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This phase II study of liarozole fumarate (R85246, liarozole), a novel imidazole with retinomimetic and aromatase inhibitory effects, was designed to determine the efficacy and tolerability in postmenopausal women with advanced breast cancer in progression, to correlate these effects with hormonal levels, and to evaluate quality of life. Twenty-nine women with ER-positive or unknown metastatic disease who received > or = 2 prior hormonal therapies were treated with 150-300 mg liarozole twice daily until disease progression. All patients were evaluable for toxicity and 25 for response. Four patients (16.0%, 95% CI 5.3-37.4%) had partial remission (PR) of their disease for a median of 7.4 months (range 1.2-12.9) and 7 (28%) had disease stabilization for a median of 4.8 months (1.6-16.0). Estradiol decreased from pre-treatment levels of 9.2-52 pM (mean 17.1) to below detection (9.2 pM, p = 0.0005) after 1 month. Similarly estrone levels fell from 14-307 pM (mean 92.7) to below detection (9.2 pM, p = 0.0001). The most common toxicity was dermatological (96.6%) with features compatible with hypervitaminosis A syndrome such as rash, pruritus, dry skin, and brittle nails. The majority of these were mild to moderate in severity. No significant improvement in quality of life scores (FLI-C) were noted. Liarozole is an active new treatment for breast cancer in patients heavily pre-treated with hormone therapies. Further studies are needed to confirm its relative efficacy in both receptor positive and negative postmenopausal breast cancer.

Purpose/Objective In the United States over 40% of incident breast cancer diagnoses are in women over 65 years of age. Effective breast cancer treatments allow elderly patients to live long, healthy lives; questions regarding long-term quality of life are increasingly important. In women over 65, post-mastectomy breast reconstruction (PMBR) is uncommon with reported rates of 6-30%. The goal of this study is to report complication rates in elderly PMBR patients and to evaluate the impact of individual surgeons on PMBR in elderly patients. Material/methods We identified 19,417 Medicare beneficiaries diagnosed with localized breast cancer between 2005 and 2011 who underwent mastectomy. Medicare claims were used to identify PMBR, post-operative complications after PMBR (within 30 days of surgery), and long-term complications related to reconstruction (within three years following surgery). Mastectomy surgeon was identified from Medicare claims with surgeon characteristics identified through linkage to the American Medical Association (AMA) Masterfile. Multi-level, multivariable logistic models clustered by surgeon and geographic area were used to determine the impact of surgeons on the likelihood of reconstruction. The intraclass correlation coefficient (ICC) and median odds ratio (MOR) were used to describe the relative impact of the individual surgeon. The ICC estimates the proportion of variability explained by the surgeon on PMBR rates. The MOR quantifies the likelihood of a patient having a different PMBR outcome if the patient were to change surgeons (or geographic area); it is directly comparable to odds ratios. Odds ratios (OR) were used to describe the impact of fixed demographic and clinical covariates. Results Among the entire cohort, 1,234 (6.4%) patients underwent PMBR. The post-operative complication rate was 8.4% and the long-term complication rate was 19.9%. Eighteen percent of the variability in PMBR use was attributed to the individual surgeon (ICC 0.181). The MOR for surgeon was found to be 1.85 (95% CI [1.70,1.99]), indicating that a patient had an 85% chance of having a different outcome (receiving or not receiving PMBR) if the patient saw a different mastectomy surgeon. The MOR for geographic area indicated that a patient had a 32% chance of having a different outcome if the patient saw a surgeon in a different geographic area (1.32, 95% CI [1.17, 1.47]). Patients who were Asian, single, older, of lower socioeconomic status, and underwent radiation therapy were less likely to undergo PMBR. Patients who had pre-operative MRI or received chemotherapy were more likely to undergo PMBR. Patients who were treated by female surgeons or plastic surgeons were significantly more likely to undergo PMBR. Overall, the individual surgeon was the most predictive of PMBR, except for the use of pre-operative MRI and mastectomy surgeon's specialty being plastic surgery. Conclusion A small minority of older women undergo PMBR despite having low post-operative and long-term complication rates. The individual surgeon and geographic area significantly influences whether older breast cancer patients will undergo PMBR. Future research should focus on surgeon characteristics that may influence a patient's decision to undergo PMBR. Citation Format: Schoenbrunner AR, Fero KE, Boero IJ, Matsuno R, Kronstadt N, Lance S, Reid C, Wallace AM, Gosman AA, Murphy JD. Post mastectomy breast reconstruction in elderly women: Complications and the impact of individual surgeons [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-14-02.