Benefits and harms of implementing [18F]FDG-PET/CT for diagnosing recurrent breast cancer: a prospective clinical study.

BACKGROUND: [18F]-fluorodeoxyglucose-positron emission tomography/computed tomography ([18F]FDG-PET/CT) has been implemented sporadically in hospital settings as the standard of care examination for recurrent breast cancer. We aimed to explore the clinical impact of implementing [18F]FDG-PET/CT for patients with clinically suspected recurrent breast cancer and validate the diagnostic accuracy. METHODS: Women with suspected distant recurrent breast cancer were prospectively enrolled in the study between September 2017 and August 2019. [18F]FDG-PET/CT was performed, and the appearance of incidental benign and malignant findings was registered. Additional examinations, complications, and the final diagnosis were registered to reflect the clinical consequence of such findings. The diagnostic accuracy of [18F]FDG-PET/CT as a stand-alone examination was analyzed. Biopsy and follow-up were used as a reference standard. RESULTS: [18F]FDG-PET/CT reported breast cancer metastases in 72 of 225 women (32.0%), and metastases were verified by biopsy in 52 (52/225, 23.1%). Prior probability and posterior probability of a positive test for suspected metastatic cancer and incidental malignancies were 27%/85% and 4%/20%, respectively. Suspected malignant incidental findings were reported in 46 patients (46/225, 20.4%), leading to further examinations and final detection of nine synchronous cancers (9/225, 4.0%). These cancers originated from the lung, thyroid, skin, pancreas, peritoneum, breast, kidney, one was malignant melanoma, and one was hematological cancer. False-positive incidental malignant findings were examined in 37/225 patients (16.4%), mainly in the colon (n = 12) and thyroid gland (n = 12). Ten incidental findings suspicious for benign disease were suggested by [18F]FDG-PET/CT, and further examinations resulted in the detection of three benign conditions requiring treatment. Sensitivity, specificity, and AUC-ROC for diagnosing distant metastases were 1.00 (0.93-1.0), 0.88 (0.82-0.92), and 0.98 (95% CI 0.97-0.99), respectively. CONCLUSION: [18F]FDG-PET/CT provided a high posterior probability of positive test, and a negative test was able to rule out distant metastases in women with clinically suspected recurrent breast cancer. One-fifth of patients examined for incidental findings detected on [18F]FDG-PET/CT were diagnosed with clinically relevant conditions. Further examinations of false-positive incidental findings in one of six women should be weighed against the high accuracy for diagnosing metastatic breast cancer. Trial registration Clinical.Trials.gov. NCT03358589. Registered 30 November 2017-Retrospectively registered, http://www.ClinicalTrials.gov.

FDG-PET/CT in high-risk primary breast cancer-a prospective study of stage migration and clinical impact.

PURPOSE: To investigate the clinical impact of FDG-PET/CT for staging and treatment planning in high-risk primary breast cancer. METHODS: Women with high-risk primary breast cancer were enrolled between September 2017 and August 2019 at Odense University Hospital, Denmark. Conventional mammography with/without MRI was performed before staging by FDG-PET/CT. We studied the accuracy of FDG-PET/CT for the detection of distant metastases, the effect on the change of treatment, and the prevalence of incidental findings. Biopsy and follow-up were used as a reference standard for the accuracy analysis. RESULTS: Of 103 women, 24 (23%) were diagnosed with distant metastases by FDG-PET/CT. Among these, breast surgery was omitted in 18 and could have been spared in six. Another sixteen (16%) patients were upstaged to more advanced loco-regional disease, leading to more extensive radiotherapy. Sensitivity and specificity for diagnosing distant metastases were 1.00 (95% confidence interval: 0.86-1.00) and 0.95 (0.88-0.99), respectively. Twenty-nine incidental findings were detected in 24 women (23%), leading to further examinations in 22 and diagnosis of eight (8/22, 36%) synchronous diseases: cancer (n = 4), thyroiditis (n = 2), aorta aneurysm (n = 1), and meningioma (n = 1). CONCLUSIONS: FDG-PET/CT had a substantial impact on staging and change of treatment in women with high-risk primary breast cancer, and further examination of incidental findings was considered clinically relevant. Our findings suggest that FDG-PET/CT should be considered for primary staging in high-risk primary breast cancer to improve treatment planning.

[18F]Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET)/Computed Tomography (CT) in Suspected Recurrent Breast Cancer: A Prospective Comparative Study of Dual-Time-Point FDG-PET/CT, Contrast-Enhanced CT, and Bone Scintigraphy.

PURPOSE: To prospectively investigate the diagnostic accuracy of [(18)F]fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) with dual-time-point imaging, contrast-enhanced CT (ceCT), and bone scintigraphy (BS) in patients with suspected breast cancer recurrence. PATIENTS AND METHODS: One hundred women with suspected recurrence of breast cancer underwent 1-hour and 3-hour FDG-PET/CT, ceCT, and BS within approximately 10 days. The study was powered to estimate the precision of the individual imaging tests. Images were visually interpreted using a four-point assessment scale, and readers were blinded to other test results. The reference standard was biopsy along with treatment decisions and clinical follow-up (median, 17 months). RESULTS: FDG-PET/CT resulted in no false negatives and fewer false positives than the other imaging techniques. Accuracy of results were similar for 1-hour and 3-hour FDG-PET/CT. For distant recurrence, the area under the receiver operating curve was 0.99 (95% CI, 0.97 to 1) for FDG-PET/CT, 0.84 (95% CI, 0.73 to 0.94) for ceCT, and 0.86 (95% CI, 0.77 to 0.94) for the combined ceCT+BS. Of 100 patients, 22 (22%) were verified with distant recurrence, and 18 of these had bone involvement. Nineteen patients (19%) had local recurrence only. In exploratory analyses, diagnostic accuracy of FDG-PET/CT was better than ceCT alone or ceCT combined with BS in diagnosing distant, bone, and local recurrence, shown by a greater area under the receiver operating curve and higher sensitivity, specificity, and superior likelihood ratios. CONCLUSION: FDG-PET/CT was accurate in diagnosing recurrence in breast cancer patients. It allowed for distant recurrence to be correctly ruled out and resulted in only a small number of false-positive cases. Exploratory findings suggest that FDG-PET/CT has greater accuracy than conventional imaging technologies in this patient group.

Trends in breast cancer in the elderly in Denmark, 1980-2012.

BACKGROUND: Breast cancer is the most frequent malignancy among women worldwide and the second most common cause of cancer-related death in developed countries. The aim of the present analysis is to describe trends in incidence, mortality, prevalence, and relative survival in Denmark from 1980 to 2012 focusing on age, comparing persons aged 70 years or more with those aged less than 70 years. MATERIAL AND METHODS: Cancer of the breast was defined as ICD-10 code C50. Data derived from the NORDCAN database with comparable data on cancer incidence, mortality, prevalence and relative survival in the Nordic countries, where the Danish data were delivered from the Danish Cancer Registry and the Danish Cause of Death Registry with follow-up for death or emigration until the end of 2013. RESULTS: The proportion of patients diagnosed with breast cancer over the age of 70 years increased with time to 29% of women and 44% of men in 2012. Incidence rates increased with time and peaked around 2010 in all age groups except for those aged 90 years or more. Mortality rates were clearly separated by age with increasing mortality rates by increasing age group for both women and men. Relative survival increased over time in all age groups, but patients aged 70 years or more had a poorer relative survival than those aged less than 70 years. In 2012, 58 521 persons (all ages) were alive in Denmark after a diagnosis of breast cancer. CONCLUSION: Poorer survival of Danish breast cancer patients over the age of 70 years is likely to be due to inferior treatment and non-adherence to treatment guidelines. There is a need for clinical trials focusing on patients over the age of 70 years.

Lack of nationwide Danish guidelines on mammography before non-oncological breast surgery.

INTRODUCTION: Non-oncological breast surgery like breast reduction and mastopexy are often performed in younger patients, i.e. in women who have not yet had mammography. Breast cancer is, however, a very frequent disease that is increasingly prevalent in women below 50 years of age. Occult breast cancer may not be recognised before breast surgery, which may result in several disadvantages for the women. Therefore, detecting a breast cancer before a woman undergoes non-oncological breast surgery is of paramount importance. METHODS: All public plastic surgery and breast surgery departments and all private clinics or hospitals providing plastic surgery were asked two questions: 1) When do you recommend a mammography prior to non-oncological breast surgery? 2) How old must a mammogram be before it needs to be repeated? RESULTS: Answers were received from all plastic surgery and breast surgery departments, and all but three of the private clinics and hospitals. Overall, information was obtained from 95.5% of the respondents (n = 63). CONCLUSION: Currently, there are no Danish guidelines on mammography before non-oncological breast surgery. A national guideline could recommend a preoperative mammogram from the age of 40 years stipulating that the mammogram should have been made within the past 12 months; however, the final recommendation should be prepared by a multidisciplinary working group counting experts from plastic surgery, breast surgery, pathology and radiology. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Attachment-oriented psychological intervention for couples facing breast cancer: protocol of a randomised controlled trial.

BACKGROUND: There is evidence that both breast cancer patients and their partners are affected emotionally, when facing a breast cancer diagnosis. Several couple interventions have been evaluated, but there is a need for couple intervention studies with a clear theoretical basis and a strong design. The Hand in Hand intervention is designed to enhance interdependent coping in the couples and to address patients and partners that are both initially distressed and non-distressed. METHODS: The Hand in Hand study is a randomised controlled trial among 199 breast cancer patients and their partners. Couples were randomised to 4-8 couple sessions with a psychologist in addition to usual care, or to usual care only, approximately 2 months after the patients' primary surgery date. The intervention was delivered within 3 months, and outcomes were assessed prior to randomisation and 5 and 10 months after primary surgery date. The primary outcome is patients' cancer-specific distress at the 5-month follow-up measured by the Impact of Event Scale. Secondary outcomes are assessed for both breast cancer patients and partners. These outcomes are: general distress, symptoms of anxiety and depression, health-related quality of life and measures of dyadic adjustment, intimacy and partner involvement. Cancer-specific distress is also assessed for partners. Eligible patients were women ≥ 18 years newly diagnosed with primary breast cancer, cohabiting with a male partner, having no previous cancer diagnoses, receiving no neo-adjuvant treatment, having no history of hospitalisation due to psychosis, and able to read and speak Danish. Partners were eligible if they could read and speak Danish and were ≥ 18 years. DISCUSSION: This study investigates the effect of an attachment-oriented psychological intervention for breast cancer patients and their partners. The intervention has a theoretical framework and a strong design. If proven effective, this intervention would be helpful in optimising psychosocial care and rehabilitation of couples coping with breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01368380.