Rescue-free laxation response with methylnaltrexone treatment in cancer patients with opioid-induced constipation: The impact of baseline ECOG status.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24083-e24083
Author(s):  
Scott Boniol ◽  
Neal E. Slatkin ◽  
Nancy Stambler ◽  
Robert J. Israel

e24083 Background: Opioid-induced constipation (OIC) is a common side effect of opioid treatment for cancer-related pain. Methylnaltrexone (MNTX) is a peripherally active µ-opioid receptor antagonist indicated for OIC that does not affect opioid central analgesia. We assessed if baseline Eastern Cooperative Oncology Group (ECOG) status impacted the rescue-free laxation (RFL) responses among cancer patients with OIC treated with repeated doses of MNTX. Methods: This pooled post hoc analysis from 2 randomized, placebo-controlled, institutional review board–approved clinical studies included cancer patients with OIC (study 302, NCT00402038; study 4000, NCT00672477). Study 302 compared subcutaneous MNTX 0.15 mg/kg vs placebo and study 4000 compared body weight‒based subcutaneous MNTX 8 mg (38–< 62 kg) or 12 mg (³ 62 kg) vs placebo. The data were stratified by baseline ECOG status (< 2 vs ≥ 2). Endpoints included the number of patients with RFL responses within 4 hours after ≥ 2 of the first 4 doses and the number of patients with RFL response within 4 hours of treatment for patients who received all 7 doses. Results: The intent-to-treat analysis included 43 patients with an ECOG < 2 (placebo = 20; MNTX = 23) and 187 patients with an ECOG ≥ 2 (placebo = 94; MNTX = 93). Those with an ECOG < 2 were younger (mean age 58 vs 65 years), predominantly male (60.5% vs 51.3%), and used a higher daily dose of oral morphine equivalent (190.7 vs 180.0 mg/d) compared with those with an ECOG ≥ 2. Cancer patients with an ECOG < 2 treated with MNTX had a significantly greater RFL response within 4 hours after ≥ 2 of the first 4 doses compared with placebo (56.5% vs 5.0%, P = 0.0003). Similar results were reported for patients with an ECOG ≥ 2 (57.0% vs 5.3%, P < 0.0001). Compared with placebo, the MNTX group had a greater proportion of patients with an RFL response, whether they had at least 1 RFL response or up to 7 RFL responses out of 7 doses, with significant treatment differences with each additional RFL per 7 doses among cancer patients with an ECOG ≥ 2 (Table). Conclusions: RFL response rates in cancer patients were significantly greater in the MNTX group vs the placebo group regardless of baseline ECOG status; responses were similar between the 2 groups despite a higher daily dose of opioids in the group with an ECOG > 2. Clinical trial information: NCT00402038; NCT00672477. [Table: see text]

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 197-197
Author(s):  
Akhila Sunkepally Reddy ◽  
Sara Dost ◽  
Marieberta Vidal ◽  
Saneese Stephen ◽  
Karen Baumgartner ◽  
...  

197 Background: Inpatients with cancer frequently undergo conversions from IV to PO hydromorphone (HM) or opioid rotation (OR) from IV HM to another PO opioid prior to discharge. Currently used conversion ratios (CR) between IV and PO HM range from 2-5 and opioid rotation ratios (ORR) between IV HM and oral morphine equivalent daily dose (MEDD) range from 10-20. This large variation in ratios may lead to uncontrolled pain or overdosing. Our aim was to determine the accurate CR from IV to PO HM and ORR from IV HM to PO morphine and oxycodone (measured as MEDD). Methods: We reviewed records of 4745 consecutive inpatient palliative care consults in our institute during 2010-14 for patients who underwent conversion from IV to PO HM or OR from IV HM to PO morphine or oxycodone. Patient characteristics, symptoms and opioid doses were determined in patients successfully discharged on oral opioids without readmission within 1 week. Linear regression analysis was used to estimate the CR or ORR between the 24 hour IV HM mg dose prior to conversion to PO and the oral opioid mg dose used in the 24 hours prior to discharge. Results: Among 394 eligible patients on IV HM, 147 underwent conversion to PO HM and 247 underwent OR to oral morphine (163) or oxycodone (84). Mean age was 54 years, 39% were male, and 95% had advanced cancer. Median time between conversion to PO and discharge was 2 days. In 147 patients the median CR (IQR) from IV to PO HM was 2.5 (2.1-2.7) and correlation of IV to PO dose of HM was .95 (P < .0001). The median CR was 2.5 in patients receiving < 30mg of IV HM/day and 2.1 in patients receiving ≥ 30mg of HM/day (P = .004). In 247 patients the median ORR (IQR) from IV HM to MEDD was 11.5 (10-13) and correlation of IV HM to MEDD was .93 (P < .0001). The median ORR was 11.5 in patients receiving < 30mg of IV HM/day and 9.9 in patients receiving ≥ 30mg of HM/day (P = .0004). ORR from IV HM to MEDDs obtained from morphine (11) and oxycodone (12.1) were significantly different (P = .0023). The CR and ORR were not significantly impacted by other variables. Conclusions: The median CR from IV to PO HM is 2.5 and ORR from IV HM to MEDD is 11.5. This implies that 1 mg IV HM is equivalent to 2.5 mg PO HM and 11.5 mg MEDD. HM may cause hyperalgesia at doses ≥ 30 mg/day and thereby requires a lower ORR to other opioids.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yun Xu ◽  
Zong-Hao Huang ◽  
Charlie Zhi-Lin Zheng ◽  
Cong Li ◽  
Yu-Qin Zhang ◽  
...  

Abstract Background Since December 2019, China has experienced a public health emergency from the coronavirus disease, which has become a pandemic and is impacting the care of cancer patients worldwide. This study evaluated the impact of the pandemic on colorectal cancer (CRC) patients at our center and aimed to share the lessons we learned with clinics currently experiencing this impact. Methods We retrospectively collected data on CRC patients admitted between January 1, 2020 and May 3, 2020; the control group comprised patients admitted between January 1, 2019 and May 3, 2019. Results During the pandemic, outpatient volumes decreased significantly, especially those of nonlocal and elderly patients, whereas the number of patients who received chemotherapy and surgery remained the same. During the pandemic, 710 CRC patients underwent curative resection. The proportion of patients who received laparoscopic surgeries was 49.4%, significantly higher than the 39.5% during the same period in 2019. The proportion of major complication during the pandemic was not significantly different from that of the control group. The mean hospital stay was significantly longer than that of the control group. Conclusions CRC patients confirmed to be infection-free can receive routine treatment. Using online medical counseling and appropriate identification, treatment and follow-up can be effectively maintained. Adjuvant and palliative chemotherapy should not be discontinued. Endoscopic polypectomy, elective, palliative, and multidisciplinary surgeries can be postponed, while curative surgery should proceed as usual. For elderly CRC patients, endoscopic surgery and neoadjuvant radiotherapy are recommended.


2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S5-S5
Author(s):  
Sierra R Young ◽  
Jeremiah Duby ◽  
Erin Louie

Abstract Introduction Opioids are considered the cornerstone of treatment for post-operative burn pain. However, detrimental adverse effects of opioid use include over-sedation, respiratory depression and dependence. Multimodal analgesia is an alternative method of pain control that utilizes a combination of opioid and non-opioid medications. Multimodal analgesia offers different mechanisms of action which may be beneficial in burn-injured patients. This study examines the impact of multimodal therapy for post-operative pain control in a burn intensive care unit (BICU). Methods This retrospective cohort study was performed at an academic burn center between 2012 and 2018. Consecutively admitted patients with burns greater than or equal to 10% total body surface area (TBSA) and BICU length of stay (LOS) greater than seven days were eligible for inclusion. Patients were excluded if they received an opioid continuous infusion greater than 48 hours. Patients treated with multimodal analgesia were compared to those treated with opioids alone. The total oral morphine equivalent (OME) dose was calculated for each 24-hour period for 5 days after a grafting surgery. Secondary endpoints included pain scores, BICU LOS, and ventilator days. Data analysis was performed with descriptive statistics. A power calculation determined that 60 patients per group were needed to detect a 30% difference in the primary endpoint. Results There were 100 patients in the non-multimodal group and 100 patients in the multimodal group. Mean cumulative OME dose was significantly lower in the multimodal group (1,028 mg vs. 1,438 mg, P &lt; 0.002). Patients with over 20% TBSA burns had a larger reduction in mean OME doses in the multimodal group (1,097 mg vs. 1,624 mg, P = 0.0049) compared to patients with 10% to 20% TBSA burns (949 mg vs 1,282 mg, P = 0.057). Utilizing more multimodal agents was not associated with lower OME doses. There was no difference in pain score on post-operative day 5 (5.5 + 2.3 vs. 6.2 + 2.2, P=0.07) or at ICU discharge (4.7 + 2.4 vs 4.7 + 2.8, P = 0.99). There was no difference in other secondary outcomes. Conclusions The use of multimodal analgesia significantly reduced cumulative OME doses without compromising pain control. Applicability of Research to Practice Multimodal analgesia may be a beneficial adjunct to burn pain management to mitigate opioid use without compromising pain control.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14075-e14075
Author(s):  
Stephen A Raymond ◽  
John F Hutchin ◽  
Arnold Degboe ◽  
Kenneth G Faulkner

e14075 Background: Patient reported pain is subjective, requiring individuals to grade the feeling of pain as “high” or “low”, typically using a numeric scale. As a supplement to self-reported pain, monitoring the dosage and type of treatment needed to keep pain at a tolerable or comfortable level has been suggested. However, differences in treatments can complicate the ability to compare analgesic effects. One approach to this problem uses a 30 mg oral dose of morphine as a standard to quantify the relative analgesic strength of different pain medications. Methods: For use in clinical research, we developed an application on a handheld device for logging opioid consumption and supporting automated determination of oral morphine equivalents (OME) for commonly prescribed analgesics. We reviewed the literature to prepare a comprehensive database of OMEs for more than 450 commonly prescribed pain medications. From treatment logs (time, dose, and route of administration), the application determines a daily “OME Score” in standardized units of mg of oral morphine. Results: As prescriptions change, the daily OME Score gives a comparable measure to track the utilization of diverse analgesic medications. OME Scores can be categorized using the Analgesic Quantification Algorithm (AQA scale) developed by Chung (1). The AQA scale has eight categories and provides 5 gradations for patients in advanced pain who receive strong opioids, each gradation reflecting adoubling in the daily OME Score. The impact of a therapy on pain may be considered clinically significant depending on the changes in self-reported pain and AQA scores related to the treatment. Conclusions: We have developed a method and associated application for easily logging the time, dose, and route of administration of analgesic treatments. This information can be used to compute the daily OME Score for a wide variety of analgesics. The daily OME score can then be tracked and used to report the AQA score alongside self-reported pain for evaluating pain relief in clinical studies. Reference: 1) Chung KC, Barlev A, Braun AH, Qian Y, Zagari M. Pain Medicine 2014; 15:225-232.


2018 ◽  
Vol 21 ◽  
pp. 256-267 ◽  
Author(s):  
Matina Symeonidi ◽  
Irene Panagiotou ◽  
Eleni Tsilika ◽  
Anna Roumeliotou ◽  
Antonis Galanos ◽  
...  

Purpose: Pain is prevalent in cancer patients, appearing to be moderate to severe in more than one third of them. Despite the fact that fentanyl is widely used with effective analgesic results, some patients do not correspond to treatment, resulting in opioid change. Methods: This is a cohort study, performed in Greek patients with cancer. Its scope was to identify potential reasons responsible for opioid change, due to transdermal-fentanyl intolerance, resulting from inadequate analgesia (pain relief<33% in 1week) and/or unacceptable adverse-events (grade≥3 at Common Terminology Criteria-v4.0). The final sample included 289 participants. To investigate responsible reasons for transdermal-fentanyl intolerance we studied its relation with patients’ history, haematology, biochemistry, body-mass-index, demographic and disease related characteristics. The Eastern Cooperative Oncology Group performance status scale, the Mini Mental State Examination questionnaire, the M.D.Anderson Symptom Inventory and the Greek Brief Pain Inventory were also used to measure performance status and quality-of-life for the same reason. Results: Almost one third of the patients had to change to an alternative opioid oral-morphine in order to achieve adequate analgesia or/and avoid adverse-events. The most common adverse-events observed were nausea/vomiting and sleepiness. Statistical analysis demonstrated that younger age (OR=0.976) and obesity (OR=0.29 against underweight, OR=0.39 against normal, OR=0.48 against pre-obese) had a higher possibility to contribute to modification of the analgesic treatment. Furthermore, a higher impact of symptoms in patient’s life (OR=1.184) and chemotherapy (OR=2.109) could also contribute to the need of change of the opioid analgesic medication. Conclusion: This study found significant variables for transdermal-fentanyl intolerance. This knowledge may help person-center care in moderate to severe cancer pain. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.


2003 ◽  
Vol 1 (2) ◽  
pp. 143-151 ◽  
Author(s):  
ALICE INMAN ◽  
KENNETH L. KIRSH ◽  
STEVEN D. PASSIK

Objective: Spirituality has been neglected when assessing the well-being of cancer patients. Traditionally, researchers have focused on areas such as physical, social, and emotional functioning. However, there is a potential for spirituality to have a large impact on quality of life in patients with cancer. The current study was conducted to investigate the relationship between spirituality and boredom, constraint, social contact, and depression.Methods: A total of 100 oncology patients completed several assessment instruments, including the Purposelessness, Under-stimulation, and Boredom (PUB) Scale, Functional Assessment of Cancer Therapy Scale–Anemia, Brief Zung Self-Rating Depression Scale (BZSDS), Cancer Behavior Inventory, Systems of Belief Inventory, and Eastern Cooperative Oncology Group Performance Status Scale.Results: The average age of the sample was 62.37 years (SD = 13.43) and was comprised of 60 women (60%) and 40 men (40%). A regression analysis conducted to explore the impact of the variables on quality of life found only the BZSDS (R2Δ = .650, F = 180.392, p < .001) and the PUB Scale (R2Δ = .077, F = 26.885, p < .001) were significant predictors of quality of life. Another set of regression analyses were conducted to explore whether spirituality had a mediating effect on this relationship, but the mediated model was not supported.Significance of results: We conclude that spirituality and boredom are difficult concepts to define, operationalize, and measure, but crucial to our understanding of quality of life in advanced cancer. More research is needed to clarify the nature of the interrelationships between these important concepts.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Fahd Elkhalloufi ◽  
Saber Boutayeb ◽  
Fouzia Mamouch ◽  
Latifa Rakibi ◽  
Sanae Elazzouzi ◽  
...  

Abstract Background In 2020, Morocco recorded more than 59,370 new cases of cancer and more than 35,265 cases of death (International Agency for Research on Cancer, Annual report Morocco, 2020). Cancer is always accompanied by socially constructed, differentiated, and contingent interpretations and practices according to the socio-cultural and religious characteristics of each region. The study aims at describing the evolution of the socio-cultural and religious aspects of Moroccan cancer patients followed at the National Institute of Oncology (NIO) of Rabat between 2010 and 2020. Methods We have prospectively studied all cancer cases diagnosed at the National Oncology Institute (NIO), Rabat in 2019. We have collected 1102 cases. The data collected was compared with the results of the study carried out in 2010 (1600 cases). Statistical analysis has been assessed by SPSS 20 software and the correlations between socio-cultural characteristics were examined using a chi-square test. Results From a socio-economic point of view, almost all patients claim that cancer is a costly disease as well as a disease that leads to a drop in income and the inevitable impoverishment of Moroccan patients. The illiteracy rate is still high; rising from 38% in 2010 to 42.80% in 2020. On the psychological level, damage to body image (alopecia, mastectomy, hysterectomy,) can lead to stigmatizing and harms the marital relationship. The number of patients experiencing divorce and marital separation that seems to occur following cancer pathology remains high, despite a decrease of nearly 50% between 2010 and 2020. Concerning the spiritual aspect, in the Arab-Amazigh-Muslim culture, the impact of the occurrence of cancer is very particular, and the repercussions are assessed differently depending on the degree of conviction. For practicing believers, cancer is considered a divine test and an opportunity to improve. In the Qur’an, God tests the best of his disciples to reward them The rate of practicing believers has evolved from 49% in 2010 to 85.50% in 2020.But for non-practicing believers, cancer is regarded as a divine punishment coming from outside. New behaviors reported by this research concern the use of “roquia”. This spiritual cure is considered as an anti-cancer remedy. It uses Allah’s words from the holy “qur’an”, his faires names and his attributes. 42% of patients use “roquia”. Concerning phytotherapy, there was an increase in the percentage of participants using medicinal plants and even the most harmful plants (Arestiloch, Euphorbia) from 26% in 2010 to 51.50% in 2020. Conclusion The precarious social level of cancer patients, the lack of social and medical coverage, illiteracy, and lack of knowledge of religion, as well as dissatisfaction with conventional medicine, may lead patients to the use of traditional medicine (medicinal plants, visit of “marabouts”, “roquia”). This can have a negative impact on the quality of access to oncology care.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18243-e18243
Author(s):  
Carla Pires Amaro ◽  
Larissa Gomes ◽  
Daniel Almeida ◽  
Kelly Reiner ◽  
Gustavo Fernandes Godoy Almeida ◽  
...  

e18243 Background: Continued and rapid evolution of diagnosis and staging methods along with the development of new treatments has changed decision-making process of cancer patient into a more complex task. We evaluated the impact of multidisciplinary tumor board meetings (MTM) in the final decision of cancer patients approach in comparison to the initial decision based on clinical oncologist’s individual choice. Methods: Between April 2016 and January 2017, data were collected prospectively during the MTM held daily at the Antônio Ermírio de Moraes Cancer Center, Sao Paulo, Brazil. Data were gathered by filling out a questionnaire. The therapeutic plan initialy proposed by the physician was compared to the proposal offered by the multidisciplinary team. We evaluated data from breast, gastrointestinal (GI) and lung cancer MTM. Results: We evaluated 100 questionnaires: 39% GI tumors, 34% lung cancer, 27% breast cancer. The main theme for discussion was selection of systemic therapy (65%). The rate of change in therapy choice was 24.6%. The recommendation suggested by the MTM surgeons and radio-oncologists showed disagreement with the one initially proposed in 21 cases. The majority of discordant cases was related to the choice of therapeutic method (57%) with 42% changes in the chemotherapy protocol. Eight patients were submitted to genetic test and mutations search. Only two cases were recommended for clinical trial enrollment. Conclusions: The rate of therapy plan change after MTM is in accordance with international studies. The largest volume of discussions on systemic therapies reflects the large number of new therapies as well as new treatment strategies. This research highlights the potential of multidisciplinary discussions in changing decision-making in cancer cases, allowing a more comprehensive care with the patient. In addition, a MTM allows the access of more patients to new medications made available through clinical trials and protocols. The small number of patients referred to a clinical study reflects the lack of clinical protocols available in Brazil, a problem that needs to be acknowledged and become a priority for Brazilian medical societies and regulatory agencies.


Cancers ◽  
2021 ◽  
Vol 13 (13) ◽  
pp. 3215
Author(s):  
Sofía Ruiz-Medina ◽  
Silvia Gil ◽  
Begoña Jimenez ◽  
Pablo Rodriguez-Brazzarola ◽  
Tamara Diaz-Redondo ◽  
...  

The COVID-19 pandemic has caused a profound change in health organizations at both the primary and hospital care levels. This cross-sectional study aims to investigate the impact of the COVID-19 pandemic in the annual rate of new cancer diagnosis in two university-affiliated hospitals. This study includes all the patients with a pathological diagnosis of cancer attended in two hospitals in Málaga (Spain) during the first year of pandemic. This study population was compared with the patients diagnosed during the previous year 2019. To analyze whether the possible differences in the annual rate of diagnoses were due to the pandemic or to other causes, the patients diagnosed during 2018 and 2017 were also compared. There were 2340 new cancer diagnosis compared to 2825 patients in 2019 which represented a decrease of −17.2% (p = 0.0001). Differences in the number of cancer patients diagnosed between 2018 and 2019 (2840 new cases; 0.5% increase) or 2017 and 2019 (2909 new cases; 3% increase) were not statistically significant. The highest number of patients lost from diagnosis in 2020 was in breast cancer (−26.1%), colorectal neoplasms (−16.9%), and head and neck tumors (−19.8%). The study of incidence rates throughout the first year of the COVID-19 pandemic shows that the diagnosis of new cancer patients has been significantly impaired. Health systems must take the necessary measures to restore pre-pandemic diagnostic procedures and to recover lost patients who have not been diagnosed.


2020 ◽  
Author(s):  
Yun Xu ◽  
Zong-Hao Huang ◽  
Charlie Zhi-Lin Zheng ◽  
Cong Li ◽  
Yu-Qin Zhang ◽  
...  

Abstract Background: Since December 2019, China has experienced the public health emergency of coronavirus disease, which has expanded globally and is impacting the care of cancer patients. This study evaluated the impact of the pandemic on colorectal cancer (CRC) patients at our center and aimed to share lessons learned with clinics currently experiencing this impact. Methods: We retrospectively collected data on CRC patients admitted between January 1, 2020 and May 3, 2020; the control group comprised patients admitted between January 1, 2019 and May 3, 2019. Results: During the pandemic, outpatient volumes decreased significantly, especially among nonlocal and elderly patients, whereas the number of patients who received chemotherapy and surgery were maintained. During the pandemic, 710 CRC patients underwent curative enterectomy. The proportion of laparoscopic surgery was 49.4%, which was significantly higher than the 39.5% patients who received a laparoscopic surgery during the same period in 2019. The proportion of major complication during the pandemic was not significantly different from that of the control group. The mean hospital stay was significantly longer than that of the control group. Conclusions: CRC patients who are confirmed to be infection-free can receive routine treatment. Using online medical counseling and appropriate identification, treatment and follow-up was effectively maintained. Adjuvant and palliative chemotherapy should not be discontinued. Endoscopic polypectomy, elective, palliative, and multidisciplinary surgeries can be postponed, whereas curative surgery should be performed. For elderly CRC patients, endoscopic surgery and neoadjuvant radiotherapy are recommended.


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