Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR).

Oral transmucosal fentanyl citrate (OTFC); Actiq) is a drug delivery formulation used for management of breakthrough cancer pain. Previous studies with open-label comparisons indicated OTFC was more effective than patients' usual opioid for breakthrough pain. The objective of this study was to compare OTFC and morphine sulfate immediate release (MSIR) for management of breakthrough pain in patients receiving a fixed scheduled opioid regimen. This double-blind, double-dummy, randomized, multiple crossover study was conducted at 19 US university- and community-based hospitals and clinics and comprised 134 adult ambulatory cancer patients. Patients were receiving a fixed scheduled opioid regimen equivalent to 60-1000 mg/day oral morphine or 50-300 microg/h transdermal fentanyl, were using a 'successful' MSIR dose (15-60 mg) as defined by entry criteria, and were experiencing 1-4 episodes of breakthrough pain per day. In open-label fashion, OTFC was titrated such that a single unit (200-1600 microg) provided adequate pain relief with acceptable side effects. Successfully titrated patients entered the double-blind phase of the study and received ten prenumbered sets of randomized capsules and oral transmucosal units. Five sets were the successful OTFC dose paired with placebo capsules, and five sets were placebo OTFC paired with capsules containing the successful MSIR dose. Patients took one set of study medication for each episode of target breakthrough pain. Pain intensity (PI), pain relief (PR) and global performance of medication (GP) scores were recorded. Pain intensity differences (PID) were calculated and 15-min PID was the primary efficacy variable. Adverse events were recorded. Sixty-nine percent of patients (93/134) found a successful dose of OTFC. OTFC yielded outcomes (PI, PID, and PR) at all time points that were significantly better than MSIR. GP also favored OTFC and more patients opted to continue with OTFC than MSIR following the study. Somnolence, nausea, constipation, and dizziness were the most common drug-associated side effects. In conclusion, OTFC was more effective than MSIR in treating breakthrough cancer pain.

Survey of analgesic use for nonmalignant pain in long-term care facilities in southern California.

OBJECTIVE: Many residents in long-term care facilities experience nonmalignant pain, and analgesic therapy is often inadequate in this setting. We examined the management of chronic nonmalignant pain in elderly nursing home residents. DESIGN: Retrospective chart review. SETTING: Forty skilled nursing facilities in southern California. PARTICIPANTS: Residents with a diagnosis of noncancer pain who were receiving a regular regimen of prescribed analgesics. MEASUREMENTS: The following information was recorded: demographic data, specific diagnosis for pain medication, all analgesics in current use by the resident, whether a pain rating score was available for the resident and, if so, the current score. RESULTS: Of the 3400 resident charts screened, 381 residents (11.2%) met the criteria for inclusion in the study. There were 443 diagnoses for chronic nonmalignant pain, primarily arthritis and other musculoskeletal disorders. Of 510 prescriptions for analgesics, 52% were for acetaminophen or nonsteroidal antiinflammatory medications. Centrally acting analgesics, primarily opioids, accounted for 48% of all prescriptions. Approximately three-fourths of opioid prescriptions were for fixed-dose combinations with acetaminophen, and 15% were for long-acting opioids. Pain scores were not recorded on any of the residents' charts. CONCLUSION: Nonmalignant pain in these elderly nursing home residents was often associated with musculoskeletal disorders and was not assessed systematically. Without routine pain assessments, it is not possible to determine whether the residents' pain was being treated adequately by the analgesics prescribed. We recommend a multidisciplinary approach to the institution of pain assessment and management guidelines in long-term care facilities.

Sublingual morphine: efficacy reviewed.

Current guidelines on the treatment of moderate to severe cancer pain recommend the use of scheduled doses of opioids for persistent pain combined with "as needed" doses of similar agents for breakthrough pain. Oral drugs given on an "as needed" basis can be problematic for patients with difficulty in swallowing or for those who suffer from nausea and vomiting. Further, breakthrough pain can become excruciating in a relatively short time, a drawback for analgesics that require gastrointestinal (GI) absorption before pain relief can begin. Hence, there is considerable interest in the development of novel drug administration routes to provide rapid relief of breakthrough pain, particularly through a route that bypasses the GI system. Sublingually administered morphine has sometimes been used in the treatment of breakthrough pain because some believe it provides effective analgesia via an appropriate alternate route. Available pharmacological data, however, do not consistently support the rapid absorption of morphine through the sublingual mucosa, and clinical data concerning the efficacy of sublingual morphine for the treatment of cancer pain are limited, not well-controlled, and inconclusive. While there seems to be a need for provision of rapid, effective analgesia to cancer patients by an alternative route, sublingual morphine may not satisfy this requirement. Newer formulations of analgesics should be tested in the treatment of breakthrough pain due to cancer.

Cancer pain management: newer perspectives on opioids and episodic pain.

Cancer pain is significantly undertreated, but the current armamentarium of opioids and other analgesics are such that no cancer patient should be in pain. The guidelines for the treatment of cancer pain suggest that a long-acting, preferably oral, opioid be administered around the clock for persistent baseline pain, along with a short-acting oral opioid for episodes of breakthrough pain. Morphine is the gold standard for ATC opioid treatment, and OTFC is emerging as a potent agent for the management of breakthrough pain. The careful assessment and management of persistent cancer pain and breakthrough pain will help realize the goal of optimal pain management for all cancer patients.

Survey of the provision of supportive care services at National Cancer Institute-designated cancer centers.

PURPOSE: The purpose of this survey was to determine the scope of supportive care services (SCS) designed to promote quality of life during cancer therapies at National Cancer Institute (NCI)-designated cancer centers. METHODS: A survey was mailed to the medical directors and nursing directors of 52 NCI-designated comprehensive (n = 26), clinical (n = 11), and planning cancer centers (n = 15) in the United States. Only one survey was completed from each institution. Survey questions identified services provided such as pain management, terminal care, psychosocial programs, and spiritual care. RESULTS: Thirty-nine questionnaires were received for a total response rate of 75%. Of the respondents, 45% were comprehensive cancer centers, 24% clinical cancer centers, and 29% planning centers. One center did not identify their NCI designation. Sixty-one percent of the centers reported research programs in supportive care. Outside funding was reported in 51% of the respondents, with 39% having American Cancer Society (ACS) or National Institutes of Health (NIH) funding and 28% having private industry funding. Overall SCS self-ratings improved from a 21% rating of excellent to very good 5 years ago to the current 54% rating. CONCLUSION: Survey results provide data on SCS across a representative sample of NCI cancer centers and can be used to develop standards for future cancer control programs.