Phase III adjuvant trial of concurrent epirubicin/taxane vs. sequential epirubicin/cyclophosphamide followed by taxane for node positive breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 573-573 ◽  
Author(s):  
R. Lambert-Falls ◽  
M. A. Deutsch ◽  
C. Desch ◽  
K. Zhou ◽  
E. Perez
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Free Survival ◽  
Adjuvant Trial ◽  
Significance Level ◽  
Her 2 ◽  
Sequential Combination ◽  
To Receive

573 Background: This study evaluates whether concurrent epirubicin/taxane (ET) improves disease-free survival (DFS) at 3 yrs compared to the sequential combination of epirubicin/cyclophosphamide followed by a taxane (EC>T) in pts with operable node (+) breast cancer. Methods: Eligible pts were randomized to receive either ET (E 75 mg/m 2) for 8 cycles q21 days or EC>T (E 90 mg/m 2, C 600 mg/m2) for 4 cycles, followed by 4 cycles of a taxane q21 days. Choice of T (paclitaxel 175 mg/m2 or docetaxel 75 mg/m 2) was at the physician’s discretion. The primary endpoint is DFS. A 0.10 increase in the probability of DFS at 3 yrs for the ET arm would be considered clinically relevant. To detect 82 events, 300 subjects per arm are required to provide 90% power at 5% significance level. Results: 617 pts were enrolled from Nov 2000 to June 2003; 308 pts received ET and 309 pts received EC>T. Both treatment arms were well balanced with respect to age, nodal+, ER status, Her-2+ and PS; median age 52.5 (42%<50 years old); 70% ER+; 61% LN (1–3); 16% Her-2+; 87% PS 0. Total of 2206 cycles of treatment were given to ET compared 2314 cycles of treatment to EC>T. At 30 months of median follow-up there were DFS 102 events occurred; 47 events in ET arm (16%) and 55 events in EC>T arm (18%); 63 total deaths; 29 deaths in ET arm and 34 deaths in EC>T arm. The most common toxicities include alopecia (50%), fatigue (31%), nausea and vomiting (30%), dyspepsia (27%), febrile neutropenia (15%), constipation (12%), diarrhea (10%), arthralgia (11%), stomatitis (10%). In cardiac safety f/u, only one pt in ET arm remained LVEF drop >15. Conclusions: Epirubicin can be combined with taxanes in both sequential and concurrent therapies and both regimens are effective and well tolerated. The study is sponsored by Pfizer Inc. No significant financial relationships to disclose.

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]

Effect of consolidation with arsenic trioxide (As2O3) on event-free survival (EFS) and overall survival (OS) among patients with newly diagnosed acute promyelocytic leukemia (APL): North American Intergroup Protocol C9710

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
B. L. Powell
Keyword(s):  
Disease Free Survival ◽  
Patient Characteristics ◽  
Phase Iii ◽  
Remission Induction ◽  
Cooperative Groups ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Phase Iii Study ◽  
To Receive

2 Background: This randomized phase III study was designed to evaluate the benefit and toxicity of two 25-day courses of As2O3 as first post-remission therapy for newly diagnosed patients with APL. Methods: Adult patients were randomized to receive 2 courses of As2O3 (0.15 mg/kg/d for 5d each wk for 5 wk) as a first consolidation if they achieved remission (CR or PR) after induction with oral tretinoin (ATRA; 45 mg/m2/d), daunorubicin (50 mg/m2 IV × 4d), and cytarabine (200 mg/m2 CIV × 7d); by study design, all but 2 children were assigned to the non-As2O3 arm. Subsequent consolidation on both arms included 2 courses of ATRA (45 mg/m2 × 7d) + daunorubicin (50 mg/m2 × 3d; 2d for age < 15 yr). CR patients were then randomized to 1 yr of ATRA maintenance (7d repeated every other wk) with or without 6- mercaptopurine (daily) + methotrexate (weekly). Results: 518 adults (15–79 yr) and 64 children (<15 yr; 11%) with untreated APL were enrolled by 5 cooperative groups (CALGB, ECOG, SWOG, COG, NCIC-CTG). Eligibility required demonstration of PML-RARA in one of 3 central labs; 37 adults and 7 children were ineligible and not included in the analyses. Patient characteristics and toxicity data have been reported (ASH 2006; Blood 108:171a). Median follow up is now 29 mos. Overall CR rate for adults was 89% and did not differ by treatment arm; CR rate for children was 89%. There were 41 deaths (8%) within 60 days. EFS, the primary endpoint, was 77% at 3 yrs on the As2O3 arm (median, not reached) compared to 59% at 3 yrs on the standard arm (median, 63 mos; p=0.0013). Overall, 84% of adults were alive at last follow up. OS was 86% at 3 yrs on the As2O3 arm compared to 77% at 3 yrs on the standard arm (medians not reached; p=0.029); EFS and OS for pediatric patients did not differ statistically from the adult arm without As2O3. Among 452 CR pts, there have been only 71 post-CR events (16%) so disease- free survival has not yet been analyzed by treatment arm. Conclusion: The addition of 2 courses of As2O3 consolidation following remission induction significantly improves EFS and OS in adults with APL. No significant financial relationships to disclose.

Adjuvant Cyclophosphamide and Docetaxel With or Without Epirubicin for Early TOP2A-Normal Breast Cancer: DBCG 07-READ, an Open-Label, Phase III, Randomized Trial

2017 ◽  
Vol 35 (23) ◽  
pp. 2639-2646 ◽  
Author(s):  
Bent Ejlertsen ◽  
Malgorzata K. Tuxen ◽  
Erik Hugger Jakobsen ◽  
Maj-Britt Jensen ◽  
Ann Soegaard Knoop ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Normal Breast ◽  
Phase Iii ◽  
Open Label ◽  
Distant Disease ◽  
Free Survival ◽  
Open Label Phase ◽  
Disease Free

Purpose Administration of anthracycline and taxane therapy in the adjuvant setting is considered a standard for breast cancer. We evaluated a non–anthracycline-based regimen in TOP2A-normal patients. Patients and Methods In this multicenter, open-label, phase III trial, 2,012 women with early TOP2A-normal breast cancer and at least one high-risk factor were randomly assigned to receive six cycles of docetaxel (75 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks (DC) or three cycles of epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) followed by three cycles of docetaxel (100 mg/m2; EC-D). The primary end point was disease-free survival (DFS) after a median of 5 years of follow-up. Secondary end points were patient-reported toxicity, overall survival (OS), and distant disease–free survival. Results At a median estimated potential follow-up of 69 months, 5-year DFS was 87.9% (95% CI, 85.6% to 89.8%) in the EC-D arm and 88.3% (95% CI, 86.1% to 90.1%) in the DC arm. There was no significant difference in the risk of DFS events (hazard ratio [HR], 1.00; 95% CI, 0.78 to 1.28; P = 1.00), distant disease–free survival (HR, 1.12; 95% CI, 0.86 to 1.47; P = .40), or mortality (HR, 1.15; 95% CI, 0.83 to 1.59; P = .41) in the intent-to-treat analysis. A significant interaction between menopausal status and treatment group was observed for DFS ( P = .04) but not for OS ( P = .07). Patients with grade 3 tumors derived most benefit from DC, and patients with grade 1 to 2 tumors derived most benefit from EC-D (DFS: interaction P = .02; and OS: interaction P = .03). Patients receiving EC-D reported significantly more stomatitis, myalgia or arthralgia, vomiting, nausea, fatigue, and peripheral neuropathy, whereas edema was more frequent after DC. Conclusion This study provides evidence to support no overall outcome benefit from adjuvant anthracyclines in patients with early TOP2A-normal breast cancer.

Phase III trial comparing 4-cycle doxorubicin plus cyclophosphamide followed by 4-cycle taxan with 8-cycle taxan as adjuvant therapy for node-positive breast cancer: Results of N-SAS-BC02 trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 516-516 ◽  
Author(s):  
T. Watanabe ◽  
M. Kuranami ◽  
K. Inoue ◽  
N. Masuda ◽  
K. Aogi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Sensory Neuropathy ◽  
Phase Iii ◽  
Node Positive ◽  
Life Threatening ◽  
Secondary Endpoints ◽  
Her 2

516 Background: Anthracyclines are the key agents in postoperative regimens for breast cancer (BC). However, relatively rare but life threatening toxicity such as cardiac failure and secondary leukemia are the major concern with anthracycline containing regimens. Retrospective analyses suggested that anthracyclines can be excluded in some pts. Methods: Eligibility included node positive BC age less than 70 yo. Pts were randomized to receive either AC (doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2) every(q) 3 weeks(wks) x 4 -> P (paclitaxel) 175 mg/m2 q3 wks x 4 (ACP), the same AC -> D(docetaxel) 75 mg/m2 q3 wks x 4 (ACD), P 175 mg/m2 q3 wks x 8 (PTX) or D 75 mg/m2 q3 wks x 8(DTX). Comparison included P vs.D (ACP+PTX vs. ACD+DTX) and with AC or without AC (ACP+ACD vs. PTX+DTX). The primary endpoint was disease free survival (DFS) and the secondary endpoints included overall survival, adverse events (AE) and quality of life (QOL). The trial was powered to prove the non-inferiority of regimens without AC to those with AC (threshold hazard ratio [HR] 1.321) in terms of DFS. Results: 1,060 pts were accrued between Dec. 2000 and Mar.2006. 270 DFS events and 106 deaths after a median follow-up of 46.5 months were observed. In all randomised patients, 8 cycles taxane is not inferior to 4 cycles AC -> 4 cycles taxane in terms of DFS (HR:1.26, 95% CI; 0.99–1.60, p = 0.67). In the subset of HER-2 positive patients, 4 cycles AC -> 4 cycles taxane produced superior DFS to 8 cycles taxane (HR:1.63, 95% CI:1.05 - 2.54) but this is not observed in patients with HER-2 negative patients (HR:1.13, 95% CI: 0.85 - 1.50). D 75 mg/m2 tends to show superior DFS to P 175 mg/m2 (HR: 0.81, 95% CI; 0.64–1.03, p = 0.08). Nausea and vomiting was more frequent with AC -> a taxane than 8 cycles taxane. Edema and febrile neutropenia was more frequently observed with D 75 mg/m2 than P 175 mg/m2. The incidence of sensory neuropathy was higher with P 175 mg/m2 than D 75 mg/m2. Conclusions: AC improved DFS in the subset of pts with HER-2 overexpressing BC but not in non-selected population. DFS was better in the arms containing D than in the arms with P. Higher incidence of severe AEs was observed in the arms containing D than in arms with P. No significant financial relationships to disclose.

Denosumab versus placebo as adjuvant treatment for women with early-stage breast cancer who are at high risk of disease recurrence (D-CARE): An international, randomized, double-blind, placebo-controlled phase III clinical trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS670-TPS670
Author(s):  
Paul Edward Goss ◽  
Carlos H. Barrios ◽  
Richard Bell ◽  
Dianne M Finkelstein ◽  
Hiroji Iwata ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Stage ◽  
Human Monoclonal Antibody ◽  
Disease Free Survival ◽  
Early Stage Breast Cancer ◽  
Phase Iii ◽  
Free Survival ◽  
Oral Bisphosphonate ◽  
Her 2

TPS670 Background: Bone is a common site of distant recurrence in women with early-stage breast cancer, and represents approximately 40% of all first recurrences. Tumor cells in bone release growth factors and cytokines that stimulate osteoclast-mediated bone resorption through the RANK ligand (RANKL) pathway. In preclinical studies, RANKL inhibition significantly delays skeletal tumor formation, reduces skeletal tumor burden, and prolongs survival of tumor-bearing mice. Denosumab is a fully human monoclonal antibody that binds to RANKL with high affinity and specificity. It is approved for the prevention of skeletal-related events in patients with established bone metastases from a variety of solid tumors. The purpose of the D-CARE trial is to evaluate the ability of denosumab to prolong bone metastasis-free survival (BMFS) and disease-free survival (DFS) in the adjuvant breast cancer setting. Methods: Approximately 4,500 women with stage II or III breast cancer, at high risk for recurrence and with known hormone and HER-2 receptor status, are eligible. Standard-of-care adjuvant or neoadjuvant chemo-, endocrine, or HER-2 targeted therapy, alone or in combination must be planned. Exclusion criteria include: a prior history of breast cancer (except DCIS or LCIS) or distant metastasis, oral bisphosphonate (BP) use within 1 year of randomization or any intravenous BP use. Patients are randomized 1:1 to receive denosumab 120 mg or placebo subcutaneously monthly for 6 months, then every 3 months for a total of 5 years of treatment. All patients receive vitamin D (≥ 400 IU) and calcium (≥ 500 mg) supplements. Primary endpoint of this event-driven trial is BMFS. Secondary endpoints include DFS and overall survival. Safety, quality of life assessments, breast density, and biomarkers are additional endpoints. The trial, sponsored by Amgen Inc. and registered with the ClinicalTrials.gov identifier NCT01077154, began enrolling patients in June 2010 and is expected to complete in October 2016. Paul Goss and Dianne Finkelstein supported in part by the Avon Foundation New York.

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 Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor–Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial

2019 ◽  
Vol 37 (2) ◽  
pp. 105-114 ◽  
Author(s):  
Thomas Ruhstaller ◽  
Anita Giobbie-Hurder ◽  
Marco Colleoni ◽  
Maj-Britt Jensen ◽  
Bent Ejlertsen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Contralateral Breast Cancer ◽  
Disease Free Survival ◽  
Luminal Breast Cancer ◽  
Free Survival ◽  
Long Term Follow Up ◽  
Disease Free

Purpose Luminal breast cancer has a long natural history, with recurrences continuing beyond 10 years after diagnosis. We analyzed long-term follow-up (LTFU) of efficacy outcomes and adverse events in the Breast International Group (BIG) 1-98 study reported after a median follow-up of 12.6 years. Patients and Methods BIG 1-98 is a four-arm, phase III, double-blind, randomized trial comparing adjuvant letrozole versus tamoxifen (either treatment received for 5 years) and their sequences (2 years of one treatment plus 3 years of the other) for postmenopausal women with endocrine-responsive early breast cancer. When pharmaceutical company sponsorship ended at 8.4 years of median follow-up, academic partners initiated an observational, LTFU extension collecting annual data on survival, disease status, and adverse events. Information from Denmark was from the Danish Breast Cancer Cooperative Group Registry. Intention-to-treat analyses are reported. Results Of 8,010 enrolled patients, 4,433 were alive and not withdrawn at an LTFU participating center, and 3,833 (86%) had at least one LTFU report. For the monotherapy comparison of letrozole versus tamoxifen, we found a 9% relative reduction in the hazard of a disease-free survival event with letrozole (hazard ratio [HR], 0.91; 95% CI, 0.81 to 1.01). HRs for other efficacy end points were similar to those for disease-free survival. Efficacy of letrozole versus tamoxifen for contralateral breast cancer varied significantly over time (0- to 5-, 5- to 10-, and > 10-year HRs, 0.62, 0.47, and 1.35, respectively; treatment-by-time interaction P = .005), perhaps reflecting a longer carryover effect of tamoxifen. Reporting of specific long-term adverse events seemed more effective with national registry than with case-record reporting of clinical follow-up. Conclusion Efficacy end points continued to show trends favoring letrozole. Letrozole reduced contralateral breast cancer frequency in the first 10 years, but this reversed beyond 10 years. This study illustrates the value of extended follow-up in trials of luminal breast cancer.

Efficacy of avelumab plus axitinib (A + Ax) versus sunitinib (S) by number of IMDC risk factors and tumor sites at baseline in advanced renal cell carcinoma (aRCC): Extended follow-up results from JAVELIN Renal 101.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 302-302
Author(s):  
Yoshihiko Tomita ◽  
Robert J. Motzer ◽  
Toni K. Choueiri ◽  
Brian I. Rini ◽  
Hideaki Miyake ◽  
...  
Keyword(s):  
Risk Factors ◽  
Objective Response ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Risk Groups ◽  
Phase Iii ◽  
Once Daily ◽  
Free Survival ◽  
To Receive

302 Background: In the phase III JAVELIN Renal 101 trial (NCT02684006), A + Ax demonstrated progression-free survival (PFS) and objective response rate (ORR) benefit across IMDC risk groups (favorable, intermediate, and poor) vs S in patients with previously untreated aRCC. Here we report efficacy of A + Ax vs S by number of IMDC risk factors (0, 1, 2, 3, and 4-6) and target tumor sites (1, 2, 3, and ≥4) at baseline from the second interim analysis of overall survival (OS). Methods: Patients were randomized 1:1 to receive A 10 mg/kg intravenously every 2 wk + Ax 5 mg orally twice daily or S 50 mg orally once daily for 4 wk (6-wk cycle). PFS and ORR per independent central review (RECIST 1.1) and OS were assessed. Results: At data cut-off (Jan 2019), median (m) follow-up for OS and PFS was 19.3 vs 19.2 mo and 16.8 vs 15.2 mo for the A + Ax vs S arm, respectively. The table shows OS, PFS, and ORR by number of IMDC risk factors and target tumor sites at baseline. A + Ax generally demonstrated efficacy benefit vs S across subgroups. Conclusions: With extended follow-up, A + Ax generally demonstrated efficacy benefit vs S across the number of IMDC risk factors and tumor sites at baseline in aRCC. OS was still immature; follow-up for the final analysis is ongoing. Clinical trial information: NCT02684006 . [Table: see text]

scholarly journals Phyllodes tumor of the breast: a clinic-pathologic study of 77 cases in a Hispanic cohort

2015 ◽  
pp. 104-108 ◽  
Author(s):  
Carlos Andres Ossa Gomez ◽  
Fernando Herazo ◽  
Monica Gil ◽  
Carolina Echeverry ◽  
Gonzalo Angel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Phyllodes Tumor ◽  
Cancer Registries ◽  
Local Relapse ◽  
Free Survival ◽  
Phyllodes Tumors ◽  
Mean Size ◽  
Reported Data

Introduction: Breast Phyllodes tumors are rare breast tumors present in less than 1% of new cases of breast cancer, usually occurring among middle-aged women (40-50 yrs). Objective: This study shows diagnostic experience, surgical management and follows up of patients with this disease during a period of ten years in a oncology referral center. Methods: Retrospectively, breast cancer registries at the institution were reviewed, identifying 77 patients with Phyllodes tumors between 2002 and 2012, who had been operated on at the Instituto de Cancerología - Clínica Las Américas, in Medellín (Colombia). Clinical and histopathological data belonging to these cases was captured and analyzed and descriptive statistics were used. Results: The follow up median was 22.5 months (IQR: 10.5-60.0), average age was 47.2 yrs (SD: 12.4), mean tumor size was 3.6 cm (SD: 4.6), 88.3% of the patients (68 cases) presented negative margins and none of them received adjuvant chemotherapy. Of the patients with Phyllodes tumors; 33.8% had benign, 31.2% had borderline and 35.0% had malignant tumor. Disease-free survival was 85.8% and overall survival was 94.5%. Discussion: Reported data in this article is in accordance with what has been reported in worldwide literature. In our cohort even the high mean size of the tumors, the risk of local relapse and metastatic disease is low than previously reported in literature. Trials with longer follow up and molecular trials in Phyllodes tumors are necessary to understand the behavior of these tumors in Hispanics population.

scholarly journals Rationale and description of a lifestyle intervention programme to achieve moderate weight loss in women with non-metastatic breast cancer: the lifestyle intervention part of the SUCCESS C Study

2020 ◽  
pp. bmjnph-2020-000119
Author(s):  
Dagmar Hauner ◽  
Brigitte Rack ◽  
Thomas Friedl ◽  
Philip Hepp ◽  
Wolfgang Janni ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Weight Loss ◽  
Lifestyle Intervention ◽  
Disease Free Survival ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Intervention Programme ◽  
Long Term Outcome ◽  
Free Survival ◽  
Disease Free

ObjectiveThere is growing evidence from observational studies that lifestyle factors such as obesity, an unhealthy diet and lack of physical activity are associated with poor long-term outcome in women with breast cancer. The primary objective of the lifestyle modification part of the Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as well as Life Style Intervention Strategies (SUCCESS C) Trial is to investigate the effect of an individualised lifestyle intervention programme aiming at moderate weight loss on disease-free survival in women with HER2/neu-negative breast cancer. Secondary objectives include the effect of the intervention on body weight, cardiovascular risk and quality of life.MethodsThe SUCCESS C Trial is an open-label, multicentre, randomised controlled phase III study using a 2×2 factorial design in women with newly diagnosed HER2/neu-negative intermediate-risk to high-risk breast cancer. The first randomisation served to compare disease-free survival in patients treated with two different chemotherapy regimens (3642 participants). The second randomisation served to compare disease-free survival in patients with a body mass index of 24–40 kg/m² (2292 participants) receiving either a telephone-based individualised lifestyle intervention programme for moderate weight loss or general recommendations for a healthy lifestyle for 2 years. Outcome analyses will be conducted after 5 years of follow-up.PerspectiveThis study will provide information on the efficacy and safety of a comprehensive lifestyle intervention programme on disease-free survival in a large cohort of women with breast cancer. EU Clinical Trials Identifier: 2008-005453-38.

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