From clinical trials to clinical practice: the use of everolimus and exemestane in the treatment of hormone receptor-positive metastatic breast cancer: real-world data.

Everolimus combined with exemestane can modulate endocrine resistance. The combination showed significant improvement in progression-free survival (PFS) in phase III clinical trials for hormone receptor positive metastatic breast cancer patients. It also showed serious adverse events. We evaluate the efficacy and prevalence of serious adverse events in a real-world setting. We retrospectively examined 91 breast cancer patients; all were previously treated with chemotherapy and fulvestrant (84% and 59%, respectively). After a 13-month median follow-up, 29% had a partial response, and 32% had stable disease. The PFS was 7.8 months. Due to adverse events, 19% of patients stopped the treatment, while 31% required a dose reduction. Despite enrolling heavier-pretreated patients, our real-world outcome for the efficacy and safety of the exemestane and everolimus match those of the clinical trials. Such results should assure clinicians and lead to wider adoption of this oral, chemotherapy-sparing regimen.

Effect of level of hormone-receptor expression on treatment outcomes of "triple-positive" early-stage breast cancer.

PURPOSE: Breast cancer that overexpresses the human epidermal growth factor receptor-2 (HER2) and both estrogen (ER) and progesterone (PR) receptors is recently recognized as a subtype (triple-positive) with distinctive behavior and response to treatment. In this study, we investigate the treatment outcomes and the beneficial effect of anti-HER2 treatment in relation to level of hormone-receptor (HR) expression. METHODS: Consecutive breast cancer patients with triple-positive disease, diagnosed, treated and followed at our institution between 2006 and 2016 were enrolled. Disease-free survival (DFS) was studied in relation to the level of HR-positivity. RESULTS: During the study period, a total of 312 were enrolled; median age (range) was 47 (20-83) years. Fifty (16.0%) of the enrolled patients received adjuvant chemotherapy without trastuzumab (cohort A). All remaining patients were treated with both chemotherapy and trastuzumab and were divided into two groups: Cohort B with both ER and PR scores ≥ 50% (n = 130, 41.7%) and Cohort C with ER and/or PR < 50% (n = 132, 42.3%). After a median follow-up of 47 months, 14 (28.0%), 30 (23.1%) and 20 (15.2%) patients in cohorts A, B, and C had an event in a form of local/system relapse or death while disease-free. The estimated 5-year DFS was 56.2%, 75.4%, and 80.8%, respectively, and at 7 year was 56.2%, 67.1%, and 78.0%, respectively (p < 0.001). CONCLUSIONS: HER2-positive tumors are not homogeneous; stronger ER/PR co-expression may weaken the beneficial effect of anti-HER2 therapy. Such findings may have potential implication on modifying anti-HER2 treatment based on the strength of HR expression.

Tumor characteristics and treatment outcomes of older patients with breast cancer in Jordan.

BACKGROUND: Less than 10% of newly diagnosed breast cancer cases in Jordan are diagnosed in women 70 years or older. Treatment plans of such patients is less clear and could result in poor outcomes. In this paper, we describe clinical presentation, tumor characteristics and treatment outcomes in this population of breast cancer patients. METHODS: Consecutive patients aged 65 years or older with pathologically-confirmed diagnosis of breast cancer were included. Medical records and hospital databases were searched for patients' characteristics and treatment outcomes. RESULTS: A total of 553 patients, mean age ± SD (71 ± 5.1) years, were included. On presentation, 114 (20.6%) patients had metastatic disease and was mostly visceral (81; 71.1%). Patients with non-metastatic disease had poor pathological features including node-positive in 244 (55.6%), high grade (grade III) in 170 (38.7%) and lymphovascular invasion in 173 (39.4%). Patients were treated less aggressively; 144 (32.8%) patients with early-stage disease and 98 (86.0%) with metastatic disease never had chemotherapy. After a median follow up of 45 months, 5-year overall survival for the whole group was 67.6%. Survival was better for patients with non-metastatic disease (78.8% vs. 25.4%, P < 0.001) and for those with node-negative compared to node-positive disease (85.4% vs. 74.1%, P = 0.002). On Cox regression, only positive lymph nodes were associated with poor outcome in patients with non-metastatic disease (Hazard Ratio [HR], 1.75; 95% CI: 1.006-3.034, P = 0.048). CONCLUSIONS: Older Jordanian patients with breast cancer present with more aggressive features and advanced-stage disease that reflect poorly on treatment outcomes. Older patients were treated less aggressively with less than a third received any chemotherapy.

Clinicopathological Characteristics And Treatment Outcomes Of Breast Cancer Among Adolescents And Young Adults In A Developing Country.

PURPOSE: Compared to Western societies, breast cancer diagnosis in our region is usually made at a younger age and at a more advanced stage. Breast cancer in younger patients tends to be more aggressive, and may result in a higher likelihood of long-term treatment-related toxicity and unique psychosocial problems. This study highlights the clinicopathological features and treatment outcomes in this age-group in a developing country like ours. METHODS: Consecutive patients aged 40 years or younger with a pathologically confirmed diagnosis of breast cancer treated and followed up at our institution were included. Medical records and hospital databases were searched for patients' characteristics and treatment outcomes. RESULTS: A total of 417 patients were enrolled. Median age at diagnosis was 35 (21-40) years. On presentation, 63 (15.1%) patients had metastatic disease, 50 (79.4%) with visceral metastasis. Patients with nonmetastatic disease had poor pathological features, including node-positivity (66.9%), grade III (51.4%), lymphovascular invasion (48.6%) and positive HER2 (31.5%). Breast-conserving surgery was performed on 32.9%, and only 36.5% of women had breast-reconstruction surgery. At a median follow-up of 59 months, 5-year overall survival for the whole group was 72%: 84% for nonmetastatic and 13% for those with metastatic disease. On Cox regression, nodal metastasis (adjusted HR 3.46, 95% CI 1.48-8.10; p=0.004) and grade III disease (HR 1.97, 95% CI 1.14-3.39; p=0.015) were associated with poor outcome. CONCLUSION: Adolescents and young Jordanian adults with breast cancer present with more advanced-stage disease and more aggressive pathological features that reflect poorly on treatment outcomes.

From clinical trials to clinical practice: outcome of NSABP-B27 neoadjuvant chemotherapy regimen for high-risk early-stage breast cancer.

PURPOSE: Majority of Jordanian breast cancer patients present at a relatively young age and with locally advanced disease highlight the importance of neoadjuvant chemotherapy. This study evaluated the efficacy and safety of NSABP-B27 regimen in high-risk patients in daily clinical practice. METHODS: Patients' medical records and hospital database were searched for all consecutive patients treated at our institution for breast cancer using neoadjuvant NSABP-B27 chemotherapy regimen. Chemotherapy was given at standard doses and schedule as originally reported in the NSABP-B27. RESULTS: 346 female patients (median age 51 years) were treated using this regimen. Majority had high-risk features including larger tumor size (>4 cm in 68.5%), positive axillary lymph nodes (78.3%), and Grade III disease (47.4%). While most patients tolerated and completed planned chemotherapy, 41 (11.8%) patients failed to complete all four cycles of docetaxel. Following neoadjuvant chemotherapy, complete pathological response (pCR) was achieved in 84 (25.0%) evaluable patients; pCR was higher in hormone receptor-negative disease (40.0 vs. 22.1%, p = 0.002), in patient with tumor size ≤4 cm (28.3 vs. 23.5%, p = 0.024) and in patients with node-negative disease (41.2 vs. 20.7%, p = 0.002). Age (<50 vs. ≥50) had no effect, with pCR of 24.2 and 26.4%, respectively (p = 0.607). Breast-conserving surgery was performed in 85 (24.6%). CONCLUSIONS: NSABP-B27 is an effective neoadjuvant regimen. Despite including higher risk patients, pCR is similar to the original NSABP-B27 and many other anthracycline-taxane-based regimens. Tumor size, LN status, hormone receptors status, but not age, were significant factors in achieving pCR.

Cytomegalovirus Reactivation in Adult Recipients of Autologous Stem Cell Transplantation: a Single Center Experience.

INTRODUCTION: Cytomegalovirus (CMV) reactivation and infection are well-recognized complications after allogeneic stem cell transplantation (SCT). Only a few studies have addressed CMV reactivation after autologous SCT (ASCT). METHODS: We retrospectively reviewed medical records of 210 adult patients who underwent ASCT for lymphoma or multiple myeloma (MM) at a single center from January 1(st), 2007 until December 31(st), 2012. All patients were monitored weekly with CMV antigenemia test till day 42 after transplantation, and for 2 months after last positive test in those who had any positive CMV antigenemia test before day 42. RESULTS: Thirty-seven (17.6%) patients had CMV reactivation; 23 patients had lymphoma while 14 had MM as the underlying disease. There was no difference in the rate of CMV reactivation between lymphoma and MM patients (20% versus 14.7%, P = 0.32). The majority of the patients were treated with ganciclovir/valganciclovir, all patients had their reactivation resolved with therapy, and none developed symptomatic CMV infection. None of the patients who died within 100 days of transplantation had CMV reactivation. Log-rank test showed that CMV reactivation had no effect on the overall survival of patients (P values, 0.29). CONCLUSION: In our cohort, CMV reactivation rate after ASCT was 17.6%. There was no difference in reactivation rates between lymphoma and MM patients. With the use of preemptive therapy, symptomatic CMV infection was not documented in any patient in our cohort. CMV reactivation had no impact on patients' survival post ASCT.