Feasibility of pegfilgrastim as haematopoietic support for dose-dense every-2-week adjuvant chemotherapy in breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18606-18606 ◽  
Author(s):  
P. Gomez ◽  
E. Vilar ◽  
C. Saura ◽  
J. Cortes ◽  
A. Ocaña ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Febrile Neutropenia ◽  
Treatment Delays ◽  
Significant Difference ◽  
Grade 3 ◽  
Dose Dense ◽  
Number Of Treatment ◽  
Stimulating Factor ◽  
Indirect Comparisons

18606 Background: Dose-dense sequential chemotherapy has been safety supported with Filgrastim (F). Pegfilgrastim (PEGF) is a pegylated recombinant human granulocyte colony-stimulating factor (G-CSF) that has a long half-life, a fact that facilitates a less frequent dosing. Its safety and efficacy has been established in 21- and 28-days schedules. Methods: We have performed a retrospective analysis of medical records of 2 cohort of patients (n=38) treated at our institution between December 2003 and November 2005. All patients received Adriamicin 60 mg/m2 plus Ciclophosphamide 600 mg/m2 q2w for 4 cycles followed by Paclitaxel 175 mg/m2 q2w for 4 cycles. As G-CSF support, in Cohort A (n=29) PEGF was administered 6 mg on day 2 of each cycle and in Cohort B (n=9) F days 3 to 10 at 5 μg/kg. The primary end point was to explore the feasibility and safety in terms of febrile neutropenia (FN) events, number of treatment delays (TD), incidence of neutropenia grade 3 (NPG3) and 4 (NPG4) and mean absolute neutrophil count (ANC) on day 14 of cycle 1 to 7 for both groups. Indirect comparisons have been performed. Results: Patients characteristics in both cohorts were well balanced, except for age in cohort A compared with cohort B (44,89 versus 52,5, p = 0,02). FN events and TD were increased in cohort B compared with cohort A (22% versus 0%, p=0.051, both comparisons). No statistically significant difference in number of episodes of NPG3 and NPG4 was observed. Median ANC on day 14 for each treatment cycle was significantly greater for Cohort A than Cohort B, except for cycle 6. Conclusions: PEGF is very safe and efficacy in patients treated with dose-dense sequential adjuvant chemotherapy for breast cancer. It could be even more efficient than F in preventing febrile neutropenia events. [Table: see text]

Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 594-594 ◽  
Author(s):  
H. J. Burstein ◽  
E. L. Mayer ◽  
J. Peppercorn ◽  
L. M. Parker ◽  
K. Hannagan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Patient Scheduling ◽  
Full Cohort ◽  
Treatment Delays ◽  
Grade 3 ◽  
Chemotherapy Patients ◽  
Dose Dense ◽  
Taxane Chemotherapy

594 Background: We sought to evaluate the feasibility of substituting nab-paclitaxel (ABI-007) for paclitaxel as part of “dose-dense” adjuvant sequential doxorubicin / cyclophosphamide (AC) followed by taxane chemotherapy. Patients and Methods: Eligible patients had stage I-III breast cancer receiving adjuvant/neoadjuvant chemotherapy, ANC > 1500, and LVEF > 50%. Patients received AC (60 mg/m2 and 600 mg/m2) every 2 weeks × 4 cycles with G-CSF support, followed by nab- paclitaxel 260 mg/m2 every 2 weeks × 4 cycles. The endpoint was incidence of treatment delay during nab-paclitaxel therapy. Results: 66 women (median age 48 years) were enrolled. Among the first 11 given nab-paclitaxel without G-CSF support, one developed febrile neutropenia, and 4 had nab-paclitaxel treatment delays related to neutropenia (ANC < 1,000). The protocol was amended to require G-CSF support (filgrastim or pegfilgrastim) during nab-paclitaxel. Among the next 55 patients, 3 had febrile neutropenia, none during nab- paclitaxel. In cycles 6–8, nab-paclitaxel was delayed only 6 times (1 neutropenia, 3 hepatic toxicity, 2 patient scheduling); 96% of these cycles were delivered on time. By comparison, 82% of such cycles were delivered on time in a prior institutional study using paclitaxel. In the full cohort, 8 patients had nab-paclitaxel dose reduction, 4 for neuropathy, while other neuropathy was moderate (grade 2, n = 6; grade 3, n=1; grade 4, n=0). Conclusions: Administration of nab-paclitaxel every 2 weeks is feasible but requires G-CSF support. Data comparing nab-paclitaxel dose-delivery, toxicities and quality of life to paclitaxel as seen in prior studies will be presented. No significant financial relationships to disclose.

scholarly journals Dose-Dense Epirubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Chemotherapy in Node-Positive Breast Cancer

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Hamid Reza Mirzaei ◽  
Parisa Sabet Rasekh ◽  
Fatemeh Nasrollahi ◽  
Parto Sabet Rasekh ◽  
Zahra Akbari Tirabad ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Febrile Neutropenia ◽  
Optimal Dose ◽  
Axillary Lymph ◽  
Node Positive ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
Dose Dense ◽  
Positive Breast Cancer

Background. Adding taxanes to anthracycline-based adjuvant chemotherapy has shown significant improvement particularly in node-positive patients, but optimal dose and schedule remain undetermined.Objectives. This study aimed to assess the feasibility of dose-dense epirubicin and cyclophosphamide followed by docetaxel in node-positive breast cancer.Methods. All Patients first received 4 cycles of epirubicin (100 mg/m2) and cyclophosphamide (600 mg/m2) at 2-week interval then followed by docetaxel (100 mg/m2) at 2-week interval for 4 cycles, with daily Pegfilgrastim (G-CSF) that was administered in all patients on days 3–10 after each cycle of epirubicin and cyclophosphamide infusion.Results. Fifty-eight patients with axillary lymph node-positive breast cancer were enrolled in the study, of whom 42 (72.4%) completed the regimen. There were two toxicity-related deaths, one patient due to grade 4 febrile neutropenia and the other due to congestive heart failure. Grade 3/4 neutropenia and febrile neutropenia were 13.8% and 5.1%. The most common grade 3/4 nonhematological complications were as follows: skin-nail disorders (48.3%), hand-foot syndrome (34.4%), paresthesia (38%), arthralgia (27.5%), and paresis (24.1%).Conclusions. Dose-dense epirubicin and cyclophosphamide followed by docetaxel with G-CSF support are not feasible, and it is not recommended for further investigation.

scholarly journals Granulocyte Colony Stimulating Factor (G-CSF) Induced Splenic Infarction in Breast Cancer Patient Treated with Dose-Dense Chemotherapy Regimen

2019 ◽  
Vol 2019 ◽  
pp. 1-4 ◽  
Author(s):  
Majed A. Alshamrani ◽  
Meteb Al-Foheidi ◽  
Ahmed H. Abdulrahim
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Splenic Infarction ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Rare Side Effect ◽  
Splenic Biopsy ◽  
Dose Dense ◽  
Stimulating Factor ◽  
Factor G

Introduction. Granulocyte colony-stimulating factor (G-CSF) is commonly used for prevention and treatment of febrile neutropenia among solid tumor patients. It is considered an effective and relatively safe supportive care medication; however, it can cause rare and serious side effects such as spleen rupture or infarction. Case Presentation. We are reporting a case of a 27-year-old female with breast cancer who has been treated with dose-dense chemotherapy and received colony-stimulating factor as primary prevention of febrile neutropenia that was complicated halfway through with splenic infarction. This finding was confirmed by computed tomography (CT) scan and splenic biopsy. Management was conservative without the need of surgical intervention. Conclusion. Although splenic infarction is an extremely rare side effect of G-CSF, it can be a serious complication that should be recognized, monitored, and managed carefully.

Safety and effectiveness of dose dense neoadjuvant chemotherapy in patients with stage II/III breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11566-e11566
Author(s):  
S. Koya ◽  
Y. Li ◽  
S. A. McDaniel ◽  
A. F. LoBuglio ◽  
H. Krontiras ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Lymph Nodes ◽  
Triple Negative ◽  
Axillary Lymph Nodes ◽  
Axillary Lymph ◽  
Free Survival ◽  
Significant Difference ◽  
Grade 3 ◽  
Dose Dense

e11566 Background: NSABP B-18 randomized women with operable breast cancer to receive chemotherapy (AC) either pre- or postoperatively; in the study there was no significant difference in disease free survival (DFS) or overall survival (OS) among patients in either group. Pathologic complete response rate (pCR) was directly proportional to DFS and OS. Dose dense adjuvant chemotherapy (ATC) has shown a statistically significant improvement in DFS and OS. Methods: We performed a single institution review of pts enrolled in a neoadjuvant trial and who received dose dense neoadjuvant chemotherapy (doxorubicin 60 mg/m2 IV Q2wks x4, paclitaxel 175 mg/m2 IV Q2wks x4, and cyclophosphamide 600 mg/m2 IV Q2wks x4) to assess response rates, safety, and DFS. Women with newly diagnosed breast cancer, T ≥ 3cm, any N, M0 were enrolled. Results: Since 02/2003, 43 pts were enrolled (mean age 47.6, range 28–64) and received dose dense chemotherapy. 41.4% of the pts were triple negative and 14.6% were Her2+ by FISH or IHC. The median follow-up is 49 months (range 8–69). Two patients dropped out without finishing therapy. Forty one pts completed dose dense chemotherapy and proceeded to surgery. 17 pts (41.4%) achieved a pCR in the breast and of those 14 pts were also negative in the axillary lymph nodes (34.1% pCR in the breast and lymph nodes). 10 of the 17 pts with pCR in the breast (8 out of the 14 pts with pCR in breast and axillary lymph nodes) were triple negative. 18 pts (43.9%) achieved PR, 3 pts (7.31%) had SD and 3 pts (7.31%) had PD. Up to November 2008, 7 pts who did not have a pCR have relapsed (4 triple negative, 1 Her2+, 1 ER/PR positive and 1 ER negative, PR positive) with a relapsed free survival rate of 85%. Hematologic toxicity consisted of grade 3 anemia in 2 patients with no grade 4 anemia, no G4 thrombocytopenia and febrile neutropenia in 2 pts. Non-hematologic grade 3 or 4 toxicity consisted of mediport thrombosis in 2 pts, hyperglycemia in 2 pts, syncope in 1 pt, neuropathy in 1 pt, and varicella zoster in 1 pt. Conclusions: Our results show that dose dense neoadjuvant chemotherapy achieves a pCR (breast + node) in about 1/3 of patients (34%) with tolerable toxicity; although the number of patients is limited, our data suggest that triple negative breast cancer seems to be the most sensitive tumor to this regimen. No significant financial relationships to disclose.

Efficacy of Pegfilgrastim and Darbepoetin Alfa As Hematopoietic Support for Dose-Dense Every-2-Week Adjuvant Breast Cancer Chemotherapy

2005 ◽  
Vol 23 (33) ◽  
pp. 8340-8347 ◽  
Author(s):  
Harold J. Burstein ◽  
Leroy M. Parker ◽  
Aparna Keshaviah ◽  
Jennifer Doherty ◽  
Ann H. Partridge ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Febrile Neutropenia ◽  
Darbepoetin Alfa ◽  
Hematologic Toxicity ◽  
Hematopoietic Growth Factors ◽  
Breast Cancer Chemotherapy ◽  
Dose Dense ◽  
Long Acting ◽  
Rbc Transfusion

Purpose Dose-dense, every-2-week adjuvant chemotherapy using doxorubicin/cyclophosphamide (AC; 60/600 mg/m2 every 2 weeks × four cycles) followed by paclitaxel (175 mg/m2 every 2 weeks × four cycles), requiring filgrastim on days 3 through 10 of each cycle has been shown to improve survival compared with every-3-week treatment schedules but is associated with greater risk of RBC transfusion (13%). The role of long-acting hematopoietic growth factors in facilitating every-2-week chemotherapy and minimizing hematologic toxicity has not been established. Patients and Methods Women with stage I to III breast cancer received dose-dense AC → paclitaxel as neoadjuvant or adjuvant chemotherapy. Patients received pegfilgrastim 6 mg subcutaneous (SQ) on day 2 of each cycle. Darbepoetin alfa was initiated at 200 μg SQ every 2 weeks for hemoglobin ≤ 12 g/dL, and administered thereafter, according to a preplanned algorithm. The primary end points were to evaluate the percentage of patients with febrile neutropenia and the percentage of patients requiring RBC transfusion. Results Among 135 women treated on this single arm study, there were two cases of febrile neutropenia (incidence 1.5%). No patients received RBC transfusion. Darbepoetin alfa therapy was initiated in 92% of patients. The modest leukocytosis seen during paclitaxel cycles was attributable, in part, to corticosteroid premedication. Other toxicity and dose-delivery were similar to dose-dense AC → paclitaxel in Cancer and Leukemia Group B 9741. Conclusion Pegfilgrastim and darbepoetin alfa are effective and safe in facilitating every-2-week AC → paclitaxel, minimizing rates of febrile neutropenia and RBC transfusion.

scholarly journals Dose-Dense Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Node-Positive Breast Cancer

2014 ◽  
Vol 2014 ◽  
pp. 1-6
Author(s):  
Hamid Reza Mirzaei ◽  
Fatemeh Nasrollahi ◽  
Ladan Mohammadi Yeganeh ◽  
Sepideh Jafari Naeini ◽  
Pegah Bikdeli ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Weekly Paclitaxel ◽  
Hematologic Toxicity ◽  
Breast Cancer Patients ◽  
Node Positive ◽  
Grade 3 ◽  
Dose Dense ◽  
Positive Breast Cancer

Background. Adding taxanes to anthracycline-based adjuvant chemotherapy has shown significant improvement in node-positive breast cancer patients but the optimal dose schedule has still remained undetermined. Objectives. The feasibility of dose-dense epirubicin in combination with cyclophosphamide (EC) followed by weekly paclitaxel as adjuvant chemotherapy in node-positive breast cancer patients was investigated. Methods. All patients were treated with epirubicin (100 mg/m2) and cyclophosphamide (600 mg/m2) every two weeks for four cycles with daily Pegfilgrastim (G-CSF) that was administered 3–10 days after each cycle of epirubicin and cyclophosphamide infusion which followed by (80 mg/m2) paclitaxel for twelve consecutive weeks. Results. Sixty consecutive patients were analyzed, of whom 57 patients (95%) completed the regimen and no case of toxicity-related death was observed. Grade 3/4 hematologic toxicity was uncommon and the most common grade 3/4 nonhematological adverse event was neuropathy disorders. Conclusions. Dose-dense epirubicin and cyclophosphamide followed by weekly paclitaxel with G-CSF support is a well-tolerated and feasible regimen in node-positive breast cancer patients without serious complications.

Feasibility and toxicity of docetaxel before or after fluorouracil, epirubicin, and cyclophosphamide as adjuvant chemotherapy for early-stage breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 604-604
Author(s):  
H. Abe ◽  
T. Umeda ◽  
Y. Kawai ◽  
M. Tanaka ◽  
T. Shimizu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Febrile Neutropenia ◽  
Adverse Events ◽  
Early Stage ◽  
Dose Intensity ◽  
Completion Rate ◽  
Early Stage Breast Cancer ◽  
Hematological Toxicity ◽  
Grade 3

604 Background: As adjuvant chemotherapy for breast cancer, the addition of docetaxel to regimens containing anthracyline has been shown to be effective. However, tolerance and safety associated with the administration order of the two drugs have not been evaluated. Methods: Breast cancer patients with node-positive or high-risk patients with node-negative were eligible. The treatment completion rate and toxicity were evaluated in 2 arms who underwent a total of 6 courses of the following regimens: Arm A: 3 courses of fluorouracil 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2 (FEC100: q3w) followed by 3 courses of docetaxel (DOC100: 100 mg/m2, q3w); and Arm B: 3 courses of DOC100 (q3w) followed by 3 courses of FEC100 (q3w). Results: June 2006 to April 2008, 42 patients were registered. To the present, analysis has been completed in 21 patients in arm A and 21 in arm B. The mean age of patients was 49.1 years and 53.8 years, respectively. In arm A, the stage of cancer was 1 in 4 patients, 2a in 10, and 2b in 7, in arm B, the stage of cancer was 1 in 3 patients, 2a in 9, and 2b in 9. The adjuvant chemotherapy completion rate was 100 % for arm A and 95.2 % for arm B. The relative dose intensity (RDI) was 94.2 % for FEC100 and 97.8 % for DOC100 in arm A, and 98.9 % for DOC100 and 95.2 % for FEC100 in arm B. In arm A, grade 3 or higher hematological toxicity was observed in 9 patients, and febrile neutropenia developed in 3 patients with FEC100. In arm B, grade 3 or higher hematological toxicity was observed in 7 patients, but febrile neutropenia was not noted in any patients. Grade 3 or higher non-hematological toxicity was observed with FEC100 in 2 patients each in the two arms. Grade 1 or 2 edema developed in 11 patients with DOC100 in the two arms. Conclusions: In both arm A and B, adverse events associated with FEC100 were frequently observed but spontaneously recovered, or adequate management was possible by supportive therapy. Adverse events associated with DOC100 were mild. The regimens in both arms A and B were safe regarding adjuvant chemotherapy for early stage breast cancer. However, DOC100 followed by FEC100 may be more tolerable and effective. No significant financial relationships to disclose.

Efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor in the prevention of chemotherapy-induced neutropenia in patients with breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12515-e12515 ◽  
Author(s):  
Xiaoyu Chong ◽  
Xiaoli Zhu ◽  
Xuejuan Li ◽  
Lingna Gao ◽  
Hongfang Ma ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Dose Adjustment ◽  
Granulocyte Colony Stimulating Factor ◽  
Efficacy And Safety ◽  
Colony Stimulating Factor ◽  
Breast Cancer Patients ◽  
Grade 3 ◽  
Stimulating Factor

e12515 Background: To explore the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF, brand name: Jinyouli) in the prevention of neutropenia in breast cancer patients receiving adjuvant chemotherapy with EC regimen (epirubicin combined with cyclophosphamide). Methods: Retrospective analysis was conducted on breast cancer patients receiving adjuvant chemotherapy with EC regimen in Hengshui People's Hospital between January 2018 to October 2019. In cycle 1, all patients developed grade 3/4 neutropenia and PEG-rhG-CSF was used prophylactically in the subsequent cycles. The incidence of grade 3/4 neutropenia, febrile neutropenia (FN), chemotherapy delay and dose adjustment were observed as well as relative dose intensity (RDI), antibiotics application and adverse events. Results: 96 breast cancer patients were enrolled and all of them developed grade 3/4 neutropenia (100%) in cycle 1. After secondary prophylactic use of PEG-rhG-CSF, the incidence of grade 3/4 neutropenia decreased to 26.32% (25/95), 12.50% (10/80) and 13.63% (9/66) in cycle 2-4, respectively, with a statistically significant difference with cycle 1 ( P<0.001); The incidence of FN decreased from 2.08% (2/96) in cycle 1 to 0% (0/95), 1.25% (1/80) and 0% (0/66) in the subsequent cycles ( P>0.05). The incidence of chemotherapy delay was 2.08% (2/96), 2.50% (2/80) and 1.52% (1/66) in cycle 2-4, respectively, and the incidence of dose adjustment was 9.38% (9/96) in cycle 2. There was no dose adjustment in cycle 3-4. The average RDI was 92%, 92% and 94% in cycle 2-4, respectively. The most common treatment-related adverse events were fever (2.08%), muscle pain (1.04%) and fatigue (1.04%). Conclusions: PEG-rhG-CSF secondary prevention can effectively reduce the incidence of neutropenia in breast cancer patients receiving adjuvant chemotherapy with EC regimen, which ensures the implementation of standard-dose chemotherapy with good safety.

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