scholarly journals Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study

2020 ◽  
Vol 38 (21) ◽  
pp. 2390-2397 ◽  
Author(s):  
Ines Vaz-Luis ◽  
Romualdo Barroso-Sousa ◽  
Antonio Di Meglio ◽  
Jiani Hu ◽  
Rebecca Rees ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Standard Of Care ◽  
Current Standard ◽  
Treatment Delays ◽  
Breast Cancer Chemotherapy ◽  
Adjuvant Breast Cancer ◽  
Dose Dense ◽  
A Prospective Study ◽  
Dose Delay

PURPOSE The use of growth factors adds considerable expense and some toxicity to adjuvant breast cancer chemotherapy. We tested the feasibility and safety of omitting routine peg-filgrastim use during the paclitaxel portion of the dose-dense doxorubicin-cyclophosphamide–paclitaxel regimen. PATIENTS AND METHODS This was a prospective, single-arm study in which patients 18 to 65 years of age who completed 4 cycles of dose-dense doxorubicin-cyclophosphamide for stage I-III breast cancer received paclitaxel 175 mg/m2 every 2 weeks. Peg-filgrastim was administered after paclitaxel only if patients had had febrile neutropenia in a prior cycle or at investigator discretion if patients had infections or treatment delays of > 1 week. Once a patient received peg-filgrastim, it was administered in all future cycles. The primary end point was the rate of paclitaxel completion within 7 weeks from cycle 1 day 1 to cycle 4 day 1. If ≥ 100 out of 125 patients completed 4 cycles of paclitaxel without dose delay, the regimen would be considered feasible. RESULTS The enrollment goal of 125 patients was met. Median age was 46 years (range, 21-65 years), and 112 patients (90% [95% CI, 83% to 94%]) completed dose-dense paclitaxel within 7 weeks. Omission of peg-filgrastim was not causally related to noncompletion of paclitaxel in any patients. The most common reasons for dose reduction or delays were nonhematologic. One patient experienced febrile neutropenia but was able to complete paclitaxel on time. Eight patients (6.4%) received peg-filgrastim during the trial. Overall, peg-filgrastim was administered in only 4.3% of paclitaxel cycles. CONCLUSION Omission of routine peg-filgrastim during dose-dense paclitaxel according to a prespecified algorithm seems to be safe and feasible and was associated with a 95.7% reduction in the use of peg-filgrastim relative to the current standard of care.

Avoiding peg-filgrastim (Peg-F) prophylaxis during the paclitaxel (T) portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-T regimen: A prospective study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 517-517
Author(s):  
Romualdo Barroso-Sousa ◽  
Ines Maria Vaz Duarte Luis ◽  
Antonio Di Meglio ◽  
Jiani Hu ◽  
Rebecca Rees ◽  
...  
Keyword(s):  
Standard Of Care ◽  
Hematologic Toxicity ◽  
Current Standard ◽  
Breast Cancer Chemotherapy ◽  
Adjuvant Breast Cancer ◽  
Secondary Endpoints ◽  
Dose Dense ◽  
Ecog Ps ◽  
A Prospective Study ◽  
Cost Implications

517 Background: Use of growth factors (GF) adds considerable expense and some toxicity to adjuvant breast cancer chemotherapy. We tested the feasibility and safety of omitting routine GF use during the T portion of DD AC-T. Methods: This is a prospective, single-arm study in which patients (pts) who completed 4 cycles of DD-AC proceeded to DD-T 175 mg/m2 every two weeks (wks) without routine GF (NCT02698891). Key inclusion: age≤ 65, ECOG PS≤1, absolute neutrophil count (ANC) ≥1500/mm3, and no febrile neutropenia (FN) during DD-AC. Criteria to treat for T included ANC ≥1000/mm3. Peg-F was given only if pts had FN in a prior cycle, or at investigator discretion if infection or treatment delay > 1 wk. Once Peg-F was given, pts received it in all future cycles. The primary endpoint was the rate of T completion ≤ 7 wks from cycle 1 day 1 (C1D1) to C4D1. Secondary endpoints included total use of Peg-F, rates of hematologic toxicity and FN, reasons for dose modification or hold. If ≥85% of pts completed T on time, the regimen would be considered feasible. If the true on-time completion rate is 75%, the chance the regimen would be declared infeasible is 91%, and if it is 85% the chance that the regimen is falsely declared infeasible is 10% (power = 0.899). ≥100/125 pts had to complete T on time for the regimen to be deemed successful. Results: Among 127 pts enrolled, 125 received ≥1 dose of protocol therapy and are included in the analysis. Median age at registration was 46 (range 21-65). Median C1D1 ANC was 7500/mm3 (range 1500-20500). 112 (90%) (95% CI 83-94%) pts completed DD-T ≤ 7 wks, and 3 (2%) completed within > 7 wks (2 due to neutropenia); 10 (8%) did not complete all cycles of T. Omission of Peg-F was not causally related to non-completion of T in any pts. The most common reasons for dose reduction or delays were non-hematologic. One pt had FN but was able to complete T on time. Eight (6.4%) pts received Peg-F during the trial. Conclusions: Omission of routine GF use during DD-T according to a pre-specified algorithm appears safe, feasible, and was associated with a 95.7% reduction in use of Peg-F, relative to the current standard of care. Additional analyses including cost implications are ongoing. Clinical trial information: NCT02698891.

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.

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 NEPA efficacy and tolerability during (neo)adjuvant breast cancer chemotherapy with cyclophosphamide and doxorubicin

2020 ◽  
pp. bmjspcare-2019-002037
Author(s):  
Winnie Yeo ◽  
Thomas KH Lau ◽  
Carol CH Kwok ◽  
Kwai T Lai ◽  
Vicky TC Chan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Complete Response ◽  
Chinese Patients ◽  
Eligibility Criteria ◽  
Randomised Study ◽  
Breast Cancer Chemotherapy ◽  
Adjuvant Breast Cancer ◽  
Registration Number ◽  
Multiple Cycles ◽  
A Prospective Study

ObjectivesThis is a prospective study evaluating NEPA in patients with breast cancer (the NEPA group), who received (neo)adjuvant AC chemotherapy (consisting of doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2). The primary objectives were to assess the efficacy and safety of NEPA in controlling chemotherapy-induced nausea and vomiting (CINV). The secondary objectives were to compare CINV between the NEPA group and historical controls (the APR group) who received aprepitant in an earlier prospective randomised study.Patients and methods60 patients participated in the NEPA group; 62 were in the APR group. Eligibility criteria of both groups were similar, that is, Chinese patients with breast cancer who were treated with (neo)adjuvant AC. NEPA group received NEPA and dexamethasone; APR group received aprepitant, ondansetron and dexamethasone. Individuals filled in self-reported diary, visual analogue scale for nausea and Functional Living Index-Emesis questionnaire.ResultsWithin the NEPA group, 70.0%, 85.7% and 60.0%, respectively reported complete response in the acute, delayed and overall phases in cycle 1 AC. When compared with the historical APR group during cycle 1 AC, NEPA group achieved significantly higher rates of complete response, complete protection, total control, ‘no significant nausea’ and ‘no nausea’ in the delayed phase; similar findings were noted in the overall phase with significantly better quality of life. Superior efficacy of NEPA was maintained over multiple cycles. Both antiemetic regimens were well tolerated.ConclusionIn this study on Chinese patients with breast cancer who were uniformly receiving AC, NEPA was effective in controlling CINV.Trial registration numberNCT03386617.

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]

scholarly journals Comparison of Estrogen and Progesterone Receptor Antibody Reagents Using Proficiency Testing Data

2017 ◽  
Vol 141 (10) ◽  
pp. 1402-1412 ◽  
Author(s):  
Megan L. Troxell ◽  
Thomas Long ◽  
Jason L. Hornick ◽  
Abiy B. Ambaye ◽  
Kristin C. Jensen
Keyword(s):  
Breast Cancer ◽  
Progesterone Receptor ◽  
Proficiency Testing ◽  
Immunohistochemical Analysis ◽  
Predictive Testing ◽  
Standard Of Care ◽  
Tissue Microarrays ◽  
Current Standard ◽  
Testing Data ◽  
Positive Results

Context.— Immunohistochemical analysis of estrogen receptor (ER) and progesterone receptor (PgR) expression in breast cancer is the current standard of care and directly determines therapy. In 2010 the American Society of Clinical Oncology and the College of American Pathologists (ASCO/CAP) published guidelines for ER and PgR predictive testing, encompassing preanalytic, analytic, postanalytic factors; antibody validation; and proficiency testing. Objective.— To compare the performance of different antibody reagents for ER and PgR immunohistochemical analysis by using CAP proficiency testing data. Design.— The CAP PM2 survey uses tissue microarrays of ten 2-mm cores per slide. We analyzed survey data from 80 ER and 80 PgR cores by antibody clone from more than 1200 laboratories. Results.— Laboratories used the ER antibodies SP1 (72%), 6F11 (17%), 1D5 (3%), and the PgR antibodies 1E2 (61%), 16 (12%), PgR-636 (13%), PgR-1294 (8%) in 2015. While 63 of 80 ER cores (79%) were scored similarly using each of the 3 antibodies, there were significant differences for others, with SP1 yielding more positive interpretations. Four cores were scored as ER negative by more than half of the laboratories using 1D5 or 6F11, while SP1 produced positive results in more than 70% of laboratories using that antibody. Despite the greater variety of PgR antibody reagents and greater PgR tumor heterogeneity, 61 of 80 cores (76%) were scored similarly across the 4 PgR antibodies. Conclusions.— Accurate ER and PgR testing in breast cancer is crucial for appropriate treatment. The CAP proficiency testing data demonstrate differences in staining results by ER clone, with SP1 yielding more positive results.

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