Giampiero Porzio

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

Abstract 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 patients.

Breakthrough Pain in Oncology: A Longitudinal Study

CONTEXT Existing studies on breakthrough pain (BP) have reported different prevalence rates because of different settings, populations, and assessment methods. These studies have used cross-sectional designs, and the relationship of BP with analgesic treatment has not been evaluated. OBJECTIVES The aim of this study was to longitudinally assess BP in cancer patients admitted to oncology units. METHODS A consecutive sample of patients admitted to oncology centers was selected. At admission (T0), three months after admission (T3), and six months after admission (T6), data on background pain and BP were recorded. BP was assessed in terms of its intensity, duration, number of episodes, onset with movement, spontaneous relief after stopping activity, limitation of physical activity, and effectiveness of analgesics. RESULTS Three hundred two patients completed the study. At T0, T3, and T6, 39%, 38%, and 33% patients, respectively, had continuous pain (P=0.294). Pain intensity significantly decreased (P=0.004 and 0.027 at T3 and T6, respectively). Most patients had BP at T0 (87.1%), T3 (80.9%), and T6 (73.2%), and there was a significant decrease in the prevalence of BP over time (P=0.016). Of 149 patients with BP, pain on movement was recorded in 43.6%, 43.4%, and 32.4% at T0, T3, and T6, respectively (P=0.228). Pain spontaneously decreased or ceased when stopping physical activity in 66%, 56%, and 62% at T0, T3, and T6, respectively (P=0.537). Pain on movement strongly limited physical activity in most patients. CONCLUSION These data expand current information about BP and underline the need for a longitudinal assessment of a phenomenon that is invariably dependent on stage of disease, patient, and therapeutic factors.

Dosing fentanyl buccal tablet for breakthrough cancer pain: dose titration versus proportional doses

Abstract Objectives: The aim of this study was to compare the efficacy and safety of doses of fentanyl buccal tablet (FBT) proportional to doses of opioids used for background analgesia versus dose titration starting with the minimal dose for the management of breakthrough cancer pain (BTcP). Methods: A total of 82 cancer patients with BTcP who were receiving strong opioids in doses of at least 60 mg of oral morphine equivalents and having acceptable background analgesia, were selected for a multicenter unblinded study. Forty-one patients were randomized to receive FBT in doses proportional to the daily opioid doses for four consecutive episodes of BTcP (group P). Forty-one patients underwent dose titration of FBT, with an initial dose of 100 µg, for four consecutive episodes (group T). Pain intensity and symptoms associated with opioid therapy were measured before administering any dose of FBT (T0) and 15 minutes after (T15). Results: In all, 80 patients were considered for analysis (39 and 41 patients in group P and T, respectively). Patients were receiving a mean of 126 ± 100 mg of oral morphine equivalents (range 60–480 mg) for background analgesia. A total of 293 episodes of BTcP (144 and 149 in group P and T, respectively) were treated and considered for analysis. No differences were found in the decrease of pain intensity between the two groups. However, in patients receiving doses of oral morphine equivalents of >120 mg/day, a significant number of patients obtained a decrease in pain intensity >50% in group P in comparison with group T (p = 0.040). Also, the need for rescue medication was significantly more frequently reported in group T for the first episode of BTcP (p < 0.0005). No differences in the level of adverse effects were observed between the two groups. No differences in patients’ satisfaction were reported. Conclusion: According to the data obtained in this study, there is no evidence for the use of dose titration in the management of BTcP in opioid-tolerant patients. Indeed, doses proportional to basal opioid regimen for background pain seem to be effective and safe in the majority of patients. Further studies should confirm this data in patients receiving higher doses of opioids, with other rapid-onset opioids, and in other settings.

Emergencies in Patients With Advanced Cancer Followed at Home

CONTEXT Patients with advanced cancer stay at home for most of their time, and acute problems may occur during home care. Caregivers may call medical services for an emergency, which can result in patients being admitted to the hospital. No data exist on emergencies in patients followed by a home care team. OBJECTIVES The aim of this multicenter prospective study was to assess the frequency, reasons for, and subsequent course of emergency calls for patients followed at home by a palliative care team. METHODS A consecutive sample of patients admitted to home care programs was surveyed for a period of seven months. Epidemiological data, and characteristics of emergency calls and outcomes, as well as environmental situations were recorded. RESULTS Six hundred eighty-nine patients were surveyed; 118 patients (17.1% of the total number of patients surveyed) made one emergency call, 23 made two calls, and four made three calls for a total number of 176 emergency calls. The mean age was 71 years (standard deviation [SD] 13), and the mean Karnofsky status the day before the emergency call was 38 (SD 14). The mean time from admission to the first emergency call was 38.4 days (SD 67), and the mean time from the first emergency call to death was 17.5 days (SD 41.5). No differences were found for age, diagnosis, gender, duration of assistance, and survival between patients making emergency calls and those who did not make a call during an emergency. Twenty-three patients were managed by phone, and 122 were visited at home for the emergency. Calls were prevalently recorded on weekdays and were primarily made by relatives. The most frequent reasons for calling were dyspnea, pain, delirium, and loss of consciousness. Calls were considered justified by home care physicians in most cases. The mean number of relatives present during the emergency home visit was 2.2 (SD 1.5). The intervention was mainly pharmacological and considered satisfactory in the majority of cases. CONCLUSION Emergency calls are relatively frequent in patients followed at home by a palliative care team. Phone consultation or intervention at home may avoid inappropriate hospital admission.

Octreotide for malignant bowel obstruction: Twenty years after

Malignant bowel obstruction (MBO) is a challenging complication of advanced cancer. Conservative treatment of inoperable MBO in terminal cancer patients has been found to be effective in controlling the distressing symptoms caused by this complication in inoperable cancer patients. Twenty years ago, octreotide was proposed to treat symptoms related to malignant bowel obstruction. Since then several reports have confirmed the efficacy of octreotide in the management of gastrointestinal symptoms of MBO. Fifteen randomized controlled trials or observational reports with a significant number of patients treated with octreotide have been reviewed; 281 patients were surveyed. Authors reported a therapeutic success ranging between 60% and 90%. Despite the limited number of controlled studies, the large experience acquired through 20 years suggests that octreotide is the first-choice antisecretory agent for MBO. As such, octreotide is the only drug approved by the health-care system in Italy for this treatment.

Gabapentin in the treatment of hiccups in patients with advanced cancer: a 5-year experience.

Aim:To evaluate safety and efficacy of gabapentin in the treatment of severe chronic hiccups in patients with advanced cancer. Methods:Charts of all patients observed in the palliative care unit of a 4-bed hospital and at home by our Home Care Service were reviewed retrospectively.The presence of hiccups was routinely assessed. Patients with severe chronic hiccups were treated with gabapentin (300 mg t.i.d.). Doses of gabapentin were titrated based on the response to treatment.Gabapentin-related adverse effects were recorded. Results:Thirty-seven (3.9%) of 944 in-hospital patients and 6 (4.5%) of 134 patients observed at home presented severe chronic hiccups.We registered an improvement of hiccups, defined as complete resolution of hiccups, in 31 (83.8%) of 37 in-hospital patients and 4 (66.7%) of 6 patients observed at home.Four (10.8%) of the 37 in-hospital patients and 2 (33.3%) of the 6 patients observed at home experienced a reduction of hiccups.In 2 patients (5.4%), we registered a worsening of hiccups.Responses were observed in 32 patients (74.4%) with gabapentin at a dosage of 900 mg/d and in 9 patients (20.93%) at 1200 mg/d.In 2 patients (4.65%), grade 2 sleepiness was observed and in 10 patients (23.25%), grade 1 sleepiness was observed based on the Epworth Sleepiness Scale. Conclusion:The results of the study allow suggesting gabapentin at least as a promising drug in the treatment of severe chronic hiccups in advanced cancer patients.

The Supportive Care Task Force at the University of L’Aquila: 2-years experience

The Supportive Care Task Force (SCTF) was established within the Medical Oncology Department at the University of L’Aquila in May 2002. The missions of the SCTF were to allow systematic evaluation and treatment of symptoms, to warrant continuity of care in all phases of disease and to provide medical oncology residents with training in the treatment of symptoms. A medical oncologist, two senior residents in medical oncology and a registered nurse comprised the SCTF. A psychiatrist, two neurologists, a dietician, and two physiotherapists served as consultants or on a part-time basis. Four beds in two-bedded rooms inside the Medical Oncology Department were reserved to SCTF. A close integration with the physicians of the Medical Oncology Department was realised. The only criterion to admission was the presence of uncontrolled symptoms. Patients were evaluated and monitored with the visual analogue scale for pain and with the Edmonton Symptom Assessment Scale (ESAS). The Palliative Prognostic Score (PaP Score) was employed to assess the prognosis. Non-clinical needs were evaluated with the Need Evaluation Questionnaire (NEQ). Protocols for the treatment of common symptoms were available in written form for consultation by physicians, residents and nurses. From 1 May 2002 to 31 May 2004, we observed 208 patients: 111 women and 97 men. The median age was 64.7 (range 28–90) years. Fifty-four patients (25.9%) were admitted more than once, for a total of 285 admissions. One hundred ninety-nine admissions (69.5%) were for supportive care while 86 admissions (30.5%) were for supportive care and active treatment. The most frequent symptoms were asthenia and anorexia. We registered excellent results regarding the treatment of pain, nausea and dyspnea while psychological symptoms, anorexia and asthenia proved more difficult to treat.Two hundred twenty patients were discharged: 142 (49.8%) home; 76 (26.7%) to the Home Care Service and two (0.7%) to others units of the hospital. Sixty-five (22.8%) died in our unit.

How Do Cancer Patients Receiving Palliative Care at Home Die? A Descriptive Study

CONTEXT Data regarding the circumstances of the process of death of terminally ill patients followed at home are lacking. OBJECTIVES The aim of this study was to describe the characteristics and assess the circumstances of the process of death of terminally ill patients followed at home. METHODS This was a prospective survey to assess the dying process of advanced cancer patients followed at home. Within a week after death, the principal caregiver was interviewed. Information from the palliative home care team and the caregiver about expectation of death, time of death, professional and nonprofessional people present at time of death, emergency admission to hospital, and administration of drugs to resuscitate was gathered. The principal clinical issues in the last two hours also were recorded. RESULTS In total, 181 of 222 caregivers provided information. Most deaths were expected. Palliative home care team physicians and nurses visited the patient on the day of death but were occasionally present at the moment of death. More than three people were generally present at time of death. More than two-thirds of patients died peacefully, without apparent suffering, and 35.7% of them received palliative sedation before dying. In the last two hours, the most frequent clinical issues were ranked as death rattle, dyspnea, and agitation. In 10 cases, emergency drugs for resuscitation were administered. CONCLUSION This study has shown how advanced cancer patients die at home and that palliative home care may be helpful in allowing a death at home, particularly when relatives are actively involved.

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

Abstract 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 studies.

Palliative Sedation in Advanced Cancer Patients Followed at Home: A Retrospective Analysis

CONTEXT Data regarding palliative sedation at home in dying patients are lacking. OBJECTIVES To describe the frequency, indication, and modality of palliative sedation (PS) in patients followed at home. METHODS A retrospective analysis of home care cancer patients was performed. Patients who received PS before dying were selected and information about epidemiologic characteristics, indications, duration, drugs, and outcomes was collected. RESULTS Of 370 medical charts of patients who died at home, 49 patients received PS before dying. PS was proposed by the team, relatives, or both in 63.3%, 4.1%, and 32.6% of cases, respectively. Delirium alone or in combination with other symptoms was the most frequent indication to begin PS. Midazolam was the most frequently used drug to initiate PS (98%), at a mean dose of 28.1 mg/day, in combination with parenteral morphine (84.7%) at a mean dose of 25.4 mg/day. At the time of death, midazolam was administered in 98% of patients (mean dose 22.3 mg/day), combined with parenteral morphine in 87.8% of patients (mean dose 28.1 mg/day). Satisfaction for physicians and principal caregivers after PS was good in 46 and 48 cases, respectively. CONCLUSION PS at home seems to be a feasible treatment option among selected patients and makes a potentially important contribution to improving care for those who choose to die at home.