Breakthrough Cancer Pain: Preliminary Data of The Italian Oncologic Pain Multisetting Multicentric Survey (IOPS-MS)

Introduction

An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first 1500 cancer patients with BTP enrolled in this study are presented here.

Methods

Thirty-two clinical centers are involved in the survey. A diagnosis of BTP was performed by a standard algorithm. Epidemiological data, Karnofsky index, stage of disease, presence and sites of metastases, ongoing oncologic treatment, and characteristics of background pain and BTP and their treatments were recorded. Background pain and BTP intensity were measured. Patients were also questioned about BTP predictability, BTP onset (≤10 or >10 min), BTP duration, background and BTP medications and their doses, time to meaningful pain relief after BTP medication, and satisfaction with BTP medication. The occurrence of adverse reactions was also assessed, as well as mucosal toxicity.

Results

Background pain was well controlled with opioid treatment (numerical rating scale 3.0 ± 1.1). Patients reported 2.5 ± 1.6 BTP episodes/day with a mean intensity of 7.5 ± 1.4 and duration of 43 ± 40 min; 977 patients (65.1%) reported non-predictable BTP, and 1076 patients (71.7%) reported a rapid onset of BTP (≤10 min). Higher patient satisfaction was reported by patients treated with fast onset opioids.

Conclusions

These preliminary data underline that the standard algorithm used is a valid tool for a proper diagnosis of BTP in cancer patients. Moreover, rapid relief of pain is crucial for patients’ satisfaction. The final IOPS-MS data are necessary to understand relationships between BTP characteristics and other clinical variables in oncologic patients.

Funding

Molteni Farmaceutici, Italy.

     

Breakthrough Cancer Pain in Patients With Abdominal Visceral Cancer Pain

Objective

The objective of this study was to assess the characteristics of breakthrough cancer pain (BTcP) in patients with abdominal cancer pain, and the eventual factors associated with its presentation.

Evaluation of 1294 Female Patients with Breast Pain: A Retrospective Study

Introduction

Mastalgia, or breast pain, is one of the most important complaints referred to outpatient clinics. The objective of this study was to evaluate the factors causing mastalgia. All patients who presented to our clinic with complaints of mastalgia were assessed along with their type of mastalgia symptoms, menopausal status, and radiology results.

Methods

A total of 3157 patients with mastalgia complaints visited our clinic between January 2015 and February 2018. Only 1294 of them were retrospectively screened. Age, sex, menopausal (premenopausal, postmenopausal) status, mastalgia type (cyclic, non-cyclic), and imaging findings of the patients were examined.

Results

The mean age was 43.8?±?11.8 (13–86) years, with 453 (35%) patients younger than 40 years and 841 (65%) older than 40. Cyclic mastalgia was found in 207 (16%) patients, and non-cyclic mastalgia was seen in 1087 (84%) patients. A total of 786 (60.7%) patients were premenopausal, and 508 (39.3%) were postmenopausal. Mammography was used in 545 (42.1%) patients; 1190 (92.0%) women had breast ultrasonography.

Conclusion

Although breast pain is a common symptom in women who are referred to breast outpatient clinics, we concluded that patients who complain of mastalgia should not be afraid of cancer. Despite this and for reassurance, clinical imaging may be necessary to alleviate these patients’ suspicions.

     

Characteristics of Advanced Cancer Patients With Cancer-Related Fatigue Enrolled in Clinical Trials and Patients Referred to Outpatient Palliative Care Clinics

ContextLimited published data exist on whether characteristics of patients with advanced cancer enrolled in cancer-related fatigue clinical trials (CCTs) differ from patients in outpatient palliative care clinics (OPCs).ObjectivesThe primary aim of this study was to compare the characteristics of two groups of patients with advanced cancer and moderate-to-severe fatigue: patients in CCTs and patients at an OPC.MethodsWe retrospectively reviewed the records of 337 patients who were enrolled in one of five CCTs for advanced cancer patients at The University of Texas M. D. Anderson Cancer Center as well as the records of 1896 consecutive patients who were referred to our OPC from January 2003 through December 2010. Patients with fatigue scores of ≥4/10 (measured by the Edmonton Symptom Assessment System [ESAS]) were eligible (1252 OPC patients and 337 CCT patients). Patient characteristics, ESAS scores, and survival times were compared using Chi-square tests, Wilcoxon rank sum tests, and the Kaplan-Meier method.ResultsCompared with the CCT patients, OPC patients were more likely to be older (58 vs. 59 years; P = 0.009) and male (38% vs. 52%; P < 0.001). The most common primary cancer type was breast cancer (22%) in the CCT patients and lung cancer (23%) in the OPC patients (P < 0.001). The median ESAS scores in the OPC and CCT groups, respectively, were 6 and 4 for pain (P < 0.001), 7 and 7 for fatigue (P = 0.525), 3 and 2 for depression (P = 0.004), 3 and 2 for anxiety (P < 0.001), 3 and 2 for dyspnea (P < 0.001), and 43 and 32 for the symptom distress score (P < 0.001). The median overall survival times were 17.9 months (95% CI 13.5–22.3 months) in the CCT group and 3.8 months (95% CI 3.5–4.1 months) in the OPC group (P < 0.001).ConclusionBaseline characteristics and overall survival times significantly differed between patients enrolled in the CCT and OPC groups. Therefore, we conclude that the results of CCTs cannot be generalized to patients being treated in OPCs.     

Symptoms of Fibromyalgia According to the 2016 Revised Fibromyalgia Criteria in Chronic Pain Patients Referred to Multidisciplinary Pain Rehabilitation: Influence on Clinical and Experimental Pain Sensitivity

Fibromyalgia (FM) is a condition with chronic widespread pain and signs of generalized pain hypersensitivity. FM has previously been classified according to the American College of Rheumatology-1990 criteria, where the presence of hypersensitivity is estimated by a tender point examination. Because of the limitations of these classification criteria, new diagnostic criteria have been proposed, abandoning this examination. This cross-sectional study investigated the prevalence of FM according to the revised 2016 FM criteria in a large cohort of chronic pain patients. Pain drawings, the FM Symptom Severity Scale, and questionnaires assessing manifestations of pain, pain-related disability, and psychological distress were collected from 1,343 patients with chronic nonmalignant pain referred to a multidisciplinary pain clinic. In addition, assessments of mechanical and thermal pain sensitivity were performed in 496 of the patients. Patients fulfilling the FM criteria (n?=?498, 37%) reported significantly higher levels of pain, pain-related disability, psychological distress, and sensitivity to mechanical and heat stimuli (P?<?.05). Moreover, the proportion using opioids were significantly higher compared with patients not fulfilling the criteria (P?=?.015). Significant associations were found between heat and mechanical pain sensitivity (P?<?.001) indicating that patients who showed higher pain sensitivity to mechanical stimulation also showed higher pain sensitivity to thermal stimulation.

Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study

PurposeVenous pain induced by peripheral intravenous infusion of gemcitabine has remained an unresolved issue in clinical practice. This study aimed to identify differences between gemcitabine formulations as well as risk factors associated with gemcitabine-induced venous pain in patients with cancer.MethodsWe retrospectively analyzed data from consecutive patients with cancer who had received chemotherapy including a lyophilized or liquid formulation of gemcitabine diluted with 5% glucose solution via a peripheral vein. The study was conducted at Ehime University Hospital using electronic medical records dated between January 2015 and July 2017. The primary end point was the prevalence of venous pain at the administration site during gemcitabine infusion, classified as injection site reaction of grade ≥2 according to the Common Terminology Criteria for Adverse Events, version 4.0. A multivariate logistic regression analysis with generalized estimating equations for longitudinal data was used to identify risk factors for venous pain during all courses of gemcitabine treatment.FindingsA total of 1150 treatment courses in 141 Japanese patients were evaluated in this study. Venous pain occurred in 115 courses (10.0%) and in 49 patients (34.8%). The multivariate logistic regression analysis with generalized estimating equations revealed that a dose increase of gemcitabine and use of the liquid formulation of gemcitabine were significantly associated with an increased risk for venous pain (dose increase, adjusted odds ratio [OR] = 1.25; 95% CI, 1.11–1.40 [P < 0.001]; and liquid formulation, adjusted OR = 12.43, 95% CI, 5.61–27.51 [P < 0.001]), whereas age, course number of gemcitabine, and use of the soft-back product of 5% glucose solution were significantly associated with a reduced risk for venous pain (age, adjusted OR = 0.75; 95% CI, 0.57–0.98 [P = 0.037]; course number, adjusted OR = 0.96; 95% CI, 0.92–0.99 [P = 0.023]; and soft back, adjusted OR = 0.39; 95% CI, 0.21–0.74 [P = 0.004]).ImplicationsThe use of the liquid formulation of gemcitabine was associated with a significant increase in the frequency of gemcitabine-induced venous pain despite dilution with 5% glucose solution compared to that with the lyophilized formulation. The lyophilized formulation of gemcitabine should hence be used in peripheral intravenous infusion for the treatment of patients with cancer.     

Breakthrough Pain: A Qualitative Study of Patients with Advanced Cancer in Northwest China

Background: Breakthrough pain is an extremely painful symptom that impairs quality of life in cancer patients. It negatively impacts their emotional wellbeing, physical function, and mental health. The aim of this study is to use a qualitative methodology to examine the perception of cancer patients with breakthrough pain in the Northwest of China. Methods: A semi-structured, face-to-face interview was conducted with nine cancer patients who experienced breakthrough pain; and a qualitative content analysis was performed. Results: Five themes were generated: (1) sufferings from breakthrough cancer pain, (2) hopelessness and helplessness, (3) perception of breakthrough cancer pain and analgesia, (4) strong as a Chinese, and (5) support needed from health care system. Conclusion: Although certain traditional cultural worldviews increase patients' acceptance of pain, healthcare providers need proper treatment guidelines to improve the quality of cancer patient care in Northwest China. We recommend that healthcare workers and hospital managers place cancer pain management in higher priority. Relevant pain management education programs should be provided to both healthcare providers and patients to improve their knowledge in these area. Healthcare professionals need to establish a mutual communication channel between patients and healthcare workers to meet patients' needs during breakthrough pain episodes in order to improve pain management. Nevertheless, the government and the healthcare system need to recognize the importance and urgency of palliative care services.     

Consistent and Breakthrough Pain in Diverse Advanced Cancer Patients: A Longitudinal Examination

Although cancer pain, both consistent and breakthrough pain ([BTP]; pain flares interrupting well-controlled baseline pain), is common among cancer patients, its prevalence, characteristics, etiology, and impact on health-related quality of life (HRQOL) are poorly understood. This longitudinal study examined the experience and treatment of cancer-related pain over six months, including an evaluation of ethnic differences. Patients with Stage III or IV breast, prostate, colorectal, or lung cancer, or Stage II–IV multiple myeloma with BTP completed surveys on initial assessment and at three and six months. Each survey assessed consistent pain, BTP, depressed affect, active coping ability, and HRQOL. Among the respondents (n = 96), 70% were white, 66% were female, and had a mean age of 56 ± 10 years. Nonwhites reported significantly greater severity for consistent pain at its worst (P = 0.009), least (P ≤ 0.001), on average (P = 0.004), and upon initial assessment (P = 0.04), and greater severity for BTP at its worst (P = 0.03), least (P = 0.02), and at initial assessment (P = 0.008). Women also had higher levels of some BTP measures. Ethnic disparities persisted when data estimation techniques were used. Examined longitudinally, consistent pain on average and several BTP measures reduced over time, although not greatly, indicating the persistence of pain in the cancer experience. These data provide evidence for the significant toll of cancer pain, while demonstrating further health care disparities in the cancer pain experience.     

Experimental Referred Pain Extends Toward Previously Injured Location: An Explorative Study

Facilitated pain mechanisms have been demonstrated in musculoskeletal pain, but it is unclear whether a recent painful injury leaves the pain system sensitized. Pain characteristics were assessed in individuals who recently recovered from ankle pain (recovered pain group; n?=?25) and sex-matched control subjects (n?=?25) in response to tonic pressure pain and saline-induced pain applied at the shin muscle. Pain intensity and pain referral patterns were recorded bilaterally after the painful muscle stimulus. Pressure pain thresholds were measured at the lower legs and shoulder. Cuff pressure algometry on the lower leg was used to assess pain detection threshold, pressure evoking 6-cm pain score on a 10-cm visual analog scale, pain tolerance, temporal summation of pain, and conditioned pain modulation. Compared with in control subjects, saline-induced and pressure-induced pain in the shin muscle were more frequently felt as referred pain in the previously painful ankle (P < .05), and the pain area within the previously affected ankle was larger after saline-induced pain (P < .05). In the recovered pain group, conditioned pain modulation responses and the cuff pressure needed to reach a 6-cm pain score on a 10-cm visual analog scale was higher in the previously painful leg compared with in the contralateral leg (P < .05). No group differences were found in pressure pain threshold, pain detection threshold, pain tolerance, and temporal summation of pain.

Epidemiology of Chronic Pain in the Latium Region,Italy: A Cross-Sectional Study on the Clinical Characteristics of Patients Attending Pain Clinics

In Italy, chronic pain affects more than a quarter of the population, whereas the average European prevalence is 21%. This high prevalence might be due to the high percentage of Italian people who do not receive treatment, even after the passing of law 38/2010 (the right to access pain management in Italy), which created a regional network for the diagnosis and treatment of noncancer chronic pain. Italian epidemiologic studies on chronic pain are scanty, and this observational, multicenter, cross-sectional study is the first to investigate the clinical characteristics of patients who attended the pain management clinics in the Latium Region, Italy, for the management of their noncancer chronic pain. A total of 1,606 patients (mean age 56.8 years, standard deviation ± 11.4), 67% women, were analyzed. Severe pain was present in 54% of the sample. Women experienced pain and had it in two or more sites more often than men (57% vs. 50%, p = .02; and 55.2% vs. 45.9%, p < .001, respectively). Chronic pain was musculoskeletal (45%), mixed (34%), and neuropathic (21%). In more than 60% of the cases, chronic pain was continuous, and in 20% it had lasted for more than 48 months; long-lasting pain was often neuropathic. Low back (33.4%) and lower limbs (28.2%) were the main locations. Severe intensity of pain was statistically significantly associated with female gender (odds ratio [OR] 1.39; 95% confidence interval [CI] 1.06-1.84); with International Classification of Diseases, Ninth Revision, codes for chronic pain syndrome (OR 2.14; 95% CI 1.55-2.95); and with continuous pain (OR 2.02; 95% CI 1.54-2.66). Neuropathic pain and mixed pain were significantly associated with number of sites, and a trend seemed to be present (OR 2.11 and 3.02 for 2 and 3 + sites; 95% CI 1.59-2.79 and 2.00-4.55, respectively).     

Burden of Neuropathic Pain in Indian Patients Attending Urban,Specialty Clinics: Results from a Cross Sectional Study

Background and Objective: Recent studies in Western populations have reported high patient burden of neuropathic pain. No data are currently available on the burden of neuropathic pain in Indian patients. Our study evaluated the burden of neuropathic pain in patients attending urban, private‐sector, specialty clinics. Methods: This cross‐sectional, observational study surveyed 467 patients with neuropathic pain to assess the burden of pain (pain severity, patient‐reported treatment effectiveness, impact of hypothetical pain relief on overall health rating), burden because of quality of life impairment (EuroQoL health state, pain interference with daily living, sleep and mood disturbances, medication‐related adverse events), and economic burden (treatment cost, impact on employment and productivity). Physicians filled out a clinical case report form to provide information on patient's neuropathic pain disorder and treatment provided. The data were analyzed to assess the overall burden of neuropathic pain. Results: Painful diabetic neuropathy was the most common cause of neuropathic pain (72%). Majority (64%) of patients reported moderate to severe pain, and about 50% reported moderate to severe pain‐related interference in activities of daily living. Substantial sleep impairment was reported as compared with general population. About 50% of patients reported co‐morbid mood disorders, while 67% reported medication‐related adverse event in the preceding week. Fifty‐seven per cent of patients reported an adverse impact on their employment status, including 13% who retired early or were unemployed. Among those currently working, 72% reported reduced productivity, including 22% who reported reduced productivity “most” or “all” of the time. Conclusions: In Indian patients with access to urban, private‐sector, specialty clinics neuropathic pain (particularly painful diabetic neuropathy) remains a significant medical condition with substantial negative impact on their quality of life. ?     

Beyond the Traditional Definition of Breakthrough Pain: An Observational Study

Introduction

Breakthrough pain (BTP) is traditionally defined as a transitory pain flare in opioid-treated patients with chronic background pain. This definition has, however, been challenged in recent years. This study aimed to analyze BTP prevalence in different pain conditions.

Methods

This was a prospective, noninterventional, observational study conducted from June to September 2011 in two Italian pain treatment reference centres. Consecutive patients aged >18 years with oncological or non-oncological pain were eligible for this study; background pain was acute/ subacute (<3 months) or chronic (>3 months). The characteristics of pain were evaluated by means of a structured interview by physicians, and patients were asked to complete a dedicated clinical study form. The following outcomes were assessed: chronic pain duration (in patients with chronic pain), BTP prevalence, and number and severity of daily BTP episodes. All outcomes were assessed in four populations of patients with: (a) chronic oncological pain; (b) chronic non-oncological pain; (c) non-chronic oncological pain; (d) nonchronic non-oncological pain. The correlation between BTP and gender was also investigated.

Results

Of 1,270 patients with chronic pain, 1,086 had non-oncological pain (85.5%). Most patients (68.6%) with non-oncological pain were female (P = 0.001). Pain duration was significantly longer in non-oncological pain versus oncological pain groups (P = 0.002). BTP prevalence was lower in non-oncological patients (P < 0.001). No differences were reported in terms of number and severity of daily BTP episodes. BTP was more frequent in females with non-oncological pain (P = 0.04). Females had a significantly higher pain severity (P = 0.02) than males.

Conclusion

BTP is frequently reported in patients who do not have BTP according to the traditional definition. BTP frequency and severity is similar in oncological and non-oncological pain.     

Economic Crisis: Consequences for Patients,Chronic Pain Clinics,and the Pharmaceutical Industry

ABSTRACT

An economic analysis of the impact of the economic crisis on pain management is presented. Cost-effectiveness in pain management is addressed. Impact on patients, pain clinics, and medication expenditures are described.     

Prevalence of Malingering in Patients With Chronic Pain Referred for Psychologic Evaluation in a Medico-Legal Context

Greve KW, Ord JS, Bianchini KJ, Curtis KL. Prevalence of malingering in patients with chronic pain referred for psychologic evaluation in a medico-legal context.

Objective

To provide an empirical estimate of the prevalence of malingered disability in patients with chronic pain who have financial incentive to appear disabled.

Design

Retrospective review of cases.

Setting

A private neuropsychologic clinic in a southeastern metropolitan area.

Participants

Consecutive patients (N=508) referred for psychologic evaluation related to chronic pain over a 10-year period (1995-2005).

Interventions

Not applicable.

Main Outcome Measures

Prevalence of malingering was examined using 2 published clinical diagnostic systems (Malingered Pain-Related Disability and Malingered Neurocognitive Dysfunction) as well as statistical estimates based on well validated indicators of malingering.

Results

The prevalence of malingering in patients with chronic pain with financial incentive is between 20% and 50% depending on the diagnostic system used and the statistical model's underlying assumptions. Some factors associated with the medico-legal context such as the jurisdiction of a workers' compensation claim or attorney representation were associated with slightly higher malingering rates.

Conclusions

Malingering is present in a sizable minority of patients with pain seen for potentially compensable injuries. However, not all excess pain-related disability is a result of malingering. It is important not to diagnose malingering reflexively on the basis of limited or unreliable findings. A diagnosis of malingering should be explicitly based on a formal diagnostic system.