Impact of Five Prophylactic Filgrastim Schedules on Hematologic Toxicity in Early Breast Cancer Patients Treated With Epirubicin and Cyclophosphamide

2005 ◽  
Vol 23 (28) ◽  
pp. 6908-6918 ◽  
Author(s):  
Paola Papaldo ◽  
Massimo Lopez ◽  
Paolo Marolla ◽  
Enrico Cortesi ◽  
Mauro Antimi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Dose Intensity ◽  
High Dose ◽  
Hematologic Toxicity ◽  
Breast Cancer Patients ◽  
Nonrandomized Trial ◽  
Grade 3 ◽  
To Receive

Purpose To evaluate the comparative efficacy of varying intensity schedules of recombinant human granulocyte colony-stimulating factor (G-CSF; filgrastim) support in preventing febrile neutropenia in early breast cancer patients treated with relatively high-dose epirubicin plus cyclophosphamide (EC). Patients and Methods From October 1991 to April 1994, 506 stage I and II breast cancer patients were randomly assigned to receive, in a factorial 2 × 2 design, epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 intravenously on day 1 every 21 days for 4 cycles ± lonidamine ± G-CSF. The following five consecutive G-CSF schedules were tested every 100 randomly assigned patients: (1) 480 μg/d subcutaneously days 8 to 14; (2) 480 μg/d days 8, 10, 12, and 14; (3) 300 μg/d days 8 to 14; (4) 300 μg/d days 8, 10, 12, and 14; and (5) 300 μg/d days 8 and 12. Results All of the G-CSF schedules covered the neutrophil nadir time. Schedule 5 was equivalent to the daily schedules (schedules 1 and 3) and to the alternate day schedules (schedules 2 and 4) with respect to incidence of grade 3 and 4 neutropenia (P = .79 and P = .89, respectively), rate of fever episodes (P = .84 and P = .77, respectively), incidence of neutropenic fever (P = .74 and P = .56, respectively), need of antibiotics (P = .77 and P = .88, respectively), and percentage of delayed cycles (P = .43 and P = .42, respectively). G-CSF had no significant impact on the delivered dose-intensity compared with the non–G-CSF arms. Conclusion In the adjuvant setting, the frequency of prophylactic G-CSF administration during EC could be curtailed to only two administrations (days 8 and 12) without altering outcome. This nonrandomized trial design provides support for evaluating alternative, less intense G-CSF schedules for women with early breast cancer.

Thymidine Labeling Index Analysis in Early Breast Cancer Patients Randomized to Receive Perioperative Chemotherapy

Oncology ◽  
2000 ◽  
Vol 60 (1) ◽  
pp. 88-93 ◽  
Author(s):  
Paolo Pronzato ◽  
Paola Queirolo ◽  
Stefania Vecchio ◽  
Rita Lionetto ◽  
Lucia Del Mastro ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Labeling Index ◽  
Perioperative Chemotherapy ◽  
Breast Cancer Patients ◽  
Index Analysis ◽  
Thymidine Labeling Index ◽  
To Receive

Hepatic intra-arterial infusion (HAI) for liver metastases in pretreated metastatic breast cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10579-10579
Author(s):  
C. Zanon ◽  
M. Airoldi ◽  
F. Pedani
Keyword(s):  
Breast Cancer ◽  
Liver Metastases ◽  
Cancer Patients ◽  
Median Survival ◽  
Median Duration ◽  
Metastatic Breast ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Breast Cancer Patients ◽  
Grade 3

10579 Background: Breast cancer patients (pts) with liver metastases have a poor prognosis. HAI has been frequently used for liver metastases from colorectal cancer, with better response and possibly survival than with intravenous administration. We evaluated the activity of HAI in pretreated breast cancer patients with liver metastases only. Methods: From December 2001 to October 2005 thirty patients previously treated with anthracyclines, taxanes and vinorelbine were enrolled. Median age 58 years (44–68) and median PS 1 (0–2). Eight patients (27%) had 5 or more liver nodes, seventeen (57%) had 5 to 10 metastases and five (16%) more than 10 nodes. Eighteen patients received 2 previous lines of chemotherapy (67 %), eleven 3 lines (30%) and one (3%) three lines and one cicle of high dose chemotherapy followed by ABMT. Seventeen pts received prior hormonotherapy. Two patients had been submitted to liver metastasectomy. Patients underwent percutaneous implantation of an arterial hepatic port-a-cath. HAI regimen administered on days 1–3 every 4 weeks, consisted of cisplatin 10 mg/sqm bid, mitomycin-C 1 mg/sqm bid, 5-fluorouracil 1000 mg/sqm 72 hours continuous infusion. Results: On an intent-to-treat analysis, four pts had CR (13%) with a duration of responses of 12, 18, 24 and 36 months. Fourteen pts (47%) had PR with a median duration of 7 months. Six patients had stable disease (20%) with a median duration of 3 months. Six patients (20%) had PD. Responses were more frequent in patients with PS 0 (10/13, 77%) and in patients treated with 2 previous lines of chemotherapy (13/18, 72%) than 3 or more (5/12, 42%). Median survival for the whole population was 11.8 months (5–44; 95% CI, 10.0 to 13.9). For pts with CR or PR and those who had SD, median survival was 16 months (10–44) and 10 months (8–18), respectively. No treatment-related death occurred. Grade 3–4 neutropenia in 7 % of pts. Grade 4 thrombocytopenia and grade 3 anemia 3 % of patients. Most frequent G3 non-haematologic toxicities were nausea and vomiting (3%) and alopecia (3%). We observed 2 dislodgements of catheter (7%), 3 cases (10%) of gastroduodenal ulcers, neither cases of thrombosis, nor sclerosing cholangitis. Conclusions: This intra-arterial regimen seems active in this patient population, with a very good safety profile. No significant financial relationships to disclose.

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.

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.

Impact of two different dose-intensity chemotherapy regimens on psychological distress in early breast cancer patients

2002 ◽  
Vol 38 (3) ◽  
pp. 359-366 ◽  
Author(s):  
L. Del Mastro ◽  
M. Costantini ◽  
G. Morasso ◽  
F. Bonci ◽  
M. Bergaglio ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Psychological Distress ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Dose Intensity ◽  
Breast Cancer Patients

scholarly journals Treatment Pattern and Safety Results of Docetaxel-(Taxotere®)-Based Chemotherapy in Early Breast Cancer Patients in Indonesia: Part of Asia-Pacific Breast Initiative II

2019 ◽  
Vol 13 (1) ◽  
pp. 1
Author(s):  
Samuel Johny Haryono ◽  
Noorwati Sutandyo ◽  
Ramadhan Karsono ◽  
Bambang Karsono ◽  
Denni Joko Purwanto ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Dose Intensity ◽  
Treatment Pattern ◽  
Asia Pacific ◽  
Observational Research ◽  
Breast Cancer Patients ◽  
Total Study Population

Background: Breast cancer is the most diagnosed cancer among Indonesian women. Adjuvant chemotherapy plays a crucial role in the management of early breast cancer patients, with docetaxel-based regimens as a cornerstone therapy. The Asia-Pacific breast initiative II registry was established to evaluate safety parameters of docetaxel-based regimens in the Asia-Pacific region within 2009–2013 period. The result from Indonesia population is presented in this study.Methods: This study was a part of International, longitudinal, multicenter, and observational research which included a group of consecutive early breast cancer patients with an intermediate-to-high risk of recurrence that was being treated with various docetaxel-based (anthracycline and non-anthracycline) adjuvant chemotherapy regimens during 2009–2013 in real-world clinical settings.Results: The analysis included 49 subjects (2.8% of total study population). Majority of subjects received non-anthracycline-containing regimen (79.6%). Docetaxel was mainly prescribed in combination (63.27%). Chemotherapy-related adverse events were reported in all subjects. Mean number of cycles received by subjects was 5.5 cycles with dose intensity of 23.78 mg/m2/week.Conclusions: The Indonesian result, as part of the Asia-Pacific Breast Initiative II Registry, identified some important factors that are relevant to clinical practice, including patient’s characteristics and treatment pattern of docetaxel use as adjuvant chemotherapy regimens. 

Repetitive cycles of cyclophosphamide, thiotepa, and carboplatin intensification with peripheral-blood progenitor cells and filgrastim in advanced breast cancer patients.

1997 ◽  
Vol 15 (2) ◽  
pp. 674-683 ◽  
Author(s):  
C L Shapiro ◽  
L Ayash ◽  
I J Webb ◽  
R Gelman ◽  
J Keating ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Median Duration ◽  
Peripheral Blood ◽  
Mononuclear Cells ◽  
High Dose ◽  
Hematologic Toxicity ◽  
Breast Cancer Patients ◽  
Multiple Cycle ◽  
Median Slope

PURPOSE As an alternative to single-cycle cyclophosphamide, thiotepa, and carboplatin (CTCb) intensification, we evaluated the feasibility of administering one-quarter dose CTCb for four cycles with peripheral-blood progenitor-cell (PBPC) and filgrastim (granulocyte colony-stimulating factor [G-CSF]) in advanced-stage breast cancer patients. PATIENTS AND METHODS From June 1992 to August 1993, 20 stage IIIB (n = 7) and IV (n = 13) breast cancer patients received 78 cycles of induction with doxorubicin 90 mg/m2 by intravenous (IV) bolus with G-CSF 5 microg/kg/d by subcutaneous injection (SC) repeated every 14 to 21 days for four cycles. PBPC were collected by 2-hour single-blood volume leukapheresis on 2 consecutive days at the time of hematologic recovery from each cycle of doxorubicin. Eighteen patients received 61 cycles of intensification with cyclophosphamide 1,500 mg/m2, thiotepa 125 mg/m2, and carboplatin 200 mg/m2 by IV continuous infusion with G-CSF 10 microg/kg/d SC and PBPC support repeated every 21 to 42 days for four cycles. RESULTS Twelve of 20 patients (60%) completed all four planned cycles of doxorubicin induction followed by four cycles of one-quarter dose CTCb intensification. Statistically significantly decreases in the yield of mononuclear cells (MNC) (median slope per day, -0.032; P = .03), granulocyte-macrophage colony-forming unit (CFU-GM) (median slope per day, -0.57; P = .0008), and burst-forming unit-erythroid (BFU-E) (median slope per day, -1.18; P = .006) were observed over the course of the eight leukaphereses. Of 18 patients who began CTCb, 12 (67%) completed four cycles. Six patients were removed from study during intensification: two for progressive disease (PD), one refused further treatment, and three for dose-limiting hematologic toxicity. A fourth patient fulfilled the criteria for dose-limiting hematologic toxicity after cycle 4. The toxicity of the multiple cycle CTCb intensification regimen consisted of grade IV leukopenia, grade IV thrombocytopenia, and febrile neutropenia in 100%, 100%, and 26% of cycles, respectively. The median duration of each CTCb cycle was 24 days (range, 18 to 63), and the median duration of an absolute neutrophil count (ANC) < or = 500/microL and platelet count < or = 20,000/microL during each cycle was 6 days (range, 2 to 15) and 4 days (range, 0 to 38), respectively. CONCLUSION It is feasible to administer repetitive cycles of one-quarter dose CTCb intensification with PBPC and G-CSF. Additional studies are required to determine whether multiple cycles of CTCb intensification might offer a therapeutic advantage over a single high-dose cycle.

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