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Our study was designed to evaluate the efficacy and safety of everolimus in patients with pre-treated metastatic gastric and esophagus cancers in a US-based population focusing on biomarker correlation. Patients with advanced upper GI adenocarcinomas who progressed after 1–2 prior regimens received everolimus 10 mg PO daily. The primary endpoint was disease control rate (DCR). Secondary endpoints included progression-free survival (PFS), toxicity, overall survival (OS) and biomarker correlatives of the mTOR pathway. Target accrual was 50 patients based on one-sided type I error of 10 % and power of 90 %. Forty-five patients were evaluable, 21 gastric, 11 esophagus and 13 from the GEJ. The median age was 64 (range 38–73); all patients had an ECOG of 0 or 1; and 18 patients (40 %) had only 1 prior regimen. The most common grade 3–4 adverse events included fatigue (24 %) and thrombocytopenia (22 %). We observed 1 partial response with 39 % of evaluable patients having stable disease. Median OS was 3.4 months (95 % CI 2.7–5.6 months), and PFS was 1.8 months (95 % CI 1.7–2.2 months). There was a strong correlation between ≥2 + IHC staining for p-S6 in tumor samples with better PFS (p

Skin-sparing mastectomy (SSM), which involves the resection of the nipple/areolar complex with the breast parenchyma, improves the aesthetic outcome for breast cancer patients. Most patients undergoing SSM desire reconstruction of the nipple/areolar complex for symmetry. These data explore the possibility of preserving the areola in selected mastectomy patients.A retrospective analysis of 217 mastectomy patients was conducted to determine the frequency of malignant nipple and/or areola involvement. The association between nipple and/or areola involvement and prognostic factors, including tumor size, stage, nuclear grade, axillary nodal status, and tumor location, was evaluated.The overall frequency of malignant nipple involvement was 23 of 217 (10.6%). In a subgroup of patients with tumors2 cm, peripheral tumors, and with two positive nodes or less, the incidence of nipple involvement was 6.7%. When the nipple and areolar involvement were analyzed separately, only 2 of 217 patients had involvement of the areola (0.9%). All patients with areolar involvement had stage 3 breast cancer and were located centrally in the breast.We conclude from these data that nipple preservation is not a reasonable option for mastectomy patients. However, preservation of the areola with mastectomy in selected patients warrants further study.