Pain Management Using Clinical Pharmacy Assessments With and Without Pharmacogenomics in an Oncology Palliative Medicine Clinic

PURPOSE: Approximately 30% of patients with cancer who have pain have symptomatic improvement within 1 month using conventional pain management strategies. Engaging clinical pharmacists in palliative medicine (PM) and use of pharmacogenomic testing may improve cancer pain management. METHODS: Adult patients with cancer with uncontrolled pain had baseline assessments performed by PM providers using the Edmonton Symptom Assessment Scale. Pharmacotherapy was initiated or modified accordingly. A subset of patients consented to pharmacogenomic testing. The first pharmacy assessment occurred within 1 week of baseline and a second assessment was done within another week if intervention was required. Each patient’s final visit was at 1 month. Pain improvement rate (a reduction of two or more points on a 0-to-10 pain scale) from baseline to final visit was compared applying the Fisher exact test to published historical control data, and between patients with and without pharmacogenomic testing. Multivariate logistic regression identified pain improvement covariates. RESULTS: Of 142 patients undergoing pharmacy assessments, 53% had pain improvement compared with 30% in historical control subjects ( P < .001). Pain improvement was not different between those who received (n = 43) and did not receive (n = 99) pharmacogenomics testing (56% v 52%; P = .716). However, of 15 patients with an actionable genotype, 73% had pain improvement. Higher baseline pain (odds ratio [OR], 1.79; 95% CI, 1.43 to 2.24; P < .001), black or other race (OR, 0.42; 95% CI, 0.18 to 0.95; P = .04), and performance status 3 or 4 (OR, 0.18; 95% CI, 0.04 to 0.83; P = .03) were associated with odds of pain improvement, but pharmacogenomic testing was not ( P = .64). CONCLUSION: Including pharmacists in PM improves pain management effectiveness. Although pharmacogenomics did not statistically improve pain, a subset of patients with actionable genotypes may have benefited, warranting larger and randomized studies.

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Pharmacogenetic (PGx) guided cancer pain management in an oncology palliative medicine (PM) clinic.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.31_suppl.117 ◽

2019 ◽

Vol 37 (31_suppl) ◽

pp. 117-117

Author(s):

Jai Narendra Patel ◽

Danielle Boselli ◽

James Thomas Symanowski ◽

Stephanie Wodarski ◽

ShRhonda Turner ◽

...

Keyword(s):

Pain Management ◽

Cancer Pain ◽

Pilot Trial ◽

Final Visit ◽

Buccal Swab ◽

Nucleotide Polymorphisms ◽

Cancer Pain Management ◽

Improvement Rate ◽

Edmonton Symptom Assessment Scale ◽

Pain Improvement

117 Background: About 30% of cancer patients presenting with pain have symptomatic improvement using conventional strategies within one month. PGx may help personalize opioid selection and improve cancer pain management. Methods: This is a pragmatic pilot trial investigating the feasibility and application of PGx testing to improve pain management in adults with uncontrolled cancer pain referred to an oncology PM clinic. PM providers assessed patients using Edmonton Symptom Assessment Scale at baseline and opioid therapy was initiated or modified. A buccal swab was obtained for genotyping single nucleotide polymorphisms in: COMT, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5, and OPRM1. The first assessment occurred within one week of baseline and a second within another week if intervention was required. PGx results were available before the first assessment and utilized, if applicable, throughout the one-month study period. Pain improvement rate (≥ 2-point reduction on a 0-10 scale) from baseline to final visit, was compared to historical control data by a one-sided exact binomial test of proportions. Results: Of 75 undergoing PGx testing, 52 were evaluable for the primary endpoint (54% female, 81% white, 17% black, median age 63, 75% stage 3 or 4 disease, median personalized pain goal 3 [0-6]). 56% had pain improvement compared to 30% in historical controls (p < 0.001). At final assessment, 35% met their personalized pain goal. Of 26 (50%) requiring opioid adjustments, 18 (69%) had an actionable genotype with a 61% pain improvement rate. The two most common genes for opioid adjustment were CYP2D6 (16/18; 89%) and COMT (8/18; 44%). The most common PGx-guided modification involved switching from a CYP2D6-metabolized drug (hydrocodone, oxycodone, tramadol) to a non-CYP2D6-metabolized drug (fentanyl, hydromorphone, methadone, morphine). Conclusions: PGx implementation in an oncology PM clinic was feasible and improved pain management. Half of those requiring opioid adjustments had an actionable genotype, with the largest impact from CYP2D6 polymorphisms. Future studies should focus on preemptive PGx testing to guide initial drug selection and confirm clinical utility in a randomized trial. Clinical trial information: NCT02542397.

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Impact of pharmacy interventions on pain management in an oncology palliative medicine (PM) outpatient clinic.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.31_suppl.119 ◽

2017 ◽

Vol 35 (31_suppl) ◽

pp. 119-119

Author(s):

Jai Narendra Patel ◽

Issam Hamadeh ◽

James Thomas Symanowski ◽

Rebecca Edwards ◽

Beth Susi ◽

...

Keyword(s):

Pain Management ◽

Primary Endpoint ◽

Stage Iv ◽

Pain Severity ◽

Final Visit ◽

Significant Pain ◽

Edmonton Symptom Assessment Scale ◽

Pain Improvement ◽

Historical Controls

119 Background: PM can improve the quality of life and survival for cancer patients (pts); however, the demand for PM challenges providers with delayed follow ups resulting in less than one-third of pts achieving significant pain improvement between clinic visits. Engaging pharmacists in the provision of PM may help improve pain management in cancer pts. Methods: Adult cancer pts starting a new pain regimen or requiring changes to an existing regimen at baseline were referred for pharmacy follow up in 3-7 days (assessment #1). The pharmacist evaluated each pt using the Edmonton Symptom Assessment Scale and recommended changes to the referring PM provider, prompting a 2nd follow up in 3-7 days (assessment #2). If no changes were required, pts continued therapy and returned for the final clinic visit (day 28 +/- 7). The primary endpoint was the proportion of pts achieving significant pain improvement (≥ 2-point decrease in pain score on a scale of 0-10) from baseline to final visit, which was compared to historical controls using Fisher’s Exact test. Changes in pain severity from baseline to final visit were compared using Generalized McNemar’s test, and descriptive statistics were used to describe characteristics at assessment #1. Results: Of 102 pts evaluable for the primary endpoint, 76% had stage IV disease, 58% were female, and median age was 57 yrs. Significantly more pts achieved pain improvement from baseline to final visit compared to historical controls (49% v 30%; P < 0.001). Changes in pain severity from baseline to final visit are described in the table. At assessment #1, 70% of pts required an intervention, primarily due to uncontrolled pain (72%), side effects (26%), and/or lack of response to non-pain medications (22%). The most common types of interventions were dose adjustments (62%), education (36%), and/or adding a new medication (30%). Over 90% of recommendations were accepted by the referring PM provider. The median time of assessment was 15 mins. Conclusions: Routine inclusion of pharmacists in the outpatient PM interdisciplinary team improves the effectiveness of pain management. [Table: see text]

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Prospective, Observational Study of Pain and Analgesic Prescribing in Medical Oncology Outpatients With Breast, Colorectal, Lung, or Prostate Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2011.39.2381 ◽

2012 ◽

Vol 30 (16) ◽

pp. 1980-1988 ◽

Cited By ~ 168

Author(s):

Michael J. Fisch ◽

Ju-Whei Lee ◽

Matthias Weiss ◽

Lynne I. Wagner ◽

Victor T. Chang ◽

...

Keyword(s):

Pain Management ◽

Pain Treatment ◽

Performance Status ◽

Multivariable Analysis ◽

Initial Assessment ◽

Explanatory Variables ◽

Patients With Cancer ◽

Pain Management Index ◽

Treatment Adequacy

Purpose Pain is prevalent among patients with cancer, yet pain management patterns in outpatient oncology are poorly understood. Patients and Methods A total of 3,123 ambulatory patients with invasive cancer of the breast, prostate, colon/rectum, or lung were enrolled onto this prospective study regardless of phase of care or stage of disease. At initial assessment and 4 to 5 weeks later, patients completed a 25-item measure of pain, functional interference, and other symptoms. Providers recorded analgesic prescribing. The pain management index was calculated to assess treatment adequacy. Results Of the 3,023 patients we identified to be at risk for pain, 2,026 (67%) reported having pain or requiring analgesics at initial assessment; of these 2,026 patients, 670 (33%) were receiving inadequate analgesic prescribing. We found no difference in treatment adequacy between the initial and follow-up visits. Multivariable analysis revealed that the odds of a non-Hispanic white patient having inadequate pain treatment were approximately half those of a minority patient after adjusting for other explanatory variables (odds ratio, 0.51; 95% CI, 0.37 to 0.70; P = .002). Other significant predictors of inadequate pain treatment were having a good performance status, being treated at a minority treatment site, and having nonadvanced disease without concurrent treatment. Conclusion Most outpatients with common solid tumors must confront issues related to pain and the use of analgesics. There is significant disparity in pain treatment adequacy, with the odds of undertreatment twice as high for minority patients. These findings persist over 1 month of follow-up, highlighting the complexity of these problems.

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Pilot study of multi-gene pharmacogenetic testing for pain management in oncology palliative medicine

Pharmacogenomics ◽

10.2217/pgs-2021-0037 ◽

2021 ◽

Author(s):

Jai N Patel ◽

Danielle Boselli ◽

James Symanowski ◽

Stephanie Wodarski ◽

ShRhonda Turner ◽

...

Keyword(s):

Palliative Medicine ◽

Pilot Trial ◽

Final Visit ◽

Test Results ◽

Pharmacogenetic Testing ◽

Point Reduction ◽

Gene Testing ◽

Pain Scores ◽

Pharmacogenetic Test ◽

Pain Improvement

Aim: We evaluated the application and clinical impact of multi-gene pharmacogenetic testing in oncology palliative medicine. Patients & Methods: In a single-arm pilot trial, cancer patients with uncontrolled pain were assessed in a palliative medicine clinic at baseline and received pharmacogenetic testing. Results were used as applicable up to the final visit (day 30). Pain scores, opioid prescribing, and use of pharmacogenetic test results were collected. Results: In 75 patients, the median baseline pain score was 7/10. Of 54 evaluable at the final visit, 28 required opioid modifications and 19 had actionable genotypes, mostly CYP2D6. Pain improvement (≥2-point reduction) was higher than historical data (56 vs 30%; p < 0.001). There were no differences in pain improvement between those with and without actionable genotypes (61 vs 53%). Conclusion: Multi-gene testing identified actionable genotypes and may improve cancer pain.

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COVID-19 and cancer registries: learning from the first peak of the SARS-CoV-2 pandemic

British Journal of Cancer ◽

10.1038/s41416-021-01324-x ◽

2021 ◽

Author(s):

Alvin J. X. Lee ◽

Karin Purshouse

Keyword(s):

Risk Factors ◽

Performance Status ◽

Poor Performance ◽

Cancer Registries ◽

Adverse Outcomes ◽

Smoking History ◽

Poor Performance Status ◽

International Studies ◽

Patients With Cancer ◽

Increased Risk

AbstractThe SARS-Cov-2 pandemic in 2020 has caused oncology teams around the world to adapt their practice in the aim of protecting patients. Early evidence from China indicated that patients with cancer, and particularly those who had recently received chemotherapy or surgery, were at increased risk of adverse outcomes following SARS-Cov-2 infection. Many registries of cancer patients infected with SARS-Cov-2 emerged during the first wave. We collate the evidence from these national and international studies and focus on the risk factors for patients with solid cancers and the contribution of systemic anti-cancer treatments (SACT—chemotherapy, immunotherapy, targeted and hormone therapy) to outcomes following SARS-Cov-2 infection. Patients with cancer infected with SARS-Cov-2 have a higher probability of death compared with patients without cancer. Common risk factors for mortality following COVID-19 include age, male sex, smoking history, number of comorbidities and poor performance status. Oncological features that may predict for worse outcomes include tumour stage, disease trajectory and lung cancer. Most studies did not identify an association between SACT and adverse outcomes. Recent data suggest that the timing of receipt of SACT may be associated with risk of mortality. Ongoing recruitment to these registries will enable us to provide evidence-based care.

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Predictors of Survival in Subtotally Resected WHO Grade I Skull Base Meningiomas

Cancers ◽

10.3390/cancers13061451 ◽

2021 ◽

Vol 13 (6) ◽

pp. 1451

Author(s):

Michele Da Broi ◽

Paola Borrelli ◽

Torstein R. Meling

Keyword(s):

Skull Base ◽

Clinical Outcomes ◽

Karnofsky Performance Status ◽

Performance Status ◽

Multivariable Analysis ◽

Advanced Age ◽

Final Visit ◽

Subtotal Resection ◽

Who Grade ◽

Skull Base Meningiomas

Background: Although gross total resection (GTR) is the goal in meningioma surgery, this can sometimes be difficult to achieve in skull base meningiomas. We analyzed clinical outcomes and predictors of survival for subtotally resected benign meningiomas. Methods: A total of 212 consecutive patients who underwent subtotal resection (STR) for benign skull base meningioma between 1990–2010 were investigated. Results: Median age was 57.7 [IQR 18.8] years, median preoperative Karnofsky performance status (KPS) was 80.0 [IQR 20.0], 75 patients (35.4%) had posterior fossa meningioma. After a median follow-up of 6.2 [IQR 7.9] years, retreatment (either radiotherapy or repeated surgery) rate was 16% at 1-year, 27% at 3-years, 34% at 5-years, and 38% at 10-years. Ten patients (4.7%) died perioperatively, 9 (3.5%) had postoperative hematomas, and 2 (0.8%) had postoperative infections. Neurological outcome at final visit was improved/stable in 122 patients (70%). Multivariable analysis identified advanced age and preoperative KPS < 70 as negative predictors for overall survival (OS). Patients who underwent retreatment had no significant reduction of OS. Conclusions: Advanced age and preoperative KPS were independent predictors of OS. Retreatments did not prolong nor shorten the OS. Clinical outcomes in STR skull base meningiomas were generally worse compared to cohorts with high rates of GTR.

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Acupuncture for palliative cancer pain management: systematic review

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2020-002638 ◽

2021 ◽

pp. bmjspcare-2020-002638

Author(s):

Juan Yang ◽

Dietlind L Wahner-Roedler ◽

Xuan Zhou ◽

Lesley A Johnson ◽

Alex Do ◽

...

Keyword(s):

Systematic Review ◽

Palliative Care ◽

Pain Management ◽

Cancer Pain ◽

Included Study ◽

Favourable Effect ◽

Levels Of Evidence ◽

Patients With Cancer ◽

Level 3 ◽

Randomised Controlled

BackgroundPain is one of the most common and problematic symptoms encountered by patients with cancer. Due to the multifactorial aetiology, pain management of these patients frequently requires multidisciplinary interventions including conventional support and specialty palliative care. Acupuncture has been identified as a possible adjunctive therapy for symptom management in cancer pain, and there is currently no systematic review focused solely on the evidence of acupuncture on cancer pain in palliative care.ObjectiveTo critically analyse currently available publications regarding the use of acupuncture for pain management among patients with cancer in palliative care settings.MethodsMultiple academic databases were searched from inception to 29 October 2020. Randomised controlled trials involving acupuncture in palliative care for treatment of cancer-related pain were synthesised. Data were extracted by two independent reviewers, and methodological quality of each included study was assessed using the Oxford Centre for Evidence-Based Medicine (OCEBM) 2011 Levels of Evidence.ResultsFive studies (n=189) were included in this systematic review. Results indicated a favourable effect of acupuncture on pain relief in palliative care for patients with cancer. According to OCEBM 2011 Levels of Evidence, they were level 2 in one case (20%), level 3 in two cases (40%) and level 4 in the remaining (40%). Low-level evidence adversely affects the reliability of findings.ConclusionsAcupuncture may be an effective and safe treatment associated with pain reduction in the palliative care of patients with cancer. Further high-quality, adequately powered studies are needed in the future.

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Trajectory of Performance Status and Symptom Scores for Patients With Cancer During the Last Six Months of Life

Journal of Clinical Oncology ◽

10.1200/jco.2010.30.7173 ◽

2011 ◽

Vol 29 (9) ◽

pp. 1151-1158 ◽

Cited By ~ 227

Author(s):

Hsien Seow ◽

Lisa Barbera ◽

Rinku Sutradhar ◽

Doris Howell ◽

Deborah Dudgeon ◽

...

Keyword(s):

Performance Status ◽

Symptom Assessment ◽

Well Being ◽

Assessment System ◽

Assessment Tools ◽

Future Research ◽

Patients With Cancer ◽

Average Pain ◽

Observational Cohort ◽

Over Time

Purpose Ontario's cancer system is unique because it has implemented two standardized assessment tools population-wide to improve care: the Edmonton Symptom Assessment System (ESAS) measures severity of nine symptoms (scale 0 to 10; 10 indicates the worst) and the Palliative Performance Scale (PPS) measures performance status (scale 0 to 100; 0 indicates death). This article describes the trajectory of ESAS and PPS scores 6 months before death. Patients and Methods Observational cohort study of cancer decedents between 2007 and 2009. Decedents required ≥1 ESAS or PPS assessment in the 6 months before death for inclusion. Outcomes were the decedents' average ESAS and PPS scores per week before death. Results Ten thousand seven hundred fifty-two (ESAS) and 7,882 (PPS) decedents were included. The mean age was 65 years, half were female, and approximately 75% of assessments occurred in cancer clinics. Average PPS score declined slowly over the 6 months before death, starting at approximately 70 and ending at 40, declining more rapidly in the last month. For ESAS symptoms, average pain, nausea, anxiety, and depression scores remained relatively stable over the 6 months. Conversely, shortness of breath, drowsiness, well-being, lack of appetite, and tiredness increased in severity over time, particularly in the month before death. More than one third of the cohort reported moderate to severe scores (ie, 4 to 10) for most symptoms in the last month of life. Conclusion In this large outpatient cancer population, trajectories of mean ESAS scores followed two patterns: increasing versus generally flat. The latter was perhaps due to available treatment (eg, prescriptions) for those symptoms. Future research should prioritize addressing symptoms that worsen over time.

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Assessing efficacy and safety of rectally vs. intravenously administered Sibazon in treatment of generalized epileptic seizures in children

Epilepsia and paroxyzmal conditions ◽

10.17749/2077-8333/epi.par.con.2021.096 ◽

2021 ◽

Vol 13 (3) ◽

pp. 200-210

Author(s):

A. G. Prityko ◽

K. V. Osipova ◽

P. L. Sokolov ◽

E. A. Ezhova ◽

I. G. Kotel’nikova ◽

...

Keyword(s):

Drug Administration ◽

Epileptic Seizures ◽

Blood Analysis ◽

Intramuscular Administration ◽

Final Visit ◽

Fisher Exact Test ◽

Efficacy And Safety ◽

Clonic Seizures ◽

Group 2 ◽

Group 1

Objective: to prove the therapeutic equivalence and similar safety profile of “Sibazon, rectal solution” (international nonproprietary name: diazepam) and “Sibazon, solution for intravenous and intramuscular administration” in children with primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted in 20 patients suffering from epilepsy with generalized seizures aged 1 to 17 years. Clinical blood and urine tests, biochemical blood analysis were used for diagnostics (glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, creatinine clearance), as well as data on electrocardiographic (ECG) and electroencephalographic (EEG) studies. The patients were divided into two groups: in Group 1 (n=8), a rectal solution was used, in Group 2 (n=12) – a solution for intravenous and intramuscular administration.Results. The number of cases in which seizures were completed within 10 minutes after using the drug without resuming within subsequent 60 minutes, in Group 1 was 7 (87.5%), and in Group 2 – 9 (75.0%) (Fisher exact test (FET): p=0.617). Repeated primary generalized or bilateral tonic/clonic/tonic-clonic seizures within 24 hours after drug administration, in Group 1 were absent in 5 (62.5%) patients, in Group 2 – in 6 (50%) (FET: p=0.670); within 48 hours after drug administration – in 5 (62.5%) and 7 (58.3%) children, respectively (FET: p=1.00). Physical examination revealed no pathology in all patients at the final visit. While comparing ECG and EEG data at the final visit, no inter-group differences were found by the number of children with deviations from the norm. The results of laboratory studies confirmed that using the studied drugs had no negative effect on the main indicators of clinical and biochemical blood tests as well as clinical urine analysis.Conclusion. The effectiveness of the rectal form of Sibazon in relieving pediatric generalized epileptic seizures is comparable to that of Sibazon for intramuscular administration. The drug rectal form, due to easy-to-use administration, is preferable for outpatient practice. “Sibazon, rectal solution” is safe and has good tolerability.

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