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Cancer survivors are often sedentary. Self-monitoring may promote physical activity through self-activation. We conducted a pilot trial to evaluate whether wearable activity tracker with personalized text message feedback would increase physical activity. We enrolled 30 patients with solid tumor cancers into a non-randomized prospective intervention trial (NCT02627079): 15 had completed treatment in the past year and 15 under active treatment. Each participant received an activity tracker and daily text messages personalized to their activity level. We assessed patient-reported outcomes and 6-min walk (6 MW) at baseline and 3 months. Twenty-six participants completed the study. There was substantial variation in baseline activity. Overall, 39% of participants increased their steps taken by at least 20%, and 23% increased their 6 MW distance by 20% or more. More participants who had completed treatment strongly agreed (73%) that the intervention increased their exercise levels than those receiving active treatment (47%). At 3 months, there was a significant improvement in median Beck Depression Inventory-II and Godin Leisure Index composite scores. At 6 months, 72% still wore their activity tracker at least 4 days per week. We found that the intervention was well-accepted with a high completion rate at 3 months and continued self-use at 6 months. In this pilot study of combined activity tracker and motivational messaging, we found a signal for increased physical activity over a 3-month period. Future research is needed to study this technique for its impact on activity and other physical and psychological measures of well-being. Activity tracker with personalized motivational messaging may be useful in promoting physical activity in cancer survivors.

Context Patients with advanced cancer face a life-limiting condition that brings a high symptom burden that often includes pain, fatigue, and psychological distress. Psychosocial interventions have promise for managing symptoms but need additional tailoring for these patients' specific needs. Patients with advanced cancer in the community also face persistent barriers—availability of interventions in community clinics as well as financial and illness-related factors—to accessing psychosocial interventions. Objectives The aim of the present study was to assess the feasibility and acceptability of telephone implementation of Engage, a novel brief combined Coping Skills Training and Acceptance and Commitment Therapy protocol, for reducing symptoms and increasing quality of life in community patients with advanced cancer. Methods Adult patients with advanced cancer receiving care in the community received Engage, four 60-minute manualized telephone sessions delivered by a trained psychotherapist and completed pretreatment and post-treatment assessments. Results Engage was feasible, achieving 100% accrual (N = 24) of a heterogeneous sample of patients with advanced cancer, with good retention (88% completed). Acceptability was demonstrated via satisfaction (mean 29 of 32; SD 2), engagement (95% attendance), and use of skills. Secondary analyses pointed to reductions in pain interference, fatigue, psychological distress, and improvements in psychological acceptance and engagement in value-guided activity after treatment. Conclusion Engage, our brief novel combined Coping Skills and Acceptance and Commitment Therapy intervention, demonstrated initial feasibility and acceptability when delivered over the telephone and increased access for community clinic patients with advanced cancer. Future research will assess the comparative efficacy of Engage in larger randomized trials.

Background As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. Methods/Design The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. Discussion As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. Trial registration This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.

Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-management strategies. This study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management behaviors. The telephone-based DCST protocol integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. A randomized clinical trial will test the DCST intervention plus diabetes education by comparing it to diabetes education alone. Symptoms, distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. This study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. Special considerations for this medically underserved population are also provided. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors. Trials registration: ClinicalTrials.gov , NCT02970344 , registered 11/22/2016.

The purpose of this study was to refine and test a mobile-health behavioral cancer pain coping skills training protocol for women with breast cancer and pain from medically underserved areas. Three focus groups (Phase 1) were used to refine the initial protocol. A single-arm pilot trial (Phase 2) was conducted to assess feasibility, acceptability, and changes in outcomes. The intervention was delivered at a community-based clinic via videoconferencing technology. Participants were women (N = 19 for Phase 1 and N = 20 for Phase 2) with breast cancer and pain in medically underserved areas. Major themes from focus groups were used to refine the intervention. The refined intervention demonstrated feasibility and acceptability. Participants reported significant improvement in pain severity, pain interference, and self-efficacy for pain management. Our intervention is feasible, acceptable, and likely to lead to improvement in pain-related outcomes for breast cancer patients in medically underserved areas. Implications for Psychosocial Oncology Practice Breast cancer patients being treated in medically underserved areas have a dearth of exposure to behavioral interventions that may improve their ability to manage pain. Evidence from this single-arm pilot trial suggests that our mobile-health behavioral cancer pain coping skills training protocol is acceptable and feasible in this vulnerable population. Appropriately adapted mobile-health technologies may provide an avenue to reach underserved patients and implement behavioral interventions to improve pain management.

BACKGROUND: Chemotherapy preference refers to a patient’s interest in receiving chemotherapy. This study examined whether chemotherapy preference was associated with toxicity, efficacy, quality of life (QoL), and functional outcomes during and after completion of adjuvant chemotherapy in older women with breast cancer. METHODS: This study is a secondary analysis of CALGB 49907, a randomized trial that compared standard adjuvant chemotherapy versus capecitabine in patients age 65 years or older with breast cancer. A subset of 145 patients completed a questionnaire to describe chemotherapy preference pre-treatment. The association of this pre-treatment preference with the patient’s perception of self-health, predicted and actual QoL, patient- and professional-reported toxicity, mental health, self-rated function, and survival was studied during and after treatment. RESULTS: The median age of patients was 71 years and 47% had a high preference for chemotherapy. On baseline demographics, the low preference group had a higher proportion of white patients (95% vs. 78%, p=0.004). Before treatment, low chemotherapy preference was associated with greater nausea/vomiting (p=0.008). Mid-treatment, low preference was associated with lower QoL, worse social, emotional and physical function (all p≤0.02) and worse nausea/vomiting, cancer symptoms and financial worries (all p

197 Background: Lung Cancer Screening provides a mechanism to detect lung cancers at stages more amendable to curative resection. Nonetheless, data suggests Low Dose Computed Tomography (LDCT) is underutilized as a screening tool; preventing medically eligible patients from diagnosis at earlier stages; leading to reduced treatment options and, ultimately, decreased survival. The Duke Cancer Network (DCN) consists of 12 affiliated cancer programs in 5 states. As several affiliates shared a common goal of improving the uptake of LDCT screening in the community, the DCN created a platform for process improvement in LDCT screening, individualized for participating sites. Methods: DCN-developed surveys for patients and providers explored attitudes toward LDCT screening, and identified targetable access issues and barriers to LDCT screening at DCN-affiliated community cancer centers (aCCC). Armed with the survey data, five aCCC self-selected to work with an experienced Quality/Process Improvement coach to develop individualized projects focusing on one or more aspects of the LDCT screening process. The Q/PI coaches utilized Bite-Size-QI software to facilitate the project and train participants in the QI/PI process. Results: Information from 312 patient and 28 of 50 surveyed providers identified numerous targetable LDCT screening barriers: lack of knowledge about and educational materials to address the benefits of LDCT and tools/analytics to track patients following LDCT screening. Additional, more systematic, barriers identified included: lack of consistent national guidelines for screening, variable insurance coverage and limited availability of smoking cessation programs. Five aCCC self-selected to create individualized process improvement activities were matched to experienced Q/PI coaches. Four sites completed the yearlong project. Three of the aCCC were able to realize improvement in LDCT screening rates with 38%, 27% and 8% increase in rates, respectively, despite overlap with COVID-19 driven shutdowns. Conclusions: An assessment of current state linked to formal Q/PI activities improved uptake of LDCT screening in the majority of participating community cancer programs despite limited resources. Geographically variable COVID-19 required closures did compromise the outcomes. The process led to creation of a number of tools and process improvements to increase awareness of LDCT screening through education and foster collaboration among providers with streamlined referral processes and improved mechanisms of tracking patients. Funding: Provided by AstraZeneca in collaboration with the Duke Cancer Network. Keywords: lung cancer, screening, community, oncology, improvement process, barriers.

PURPOSE Older women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years. PATIENTS AND METHODS Patients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician’s choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS. RESULTS The design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80; P = .03); breast cancer–specific survival rates were 88% and 82%, respectively (HR, 0.62; P = .03); and overall survival rates were 62% and 56%, respectively (HR, 0.84; P = .16). With longer follow-up, standard chemotherapy remains superior to capecitabine among hormone receptor–negative patients (HR, 0.66; P = .02), but not among hormone receptor–positive patients (HR, 0.89; P = .43). Overall, 43.9% of patients have died (13.1% from breast cancer, 16.4% from causes other than breast cancer, and 14.1% from unknown causes). Second nonbreast cancers occurred in 14.1% of patients. CONCLUSION With longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor–negative disease. Competing risks in this older population dilute overall survival benefits.

Background Women with breast cancer in medically underserved areas are particularly vulnerable to persistent pain and disability. Behavioral pain interventions reduce pain and improve outcomes. Cancer patients in medically underserved areas receive limited adjunctive cancer care, as many lack access to pain therapists trained in behavioral interventions, face travel barriers to regional medical centers, and may have low literacy and limited resources. mHealth technologies have the potential to decrease barriers but must be carefully adapted for, and efficacy-tested with, medically underserved patients. We developed an mHealth behavioral pain coping skills training intervention (mPCST-Community). We now utilize a multisite randomized controlled trial to: 1) test the extent mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress; 2) examine potential mediators of intervention effects; and 3) evaluate the intervention's cost and cost-effectiveness. Methods/design Breast cancer patients (N = 180) will be randomized to mPCST-Community or an attention control. mPCST-Community's four-session protocol will be delivered via videoconferencing at an underserved community clinic by a remote pain therapist at a major medical center. Videoconference sessions will be supplemented with a mobile application. Participants will complete self-report measures at baseline, post-intervention, and 3- and 6-month follow-ups. Conclusions mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas. This is one of the first trials to test an mHealth behavioral cancer pain intervention developed specifically for medically underserved communities. If successful, it could lead to widespread implementation and decreased health disparities.

e19218 Background: Lung cancer screening (LCS) has potential to detect earlier stage cancer, favorably impacting patient outcomes, however evolving data suggest that LCS is underutilized. Because LCS is an extensive process with diverse barriers specific to each clinical setting, a multidisciplinary quality improvement (QI) initiative was undertaken to develop and test LCS processes to improve effective LCS. Baseline findings and approaches are presented. Methods: To inform the development of effective strategies to improve LCS, a survey was developed to examine perceptions and barriers to LCS across a group of community oncology programs in the Duke Cancer Network (DCN). The survey analyzed contextual, institutional, and patient factors influencing utilization of LCS. Survey results were used to support purpose-driven multidisciplinary teams to develop site-specific improvement plans for LCS with the support of QI consultants from Bite-Size QI. Results: Surveys were sent to 62 administrators and providers at 12 community oncology programs, with 36 respondents across 9 sites. LCS rates ranged between 4%-16% at participating sites. Respondents identified the lack of processes and infrastructure to support LCS as the most common challenges. Processes related to identification of LCS candidates, conduct of shared decision-making (SDM), follow up of lung nodules, and recurring screens were named specifically. Contributing factors identified were lack of robust community outreach, patient education, and protocols for providers. With regard to SDM, both administrators and providers reported systematic issues including provider time constraints and nonexistent or inconsistent identification/tracking systems, with patient compliance and health literacy as further barriers. The lack of these processes not only affected patients receiving initial LCS, but also how recurrent screenings were tracked. Conclusions: Identifying challenges in processes facilitated creation of improvement projects for participating sites. Initial improvement projects focus on patient notification of LCS results through follow up letters, integration of tracking LCS into hospital systems, development of patient education, community outreach and smoking cessation programs. Follow-up analyses will be undertaken to evaluate each approach.

Adjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. The goal of this study is to test a novel, telephone-based coping skills training that teaches patients adherence skills and techniques for coping with problematic symptoms (CST-AET). Adherence to AET will be assessed in real-time for 18 months using wireless smart pill bottles. Symptom interference (i.e., pain, vasomotor symptoms, sleep problems, vaginal dryness) and cost-effectiveness of the intervention protocol will be examined as secondary outcomes. Participants (N = 400) will be recruited from a tertiary care medical center or community clinics in medically underserved or rural areas. Participants will be randomized to receive CST-AET or a general health education intervention (comparison condition). CST-AET includes ten nurse-delivered calls delivered over 6 months. CST-AET provides systematic training in coping skills for managing symptoms that interfere with adherence. Interactive voice messaging provides reinforcement for skills use and adherence that is tailored based on real-time adherence data from the wireless smart pill bottles. Given the high rates of non-adherence and recent recommendations that women remain on AET for 10 years, we describe a timely trial. If effective, the CST-AET protocol may not only reduce the burden of AET use but also lead to cost-effective changes in clinical care and improve breast cancer outcomes. Trials registration: ClinicalTrials.gov , NCT02707471 , registered 3/3/2016.

Many cancer survivors continue to smoke. Further, most survivors also report high levels of persistent pain and smoke in response to pain. The investigators tested the feasibility, acceptability, and preliminary efficacy of a smoking cessation program paired with a pain management program for cancer survivors. The investigators conducted a two-arm, wait-list randomized controlled pilot study in which they delivered a combined smoking cessation and pain management intervention. The investigators randomized 30 survivors (14 intervention and 16 wait-list control). Seventy-one percent of the survivors who received the intervention rated it as extremely useful (5 out of 5) in helping them quit smoking. Further, 86% would recommend the program to other survivors. Although we could not conduct inferential statistics, 14% of those in the intervention arm, compared to 6% in the control condition had biochemically validated cessation at 2-months post-randomization. Survivors in the intervention also reported less pain, had improvements in depressive symptoms, and better physical function than those in the control arm. Our pilot data suggest the feasibility, acceptability, and preliminary efficacy of this approach. The next step is to conduct a large randomized controlled trial to fully test the efficacy of the intervention. A combined smoking cessation and pain program might help improve both issues simultaneously.

Background: In CALGB-49907 (NEJM 2009;360:2055), older patients (pts) with ESBC were randomized to standard adjuvant chemo (AC or CMF versus capecitabine). The objective of this secondary QoL analysis is to assess if pts’ BL chemo preference (CP, defined as high or low), is associated with the following during and after completion of chemo: self and professional-reported toxicity, changes in mental health, function, QoL, recurrence-free (RFS) and overall (OS) survival. Patients and Methods: Of 633 trial pts 350 participated in the QoL substudy; 145/350 pts completed the BL assessment regarding CP. CP was measured by asking the amount of benefit women would require to choose adjuvant chemo in a hypothetical situation, irrespective of chemo agents. Women who chose chemo for an increase in OS of ≤12 months (mo) were designated as high chemo preference (HCP) and those who chose >12 mo were designated low chemo preference (LCP). CP associations were evaluated with: BL perception of self-health and perceived QoL on chemo; patient reported outcomes (PROs), changes in function and QoL (based on EORTC-QLQ-C30); anxiety and depression (Hospital Anxiety and Depression Scale); observed grade 3-5 adverse events (AEs) by NCI common toxicity criteria (CTC v2.0). Pts were assessed at midtreatment and at 1, 12, 18 and 24 mo post-treatment. Chi-square tests, t-tests, and Cox models were used for categorical, continuous, and time-to-event variables, respectively. Results: The demographic and tumor characteristics of women (median age 71) who provided CP at BL were not different from women in the QoL subset or from non-QoL pts. 68/145 (47%) women had a HCP. CP groups did not differ based on age, surgery type, tumor and nodal stage, hormone receptor status, performance status, chemo assignment, education, marital or employment status except the LCP group had a higher proportion of white women (95% vs. 78%, p=0.004). At BL, there were no differences in perception of self-health based on CP but women with LCP predicted QoL on chemo to be worse than women with HCP (p=0.006) and reported greater nausea/vomiting. Mid-treatment, LCP pts reported worse nausea/vomiting, financial worries, and cancer symptoms. Post-treatment, LCP pts had worse constipation (at 1 mo) and financial worries (at 24 mo). There were no differences based on CP for dyspnea, pain, fatigue, insomnia, anxiety or depression at any timepoint. Mid-treatment, LCP women reported lower QoL and worse social, emotional and physical function compared to HCP women. These scores were not significantly different after treatment completion. LCP women had significantly higher rates of grade 3-5 AEs (53 vs. 34%, p=0.02) during treatment but these did not persist post-therapy. CP was not significantly associated with OS (HR =0.75, p=0.36) or RFS (HR=0.94, p=0.84). Conclusions: LCP at BL was associated with lower QoL, worse physical symptoms, AEs and function mid-therapy, but not mental health. Mid-therapy declines in women with LCP largely reversed post-therapy. This information may be useful for oncology professionals to counsel older ESBC pts with LCP receiving adjuvant chemo. Citation Format: Ajeet Gajra, Linda McCall, Hyman B Muss, Harvey J Cohen, Aminah Jatoi, Karla V Ballman, Ann H Partridge, Linda Sutton, Barbara A Parker, Gustav Magrinat, Jaqueline M Lafky, Arti Hurria. Association of patient preference for adjuvant chemotherapy (chemo) at baseline (BL) with toxicity, mental health, function, quality of life (QoL) and survival in older women with early stage breast cancer (ESBC) [CALGB 49907 Alliance] [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-15-07.

Creating an effective platform for multidisciplinary tumor conferences can be challenging in the rural community setting. The Duke Cancer Network created an Internet-based platform for a multidisciplinary conference to enhance the care of patients with lung cancer. This conference incorporates providers from different physical locations within a rural community and affiliated providers from a university-based cancer center 2 hours away. An electronic Web conferencing tool connects providers aurally and visually.Conferences were set up using a commercially available Web conferencing platform. The video platform provides a secure Web site coupled with a secure teleconference platform to ensure patient confidentiality. Multiple disciplines are invited to participate, including radiology, radiation oncology, thoracic surgery, pathology, and medical oncology. Participants only need telephone access and Internet connection to participate.Patient histories and physicals are presented, and the Web conferencing platform allows radiologic and histologic images to be reviewed. Treatment plans for patients are discussed, allowing providers to coordinate care among the different subspecialties. Patients who need referral to the affiliated university-based cancer center for specialized services are identified. Pertinent treatment guidelines and journal articles are reviewed. On average, there are 10 participants with one to two cases presented per session.The use of a Web conferencing platform allows subspecialty providers throughout the community and hours away to discuss lung cancer patient cases. This platform increases convenience for providers, eliminating travel to a central location. Coordination of care for patients requiring multidisciplinary care is facilitated, shortening evaluation time before definitive treatment plan.

The NCCN Guidelines for Palliative Care provide interdisciplinary recommendations on palliative care for patients with cancer. The NCCN Guidelines are intended to provide guidance to the primary oncology team on the integration of palliative care into oncology. The NCCN Palliative Care Panel's recommendations seek to ensure that each patient experiences the best quality of life possible throughout the illness trajectory. Accordingly, the NCCN Guidelines outline best practices for screening, assessment, palliative care interventions, reassessment, and after-death care.

Purpose. For patients with metastatic colorectal cancer (mCRC), no standard therapy exists after progression on 5-fluorouracil, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab. Preclinical data demonstrated that combined vascular endothelial growth factor and mammalian target of rapamycin inhibition has greater antiangiogenic and antitumor activity than either monotherapy. A phase I study of bevacizumab plus everolimus demonstrated that the combination is safe; activity was seen in several patients with refractory mCRC. Methods. Fifty patients with refractory mCRC were enrolled and received bevacizumab at 10 mg/kg every 2 weeks and everolimus at 10 mg orally daily. Results. Of the 50 patients enrolled, the median age was 56 years and the median number of prior regimens was four. Forty-seven patients (96%) had prior bevacizumab exposure and 42 patients (84%) had documented progression on prior bevacizumab-based therapy. Forty-nine patients were evaluable for response; eight patients had minor responses (16%) and an additional 15 patients (30%) had stable disease (SD). No complete or partial responses were seen. The median progression-free survival interval was 2.3 months; however, 26% of patients achieved prolonged SD for ≥6 months, and three patients (6%) were on study for >1 year. The median overall survival duration was 8.1 months. The most common grade 1–2 toxicities were mucositis (68%) and hyperlipidemia (64%). Clinically significant grade ≥3 toxicities included hypertension (14%), fistula/abscess/perforation (8%), mucositis (6%), and hemorrhage (2%). Conclusions. Bevacizumab plus everolimus is generally tolerable but may have risks related to mucosal damage and/or wound healing. Bevacizumab plus everolimus appears to have modest activity in refractory mCRC in patients.

The purpose of this study was to evaluate the efficacy and safety of short-course bortezomib, melphalan, prednisone (VMP) in previously untreated multiple myeloma as frontline therapy for transplant-ineligible patients and induction prior to autologous stem cell transplantation (ASCT). Patients received up to 6 28-day cycles of bortezomib 1.3 mg/m(2), days 1, 4, 8, and 11, plus melphalan 6 mg/m(2) and prednisone 60 mg/m(2), days 1-7. After 2-6 cycles, eligible and consenting patients could proceed to ASCT. Responses were assessed by International Uniform Response Criteria. The primary endpoint was complete response (CR) rate with VMP. Forty-five patients were enrolled. Among 44 evaluable patients, response rate was 95%, including 18%or=CR (9% stringent CR), 27% very good partial responses (VGPR), and 50% partial responses (PR). Twenty patients proceeded to ASCT. Stem cell collection was successful in all; median yield was 5.6 x 10(6) CD34(+) cells/kg. Posttransplant response rates were 30%or=CR (10% stringent CR), 65% VGPR, and 5% PR. After median follow-up of 14.0/14.6 months, median time to progression and progression-free survival were both 19.8/27.9 months in non-ASCT/ASCT patients. Seven patients have died; 1-year survival rates were 82%/95% in non-ASCT/ASCT patients. The most common grade 3/4 toxicities were thrombocytopenia (20%), neutropenia (28%), and infection (9%). Peripheral neuropathy grade 2-4 was the most common nonhematopoietic side effect occurring 17 patients (38%), although it was typically reversible, and only 5 patients (11%) discontinued therapy as a result of it. Short-course VMP is highly effective and generally well tolerated, both as initial treatment in non-ASCT patients and induction prior to ASCT. VMP did not negatively affect stem cell collection. Longer follow-up and prospective phase III trials are required to validate these initial observations.

CHAMBER was a regional educational initiative for providers of care to patients with HER2+ breast cancer. The study goals were to (1) enhance testing for HER2/neu overexpression in patients with invasive breast cancer; (2) increase the appropriate use of targeted therapy for patients with HER2+ breast cancer; and (3) enhance patients' coping ability. This Performance Improvement Continuing Medical Education (PI-CME) initiative included clinical practice assessment, educational activities, and reassessment. Chart review revealed a high rate of HER2 testing (98%) before and after education. Targeted therapy for patients with HER2+ breast cancer declined after the program (from 96% to 61%), perhaps attributable to an increase in awareness of medical reasons to avoid use of targeted therapy. Assessment for patients' emotional coping ability increased after education (from 55% to 76%; P=.01). Rates of testing for HER2 amplification and assessment of emotional well-being after education were consistent with ASCO Quality Oncology Practice Initiative benchmark values. Documentation of actions to address emotional problems remained an area for improvement.

Study objectives: To explore the flow and time domain characteristics of resting tidal airflow profiles in the presence of obstructive airway disease. Methods: Spirometry was performed on 81 adults and 46 juveniles in the lung function laboratory. All the juveniles had cystic fibrosis (CF), as did some of the adults (n 25), with the remainder having either healthy lungs or COPD. Resting breathing profiles were recorded using a pneumotachograph. Thirteen flow and time domain parameters were extracted from each profile. Two new indexes were derived that are influenced by the shape of the post-peak expiratory flow portion of the expirogram. In this expirogram, the first index (change in post-peak expiratory flow at time 20% [TPPEF20]) describes early changes in post-peak flow, while the second index (change in post-peak expiratory flow at time 80% [TPPEF80]) describes later changes in flow. Multiple linear regression techniques were used to define the relationship between body size, flow and time domain parameters, and FEV1, a measure of obstructive airway disease. Results: In juvenile subjects with CF, body weight and the time to reach peak expiratory flow are the main correlates with FEV1 (adjusted r 2 0.74). The adult CF group are different with the expiratory flow index (TPPEF20) being the major correlate with FEV1 (adjusted r 2 0.77). In the COPD group, the second expiratory flow index (TPPEF80) is the major correlate instead (adjusted r 2 0.6). Conclusions: Using multiple linear regression techniques has allowed the description of the interrelationships between body size, age, and tidal breathing profile in obstructive airway disease. The relationship between the flow indexes TPPEF20 and TPPEF80 show that in adults with CF, the loss of expiratory flow braking is an important adaptation to disease, while in COPD pulmonary hyperinflation is the predominant factor. (CHEST 2004; 125:901–908)

TPS10128 Background: Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem, with rates of non-adherence ranging from 28% to 59%. Non-adherence to AET contributes to increased medical costs and increased mortality. Symptoms (e.g., pain, hot flashes, sleep problems, vaginal dryness) associated with AET are related to non-adherence and early discontinuation of treatment. Our goal is to test the efficacy of a novel self-management intervention (SMAET) that teaches patients skills for enhancing adherence to AET and coping with AET-related symptoms. Methods: Trial participants will be recruited from a tertiary care medical center and community clinics that are located in medically underserved areas. Target enrollment is 400 patients. Prospective participants must meet the following criteria: diagnosis of Stage I to III breast cancer; hormone receptor positive tumor; local definitive cancer treatment complete; within 12 months of beginning AET; have at least 18 months of AET recommended; and at least 21 years of age. We will test the effects of the SMAET intervention (n = 200) by comparing it to a general health education intervention (n = 200; attention control). The SMAET protocol includes 7 sessions providing systematic training in coping skills for managing symptoms that interfere with adherence and 3 maintenance calls delivered over 6 months by a nurse via the phone. The intervention also includes interactive voice messaging that is tailored based on real-time adherence data. The primary study outcome, adherence to AET, will be assessed in real-time for 18 months using wireless smart pill bottles (i.e., bottle opening and percent of pills remaining). Symptom interference will be examined as a secondary outcome and will be assessed over 18 months. If effective, the intervention may reduce the burden of AET use. Clinical trial information: NCT02707471.

Context Lung cancer is one of the most common cancers in the United States and is associated with high levels of symptoms, including pain, fatigue, shortness of breath, and psychological distress. Caregivers and patients are adversely affected. However, previous studies of coping skills training (CST) interventions have not been tested in patients with lung cancer nor have systematically included caregivers. Objectives This study tested the efficacy of a caregiver-assisted CST protocol in a sample of patients with lung cancer. Methods Two hundred thirty-three lung cancer patients and their caregivers were randomly assigned to receive 14 telephone-based sessions of either caregiver-assisted CST or education/support involving the caregiver. Patients completed measures assessing pain, psychological distress, quality of life (QOL), and self-efficacy for symptom management; caregivers completed measures assessing psychological distress, caregiver strain, and self-efficacy for helping the patient manage symptoms. Results Patients in both treatment conditions showed improvements in pain, depression, QOL, and self-efficacy, and caregivers in both conditions showed improvements in anxiety and self-efficacy from baseline to four-month follow-up. Results of exploratory analyses suggested that the CST intervention was more beneficial to patients/caregivers with Stage II and III cancers, whereas the education/support intervention was more beneficial to patients/caregivers with Stage I cancer. Conclusion Taken together with the broader literature in this area, results from this study suggest that psychosocial interventions can lead to improvements in a range of outcomes for cancer patients. Suggestions for future studies include the use of three-group designs (e.g., comparing two active interventions with a standard-care control) and examining mechanisms of change.

Several reports have suggested that breast cancer patients with elevated serum levels of interleukin-6 (IL-6) have a worse prognosis than patients with lower levels. We have studied IL-6 in breast cancer cell lines and have shown that autocrine production of IL-6 can confer multi-drug resistance in vitro by inducing multidrug resistance gene-1 transcription with subsequent overexpression of P-glycoprotein (PGP). Both IL-6 and PGP expression can be measured in malignant cells using immunohistochemical (IHC) techniques. We hypothesized that patients whose tumors expressed higher amounts of IL-6 or PGP would be less likely to respond to paclitaxel, an agent affected by the PGP pathway. If so, then IL-6 could serve as a predictive factor for paclitaxel sensitivity. Both IL-6 and PGP expression were measured in patients treated in a randomized trial that compared three doses of single agent paclitaxel (175, 210, and 250 mg/m(2) over 3 h every 3 weeks) in 469 women with metastatic breast cancer (CALGB 9342). No difference in complete and partial response was found among the three treatment arms. Tissue blocks in this trial were analyzed for IL-6 (154 patients) and PGP (149 patients) in paraffin-embedded sections from tumor samples; clinical characteristics of these patients were similar to the total sample of 469 patients. There were no significant differences among IL-6 or PGP scores whether measured as continuous or dichotomous variables, or by other scoring, and response to paclitaxel. In multivariate analysis neither IL-6 nor PGP was a significant predictor of time to progression or overall survival. IHC expression of IL-6 and PGP levels in tumor cells is not a predictive marker for response to paclitaxel in women with metastatic breast cancer.

Summary Advances in health care and changing demographics worldwide have led to an ageing population whose care at the end of life has become increasingly complicated. Clinicians face a difficult challenge in the effective management of symptoms and suffering of elderly patients with terminal cancer, against a backdrop of complicated family and social structures. We describe the most pertinent features of management of key symptoms, focusing on pain, dyspnoea, constipation, and anorexia–cachexia syndromes. We present a rational approach to nutritional issues along with a description of the psychosocial issues that must be included in the overall management of these patients.

PURPOSE: Eniluracil (776C85), a potent inactivator of dihydropyrimidine dehydrogenase, allows fluorouracil (5-FU) to be administered orally on a schedule that simulates continuous-infusion 5-FU. The primary objective of this study was to estimate the objective tumor response rate of orally administered eniluracil and 5-FU in the treatment of anthracycline- and taxane-resistant advanced breast cancer. PATIENTS AND METHODS: Patients with anthracycline- and taxane-resistant advanced breast cancer were enrolled onto this open-label, phase II, multicenter study. Patients received orally administered 5-FU 1.0 mg/m2 with eniluracil given in a 10:1 ratio (eniluracil:5-FU) twice daily for the first 28 days of each 35-day cycle. RESULTS: Eighty-four patients were enrolled. Eight partial responses were observed in 84 patients (10%; 95% confidence interval [CI], 4.2% to 17.9%), and 20 patients (24%) had stable disease. The median duration of partial response was 20.1 weeks (95% CI, 12 to 26.7 weeks). The median duration of progression-free survival and overall survival for all patients was 9.9 weeks and 40.4 weeks, respectively. Most adverse events were grade 1 or 2 in intensity. Diarrhea, nausea, malaise/fatigue, vomiting, and mucositis were the most common treatment-related nonhematologic adverse events. The most frequently occurring grade 3 or 4 treatment-related adverse events were malaise/fatigue and diarrhea, occurring in 17% and 7% of patients, respectively. The incidence of grade 3 or 4 hematologic toxicity was low. Grade 3 or 4 hyperbilirubinemia occurred in 17% of patients. CONCLUSION: Eniluracil–5-FU has modest antitumor activity and an acceptable safety profile in anthracycline- and taxane-resistant breast cancer. Treatment was convenient, and patient compliance was high.

Although most gynecologists recognize the importance of discussing hormonal replacement therapy (HRT) with their patients, the controversies regarding the association between HRT and cancers, the questions about HRT use in women with a high risk of breast cancer, and the increasing number of women with breast cancer and menopausal symptoms make HRT a significant cancer issue. The scope is immense and growing as the “baby boom” generation approaches menopause. Currently, over 30 million woman are postmenopausal, and the average life expectancy after menopause is 30 years.[1] Despite the well-recognized benefits of HRT with regards to heart disease and osteoporosis, concern about the risk of cancer seems to prevent some physicians from prescribing HRT and many patients from using HRT.

Purpose: The purpose of this trial was to evaluate tumor cytoreduction by all-trans retinoic acid (ATRA) in patients with metastatic breast cancer and to characterize the initial pharmacokinetics of this agent. Methods: The study was a single institution, phase II study. The treatment regimen consisted of ATRA administered orally at a dose of 50 mg/m2 three times a day for 14 consecutive days of a 21-day cycle. Cycles were repeated until disease progression, unacceptable toxicity or patient withdrawal. Plasma samples were obtained following the first dose of ATRA for pharmacokinetic analysis. Results: A total of 17 patients with metastatic breast cancer were enrolled in the study, and 14 completed at least one cycle of therapy and were evaluable for response. One patient achieved a partial response in soft tissue of 4 months duration. Three patients had stable disease for 4, 2, and 2 months duration. The remainder had progressive disease. ATRA was reasonably well tolerated. Pharmacokinetic analysis revealed a high degree of interpatient variability in systemic exposure following the initial dose of ATRA. Conclusions: We conclude, that in the dose and schedule tested, ATRA does not have significant activity in patients with hormone-refractory, metastatic breast cancer. Future studies should focus on more intensive investigation of those individuals with very high or low ATRA initial systemic exposure in the hope of expanding our understanding of ATRA's clinical pharmacology, ultimately leading to improved efficacy.

251 Background: Chemotherapy administration is a complex process involving several steps and checkpoints. Any of these can improve or delay efficiency in patients receiving timely care. We conducted a time study auditing delays to the start of chemo infusion to determine the main causes of treatment delays and identify areas for improvement. Methods: Within the Duke Oncology Network (DON), an outreach network assisting rural cancer clinics with clinical operations, we identified one site for the study. A DON nurse practitioner and chemotherapy nurse analyzed records from 157 patients who received intravenous (IV) chemotherapy from January to March of 2011. We collected data on timepoints from administrative schedules, nurses’ infusion records and faxes to and from the lab and pharmacy, and median times and ranges were calculated. Results: Causes of chemotherapy infusion delays can be investigated through usual patient and operational documentation. Clear and accurate data could be obtained regarding patient arrival times, time seated in infusion chair, time IV access was obtained, times labs were sent/resulted, times chemotherapy drugs were requested/received and times infusions were started. The longest delays generally involved the earlier steps, including from arrival to treatment start (see Table). Surprisingly, a thorough search did not find any literature-based benchmarks for comparison. Conclusions: It is logistically feasible and clinically helpful to conduct a time study of chemotherapy infusion delays by compiling data from timepoints available in infusion records, admin notations and faxed reports. Interestingly, in our study lab and pharmacy turnaround times were not the main cause of delays as initially expected, nor were MD visits. We identified concrete areas for improvement and will use this data to design a plan for administrators, nurses and clinicians to reduce delays to infusion start by 50%. [Table: see text]

325 Background: Creating an effective platform for multidisciplinary tumor conferences can be challenging in the rural community setting. The Duke Oncology Network, which is affiliated with hospitals in rural locations throughout North Carolina, created an internet-based platform for a multidisciplinary conference to enhance the care of lung cancer patients in the community. This conference incorporates providers from different physical locations within the community and affiliated providers from a university-based cancer center two hours away. An electronic approach connects providers through space and time vocally and visually. Methods: Development of the virtual conference began in February 2009. Biweekly conferences were set up using the Adobe Connect web conferencing platform. This provides a secure website and phone line to ensure patient confidentiality. Case information is de-identified and incorporated into a slideshow uploaded to the platform. Multiple disciplines are invited to participate, including radiology, radiation oncology, thoracic surgery, pathology, pulmonology, and medical oncology. Participants only need telephone access and internet connection to participate. Results: The first virtual tumor board occurred December 14, 2009. Patient histories and physicals are presented, and the web conferencing platform allows radiologic and histologic images to be reviewed. Treatment plans for patients are discussed, allowing providers to coordinate care among the different subspecialties. Patients are identified that need referral to the affiliated university-based cancer center for specialized services. Pertinent treatment guidelines and journal articles are reviewed. In 2011, there were 9-10 participants per session, with 2-3 cases presented, on average. Conclusions: The use of a web conferencing platform allows subspecialty providers throughout the community and hours away to participate in discussing lung cancer patient cases. This platform increases convenience for providers, eliminating travel time to a central location. Coordination of care for patients requiring multidisciplinary care is facilitated, shortening evaluation time prior to definitive treatment plan.

High-dose therapy plus autologous stem cell transplant (ASCT) is the standard of care for patients with multiple myeloma (MM) aged ≤65 years. Melphalan–prednisone (MP)-based therapy is the standard for non-ASCT candidates but is not typically used for transplant-eligible patients as prolonged therapy with melphalan can adversely affect stem cell collection. The phase 3 VISTA study demonstrated the superior efficacy of bortezomib plus MP (VMP) versus MP in previously untreated MM patients ineligible for ASCT. In this phase 2 study, we evaluated the efficacy of a shorter course of VMP on a different treatment schedule as induction therapy prior to ASCT or as frontline therapy in non- ASCT candidates. Patients aged ≥18 years with previously untreated MM received up to six 28-day cycles of bortezomib 1.3 mg/m2 IV, days 1, 4, 8, and 11, plus oral melphalan 6 mg/m2 and oral prednisone 60 mg/m2, days 1–7. After 2–6 cycles, ASCT-eligible patients could proceed to stem cell mobilization (G-CSF 10 mg/kg/day ± GM-CSF 250 mg/m2/ day or cyclophosphamide 4 g/m2 + GM-CSF) and conditioning with melphalan 200 mg/ m2 (140 mg/m2 if aged >65 years). Response was assessed every two cycles and post- ASCT by International Uniform Response Criteria. The primary end point was complete response (CR) rate to VMP. A total of 45 patients were enrolled; 27 were male. Median age was 63 years (range 33–75). MM subtype was 67% IgG, 16% IgA, and 9% each κ- and λ- light-chain; 37% of patients had ISS Stage III MM, 22% had ECOG performance status >1, and 70% had ≥40% plasma cells in bone marrow. In total, 20 patients proceeded to ASCT. Median duration of VMP was 4 cycles in both non-ASCT (range 1–6) and ASCT (range 2–6) patients. Response rate (best response) to VMP was 95% (42 of 44 evaluable patients), including 9% stringent CR (sCR), 9% CR (18% ≥CR [95% CI: 7%, 30%]), 27% very good partial response (VGPR), and 50% partial response (PR). Best response was achieved after cycle 2 in 10 patients, cycle 4 in 25 patients, and cycle 6 in 7 patients. All 20 ASCT patients had successful stem cell mobilization; median yield of CD34+ cells/ kg was 5.6 x 106 (range 2.3–12.2 x 106), in a median of 2 collection days. Post-transplant responses were 10% sCR, 20% CR, 55% VGPR, and 5% PR; the remaining 2 patients need further follow-up for response assessment. Response improved post-VMP to post-ASCT in 10 patients (6 PR to VGPR, 2 PR to CR, 2 VGPR to CR). After median follow-up of 14.0 months (range 7.4–47.7) and 14.6 months (range 8.2–42.9) in non-ASCT and ASCT patients, respectively, both median time to progression and progression-free survival were 19.8 months (95% CI: 14.3 months, not estimable [NE]) in non-ASCT patients and 27.9 months (95% CI: 14.6 months, NE) in ASCT patients. A total of 7 patients (5 non- ASCT, 2 ASCT) have died; 1-year survival rate was 82% (95% CI: 59%, 93%) in non- ASCT patients and 95% (95% CI: 69%, 99%) in ASCT patients. Most common grade 3/4 adverse events in all 45 patients during VMP therapy included peripheral neuropathy (24%), thrombocytopenia (20%), neutropenia (18%), and infection (9%). Only 1 patient had deep-vein thrombosis. In conclusion, VMP represents a highly effective therapy for previously untreated MM, with 45% of patients achieving VGPR or better, including 18% sCR/CR. Toxicities were predictable and generally manageable. Short-course VMP therapy did not negatively impact stem cell mobilization, supporting its use as induction therapy prior to ASCT. Very high post-transplant response rates were seen, with 85% of patients achieving ≥VGPR, including 30% sCR/CR. Since achievement of CR/VGPR is associated with improved long-term outcomes in MM, the preliminary outcome data presented here appear promising; however, longer follow-up is required.

Over the past 20 years, increasing attention has been paid to quality-of-life issues in oncology. As the hospice movement has grown in this country, palliative care has developed into an integral part (rather than the antithesis) of comprehensive cancer care. Palliative care must be integrated earlier into the continuum of cancer care, and palliative, symptom-modifying therapy should be provided simultaneously with disease-modifying therapy from diagnosis. The goal of the NCCN palliative care guidelines is to help assure that each patient with cancer experiences the best possible quality of life throughout the illness trajectory. These guidelines are intended to help oncology teams provide the best care possible for their patients with incurable cancer. For the most recent version of the guidelines, please visit NCCN.org

3541 Background: BV, a monoclonal antibody against vascular endothelial growth factor, provides a survival advantage when added to first line therapy for metastatic colorectal cancer. CAP allows for fluoropyrimide treatment without the inconvenience of an infusion pump. We aimed to investigate the combination of OX, CAP, and BV (XeloxA) as a more convenient and active regimen. Methods: Pts with untreated metastatic colorectal cancer received OX 85 mg/m2 d1, CAP 1000 mg/m2 BID d1–5 and 8–12, and BV 10 mg/kg d1. Cycles were repeated every two weeks. The starting dose of CAP was changed to 850 mg/m2 BID due to toxicity in the first 28 patients. Data were analyzed under an intention to treat method. Results: 50 pts received therapy (28M, 22F), median age 55 (range 24–81). Data were available on 49 pts. The most common toxicity was diarrhea, with 12/49 (24%) having grade 3 diarrhea, and 22% with grade 2. After the dose reduction of CAP, 3/21 (14%) pts had grade 3 diarrhea and 2/21 (10%) with grade 2 as compared to 32% grade 3 and 32% grade 2 at the higher dose. At the higher dose of CAP 4% of pts had grade 3 hand-foot syndrome (HFS) and 39% had grade 2. At the lower dose, 10% had grade 3 and 5% had grade 2. Other grade 3 toxicities were minimal, including neurotoxicity (8%), vomiting (6%), and neutropenia (4%). There were 23 responses, 1 CR and 22 PR (RR=47%; 95% CI: 33%-62%). 21 pts had stable disease (43%). Median progression free survival (PFS) was 10.7 months (95% CI: 8.6–13.6). Conclusions: XeloxA is a well tolerated, active regimen in the first line treatment of metastatic colorectal cancer. RR and PFS data approximate that of infusional 5-FU regimens in combination with BV without the necessity of an infusion pump. [Table: see text]