scholarly journals Phase III Comparison of Standard Doxorubicin and Cyclophosphamide Versus Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus Granulocyte Colony-Stimulating Factor As Neoadjuvant Therapy for Inflammatory and Locally Advanced Breast Cancer: SWOG 0012

2011 ◽  
Vol 29 (8) ◽  
pp. 1014-1021 ◽  
Author(s):  
Georgiana K. Ellis ◽  
William E. Barlow ◽  
Julie R. Gralow ◽  
Gabriel N. Hortobagyi ◽  
Christy A. Russell ◽  
...  

Purpose Patients with inflammatory breast cancer (IBC) or locally advanced breast cancer (LABC) were randomly assigned to 21-day doxorubicin and cyclophosphamide administered for five cycles (standard arm) versus weekly doxorubicin and daily oral cyclophosphamide administered with granulocyte colony-stimulating factor support for 15 weeks (continuous arm). All patients had subsequent weekly paclitaxel for 12 weeks before surgery. Patients and Methods Patients (n = 372) were randomly assigned to the standard arm (n = 186) or the continuous arm (n = 186) stratified by disease type (LABC, n = 256; IBC, n = 116). The primary outcome was microscopic pathologic complete response (pCR) at surgery. Secondary outcomes included disease-free survival, overall survival, and toxicity. Results More patients in the standard arm had grade 3 to 4 leukopenia and neutropenia, but there were more instances of stomatitis/pharyngitis and hand-foot skin reaction in the continuous arm. Assessed among 356 eligible patients, pCR was not different between the treatment groups stratified by disease type (P = .42). In subset analysis, higher pCR rates were observed in the continuous arm versus the standard arm only for stage IIIB disease (P = .0057) and in IBC (P = .06). Comparison of overall survival and disease-free survival showed no difference between treatment groups (P = .37 and P = .87, respectively). Conclusion No significant clinical benefit was seen for the investigational arm in this trial overall.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e12033-e12033
Author(s):  
Tahir Mehmood ◽  
Muhammad Ali ◽  
Kamran Saeed ◽  
Atif Munawar ◽  
Sadaf Usman ◽  
...  

e12033 Background: Pakistan has the highest rate of breast cancer for any South Asian population and majority of the patients present with locally advanced or metastatic disease. We report on response and survival of primary locally advanced non-metastatic breast cancer in women treated with neoadjuvant Adriamycin/Taxanes (AT) based regimens at our institute. Methods: Between 1995 to 2009 the hospital information system identified 517 women with pathologically confirmed locally advanced breast cancer. All patients received neoadjuvant chemotherapy with AT based regimen followed by surgery. Median age was 43 years (range 17-71 years). AJCC stage; stage II 54% and stage III 46% of the patients. Axillary nodes were palpable in 72% of the patients at presentation. Histological sub-types; infiltrating ductal carcinoma 95%, infiltrating lobular carcinoma 3% and others 2% respectively. Pathological grade was I/II in 44% and grade III 56% of the patients. ER, PR, and Her2-neu receptors were positive in 44%, 40% and 24% of the patients respectively. Twenty one percent of the patients had triple negative breast cancer. Post operative radiotherapy was delivered to 94% of the patients. Patients with positive ER/PR receptors also received hormonal manipulation. Results: Following neo-adjuvant chemotherapy, pathological response was; complete response (CR) 13.5%, partial response 21%, stable disease 52% and progressive disease in 13% of the patients respectively. Breast conservation was possible in 36% of the patients. The 5 year disease free survival in patients with and without CR was 81% and 36% respectively. On multivariate analysis, T stage (p = 0.001) and response to neo-adjuvant chemotherapy (p = 0.001) were found to be independent predictors for disease free survival. Conclusions: Pathological response to neoadjuvant chemotherapy is a predictor of long term survival. Chemotherapy regimens with high response rates merit evaluation in randomized trials to improve outcome in locally advanced breast cancer.


2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e11536-e11536 ◽  
Author(s):  
Katerin Ingrid Rojas ◽  
Raymundo Flores ◽  
Claudio J Flores ◽  
Joseph A. Pinto ◽  
Henry Leonidas Gomez ◽  
...  

2016 ◽  
Vol 23 (3) ◽  
pp. 164 ◽  
Author(s):  
S. Lupichuk ◽  
D. Tilley ◽  
X. Kostaras ◽  
A.A. Joy

Purpose We compared the efficacy, toxicity, and use of granulocyte colony–stimulating factor (G-CSF) with TAC (docetaxel–doxorubicin–cyclophosphamide) and FEC-D (5-fluorouracil–epirubicin–cyclophosphamide followed by docetaxel) in women less than 50 years of age.Methods The study included all women more than 18 years but less than 50 years of age with her2-negative, node-positive, stage II or III breast cancer diagnosed in Alberta between 2008 and 2012 who received TAC (n = 198) or FEC-D (n = 274).Results The patient groups were well-balanced, except that radiotherapy use was higher in the TAC group (91.9% vs. 79.9%, p < 0.001). At a median follow-up of 49.6 months, disease-free survival was 91.4% for TAC and 92.0% for FEC-D (p = 0.76). Overall survival (OS) was 96% with TAC and 95.3% with FEC-D (p = 0.86).The incidences of grades 3 and 4 toxicities were similar in the two groups (all p > 0.05). Overall, febrile neutropenia (FN) was reported in 11.6% of TAC patients and 15.7% of FEC-D patients (p = 0.26). However, use of G-CSF was higher in the TAC group than in the FEC-D group (96.4% vs. 71.5%, p < 0.001). Hospitalization for FN was required in 10.5% of TAC patients and 13.0% of FEC-D patients (p = 0.41). In G-CSF–supported and –unsupported patients receiving tac, FN occurred at rates of 11.1% and 33.3% respectively (p = 0.08); in patients receiving the FEC portion of FEC-D, those proportions were 2.9% and 8.1% respectively (p = 0.24); and in patients receiving docetaxel after FEC, the proportions were 4.1% and 17.6% respectively (p < 0.001).Conclusions In women less than 50 years of age receiving adjuvant TAC or FEC-D, we observed no differences in efficacy or other nonhematologic toxicities. Based on the timing and rates of FN, use of prophylactic G-CSF should be routine for the docetaxel-containing portion of treatment; however, prophylactic G-CSF could potentially be avoided during the FEC portion of FEC-D treatment.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11628-e11628
Author(s):  
M. Gumus ◽  
B. O. Ustaalioglu ◽  
M. Seker ◽  
A. Bilici ◽  
T. Salman ◽  
...  

e11628 Background: Neoadjuvant chemotherapy is one of the standard treatment options for patients with locally advanced breast cancer for twenty five years. In this study, we evaluate results of neoadjuvant chemotherapy in breast cancer patients. Methods: We retrospectively analyzed 68 patients with locally advanced breast cancer. Anthracycline/taxane-based chemotherapy regimens were prescribed mostly for neoadjuvant chemotherapy. Before chemotherapy was given, patients were examined for distant metastasis by radiologic methods thereafter if patient had distant metastasis, they were excluded. Patients with breast cancer received neoadjuvant chemotherapy were analyzed according to age, menopausal status, type of surgery, response to the treatment, histopathological properties and survival. After 3 to 6 cycle of chemotherapy patients were reevaluated by clinically and radiologically for response. Surgery was performed for appropriate patient thereafter adjuvant locoregional and systemic chemotherapy were continued. Results: Median age was 47 (29–43) years. 17,6 % of them were younger than 35 years and 42,6 % were premenopausal. Median follow-up time was 19 month. After 3 to 6 cycle of neoadjuvant chemotherapy 64 of patients responded to therapy (94,1 %). Breast conserving surgery was performed for 15,6 % patients. In histopathologic analysis most of patients were invasive ductal carcinoma and there was lymph node invasion for 84,9 %. Estrogen and progesterone receptor status were negative for 18,6 % of patients and cerbB2 was positive for 14,8 % of patients. Median disease free survival time was 44 month (SE: 9; 95% CI: 25–62) but median overall survival time could not be reached. Three years disease free survival rate and overall survival rate were 55,3% and 90,1% respectively. According to Cox regression analyses; we did not find any demographic and pathologic characteristic of breast cancer that is related to prognosis. Conclusions: In recent years neoadjuvant chemotherapy in breast cancer is increasingly being used for early stage disease. Further study will be facilitated establishment of guidelines for preselecting patients for neoadjuvant chemotherapy and will provide beneficial effect on treatment option and survival. No significant financial relationships to disclose.


2011 ◽  
Vol 77 (7) ◽  
pp. 850-855 ◽  
Author(s):  
Raeshell S. Sweeting ◽  
Nancy Klauber-Demore ◽  
Michael O. Meyers ◽  
Allison M. Deal ◽  
Emily M. Burrows ◽  
...  

Women with locally advanced breast cancer (LABC) who are breast conservation (BCT) candidates after neoadjuvant chemotherapy have the best long-term outcome and low local-regional recurrence (LRR) rates. However, young women are thought to have a higher risk of LRR based on historical data. This study sought to evaluate LRR rates in young women who undergo BCT after neoadjuvant chemotherapy. We identified 122 women aged 45 years or younger with American Joint Committee on Cancer (AJCC) Stage II to III breast cancer, excluding T4d, treated with neoadjuvant chemotherapy from 1991 to 2007 from a prospective, Institutional Review Board-approved, single-institution database. Data were analyzed using Fisher eExact test, Wilcoxon tests, and the Kaplan-Meier method. Median follow-up was 6.4 years. Fifty-four (44%) patients had BCT and 68 (56%) mastectomy. Forty-six per cent were estrogen receptor-positivity and 28 per cent overexpressed Her2. Mean pretreatment T size was 5.6 cm in the BCT group and 6.7 cm in the mastectomy group ( P = 0.04). LRR rates were no different after BCT compared with mastectomy (13 vs 18%, P = 0.6). Higher posttreatment N stage ( P < 0.001) and AJCC stage ( P = 0.008) were associated with LRR but not pretreatment staging. Disease-free survival was better for patients achieving BCT, with 5-year disease-free survival rates of 82 per cent (95% CI, 69 to 90%) compared with 58 per cent (95% CI, 45 to 69%) for mastectomy ( P = 0.03). Young women with LABC who undergo BCT after neoadjuvant chemotherapy appear to have similar LRR rates compared with those with mastectomy. This suggests that neoadjuvant chemotherapy may identify young women for whom BCT may have an acceptable risk of LRR.


1997 ◽  
Vol 15 (8) ◽  
pp. 2873-2881 ◽  
Author(s):  
S D Merajver ◽  
B L Weber ◽  
R Cody ◽  
D Zhang ◽  
M Strawderman ◽  
...  

PURPOSE To determine whether breast conservation and prolonged neoadjuvant chemotherapy have efficacy in locally advanced breast cancer (LABC), as measured by survival and rate of breast conservation. MATERIALS AND METHODS Eighty-nine patients with stage III disease were enrolled at the University of Michigan (UM) onto a prospective nonrandomized trial. Patients received nine 21-day cycles of neoadjuvant chemohormonal therapy that consisted of doxorubicin 30 mg/m2 and cyclophosphamide 750 mg/m2 intravenously on day 1, conjugated estrogens 0.625 mg orally twice daily on days 6 to 8, methotrexate 40 mg/m2 and fluorouracil 500 mg/m2 intravenously on day 8, and tamoxifen 10 mg orally twice daily on days 9 to 14. Patients with a negative biopsy received radiation only, while those with residual disease underwent mastectomy and postoperative radiotherapy. Eight more cycles of chemohormonal therapy were administered after local-regional therapy. RESULTS The clinical response rate to neoadjuvant therapy was 97%, 28% of patients had a complete pathologic response evaluated at biopsy. Five-year overall and disease-free survival probabilities were 54% and 44%, respectively. The median disease-free survival time was 2.4 years. The 5-year actuarial rates of local-regional control with local failure as only first failure were 82% and 78% following radiotherapy, and mastectomy and radiotherapy, respectively (P = .99). CONCLUSION Prolonged neoadjuvant chemohormonal therapy and biopsy-driven local therapy have efficacy in LABC, with 28% of patients being candidates for breast conservation and a 5-year overall survival rate of 54%.


2021 ◽  
Vol 4 (2) ◽  
pp. 219-239
Author(s):  
Aan Setiawan ◽  
Mulawan Umar ◽  
Erial Bahar

Background: Post Chemotherapy Ki67 in recent year has been investigated as a predictive and prognostic factor in locally advanced breast cancer patient undergoing neoadjuvant chemotherapy. Objectives: To describe the relationship between post-chemotherapy Ki67 and disease-free survival after neoadjuvant chemotherapy in patients with locally advanced breast cancer at Dr. Hospital. Mohammad Hoesin Palembang. Methods: This study is an analytical observational study with prognostic test design conducted in 30 stage III B breast cancer patient. A retrospective search of a prospectively maintained clinical database was performed to identify patient treated with neoadjuvant chemotherapy at the Mohammad Hoesin Hospital. The expression of Ki67 was assessed using immunohisto-chemistry in post therapy surgical excision specimen. Results: From 30 patients, there was a significant relationship between Post Chemotherapy Ki67 and disease- free survival in patients with locally advanced breast cancer (r = -0,742, p = 0.000). The cut off point value of Ki67 was 27,5% with an area under curve (AUC) of 0,716. The results of the post-chemotherapy Ki67 prognosis test included sensitivity 64%, specificity 60%, Positive Predictive Value 88,9%, Negative Predictive Value 25%, accuracy 63,3%. Conclusion: There is a significant relationship between Post Chemotherapy Ki67 to disease free survival and Post Chemotherapy Ki67 can be used as a prognostic biomarker in breast carcinoma patients undergoing neoadjuvant chemotherapy.


Sign in / Sign up

Export Citation Format

Share Document