FORT LAUDERDALE, Fla--Given the existence of the cancer pain guidelines formulated by the Agency for Health Care Policy and Research (AHCPR), is there really a need for the National Comprehensive Cancer Network (NCCN) to develop practice guidelines on cancer pain? Yes, asserted Richard Payne, MD, at the NCCNs third annual conference.
Based on a detailed analysis of the status of the AHCPR guidelines, the NCCN, a coalition of 16 leading US cancer centers, has decided to create its own cancer pain guidelines, which will be presented at the networks fourth annual meeting in March 1999.
Dr. Payne, of M.D. Anderson Cancer Center, cited several reasons why new cancer pain guidelines are warranted:
- Undertreatment of cancer pain remains a significant problem in 1998.
- A number of new analgesics have received FDA approval since the 1994 publication of the AHCPR guidelines.
- The AHCPR guidelines do not reflect new comparative data on older analgesics.
- There is little evidence that the AHCPR guidelines have been systematically adopted into clinical practice, suggesting the need for new approaches to changing practice behavior.
A recent study from Cleland found that 45% of 1,300 cancer patients participating in ECOG trials experienced daily pain, and 20% had severe pain, Dr. Payne noted. Furthermore, when measured against the standards set forth by the AHCPR and World Health Organization (WHO), nearly half (46%) of the patients were being undertreated with respect to the use of analgesics.
Another recent study suggested that the problem is even worse in minority patients. That study showed that 60% of minority cancer patients, primarily African-Americans and Hispanics, are being undertreated for pain.
One of the core principles of the AHCPR guidelines is the appropriate use of analgesic drugs as a part of the comprehensive assessment and management of the patient, Dr. Payne said, adding that a number of new analgesics have been approved in the United States since 1994.
These new agents include a once-daily morphine preparation, sustained-release oxycodone (OxyContin), epidural clonidine (Duraclon), oral transmucosal fentanyl (Oralet), tramadol (Ultram), and bromfenac sodium (Duract). Also, two new radiopharmaceuticals--strontium-89 (Metastron) and samarium-153 (Quadramet)--have been approved for metastatic bone pain.
"The immediate question is, how do we incorporate the information about these drugs into our current understanding of the clinical practice guidelines?" Dr. Payne asked.
Another core principle of the AHCPR guidelines, Dr. Payne said, is use of the WHO three-step analgesic ladder paradigm for cancer pain management, and one of the key assumptions of that paradigm is that morphine is the opioid of first choice for severe pain.
A recent study conducted by Dr. Payne and colleagues from six institutions, however, casts doubt on this assumption. This cross-sectional study compared certain aspects of quality of life, patient satisfaction, and side effects in 96 patients taking controlled-release oral morphine and in 213 patients treated with transdermal fentanyl (Duragesic).
Although physical functioning was better in the morphine group, patient satisfaction scores were higher in the transdermal fentanyl group, due to a significantly lower frequency and severity of side effects, especially constipation and nausea, Dr. Payne reported.
He also described other new data suggesting that response to certain analgesics may be gender specific. In a small, blinded study, 20 women and 28 men undergoing dental extractions were given doses of either butorphanol (Stadol) or nalbuphine. The women reported a greater intensity and longer duration of analgesia than men given the same dose of the drugs.
"So we now know that gender, race, and other genetic factors influence analgesic responsiveness, and the degree to which this becomes a factor in selecting analgesics that optimize analgesia and minimize side effects becomes very critical," Dr. Payne said. He called for large, cooperative, controlled trials to determine how to apply these new findings to clinical practice.
Changing Practice Behavior
Besides incorporating new drugs and new data, another important aspect of guideline development, refinement, and implementation is ensuring compliance with guideline recommendations.
"It is being increasingly recognized that education alone has been insufficient to change practice behavior," he said, "and it may be necessary to look at other models, such as incorporating best analgesic practices into protocols, to truly make an impact on changing pain therapies."
One such model for quality assurance assessment was described in 1995 by the American Pain Societys Quality of Care Committee. In addition to using objective scales to quantify pain and assess the impact of pain on functioning, this study looked at "process issues," such as how long patients had to wait to receive analgesics and how clear instructions were about taking medications, as well as global measures of patients satisfaction with their pain management.
Studies conducted by the American Pain Society validated this approach to quality assessment. "The advantage of these kinds of approaches is that they tend to make pain visible within an institution, permit the institution to change, provide a basis for educating patients and clinicians, and help immediately to minimize errors in prescribing," he said.
As to what steps the NCCN should take in formulating pain guidelines, Dr. Payne suggested that serious consideration be given to implementing and standardizing very simple pain assessment tools for routine care.
These should depend on "implementing what are really validated WHO analgesic ladder principles and AHCPR principles of pain assessment," he said, adding that the American Pain Societys model of standard quality assurance assessments is a good starting point.
The NCCN also could provide the infrastructure to support large cooperative clinical trials to evaluate new drugs and improved quality of life methodologies.