Spine Pain and Metastatic Prostate Cancer: Defining the Contribution of Nonmalignant Etiologies.

PURPOSE: In patients with metastatic prostate cancer (MPC), the contribution of nonmalignant etiologies to morbidity is often overlooked. METHODS: We retrospectively reviewed the documented specialist assessments of back pain in men with MPC in a joint medical oncology and physiatry clinic at our tertiary cancer care center. Data on cancer disease extent, hormonal status, sites of spread, pain characteristics, physiatric examination findings, imaging, and recommended management were reviewed, extracted, and codified. For those with back pain at a site of known disease, pain etiology was classified as malignant, nonmalignant, or mixed. RESULTS: Ninety-three men were collaboratively assessed for back pain, 24 (26%) with a biochemical recurrence and 69 (74%) with MPC of whom 53 (77%) reported pain in an area of known spinal metastases including 35 (66%) metastatic castration-resistant disease and 34 (64%) a precancer history of back pain. The presenting pain symptoms of the 53 patients were activity-related in 22 (42%), radicular in eight (15%), transitional movement-related in seven (13%), biologic in five (9%), and multifactorial in 11 (21%). Overall, pain was deemed malignant in 20 (38%; five castration-sensitive, 15 metastatic castration resistant prostate cancer), nonmalignant in 12 (23%; four castration-sensitive, eight CRPC), and of mixed etiology in 21 (40%; nine castration-sensitive, 12 CRPC). CONCLUSION: Nonmalignant etiologies contributed significantly to back pain at sites of metastatic spread for 33/53 (62%) patients with MPC assessed by medical oncology and physiatry. We recommend multidisciplinary care for patients with MPC and back pain to address nonmalignant etiologies that contribute to functional compromise.

Joint pain and falls among women with breast cancer on aromatase inhibitors.

PURPOSE: Arthralgia is common among women with breast cancer on adjuvant aromatase inhibitor (AI) therapy. Pain is associated with falls in the general population; however, little is known about the relationship between arthralgia and falls among AI users. Our objective was to determine whether joint pain severity and interference predict future falls. METHODS: We conducted a prospective cohort study of postmenopausal women with stage I-III estrogen receptor-positive breast cancer who were prescribed a third-generation AI. Arthralgia symptoms were measured at baseline using a modified version of the Brief Pain Inventory. Fall occurrence was obtained at 24-month follow-up. RESULTS: Among 667 participants (median age 63 years, interquartile range 57-69 years), 232 (35%, 95% CI 31 to 39%) reported falls 12-24 months after baseline. Among women who fell, 65 (28%) reported seeking medical assistance. After controlling for multiple fall risk factors, we found significant non-linear associations between baseline joint pain severity and risk of falls (p = 0.001). Women with joint pain severity scores ≥ 4 had a more than twofold increase in fall risk compared to those without pain (41% vs. 20%). We observed a similar relationship for pain interference and fall risk (p < 0.001). Fewer than half of participants reported having been asked about falls in the past 12 months by their primary care physician (44%) or oncologist (36%). CONCLUSION: Joint pain increases the risk of falls among women with breast cancer on adjuvant AI therapy. Health care providers should evaluate and manage arthralgia symptoms and implement fall-prevention strategies for those who are at increased risk.

Repository corticotropin injection as adjunctive therapy in patients with rheumatoid arthritis who have failed previous therapies with at least three different modes of action.

OBJECTIVE: Many types of treatment are available for patients with rheumatoid arthritis (RA), however, some patients fail to achieve remission. This report aims to determine the safety and efficacy of using repository corticotropin injection (RCI) as an adjunctive therapy in patients with RA refractory to at least three therapeutics with different mechanisms of action. METHOD: In this open-label, interventional, single-group study, patients received 80 U RCI twice weekly via subcutaneous injection over 12 weeks. Changes in the Ritchie-Camp Articular Index and health assessment questionnaire scores were monitored for changes from baseline measures. RESULTS: Eight patients were enrolled and consisted of seven females and one male with an average age of 64.6 years and disease duration of 20.9 years. Use of RCI resulted in significant improvement in swollen and tender joint counts. The disease activity score 28 and the physician and patient visual analog scale scores were significantly reduced at treatment week 12. The reduction in health assessment questionnaire scores did not reach statistical significance after RCI treatment. Once RCI therapy was discontinued, all improvements in disease activity score 28, physician and patient visual analog scale, and tender and swollen joint counts achieved during treatment were lost by the week 16 follow-up visit. CONCLUSION: While larger clinical trials are necessary to further confirm the efficacy of RCI in patients with refractory RA, the response of patients with refractory RA in this study suggests that RCI can be an effective add-on therapy for patients who have exhausted several classes of treatments. Furthermore, this study suggests that RCI has an alternative mode of action, compared to other available antirheumatic drugs.

Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

IMPORTANCE: To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). OBJECTIVE: To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. DESIGN, SETTING, AND PARTICIPANTS: A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit. MAIN OUTCOMES AND MEASURES: Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). RESULTS: A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006). CONCLUSIONS AND RELEVANCE: Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.

Rehabilitation of the sarcoma patient-enhancing the recovery and functioning of patients undergoing management for extremity soft tissue sarcomas.

Although relatively rare, soft tissue sarcomas cause significant morbidity and mortality due to their advanced stage at initial diagnosis. Rehabilitation and surgical outcomes have traditionally focused on physical parameters to assess function and recovery, emphasizing return to ambulation, activities of daily living (ADLs) and community re-integration. Assessments of functional impairment and other quality-of-life parameters are necessary to better understand the experience of the patient with extremity soft tissue sarcoma and thereby improve outcomes.

The cancer psychosocial care matrix: a community-derived evaluative tool for designing quality psychosocial cancer care delivery.

OBJECTIVE: Although the Institute of Medicine provided a vision for effective psychosocial care for cancer survivors, limited guidance exists regarding the essential components of comprehensive care or progressive steps for implementing each component. This paper describes the development of a unique tool for assessing capacity to provide quality psychosocial care to cancer survivors and the results of the first implementation of this tool in community settings. METHODS: The psychosocial working group of the National Cancer Institute Community Cancer Centers Program (NCCCP) developed the Cancer Psychosocial Care Matrix assessment tool. All NCCCP sites (n=30, enrolled in 2007 nd 2010) completed the matrix indicating their capacity for providing psychosocial care at entry into NCCCP ('baseline') after 2 years of NCCCP participation (2007 sites only) and within the coming year ('future aspirations'). RESULTS: At baseline, matrix responses reflected few or no systematic processes in place for most components of comprehensive psychosocial care. However, reported capacity to deliver specific components improved at 2 years post-NCCCP entry for the 2007 sites and in all NCCCP sites' future aspirations. CONCLUSIONS: With growing demand on cancer centers to meet new metrics of quality care, the psychosocial matrix can help centers systematically identify and develop steps to address gap areas in their capacity to meet these new standards. The Cancer Psychosocial Care Matrix appears to enable evaluation of psychosocial programs, may promote intentions to improve psychosocial services, and can facilitate communication of 'best practices' among cancer centers.

Spinal accessory nerve monitoring with clinical outcome measures.

We conducted a prospective study of 11 patients to (1) determine the feasibility of electrophysiologic monitoring of the spinal accessory nerve (SAN) during modified radical neck dissection, (2) determine whether a threshold increase in current is required to stimulate the SAN by comparing the amount of current on initial identification of the SAN and the amount of current after completion of the dissection prior to closure, and (3) determine whether clinical outcome measures of shoulder syndrome at 72 hours and 45 days postoperatively are affected by a threshold increase. We found that 3 of 11 patients (27.3%) experienced significant threshold increases (>0.4 mA) on completion of the dissection. Of 8 patients who completed a shoulder syndrome evaluation, 3 (37.5%) had scapular winging, mild to moderate pain, and less than 90% of shoulder abduction. Two of 3 patients with shoulder syndrome had a threshold increase on electrophysiologic monitoring. We conclude that electrophysiologic monitoring of the SAN is feasible. It did not identify a threshold increase in more than 70% of patients. Electrophysiologic integrity of the SAN did not completely correlate with clinical outcome measures for shoulder syndrome.

Objective evaluation of physical function in patients with advanced lung cancer: a preliminary report.

PURPOSE: This prospective study was designed in order to compare the most common subjective measurements of physical function in patients with advanced lung cancer with an objective physical functional test (Simmonds Functional Assessment Tool [SFA]). PATIENTS AND METHODS: One hundred patients agreed to participate and complete the study before or after their outpatient medical oncology appointment. Patients underwent assessment using the Karnofsky, the Brief fatigue Inventory, The Functional Assessment of Cancer Therapy-Lung patients (FACT-L) and the Edmonton Symptom Assessment Scale (ESAS). These results were compared to the SFA tool. The SFA consists of six tasks: tying a belt, putting coins in a cup, reaching above head, standing up/sitting down, reaching forward and walking 50 feet. RESULTS: Ninety-nine patients completed the study over 8 months: median Karnofsky performance status was 85 (70 to 100), Edmonton Symptom Assessment Scale (ESAS) score (0 to 10) was generally low (0.5 to 2.8). SFA scores were significantly different in patients compared to a control group. The correlation between the subscales of the SFA and the Karnofsky, the Brief Fatigue Inventory, The FACT-L and the ESAS was generally low to moderate (r values: 0.22 to 0.38). There was generally a moderate correlation between the different subjective scales (r values: 0.3 to 0.62). CONCLUSION: Adherence to the SFA tool was excellent. The low to moderate correlation between the abnormalities found in the objective SFA and the subjective fatigue tests suggest that objective evaluation of the functional capacity provides a potentially useful and independent end-point for clinical trials and therapeutic interventions. These assessment tools should be used complementary to each other to better assess the functional status of patients with advanced lung cancer. Large trials of objective functional assessment are justified.