Methadone as First-line Opioid for the Management of Cancer Pain

Aim The aim of this study was to assess the efficacy and adverse effects of methadone when used as first-line therapy in patients that are either receiving low doses of opioids or none. Methods Patients with advanced cancer were prospectively assessed. Opioid-naive patients (L-group) were started with methadone at 6 mg/day. Patients receiving weak or other opioids in doses of <60 mg/day of OME (H-group) were started with methadone at 9 mg/day. Methadone doses were changed according to the clinical needs to obtain the most favorable balance between analgesia and adverse effects. Edmonton Symptom Asssement Score (ESAS), Memorial Delirium Assessment Score (MDAS), doses of methadone, and the use of adjuvant drugs were recorded before starting the study treatment (T0), 1 week after (T7), 2 weeks after (T14), 1 month after (T30), and 2 months after (T60). Methadone escalation index percent (MEI%) and in mg (MEImg) were calculated at T30 and T60. Results Eighty-two patients were assessed. In both groups H and L, there were significant changes in pain and symptom intensity at the different times during the study. Adverse effects as causes of drop-out were minimal. Mean MEImg was 0.09 (SD 0.28) and 0.02 (SD 0.07) at T30 and T60, respectively. MEI% was 1.01 (SD 3.08) and 0.27 (SD 0.86) at T30 and T60, respectively. Conclusion Methadone used as a first-line opioid therapy provided good analgesia with limited adverse effects and a minimal opioid-induced tolerance

Opioid switching from and to tapentadol extended release in cancer patients: conversion ratio with other opioids

Objectives: The aim of this exploratory study was to assess the conversion ratios between tapentadol and other opioids in patients requiring an opioid switching. Methods: A prospective study was carried out in a convenience sample of consecutive patients admitted to an acute palliative care unit and a home care unit for a period of 1 year. Patients who were switched from/to tapentadol were selected. The initial ratio between tapentadol and other opioids, expressed as oral morphine equivalents was 1:3.3. The subsequent doses were flexible and were changed to fit the patients’ needs. Pain intensity and distress score were recorded until opioid doses were stable. In all, 37 patients were examined; 24 and 13 patients were switched from and to tapentadol, respectively. Results: The most frequent sequences were tapentadol–morphine (18 patients) in one direction, and morphine–tapentadol (8 patients) in the other direction. In the sequence tapentadol–morphine and morphine–tapentadol, the mean final tapentadol–morphine ratios were 3.9:1 (SD 2.3), and 1:4.5 (SD 3.2), respectively, which did not differ significantly from the initial established conversion ratio. A minority of patients were switched from/to tapentadol to/from other opioids. Globally, the initial ratio did not change after switching took place. Conclusion: Data suggest that a conversion ratio between tapentadol and other opioids, expressed in oral morphine equivalents could be 1:3.3 in both direction, particularly in patients who are switched in conditions of equianalgesia. The limited number of patients prevents a definitive conclusion to be drawn, and data should be interpreted with caution, given the exploratory nature of the study and the question of the low number of patients should be addressed in future studie

Orphan symptoms in advanced cancer patients followed at home.

Abstract Orphan symptoms are rarely assessed, particularly at home. The aim of this multicenter prospective study was to assess the prevalence of these symptoms and eventual factors possibly associated in advanced cancer patients at admission of a home care program. A prospective study was performed at three home care programs in Italy. Patients' data were collected, including age, sex, diagnosis, and Karnofsky status. Possible contributing factors were analyzed; preexisting neurological diseases, cerebral metastases, hyperthermia, diabetes, a state of dehydration clinically evident and/or oliguria, possible biochemical parameters when available, data regarding recent chemotherapy, opioids and doses, use of neuroleptics, benzodiazepine or anticonvulsants, corticosteroids, anti-inflammatory, and antibiotics were collected. Myoclonus, hiccup, sweating, pruritus, and tenesmus, either rectal or vesical, were assessed, according to a preliminary definition, at time of home care program admission. Three hundred sixty-two patients were surveyed at the three home care programs. Globally, 48 patients presented one or more orphan symptoms in the period taken into consideration, and 7 patients presented more than 1 symptom. One patient presented occasional and diffuse myoclonus. Nineteen patients presented sweating, 13 patients presented pruritus, and 14 patients presented hiccup. Finally, nine patients presented rectal or vesical tenesmus. There was a significant correlation between sweating and transdermal fentanyl use (P = 0.044), fever (P = 0.001), hiccup (P < 0.0005), and vesical tenesmus (P = 0.028). Pruritus was not associated to any factor. Hiccup was associated with gender (males, P = 0.006) and sweating (P < 0.0005). Vesical tenesmus was associated with fever (P = 0.019) and sweating (P = 0.028). Although the symptoms examined have a low prevalence in advanced cancer patients admitted to home care, the distress for patients may be high and deserve further analyses. Given the low prevalence of these symptoms, large studies are needed to find possible associated factors

Tapentadol in cancer pain management: a prospective open-label study.

OBJECTIVES: The aim of this prospective, open-label study was to evaluate the efficacy and tolerability of tapentadol (TP) in the management of cancer pain. METHODS: A 4 weeks' prospective study was carried out in 50 opioid-naive cancer patients with moderate-severe pain. Each patient initially received twice-daily doses of slow-release TP 50 mg. Doses were then managed to maintain adequate relief or dose-limiting toxicity, on the basis of the clinical response. The following parameters were recorded at weekly intervals for 4 weeks: pain and opioid-related adverse effects, quality of life measured with the Spitzer score, TP escalation index percent (TPEI%) and TP escalation index in mg (TPEImg), calculated at the end of the study, pain mechanisms, and PainDETECT at baseline. RESULTS: Of 50 patients, 39 completed the entire study and 11 discontinued the treatment for different reasons. Pain intensity significantly decreased from baseline to all the week intervals (p < 0.0005), and adverse effects did not changed significantly, while quality of life improved. TP escalation indexes were low and no relationship was found with age, gender, and pain mechanisms. CONCLUSION: Tapentalol started in doses of 100 mg/day was well-tolerated and effective in opioid-naive patients with cancer pain, regardless of the pain mechanism. It can be considered as a flexible drug to be used in patients with moderate-severe pain. LIMITATIONS: This was an open-label study for exploratory purposes. Data should be confirmed in controlled studies with a larger number of patient

Personalized Pain Goals and Responses in Advanced Cancer Patients

To assess the personalized pain intensity goal (PPIG), the achievement of a personalized pain goal response (PPGR), and patients' global impression (PGI) in advanced cancer patients after a comprehensive pain and symptom management

Intranasal fentanyl versus fentanyl pectin nasal spray for the management of breakthrough cancer pain in doses proportional to basal opioid regimen.

Abstract The aim of this randomized, crossover, comparison study was to assess the analgesic and adverse effects of 2 nasal preparations, intranasal fentanyl (INFS) and fentanyl pectin nasal spray (FPNS), for breakthrough pain, given in doses proportional to opioid basal regimen. Each patient randomly received INFS or FPNS in doses proportional to opioid dosages used for background analgesia for 2 pairs of episodes. For each episode of breakthrough pain, pain intensity and adverse effects intensity were recorded just before starting the INFS or FPNS (T0) and 5 minutes (T5), 10 minutes (T10), and 20 minutes (T20) after the administration of the nasal drugs. Sixty-nine patients were studied. The mean age was 63.4 years, and 37 patients were males. For the present analysis, 188 episodes were considered. A statistical decrease in pain intensity was observed with both nasal drugs after 5, 10, and 20 minutes. A decrease in pain intensity of >33% was observed in 16, 102, and 159 treated episodes at T5, T10, and T20, respectively. Adverse effects were of mild nature in most cases or were preexistent because of basal opioid therapy. No differences were found in summed pain intensity difference 20 minutes after dosing. Most of patients did not find substantial preferences. INFS and FPNS were effective and well-tolerated treatments for breakthrough pain management. Both delivery systems, in doses proportional to the basal opioid regimen, provided significant analgesia within 10 minutes, without producing relevant adverse effects. PERSPECTIVE: This article showed that INFS and FPNS in doses proportional to basal opioid regimen are equally safe and effective for the management of breakthrough pain in cancer patients. These data provide new insights on the use of nasal preparations of fentanyl

Characteristics of patients with an unplanned admission to an acute palliative care unit

The aim of this cohort study is to compare the symptom burden of patients who have an unplanned admission to an acute palliative care unit (APCU) with patients who have a regular planned admission. A consecutive sample of advanced cancer patients who were admitted to an APCU was prospectively assessed. The reasons and the kind of admission were recorded (unplanned, UP, or planned, P). Anticancer treatments, whether patients were on/off treatment or uncertain, previous care setting, and who referred the patient to the unit were also recorded. The Edmonton Symptom Assessment Scale (ESAS) was used at admission and at time of discharge, as well as the Memorial Delirium Assessment Scale. Analgesics and their doses at admission and discharge were recorded. Hospital staying was also recorded. At the time of discharge, subsequent referral to other care settings, and the pathway of oncologic treatment were re-considered. Fifty-five (17.5%) of 314 consecutive admissions recorded in a period of 10 months were UP. UP-patients are more frequently referred from other hospitals (P = 0.0005), and are reported by physicians of other units (P = 0.05). UP-patients have a longer hospital admission (P = 0.032), a higher hospital death rate (P = 0.025), and are less frequently discharged home (P = 0.031). A significant decrease in intensity of ESAS items was observed in both groups, with no differences in symptom burden either at admission and time for discharge. At discharge, opioid doses are higher in UP-patients. An APCU may admit UP-patients at any stage of disease, providing effective treatment outcomes, as reported with P-patients. This study suggests that patients referred from other settings or hospitals may provide specialist advice and rapid symptom control. Although symptom burden is similar, these patients have longer hospital admission, higher hospital death rate, and are less frequently discharged home, suggesting the need for more complex treatments. Such units in a comprehensive cancer center might improve symptom control and pose as referral centers for non-cancer hospitals, emergency departments, or the territory

The effects of alcoholism and smoking on advanced cancer patients admitted to an acute supportive/palliative care unit

Aim: The aim of this prospective study was to determine the characteristics and symptom burden of advanced cancer patients with alcoholism problems and smoking, who were referred to an acute palliative/supportive care unit (ASPCU) of a comprehensive cancer center. Methods: Patientsâ characteristics, indications for admission, kind of admission, awareness of prognosis, and anticancer treatments were recorded. The Edmonton Symptom Assessment Scale (ESAS) was used to assess physical and psychological symptoms, and the CAGE questionnaire for the diagnosis of alcoholism. Patients were also divided in three groups: persistent smokers (PS), former smokers (FS), and non-smokers (NS). The Memorial Delirium Assessment Scale (MDAS) was used to assess the cognitive status of patients. Analgesic drugs and their doses at admission and discharge were recorded, as well opioid escalation index during hospital stay. Results: Three hundred fourteen consecutive cancer patients were surveyed. Forty-seven (14.9%), 143 (45.5%), and 124 (39.5%) subjects were PS-patients, FS-patients, and NS-patients, respectively. Sixteen patients were CAGE-positive. Females were more frequently NS, while males were more frequently FS (p = 0.0005). Statistical differences were also observed in disease awareness among the categories of smoking (p = 0.048). No statistical differences were found in ESAS items, except for drowsiness at T0 in NS-patients. Differences were found in OME and OEI, although the large variability of data did not determined a statistical difference. Higher values of nausea (at T0, p = 0.0005), dyspnea (at T0 and TX, p = 0.08 and 0.023, respectively), and well-being (at TX p = 0.003) were reported in CAGE-positive patients. No correlation was found between CAGE-positive patients and smokers. Conclusion: Although smoking and alcoholism have obvious implications in advanced cancer patients, data remain controversial, as present data did provide limited data to confirm risk factors for advanced cancer patients. Clinical response was not strongly influenced by these risk factors

Characteristics of advanced cancer patients who were readmitted to an acute palliative/supportive care unit

Objectives: The aim of this study was to assess the characteristics of patients readmitted to an acute supportive/palliative care unit (ASPCU), the reasons for readmission, and the outcome after receiving specialistic assessment and treatment. Methods: A consecutive sample of patients was assessed for a period of 10 months. Epidemiological characteristics, including age, gender, Karnofsky level, diagnosis, caregivers, education, disease awareness, kind of admission, and anticancer treatment in the previous 30 days, were recorded, as well as hospital stay, death, and discharge at home. The principal reasons for admission were recorded. Symptom intensity and opioid doses, expressed as oral morphine equivalents, were also measured. Results: In the study period, 79 (25.2%) readmissions were recorded. Thirty-seven (46.8%) readmissions occurred within 30 days after discharge. Pain was more frequently reported as indication for admission at the first and the second readmission in comparison with the first admission. The burden of symptoms was significantly higher in patients with a readmission in comparison with patients at the first admission. Opioid doses, expressed as oral morphine equivalents, were significantly different between the first admission and readmissions. In both patients at the first admission or readmission, a significant decrease in symptom intensity has been reported at discharge. Conclusion: About 25% of patients discharged from an ASCPU are expected to be readmitted for reemerging of clinical problems. Re-exacerbation of pain seems to be the most frequent reason. A further clinical reassessment and treatment were equally effective in controlling the symptom burden of these patients at any readmission