Lack of effect of pegfilgrastim on anemia in breast cancer patients treated with dose-dense chemotherapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11071-11071
Author(s):  
M. Manzoni ◽  
K. Bencardino ◽  
B. Rovati ◽  
S. Mariucci ◽  
F. Cappuzzo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Breast Cancer Patients ◽  
Adjuvant Setting ◽  
Group A ◽  
The Mean ◽  
Dose Dense ◽  
Group B ◽  
The Impact

11071 Background: A greater risk of anemia has been evidenced among breast cancer (BC) pts receiving dose-dense CT. A recent report showed that filgrastim may play a role in worsening anemia in BC pts receiving intensified Epirubicin (E) + Cyclophosphamide (CTX), by inducing stem cells to differentiate into more committed hematopoietic progenitors (Papaldo P. JCO, 2006). No data are available about the impact of pegfilgrastim-induced leucocytosis on Hb levels without prophylactic erythropoietic support. Methods: We have focused on this point in 36 BC pts. 14 N+ pts received 4 cycles of E 90 mg/sqm + CTX 600 mg/sqm every 14 days in adjuvant setting. 22 pts with locally advanced disease received 4 cycles of E 75 mg/sqm + Docetaxel 80 mg/sqm every 14 days as primary CT. All pts received prophylactic pegfilgrastim 6 mg s.c, after CT. Three groups were defined on the basis of WBC: A = <10 x 103/mL; B = between 10 and 20 x 103/mL and C = > 20 x 103/mL. WBC and Hb levels at the beginning of treatment were normal in all pts and were subsequently determined on day 1 of each treatment cycle. Results: All pts received the planned CT dose intensity. Only 3 pts developed G2 anemia and were excluded from the analysis, because of receiving darbepoietin alpha support. Among the 14 pts treated in adjuvant setting, 5 dropped in group A, 6 in group B and 3 in group C. The mean Hb decrease from the baseline to the last CT course was - 1.5 g/dL; -1.4, -1.8 and -1.4 in group A, B and C, respectively. In the primary setting, 4 pts dropped in group A, 12 in group B and 4 in group C. The mean Hb decrease was -1.5 g/dL; -1.3, -1.4 and -1.8 in group A, B and C respectively. No statistically significant correlation was found between the Hb levels and the degree of leukocytosis. Conclusions: Pegfilgrastim does not worsen anemia in BC pts treated with dose- dense CT, even when its use is related to some degree of leucocytosis. No significant financial relationships to disclose.

Aesthetic outcome and patient’s quality of life in breast cancer patients undergoing mastectomy with or without immediate reconstruction.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12587-e12587
Author(s):  
Sidra Afzal ◽  
Asad Parvaiz ◽  
Nida Javed
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Well Being ◽  
Mean Difference ◽  
Breast Cancer Patients ◽  
Immediate Reconstruction ◽  
Patient’S Satisfaction ◽  
Group A ◽  
The Mean ◽  
Group B

e12587 Background: : Although post mastectomy Immediate breast reconstruction has shown to improve physical and psychosocial well-being of breast cancer patients, this is not a usual procedure in Pakistan due to limited resources and lack of awareness. The aim of our study is to evaluate patient’s satisfaction/ aesthetic outcomes between the patients undergoing mastectomy alone (Group A) and the ones undergoing mastectomy followed by immediate reconstruction (Group B). Methods: This is a prospective study conducted at Shaukat Khanum Hospital Pakistan comparing aesthetic outcome, patient’s satisfaction and Quality of life between two groups using Breast Q module. All patients undergoing mastectomy with and without reconstruction between April 2017 to July 2019 are included. Sample size of 84 was calculated (42 in each group). Results: The mean Q score of satisfaction with the breast in group B is 82.64 and in group A is 35.82 (P = 0.001). The mean Q score of Psychosocial well-being in group B is 89 vs 44.95 in group A (P = 0.001). The mean Q score of Physical well-being in group B is 98.23 vs 90.41 in group A (P = 0.002). The mean Q score of sexual well-being in group B is 81.93 vs 43 in Group A (P = 0.001). [Mean difference in score of 5-10 - little change, 10-20 - moderate change, > 20 - significant change].The mean difference between two groups in satisfaction with breast , psychosocial well-being and sexual well-being is more than 20 with a statistically significant p-value, while in physical well-being the mean difference is 7.8 which falls in little change group. Conclusions: Our study shows that reconstruction helps breast cancer patients in providing comprehensive care in a manner that they achieve a higher satisfaction with their appearance, psychological and sexual well-being without compromising oncological safety and this should be practiced more in our country. Also patients education about these procedures should be raised to help them fighting against this disease

scholarly journals Impact of Different Modules of 21-Gene Assay in Early Breast Cancer Patients

2021 ◽  
Author(s):  
Mengdi Chen ◽  
Deyue Liu ◽  
Weilin Chen ◽  
Weiguo Chen ◽  
Kunwei Shen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Young Patients ◽  
Breast Cancer Patients ◽  
Old Patients ◽  
Gene Assay ◽  
Risk Patients ◽  
Group A ◽  
Group B ◽  
The Impact

Abstract Background: Young patients were under-evaluated in the construction and validation of the 21-gene Assay Recurrence Score (RS). Previous evidence suggested that RS performed differently according the ages of patients. Our study aimed to explore the molecular driving patterns in patients of different ages.Methods: A total of 1,078 estrogen receptor (ER)-positive breast cancer patients between Jan 2009 and Mar 2017 from Shanghai Jiao Tong University Breast Cancer Data Base were divided into three subgroups: Group A, ≤40y and premenopausal (n=97); Group B, >40y and premenopausal (n=284); Group C, postmenopausal (n=697). The correlation of RS and its modules and the variance of RS modules was explored.Results: Estrogen module had a stronger correlation with RS in patients >40y (ρ = -0.76 in Group B and -0.79 in Group C) compared with patients ≤40y (ρ = -0.64). Contrarily, the correlation between RS and invasion group was weaker in patients >40y (ρ = 0.29 in Group B and 0.25 in Group C) than in patients ≤40y (ρ = 0.44). The proliferation module contributed most to the variance in young patients (37.3%) while ER module contributed most in old patients (54.1% in Group B and 53.4% in Group C). For RS >25, proliferation module was the leading driver in all three subgroups (ρ = 0.38, 0.53 and 0.52 in Group A, B and C) while estrogen module had a weaker association with RS. The negative impact of ER related features on RS was stronger in clinical low-risk patients while the positive effect of proliferation module was stronger in clinical high-risk patients.Conclusions: RS was primarily driven by estrogen module in patients regardless of age, but the proliferation module had a stronger impact on RS in patients ≤40y than in those >40y. The impact of modules varied in patients with different genetic and clinical risk.

CEA as a prognostic factor in locally advanced breast cancer patients undergoing neoadjuvant chemotherapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10705-10705
Author(s):  
N. Valeri ◽  
N. Battelli ◽  
C. Mariotti ◽  
A. Santinelli ◽  
W. Siquini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Breast Cancer ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Advanced Breast ◽  
Breast Cancer Patients ◽  
Ca 15.3 ◽  
Group A ◽  
Group B

10705 Background: CEA and CA 15.3 are most commonly used to evaluate disease progression in metastatic and recurrent breast cancer. Only few significant studies showed a potential predictive role of CEA and CA 15.3 in adjuvant or neoadjuvant setting. We evaluated the correlation between tumour markers level at diagnosis and outcome in locally advanced breast cancer patients treated with neoadjuvant chemotherapy. Methods: Patients with locally advanced breast cancer (T > 3.5 cm and T4) at diagnosis entered the study. All patients had to have initial negative staging (chest X-ray, abdominal ultrasonography, bone scintigraphy and CT scan), whereas all patients who developed metastatic disease in sites which were uncertain during initial staging were excluded. Tumour markers at diagnosis were considered negative if CEA was inferior to 5 ng/ml and CA 15.3 inferior to 35 U/ml. All patients received neoadjuvant chemotherapy (4–6 cycles with regimens containing Anthracyclines and Taxanes or FEC). Most of patients underwent radical mastectomy followed by sequential radiation therapy and adjuvant chemotherapy and/or hormonotherapy in hormonal responsive patients. Results: Fifty-three patients entered the study. At a median follow up of 73 months, 35 patients were disease free after adjuvant treatment (group A), whereas 18 patients developed metastatic disease during follow-up (group B). At diagnosis 14 patients had CA 15.3 greater than 34 U/ml (7 in group A and 7 in group B), 6 patients had CEA greater than 5 ng/ml (1 in group A and 5 in group B) and 18 patients had CEA or CA 15.3 greater than normal values (7 in group A and 11 in group B).We analyzed DFS and OS in patients with normal (CEA < 5 ng/ml, CA15.3 < 35 U/ml) and elevated (CEA ≥ 5 ng/ml, CA 15.3 ≥ 35 U/ml) tumour markers at diagnosis; DFS (p = 0.001) and OS (p = 0.03) were significantly reduced in patients with elevated CEA at diagnosis; differences were not statistically significant for CA 15.3 (p > 0.05). Conclusions: CEA levels before neoadjuvant treatment could represent an important prognostic factor and may influence the choice of treatment in locally advanced breast cancer patients . No significant financial relationships to disclose.

Breast Cancer With Synchronous Metastases: Survival Impact of Exclusive Locoregional Radiotherapy

2009 ◽  
Vol 27 (9) ◽  
pp. 1375-1381 ◽  
Author(s):  
Romuald Le Scodan ◽  
Denise Stevens ◽  
Etienne Brain ◽  
Jean Louis Floiras ◽  
Christine Cohen-Solal ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Multivariate Analysis ◽  
Cancer Patients ◽  
Primary Tumor ◽  
Alternative Form ◽  
Breast Cancer Patients ◽  
Group A ◽  
Synchronous Metastases ◽  
Group B ◽  
The Impact

Purpose Several studies suggest that surgical excision of the primary tumor improves survival among patients with stage IV breast cancer at diagnosis. Exclusive locoregional radiotherapy (LRR) is an alternative form of locoregional treatment (LRT) in this setting. We retrospectively studied the impact of LRT on the survival of breast cancer patients with synchronous metastases. Patients and Methods Among 18,753 breast cancer patients treated in our institution between 1980 and 2004, 598 patients (3.2%) had synchronous metastasis at diagnosis. Demographic data, tumor characteristics, metastatic sites, and treatments were prospectively recorded. The impact of LRT on overall survival (OS) was evaluated by multivariate analysis including known prognostic factors. Results Among 581 eligible patients, 320 received LRT (group A), and 261 received no LRT (group B). LRT consisted of exclusive LRR in 249 patients (78%), surgery of the primary tumor with adjuvant LRR in 41 patients (13%), and surgery alone in 30 patients (9%). With a median follow-up time of 39 months, the 3-year OS rates were 43.4% and 26.7% in group A and group B (P =.00002), respectively. The association between LRT and improved survival was particularly marked in women with visceral metastases. LRT was an independent prognostic factor in multivariate analysis (hazard ratio [HR] = 0.70; 95% CI, 0.58 to 0.85; P = .0002). The adjusted HR for late death (≥ 1 year) was 0.76 (95% CI, 0.61 to 0.96; P = .02). Conclusion In our experience, LRT, consisting mainly of exclusive LRR, was associated with improved survival in breast cancer patients with synchronous metastases. Exclusive LRR may thus represent an active alternative to surgery.

scholarly journals Cyclic variation of integrated backscatter detects radiotherapy-induced changes better than global longitudinal strain, a three-year follow-up study in early-stage breast cancer patients

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
S Tuohinen ◽  
T Skytta ◽  
V Virtanen ◽  
P-L Kellokumpu-Lehtinen ◽  
P Raatikainen
Keyword(s):  
Breast Cancer ◽  
Longitudinal Strain ◽  
Global Longitudinal Strain ◽  
Posterior Wall ◽  
Cyclic Variation ◽  
Breast Cancer Patients ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Induced Changes

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Paavo and Eila Salonen Legacy The Finnish Foundation for Cardiovascular Research onbehalf - Aims To characterize the early phases of radiotherapy-induced changes in myocardial deformation echocardiography. Methods Ninety-nine breast cancer patients were studied prior adjuvant treatment, after chemotherapy (CT), after radiotherapy (RT) and three years after RT (3Y). Nineteen patients with left-sided breast cancer received adjuvant CTand RT (Group A). Sixty patients with left-sided (Group B) and 20 patients with right-sided breast cancer (Group C) were treated with RT only. Echocardiography with the analysis of cyclic variation of the integrated backscatter of the septum (sCV) and the posterior wall (pCV) and global longitudinal strain (GLS) were performed. Results Group A patients had a sCV decline from baseline to after CT, after RT and  at 3Y by 1.2 ± 3.4 dB (p = 0.146), 2.6 ± 3.9 dB (p = 0.010) and 4.1 ± 5.4 dB (p = 0.011), and GLS decline by 0.9 ± 1.7 % (p = 0.027), 0.1 ± 2.4 % (p = 0.848), and 0.9 ± 2.9 % (p = 0.124), respectively. Group B displayed sCV changes after RT by 1.4 ± 3.5 dB (p = 0.007) and at 3Y by 2.4 ± 3.2 dB (p &lt; 0.001) and the respective GLS changes were 1.1 ± 2.7 % (p = 0.003) and 1.7 ± 3.5 % (p = 0.001). sCV changes in Group C were 1.3 ± 3.9 dB (p = 0.159) after RT and  2.0 ± 4.1 dB (p = 0.049) at 3Y whereas GLS remained stable. A late decline in pCV was observed in all groups. In the whole patient population, sCV decline was independently associated with the mean LAD dose (p = 0.023, β= -0.251), CT (p = 0.044, β= -0.240) and with the use of aromatase inhibitor (AI) (p = 0.027, β=0.251).  GLS impairment was independently associated with AI (p = 0.017, β= -0.281). Conclusions Radiation-exposed septal areas displayed a significant decline early after RT in Group A and B patients in contrast to posterior wall and patients with right-sided breast cancer. In addition, the changes were independently associated with the mean LAD radiation dose. GLS had no independent association with radiation dose . CV appears to be a more sensitive marker of radiotherapy-induced changes of the myocardial contractility than GLS.

scholarly journals Prospective study of hair recovery after (neo)adjuvant chemotherapy with scalp cooling in Japanese breast cancer patients

2021 ◽  
Author(s):  
Shozo Ohsumi ◽  
Sachiko Kiyoto ◽  
Mina Takahashi ◽  
Seiki Takashima ◽  
Kenjiro Aogi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Prospective Study ◽  
Cancer Patients ◽  
Scalp Cooling ◽  
Breast Cancer Patients ◽  
Chemotherapy Infusion ◽  
Group A ◽  
Neo Adjuvant Chemotherapy ◽  
Group B

Abstract Purpose Scalp cooling during chemotherapy infusion to mitigate alopecia for breast cancer patients is becoming widespread; however, studies regarding hair recovery after chemotherapy with scalp cooling are limited. We conducted a prospective study of hair recovery after chemotherapy with scalp cooling. Patients and methods One hundred and seventeen Japanese female breast cancer patients who completed planned (neo)adjuvant chemotherapy using the Paxman Scalp Cooling System for alopecia prevention were evaluated for alopecia prevention in our prospective study. We evaluated their hair recovery 1, 4, 7, 10, and 13 months after chemotherapy. Primary outcomes were grades of alopecia judged by two investigators (objective grades) and patients’ answers to the questionnaire regarding the use of a wig or hat (subjective grades). Results Of 117 patients, 75 completed scalp cooling during the planned chemotherapy cycles (Group A), but 42 discontinued it mostly after the first cycle (Group B). Objective and subjective grades were significantly better in Group A than in Group B throughout 1 year, and at 4 and 7 months after chemotherapy. When we restricted patients to those with objective Grade 3 (hair loss of > 50%) at 1 month, Group A exhibited slightly faster hair recovery based on the objective grades than Group B. There was less persistent alopecia in Group A than in Group B. Conclusions Scalp cooling during chemotherapy infusion for Japanese breast cancer patients increased the rate of hair recovery and had preventive effects against persistent alopecia.

Totally Implantable Venous Access Port Systems: Implant Depth-based Complications in Breast Cancer Therapy - A Comparative Study

2021 ◽  
Vol 27 ◽  
Author(s):  
Kuo Chen ◽  
Narasimha M. Beeraka ◽  
Yuanting Gu ◽  
Jingruo Li ◽  
Mikhail Sinelnikov ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Therapy ◽  
Venous Access ◽  
Breast Cancer Patients ◽  
Breast Cancer Therapy ◽  
Access Port ◽  
Group A ◽  
Venous Access Port ◽  
Group B ◽  
Group D

Background: Totally implantable venous access port system (TIVAPS) is widely used in breast cancer therapy; TIVAPS has several associated complications depending on the depth of implantation in breast cancer (BC) patients during continuous infusional chemotherapy regimens. The purpose of this study is to find out the optimal depth of TIVAPS implantation to reduce the incidence of complications during infusional chemotherapy. Methods: This study reviewed the depth TIVAPS implantation in the internal jugular vein in 1282 breast cancer patients over a ten-year period (2009-2019), and associated complications. We segregated the patients as 5 groups: ‘Group A (depth < 4 mm), Group B (depth of 4-8 mm), Group C (depth of 8-12 mm), and Group D (depth of 12-16 mm), and Group E (depth of > 16 mm)’. Consequently, the ‘internal complications’ such as infection, venous thrombotic syndrome, catheter folding & migration, extravasation, whereas the ‘external complications’ viz., inflammation, local hematoma, local cutaneous reactions, and port exteriorization were significantly analyzed during TIVAPS implantation at different depths in BC patients. Results: Overall incidence of ‘internal complications’ such as infections, venous thrombotic syndrome, catheter folding & migration, and extravasation was comparatively lesser in Group C (8-12 mm) than Group A, Group B, Group D, and Group E, respectively. Mainly, the external complications such as inflammation Group C (8-12 mm) (p<0.01) were lesser (6.8%, 3/44 cases) than Group A, Group B, Group D, Group E. On a similar note, the local hematoma, and local cutaneous reaction, and port exteriorization were observed as ‘5% (1/20 cases), 4.2% (2/47 cases), and (3.2%, 1/31 cases)’ in Group C patients (p<0.01), which were comparatively lesser than the other groups. Conclusion: Subcutaneous implantation of TIVAPS at a depth of 8-12 mm could be preferred due to the lowest incidence of internal and external complications compared to the incidence of these complications in other groups; this depth could be referred to as the safe and convenient implantation depth for the effective delivery of chemotherapy regimen in BC patients without difficulty in transcutaneous access to the port.

Radioimmunoguided surgery after primary treatment of locally advanced breast cancer.

1996 ◽  
Vol 14 (5) ◽  
pp. 1599-1603 ◽  
Author(s):  
P Percivale ◽  
S Bertoglio ◽  
P Meszaros ◽  
G Canavese ◽  
F Cafiero ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Primary Tumor ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Advanced Breast ◽  
Primary Chemotherapy ◽  
Radioimmunoguided Surgery ◽  
Group A ◽  
Group B

PURPOSE To assess the role of radioimmunoguided surgery (RIGS) using a handheld intraoperative gamma-detecting probe (GDP) to identify neoplastic disease after primary chemotherapy in locally advanced breast cancer (LABC) patients injected with iodine 125-labeled monoclonal antibodies (MAbs). PATIENTS AND METHODS Twenty-one patients with histologically documented LABC were treated with a combined modality approach. After three courses of primary chemotherapy and before modified radical mastectomy, the 125I-radiolabeled MAbs B72.3 (anti-TAG72) and FO23C5 (anti-carcinoembryonic antigen [CEA]) were administered to 11 patients (group A) and 10 patients (group B), respectively. At surgery, a GDP was used to locate the primary tumor and to assess possible tumor multicentricity and the presence of ipsilateral axillary metastases. Routine pathologic examination was performed in neoplastic and normal tissue specimens of all 21 patients. In addition, immunohistochemical assay for TAG72 and CEA expression was performed. RESULTS In group A patients, RIGS identified primary tumor in seven of 11 patients (63.3%) and unpalpable multicentric tumor lesions were located in two of four (50%). Positive axillary lymph nodes were histologically documented in eight of 11 patients (72.7%) and RIGS identified three of eight (37.5%). In group B, RIGS located the primary tumor lesion in four of 10 patients (40%); in two cases, the tumor was not clinically evident. Multicentricity was observed in one of two patients and lymph node involvement in three of nine (33.3%). No false-positive results were observed in either group A or B. CONCLUSION RIGS appears to be a safe and reliable technique. However, the MAbs used in this study are not sufficiently specific. RIGS represents a technique for which the full potential for intraoperative assessment of breast cancer lesions can be reached when more specific antibodies become readily available.

scholarly journals Effects of Different Exercise Interventions on Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial

2019 ◽  
Vol 18 ◽  
pp. 153473541988059
Author(s):  
Tetiana Odynets ◽  
Yuriy Briskin ◽  
Valentina Todorova
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Well Being ◽  
Breast Cancer Patients ◽  
Exercise Interventions ◽  
Water Exercise ◽  
Group A ◽  
Group B

Purpose: The aim of the present study was to evaluate the effects of different exercise interventions on quality of life parameters in breast cancer patients during 1 year of outpatient rehabilitation. Material and Methods: A total of 115 breast cancer patients met the eligibility criteria and completed the study. Participants were randomly allocated for the water exercise interventions (group A, n = 45), for the Pilates exercise interventions (group B, n = 40), and yoga exercise interventions (group C, n = 30). The 3 groups attended relevant programs for 1 year and received 144 rehabilitation sessions. Quality of life parameters were assessed using the Functional Assessment of Cancer Therapy questionnaire with a specific module for breast cancer patients (FACT-B). Quality of life data were recorded at baseline and after 6 and 12 months of exercise interventions. Results: A significant increase in quality of life indicators was observed in participants of all groups. Based on the results of the 12-month monitoring, patients of group A scored significantly more points for emotional well-being compared with group B and group C by 1.40 points ( P < .05) and 1.69 points ( P < .01), respectively, as well as by breast cancer subscale by 2.15 points ( P < .05) compared with group B. Patients in group C scored significantly better compared with group A in social/family well-being by 2.80 points ( P < .01). Conclusions: It was found that using water exercise intervention is more effective for improving emotional well-being and decreasing negative symptoms associated with breast cancer treatment compared with Pilates and yoga interventions, while yoga was more effective in improving social/family well-being. Further research on water interventions for different populations is warranted.

Pegfilgrastim in dose-dense, sequential adjuvant chemotherapy for patients with breast cancer (BC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10708-10708 ◽  
Author(s):  
E. Stickeler ◽  
M. Földi ◽  
A. Kummle ◽  
A. Hinke ◽  
P. C. Hartmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Lymph Node Involvement ◽  
Weekly Schedule ◽  
Significant Prolongation ◽  
Cycle 24 ◽  
Dose Dense ◽  
Wbc Count

10708 Background: Large randomized trials in the US and Europe have recently shown, that increased dose density of adjuvant chemotherapy leads to a relevant and significant prolongation of disease-free and overall survival in breast cancer. Dose density refers to the administration of drugs with a shortened intertreatment interval. G-CSF support is an essential requirement for increasing dose intensity. We explored the feasibility of pegylated filgrastim (Neulasta) in this setting. Methods: Patients (pts) up to the age of 60 with a confirmed histology of breast cancer and lymph node involvement were recruited into the study. A dose-dense chemotherapy, consisting of 3 x 4 sequential single drug cycles of epirubicin 90 mg/m2, paclitaxel 175 mg/m2, and cyclophosphamide 600 mg/m2 was planned on a two-weekly schedule (similar to Citron et al., J Clin Oncol, 21 (2003): 1431–1439). Pegfilgrastim was to be administered on day 2 of each cycle, 24 h after chemotherapy application. Results: Seventeen pts with a mean age of 49 years were enrolled into this feasibility study. 76% of pts had pN2–3 stage, 65% G2 and 35% G3 tumors, 71%/47% a positive estrogen/progesterone receptor status, respectively. All but one pt were HER2-negative. The full number of 12 cytotoxic courses could be administered in all but one patient due to an anaphylactic reaction against paclitaxel. A total of nine weeks of treatment delay was recorded in 6 of the remaining 16 patients (38%), resulting in an overall mean relative dose intensity of 95.9% (range 80– 100%). Pegfilgrastim was given during 85% of the 198 courses. Febrile or grade 4 neutropenia were not recorded, grade 3 neutropenia in one cycle (6%) without G-CSF support. Antibiotic treatment was necessary in only 18% of pts. Median peak WBC count during the complete treatment course was 28,150/μl, no values above 100,000/μl were recorded. Bone pain was reported in 4 patients (24%) and occurred in a total of 6 cycles (3%). Conclusions: Pegfilgrastim can be used safely and seems to achieve the required supportive efficiency in a dose dense sequential chemotherapy schedule for locally advanced BC. [Table: see text]

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