Brief Pain Inventory Scores Research Articles

Health-Related Quality of Life for Gemcitabine and Nab-paclitaxel Plus Radiation Therapy Versus Gemcitabine and S-1 Plus Radiation Therapy in Patients with Metastatic Pancreatic Cancer: A Propensity Score Matched Analysis

Nearly 50% of patients had metastatic pancreatic cancer at initial diagnose. Therefore, priority may be given to quality of life, which required improvement of survival without simultaneously compromise of health-related quality of life (HRQOL) during treatment. Moreover, radiotherapy could be an option for amelioration of local symptoms in addition to potential abscopal effects, contributing to improvement of HRQOL. Hence, we sought to evaluate the HRQOL after SBRT and different chemotherapy regimens in the management of metastatic pancreatic cancer. Patients with biopsy-proven and radiographically metastatic pancreatic cancer were included and prospectively followed up from 2013 to 2017. Chemotherapy was delivered after SBRT with an interval of 3 weeks, which were required for 4 cycles. The regimens were gemcitabine plus nab-paclitaxel (GT group) or gemcitabine plus S-1 (GS group). The Chinese version of Brief Pain Inventory (BPI) and 5-level European quality of life 5-dimensions (EQ-5D-5L) were used in this study. Due to limited survival of patients with metastatic pancreatic cancer, questionnaires were completed before SBRT and right after the whole treatment. Patient-reported global changes and scores of questionnaires were assessed. To be simplified, all changes were stratified into “better”, “no change” and “worse” in the analysis. Data were analyzed with Spearman’s rank correlation, ordinal regression. Propensity score matched analysis was further performed to evaluate these two regimens. Seventy-five and eighty-nine patients received gemcitabine plus nab-paclitaxel and gemcitabine plus S-1, respectively. No differences of baseline characteristics were found between these two groups. No differences of BPI scores were found between pre- and post-treatment in each group, while only the post-treatment EQ-5D-5L score was higher than that at baseline in GS group (P<0.001). The response “better” of BPI was found in 15 and 38 patients in GT and GS group, respectively (P<0.001). On multinomial logistic regression, compared with GS group, the probability of GT group achieving “better” global change of BPI was 0.289 (P=0.015). The “better” change of EQ-5D-5L was found in 20 and 42 patients in GT and GS group, respectively (P<0.001). After multinomial analysis, compared with GS group, the probability of GT group gaining improvement of EQ-5D-5L was 0.334 (P=0.031). After propensity score matched analysis, more patients had improvement of BPI and EQ-5D-5L in GS group compared with GT group (n=24 vs. n=12, P=0.002; n=28 vs. n=16, P=0.002). No grade 3 or more radiation-induced toxicity occurred. More patients in GT group experienced grade 3 or more hematological and gastrointestinal toxicity than those in GS group (n=25 vs. n=16, P=0.024; n=17 vs. n=10, P=0.049). GS may achieve better HRQOL than GT. Therefore, GS may be an alternative of GT for metastatic pancreatic cancer, especially for Asians.

Effect of Post-Hospital Discharge Follow-up on Health Status in Patients with Burn Injuries: A Randomized Clinical Trial.

Patients with burn injuries still face various burn-related challenges after being discharged from the hospital. Hence, a follow-up program for such patients is essential. The present study aimed to evaluate the health status of burn victims after 1.5 months follow-up. The present randomized clinical trial was of a pretest-posttest design, carried out in Kermanshah (Iran) from July 2016 to September 2017. A total of 117 participants were recruited out of which 86 were included in the analysis. The participants were randomly assigned into two groups, namely the intervention group (N=42) and the control group (N=44). All participants were evaluated both at the time of hospital discharge and at 1.5 months post-discharge. The follow-up plan for the intervention group included home visits, telenursing, and referral to specialists or health education centers. To evaluate the physical and psychological status of the participants, five different instruments were used; namely the Burn Specific Health Scale-Brief (BSHS-B), the General Health Questionnaire-28 (GHQ-28), the Brief Pain Inventory (BPI), the Vancouver Scar Scale (VSS), and the Visual Analogue Scale (VAS). All statistical analyses were performed using the SPSS software (version 17.0). Data were analyzed using the Chi-square test, independent t-test, and paired t-test. P<0.05 was considered statistically significant. The mean score of the BSHS-B questionnaire at both the time of discharge and 1.5 months post-discharge follow-up for the control and intervention groups was 61.22±19.07, 57.14±18.92; 83.70±24.73 and 105.16±29.17, respectively. There was a significant difference between the groups at 1.5 months post-discharge follow-up (P<0.001). At 1.5 months, the VSS score was 5.16±1.68 and 6.77±3.46 for the intervention and control groups, respectively. The GHQ-28 score was 28.69±12.39 and 40.79±16.20 for the intervention and control groups, respectively. The VAS and BPI scores of the control group were 5.56±3.11 and 21.93±29.25, respectively. For the intervention group, these scores were 4.85±3.49 and 15.61±27.47, respectively. There was a significant difference between the groups as to the GHQ and VSS scores (P<0.05). However, no significant difference was noted in the BPI and VAS scores (P<0.05). Health status, psychological status, and scar management were improved due to post-discharge follow-up. However, burn patients required continued care for pain, psychological health, and itching problems. Trial Registration Number: IRCT2016110630712N.

Health-related quality of life for gemcitabine and nab-paclitaxel plus radiotherapy versus gemcitabine and S-1 plus radiotherapy in patients with metastatic pancreatic cancer.

PurposeTo compare the effects of gemcitabine and nab-paclitaxel (GT) plus stereotactic body radiation therapy (SBRT) or gemcitabine and S-1 (GS) plus SBRT on health-related quality of life (HRQOL) of metastatic pancreatic cancer.MethodsPatients with biopsy-proven and radiographically metastatic pancreatic cancer were included. HRQOL was assessed using the Chinese version of Brief Pain Inventory (BPI) and 5-level European quality of life 5-dimensions (EQ-5D-5L). Data were analyzed with Spearman’s rank correlation, ordinal regression, and propensity score-matched analysis.ResultsA total of 75 and 89 patients received GT and GS, respectively. The median biological effective dose of GT group and GS group was 59.5 Gy (range 48–85.5 Gy) and 64.4 Gy (range 52.48–85.5 Gy) in 5–8 fractions, respectively. More patients in the GS group had improvement in BPI and EQ-5D-5L compared with those in the GT group (n=38 vs n=15, P<0.001; n=42 vs n=20, P<0.001). No differences of BPI scores were found between pre- and post-treatment in each group, while only the post-treatment EQ-5D-5L score was higher than that at baseline in GS the group (P<0.001). Compared with GS group, it was unlikely for patients receiving GT to have better BPI and EQ-5D-5L. After propensity-matched analysis, more patients in GS group had improvement in BPI and EQ-5D-5L (n=24 vs n=12, P=0.002; n=28 vs n=16, P=0.002). Furthermore, patients with GS had a superior overall survival than those with GT (11.1 months [95% CI: 10.6–11.6 months] vs 9.9 months [95% CI: 8.8–11.0 months]; P=0.005). Both incidences of grade 3 hematological (P=0.024) and gastrointestinal (P=0.049) toxicities were higher in the GT group.ConclusionGS may achieve better HRQOL than GT. Therefore, GS may be an alternative of GT for metastatic pancreatic cancer, especially for Asians.

Impact of post-transplantation maintenance therapy on health-related quality of life in patients with multiple myeloma: data from the Connect\xae MM Registry

Maintenance therapy after autologous stem cell transplantation (ASCT) is recommended for use in multiple myeloma (MM); however, more data are needed on its impact on health-related quality of life (HRQoL). Presented here is an analysis of HRQoL in a Connect MM registry cohort of patients who received ASCT ± maintenance therapy. The Connect MM Registry is one of the earliest and largest, active, observational, prospective US registry of patients with symptomatic newly diagnosed MM. Patients completed the Functional Assessment of Cancer Therapy-MM (FACT-MM) version 4, EuroQol-5D (EQ-5D) questionnaire, and Brief Pain Inventory (BPI) at study entry and quarterly thereafter until death or study discontinuation. Patients in three groups were analyzed: any maintenance therapy (n = 244), lenalidomide-only maintenance therapy (n = 169), and no maintenance therapy (n = 137); any maintenance and lenalidomide-only maintenance groups were not mutually exclusive. There were no significant differences in change from pre-ASCT baseline between any maintenance (P = 0.60) and lenalidomide-only maintenance (P = 0.72) versus no maintenance for the FACT-MM total score. There were also no significant differences in change from pre-ASCT baseline between any maintenance and lenalidomide-only maintenance versus no maintenance for EQ-5D overall index, BPI, FACT-MM Trial Outcomes Index, and myeloma subscale scores. In all three groups, FACT-MM, EQ-5D Index, and BPI scores improved after ASCT; FACT-MM and BPI scores deteriorated at disease progression. These data suggest that post-ASCT any maintenance or lenalidomide-only maintenance does not negatively impact patients’ HRQoL. Additional research is needed to verify these findings.

Psychometric properties of the brief pain inventory modified for proxy report of pain interference in children with cerebral palsy with and without cognitive impairment.

Introduction:Cerebral palsy (CP) is the most common cause of physical disability in children and is often associated with secondary musculoskeletal pain. Cerebral palsy is a heterogeneous condition with wide variability in motor and cognitive capacities. Although pain scales exist, there remains a need for a validated chronic pain assessment tool with high clinical utility for use across such a heterogeneous patient population with and without cognitive impairment.Objectives:The purpose of this study was an initial assessment of several psychometric properties of the 12-item modified brief pain inventory (BPI) pain interference subscale as a proxy-report tool in a heterogeneous sample of children with CP with and without cognitive impairment.Methods:Participants (n = 167; 47% male; mean age = 9.1 years) had pain assessments completed through caregiver report in clinic before spasticity treatment (for a subgroup, the modified BPI was repeated after procedure). To measure concurrent validity, we obtained pain intensity ratings (Numeric Rating Scale of pain) and pain intensity, duration, and frequency scores (Dalhousie Pain Interview).Results:Modified BPI scores were internally consistent (Cronbach α = 0.96) and correlated significantly with Numeric Rating Scale intensity scores (rs = 0.67, P < 0.001), Dalhousie Pain Interview pain intensity (rs = 0.65, P < 0.001), pain frequency (rs = 0.56, P = 0.02), and pain duration scores (rs = 0.42, P = 0.006). Modified BPI scores also significantly decreased after spasticity treatment (pretest [scored 0–10; 3.27 ± 2.84], posttest [2.27 ± 2.68]; t (26) = 2.14, 95% confidence interval [0.04–1.95], P = 0.04).Conclusion:Overall, the modified BPI produced scores with strong internal consistency and that had concurrent validity as a proxy-report tool for children with CP.

Indirect treatment comparison (ITC) of abiraterone acetate (AA) plus prednisone (P) and docetaxel (DOC) on patient-reported outcomes (PROs) in metastatic castration-naïve prostate cancer (mCNPC).

200 Background: AA + P added to androgen deprivation therapy (ADT) improved overall survival among newly diagnosed mCNPC patients (pts) with high-risk disease (HRD) vs placebos (PBOs) + ADT in the phase 3 LATITUDE study. Although ADT with or without chemotherapy is recommended in clinical guidelines as the mainstay of management for mCNPC, adding DOC to ADT does not consistently improve health-related quality of life (HRQoL). We performed an ITC to understand the relative impact of AA + P vs DOC on PROs in mCNPC pts. Methods: PROs were assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory (BPI). Mean change from baseline (BL) was based on differences in FACT-P and BPI scores between active vs control arms in LATITUDE (intention-to-treat [ITT] population) and CHAARTED (available data included mCNPC pts with high-volume disease [HVD] and low-volume disease [LVD]). Higher FACT-P score indicates better outcome/function; lower BPI score indicates better outcome/less pain. The probability of AA + P being better than DOC at 3, 6, 9, and 12 mos after treatment was based on fixed-effects Bayesian network meta-analysis. Results: Benefits in PROs with AA + P vs DOC were observed from 3 mos and sustained at least 1 year after treatment. Bayesian probability of AA + P being the better treatment for PROs ranged from 92.3% to 100%. Conclusions: Results from a Bayesian ITC suggest that AA + P was superior to DOC in improving PROs for at least 1 year after initiating treatment in men with mCNPC. In the absence of head-to-head trials, these analyses can provide useful insights on the relative impact of treatment options on HRQoL in mCNPC pts. Clinical trial information: NCT01715285. [Table: see text]

Early Improvement in Pain and Functional Outcome but Not Quality of Life After Surgery for Metastatic Long Bone Disease.

Bone metastases represent the most frequent cause of cancer-related pain, affecting health-related quality of life and creating a substantial burden on the healthcare system. Although most bony metastatic lesions can be managed nonoperatively, surgical management can help patients reduce severe pain, avoid impending fracture, and stabilize pathologic fractures. Studies have demonstrated functional improvement postoperatively as early as 6 weeks, but little data exist on the temporal progress of these improvements or on the changes in quality of life over time as a result of surgical intervention. (1) Do patients' functional outcomes, pain, and quality of life improve after surgery for long bone metastases? (2) What is the temporal progress of these changes to 1 year after surgery or death? (3) What is the overall and 30-day rate of complications after surgery for long bone metastases? (4) What are the oncologic outcomes including overall survival and local disease recurrence for this patient population? A multicenter, prospective study from three orthopaedic oncology centers in Quebec, Canada, was conducted between 2008 and 2016 to examine the improvement in function and quality of life after surgery for patients with long bone metastases. During this time, 184 patients out of a total of 210 patients evaluated during this period were enrolled; of those, 141 (77%) had complete followup at a minimum of 2 weeks (mean, 23 weeks; range, 2-52 weeks) or until death, whereas another 35 (19%) were lost to followup but were not known to have died before the minimum followup interval was achieved. Pathologic fracture was present in 34% (48 of 141) of patients. The median Mirel's score for those who underwent prophylactic surgery was 10 (interquartile range, 10-11). Surgical procedures included intramedullary nailing (55), endoprosthetic replacement (49), plate osteosynthesis (31), extended intralesional curettage (four), and allograft reconstruction (two). Seventy-seven percent (108 of 141) of patients received radiotherapy. The Musculoskeletal Tumor Society (MSTS), Toronto Extremity Salvage Score (TESS), Brief Pain Inventory (BPI) form, and Quality Of Life During Serious Illness (QOLLTI-P) form were administered pre- and postoperatively at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. Analysis of variance followed by post hoc analysis was conducted to test for significance between pre- and postoperative scores. The Kaplan-Meier estimate was used to calculate overall survivorship and local recurrence-free survival. A p value of < 0.05 was considered statistically significant. MSTS and BPI pain scores improved at 2 weeks when compared with preoperative scores (MSTS: 39% ± 24% pre- versus 62% ± 19% postoperative, mean difference [MD] 23, 95% confidence interval [CI], 16-32, p < 0.001; BPI: 52% ± 21% pre- versus 30% ± 21% postoperative, MD 22, 95% CI, 16-32, p < 0.001). Continuous and incremental improvement in TESS, MSTS, and BPI scores was observed temporally at 6 weeks, 3 months, 6 months, and 1 year; for example, the TESS score improved from 44% ± 24% to 73% ± 21% (MD 29, p < 0.001, 95% CI, 19-38) at 6 months. We did not detect a difference in quality of life as measured by the QOLLTI-P score (6 ± 1 pre- versus 7 ± 4 postoperative, MD 1, 95% CI, -0.4 to 3, p = 0.2). The overall and 30-day rates of systemic complications were 35% (49 of 141) and 14% (20 of 141), respectively. The Kaplan-Meier estimates for overall survival were 70% (95% CI, 62.4-78) at 6 months and 41% (95% CI, 33-49) at 1 year. Local recurrence-free survival was 17 weeks (95% CI, 11-24). Surgical management of metastatic long bone disease substantially improves patients' functional outcome and pain as early as 2 weeks postoperatively and should be considered for impending or pathologic fracture in patients whose survival is expected to be longer than 2 weeks provided that there are no immediate contraindications. Quality of life in this patient population did not improve, which may be a function of patient selection, concomitant chemoradiotherapy regimens, disease progression, or terminal illness, and this merits further investigation. Level II, therapeutic study.

A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy

BackgroundThis phase II study was conducted to assess clinical efficacy of tasquinimod maintenance therapy in patients with metastatic castrate-resistant prostate cancer not progressing during first-line docetaxel-based therapy. Patients and methodsPatients were randomly assigned (1:1) to receive tasquinimod (0.25–1.0mg/day orally) or placebo. The primary end point was radiologic progression-free survival (rPFS); secondary efficacy end points included: overall survival (OS); PFS on next-line therapy (PFS 2) and symptomatic PFS, assessed using the Brief Pain Inventory (BPI) questionnaire and analgesic use. Quality of life was measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol-5 Dimension Quality of Life Instrument (EQ-5D). Adverse events were recorded. ResultsA total of 219 patients were screened and 144 patients randomized. The median duration of treatment was 18.7weeks (range 0.6–102.7weeks) for the tasquinimod arm and 19.2weeks (range 0.4–80.0weeks) for the placebo arm. Median (90% CI) rPFS was 31.7 (24.3–53.7) and 22.7 (16.1–25.9)weeks in the tasquinimod and placebo arms, respectively [HR (90% CI) 0.6 (0.4–0.9), P=0.0162]. The median OS was not reached because only 14 deaths occurred by the cut-off date. No statistically significant differences between treatment arms were noted for symptomatic PFS, PFS 2, BPI score, FACT-P score, or EQ-5D. The incidence of any treatment emergent adverse event (TEAE) was similar in the tasquinimod and placebo arms (97.2% versus 94.3%, respectively), whereas severe TEAEs (NCI-CTC Grade 3–5) incidence was higher in the tasquinimod group (50.7% versus 27.1%). ConclusionsRandomized trials testing new drugs as maintenance can be successfully conducted after chemotherapy in castrate-resistant prostate cancer. Maintenance tasquinimod therapy significantly reduced the risk of rPFS by 40%. ClinicalTrialsgov identifier NCT01732549.

Comparing the Effectiveness of Combined External Beam Radiation and Hyperthermia Versus External Beam Radiation Alone in Treating Patients With Painful Bony Metastases: A Phase 3 Prospective, Randomized, Controlled Trial

To compare the response, duration of pain relief, and time to achieve complete pain relief after radiation therapy (RT) with or without hyperthermia (HT) in patients with painful bony metastases. Cancer patients with bony metastases and pain score ≥4 on the Brief Pain Inventory (BPI) were randomized to RT of 30Gy in 10 fractions combined with HT (RT+HT) versus RT alone. Hyperthermia was performed by the Thermotron RF-8, with maintenance of the target temperature for 40minutes per treatment within 2hours after RT, twice weekly for 2weeks. Patients were stratified by lesion number (solitary or multiple), BPI score (4-6 vs 7-10), and primary site. The primary endpoint was complete response (CR) (BPI=0 with no increase of analgesics) within 3months after treatment. This study was registered with ClinicalTrials.gov. The study was terminated early after an interim analysis of 57 patients, 3years after the first enrollment (November 2013 to November 2016): 29 patients in the RT+HT group and 28 patients in the RT-alone group. The CR rate at 3months after treatment was 37.9% in the RT+HT group versus 7.1% in the RT-alone group (P=.006). The accumulated CR rate within 3months after treatment was 58.6% in the RT+HT group versus 32.1% in the RT-alone group (P=.045). Median time to pain progression was 55days in patients with CR (n=9) in the RT-alone group, whereas the endpoint was not reached during the 24-week follow-up in the RT+HT group (P<.01). The addition of HT to RT significantly increases the pain control rate and extends response duration compared with RT alone for painful bony metastases.

Psychosocial Stress After a Disaster and Low Back Pain-Related Interference With Daily Living Among College Students: A Cohort Study in Fukushima.

A cohort study. To investigate the association between psychosocial stress and low back pain (LBP)-related interference with daily living among college students. Few longitudinal studies have examined the likelihood of developing LBP in the presence of a designated psychosocial stressor. All participants in the present study were suddenly affected by the Great East Japan disaster after enrolment in our cohort study. The present study was initiated among 95 students at Fukushima Medical University in January 2011. We assessed psychosocial stress in students using the Japanese version of the Perceived Stress Scale (JPSS). Follow-up surveys were conducted in July 2011 and May 2013, analyzing 94 students. Students were then divided into three groups (improved, -19 to -4; Maintained, -3 to +4; Aggravated, +5 to +22) based on the tertile points of JPSS change from baseline to 4 months after the disaster. LBP-related interference with daily living was assessed using the Brief Pain Inventory (BPI) questionnaire. Linear regression modeling was performed with BPI at 4 months after the disaster as the outcome, and JPSS change, sex, history of LBP, baseline physical activity, and baseline BPI as explanatory variables. We found a significant increase in BPI score for the aggravated stress group (β coefficient, +0.79; 95% confidence interval, +0.06-+1.53), compared with the improved stress group. History of LBP and higher physical activity were also significantly associated with BPI. The present study suggests that perceived psychosocial stress induced by the disaster may be associated with LBP-related interference with daily living among college students in Fukushima. 3.

Iranian Brief Pain Inventory: Validation and Application in Elderly People With Cancer Pain

ContextCancer is a major health problem in the elderly, and pain is one of the most common symptoms among older patients with cancer. Sufficient pain treatments depend on the accuracy of the pain assessment tool. ObjectivesThis study aimed to assess the psychometric properties of the Iranian version of the Brief Pain Inventory (BPI-IR) among elderly individuals with cancer. MethodsThis validation study was conducted with 368 people aged 60+ years old who were undergoing oncology treatments. The BPI-IR was applied to the elderly participants through face-to-face interviews. Reliability of the BPI-IR was evaluated using Cronbach's alpha coefficient and intraclass correlation coefficient between test-retest scores. Criterion validity was determined by calculating the Spearman's correlation coefficient between scores on the BPI-IR and those on the SF-36 physical function, Activities of Daily Living, Instrumental Activities of Daily Living, Center for Epidemiological Studies Depression, Patient Pain Questionnaire, and Symptom Distress Scale. Construct validity of the BPI-IR was evaluated using exploratory factor analyses. ResultsCronbach's alpha coefficient was calculated to be 0.94, and the intraclass correlation coefficient between twice the BPI-IR scores over two weeks obtained was 0.89. There were moderate-to-high correlations between the BPI-IR and the Patient Pain Questionnaire (r = 0.886), Symptom Distress Scale (r = 0.492), SF-36 physical function (r = 0.554), and Center for Epidemiological Studies Depression (r = 0.608). Two factors were extracted in exploratory factor analyses, and they explained 73.86% of total variance. ConclusionThe BPI-IR is a reliable and valid tool for assessing pain among older adults with cancer.

Predictors of clinical outcomes in metastatic castration-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate or placebo: An exploratory post-hoc analysis of COU-AA-302 trial data.

e16529 Background: A post-hoc analysis of COU-AA-302 trial data showed that brief pain inventory (BPI), lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and bone metastases were predictors for overall survival in men with mCRPC treated with AA+P. This study aimed to identify baseline predictors of other clinical outcomes. Methods: COU-AA-302 trial data were used to develop predictive models for prostate-specific antigen (PSA) progression, Eastern Cooperative Oncology Group performance status (ECOG PS) deterioration, and opiate use. Associations between baseline factors and outcomes were first assessed using multivariable Cox models among AA+P patients (Step 1). In Step 2, interaction testing was conducted between treatment (AA+P vs. placebo) and each potential predictor (P &lt; 0.2) identified in Step 1. Final Cox models included predictors and any significant interactions (p &lt; 0.05). Results: A total of 1,034 men (525 AA+P; 509 placebo) were included in the analysis. Baseline BPI, PSA, LDH, and ALP were predictors of PSA progression and opiate use regardless of AA+P or placebo with higher values indicating higher risks (all P &lt; 0.05). Younger age, shorter time from luteinizing hormone-releasing hormone to randomization, higher Gleason score, and lower PSA at diagnosis were also associated with higher risks of opiate use: (all P &lt; 0.05). For ECOG PS deterioration, higher baseline BPI, PSA, LDH, and Gleason score, older age, and lower baseline ECOG were associated with higher risks regardless of AA+P or placebo (all P &lt; 0.05). Baseline ALP and site of metastasis also predicted ECOG PS deterioration but the effect varied by treatment (lower risk in AA+P versus placebo; both interactions’ P &lt; 0.05). Conclusions: Predictors of PSA progression, ECOG PS deterioration, and opiate use were identified in AA+P and placebo-treated men with mCRPC. No predictors were associated with worse outcomes for AA+P versus placebo, while the negative impact of certain predictors on ECOG PS was favorably modified by AA+P. Further study is needed on the relationship between AA+P and prognostic factors.

Abstract P5-12-01: Randomized trial of exercise intervention vs. usual care for breast cancer patients with aromatase inhibitor to prevent and improve the aromatase inhibitor induced arthralgia

Abstract Purpose: Arthralgia sometimes occurs in the breast cancer patients treated with aromatase inhibitors (AIs). It is one of the most important reasons for poor AIs adherence. Background; The HOPE study previously demonstrated that exercise was effective in improving AI-induced arthralgia in breast cancer patients. However, recruitment to this study was limited to severe cases (Criteria; physically inactive, &amp;gt;6 months AT treatment, &amp;gt;2 months arthralgia). To asses if these findings were more generalizable to all breast cancer contexts we conducted a randomized trial of exercise intervention using wider eligibility criteria that the hope study to assess the impact on AI induced arthralgia in breast cancer patients. Methods: We examined Japanese breast cancer patients operated at Nahanishi Clinic, Okinawa, Japan. Following the informed consent the patients were randomly assigned to a 3:1 ratio to exercise intervention or usual care, . Eligibility criteria included receiving an AI for 0-4 years, no metastases, any arthralgia level and any exercise habits. Following randomization participants could choose from 3 types of exercise including strong (120-150 minutes per week of walking or running), intermediate (gentle calisthenics (daily NIPPON HOSO KYOKAI: NHK broadcast exercise)) and weak (going up the stairs- frequency). Arthralgia was assessed using the Brief Pain Inventory (BPI), in which the patients completed a baseline, 6month and 12 month BPI assessment. Primary endpoint was BPI change at 12 months. Results: Among 227 women screened, we randomized 108 women, with 80 to exercise intervention (46 of strong, 19 of intermediate and 15 of weak) and 28 to usual care. Base line BPI were well balanced between exercise intervention and usual care. Overall exercise intervention reduced BPI scores relative to control. The BPI changes of worst pain, least pain, average pain and pain right now were 0.09, -0.25, -0.14 and 0 for exercise intervention group and 0.21, 0.46, 0.07 and 0.61 for usual care group, respectively. There was a statistically significant difference of AIs adherence between exercise intervention group (99%) and usual care group (92%) (P=0.03). Conclusion: Exercise intervention tends to improve the AI-induced arthralgia and has a positive effect on AIs adherence. Citation Format: Tajaesu M, Tamaki K, Nagamine S, Kamada Y, Uehara K, Arakaki M, Tamatsu Y, Yamashiro K, Miyashita M, Ishida T, Ohuchi N, McNamara K, Terukina S, Sasano H, Tamaki N. Randomized trial of exercise intervention vs. usual care for breast cancer patients with aromatase inhibitor to prevent and improve the aromatase inhibitor induced arthralgia [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-12-01.

Spine stereotactic radiosurgery for the treatment of multiple myeloma.

OBJECTIVE The objective of this study was to define symptomatic and radiographic outcomes following spine stereotactic radiosurgery (SRS) for the treatment of multiple myeloma. METHODS All patients with pathological diagnoses of myeloma undergoing spine SRS at a single institution were included. Patients with less than 1 month of follow-up were excluded. The primary outcome measure was the cumulative incidence of pain relief after spine SRS, while secondary outcomes included the cumulative incidences of radiographic failure and vertebral fracture. Pain scores before and after treatment were prospectively collected using the Brief Pain Inventory (BPI), a validated questionnaire used to assess severity and impact of pain upon daily functions. RESULTS Fifty-six treatments (in 38 patients) were eligible for inclusion. Epidural disease was present in nearly all treatment sites (77%). Moreover, preexisting vertebral fracture (63%), thecal sac compression (55%), and neural foraminal involvement (48%) were common. Many treatment sites had undergone prior local therapy, including external beam radiation therapy (EBRT; 30%), surgery (23%), and kyphoplasty (21%). At the time of consultation for SRS, the worst, current, and average BPI pain scores at these treatment sites were 6, 4, and 4, respectively. The median prescription dose was 16 Gy in a single fraction. The median clinical follow-up duration after SRS was 26 months. The 6- and 12-month cumulative incidences of radiographic failure were 6% and 9%, respectively. Among painful treatment sites, 41% achieved pain relief adjusted for narcotic usage, with a median time to relief of 1.6 months. The 6- and 12-month cumulative incidences of adjusted pain progression were 13% and 15%, respectively. After SRS, 1-month and 3-month worst, current, and average BPI scores all significantly decreased (p < 0.01). Vertebral fracture occurred following 12 treatments (21%), with an 18% cumulative incidence of fracture at 6 and 12 months. Two patients (4%) developed pain flare following spine SRS. CONCLUSIONS This study reports the largest series of myeloma lesions treated with spine SRS. A rapid and durable symptomatic response was observed, with a median time to pain relief of 1.6 months. This response was durable among 85% of patients at 12 months following treatment, with 91% local control. The efficacy and minimal toxicity of spine SRS is likely related to the delivery of ablative and conformal radiation doses to the target. SRS should be considered with doses of 14-16 Gy in a single fraction for patients with multiple myeloma and limited spinal disease, myelosuppression requiring "marrow-sparing" radiation therapy, or recurrent disease after EBRT.

Investigating high-concentration 8% capsaicin patch in chronic cancer-treatment related peripheral neuropathic pain.

208 Background: Cancer-treatment related peripheral neuropathic pain is a challenging clinical problem as current interventions have limited efficacy and significant toxicities. This study aims to examine the analgesic effect of high-concentration 8% capsaicin patch in this cohort of patients. Methods: A single arm study was conducted. Patients with long-term peripheral neuropathic pain received a single application of 8% transdermal capsaicin patch to the affected area (chest wall, hands or feet). Assessments at baseline, 4 weeks and 12 weeks post-treatment included: Brief Pain Inventory (BPI) short form (pain severity and interference with function); Hospital Anxiety and Depression Scale (HADS). The primary efficacy measure was a clinically significant improvement in pain (≥ 30% reduction in total BPI score (responders) from baseline to 4 weeks and 12 weeks). Secondary efficacy measures assessed worst pain, function and associated changes in mood. Results: 19 patients, median age 61.5 all had peripheral neuropathic pain for a median of 2 years (IQR 1-3) following treatment for various types of cancer: gynecological (n = 2), breast (n = 6), colorectal (n = 8), multiple myeloma (n = 2) or other (n = 1). At 4 weeks, 37% (7/19) patients showed a clinically significant improvement in pain (≥ 30%). Of the 7 responders, 5 had &gt; 50% reduction in pain. 16% (3/19) suggested a partial improvement (mean 17%). Of the patients reassessed at 12 weeks, 50% (7/14) were responders with all patients exhibiting a reduction in: worst pain score, -1.3 (95% CI: -2.5, -0.06; p = 0.04), interference with function, -10.9 (95% CI: -21.5, -0.4; p = 0.04) and HADS depression score, -1.7 (95% CI: -3.4, 0.02; p = 0.05). Total HADS score correlated with total BPI at 4 weeks (r = 0.68) and 12 weeks (r = 0.70). HADS depression score also correlated with BPI at 12 weeks (r = 0.73). All correlations were significant (p &lt; 0.01). Conclusions: In patients with chronic, resistant, cancer-treatment related peripheral neuropathic pain, high-concentration 8% capsaicin patch may provide some benefit in pain severity, function and mood with the effect continuing at 12 weeks post-treatment. This may warrant further long-term follow up in a larger cohort.

Survival and Clinical Outcomes in Patients with Metastatic Epidural Spinal Cord Compression: Results from the AOSpine Prospective Multi-Centre Study of 142 patients

Introduction Although surgery is being increasingly used in patients with Metastatic Epidural Spinal Cord Compression (MESCC) as a complementary strategy to radiation and chemotherapy, the impact of surgery on quality of life (QoL) is not well established. This study aimed to prospectively evaluate survival, neurological, functional, and QoL outcomes in MESCC patients undergoing operative management. Material and Methods A total of 142 surgically treated patients with a single symptomatic MESCC lesion enrolled in a prospective North American multi-center study were followed for 12 months. Clinical data, such as Brief Pain Inventory (BPI), ASIA, SF-36, Oswestry Disability Index (ODI), and EQ-5D scores, were obtained both pre- and post-operatively. Results The median survival was 7.7 months. The 30-day and 12-month mortality rates were 9% and 62%, respectively. Six weeks post-operatively, ambulatory status ( p = 0.02) and bladder control ( p = 0.03) were significantly improved. Overall, 67.5% of ASIA B, C, or D patients gained at least 1 grade after surgery, 25% remained stable, and 7.5% deteriorated. ODI, EQ-5D, BPI scores were significantly improved at each follow-up (p ≤ 0.01). SF-36 scores were generally higher after surgery for mental and physical components, and for all domains except energy/fatigue. The incidence of wound complications was 10% and 2 patients required a second surgery (screw malposition and epidural hematoma). Conclusion Surgical intervention, as a complementary adjunct to radiation and chemotherapy, provides immediate and sustained improvement in pain, neurological, functional, and QoL outcomes with acceptable risks in patients with a focal symptomatic MESCC lesion.

Opioid Use as a Predictor of Health Care Use and Pain Outcomes: Analysis of Clinical Trial Data.

To examine effects of pre-enrollment opioid use on outcomes of a 12-month collaborative pain care management trial. We hypothesized that participants with opioid use would have worse pain at baseline; use more health care services and analgesics; and have worse pain outcomes during the trial. Secondary analysis of randomized controlled trial data. Veterans Affairs (VA) primary care. Patients age 18-65 years with chronic pain of at least moderate severity who were enrolled in a 12-month pragmatic trial of a telephone-based collaborative care intervention for chronic musculoskeletal pain. Participants were categorized as opioid users (n = 84) or non-users (n = 166) at baseline and trial randomization was stratified by opioid use. We used logistic regression to examine cross-sectional associations with baseline opioid use and mixed-effect models for repeated measures to examine baseline opioid use as a predictor of Brief Pain Inventory (BPI) scores over 12 months. At baseline, 33.6% reported use of prescribed opioids. Baseline opioid users had higher baseline BPI scores and higher health-related disability than non-users. Baseline opioid users also had more outpatient visits (15.0 vs. 10.1; p = 0.001) and received more analgesics (p < 0.001) during the trial. In the final multivariable model examining effects of baseline opioid use on BPI over 12 months, opioid users and nonusers had a non-significant difference of 0.25 points (p = 0.098). In conclusion, although baseline opioid users had worse pain at baseline and used more health care during the study, response to the intervention was not significantly modified by pre-existing opioid therapy.

Usefulness of a Hanging Position With Internal Rotation of Shoulder in Ultrasonography-Guided Intra-articular Steroid Injection for Adhesive Capsulitis.

ObjectiveTo evaluate the feasibility of a new position (internal rotation in hanging) in ultrasonography, we compared the length of the glenohumeral joint space and the effectiveness of steroid injection with the hanging position and with the commonly used abdomen or cross position.MethodsA prospective, randomized controlled trial was performed in 42 patients with adhesive capsulitis of shoulder. We used three arm positions for the posterior approach as follows: the patient's palm on thigh, other hand on abdomen (abdomen position); hand on patient's opposite shoulder (cross position); arm in hanging position with internal rotation of shoulder (hanging position). The order of shoulder position was randomized and blinded. Real-time ultrasonography-guided intra-articular steroid injection was performed by posterior approach at the first position in each patient. The Brief Pain Inventory (BPI), the Shoulder Pain and Disability Index (SPADI), and range of motion (ROM) were measured before steroid injection and 2 weeks after injection.ResultsThe lengths of the joint space were 2.88±0.75, 2.93±0.89, and 2.82±0.79 mm in abdomen, cross, and hanging position respectively, with no significant difference among the three positions (p=0.429). Treatment efficacy was significantly improved in ROM, total BPI, and SPADI in all three positions (p<0.001). The changes in ROM for shoulder abduction were 23.6°±19.7°, 22.2°±20.9°, and 10.0°±7.8° in abdomen, cross, and hanging position, respectively. Changes in total BPI scores were 25.1±15.7, 23.6.±18.0, 11.6±6.1, and changes in total SPADI score were 35.0±14.2, 30.9±28.9, and 16.5±10.3 in abdomen, cross, and hanging position, respectively. There were no significant difference among the three positions for all parameters (p=0.194, p=0.121, and p=0.108, respectively.ConclusionFor patients with adhesive capsulitis who cannot achieve or maintain abdomen or cross position, scanning and injection with the shoulder in internal rotation with hanging position may be a useful alternative.

An exploratory study on the effectiveness of “Calmare therapy” in patients with cancer-related neuropathic pain: A pilot study

PurposeCalmare therapy (CT) has been suggested as a novel treatment for managing chronic pain. Recently, it was reported to show a positive therapeutic outcome for managing neuropathic pain condition. We performed an exploratory prospective study on the effectiveness of CT in patients with various types of cancer-related neuropathic pain (CNP). MethodWe performed an open-labeled, single-arm, exploratory study on the effectiveness of CT in patients with various types of cancer-related neuropathic pain (CNP). The primary endpoint was a comparison of the 11-point Numerical Rating Scale (NRS) pain score at one month with the baseline score in each patient. Brief Pain Inventory (BPI) and consumption of opioid were also evaluated during follow-up period. ResultsCT significantly decreased NRS pain score at one month from baseline (p < 0.001) in 20 patients with chemotherapy-induced peripheral neuropathy (n = 6), metastatic bone pain (n = 7), and post-surgical neuropathic pain (n = 7). It also improved overall BPI scores, decreased consumption of rescue opioid (p = 0.050), and was found satisfactory by a half of patients (n = 10, 50.0%). ConclusionsOur preliminary results suggest that CT may be considered for cancer patients with various types of CNP. Large studies are necessary to confirm our findings and ascertain which additional CNP show positive response to CT.

Efficacy and safety profile of prolonged release oxycodone in combination with naloxone (OXN PR) in Parkinson's disease patients with chronic pain.

Pain is a relevant and often underestimated non-motor symptom affecting the quality of life of patients with Parkinson's disease (PD). Although some pain symptoms can be effectively treated by dopaminergic medication, a correct diagnosis of the different types and distribution of pain in PD is challenging, and accordingly, its treatment remains troublesome. We evaluated the efficacy and the safety of a prolonged release oral formulation of oxycodone hydrochloride combined with naloxone hydrochloride dehydrate, in a fixed ratio of 2:1 (OXN PR). A total of 16 PD patients with history of pain with a minimum intensity of four on numerical rating scale (NRS) received low-dose OXN PR (5/2.5mg twice daily) and were observed for a period of 8weeks. The primary efficacy measure was the pain severity measured with NRS and Brief Pain Inventory (BPI). Secondary efficacy measured the safety profile by recording the occurrence of side effects, clinical global impression of change (CGI-C), Parkinson's disease sleep scale 2 (PDSS-2), Bowel function index (BFI). Data were collected and analyzed using descriptive statistics. Patients who completed the study (14 out of 16) reported a significant pain relief as observed by the reduction of NRS and BPI scores. No adjustment of dopaminergic therapy was required. No significant changes were observed in bowel function and constipation symptoms as measured by the BFI during the 8-week period. Similarly, no changes were observed in PDSS-2 score, whereas an improvement was recorded by CGI-C compared to baseline. Low-dose oral OXN PR was efficacious for the management of pain symptoms of patients with PD. More importantly, patients did not experience significant side effects, such as constipation or sedation. Our study provides evidence that opioids can be used to treat pain symptoms in PD patients.