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Introduction Phase II clinical trials including geriatric assessment (GA) measures are critical for improving the evidence base for older adults with cancer. We assessed the efficacy and tolerability of nab-paclitaxel in older adults with metastatic breast cancer (MBC). Patients and Methods Patients aged ≥ 65 years with MBC and ≤ 1 previous line of chemotherapy received 100 mg of nab-paclitaxel on days 1, 8, and 15 of a 28-day cycle. A GA was completed pre-chemotherapy, and the validated Cancer and Aging Research Group (CARG) chemotherapy toxicity risk score was calculated. Relationships between tolerability (number of courses, hospitalizations, dose reductions, and toxicity) and risk score were assessed using general linear models, Student t tests, and the Fisher test. Response rate and progression-free survival were evaluated using the Kaplan-Meier method. Results Forty patients (mean age, 73 years; range, 65-87 years) were included. The median number of cycles was 6, 75% (n = 30) of patients had ≥ 1 dose hold, and 50% (n = 20) had ≥ 1 dose reduction. Fifty-eight percent (n = 23) had treatment-related ≥ grade 3 toxicities, and 30% (n = 12) were hospitalized owing to toxicity. Thirty-five percent (n = 14) responded, and the median progression-free survival was 6.5 months (95% confidence interval, 5.5 months to undefined). Patients with intermediate/high toxicity risk scores had higher risk of grade ≥ 3 toxicity than those with low risk scores (odds ratio, 5.8; 95% confidence interval, 1.3-33.1; P = .01). A higher mean risk score was associated with higher likelihood of dose reductions and hospitalizations. Conclusions Among older adults with MBC receiving weekly nab-paclitaxel, more than one-half experienced ≥ grade 3 chemotherapy toxicity. However, a GA-based risk score could predict treatment tolerability.

Purpose The purpose of this study was to determine the incidence of metastatic bone disease (MBD), the frequency of intravenous (I.V.) bisphosphonate use and its impact on skeletal-related events (SREs), and opioid use. Patients and Methods Patients diagnosed with MBD between 2000 and 2004 were identified using 2 Thomson MarketScan® Research Databases. A total of 6783 patients, 1431 with breast cancer, fulfilled the criteria. Pain was assessed as the number of days on opioids, the strength of which was categorized according to the World Health Organization 3-step ladder for pain. Results Use of I.V. bisphosphonates steadily increased for all cancers from 17% in 2000 to 38% in 2004. For all patients, 61% received mild opioids and 35% received moderate to severe opioids at baseline. Use of I.V. bisphosphonates within the first 90 days after diagnosis of MBD was associated with a 63% decrease in SREs and reduction in use of moderate to severe opioids. Among patients with breast cancer, 10.6% received oral bisphosphonates before diagnosis of MBD, and 33.8% had pain at baseline. There was a 5.4% reduction in the use of moderate to severe opioids. Conclusion Our data support the role of I.V. bisphosphonates in decreasing SRE and improving the quality of life for patients with MBD; the result is less pain and fewer SREs. More than 73% of all patients and 53% of patients with breast cancer never receive I.V. bisphosphonate treatment. Educational measures are warranted to increase the awareness by patients and physicians of the value of I.V. bisphosphonates in MBD.

Introduction This study evaluated the association between aromatase inhibitor (AI) therapy and cognitive function (over a 6-month period) in a cohort of patients aged ≥ 60 years compared with an age-matched healthy control group, and it evaluated changes in regional cerebral metabolism as measured by positron emission tomography (PET) scans of the brain done in a subset of the patient cohort. Patients and Methods Thirty-five patients (32 evaluable) and 35 healthy controls were recruited to this study. Patients with breast cancer completed a neuropsychological battery, self-reported memory questionnaire, and geriatric assessment before initiation of AI therapy and again 6 months later. Age-matched healthy control participants completed the same assessments at the same time points as the patient group. Results No significant decline in cognitive function was seen among individuals receiving an AI from pretreatment to 6 months later compared with healthy controls. In the PET cohort over the same period, both standardized volume of interest and statistical parametric mapping analyses detected specific changes in metabolic activity between baseline and follow-up uniquely in the AI patients, most significantly in the medial temporal lobes. Conclusion Although patients undergoing AI treatment had few changes in neuropsychological performance compared with healthy controls over a 6-month period, regionally specific changes in cerebral metabolic activity were identified during this interval in the patient group. Additional longitudinal follow-up is needed to understand the potential clinical implications of these findings.

Purpose We investigated the efficacy and toxicity of sorafenib, a multikinase inhibitor of vascular endothelial growth factor receptor tyrosine kinase, in combination with vinorelbine therapy in a phase I/II trial in patients with metastatic breast cancer. Patients and Methods We enrolled 11 patients in the phase I portion to determine the maximum tolerated dose (MTD) of the combination, followed by 35 extra patients treated at the MTD in phase II. The median age of patients was 54 years old (range, 31-72 years old). Tumors were estrogen receptor and progesterone receptor (ER/PR) positive in 54% (22/54) of patients, and triple negative (ER − , PR − , HER2 − ) in 41% (17/54) of patients. Of all patients, 22% received sorafenib and vinorelbine as first-line therapy, 37% as second-line therapy, and 41% as third-line therapy. Results In total, 41 patients were treated at the MTD (6 during phase I; 35 in phase II). The observed 44% 4-month progression-free survival rate was similar to the estimated historical rate of 43% with vinorelbine treatment. The combination was tolerated with expected toxicities. Patients treated at the MTD who had received prior bevacizumab treatment received a median of 1.5 cycles (range, 1-10 cycles) compared with a median of 5 cycles (range, 2-12 cycles) for patients without prior bevacizumab treatment. Conclusion Further evaluation of vinorelbine and sorafenib in bevacizumab-naive patients may be of interest if specific biomarkers guiding patient selection can be identified.

Fatigue is a common complication of adjuvant chemotherapy and compromises the quality of life of breast cancer survivors. We sought to correlate serial hemoglobin (Hb) levels with fatigue in a population of women on adjuvant chemotherapy, none of whom received erythropoietin-stimulating agents or red blood cell transfusions.Seventy-five women participated in a study using quality-of-life questionnaires to assess changes in need for psychosocial support over time. Questionnaires were administered within 30 days of initiating adjuvant therapy and at 2, 6, and 12 months. Fatigue was assessed by the 36-Item Short-Form Health Survey (SF-36). Hemoglobin levels at each time point were captured retrospectively. Complete data are included for 40 of the 46 women who received adjuvant chemotherapy. Paired-samples t tests were conducted to compare mean SF-36 Energy/Fatigue scores between time points, and independent-samples t tests were conducted for comparisons against norms. Simple correlations (Pearson R) were conducted between SF-36 variables and Hb levels at each time point.At 2 months, 23.4% of women had Hb11 g/dL compared with 12.9% at 12 months. Compared with norms for women in the general population and breast cancer survivors, these women reported worse fatigue at baseline and at 2 and 6 months. A strong linear relationship was observed between Hb at 2 months and SF-36 Energy/Fatigue scores at 12 months (r=0.71; P=.002).Participants with high fatigue at 12 months had Hb levels at 2 months 13% lower than those with low fatigue. This finding suggests that chemotherapy-induced decline in Hb might be a marker of physiologic reserve.

Our objective was to review the presentation and management of patients with tubular breast cancer treated at Barnes-Jewish Hospital and compare our findings with the available literature. Of 3908 cases of breast cancer treated at our institution between 1986 and 1995, the incidence of tubular breast cancer at Barnes-Jewish Hospital was 1.25%. We reviewed the breast cancer risks, initial presentation, treatment, and outcome of 39 women with 40 tubular breast cancers and compared our series with others in the literature. The mean patient age was 67 years, which is older than most other series. Twenty-nine of the 39 cancers (74%) were detected by screening mammography; the remainder presented with a palpable breast mass. The mean tumor size was 8 mm (range, 1-60 mm). Twenty-three of 25 tumors were ER+ (92%) and none had axillary nodal involvement. Bilateral breast cancer developed in 3 patients (8%). An additional 500 cases of tubular breast cancer have been described in the literature. When the component of the invasive tumor is > 75% tubular carcinoma, most patients present with early-stage disease that is ER+ in 47 of 56 tumors (84%). The natural history is indolent and metastases are rare. Bilateral breast cancer developed in 58 of the 540 cases (11%), 4 of which were tubular carcinomas. Local recurrences developed in 9 of 29 patients (31%) treated by excision alone. The role of tamoxifen has not been determined. Given the available data, the initial surgical staging and management of tubular carcinoma should be identical to other invasive histologies.