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Gabapentin is used for the treatment of hot flashes and neuropathic pain in breast cancer survivors, and is commonly used off-label for the treatment of anxiety. Yet, clinical trial evidence to support the use of gabapentin for anxiety symptoms is lacking. In a randomized, double-blinded controlled trial we compared 300 mg gabapentin versus 900 mg gabapentin versus placebo. Subjects were 420 breast cancer patients who had completed all chemotherapy cycles. Anxiety traits and current (state) anxiety were measured using the Speilberger Strait-Trait Anxiety Inventory at baseline, 4 and 8 weeks. Pain was measured at baseline using a 10-point scale. Analyses included analysis of covariance and ordinary least squares regression. At 4 weeks, state anxiety change scores were significantly better for gabapentin 300 and 900 mg (p = 0.005) compared to placebo. The magnitude of improvement was proportional to baseline state anxiety. At 8 weeks, the anxiolytic effects of gabapentin compared to placebo persisted (p < 0.005). We found no significant interactions. The lower dose (300 mg) was associated with the best treatment outcomes for all patients except those with the highest baseline anxiety. Given its similar pharmacology, efficacy in the treatment of hot flashes, and low cost, gabapentin may provide a low cost and parsimonious alternative treatment choice for breast cancer survivors presenting in primary care practices with anxiety symptoms. Gabapentin is effective for hot flashes, and, therefore, may provide therapeutic benefit for both anxiety and hot flashes at a generic drug price. For patients reluctant to take a controlled substance, such as a benzodiazepine, gabapentin may offer an alternative therapy. Similarly, patients with a history of substance use may benefit from gabapentin without risk of addiction or abuse. For cancer survivors experiencing both hot flashes and anxiety, gabapentin may provide a single effective treatment for both and is an alternative therapy for anxiety for patients unwilling to take a benzodiazepine or those with a history of substance use.

Background The purpose of this study was to determine the cardiac safety and clinical activity of trastuzumab and bevacizumab with docetaxel after epirubicin with cyclophosphamide (EC) in patients with HER2-positive locally advanced breast cancer (LABC) or pathologic stage 3 breast cancer (PS3BC). Patients and Methods Patients received every 3 week treatment with 4 cycles of EC (90/600 mg/m2) followed by 4 cycles of docetaxel (100 mg/m2). Targeted therapy with standard-dose trastuzumab with bevacizumab 15 mg/kg was given for a total of 1 year. Coprimary end points were (1) rate of cardiac events (CEs) in all patients defined as clinical congestive heart failure with a significant decrease in left ventricular ejection fraction or cardiac deaths; and (2) pathologic complete response (pCR) in breast and nodes in the neoadjuvant cohort. An independent cardiac review panel determined whether criteria for a CE were met. Results A total of 105 patients were accrued, 76 with LABC treated with neoadjuvant therapy and 29 with PS3BC treated with adjuvant therapy. Median follow-up was 59.2 months. Among 99 evaluable patients for cardiac safety, 4 (4%; 95% confidence interval [CI], 1.1%-10.0%) met CE criteria. The pCR percentage in LABC patients was 46% (95% CI, 34%-59%). Five-year recurrence-free survival (RFS) and overall survival (OS) for all patients was 79.9% and 90.8%, respectively. Conclusion The regimen met predefined criteria for activity of interest with an acceptable rate of CEs. Although the pCR percentage was comparable with chemotherapy regimens with trastuzumab alone the high RFS and OS are of interest in these high-risk populations.

Up to 38 % of prostate cancer survivors experience significant psychological distress; 6–16 % are diagnosed with depression or anxiety disorders. Support from a relationship partner can ameliorate psychological distress, but many studies treat relationship status as a dichotomous predictor without accounting for level of support provided by the partner. The current study is a secondary analysis of a sample of 292 prostate cancer survivors recruited by nine Community Clinical Oncology Program (CCOP) sites around the USA to a larger randomized controlled trial. Self-reported distress was measured at a baseline visit using the Profile of Mood States (POMS) and partner support was measured using the Social Network and Support Assessment (SNSA). Post hoc groups consisting of unmarried survivors, married survivors with low partner support (SNSA scores below the median), and married survivors with high partner support (SNSA scores above the median) were compared on distress using univariate and analysis of covariance (ANCOVA) analyses. Married prostate cancer survivors with high partner support reported significantly lower levels of psychological distress than the other two groups on the total distress scale (16.20–19.19 points lower, p

While the benefits of exercise for managing cancer and treatment-related side effects have been shown among various populations of cancer survivors, a relative dearth of information exists among older cancer patients. Objectives To determine the prevalence of exercise participation during and after primary cancer treatment in older (≥ 65 years) and the oldest (≥ 80 years) cancer patients and to examine the relationships between exercise, symptoms, and self-rated health (SRH). Materials and methods 408 newly diagnosed older cancer patients (mean age = 73, range = 65–92) scheduled to receive chemotherapy and/or radiation therapy reported symptoms and SRH prior to, during, and 6 months after treatment, and exercise participation during and following treatment. Results Forty-six percent of older and 41% of the oldest patients reported exercising during treatment. Sixty percent of older and 68% of the oldest patients reported exercising in the 6 months thereafter. Older patients who exercised during treatment reported less shortness of breath and better SRH during treatment, and better SRH following treatment. The oldest patients who exercised during treatment reported less memory loss and better SRH during treatment and less fatigue and better SRH following treatment. The oldest patients who exercised following treatment reported less fatigue, skin problems, and total symptom burden following treatment. Conclusion These data suggest a willingness of older cancer patients to attempt exercise during and after treatment. Exercise during these times is associated with less severe symptoms; further clinical research examining the efficacy of formal exercise interventions to reduce symptoms and improve SRH in older cancer patients is needed.

Cancer patients vary in their preferred level of involvement in medical decision making, and responding to patients' desired level of involvement is a key element of good medical care. While the literature has clearly demonstrated heterogeneity among cancer patients' preferences, less is known about how the preferences of any given patient may change over time. This longitudinal study compared cancer patients' preferences for involvement in medical decision making from the time of diagnosis to the time of completion of therapy. Data from 729 cancer patients with mixed diagnoses were analyzed. Most patients reported a change in preferred level of involvement over time, and multivariate analysis demonstrated that patients tend to prefer a decreasing level of involvement over time (p

Background: In diffuse large B-cell lymphoma (DLBCL), a MYC-rearrangement (MYC-R) is present in approximately 10% of cases and has been associated with an inferior outcome following R-CHOP chemotherapy. In a previous report that retrospectively analyzed the prognostic impact of a MYC-R on survival following DA-EPOCH-R, patients with a MYC-R had a similar outcome to MYC negative cases (4 year EFS of 83% versus 76% respectively: p=0.46 Ann Oncol 2011 (22) Suppl 4 # 71). We set out to prospectively validate these results in a multicenter study. Methods: Patients were newly diagnosed with DLBCL or B-cell lymphoma unclassifiable (BCL-U) with features intermediate between DLBCL and Burkitt lymphoma (BL). Only cases that harbored a MYC translocation by fluorescent in-situ hybridization (FISH) or conventional cytogenetic testing were included in this report. Treatment consisted of 6 cycles of DA-EPOCH-R. R esults: 52 patients were included in this preliminary analysis. Characteristics were median (range) age 61 (29-80) years; male sex 37 (71%); stage III or IV disease 38 (73%); IPI score 0-2 in 35% versus 3-5 in 65%; HIV positive 4 (7%). Histologic diagnosis was DLBCL in 45 (86%) and BCL-U in 7 (14%). All cases had a MYC-rearrangement. BCL2 was rearranged in 14/31 (45%) and overexpressed by IHC in 24/43 (56%) cases tested. There were 3 deaths secondary to infectious complications and otherwise toxicities were similar to previous reports of the regimen. At a median follow-up time of 14 months, progression-free survival (PFS), time to progression (TTP) and overall survival (OS) were 79%, 86% and 77% respectively for all patients. PFS was 87% and 64% in cases that were FISH positive (double-hit) and IHC positive for BCL2 respectively. Conclusions: Albeit short follow-up, DA-EPOCH-R in MYC-R DLBCL demonstrates promising activity in a multicenter prospective setting. Further analysis of this data is planned with central pathology review of cases and longer follow-up. The principal arm of this study testing the regimen in BL remains open to accrual (NCT01092182). Figure 1 Figure 1. Disclosures LaCasce: Seattle Genetics, Inc.: Research Funding.

9533 Background: Receiving a diagnosis of cancer can lead to psychological effects including symptoms of traumatic stress. Trauma symptoms can dysregulate sleep and sleep disturbance has been linked with negative health outcomes. Cancer-related trauma symptoms and sleep disturbance can affect the spouse of the cancer patient and the couple’s relationship; conversely, a supportive relationship can improve cancer survivors’ mental health. The impact of spousal support on trauma and sleep disturbance among prostate cancer survivors has not yet been examined. Methods: 315 prostate cancer survivors (mean age 66, 89% Caucasian), of whom 265 were married and 50 were unmarried (single, widowed, separated or divorced) completed the Impact of Events Scale (IES), Stanford Sleep Questionnaire, and a measure of positive spousal support. Data are self-report. Rates of trauma symptoms and sleep disturbance by marital status were compared using t-tests, and the contribution of marital status and spousal support to variance in these outcomes was evaluated using linear regression. Results: 13.4% of survivors reported significant (i.e., >27 point IES cutoff) symptoms of traumatic stress and 23.2% reported moderate or higher rates of sleep disturbance. Trauma symptoms (t= -2.16, p.05). Conclusions: Spousal support is associated with reductions in trauma and sleep disturbance, over and above dichotomous marital status. This area needs further study, given high rates of trauma symptoms and difficulty disclosing health-related concerns among men with prostate cancer. Future research needs to explore mechanisms by which spousal support leads to improvement in trauma symptoms and sleep outcomes. Interventions bolstering spousal support could improve mental health in prostate cancer survivors.

9141 Background: Hot flashes reduce quality of life (QOL) in women with breast cancer. In a randomized, double-blind, placebo-controlled trial of gabapentin for hot flashes, 900 mg of the drug was found to reduce hot flashes in women with breast cancer; however, their QOL of has not been studied. We conducted secondary analyses to study two domains of QOL: physical (PWB) and functional well-being (FWB) in women in this trial. Methods: A nationwide sample of women with breast cancer and hot flashes ≥ 2/day was studied at baseline (T1), 4 weeks (T2), and 8 weeks (T3) of treatment with gabapentin 300mg/day (G300) and 900mg/day (G900) in divided doses, and a matching placebo (PL). PWB and FWB were assessed via subscales of the Functional Assessment of Cancer Therapy-Breast. Linear mixed model analyses of PWB and FWB were conducted, adjusted for demographic and treatment variables. Results: The mean age of women (N=384) was 54.9 years ± 8.07 (range: 31-81, 72% >50 years); 76% were married; 71% had more than high school education; 95% were Caucasian and 3% African-American; 10% were undergoing chemotherapy, and 9% radiotherapy (RT). PWB showed significant time effect (p

9036 Background: The number of older (>65 yrs) and oldest old (>80 yrs) cancer patients (pts) is increasing. Older pts may have more side effects and functional deficits from treatments. Exercise (...

5067 Background: African American (AA) men are nearly twice as likely as white (W) men to be diagnosed with prostate cancer. Cancer-related self-efficacy (i.e., confidence in one's ability to manage cancer) has been associated with better physical and psychosocial functioning, but little is known about self-efficacy in African American prostate cancer patients. This study compared AA and W ratings of cancer-related self-efficacy for 308 prostate cancer patients (M age = 66.13, SD = 8.48; 9% AA) who participated in a group therapy intervention. Method: Independent groups t-tests were used to determine whether there were significant differences at baseline in mean scores for each group on the Stanford Self-Efficacy Scale (SSE), which asks respondents to rate their confidence in the ability to cope with cancer on a 0–100 scale, with 0 indicating no confidence. SSE subscales measure self-efficacy in the ability to: a) communicate with family, friends, and healtcare providers; b) focus and relax; and c) cope with the possibility of dying. Results: A significant difference was observed on SSE total scores (AA mean = 60.39 vs. W mean = 72.70; t = 3.30; p = 0.003). There were also significant differences on the Focus/Relax (AA mean = 68.90 vs. W mean = 77.64; t = 2.04; p = 0.011) and Cope with Dying (AA mean = 49.72 vs. W mean = 70.12; t = 4.85; p = 0.001) subscales, with a trend towards significance on the Ability to Communicate (AA mean = 62.55 vs. W mean = 70.76; t = 3.36; p = 0.095). Conclusions: Results suggest that, compared to W men, AA men have less confidence in their ability to cope with prostate cancer following diagnosis. AA men report the least confidence in their ability to cope with the possibility of death as a result of cancer, and they also report less confidence in their ability to focus and relax. They may also have greater difficulty discussing their cancer with family, friends, and healthcare personnel. As cancer-related self-efficacy has been linked to symptom-related and psychological adjustment, interventions targeting self-efficacy in AA prostate cancer patients are needed that are tailored to their unique needs. No significant financial relationships to disclose.