scholarly journals A randomised trial of secondary prophylaxis using granulocyte colony-stimulating factor (‘SPROG’ trial) for maintaining dose intensity of standard adjuvant chemotherapy for breast cancer by the Anglo-Celtic Cooperative Group and NCRN

2015 ◽  
Vol 26 (12) ◽  
pp. 2437-2441 ◽  
Author(s):  
R.C.F. Leonard ◽  
J.L. Mansi ◽  
C. Keerie ◽  
A. Yellowlees ◽  
S. Crawford ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Randomised Trial ◽  
Dose Intensity ◽  
Secondary Prophylaxis ◽  
Cooperative Group ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Stimulating Factor

Five-day course of granulocyte colony-stimulating factor in patients with prolonged neutropenia after adjuvant chemotherapy for breast cancer is a safe and cost-effective schedule to maintain dose-intensity.

1996 ◽  
Vol 14 (5) ◽  
pp. 1573-1580 ◽  
Author(s):  
A Ribas ◽  
J Albanell ◽  
J Bellmunt ◽  
L A Solé-Calvo ◽  
B Bermejo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Treatment ◽  
Dose Intensity ◽  
Cost Effective ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Median Percentage ◽  
Subsequent Cycle ◽  
Intent To Treat ◽  
Stimulating Factor

PURPOSE To analyze the safety and efficacy of a short course of granulocyte colony-stimulating factor (G-CSF) to maintain dose-intensity of subsequent cycles of chemotherapy after a prior episode of prolonged neutropenia, without febrile complications, in patients receiving adjuvant treatment for breast cancer. PATIENTS AND METHODS Thirty-two patients undergoing adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin-CMF for stages I to II breast cancer were included after having chemotherapy delays due to neutropenia (absolute neutrophil count [ANC] < 1.5 x 10(9)/L) on day 22. G-CSF was administered subcutaneously on days 15 to 19 of each subsequent cycle. RESULTS None of the patients included in this study had to be admitted to the hospital for fever and neutropenia. The median percentage of the projected dose-intensity for CMF or doxorubicin-CMF on an intent-to-treat basis was 0.994, which was significantly higher than the delivered dose-intensity before the start of G-CSF treatment (P < .0001). Patients who received concomitant G-CSF and radiotherapy achieved a similar dose-intensity as patients who did not undergo radiotherapy. Seven patients discontinued G-CSF treatment due to musculoskeletal pain. These patients had more subsequent cycle delays because of day 22 neutropenia than the 25 patients who followed the G-CSF schedule (P = .0028). CONCLUSION A 5-day course of G-CSF in patients with prior chemotherapy delays due to prolonged neutropenia seems to be a safe and cost-effective schedule to maintain CMF or doxorubicin-CMF dose-intensity in the adjuvant treatment of 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.

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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