Dose-dense (DD) two-weekly docetaxel/doxorubicin/cyclophosphamide (TAC) with G-CSF support compared to standard adjuvant TAC in breast cancer patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11052-11052
Author(s):  
S. Z. Latifzadeh ◽  
M. Salimi ◽  
M. Naghnaeian ◽  
V. Entezari
Keyword(s):  
Breast Cancer ◽  
Liver Function ◽  
Supportive Therapy ◽  
Liver Function Tests ◽  
Breast Cancer Patients ◽  
Prophylactic Use ◽  
Dose Dense ◽  
Significant Disease ◽  
Disease Free ◽  
Grade Iii

11052 Background: TAC confers a significant disease free and overall survival benefits vs. FAC for patients with node positive breast cancer and prophylactic use of G-CSF is a reasonable supportive therapy to minimize myelosuppresive complications of this regimen. DD scheduling has shown improved clinical outcomes in breast cancer therapy. This study is trying to compare toxicities and tolerability of DD TAC with G-CSF support with TAC every 3 wks supported with G-CSF. Methods: Thirty seven patients were enrolled during the period 1/04 to 1/06. Cohort A (N=25) received six cycles of TAC (75/50/500 mg/m2 every 3 wks) plus GCSF started on day 5 and Cohort B (N=12) received six cycles of TAC (75/50/500 mg/m2 every 2 wks) plus GCSF started on day 2. All patients had normal cardiac, renal and liver function. Toxicities were evaluated by clinical assessment, CBC and liver function tests. Results: The incidence of febrile neutropenia was 15.8% and 16.7% in cohort A and B respectively (RR =1.06, 95% CI = 0.20–5.42). Grade III/IV anemia was detected in 5.3% of cohort A patients and 8.0 % of cohort B patients (RR=1.58, 95% CI=0.10–22.99). Ten percent of cohort A patients developed stomatitis grade III/IV while none of cohort B patients had this toxicity (RR=1.06, 95% CI = 0.94–1.17). Hospitalization due to chemotherapy complications (mainly neutropenia) in cohort A and B were 5.3% and 8.3% (RR =1.58, 95%CI = 0.10–22.99). Conclusions: DD two weekly TCA was reported to be feasible in patients with stage II - III breast cancer (Margolis et al. JCO, 2005). This study shows that DD TCA plus G-CSF has comparable toxicity profile with standard TCA regimen with shorter treatment period.

Oral silymarin formulation efficacy in management of AC-T protocol induced hepatotoxicity in breast cancer patients: A randomized, triple blind, placebo-controlled clinical trial

2021 ◽  
pp. 107815522110061
Author(s):  
Ghazal Sadat Askarpour Moezian ◽  
Seyed Alireza Javadinia ◽  
Soodabeh Shahid Sales ◽  
Azar Fanipakdel ◽  
Sepideh Elyasi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Liver Function ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Liver Function Tests ◽  
Controlled Clinical Trial ◽  
Breast Cancer Patients ◽  
Function Tests

Background Chemotherapeutic agents, with or without other drugs and radiation, may cause indirect or direct hepatotoxicity. Doxorubicin-induced hepatotoxicity (DIH) is a major health concern in cancer patients receiving this cytotoxic drug that is mostly resulted from the production of reactive oxygen species leading to transient or permanent liver damages. Silymarin, a flavonoid extracted from the Silybum marianum, exhibits antioxidant and anti-inflammatory activities. Purpose This study aimed to investigate the clinical efficacy of systemic administration of silymarin in management of chemotherapy induced hepatotoxicity in patients with non-metastatic breast cancer who received doxorubicin/cyclophosphamide-paclitaxel (AC-T) regimen. Material: In this randomized, triple blind, placebo-controlled clinical trial, 30 patients who received AC-T who fulfilled the inclusion criteria were randomly allocated to silymarin (n = 15) or placebo (n = 15) groups to receive oral silymarin 140 mg three times a day or placebo tablets, respectively. Fatty liver severity was assessed by liver ultrasound imaging and FibroScan® and also measurement of liver function tests before and after the intervention. Results There was a non-significant trend toward more severe liver involvement in placebo group comparing to the silymarin group after intervention based on ultrasonography (p = 0.083). Besides, in silymarin group, hepatic involvement grade based on ultrasonography considerably reduced after intervention (p = 0.012). However, no difference was found between two groups based on FibroScan and liver function tests. Conclusion Oral administration of silymarin could significantly reduce hepatotoxicity severity after 1 month of treatment in non-metastatic breast cancer patients treated with AC-T regimen.

Prevention of febrile neutropenia by prophylactic use of G-CSF with adjuvant TAC based on risk assessment—Single institute study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10711-10711
Author(s):  
M. K. Chellama ◽  
S. A. Awadhi ◽  
V. Vyas ◽  
J. Nemec ◽  
A. Khodary ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Assessment ◽  
Febrile Neutropenia ◽  
Dose Intensity ◽  
Organ Function ◽  
Prophylactic Use ◽  
To Receive ◽  
Significant Disease ◽  
Disease Free ◽  
Positive Breast Cancer

10711 Background: TAC confers significant disease free and overall survival benefits vs FAC for patients with node positive breast cancer. However TAC is associated with higher incidence of febrile neutropenia. In our study prophylactic G-CSF was used in patients, who developed grade 4 neutropenia with ANC < 100 or febrile neutropenia to prior cycle of TAC. Methods: Following surgery, patients with operable, 1–9 nodes positive breast cancer, ECOG 0–1, and adequate hematologic and organ function were enrolled on to the study, and were to receive TAC day 1 every 3 weeks for 6 cycles . All patients received prophylactic Ciprofloxacin 500-mg bid from days 5–14 after each cycle of chemotherapy unless prophylactic G-CSF was given. Eighty three patients were enrolled during the period 13–1-04 to 30–12–05. Patients who had received at least 2 cycles of TAC were eligible for evaluation. Patients were given prophylactic G-CSF if they had profound neutropenia (ANC < 100) or febrile neutropenia in prior cycle. Results: At the cut-off date for this analysis 79 patients were evaluable. 68 patients had completed the planned 6 cycles of TAC. Three, 2, 3 and 3 patients completed 2, 3, 4 and 5 cycles respectively. Sixty one patients required prophylactic G-CSF - 21 after febrile neutropenia in prior cycle, 39 after profound neutropenia in prior cycle and 1 received from first cycle itself because of post operative seroma with diabetes mellitus. 23 patients developed febrile neutropenia (29.1%) - 3, 8, and 12 after 3, 2 and 1 cycles respectively. Only two patients (3.2%) who received prophylactic G-CSF developed febrile neutropenia. Full dose of TAC could be maintained in 98.6% cycles. Conclusions: The use of G-CSF prophylaxis based on risk assessment could prevent febrile neutropenia in patients, who had profound neutropenia in prior cycle. Also G-CSF could prevent further febrile neutropenia in patients who had developed the same in prior cycle. The above strategy helped in maintaining the dose intensity of TAC. No significant financial relationships to disclose.

A retrospective study of dose-dense adjuvant paclitaxel without G-CSF support in patients with breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20547-e20547
Author(s):  
Anurag Kumar Singh ◽  
Akshiv Malhotra ◽  
Sheila M. Lemke
Keyword(s):  
Breast Cancer ◽  
Standard Of Care ◽  
Liver Function Tests ◽  
Primary Prophylaxis ◽  
Neutropenic Fever ◽  
Her2 Status ◽  
Breast Cancer Patients ◽  
Common Grade ◽  
Hand Foot Syndrome ◽  
Dose Dense

e20547 Background: Dose dense AC (Adriamycin plus Cyclophosphamide) followed by paclitaxel (Pac) given every 2 weeks with Granulocyte-Colony Stimulating factor (G-CSF) support remains the standard of care for adjuvant chemotherapy in newly diagnosed breast cancer patients . Although, the need for growth factor support with AC is clear, its role with dose dense Pac is not so clear. The objective of this retrospective single institution study was to evaluate the need for primary prophylaxis with G-CSF with dose dense Pac. Methods: Data from 115 patients treated at Upstate Medical University from 2005-2012 was collected after IRB approval. All patients received four cycles of dose dense AC (A- 60mg/m2 with C- 600 mg/m2) with G-CSF support on day 2 followed by Pac (175 mg/m2) with no primary G-CSF support. The median age of patients was 48 years. There were 11 patients (10%) with Stage I, 68 (60%) with stage II and 36 (30%) with stage III disease. The prevalence of ER/HER2 status was as follows: ER+/Her2 + (13%), ER+/Her2-(60%), triple negative (26%) and ER-/Her2+ (1%). Results: Only 3 patients (2.6%) in this study population developed neutropenic fever. 109 patients received no G-CSF support and completed a total of 382 doses of Pac (average 3.5). Dose reduction was needed in 6 patients, related to neutropenic fever (n=3), neutropenia without fever (n=2) and severe arthralgia (n=1). A total of 88 patients completed all planned four cycles. Of the 27 patients who got less than the planned 4 cycles, most stopped because of neuropathy (n=17), arthralgia (n=4), hand foot syndrome (n=2), elevated LFTs (n=1), allergic reaction (n=1) and unknown reason (n=1). Most common Grade III/IV toxicity was neuropathy. Dose delays were seen in only 5 patients, 3 related to neutropenia and 2 because of elevated liver function tests. Conclusions: G-CSF has its own side effects, most common being bone pain. G-CSF also adds significantly to climbing costs of oncology care. Although retrospective in nature, this study shows that only a small minority of the patients develop neutropenic complications with dose-dense Pac. Avoiding primary prophylaxis with G-CSF will not only reduce costs but also reduce toxicity that can be additive to Pac toxicity.

Neutrophil-lymphocyte index as prognostic factor for overall survival and disease-free survival in breast cancer patients

2020 ◽  
Vol 33 (4) ◽  
pp. 137-144
Author(s):  
Guillermo Peralta-Castillo ◽  
Antonio Maffuz-Aziz ◽  
Mariana Sierra-Murguía ◽  
Sergio Rodriguez-Cuevas
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Prognostic Factor ◽  
Cancer Patients ◽  
Disease Free Survival ◽  
Breast Cancer Patients ◽  
Free Survival ◽  
Disease Free
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