scholarly journals Clinical Outcomes of Secondary Prophylactic Granulocyte Colony-Stimulating Factors in Breast Cancer Patients at a Risk of Neutropenia with Doxorubicin and Cyclophosphamide-Based Chemotherapy

2021 ◽  
Vol 14 (11) ◽  
pp. 1200
Author(s):  
Jae Hee Choi ◽  
Min Jung Geum ◽  
Ji Eun Kang ◽  
Nam Gi Park ◽  
Yun Kyoung Oh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Outcomes ◽  
Early Stage ◽  
Significant Risk ◽  
Dose Intensity ◽  
Secondary Prophylaxis ◽  
Breast Cancer Patients ◽  
Dosing Regimen ◽  
Standard Regimen ◽  
Stimulating Factor

Doxorubicin and cyclophosphamide (AC)-based chemotherapy has been a standard regimen for early-stage breast cancer (ESBC) with an intermediate risk (10–20%) of febrile neutropenia (FN). Secondary prophylaxis of granulocyte colony-stimulating factor (G-CSF) is considered in patients receiving AC-based chemotherapy; however, relevant studies are limited. Here, we retrospectively reviewed the electronic medical records of 320 patients who completed adjuvant AC-based chemotherapy from September 2016 to September 2020. Approximately 46.6% of the patients developed severe neutropenic events (SNE) during AC-based chemotherapy. Secondary prophylaxis of G-CSF reduced the risk of recurrent SNE (p < 0.01) and the relative dose intensity (RDI) < 85% (p = 0.03) in patients who had experienced SNE during AC-based chemotherapy. Age ≥ 65 years (p = 0.02) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 60 IU/L (p = 0.04) were significant risk factors for RDI < 85%. The incidences of FN, grade 4 neutropenia, unscheduled hospitalization, and interruption to the dosing regimen were reduced in patients administered secondary prophylaxis with G-CSF (before vs. after administration: FN, 19.4% vs. 4.6%; grade 4 neutropenia, 86.1% vs. 14.8%; unscheduled hospitalization, 75.9% vs. 11.1%; interruption to the dosing regimen, 18.5% vs. 8.3%). This study indicated the importance of active intervention of G-CSF use to prevent recurrent SNE and improve clinical outcomes in patients with breast cancer who receive AC-based chemotherapy.

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.

Comparative study of dose escalation versus interval reduction to obtain dose-intensification of epirubicin and cyclophosphamide with granulocyte colony-stimulating factor in advanced breast cancer.

1997 ◽  
Vol 15 (4) ◽  
pp. 1367-1376 ◽  
Author(s):  
R I Lalisang ◽  
J A Wils ◽  
H W Nortier ◽  
J T Burghouts ◽  
P S Hupperets ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Dose Intensity ◽  
Advanced Breast ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Breast Cancer Patients ◽  
Hematopoietic Growth Factors ◽  
Higher Doses ◽  
Stimulating Factor

PURPOSE A potential application of hematopoietic growth factors is to obtain an increased dose-intensity. This can be achieved by either higher doses of chemotherapy with standard intervals, or by standard doses with shorter intervals. The potential of these approaches has not been investigated systematically. PATIENTS AND METHODS In a randomized, multicenter study, 49 advanced breast cancer patients were treated with granulocyte colony-stimulating factor (G-CSF) and either increasing doses of epirubicin and cyclophosphamide with fixed intervals (arm one) or progressively shorter intervals with fixed doses of epirubicin and cyclophosphamide (arm two). A cohort of at least six patients was studied at each interval/dose. A more intensified interval/dose was given if less than 50% of patients encountered a dose-intensity limiting criterium (DILC) in the first three courses. RESULTS In arm one, epirubicin 140 mg/m2 and cyclophosphamide 800 mg/m2 every 21 days was too toxic. Subsequently, epirubicin 120 mg/m2 and cyclophosphamide 700 mg/m2 was tested with two of 10 patients encountering a DILC. All initial DILCs consisted of febrile neutropenia. In arm two, epirubicin 75 mg/m2 and cyclophosphamide 500 mg/m2 could be administered safely with 14- and 12-day intervals. In the 10-day interval, eight of 12 patients completed the first three cycles without a DILC. In the 8-day interval, seven of eight patients encountered a DILC. Incomplete neutrophil recovery, and to a lesser extent stomatitis, were dose-limiting. CONCLUSION In combination with G-CSF, epirubicin 120 mg/m2 and cyclophosphamide 700 mg/m2 every 21 days was feasible (projected dose-intensity, 40 mg/m2/wk and 233 mg/m2/wk, respectively). Epirubicin 75 mg/m2 and cyclophosphamide 500 mg/m2 could be administered safely every 10 days, allowing a projected dose-intensity of 52.5 mg/m2/wk and 350 mg/m2/wk, respectively.

Retrospective analysis of the use of GCSF and its impact on dose-response effect for anthracycline plus taxane-based schedules in early breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11523-e11523
Author(s):  
Begona Bermejo ◽  
Jose Alejandro Perez-Fidalgo ◽  
Isabel Chirivella ◽  
Isabel Catoira ◽  
Patricia Martinez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Dose Intensity ◽  
Secondary Prophylaxis ◽  
Breast Cancer Patients ◽  
Database Analysis ◽  
Retrospective Database Analysis ◽  
Dose Response Effect ◽  
To Receive ◽  
Retrospective Database

e11523 Background: Previous studies have confirmed that prophylactic GCSF significantly reduced the incidence of febrile neutropenia. Less is known about its impact on the dose-density administered in taxane-based schedules. The objective of this observational, retrospective database analysis was to evaluate the relative dose-intensity (RDI) achieved in a non-selected population in whom GCSF was administered under clinician criteria according to guidelines. Methods: Early breast cancer (stage I-IIIA) patients diagnosed from January 1999 through December 2006 and considered candidates for adjuvant anthracyclines and taxanes were included. RDI administered was measured by the number of delayed cycles as well as by the number of delayed days. GCSF was considered to have been administered even if it was given in only 1 cycle, as primary or secondary prophylaxis, or to treat neutropenia. Results: 231 breast cancer patients were included. Patients had a median age of 59 years (26-80) of whom 52% had stage III cancer. Most patients had tumors positive for hormonal receptors (83%) and 7% of tumors were considered triple negative. Adjuvant schedules administered included docetaxel (68%) or paclitaxel (32%) plus anthracyclines. GCSF was given to 40% of patients, as primary (60%) or secondary prophylaxis (31%), as well as to treat neutropenia (9%). Prophylactic GCSF was mostly given in schedules with docetaxel and anthracyclines such as TAC (85% of patients). Overall, 5 patients (2%) received <85% of the RDI, 23 (10%) delayed 1 cycle and 15 (7%) delayed ≥2 cycles, and 5 (2%) showed a delay of ≥15 days. 5 and 10-year DFS rates were 0.88 (95% CI: 0.84-0.92) and 0.80 (95% CI: 0.72-0.87), respectively. No differences in terms of DFS between patients with <85% vs. ≥85% of RDI were found (p=0.695). Conclusions: With adequate use of GCSF in patients treated with taxane-based schedules, 98% of patients achieved a RDI ≥85%. Schedules with docetaxel or given concurrently with anthracyclines were more likely to receive GCSF. This study was partially funded by Amgen SA.

Comparison of clinical outcomes in patents with early stage ER-/PR+, HER2- breast cancer patients with triple negatives.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e12556-e12556
Author(s):  
Ozan Yazici ◽  
Gokmen Umut Erdem ◽  
Sercan Aksoy ◽  
Mehmet Ali Nahit Sendur ◽  
Nuriye Özdemir ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Early Stage ◽  
Breast Cancer Patients ◽  
Her2 Breast Cancer
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