Correlation between changes in 2- or 3-year disease-free survival (DFS) and 5-year overall survival (OS) in adjuvant breast cancer trials from 1966–2006

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 581-581
Author(s):  
R. C. Ng ◽  
G. R. Pond ◽  
P. A. Tang ◽  
P. W. MacIntosh ◽  
L. L. Siu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Sample Size ◽  
Prediction Interval ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Free Survival ◽  
Adjuvant Breast Cancer ◽  
Cancer Trials ◽  
Disease Free

581 Background: Although disease-free survival (DFS) is accepted as a valid endpoint in adjuvant breast cancer trials, improvement in 2- or 3-year DFS has never been formally established as an adequate surrogate for 5- or 10-year overall survival (OS). We set out to establish if changes in 2- or 3-year DFS can be used to accurately predict changes in 5- or 10-year OS. Method: We conducted a systematic Medline search for phase III randomized adjuvant breast cancer trials published between 1966–2006 with >100 patients per arm with data for 2- and 3-year DFS as well as 5- or 10-year OS. Only trials of systemic therapies (e.g. chemotherapy, hormonal therapy) were included. We excluded studies investigating the effects of surgery, radiotherapy and neoadjuvant treatment. A univariate regression model weighted by trial sample size was constructed to determine if changes in 2-year DFS between treatment arms within trials were predictive of changes in 5- year OS. Computations of the correlation coefficient, proportion of variation, predicted estimates and 95% prediction interval were undertaken. Results: 126 studies containing 149 treatment arms met the inclusion criteria. Median sample size per trial was 533 and median follow up time was 81 months. Only 26 trials provided 10-year OS data thus association with 10-year OS was not attempted. Results were similar between analyses using either 2- or 3-year DFS, hence only 2-year DFS statistics are reported. 2-year DFS was a significant predictor of 5-year OS regardless of what other covariates were included (p<0.001). For every 1% increase in difference between treatment arms in 2-year DFS, the estimated difference in 5-year OS increased by 0.52%. The proportion of variation explained (R2) ranged from 0.38 to 0.49, with a wide prediction interval. Indeed, if a future trial accrued 1,000 patients and the 2-year DFS in the experimental arm was better than the control by 10%, the 95% prediction interval would still range from -0.2% to 11%. Conclusion: There is a statistically significant correlation, of moderate strength, between changes in 2-year DFS between treatment arms and changes in 5-year OS but the wide prediction intervals mean that the correlation is not strong enough to be used as a surrogate. No significant financial relationships to disclose.

Adjuvant capecitabine for invasive lobular/mixed early breast cancer (EBC): USON 01062 exploratory analyses.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 547-547
Author(s):  
Joyce O'Shaughnessy ◽  
John E. Pippen ◽  
Devchand Paul ◽  
Christopher T. Stokoe ◽  
Joanne Lorraine Blum ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Event Rate ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Molecular Characteristics ◽  
Genetic Pathway ◽  
Free Survival ◽  
Molecular Analyses ◽  
Disease Free

547 Background: Randomized phase III USON 01062 trial determining if patients with EBC would benefit from addition of capecitabine to docetaxel after AC (AC-T vs AC-XT). AC-T: docetaxel 100mg/M2 IV; AC-XT: docetaxel 75mg/M2 IV with capecitabine 825mg/M2 PO BID 14/7 days every 21days for 4 cycles. The primary endpoint, improvement in disease-free survival (DFS) at 5 years, was not met (HR=0.84, p=0.12) likely due to lower-than-expected event rate. The secondary endpoint, overall survival (OS), was improved with capecitabine (HR 0.68, p=0.01) (O’Shaughnessy, J. ASCO, 2011). Methods: Molecular analyses demonstrate that pleomorphic lobular (mixed lobular/ductal) carcinomas evolve from the same precursor and/or through the same genetic pathway as classical lobular cancers (Reis-Filho, J., J Path, 2005). We conducted exploratory analyses to evaluate the addition of adjuvant capecitabine in ductal vs lobular or lobular/ductal (mixed) EBC within USON 01062. Histology was classified according to local pathology assessment on patients’ primary cancers. Results: In ductal patients (n=2195), there was no difference in DFS (HR=0.92, p=0.48) and OS (HR=0.75, p=0.07) with AC-T vs AC-XT. In lobular/mixed patients (n=355), adding capecitabine improved DFS (HR=0.55, p=0.055) and OS (HR=0.38, p=0.04). There was no difference in DFS (HR=1.004, p=0.98) in the ER+ ductal patients (n=1258) with the addition of capecitabine. Conclusions: Ductal and lobular cancers have distinct histologic and molecular characteristics; lobular cancers are generally less sensitive to chemotherapy (Cristofanilli, M. JCO, 2005). This exploratory analysis suggests that patients with lobular/mixed EBC may benefit from adjuvant capecitabine. This hypothesis requires evaluation in other adjuvant capecitabine trials. [Table: see text]

scholarly journals The role of functional polymorphisms in oxidative stress-related genes on early-stage breast cancer survival

2021 ◽  
pp. 172460082110111
Author(s):  
Erika Korobeinikova ◽  
Rasa Ugenskiene ◽  
Ruta Insodaite ◽  
Viktoras Rudzianskas ◽  
Jurgita Gudaitiene ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Single Nucleotide Polymorphisms ◽  
Early Stage ◽  
Disease Free Survival ◽  
Early Stage Breast Cancer ◽  
Nucleotide Polymorphisms ◽  
Single Nucleotide ◽  
Free Survival ◽  
Disease Free

Background: Genetic variations in oxidative stress-related genes may alter the coded protein level and impact the pathogenesis of breast cancer. Methods: The current study investigated the associations of functional single nucleotide polymorphisms in the NFE2L2, HMOX1, P21, TXNRD2, and ATF3 genes with the early-stage breast cancer clinicopathological characteristics and disease-free survival, metastasis-free survival, and overall survival. A total of 202 Eastern European (Lithuanian) women with primary I–II stage breast cancer were involved. Genotyping of the single nucleotide polymorphisms was performed using TaqMan single nucleotide polymorphisms genotyping assays. Results: The CA+AA genotypes of P21 rs1801270 were significantly less frequent in patients with lymph node metastasis and larger tumor size ( P=0.041 and P=0.022, respectively). The TT genotype in ATF3 rs3125289 had significantly lower risk of estrogen receptor (ER), progesterone receptor (PR) negative, and human epidermal growth factor receptor 2 (HER2) positive status ( P=0.023, P=0.046, and P=0.040, respectively). In both, univariate and multivariate Cox analysis, TXNRD2 rs1139793 GG genotype vs. GA+AA was a negative prognostic factor for disease-free survival (multivariate hazard ratio (HR) 2.248; P=0.025) and overall survival (multivariate HR 2.248; P=0.029). The ATF3 rs11119982 CC genotype in the genotype model was a negative prognostic factor for disease-free survival (multivariate HR 5.878; P=0.006), metastasis-free survival (multivariate HR 4.759; P=0.018), and overall survival (multivariate HR 3.280; P=0.048). Conclusion: Our findings suggest that P21 rs1801270 is associated with lymph node metastasis and larger tumor size, and ATF3 rs3125289 is associated with ER, PR, and HER2 status. Two potential, novel, early-stage breast cancer survival biomarkers, TXNRD2 rs1139793 and ATF3 rs11119982, were detected. Further investigations are needed to confirm the results of the current study.

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

Development of prognostic nomograms using institutional data for patients with triple-negative breast cancer

2021 ◽  
Author(s):  
Jie-Yu Zhou ◽  
Kang-Kang Lu ◽  
Wei-Da Fu ◽  
Hao Shi ◽  
Jun-Wei Gu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Predictive Accuracy ◽  
Area Under The Curve ◽  
Disease Free Survival ◽  
Discriminative Ability ◽  
Free Survival ◽  
Disease Free

Background: Triple-negative breast cancer (TNBC) is an aggressive disease. Nomograms can predict prognosis of patients with TNBC. Methods: A total of 745 eligible TNBC patients were recruited and randomly divided into training and validation groups. Endpoints were disease-free survival and overall survival. Concordance index, area under the curve and calibration curves were used to analyze the predictive accuracy and discriminative ability of nomograms. Results: Based on the training cohort, neutrophil-to-lymphocyte ratio, positive lymph nodes, tumor size and tumor-infiltrating lymphocytes were used to construct a nomogram for disease-free survival. In addition, age was added to the overall survival nomogram. Conclusion: The current study developed and validated well-calibrated nomograms for predicting disease-free survival and overall survival in patients with TNBC.

scholarly journals Circulating Tumor Cells and Cancer Stem Cells: Clinical Implications in Nonmetastatic Breast Cancer

2016 ◽  
Vol 10 ◽  
pp. BCBCR.S40856 ◽  
Author(s):  
M. Sayed ◽  
A.M. Zahran ◽  
M.S.F. Hassan ◽  
D.O. Mohamed
Keyword(s):  
Breast Cancer ◽  
Stem Cells ◽  
Overall Survival ◽  
Cancer Stem Cells ◽  
Tumor Cells ◽  
Circulating Tumor Cells ◽  
Disease Free Survival ◽  
Free Survival ◽  
The Third ◽  
Disease Free

Purpose Despite the therapeutic advances, disease recurrence remains an ever-present threat to the health and well-being of breast cancer survivors. Assessment of circulating tumor cells (CTCs) and cancer stem cells (CSCs) during and after treatment may be of value in refining treatment. Methods Three 5 mL blood samples were taken from each patient: the first, at diagnosis; the second, after completion of neoadjuvant anthracyclin-based chemotherapy; and the third, a month after surgery and completion of adjuvant radiotherapy. The absolute numbers of CTCs were identified as CD45-cytokeratin+ cells. CTCs per 5 mL of blood were determined by recording all events in the whole suspension. CSCs were identified as cytokeratin+CD44+CD24-/CD45- cells. The CSCs were expressed as a percentage of CTCs. Results Univariate analysis identified the measurements of baseline CTCs and CSCs, taken after chemotherapy and one month after the cessation of radiotherapy, as prognostic factors for both four-year disease-free survival and four-year overall survival. Multivariable analysis identified the third measurement of CSCs, taken one month after the completion of radiotherapy, as the only independent prognostic factor for the four-year disease-free survival (P < 0.002, hazard ratio [HR] = 1.231, 95% CI 1.077–1.407). The initial CTC measurement was the one factor that reached significance on multivariate analysis (P < 0.03, HR 1.969, 95% CI 1.092–3.551) for the four-year overall survival. Correlation was higher between CTC and CSC counts at diagnosis ( r = 0.654, P < 0.001) than after chemotherapy ( r = 0.317, P < 0.03), because of the more rapid decrease in the mean CTC count with chemotherapy. Conclusion The CTC count could be suitable as one of the measures for monitoring response to chemotherapy, while persistence of CSC after cessation of the treatment of nonmetastatic breast cancer, except hormonal therapy when indicated, may be a reason to consider additional therapy in the future. These findings need confirmation in larger randomized trials.

scholarly journals Weight changes during chemotherapy for breast cancer

2002 ◽  
Vol 120 (4) ◽  
pp. 113-117 ◽  
Author(s):  
Luciano José Megale Costa ◽  
Paulo César Spotti Varella ◽  
Auro del Giglio
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Body Weight ◽  
Weight Gain ◽  
Weight Change ◽  
Prognostic Significance ◽  
Disease Free Survival ◽  
Weight Changes ◽  
Free Survival ◽  
Disease Free

CONTEXT: Patients receiving adjuvant chemotherapy for breast cancer have a tendency to gain weight. This tendency has determining factors not completely defined and an unknown prognostic impact. OBJECTIVE: To evaluate weight change during chemotherapy for breast cancer in a defined population and to identify its predisposing factors and possible prognostic significance. DESIGN: Observational, retrospective cohort study. SETTING: Private clinical oncology service. PARTICIPANTS: 106 consecutive patients with breast cancer treated between June 1994 and April 2000, who received neoadjuvant (n = 8), adjuvant (n = 74) or palliative (n = 24) chemotherapy. INTERVETION: Review of medical records and gathering of clinical information, including patients’ body weights before treatment and at follow-up reviews. MAIN MEASUREMENTS: Body weight change, expressed as percentage of body weight per month in treatment; role of clinical data in weight change; and influence of weight change in overall survival and disease-free survival. RESULTS: There was a mean increase of 0.50 ± 1.42% (p = 0.21) of body weight per month of treatment. We noted a negative correlation between metastatic disease and weight gain (r = -0.447, p < 0.0001). In the adjuvant and neoadjuvant therapy groups there was a mean weight gain of 0.91 ± 1.19 % (p < 0.00001) per month, whereas in the metastatic (palliative) group, we observed a mean loss of 0.52 ± 1.21% (p = 0.11) of body weight per month during the treatment. We did not observe any statistically significant correlation between weight changes and disease-free survival or overall survival. CONCLUSIONS: Women with breast cancer undergoing adjuvant or neoadjuvant chemotherapy gain weight, whereas metastatic cancer patients will probably lose weight during palliative chemotherapy. Further studies are needed in order to evaluate the prognostic significance of weight changes during chemotherapy.

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.

scholarly journals Association between the Dietary Inflammatory Index and Risk for Cancer Recurrence and Mortality among Patients with Breast Cancer

Nutrients ◽  
2018 ◽  
Vol 10 (8) ◽  
pp. 1095 ◽  
Author(s):  
Hyeonjeong Jang ◽  
Min Chung ◽  
Shin Kang ◽  
Yongsoon Park
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Cancer Recurrence ◽  
Disease Free Survival ◽  
Dietary Inflammatory Index ◽  
Free Survival ◽  
Inflammatory Index ◽  
Node Metastasis ◽  
Disease Free ◽  
Overall Mortality

The dietary inflammatory index (DII) has been associated with breast cancer incidence and survival. However, the association between DII and cancer recurrence and mortality among patients with breast cancer has not been investigated. Therefore, the present study aimed to investigate whether DII was positively associated with risk for cancer recurrence and overall mortality among patients with breast cancer. Among 511 women (51.9 ± 10.7 years; stage 0–3) who underwent breast cancer surgery, 88 had cancer recurrence, and 44 died during follow–up until 213 months (average disease free survival of 84.3 ± 42.4 months and overall survival of 69.3 ± 38.9 months). The DII assessed after surgery (5.4 ± 5.2 months after diagnosis) was significantly higher in patients with recurrence than those without recurrence, and Cox proportional hazards regression analysis showed that it was positively associated with the risk for cancer recurrence (hazard ratio (HR) 2.347, confidence interval (CI) 1.17–4.71) and overall mortality (HR 3.049, CI 1.08–8.83) after adjusting for confounding factors. Disease-free survival and overall survival rates were significantly lower in patients with higher DII scores. In addition, the DII was positively associated with the risk for cancer recurrence according to prognostic factors, such as age (<50 years), premenopausal status, body mass index (≥25 kg/m2), HR+, tumor size (>2 cm), and presence of lymph node metastasis. The present study showed that anti-inflammatory diets may decrease the risk of cancer recurrence and overall mortality in patients with breast cancer, particularly those with prognostic factors, such as younger age, premenopausal status, obesity, HR+ breast cancer, tumor size >2 cm, and presence of lymph node metastasis.

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