cyclophosphamide and paclitaxel on a 14 day schedule. Herceptin was given with paclitaxel and/or cyclophosphamide in 2 patients. Results: 64 patients with a median age of 50 years (range 22–67 years) were treated. 14 patients had stage I disease, 39 stage II and 11 stage III disease. Forty-one patients were treated postoperatively and 23 preoperatively. 211 cycles of doxorubicin were administered. After administration of doxorubicin, pegfilgrastim 6 mg s.c. was given on the same day. The lowest absolute neutrophil count on day 14 after doxorubicin was 1693/mm3 with no episodes of febrile neutropenia. The highest absolute neutrophil count was 23,671/mm3. The only dose reductions were five doxorubicin doses for grade 1–2 mucositis. Grade 1–2 nausea and vomiting was the most common toxicity seen after doxorubicin. Grade 1 bone pain was the most common side effect seen after pegfilgrastim occurring in 13/64 patients. There was no grade 3 or 4 toxicity of any kind. Conclusion: Pegfilgrastim administered on the same day as doxorubicin on a 14 day schedule was both safe and effective. Side effects were mild and included bone pain most likely attributable to pegfilgrastim. Neither granulocytopenia nor febrile neutropenia were seen and no treatments were delayed or postponed. Pegfilgrastim given on the same day as chemotherapy was effective in maintaining adequate granulocyte counts to allow treatment 14 days later and to avoid infection from granulocytopenia. Toxicity from pegfilgrastim was mild and tolerable. [Table: see text]

Cost–effectiveness analysis of ribociclib plus fulvestrant for hormone receptor-positive/human EGF receptor 2-negative breast cancer

Immunotherapy ◽  
2021 ◽  
Author(s):  
Wei Jiang ◽  
Zhichao He ◽  
Tiantian Zhang ◽  
Chongchong Guo ◽  
Jianli Zhao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Hormone Receptor ◽  
Egf Receptor ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Cost Effectiveness Ratio ◽  
Hormone Receptor Positive ◽  
The Cost ◽  
Quality Adjusted Life

Aim: To evaluate the cost–effectiveness of ribociclib plus fulvestrant versus fulvestrant in hormone receptor-positive/human EGF receptor 2-negative advanced breast cancer. Materials & methods: A three-state Markov model was developed to evaluate the costs and effectiveness over 10 years. Direct costs and utility values were obtained from previously published studies. We calculated incremental cost–effectiveness ratio to evaluate the cost–effectiveness at a willingness-to-pay threshold of $150,000 per additional quality-adjusted life year. Results: The incremental cost–effectiveness ratio was $1,073,526 per quality-adjusted life year of ribociclib plus fulvestrant versus fulvestrant. Conclusions: Ribociclib plus fulvestrant is not cost-effective versus fulvestrant in the treatment of advanced hormone receptor-positive/human EGF receptor 2-negative breast cancer. When ribociclib is at 10% of the full price, ribociclib plus fulvestrant could be cost-effective.

scholarly journals Cost analysis of breast cancer diagnostic assessment programs

2017 ◽  
Vol 24 (5) ◽  
pp. 354 ◽  
Author(s):  
G.N. Honein-AbouHaidar ◽  
J.S. Hoch ◽  
M.J. Dobrow ◽  
T. Stuart-McEwan ◽  
D.R. McCready ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Medical Records ◽  
Diagnostic Tests ◽  
Estimation Method ◽  
Financial Data ◽  
Diagnostic Assessment ◽  
Future Cost ◽  
Total Cost ◽  
The Cost

Objectives Diagnostic assessment programs (daps) appear to improve the diagnosis of cancer, but evidence of their cost-effectiveness is lacking. Given that no earlier study used secondary financial data to estimate the cost of diagnostic tests in the province of Ontario, we explored how to use secondary financial data to retrieve the cost of key diagnostic test services in daps, and we tested the reliability of that cost-retrieving method with hospital-reported costs in preparation for future cost-effectiveness studies.Methods We powered our sample at an alpha of 0.05, a power of 80%, and a margin of error of ±5%, and randomly selected a sample of eligible patients referred to a dap for suspected breast cancer during 1 January–31 December 2012. Confirmatory diagnostic tests received by each patient were identified in medical records. Canadian Classification of Health Intervention procedure codes were used to search the secondary financial data Web portal at the Ontario Case Costing Initiative for an estimate of the direct, indirect, and total costs of each test. The hospital-reported cost of each test received was obtained from the host-hospital’s finance department. Descriptive statistics were used to calculate the cost of individual or group confirmatory diagnostic tests, and the Wilcoxon signed-rank test or the paired t-test was used to compare the Ontario Case Costing Initiative and hospital-reported costs.Results For the 191 identified patients with suspected breast cancer, the estimated total cost of $72,195.50 was not significantly different from the hospital-reported total cost of $72,035.52 (p = 0.24). Costs differed significantly when multiple tests to confirm the diagnosis were completed during one patient visit and when confirmatory tests reported in hospital data and in medical records were discrepant. The additional estimated cost for non-salaried physicians delivering diagnostic services was $28,387.50.Conclusions It was feasible to use secondary financial data to retrieve the cost of key diagnostic tests in a breast cancer dap and to compare the reliability of the costs obtained by that estimation method with hospital-reported costs. We identified the strengths and challenges of each approach. Lessons learned from this study have to be taken into consideration in future cost-effectiveness studies.

CYP2D6*10 pharmacogenetic-guided SERM could be a cost-effective strategy in Chinese patients with hormone receptor-positive breast cancer

2020 ◽  
Vol 21 (1) ◽  
pp. 43-53 ◽  
Author(s):  
Xiaoxia Wei ◽  
Jiaqin Cai ◽  
Jie Zhuang ◽  
Bin Zheng ◽  
Yuxia Sui ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Hormone Receptor ◽  
Cost Effective ◽  
Chinese Patients ◽  
Hormone Receptor Positive ◽  
Receptor Modulator ◽  
The Cost ◽  
Quality Adjusted Life ◽  
Positive Breast Cancer

Aim: To assess the cost–effectiveness of CYP2D6*10 genetic testing for the management of Chinese women with hormone receptor-positive (HR+) breast cancer treated with selective estrogen receptor modulator. Methods: A Markov model was developed to evaluate a total expected cost and an incremental cost-effectiveness ratio (ICER). Robustness of the model was addressed in one-way analyses and probabilistic sensitivity analysis. Results: The cost of strategies of tamoxifen, toremifene without genotyping and the strategy base on CYP2D6*10 genotype were $63,879.19, $90,156.60 and $95,021.41, and the quality-adjusted life years gained are 8.1588, 12.89687 and 13.85911, respectively. The incremental cost-effectiveness ratio of the CYP2D6*10 testing versus toremifene were 5,055.74221/quality-adjusted life year, respectively. Conclusion: CYP2D6*10 pharmacogenetic-guided selective estrogen receptor modulator can be a cost-effective strategy in the Chinese patients with hormone receptor-positive breast cancer.

scholarly journals Economic evaluation of hormonal therapies for postmenopausal women with estrogen receptor–positive early breast cancer in Canada

2015 ◽  
Vol 22 (2) ◽  
pp. 84 ◽  
Author(s):  
S. Djalalov ◽  
J. Beca ◽  
E. Amir ◽  
M. Krahn ◽  
M.E. Trudeau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Cost Effectiveness ◽  
Postmenopausal Women ◽  
Early Breast Cancer ◽  
Base Case ◽  
Parameter Uncertainties ◽  
System Perspective ◽  
Er Positive ◽  
The Cost

BackgroundAromatase inhibitor (ai) therapy has been subjected to numerous cost-effectiveness analyses. However, with most ais having reached the end of patent protection and with maturation of the clinical trials data, a re-analysis of ai cost-effectiveness and a consideration of ai use as part of sequential therapy is desirable. Our objective was to assess the cost-effectiveness of the 5-year upfront and sequential tamoxifen (tam) and ai hormonal strategies currently used for treating patients with estrogen receptor (er)–positive early breast cancer.Methods The cost-effectiveness analysis used a Markov model that took a Canadian health system perspective with a lifetime time horizon. The base case involved 65-year-old women with er-positive early breast cancer. Probabilistic sensitivity analyses were used to incorporate parameter uncertainties. An expected-value-of-perfect-information test was performed to identify future research directions. Outcomes were quality-adjusted life-years (qalys) and costs.Results The sequential tam–ai strategy was less costly than the other strategies, but less effective than upfront ai and more effective than upfront tam. Upfront ai was more effective and less costly than upfront tam because of less breast cancer recurrence and differences in adverse events. In an exploratory analysis that included a sequential ai–tam strategy, ai–tam dominated based on small numerical differences unlikely to be clinically significant; that strategy was thus not used in the base-case analysis.ConclusionsIn postmenopausal women with er-positive early breast cancer, strategies using ais appear to provide more benefit than strategies using tam alone. Among the ai-containing strategies, sequential strategies using tam and an ai appear to provide benefits similar to those provided by upfront ai, but at a lower cost.

Modeling the cost-effectiveness of granulocyte colony-stimulating factor use in early-stage breast cancer.

1998 ◽  
Vol 16 (7) ◽  
pp. 2435-2444 ◽  
Author(s):  
J H Silber ◽  
M Fridman ◽  
A Shpilsky ◽  
O Even-Shoshan ◽  
D S Smink ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Response Curve ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Breast Cancer Patients ◽  
The Cost ◽  
Stimulating Factor

PURPOSE To model the cost-effectiveness (CE) of granulocyte colony-stimulating factor (G-CSF) in early-stage breast cancer when its use is directed to those most in need of the medication. METHODS A conditional CE model was developed for the use of G-CSF based on a ranking of patient need as determined by patient blood counts during the first cycle of chemotherapy. In the base case, no G-CSF was used. In the alternative case, G-CSF was used in the following manner. If the risk of a neutropenic event (as defined by a predictive model based on nadir absolute neutrophil count [ANC] and hemoglobin decrease in cycle 1) was equal to or exceeded a predetermined critical value "T," then patients would receive G-CSF in cycles 2 through 6 of chemotherapy. If the risk of an event was less than T, patients would not use G-CSF unless an event occurred, at which time G-CSF would be administered with every subsequent cycle. RESULTS A decision rule (T) that would allow the most needy 50% of early-stage breast cancer patients to receive G-CSF after the first cycle of chemotherapy resulted in a CE ratio of $34,297 dollars per life-year saved (LYS). If only the most needy 10% of patients received G-CSF, then the associated CE ratio was $23,748/LYS; if 90% of patients could receive the medication, the CE ratio would be $76,487/LYS. These estimates were relatively insensitive to inpatient hospital cost estimates (inpatient costs for fever and neutropenia of $3,090 to $7,726 per admission produced dollar per LYS figures of $34,297 to $32,415, respectively). However, the model was sensitive to assumptions about the shape of the relationship between dose reduction and disease-free survival (DFS) at 3 years. CONCLUSION Providing G-CSF to the neediest 50% of early-stage breast cancer patients (as defined by first-cycle blood counts) starting after the first cycle of chemotherapy is associated with a CE ratio of $34,297/LYS, which is well in the range of CE ratios for treatment of other common medical conditions. Furthermore, conditional CE studies, based on predictive models that incorporate individual patient risk, allow one to define populations for which therapy is, or is not, cost-effective. Limitations of our present understanding of the shape of the chemotherapy dose-response curve, especially at low levels of dose reductions, affect these results. Further work is required to define the shape of the dose-response curve in early-stage breast cancer.

40LBA Results of an RCT investigating the cost-effectiveness of four follow-up strategies after breast cancer

2009 ◽  
Vol 7 (3) ◽  
pp. 18 ◽  
Author(s):  
M.L. Kimman ◽  
C.D. Dirksen ◽  
P. Falger ◽  
A. Voogd ◽  
A. Kessels ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
The Cost
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