[Show abstract][Hide abstract]ABSTRACT: The goal in breast conserving surgery (BCS) of ductal carcinoma in situ (DCIS) is removal of the tumor with a clear surgical margin. However, re-excision rates are regrettably high. To date, there are no adequate procedures for intraoperative margin assessment of DCIS. A multicenter, single arm study was conducted to evaluate the benefit of a novel device (MarginProbe(®)) in intraoperative margin assessment during BCS of DCIS, the associated reduction of re-excisions and the cosmetic outcome of the treated patients. We present results of 42 patients enrolled in 3 German institutions. The device was used as an adjunctive tool to standard of care. The device use was associated with a reduction in re-excision rates by 56%, from 39% to 17% (p = 0.018).
Full-text Article · Nov 2013 · Breast (Edinburgh, Scotland)
[Show abstract][Hide abstract]ABSTRACT: Background
We carried out a prospective clinical study to evaluate the impact of the Recurrence Score (RS) on treatment decisions in early breast cancer (EBC).Patients and methodsA total of 379 eligible women with estrogen receptor positive (ER+), HER2-negative EBC and 0-3 positive lymph nodes were enrolled. Treatment recommendations, patients' decisional conflict, physicians' confidence before and after knowledge of the RS and actual treatment data were recorded.ResultsOf the 366 assessable patients 244 were node negative (N0) and 122 node positive (N+). Treatment recommendations changed in 33% of all patients (N0 30%, N+ 39%). In 38% of all patients (N0 39%, N+ 37%) with an initial recommendation for chemoendocrine therapy, the post-RS recommendation changed to endocrine therapy, in 25% (N0 22%, N+ 39%) with an initial recommendation for endocrine therapy only to combined chemoendocrine therapy, respectively. A patients' decisional conflict score improved by 6% (P = 0.028) and physicians' confidence increased in 45% (P < 0.001) of all cases. Overall, 33% (N0 29%, N+ 38%) of fewer patients actually received chemotherapy as compared with patients recommended chemotherapy pre-test. Using the test was cost-saving versus current clinical practice.ConclusionRS-guided chemotherapy decision-making resulted in a substantial modification of adjuvant chemotherapy usage in node-negative and node-positive ER+ EBC.
[Show abstract][Hide abstract]ABSTRACT: Abstract Objective: The 21-gene assay (Oncotype DX Breast Cancer Test (Genomic Health Inc., Redwood City, CA)) is a well validated test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER+, HER2- early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany. Methods: A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy, and direct costs for patients with ER+, HER2-, node-negative, or up to 3 node-positive early-stage breast cancer. Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospective, multi-center trial in 366 patients. Transition probabilities and risk adjustment were based on published landmark trials. Costs (2011 Euros (€)) were estimated from a sick fund perspective based on resource use in patients receiving chemotherapy. Future costs and clinical benefits were discounted at 3% annually. Results: The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality-adjusted life expectancy by 0.06 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon. Clinical benefits were driven by optimized allocation of adjuvant chemotherapy. Costs from a healthcare payer perspective were lower with the 21-gene assay by ∼€561 vs standard of care. Probabilistic sensitivity analysis indicated that there was an 87% probability that the 21-gene assay would be dominant (cost and life saving) to standard of care. Limitations: Country-specific data on the risk of distant recurrence and quality-of-life were not available. Conclusions: Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival, quality-adjusted life expectancy, and be cost saving vs the current standard of care women with ER+, HER2- early-stage breast cancer.
[Show abstract][Hide abstract]ABSTRACT: Since cure is a rare event in metastasizing breast cancer, therapy has to focus on improving and sustaining quality of life. Progress in therapy during the last 10 years has increased mean survival time by 50%. Therefore systemic therapy is recommended for patients with metastasizing breast cancer. Therapeutic effect has to be monitored via controlling a lead metastasis (symptoms, tumor marker, metric measurement of metastases). Choice of therapy depends on an individual patient's needs. Benefit from treatment has to outweigh side effects. In women with receptor positive tumors endocrine therapy is primarily indicated because of its favorable benefit-toxicity-ratio. Expression of estrogen and progestin receptors has high predictive value. Endocrine treatment depends on menopausal status. In postmenopausal women 3rd generation aromatase inhibitors are first choice, Tamoxifen, Toremifen or fulvestrant second choice. When disease progresses again after remission or more than 6 months no change on a first line endocrine therapy, switch to a second line endocrine drug is recommended. In premenopausal women ovarian suppression is combined with Tamoxifen as first and with aromatase inhibitors as second line treatment. Chemotherapy is indicated either when remission is urgently needed, or if endocrine therapy is no longer effective, or in receptor negative cancers. Monochemotherapy is better tolerated, polychemotherapy shows a slight survival benefit, although with more toxicity. Monotherapy is therefore endorsed for patients with few symptoms, slow progression or ineffective endocrine treatment, polytherapy for cases with urgency for re-emission. Doses and schedule should be in accordance with established and published regimens. Chemotherapy is administered as long as benefit outweighs toxicity. Sustaining chemotherapy after best effect carries additional toxicity without increasing survival time. Therapy with trastuzumab is useful only in HER-2/neu-positive tumors and should be started as early as possible in metastatic disease either in combination with taxanes or as a monotherapy if patients are pretreated with anthracyclines and taxanes. The clinically most important side effect of trastuzumab is cardiotoxicity. Bisphosphonates are indicated in hypercalcemia, metastases-related bone pain, osteolytic metastases or in therapy-related osteoporosis. Therapy of choice in cases with symptomatic bone metastases or risk for pathologic fractures is radiation therapy. If fractures are imminent or existent, surgical therapy has to be considered instead of or together with irradiation. Multiple brain metastases are treated with whole brain irradiation. With an isolated brain filia surgery or stereotactic radiosurgery followed by percutaneous radiation is best choice. In selected cases a singular visceral metastasis may be treated by surgical excision. Approximately 50% of all breast cancer patients use complementary methods, in most cases with out knowledge of their oncologists. Therefore, physicians should actively ask their patients. Psychooncologic management by specialists should be integrated into the oncologic setting.