scholarly journals Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial

Author(s):  
Heikki Joensuu ◽  
Pirkko-Liisa Kellokumpu-Lehtinen ◽  
Riikka Huovinen ◽  
Arja Jukkola ◽  
Minna Tanner ◽  
...  

PURPOSE Few data are available regarding the influence of adjuvant capecitabine on long-term survival of patients with early breast cancer. METHODS The Finland Capecitabine Trial (FinXX) is a randomized, open-label, multicenter trial that evaluates integration of capecitabine to an adjuvant chemotherapy regimen containing a taxane and an anthracycline for the treatment of early breast cancer. Between January 27, 2004, and May 29, 2007, 1,500 patients with axillary node-positive or high-risk node-negative early breast cancer were accrued. The patients were randomly allocated to either TX-CEX, consisting of three cycles of docetaxel (T) plus capecitabine (X) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX, 753 patients), or to T-CEF, consisting of three cycles of docetaxel followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (CEF, 747 patients). We performed a protocol-scheduled analysis of overall survival on the basis of approximately 15-year follow-up of the patients. RESULTS The data collection was locked on December 31, 2020. By this date, the median follow-up time of the patients alive was 15.3 years (interquartile range, 14.5-16.1 years) in the TX-CEX group and 15.4 years (interquartile range, 14.8-16.0 years) in the T-CEF group. Patients assigned to TX-CEX survived longer than those assigned to T-CEF (hazard ratio 0.81; 95% CI, 0.66 to 0.99; P = .037). The 15-year survival rate was 77.6% in the TX-CEX group and 73.3% in the T-CEF group. In exploratory subgroup analyses, patients with estrogen receptor–negative cancer and those with triple-negative cancer treated with TX-CEX tended to live longer than those treated with T-CEF. CONCLUSION Addition of capecitabine to a chemotherapy regimen that contained docetaxel, epirubicin, and cyclophosphamide prolonged the survival of patients with early breast cancer.

2017 ◽  
Vol 18 (9) ◽  
pp. 1211-1220 ◽  
Author(s):  
Marloes G M Derks ◽  
Erik J Blok ◽  
Caroline Seynaeve ◽  
Johan W R Nortier ◽  
Elma Meershoek-Klein Kranenbarg ◽  
...  

2020 ◽  
Author(s):  
Chengyu Luo ◽  
Guang Cao ◽  
wenbin Guo ◽  
Jie Yang ◽  
Qiuru Sun ◽  
...  

Abstract Backgroud: Longer follow-up was necessary to testify the exact value of mastoscopic axillary lymph node dissection (MALND).Methods:From January 1, 2003 to December 31, 2005,1027 patients with operable breast cancer were randomly assigned to two groups: MALND and CALND. 996 eligible patients were enrolled. The end points are disease free survival and overall survival.Results:The final cohort of 996 patients was followed for an average of 184 months. The distribution of all events was fairly similar between two groups of patients. The incidence of local in-breast events did not differ in a significant manner between two cohorts. Similarly, the rate of distant metastases was not significantly different with 30.0% in MLND and 32.6% in CALND. And no significant difference was observed in other primary tumor between two groups (p=0.46). Patients who remain alive with no event comprise a total of 37.2% in MALND and 35.4% in CALND. Other primary cancers and deaths from other causes were distributed equally between two groups. The 15-year disease-free survival rates were41.1 percent for the MALND group and 39.6 percent for the CALND group (p=0.79). MALND was found to be not inferior for overall survival (P =0.54). The 15-year overall survival rates were 49.5 percentafter MALND and 51.2 percentafter CALND (p=0.86). Probability of overall survival was not significantly different between two groups.Conclusions:MALND does not increase unfavorable events, and also does not affect the long-term survival of patients. Therefore, MALND should be one of the preferred approaches for breast cancer surgery.


2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 70-70 ◽  
Author(s):  
J. M. Buckley ◽  
S. Coopey ◽  
S. Samphao ◽  
M. C. Specht ◽  
K. S. Hughes ◽  
...  

70 Background: Young age at diagnosis of breast cancer has been reported to be an independent risk factor for disease recurrence. However, there is little data on long term survival of young patients. We present long term follow up of a large cohort of women diagnosed with breast cancer at age 40 and younger. We determined rates of loco-regional recurrence (LRR), distant recurrence, and overall survival and adjusted for the patient and tumor characteristics which potentially predict outcomes. Methods: Following Institutional Review Board approval, data from the medical records of 628 women diagnosed with breast cancer at age 40 or younger between 1996 and 2008 were collected. Survival curves were estimated using the Kaplan Meier method. Results: Median age was 37 years (range: 21-40) and median follow-up was 72 months (range: 5-177). The rates of LRR as a first site of recurrence were 5.56% at 5 years and 12.11% at 10 years. In the entire population, with median follow-up of 72 months, there was no difference in the rates of loco-regional failure between patients who underwent breast conserving therapy (7.34%) compared to mastectomy (7.40%) (p=0.980). The rates of distant recurrence as a first event were 10.65% at 5 years and 14.58% at 10 years. Overall survival was 93.1% at 5 years and 87.26% at 10 years. 79.1% of patients received systemic therapy. For patients who developed disease recurrence, either LRR or distant, median time to first recurrence was 35 months (range: 3-167). Conclusions: Women aged 40 and younger at diagnosis of breast cancer have a good prognosis, with low overall recurrence rates at 5 and 10 years. Local recurrence in our cohort is lower than in prior studies, suggesting advances in therapy have made breast conservation a safe option in young breast cancer patients.


2005 ◽  
Vol 23 (12) ◽  
pp. 2686-2693 ◽  
Author(s):  
Jacques Bonneterre ◽  
Henri Roché ◽  
Pierre Kerbrat ◽  
Alain Brémond ◽  
Pierre Fumoleau ◽  
...  

Purpose The French Adjuvant Study Group 05 (FASG-05) showed that fluorouracil 500 mg/m2, cyclophosphamide 500 mg/m2, and epirubicin 100 mg/m2 (FEC 100) was superior to the same regimen with epirubicin 50 mg/m2 (FEC 50) in terms of disease-free survival (DFS) and overall survival (OS) in adjuvant treatment of early breast cancer. We report 10-year data on efficacy, and long-term side effects for FASG-05. Patients and Methods We randomly assigned 565 patients to treatment with FEC 50 or FEC 100 after surgery. Postmenopausal patients also received tamoxifen for 3 years, and almost all patients (96%) also received radiotherapy. Results Median follow-up was 110 months. The 10-year DFS was 45.3% (95% CI, 41.9% to 48.7%) with FEC 50 and 50.7% (95% CI, 47.3% to 54.1%) with FEC 100 (Wilcoxon P = .036; log-rank P = .08). The 10-year OS was 50.0% (95% CI, 46.7% to 53.3%) with FEC 50 and 54.8% (95% CI, 51.3% to 58.3%) with FEC 100 (Wilcoxon P = .038; log-rank P = .05). Delayed cardiac toxicity (before relapse) occurred in four patients (1.5%) in the FEC 50 arm and three patients (1.1%) in the FEC 100 arm. Cardiac toxicity after relapse occurred in six (4.3%) and five (4.1%) patients treated with FEC 50 and FEC 100, respectively. Conclusion Treatment with adjuvant FEC 100 demonstrated superior DFS and OS versus FEC 50 at 10 years of follow-up. This survival advantage was not offset by long-term complications such as cardiac toxicity and second malignancy. Given the risk-benefit ratio, FEC 100 is a more optimal regimen for long-term survival in patients with poor prognosis.


2007 ◽  
Vol 25 (19) ◽  
pp. 2664-2670 ◽  
Author(s):  
Manfred Kaufmann ◽  
Walter Jonat ◽  
Jörn Hilfrich ◽  
Holger Eidtmann ◽  
Günther Gademann ◽  
...  

Purpose In postmenopausal women with estrogen receptor–positive early breast cancer, surgery is usually followed by a 5-year course of tamoxifen. This report presents results of a prospective, open-label, randomized study, designed to evaluate the benefits of switching to anastrozole after 2 years of tamoxifen treatment, compared with continuing on tamoxifen for 5 years. Patients and Methods After receiving tamoxifen treatment for 2 years, eligible patients (n = 979) were randomly assigned to switch to anastrozole (1 mg/d) or continue tamoxifen (20 or 30 mg/d) for an additional 3 years. Patients were monitored every 6 months during years 1 to 3 and annually thereafter. The primary efficacy variable was disease-free survival, including local or distant recurrence, new contralateral breast cancer, or death. Secondary variables were overall survival and assessment of safety. Results Switching to anastrozole resulted in a significant reduction in the risk of disease recurrence (hazard ratio [HR], 0.66; 95% CI, 0.44 to 1.00; P = .049), and improved overall survival (HR, 0.53; 95% CI, 0.28 to 0.99; P = .045) compared with continuing on tamoxifen. Fewer patients who switched to anastrozole reported serious adverse events (22.7% v 30.8%) compared with those who continued on tamoxifen, mainly due to more patients in the tamoxifen group with endometrial events. The overall safety profile for anastrozole was consistent with previous reports and no new safety issues were identified. Conclusion Postmenopausal women who have taken tamoxifen for 2 years as adjuvant therapy are less likely to experience a recurrence of breast cancer and have improved overall survival if they switch to anastrozole compared with continuing to receive tamoxifen.


2019 ◽  
Vol 37 (26) ◽  
pp. 2338-2348 ◽  
Author(s):  
Hyman B. Muss ◽  
Mei-Yin C. Polley ◽  
Donald A. Berry ◽  
Heshan Liu ◽  
Constance T. Cirrincione ◽  
...  

PURPOSE Older women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years. PATIENTS AND METHODS Patients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician’s choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS. RESULTS The design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80; P = .03); breast cancer–specific survival rates were 88% and 82%, respectively (HR, 0.62; P = .03); and overall survival rates were 62% and 56%, respectively (HR, 0.84; P = .16). With longer follow-up, standard chemotherapy remains superior to capecitabine among hormone receptor–negative patients (HR, 0.66; P = .02), but not among hormone receptor–positive patients (HR, 0.89; P = .43). Overall, 43.9% of patients have died (13.1% from breast cancer, 16.4% from causes other than breast cancer, and 14.1% from unknown causes). Second nonbreast cancers occurred in 14.1% of patients. CONCLUSION With longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor–negative disease. Competing risks in this older population dilute overall survival benefits.


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