CEA, CA15.3 and 18-FDG PET in the follow-up of early breast cancer (BC) patients (pts): A prospective, multicentric, randomized trial—KRONOS patient-oriented new surveillance study Italy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS11627-TPS11627 ◽  
Author(s):  
Claudio Zamagni ◽  
Massimo Gion ◽  
Luigi Mariani ◽  
Petra Stieber ◽  
Daniela Rubino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Fdg Pet ◽  
Distant Metastases ◽  
Primary Treatment ◽  
Asymptomatic Patients ◽  
Clinical Scenarios ◽  
New Findings ◽  
The Impact

TPS11627 Background: Current recommendations for breast cancer (BC) surveillance in asymptomatic patients (pts) include only mammography and physical examination and arise from two trials conducted in the 80’s. Since then new findings about BC biology, treatment and the introduction of cutting-edge diagnostic technologies such as 18-FDG PET have deeply modified our clinical scenarios. The aim of this prospective randomized trial is to verify if the serial measurement of CEA and CA15-3 followed by 18-FDG PET can anticipate the diagnosis of BC recurrence compared to control arm by estimation of the difference of restricted mean survival time (RMST) between the two arms. If the end-point will be met a subsequent extension trial will investigate the impact of the earlier diagnosis of distant metastases on survival. Methods: Pts diagnosed with stage I-III BC, who underwent adequate surgery are eligible. Special histologies and low-risk cases according to St. Gallen criteria are excluded. The study includes pts at the beginning of the follow-up after the conclusion of primary treatment (cohort 1), and pts that have concluded without relapse the first 5 years of follow-up (cohort 2). Eligible pts will be randomized in a 1:1 ratio to follow-up according to local practice (control arm) or to three-monthly serial dosing of CEA and CA15-3 and subsequent 18 FDG-PET only in case of an increase of CEA and/or CA 15.3 greater than a critical difference compared to baseline (experimental arm). The following stratification factors will be used: node negative vs positive, HER2 negative vs positive, ER positive vs negative. Eight-hundred pts will be enrolled over 3 years. For such a calculation, we made the assumption of a 20% baseline 5-year incidence of relapse. The target reduction of three months in RMST implies a median time of diagnostic anticipation, conditional on having BC recurrence, of 10 months. The follow-up will continue until 10 years from surgery. Since 23rd October 2014 573 pts have been enrolled. The present trial was approved by the Ethical Committee of each participating centre and is registered on Clinical trial information: NCT02261389.

Sector Resection With or Without Postoperative Radiotherapy for Stage I Breast Cancer: 20-Year Results of a Randomized Trial

2014 ◽  
Vol 32 (8) ◽  
pp. 791-797 ◽  
Author(s):  
Åsa Wickberg ◽  
Lars Holmberg ◽  
Hans-Olov Adami ◽  
Anders Magnuson ◽  
Kenneth Villman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Trial ◽  
Postoperative Radiotherapy ◽  
Similar Rate ◽  
Primary Treatment ◽  
Cumulative Probability ◽  
Tumor Control ◽  
Breast Cancer Death ◽  
Breast Cancer Event

Purpose To investigate how radiotherapy (XRT) adds to tumor control using a standardized surgical technique with meticulous control of surgical margins in a randomized trial with 20 years of follow-up. Patients and Methods Three hundred eighty-one women with pT1N0 breast cancer were randomly assigned to sector resection with (XRT group) or without (non-XRT group) postoperative radiotherapy to the breast. With follow-up through 2010, we estimated cumulative proportion of recurrence, breast cancer death, and all-cause mortality. Results The cumulative probability of a first breast cancer event of any type after 20 years was 30.9% in the XRT group and 45.1% in the non-XRT group (hazard ratio [HR], 0.58; 95% CI, 0.41 to 0.82). The benefit of radiotherapy was achieved within the first 5 years. After 20 years, 50.4% of the women in the XRT group died compared with 54.0% in the non-XRT group (HR, 0.92; 95% CI, 0.71 to 1.19). The cumulative probability of contralateral cancer or death as a result of cancer other than breast cancer was 27.1% in the XRT group and 24.9% in the non-XRT group (HR, 1.17; 95% CI, 0.77 to 1.77). In an anticipated low-risk group, the cumulative incidence of first breast cancer of any type was 24.8% in the XRT group and 36.1% in the non-XRT group (HR, 0.61; 95% CI, 0.35 to 1.07). Conclusion Radiotherapy protects against recurrences during the first 5 years of follow-up, indicating that XRT mainly eradicates undetected cancer foci present at primary treatment. The similar rate of recurrences beyond 5 years in the two groups indicates that late recurrences are new tumors. There are subgroups with clinically relevant differences in risk.

The impact of 18F-fluorodeoxyglucose positron emission tomography (18F-FDG-PET) on the decision-making process in breast cancer patients: The experience of Bologna’s S.Orsola-Malpighi Hospital

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10588-10588
Author(s):  
F. Sperandi ◽  
S. Fanti ◽  
R. Franchi ◽  
A. Martoni
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Cancer Patients ◽  
Fdg Pet ◽  
Therapeutic Strategy ◽  
Disease Stage ◽  
Clinical Approach ◽  
Breast Cancer Patients ◽  
The Impact

10588 Background: 18F-FDG-PET is rapidly spreading “technology” in oncology. Its appropriate use and the clinical settings in which it can modify decision-making need to be defined. Methods: All the requests for 18F-FDG-PET issued by the Medical Oncology Unit are submitted to internal audit. The aim is to evaluate the impact of the information deriving from the test on the subsequent therapeutic strategy in breast cancer patients (pts). From July 2002 to July 2005, 195 18F-FDG-PET examinations were performed in 110 pts. Pt series have been subdivided according to disease stage or clinical setting: Group 1) NED during the follow-up 23 (11.8%); Group 2) suspected first recurrence 52 (26.7%) (included 20 cases with an isolated elevation of CA15.3 and/or CEA serum levels); Group 3) overt metastases: a) single lesion 10 (5.1%), b) multiple lesions with suspected disease progression 26 (13.3%), c) re-evaluation of non-progressive metastatic disease 84 (43.1%). Results: Overall, 18F-FDG-PET was positive in 112 (57.4%) cases: in Groups 1), 2), 3a), 3b) and 3c) positivity was 13%, 63.5%, 60%, 73.1% and 60.7%, respectively. As concerns those pts with an isolated marker serum level increase during the follow-up, 18F-FDG-PET was positive in 13 (65%) cases. Overall, the result of 18F-FDG-PET determined a therapeutic strategy change in 79 (40.5%) cases. This change consisted in a decision to start or re-start anti-tumor medical treatment in 46 (58.2%), to perform or exclude surgery or radiotherapy with a potentially radical purpose in 10 (12.7%), to continue follow-up or to stop treatment in 23 (29.1%). The change of strategy according to Groups 1), 2), 3a), 3b) and 3c) was 13%, 75%, 90%, 61.5% and 14.3%, respectively. Conclusions: A “clinical” approach to the use of 18F-FDG-PET in breast cancer pts allows us to change the decision-making in about 40% of pts. Clinical situations in which 18F-FDG-PET is more useful are in cases of suspected recurrence and oligometastatic disease. No significant financial relationships to disclose.

scholarly journals Improved risk estimation of locoregional recurrence, secondary contralateral tumors and distant metastases in early breast cancer: the INFLUENCE 2.0 model

2021 ◽  
Author(s):  
Vinzenz Völkel ◽  
Tom A. Hueting ◽  
Teresa Draeger ◽  
Marissa C. van Maaren ◽  
Linda de Munck ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Locoregional Recurrence ◽  
Clinical Decision Making ◽  
Metastatic Breast ◽  
Distant Metastases ◽  
Time Dependent ◽  
Individual Risk ◽  
Primary Tumors ◽  
Statistical Approaches

Abstract Purpose To extend the functionality of the existing INFLUENCE nomogram for locoregional recurrence (LRR) of breast cancer toward the prediction of secondary primary tumors (SP) and distant metastases (DM) using updated follow-up data and the best suitable statistical approaches. Methods Data on women diagnosed with non-metastatic invasive breast cancer were derived from the Netherlands Cancer Registry (n = 13,494). To provide flexible time-dependent individual risk predictions for LRR, SP, and DM, three statistical approaches were assessed; a Cox proportional hazard approach (COX), a parametric spline approach (PAR), and a random survival forest (RSF). These approaches were evaluated on their discrimination using the Area Under the Curve (AUC) statistic and on calibration using the Integrated Calibration Index (ICI). To correct for optimism, the performance measures were assessed by drawing 200 bootstrap samples. Results Age, tumor grade, pT, pN, multifocality, type of surgery, hormonal receptor status, HER2-status, and adjuvant therapy were included as predictors. While all three approaches showed adequate calibration, the RSF approach offers the best optimism-corrected 5-year AUC for LRR (0.75, 95%CI: 0.74–0.76) and SP (0.67, 95%CI: 0.65–0.68). For the prediction of DM, all three approaches showed equivalent discrimination (5-year AUC: 0.77–0.78), while COX seems to have an advantage concerning calibration (ICI < 0.01). Finally, an online calculator of INFLUENCE 2.0 was created. Conclusions INFLUENCE 2.0 is a flexible model to predict time-dependent individual risks of LRR, SP and DM at a 5-year scale; it can support clinical decision-making regarding personalized follow-up strategies for curatively treated non-metastatic breast cancer patients.

scholarly journals Rate of Distant Metastases on 18 F-FDG PET/CT at Initial Staging of Breast Cancer: Comparison of Women Younger and Older Than 40 Years

2016 ◽  
Vol 58 (2) ◽  
pp. 252-257 ◽  
Author(s):  
Vincent Lebon ◽  
Jean-Louis Alberini ◽  
Jean-Yves Pierga ◽  
Véronique Diéras ◽  
Nina Jehanno ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Fdg Pet ◽  
Distant Metastases ◽  
Pet Ct ◽  
Fdg Pet Ct ◽  
Initial Staging
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