Brief Pain Inventory Pain Scores Research Articles

Prospective Multicenter Evaluation of Pain Before and After Removal of Nonobstructing Renal Calculi: A CoRE Initiative.

Flank pain associated with stone disease is typically caused by a stone that obstructs urine flow. However, it is plausible that nonobstructing kidney stones may still cause pain. We performed a multicenter, observational trial to evaluate whether treatment of small nonobstructing calyceal stones improves pain and kidney stone-specific health-related quality of life. Patients aged 18 years or older with nonobstructing renal stone(s) up to 10 mm in longest diameter and moderate to severe pain were recruited. All participants completed 3 questionnaires: the Brief Pain Inventory (BPI), the Patient-Reported Outcomes Measurement Information System pain interference form 6a, and the Wisconsin Stone Quality of Life questionnaire. Thereafter, all participants underwent ureteroscopy for renal stone treatment. All 3 questionnaires were repeated at 2, 6 to 8, and at 12 weeks postprocedure. The primary outcomes were change in preoperative to 12-week postoperative mean BPI score and worst BPI pain score. A total of 43 patients with nonobstructing kidney stones and associated flank pain were recruited. All stones were removed. Preoperatively, BPI scores for mean pain and worst pain were 5.5 and 7.2, respectively which decreased to 1.8 and 2.8 respectively at 12 weeks postoperatively. Wisconsin Stone Quality of Life questionnaire mean score increased from 70.4 to 115.3 at 12 weeks postoperatively. A total of 86% and 69% of patients had at least a 20% and 50% reduction in their mean pain scores, respectively. This study determined that patients benefit significantly from the removal of calyceal nonobstructing kidney stones for at least 12 weeks with a reduction in pain and an increase in quality of life. Therefore, surgical removal of these stones in this patient population should be offered as a treatment option.

Comparison of the Novel Digital Multi-dimension Botong Score with the Brief Pain Inventory for Evaluating Cancer-Related Pain: A Randomized Crossover Trial.

Pain is a common symptom in patients with cancer, and comprehensive assessments of pain are crucial for decision-making of treatment regimens. This study aimed to compare the practicality of the novel digital multi-dimension Botong score (BTS) and the brief pain inventory (BPI) for evaluating cancer-related pain. This randomized crossover trial enrolled patients with cancer-related pain at the Affiliated Cancer Hospital of Shandong First Medical University between July and December 2022. The participants were randomized 1:1 to BTS evaluation followed by BPI or vice versa. The consistency of BTS and BPI was analyzed, including pain score and the impact of pain on emotions and sleep. The convenience, patient preference, and the filling time of the two tools were compared. The accuracy of BTS in detecting breakthrough pain and neuropathic pain was analyzed. A total of 308 patients with cancer-related pain were screened and 233 were finally included in the analysis. The Pearson correlation coefficients of pain score for BTS and BPI (4 relevant questions) were 0.583 for the worst pain score within 24h, 0.394 for the mildest pain score within 24h, 0.551 for the average pain score within 24h, and 0.511 for the current pain score, respectively (all P<0.01), indicating a positive correlation between the BTS and BPI pain scores. BTS was superior to BPI for filling time, convenience, and patient preference (191.03 vs. 256.76, 7.70 vs. 6.78, 7.58 vs. 6.70; all P<0.01). The accuracy of BTS in detecting breakthrough pain and neuropathic pain was 98.28% and 97.42%, respectively. Pain scores evaluated by BTS have a positive correlation with those evaluated by BPI. BTS reduces the filling time, is more convenient to use, and is more favored by patients. In addition, BTS could help identify breakthrough pain and neuropathic pain. Chictr.org.cn, identifier: ChiCTR220062624.

Smartphone pain app for assessment of radiation-induced oral mucositis pain.

420 Background: Oral Mucositis related pain is one of the most common radiation therapy (RT) related toxicities associated with the treatment of head and neck cancer (HNC). Questionnaire-based assessment of mucositis pain is based on a patient's recall which can be inaccurate sometimes. Therefore, real-time monitoring of patient-reported pain is required for better evaluation of mucositis pain. Methods: We performed a single-arm, observational study (NCT02727062) to investigate the feasibility of a smartphone-based pain app (OMP) in assessing mucositis pain in locally advanced HNC patients(pts) undergoing a course of definitive or adjuvant RT (&gt; 50 Gy), +/- chemotherapy, for oral cavity or oropharynx cancer. The app prompted pts to input pain severity scores using a visual analog (0-10) scale (VAS) at multiple time points during a day throughout the study. OMP software-generated time-weighted average weekly summary measure of pain by integrating multiple serial daily pain assessments. In addition, pts completed weekly Brief pain inventory (BPI) and MD Anderson head &amp; neck symptom inventory (MDASI-HN) questionnaires. Feasibility surveys were also collected to assess the ease of use of OMP and the burden of study participation. Responses to questions on this survey were scored on a scale of 0-3, with 0 standing for not at all and 3 for extremely. Linear mixed models (LMM) controlling for person random effects were used to evaluate association and quantify differences between average weekly pain (AWP) calculated by OMP and AWP recorded using VAS by BPI survey (question 5). LMM was also used to evaluate the association between AWP score from OMP and BPI pain score with MDASI-HN scores. Descriptive statistics, including averages and frequency, were used to analyze feasibility surveys. Results: We report results of 15 pts who have complete data out of 18 registered pts. Using LMM, we compared AWP score curves calculated from BPI and OMP. We observed that both curves followed a parallel trajectory. However, pain scores calculated from OMP were 0.40 units higher than BPI pain. The Bland-Altman plot also confirmed that BPI pain and OMP did not clearly agree. Additionally, AWP scores from OMP had a positive correlation with fatigue (p &lt; 0.001), drowsiness (p &lt; 0.001), decreased activity (p &lt; 0.001), and interference with work (p &lt; 0.001) related scores recorded in MDASI-HN. In terms of feasibility, most surveys indicated that it was extremely easy for subjects to enter responses and not at all difficult for them to use all features of OMP. Furthermore, study participation did not interfere with subjects’ usual activities. Conclusions: Our study showed that pain scores calculated through OMP were, on average higher than those reported by BPI. It also showed the correlation between pain and physical activity. Hence, utilization of OMP in conjunction with questionnaires may improve our understanding of the severity of mucositis-related pain. Clinical trial information: NCT02727062.

Extent of sleep problems and relationship with severity of chronic pain using three validated sleep assessment tools

ObjectiveChronic pain can impact on sleep, but the extent and nature of sleep problems in patients with chronic pain are incompletely clear. Several validated tools are available for sleep assessment but they each capture different aspects. We aimed to describe the extent of sleep issues in patients with chronic non-malignant pain using three different validated sleep assessment tools and to determine the relationship of sleep issues with pain severity recorded using the Brief Pain Inventory (BPI), a commonly used self-assessment tool in pain clinics. The BPI has a single question on the interference of pain on sleep and we also compared this with the validated sleep tools.DesignProspective, cross-sectional study.SettingPain management clinic at a large teaching hospital in the United Kingdom.SubjectsAdult patients (with chronic non-malignant pain of at least 3 months’ duration) attending clinic during a 2-month period.MethodsParticipants completed the Pittsburgh Sleep Quality Index (PSQI), the Pain and Sleep Questionnaire-3 (PSQ-3) and the Verran Snyder-Halpern (VSH) sleep scale, plus the BPI. Duration and type of pain, current medications and demographic data were recorded.ResultsWe recruited 51 patients and 82% had poor sleep quality as shown by PSQIscores above five. PSQI (p = 0.0002), PSQ-3 (p = 0.0032), VSH sleep efficiency (p = 0.012), sleep disturbance (p = 0.0014) and waking after sleep onset (p = 0.0005) scores were associated with worse BPI pain scores. BPI sleep interference scores concurred broadly with the validated sleep tools. Median [range] sleep duration was 5.5 [3.0–10.0] hours and was also related to pain score (p = 0.0032).ConclusionChronic pain has a marked impact on sleep regardless of the assessment tool used. The sleep interference question in the BPI could be used routinely for initial identification of sleep problems in patients with chronic pain.

Risk factors of pain, physical function, and health-related quality of life in elderly people with knee osteoarthritis: A cross-sectional study

Data on the precise mechanisms of the complex interactions of factors related to clinical impact of knee osteoarthritis (KOA) in the elderly population remain limited. To find predictors that explain pain intensity, physical function, and quality of life in elderly KOA subjects, we performed a cross-sectional analysis of the baseline data from a randomized trial. The trial included 104 subjects (aged ≥60) with KOA pain and dysfunctional endogenous pain-inhibitory system activity assessed by conditioned pain modulation (CPM). Three multiple linear regression models were performed to understand the independent predictors of Brief Pain Inventory (BPI), WOMAC function subscale (WOMACFunc), and SF-12 physical subscale (SF12-PCS). Model 1 showed that BPI pain score was predicted by low CPM response, high von-Frey light touch threshold, worse radiological severity as indexed by Kellgren-Lawrence grade (KL), high von-Frey punctate pain intensity and high levels of anxiety (adjusted R2 = 27.1%, F (6,95) = 7.27, P < 0.0001). In model 2, von-Frey light touch threshold, KL, depressive symptoms indexed by Beck Depression Inventory (BDI), level of sleepiness and pain pressure threshold were risk factors for SF12-PCS (adjusted R2 = 31.9%, F (5,96) = 10.5, P < 0.0001). Finally, model 3 showed that WOMACFunc was predicted by BDI, KL and BPI (adjusted R2 = 41%, F (3,98) = 24.42, P < 0.0001). Our data provides an interesting framework to understand the predictors of KOA pain in the elderly and highlights how its related outcomes are affected by disease-specific factors, somatosensory dysfunction and emotional factors.

An exploratory, large-scale study of pain and quality of life outcomes in cancer patients with moderate or severe pain, and variables predicting improvement.

BackgroundThere have been few large-scale, real world studies in Spain to assess change in pain and quality of life (QOL) outcomes in cancer patients with moderate to severe pain. This study aimed to assess changes on both outcomes after 3 months of usual care and to investigate factors associated with change in QoL.Patients and methodsLarge, multi-centre, observational study in patients with lung, head and neck, colorectal or breast cancer experiencing a first episode of moderate to severe pain while attending one of the participating centres. QoL was assessed using the EuroQol-5D questionnaire and pain using the Brief Pain Inventory (BPI). Instruments were administered at baseline and after 3 months of follow up. Multivariate analyses were used to assess the impact of treatment factors, demographic and clinical variables, pain and other symptoms on QoL scores.Results1711 patients were included for analysis. After 3 months of usual care, a significant improvement was observed in pain and QoL in all four cancer groups (p<0.001). Effect sizes were medium to large on the BPI and EQ-5D Index and Visual Analogue Scale (VAS). Improvements were seen on the majority of EQ-5D dimensions in all patient groups, though breast cancer patients showed the largest gains. Poorer baseline performance status (ECOG) and the presence of anxiety/depression were associated with significantly poorer QOL outcomes. Improvements in BPI pain scores were associated with improved QoL.ConclusionIn the four cancer types studied, pain and QoL outcomes improved considerably after 3 months of usual care. Improvements in pain made a substantial contribution to QoL gains whilst the presence of anxiety and depression and poor baseline performance status significantly constrained improvement.

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.

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.

Randomized Controlled Trial versus Real-World Study in Postherpetic Neuralgia

Background: Potential flaws in the design of randomized controlled trials (RCTs) and their low generalizability to clinical practice are being increasingly discussed. As some recent RCTs in neuropathic pain, including postherpetic neuralgia (PHN), demonstrated moderate or no treatment effect, better understanding of factors that may improve trial design, effectiveness, and data interpretation is needed. Objective: To compare RCTs and a real-world study of gastroretentive gabapentin (G-GR) in PHN Methods: Data from two RCTs (Phase 3; n=359) and one real-world study (Phase 4; n=197) of patients with PHN who received G-GR 1800 mg once-daily. The Visual Analog Scale (VAS) and Brief Pain Inventory (BPI) were completed at baseline and the end of study. Patients’ Global Impression of Change (PGIC) was completed at the end of study. Results: Main differences in patient characteristics included higher baseline pain intensity on the VAS and BPI and no use of concomitant neuropathic pain medication in Phase 3. Reductions from baseline in the VAS (p=0.0201) and BPI pain scores (all p<0.05) were significantly greater in Phase 3 compared with Phase 4. In contrast, more patients reported “Very Much” or “Much” improvement on the PGIC in Phase 4 (p=0.0446). Similar proportion of patients experienced ≥1 AE (Phase 3, 54.6%; Phase 4, 50.8%), and AE incidence decreased rapidly to steady low levels after the 2-week titration. More patients discontinued treatment due to AEs during titration in Phase 4 (12.2% vs. 3.1%). Conclusion: To support evidence relevant to clinical practice in PHN and other neuropathic pain syndromes, real-world studies should be a standard complement to RCTs. Based on the RCT vs. real-world study comparison, management of AEs during titration seems important for achieving optimal treatment in clinical practice. For better trial design, measures of overall improvement (e.g., PGIC) should be considered as co-primary efficacy endpoints, along with pain intensity.

Agalsidase Alfa

The enzyme replacement therapy agalsidase alfa (Replagal®) has an amino acid sequence identical to that of native α-galactosidase A; intravenous agalsidase alfa 0.2 mg/kg every other week is indicated for the long-term treatment of patients with confirmed Fabry disease. This article reviews the efficacy and tolerability of agalsidase alfa in patients with Fabry disease, as well as summarizing its pharmacologic properties. Agalsidase alfa had beneficial effects in adult men with Fabry disease, according to the results of two randomized, double-blind, placebo-controlled, 6-month trials (n = 15 and 26). For example, left ventricular mass index was reduced to a significantly greater extent with agalsidase alfa than with placebo. Although the change in myocardial globotriaosylceramide content (primary endpoint in one study) did not significantly differ between agalsidase alfa and placebo recipients, the change in the Brief Pain Inventory (BPI) 'pain at its worst' score (reflecting neuropathic pain while without pain medications; primary endpoint in the second study) was improved to a significantly greater extent with agalsidase alfa than with placebo. In addition, the change in creatinine clearance, but not inulin clearance, significantly favored agalsidase alfa versus placebo recipients. Abnormalities in functional cerebral blood flow and cerebrovascular responses were also reversed with agalsidase alfa therapy. In extensions of these placebo-controlled trials, the reduction in left ventricular mass and improvements in BPI pain scores were maintained after longer-term agalsidase alfa therapy. The significant decline in estimated glomerular filtration rate (eGFR) seen after 48 months' agalsidase alfa treatment was mainly driven by a marked decline in eGFR seen in four patients with stage 3 chronic kidney disease at baseline (although the progression of decline appeared slower than that seen in historic controls); renal function appeared stable in patients with stage 1 or 2 chronic kidney disease. Certain benefits of agalsidase alfa became apparent with longer-term therapy. For example, a significant reduction in cold and warm detection thresholds and a significant improvement in sweat function were seen after 3 years' therapy. Final results from a head-to-head trial comparing the effects of agalsidase alfa and agalsidase beta at approved dosages are not yet available. The only available fully published study compared agalsidase alfa 0.2 mg/kg every other week with an off-label dosage of agalsidase beta 0.2 mg/kg every other week. This randomized, open-label, 24-month trial in adult men and women with Fabry disease generally found no significant differences in outcome between treatment arms. It should be noted that concerns were subsequently raised by the European Medicines Agency regarding the use of agalsidase beta at dosages other than the approved dosage of 1 mg/kg every other week. Preliminary results from an ongoing, randomized, open-label study suggest no differences in outcome between patients with Fabry disease receiving intravenous agalsidase alfa 0.2 mg/kg every other week and those receiving the approved regimen of agalsidase beta 1 mg/kg every other week. In three switching studies, no safety concerns were raised and disease stability was generally maintained following the switch from agalsidase beta 1 mg/kg every other week to agalsidase alfa 0.2 mg/kg every other week. Agalsidase alfa also demonstrated beneficial effects, including in women and pediatric patients, in noncomparative studies and in the Fabry Outcome Survey. Agalsidase alfa was generally well tolerated in patients with Fabry disease, with infusion reactions (e.g. rigors, pyrexia, flushing) being the most commonly occurring adverse event. IgG antibodies developed in ≈24% of male patients with Fabry disease who received agalsidase alfa. After 12-54 months of treatment, 17% of agalsidase alfa recipients were still IgG antibody positive, with immunologic tolerance developing in 7% of agalsidase alfa recipients. No IgE antibodies have been detected in any patient receiving agalsidase alfa. No antibody formation was reported in women receiving agalsidase alfa in noncomparative studies. In conclusion, agalsidase alfa is an effective and well tolerated treatment option for use in patients with Fabry disease.

Quantitative Sensory Testing to assess the sensory characteristics of cancer‐induced bone pain after radiotherapy and potential clinical biomarkers of response

Radiotherapy (XRT) is the gold standard treatment for cancer-induced bone pain (CIBP), but only 50% of patients achieve adequate pain relief within 6 weeks. No predictors of analgesic response to XRT are known. The aim of this preliminary study was to explore the effect of XRT on sensory changes in CIBP with a view to predicting response. After ethics committee approval, patients with CIBP were assessed prior to and 4-6 weeks after palliative XRT. This included completion of the Brief Pain Inventory (BPI) and bedside Quantitative Sensory Testing (QST) measuring evoked sensations to quantified stimuli on the skin over the area of CIBP and a control site. Twenty-three patients were assessed pre and post XRT. Thirteen (57%) had an analgesic response (defined as ≥30% reduction in total BPI). Those patients who had normalisation of abnormal warm sensation ("warm responders", n = 6) were different in that they had higher baseline functional BPI pain scores (median score (IQR) in warm responders = 43 (31.75-58) compared to 31 (12-39.5) in the remaining patients, p = 0.039), larger reductions in pain scores (median difference of 33.5 in total BPI, p = 0.027) and increased likelihood of resolution of sensitivity to pinprick. This is the first clinical study to demonstrate alterations in sensory responses in CIBP. Alterations in specific sensory characteristics seem to be associated with an increased likelihood of successful analgesia from palliative XRT. This supports the use of QST in further biomarker studies to predict response to therapy and aid clinical decision making.

Use of the Brief Pain Inventory and Hospital Anxiety/Depression Scale questionnaires in a district general hospital pain clinic

Introduction: A chronic pain database (PACS) was introduced at the Pain Management Clinic of University Hospital Lewisham (UHL) in July 2001. Each patient attending the outpatient clinic to see the Consultant or the Specialist Nurse was asked to complete the brief pain inventory (BPI) and the hospital anxiety and depression scale (HAD). We looked at the data of patients who had received the tricyclic antidepressant (TCA) amitriptyline as a part of a multi-treatment regime over a period of 4 years from August 2001 to July 2005. Material and Methods: We looked at the data of patients who were treated with amitriptyline in a 4-year period, starting from August 2001. We selected 124 patients on whom full information and follow up was available. In addition to treatment received we also looked at BPI pain score and HAD mood scores. Results: We found an average pain relief of 40.5% as assessed by BPI, with 72 out of 124 patients (40%) achieving at least 50% relief. We found that the two main outcomes of the BPI (percentage pain relief and change in interference score) showed a significant correlation. The HAD score did not correlate with pain relief. The extent of the use of other concurrent treatments showed no correlation with pain relief. The pain relief was not related to the TCA dose. Discussion: In our analysis, the combination of amitriptyline with other pain relief treatments produced a meaningful beneficial effect. It was not, however, possible to establish the individual contribution of the TCA.

Effect of zoledronic acid (Zol) compared with pamidronate (Pam) on disease progression in breast cancer (BC) patients with bone metastases stratified by baseline characteristics

678 Background: Zol has been shown to significantly reduce the risk of skeletal complications compared with Pam in BC pts with bone metastases. Zol has also demonstrated antitumor effects in animal models of human BC and significantly delayed bone lesion progression in pts with renal cancer. To assess whether Zol may reduce the risk of overall disease progression compared with Pam, we conducted a retrospective analysis of BC pts enrolled in a large randomized, controlled trial. Methods: Patients treated with Zol or Pam were retrospectively stratified by baseline characteristics, including Brief Pain Inventory (BPI) composite pain score, time from initial cancer diagnosis to development of bone metastases, and duration of cancer. The relative risk of overall disease progression during 25 months on study was analyzed using the Cox proportional hazards model. Results: Median BPI pain score at baseline was 2.75, median time to development of bone metastases was 44 months, and median time with cancer was 58 months for all patients. In the subset of pts with a baseline BPI score ≥ 2.75 (n = 556), treatment with Zol significantly reduced the risk of disease progression by 21% compared with Pam (hazard ratio [HR] = 0.793; P = .018). Similarly, among pts who developed bone metastases &lt; 44 months from initial diagnosis of cancer (n = 564) and pts with cancer for &lt; 58 months (n = 563), treatment with Zol reduced the risk of disease progression by approximately 20% compared with Pam (HR = 0.805; P = .026 and HR = 0.800; P = .023, respectively). Conclusions: Zol significantly reduced the risk of overall disease progression compared to Pam in specific subsets of pts with higher pain scores and shorter time to development of bone metastases. This exploratory analysis suggests that Zol has potential antitumor effects that may reduce the risk of disease progression in this patient population. These results are consistent with published reports and provide the initiative for further investigations with additional clinical studies. [Table: see text]

Effect of zoledronic acid (Zol) compared with placebo on overall disease and bone lesion progression in patients (pts) with bone metastases from certain solid tumors: Stratification by baseline characteristics

18541 Background: Zol has been shown to significantly reduce the risk of skeletal complications compared with placebo in pts with bone metastases from a wide range of solid tumors including a delay of bone lesion progression in pts with renal cancer. To assess whether Zol may reduce the risk of overall disease or bone lesion progression in pts with solid tumors other than breast, non-small cell lung, and prostate cancers, we conducted a retrospective analysis of pts enrolled in a large, randomized, controlled trial. Methods: Pts treated with Zol or placebo were retrospectively stratified by baseline characteristics, including Brief Pain Inventory (BPI) composite pain score, time from initial cancer diagnosis to development of bone metastases, and duration of cancer. The relative risk (RR) of disease progression during 25 months on study was analyzed using the Cox proportional hazards model (stratified log rank). Results: Median baseline BPI pain score was 2.75, median time with cancer was 15 months, and median time to development of bone metastases was 8.5 months. In pts with a baseline BPI score ≥ 2.75 (n = 236), Zol treatment significantly reduced the RR of disease progression by 34% (hazard ratio [HR] = 0.657; P = .014) and the RR of bone lesion progression by 32% (HR = 0.680; P = .028) compared with placebo. Additionally, in pts with cancer duration &lt;15 months (n = 193), Zol treatment reduced the RR of disease progression by 45% (HR = 0.547; P = .002) and the RR of bone lesion progression by 40% (HR = 0.605; P = .016) compared with placebo. Similarly, among pts who developed bone metastases &lt; 8.5 months from initial diagnosis of cancer (n = 193), Zol treatment significantly reduced the RR of disease progression by 39% and the RR of bone lesion progression by 48% compared with placebo (HR = 0.611; P = .009 and HR = 0.519; P = .004, respectively). Conclusions: This exploratory analysis suggests that Zol has potential antitumor effects that may reduce the risk of overall disease and bone lesion progression in pts who have higher pain scores and shorter time to development of bone metastases. Prospective studies are needed to confirm this result. [Table: see text]