Sequential epirubicin-docetaxel-CMF as adjuvant therapy of early breast cancer: Results of the Taxit216 multicenter phase III trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. LBA520-LBA520 ◽  
Author(s):  
A. R. Bianco ◽  
A. De Matteis ◽  
L. Manzione ◽  
C. Boni ◽  
S. Palazzo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Early Breast Cancer ◽  
Estrogen Receptor Status ◽  
Menopausal Status ◽  
Disease Free Survival ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Combination Regimen

LBA520 Background: Docetaxel is among the most active drugs for advanced breast cancer and it has recently shown efficacy in the adjuvant setting too. This trial is aimed at comparing the efficacy and tolerability of a sequential approach of a chemotherapy combination regimen containing docetaxel to a standard anthracycline-based regimen as adjuvant therapy in node-positive (N+) early breast cancer. Methods: Between July 1998 and July 2002, 972 N+ early breast cancer patients were randomized to either arm A (E→CMF): Epirubicin (E) 120 mg/m2 iv d1 q21 × 4 cycles followed by Cyclophosphamide 600 mg/m2 iv, Methotrexate 40 mg/m2 iv and Fluorouracil 600 mg/m2 iv (CMF) d1,8 q28 × 4 cycles; or armB (E→T→CMF) in which Docetaxel 100 mg/m2 iv (T) d1 q21 × 4 cycles was administered after the 4th cycle of E and before the 1st cycle of CMF. Treatment allocation was performed by a computer program using a dynamic balancing algorithm. Balancing factors were: center, lymph node involvement (1 to 3, 4 to 9, >10), estrogen receptor status (negative/positive/unknown), menopausal status (pre/post). During chemotherapy pts were subjected to physical examination and blood chemistry tests every 3 wks, hematology was repeated weekly. At the completion of treatment pts were followed up every 3 months for the first 2 years, every 6 months for years 3–5 and every 12 months for years 6–10. Primary endpoint was disease free survival (DFS) and secondary endpoints were tolerability and overall survival (OS). The study was designed to detect a hazard ratio of 0.70, assuming an α of 0.05 (two sided), a power of 0.80 and an expected DFS in Arm A of 0.65 at 5 years. This required 480 pts per Arm and 250 events. Results: As of March 27th 2006, 486 pts were enrolled in arm A and 486 in arm B, 252 primary events were recorded and the median follow up was 53 months. DFS at 5 years was 0.67 in arm A vs 0.74 in arm B with an estimated Hazard Ratio (HR) of 0.80 (95% CI: 0.62–1.03, p = 0.079). After adjustement by predefined balancing factors (ER, Nodal and menopausal status) the HR was 0.78 (95% CIs: 0.61–1.00; p = 0.05). As for OS, 117 deaths were observed with HR of 0.74 (95% CIs: 0.51–1.07, p = 0.10). Conclusions: Sequential E→T→CMF yields a borderline significant improvement of DFS. Follow up update is still ongoing. [Table: see text]

10-year update of E2197: Phase III doxorubicin/docetaxel (AT) versus doxorubicin/cyclophosphamide (AC) adjuvant treatment of LN+ and high-risk LN- breast cancer and the comparison of the prognostic utility of the 21-gene recurrence score (RS) with clinicopathologic features.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1021-1021 ◽  
Author(s):  
Joseph A. Sparano ◽  
Anne O'Neill ◽  
Robert James Gray ◽  
Edith A. Perez ◽  
Lawrence N. Shulman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Menopausal Status ◽  
Disease Free Survival ◽  
Recurrence Score ◽  
Phase Iii ◽  
Clinicopathologic Characteristics ◽  
Accurate Predictor ◽  
Gene Assay ◽  
Node Positive Disease

1021 Background: At 5 years, AT did not improve disease free survival or overall survival and RS was a more accurate predictor of relapse than standard clinicopathologic characteristics for patients with hormone receptor (HR) positive tumors. Methods: A Phase III Intergroup trial tested adjuvant AT vs. AC. Women with 1-3 N + or N - and T-size > 1cm were randomized to 4 cycles of AT (60 mg/m2/60 mg/ m2) or AC (60 mg/m2/600 mg/m2) q 3 wk x 4. Patients(pts) with ER + and/ or PR + tumors received tam for 5 yrs. Pts were stratified by nodal, HR (ER+ PR+, ER+PR-, ER-PR+, ER-PR-, ER/PR unk) and menopausal status. The primary endpoint was DFS. A sample of 465 pts with HR + breast cancer with 0 to 3 positive axillary nodes who did (N =116) or did not have a recurrence had tumor tissue evaluated using the 21- gene assay. Grade and HR expression were evaluated locally and centrally. Results: 2952 pts were randomized between 7/30/98 and 1/21/00. 2883 were eligible and analyzable. Arms were balanced for age, HR, menopause, nodes, surgery, grade and T-size: median age 51; 64% ER +; 65% LN-; grade: 10% low, 38% int., 46% high; and median T-size - 2.0 cm. At a median follow-up of 11.5 years the DFS/OS results are shown in the table below. RS was a highly significant predictor of recurrence including node negative and node positive disease (P < .0001) and predicted recurrence more accurately than clinical variables. Conclusions: At 11.5 yrs. median follow-up, there remains no difference in DFS or OS, although there continue to be fewer events in the AT arm in the prespecified ER/PR negative subgroup. At 10 years, the RS continues to be a more accurate predictor of relapse than standard clinical features. [Table: see text]

Evaluation of prevalence, number, and temporal changes of circulating tumor cells as assessed after 2 and 5 years of follow-up in patients with early breast cancer in the SUCCESS A study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 11042-11042 ◽  
Author(s):  
Emanuel C. A. Bauer ◽  
Julia Katharina Neugebauer ◽  
Ulrich Andergassen ◽  
Bernadette Jaeger ◽  
Julia Kathrin Jueckstock ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Tumor Cells ◽  
Circulating Tumor Cells ◽  
Early Breast Cancer ◽  
Disease Free Survival ◽  
Primary Diagnosis ◽  
Temporal Changes ◽  
Phase Iii ◽  
Time Points

11042 Background: Recent studies revealed that temporal changes in circulating tumor cells (CTC) prevalence assessed before and immediately after adjuvant chemotherapy (CT) might indicate treatment response in early breast cancer (EBC). However, there is limited knowledge on CTC status one or more years after chemotherapy treatment. Here we present descriptive data on CTC status prospectively evaluated 2 and 5 years after primary diagnosis in the German SUCCESS A study. Methods: The SUCCESS A trial is a large, randomized, open-label, 2x2 factorial design Phase III study comparing disease free survival (DFS) in patients with EBC treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide (FEC) followed by either 3 cycles of Docetaxel (D) or 3 cycles of Gemcitabine-Docetaxel (DG), and comparing DFS in patients treated with 2 years or 5 years of Zoledronate. CTC status at various time points was assessed using the FDA-approved CellSearch System (Veridex, USA). Results: Data on CTC status both at 2 years and at 5 years after primary diagnosis were available for 983 (26.2%) out of 3754 randomized patients. After 2 and 5 years, CTCs were found in 132 (13.4%; median 1; range 1 – 99) and 88 (9.0%; median 1; range 1 – 60) patients, respectively. The majority of patients (n = 779; 79.2%) had no CTCs at any of the two time points. CTCs were found at 2 years but not at 5 years after primary diagnosis in 116 (11.8%) patients, at 5 years but not at 2 years of follow-up in 72 (7.3%) patients, and both at 2 and at 5 years of follow-up in 16 (1.6%) patients. Conclusions: CTCs in peripheral blood were detected in a subset of early breast cancer patients without relapse up to five years after primary diagnosis. These CTCs may indicate the presence of occult “dormant” micrometastases.

Computer Program to Assist in Making Decisions About Adjuvant Therapy for Women With Early Breast Cancer

2001 ◽  
Vol 19 (4) ◽  
pp. 980-991 ◽  
Author(s):  
Peter M. Ravdin ◽  
Laura A. Siminoff ◽  
Greg J. Davis ◽  
Mary Beth Mercer ◽  
Joan Hewlett ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Computer Program ◽  
Early Breast Cancer ◽  
Treatment Guidelines ◽  
Tumor Staging ◽  
Menopausal Status ◽  
Disease Free Survival ◽  
Term Survival ◽  
Project Outcomes

PURPOSE: The goal of the computer program Adjuvant! is to allow health professionals and their patients with early breast cancer to make more informed decisions about adjuvant therapy. METHODS: Actuarial analysis was used to project outcomes of patients with and without adjuvant therapy based on estimates of prognosis largely derived from Surveillance, Epidemiology, and End-Results data and estimates of the efficacy of adjuvant therapy based on the 1998 overviews of randomized trials of adjuvant therapy. These estimates can be refined using the Prognostic Factor Impact Calculator, which uses a Bayesian method to make adjustments based on relative risks conferred and prevalence of positive test results. RESULTS: From the entries of patient information (age, menopausal status, comorbidity estimate) and tumor staging and characteristics (tumor size, number of positive axillary nodes, estrogen receptor status), baseline prognostic estimates are made. Estimates for the efficacy of endocrine therapy (5 years of tamoxifen) and of polychemotherapy (cyclophosphamide/methotrexate/fluorouracil–like regimens, or anthracycline-based therapy, or therapy based on both an anthracycline and a taxane) can then be used to project outcomes presented in both numerical and graphical formats. Outcomes for overall survival and disease-free survival and the improvement seen in clinical trials, are reasonably modeled by Adjuvant!, although an ideal validation for all patient subsets with all treatment options is not possible. Additional speculative estimates of years of remaining life expectancy and long-term survival curves can also be produced. Help files supply general information about breast cancer. The program’s Internet links supply national treatment guidelines, cooperative group trial options, and other related information. CONCLUSION: The computer program Adjuvant! can play practical and educational roles in clinical settings.

Randomized, Phase III Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin Alone in Postmenopausal Patients With Node-Positive Breast Cancer

2011 ◽  
Vol 29 (24) ◽  
pp. 3247-3254 ◽  
Author(s):  
R. Charles Coombes ◽  
Judith M. Bliss ◽  
Marc Espie ◽  
Frans Erdkamp ◽  
Jacob Wals ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Postmenopausal Women ◽  
Early Breast Cancer ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Node Positive

Purpose The Docetaxel Epirubicin Adjuvant (DEVA) trial evaluated the efficacy and toxicity of incorporating docetaxel after epirubicin to create a sequential anthracycline-taxane regimen in early breast cancer. Patients and Methods After complete tumor excision, postmenopausal women with node-positive early breast cancer were randomly assigned to either epirubicin 50 mg/m2 on days 1 and 8 every 4 weeks for six cycles (EPI × 6) or three cycles of epirubicin 50 mg/m2 on days 1 and 8 every 4 weeks followed by three cycles of docetaxel 100 mg/m2 on day 1 every 3 weeks (EPI-DOC). A subset of patients also participated in a quality of life (QOL) study. The primary end point was disease-free survival (DFS). Results From 1997 to 2005, 803 patients entered DEVA (EPI × 6, n = 397; EPI-DOC, n = 406). At a median follow-up of 64.7 months (interquartile range, 45.2 to 84.4 months), 198 DFS events had been reported (EPI × 6, n = 114; EPI-DOC, n = 84). The 5-year DFS rates were 72.7% (95% CI, 68.0% to 77.3%) for epirubicin alone and 79.5% (95% CI, 75.2% to 83.8%) for epirubicin followed by docetaxel; evidence of improvement in DFS was observed with EPI-DOC (hazard ratio [HR], 0.68; 95% CI, 0.52 to 0.91; P = .008). One hundred twenty-seven patients have died (EPI × 6, n = 75; EPI-DOC, n = 52); a reduction in deaths was observed with EPI-DOC (HR, 0.66; 95% CI, 0.46 to 0.94; P = .02). The 5-year overall survival rates were 81.8% (95% CI, 77.7% to 85.9%) for epirubicin and 88.9% (95% CI, 85.5% to 92.2%) for epirubicin followed by docetaxel. Assessment of toxicity and QOL showed that EPI-DOC was associated with greater toxicity but with no difference in QOL between arms during follow-up. Conclusion These results suggest, within a relatively small trial, that substitution of docetaxel for epirubicin for the last three cycles of chemotherapy results in improved outcome in postmenopausal women with node-positive, early breast cancer compared with six cycles of epirubicin monotherapy.

Trastuzumab use and survival in HER2 (+) nonmetastatic breast cancer among Turkish women.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 56-56
Author(s):  
M. Kayahan ◽  
H. Kadioglu ◽  
M. Muslumanoglu ◽  
A. Igci ◽  
V. Ozmen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Histological Grade ◽  
Menopausal Status ◽  
Disease Free Survival ◽  
Metastatic Breast ◽  
Her2 Overexpression ◽  
Cardiac Side Effects ◽  
Significant Difference

56 Background: HER2 overexpression observed in 10-25% of breast cancers is associated with rapid proliferation. HER2-targeted trastuzumab has been used in metastatic breast cancer, and since 2004 in early breast cancer. However, trastuzumab therapy is expensive and long lasting resulting sometimes in cardiac side effects. In this study we tried to find out whether there was a subgroup of early breast cancer patients trastuzumab could be omitted. Methods: Records of patients treated for HER2-positive breast cancer in Istanbul Medical School between Jan 2000 and Sept 2009 were retrospectively evaluated. Disease-free survival (DFS) and overall survival (OS) were calculated either from follow-ups, or by calling. Kaplan meier and LogRank tests have been used for comparison (P<0.05, 95% CI). Results: Follow up period was 32.2±14.9mo for trastuzumab group (TG, n:87) compared to 47.4±20.8mo for non-trastuzumab group (NTG, n:63) (P=0.0001). Groups were similar for age, menopausal status, size (T), histological grade and type, location, hormone responsiveness, presence of lymphovascular invasion, surgery, and use of local/systemic/hormonal therapy. NTG had more N0 cases (44.4% vs. 12.6%, P=0.0001), breast related deaths (15.9% vs. 5.7%, P=.042) and systemic metastases (27% vs. 13.8%, P=.043). Number of local recurrences was similar. Mean DFS and OS were significantly less in TG (P<0.0001). However differences between DFS and OS of groups were not significant despite a considerable increase for both in TG at fifth year (P=0.147, P=0.450). No difference in DFS and OS between TG and NTG was observed when patients who had chemotherapy and/or radiotherapy and/or hormonotherapy were compared to those who did not. OS was not different between TG and NTG for T1, T2, and T3 tumors and for patients ≤35y. But in N2 and N3 tumors, use of trastuzumab increased OS significantly (P=0.007). Conclusions: Both number of events and systemic relapses were less in TG but we could not find a significant difference in DFS and OS between TG and NTG in Turkish nonmetastatic cancers. Prolonged follow up might be necessary to search for the subgroup who would not benefit, if any, as an incremental benefit in both DFS and OS was observed with trastuzumab use at fifth year.

scholarly journals Sequential Versus Concurrent Trastuzumab in Adjuvant Chemotherapy for Breast Cancer

2011 ◽  
Vol 29 (34) ◽  
pp. 4491-4497 ◽  
Author(s):  
Edith A. Perez ◽  
Vera J. Suman ◽  
Nancy E. Davidson ◽  
Julie R. Gralow ◽  
Peter A. Kaufman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Growth Factor Receptor ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Phase Iii ◽  
P Value ◽  
Sequential Administration ◽  
Taxane Chemotherapy

Purpose NCCTG (North Central Cancer Treatment Group) N9831 is the only randomized phase III trial evaluating trastuzumab added sequentially or used concurrently with chemotherapy in resected stages I to III invasive human epidermal growth factor receptor 2–positive breast cancer. Patients and Methods Patients received doxorubicin and cyclophosphamide every 3 weeks for four cycles, followed by paclitaxel weekly for 12 weeks (arm A), paclitaxel plus sequential trastuzumab weekly for 52 weeks (arm B), or paclitaxel plus concurrent trastuzumab for 12 weeks followed by trastuzumab for 40 weeks (arm C). The primary end point was disease-free survival (DFS). Results Comparison of arm A (n = 1,087) and arm B (n = 1,097), with 6-year median follow-up and 390 events, revealed 5-year DFS rates of 71.8% and 80.1%, respectively. DFS was significantly increased with trastuzumab added sequentially to paclitaxel (log-rank P < .001; arm B/arm A hazard ratio [HR], 0.69; 95% CI, 0.57 to 0.85). Comparison of arm B (n = 954) and arm C (n = 949), with 6-year median follow-up and 313 events, revealed 5-year DFS rates of 80.1% and 84.4%, respectively. There was an increase in DFS with concurrent trastuzumab and paclitaxel relative to sequential administration (arm C/arm B HR, 0.77; 99.9% CI, 0.53 to 1.11), but the P value (.02) did not cross the prespecified O'Brien-Fleming boundary (.00116) for the interim analysis. Conclusion DFS was significantly improved with 52 weeks of trastuzumab added to adjuvant chemotherapy. On the basis of a positive risk-benefit ratio, we recommend that trastuzumab be incorporated into a concurrent regimen with taxane chemotherapy as an important standard-of-care treatment alternative to a sequential regimen.

scholarly journals Adding pertuzumab to adjuvant therapy for high-risk HER2-positive early breast cancer in APHINITY: a GRADE analysis

2020 ◽  
Vol 9 (6) ◽  
pp. 423-430 ◽  
Author(s):  
Alberto Zambelli ◽  
Giovanni Pappagallo ◽  
Paolo Marchetti
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Early Breast Cancer ◽  
Disease Free Survival ◽  
Invasive Disease ◽  
Her2 Positive ◽  
Free Survival ◽  
Distant Relapse ◽  
Disease Free

Aim: Adding pertuzumab to standard trastuzumab-based adjuvant therapy significantly improved invasive disease-free survival (IDFS) in the APHINITY trial. However, the magnitude of benefit was marginal in the overall population. Methods: We used GRADE (Grading of Recommendations Assessment, Development and Evaluation) analysis on data from APHINITY to build summary-of-findings tables to evaluate the efficacy, safety and quality of evidence of predefined clinical outcomes for the addition of pertuzumab to trastuzumab-based adjuvant therapy in patients with high-risk HER2-positive early breast cancer. Results: Pertuzumab significantly improved 3-year, event-free, absolute benefit in disease-free survival, IDFS and distant relapse-free interval (DFRI) in patients with node-positive or hormone receptor-negative disease. The analysis provides strength of evidence supporting the addition of pertuzumab in this patient population.

Long-Term Benefits of 5 Years of Tamoxifen: 10-Year Follow-Up of a Large Randomized Trial in Women at Least 50 Years of Age With Early Breast Cancer

2011 ◽  
Vol 29 (13) ◽  
pp. 1657-1663 ◽  
Author(s):  
Allan Hackshaw ◽  
Michael Roughton ◽  
Sharon Forsyth ◽  
Kathryn Monson ◽  
Krystyna Reczko ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Contralateral Breast Cancer ◽  
Disease Free Survival ◽  
Contralateral Breast ◽  
Free Survival ◽  
Free Data ◽  
Cv Disease

Purpose The Cancer Research UK “Over 50s” trial compared 5 and 2 years of tamoxifen in women with early breast cancer. Results are reported after median follow-up of 10 years. Patients and Methods Between 1987 and 1997, 3,449 patients age 50 to 81 years with operable breast cancer who had been taking 20 mg of tamoxifen for 2 years were randomly assigned to either stop or continue for an additional 3 years, if they were alive and recurrence free. Data on recurrences, new tumors, deaths, and cardiovascular events were obtained (April 2010). Results There were 1,103 recurrences, 755 deaths as a result of breast cancer, 621 cardiovascular (CV) events, and 236 deaths as a result of CV events. Fifteen years after starting treatment, for every 100 women who received tamoxifen for 5 years, 5.8 fewer experienced recurrence, compared with those who received tamoxifen for 2 years. The risk of contralateral breast cancer was significantly reduced (hazard ratio, 0.70; 95% CI, 0.48 to 1.00). Among women age 50 to 59 years, there was a 35% reduction in CV events (P = .005) and 59% reduction in death as a result of a CV event (P = .02); in older women, the effect was much smaller and not statistically significant. Conclusion Taking tamoxifen for the recommended 5 years reduces the risk of recurrence or contralateral breast cancer 15 years after starting treatment. It also lowers the risk of CV disease and death as a result of a CV event, particularly among those age 50 to 59 years. Women should therefore be encouraged to complete the full course. Although aromatase inhibitors improve disease-free survival, tamoxifen remains a cheap and highly effective alternative, particularly in developing countries.

Phase III study of doxorubicin-cyclophosphamide followed by paclitaxel or docetaxel given every 3 weeks or weekly in operable breast cancer: Results of Intergroup Trial E1199

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 516-516 ◽  
Author(s):  
J. A. Sparano ◽  
M. Wang ◽  
S. Martino ◽  
V. Jones ◽  
E. Perez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Axillary Lymph ◽  
Free Survival ◽  
Significant Difference ◽  
Phase Iii Study ◽  
Grade 3

516 Background: Evidence suggests that docetaxel is more effective than paclitaxel, and paclitaxel is more effective when given weekly than every 3 weeks in metastatic breast cancer (BC). Methods: Eligibility included axillary lymph node positive or high-risk (tumor at least 2 cm) node-negative BC. All patients received 4 cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) every 3 weeks, followed by either: (1) paclitaxel 175 mg/m2 every 3 weeks × 4 (P3), (2) paclitaxel 80 mg/m2 weekly × 12 (P1), (3) docetaxel 100 mg/m2 every 3 weeks × 4 (D3), or (4) docetaxel 35 mg/m2 weekly × 12 (D1). The primary comparisons included taxane (P vs. D) and schedule (every 3 weeks vs. weekly), and secondary comparisons included P3 vs. other arms. The trial had 86% power to detect a 17.5% decrease in disease-free survival (DFS) for either primary comparison, and 80% power to detect a 22% decrease for the secondary comparisons (2-sided nomimal 5% level tests corrected for multiple comparisons). Results: A total of 4,950 eligible patients were accrued. There was no difference in the primary comparisons afer 856 DFS events and 483 deaths after a median follow-up of 46.5 months at the 4th interim analysis ( www.sabcs.org , abstract 48). This is the final pre-specified analysis for the primary comparisons after 1,042 DFS events and 650 deaths (with 1,020 DFS events at this time, to be updated at the meeting). After a median followup of 60.2 months, there remains no significant difference in the hazard ratio (HR) for the taxane (1.02; p=0.73) or schedule (1.07; p=0.30) (as in the first analysis). In secondary comparisons of the standard arm (P3) with the other arms (HR > 1 favoring the experimental arms), the HRs were 1.30 (p = 0.003) for arm P1, 1.24 (p=0.02) for arm D3, and 1.09 (p=0.33) for arm D1. Analysis of interaction by hormone-receptor status will be presented. The incidence of worst grade toxicity (grade 3/4) was 24%/6% for arm P3, 24%/3% for arm P1, 21%/50% for arm D3, and 38%/6% for arm D1. Conclusions: There were no differences in DFS when comparing taxane or schedule overall. DFS was significantly improved in the weekly paclitaxel and every 3-week docetaxel arms compared with the every 3-week paclitaxel arm. [Table: see text]

Clinical significance of proliferative activity evaluated by MIB-1 in the treatment and postoperative follow-up of early breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21054-21054
Author(s):  
R. Nishimura ◽  
N. Arima
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Recurrence Rate ◽  
Clinical Significance ◽  
Proliferative Activity ◽  
Disease Free Survival ◽  
Her2 Status ◽  
City Hospital ◽  
Mib 1

21054 Background: To evaluate a clinical significance of proliferative activity in breast cancer, we studied relationships between proliferative activity and recurrence rate, the time of recurrence or adjuvant therapy. Methods: We analyzed 2448 patients with primary breast cancer between 1987 and 2004 in the Kumamoto City Hospital, and 437 cases out of the patients developed recurrence. Furthermore, the rate of recurrence before and after 1999 when postoperative adjuvant therapy (such as CEF or Taxanes) was started as standard treatment was investigated. Proliferative activity was judged by immunostaining for MIB-1. The fraction of proliferating cells was classified into 3 degrees (=19%, 20–49%, 50%=). Median observation period was 70 months. Results: 1) Distribution of patients by proliferation was as follows; =19%:1215 cases(50%), 20–49%: 870 cases(35%), or 50%=: 363 cases(15%). There was a significant relationship between proliferative activity and tumor size, nodal status, ER, PgR, p53 or HER2 status. 2) Multivariate analysis for disease-free survival revealed that a proliferative activity was one of significant factors in node-negative and positive cases. Recurrence rate was 11.6% in cases with low proliferation and 31.0% in high proliferation. The mean period from operation to recurrence in cases with low proliferation was 50.2 months, whereas 19.9 months in high proliferation (p<0.0001). Moreover, 74% of recurrent cases with high proliferation recurred within 2 years after operation, and there were few recurrences from the fifth year. 3) Patients with low proliferation frequently developed bone metastasis. In local recurrence, diffuse skin recurrence was often seen in cases with high proliferation. 4) The prognosis of patients in the later period (standard therapy group) was significantly better than that of patients in the earlier period, especially in high proliferation group. Conclusions: Proliferative activity might reflect aggressive behavior of breast cancer and predict the time of recurrence. The standard adjuvant therapy was effective in inhibiting early recurrence with high proliferation. It is important to take proliferative activity into consideration in the treatment and follow-up of breast cancer. No significant financial relationships to disclose.

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