T726 ZICONOTIDE ADVERSE EVENTS IN PATIENTS WITH CANCER PAIN: A MULTICENTER OBSERVATIONAL STUDY OF A SLOW TITRATION, MULTIDRUG PROTOCOL

e19350 Background: Opioids have been the cornerstone of analgesic treatment for severe chronic pain. OIC is the most commonly reported adverse effect associated with opioids, and compromises patient satisfaction and adherence to analgesic treatment and also quality of life. Naloxegol is a PEGylated derivative of the µ-opioid receptor antagonist naloxone indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives. This real-world (RW) study (NCT03638440) aims to evaluate safety and efficacy of Naloxegol in patients with cancer pain diagnosed with OIC. Methods: This is a single-arm, multinational, prospective, RW observational study in adult subjects receiving treatment with opioids for at least 4 weeks, diagnosed with OIC that receive naloxegol in routine clinical practice. This study will recruit patients from 25 European hospitals. Data for efficacy are collected through the patient's diary during a 4-week period. Results: One hundred fifty-two patients, median age 66 years, 54% women, have been included in this analysis. Main cancer locations were lung (26%), breast (21%), prostate (10%), pancreas (9%) and head and neck (9%), and 67% had metastasis, mainly in bone (37%). Most frequent opioid treatments were fentanyl (29%), oxycodone (22%), and morphine (15%). Most frequent previous laxatives were osmotic (61%) and stimulant (27%) laxatives. Over 109 patients with at least one BFI score available after baseline, change in BFI score was ≥12 points in 61% of patients and 33% had BFI score <30 points after 4 weeks of treatment. There were statistically significant differences between baseline and final visit in BFI overall score as well as in the score of each of the three questions. Most common adverse reactions to naloxegol were abdominal pain (7.9%), diarrhea (2.6%), flatulence (1.3%) and nausea (1.3%), most of them grade 1-2. Eight patients had adverse reactions leading to study discontinuation: abdominal pain (5), diarrhea (2), intestinal perforation (1) and fatigue (1). Only one patient died due to an adverse reaction: intestinal perforation. Conclusions: Preliminary results show a promising efficacy of naloxegol in this RW treatment study. Toxicity profile was as expected. RW evidence seems to be a useful methodology to assess the real-life use of naloxegol and its efficacy in cancer patients.

Download Full-text

Relationship Between Prognostic Nutritional Index and Mortality in Overweight or Obese Patients with Cancer: A Multicenter Observational Study

Journal of Inflammation Research ◽

10.2147/jir.s321724 ◽

2021 ◽

Vol Volume 14 ◽

pp. 3921-3932

Author(s):

Xi Zhang ◽

Jing-Hua Li ◽

Qi Zhang ◽

Qin-Qin Li ◽

Kang-Ping Zhang ◽

...

Keyword(s):

Observational Study ◽

Prognostic Nutritional Index ◽

Obese Patients ◽

Multicenter Observational Study ◽

Patients With Cancer ◽

Nutritional Index

Download Full-text

Efficacy and safety of lenvatinib in combination with everolimus in metastatic renal cell carcinoma resistant to antiangiogenic targeted therapy: Russian multicenter observational study ROSLERCM

Cancer Urology ◽

10.17650/1726-9776-2019-15-3-56-69 ◽

2019 ◽

Vol 15 (3) ◽

pp. 56-69 ◽

Cited By ~ 1

Author(s):

M. I. Volkova ◽

A. M. Abdelgafur ◽

M. T. Aivazov ◽

Z. V. Amoev ◽

K. G. Babina ◽

...

Keyword(s):

Renal Cell Carcinoma ◽

Targeted Therapy ◽

Adverse Events ◽

Observational Study ◽

Response Rate ◽

Objective Response ◽

Tumor Control ◽

Efficacy And Safety ◽

Multicenter Observational Study ◽

Grade Iii

Objective: an assessment of efficacy and safety of lenvatinib in combination with everolimus in unselected patients with metastatic renal cell carcinoma (mRCC) progressed during or following ≥1 line of antiangiogenic targeted therapy.Material. Russian multicenter observational study ROSLERCM included 73 consecutive patients with morphologically verified mRCC progressed during or following ≥1 line of antiangiogenic targeted therapy, treated with lenvatinib (18 mg/d) and everolimus (5 mg/d) in 20 Russian centers. Median age of the patients was 59 (23–73) years, a male-to-female ratio – 3:1. Most common histological type of kidney cancer was clear-cell RCC (71 (95.8 %)). More than 2 lines of previous therapy were administered in 45 (61.6 %) cases. Most patients were diagnosed with multiple metastases (71 (97.3 %)) in >1 site (61 (83.6 %)). Nephrectomy was performed in 87.7 % (64/73) of cases. At the combined therapy start ECOG PS 2–4 was registered in 16 (20.5 %), poor prognosis according to IMDC score – in 33 (45.2 %) patients. Median follow-up was 9.7 (1–26) months.Results. Median progression-free survival achieved 16.9 (95 % confidence intervals (CI) 12.1–20.6), overall survival – 20.8 (95 % CI 15.7–25.9) months. Objective response rate was 11 % (8/73); tumor control was reached in 93.2 % (68/73) of cases. Median objective response duration was 10.5 (4.3–16.8) months, tumor control duration – 10.0 (2.5–17.5) months. Any adverse events developed in 83.6 % (61/73), adverse events grade III–V – in 23.3 % (17/73) of cases. Most frequent AE grade III–IV were diarrhea (10 (13.6 %)) and arterial hypertension (6 (8.2 %)). Unacceptable toxicity demanded treatment cancellation in 4.2 % (3/73), therapy interruption – in 30.1 % (22/73) and dose reduction – in 32.9 % (24/73) of patients.Conclusion. Unselected mRCC patients administered with combined targeted therapy in the real world practice were registered with similar survival, lower objective response rate, and better tolerability comparing with population assigned for lenvatinib plus everolimus in the randomized phase II trial.

Download Full-text

Genetics and Opioids: Towards More Appropriate Prescription in Cancer Pain

Cancers ◽

10.3390/cancers12071951 ◽

2020 ◽

Vol 12 (7) ◽

pp. 1951

Author(s):

Dario Bugada ◽

Luca F. Lorini ◽

Roberto Fumagalli ◽

Massimo Allegri

Keyword(s):

Adverse Events ◽

Cancer Pain ◽

Genetic Variants ◽

Drug Prescription ◽

Gene Variants ◽

Opioid Prescription ◽

New Approach ◽

Patients With Cancer ◽

Patient’S Outcome ◽

Complex Scenario

Opioids are extensively used in patients with cancer pain; despite their efficacy, several patients can experience ineffective analgesia and/or side effects. Pharmacogenetics is a new approach to drug prescription based on the “personalized-medicine” concept, i.e., the ability of tailoring treatments to each individual’s genetic/genomic profile. Pharmacogenetics aims to identify specific genetic variants that influence pharmacokinetics and pharmacodynamics of drugs, better determining their effectiveness/safety profile. Opioid response is a complex scenario, but some gene variants have shown a correlation with pain sensitivity, as well as with opioid metabolism and clinical efficacy/adverse events. Although questions remain unanswered, some of these gene variants may already be used to identify specific patients’ phenotypes that are more prone to experience better clinical response (i.e., better analgesia and/or less adverse events). Once adopted, this approach to opioid prescription may improve a patient’s outcome. This review summarizes the available data on genetic variants and opioid response: we will focus on basic pharmacogenetic and its impact in the clinical scenario discussing how they may lead to more appropriate opioid prescription in cancer patients.

Download Full-text

Efficacy of Epidural Analgesia in Patients with Cancer Pain: A Retrospective Observational Study

Yonsei Medical Journal ◽

10.3349/ymj.2012.53.3.649 ◽

2012 ◽

Vol 53 (3) ◽

pp. 649 ◽

Cited By ~ 13

Author(s):

Yeon Soo Jeon ◽

Jung Ah Lee ◽

Jin Woo Choi ◽

Eu Gene Kang ◽

Hong Soo Jung ◽

...

Keyword(s):

Observational Study ◽

Epidural Analgesia ◽

Cancer Pain ◽

Retrospective Observational Study ◽

Patients With Cancer

Download Full-text

A Prospective Observational Study to Determine Rate of Thromboprophylaxis in Oncology Patients Undergoing Abdominal or Pelvic Surgery

Indian Journal of Surgical Oncology ◽

10.1007/s13193-021-01281-0 ◽

2021 ◽

Author(s):

Shailesh V. Shrikhande ◽

Manish Verma

Keyword(s):

Observational Study ◽

Prospective Observational Study ◽

Physician Education ◽

Pelvic Surgery ◽

Low Molecular Weight ◽

Compression Stockings ◽

Multicenter Observational Study ◽

Vte Prophylaxis ◽

Patients With Cancer ◽

Prospective Multicenter Observational Study

AbstractVenous thromboembolism (VTE) is common in patients with cancer and is a leading cause of death. In addition to the hypercoagulable state associated with malignancy, cancer-related surgery and subsequent immobilization further increase the risk of VTE. Guidelines suggest extended prophylaxis up to 4 weeks with low-molecular-weight heparin (LMWH) in such patients. This study is conducted to determine the proportion of patients receiving thromboprophylaxis among those undergoing surgery for malignant abdominal or pelvic tumor. This prospective, multicenter, observational study included 300 patients (217 [72.3%] were women). Mean age and duration of cancer were 53.2 and 1.2 years, respectively. A total of 162 (54%) patients received thromboprophylaxis of which only pharmacological in 78 [48.1%], only mechanical in 27 [16.7%], and both pharmacological and mechanical in 57 [35.2%] patients. LMWH (128, 79.0%) and graduated compression stockings (74, 45.7%) were the commonly used modalities. VTE prophylaxis was given in only half of the patients. Physician education to increase adherence to international guidelines is very important. Trial Registration No. CTRI/2013/05/003617.

Download Full-text

COVID-19 in solid organ transplant recipients: initial report from national multicenter observational study «ROKKOR-recipient»

Russian Journal of Transplantology and Artificial Organs ◽

10.15825/1995-1191-2020-3-8-17 ◽

2020 ◽

Vol 22 (3) ◽

pp. 8-17

Author(s):

S. V. Gautier ◽

A. O. Shevchenko ◽

O. M. Tsirulnikova ◽

S. M. Khomyakov ◽

O. N. Kotenko ◽

...

Keyword(s):

Adverse Events ◽

Observational Study ◽

Organ Transplant ◽

Solid Organ Transplant ◽

Solid Organ ◽

Transplant Recipients ◽

Initial Report ◽

Organ Transplant Recipients ◽

Multicenter Observational Study ◽

Solid Organ Transplant Recipients

We herein present our initial report from «ROKKOR-recipient», a national multicenter observational study. The prevalence, risk factors, clinical manifestations and outcomes of the novel coronavirus disease 2019 (COVID-19) in solid organ transplant recipients receiving immunosuppressive therapy were investigated. The study enrolled 251 COVID-19 patients (220 kidney recipients, 7 liver recipients, 1 liver-kidney recipient, and 23 heart recipients). The subjects came from 20 regions in Russia. The symptoms, clinical presentation, imaging and lab test results, therapy and outcomes of COVID-19 were described. It was established that solid organ transplant recipients with COVID-19 have a higher risk of developing adverse events. Predictors of adverse events include associated cardiovascular diseases, pulmonary diseases, diabetes, and kidney failure. Symptoms of the disease include dyspnea, rash and catarrhal signs, as well as initial low blood oxygen saturation (SpO2 <92%), leukocytosis (white blood cell count >10 × 109/L), elevated creatinine levels (>130 μmol/L) and a marked decrease in glomerular filtration rate, requiring hemodialysis. Performing organ transplant surgery in COVID-19 does not increase the risk of adverse events but could save the lives of waitlisted terminally ill patients.

Download Full-text