CHAPTER 81 Integrating Palliative and Curative Care Strategies in the Practice of Otolaryngology
As of 2006 there were 10.5 million cancer survivors in the United States, with 1 million more anticipated each year.1 With advances in treatment regimens that allow individuals with cancer to live prolonged periods beyond the time of diagnosis—even for cancers with trajectories that are expected to ultimately end life—symptom management becomes a critical focus of the doctor-patient relationship. Five-year survival rates for patients diagnosed with head and neck cancer (all types and stages) is 59%.2 Although treatment has improved the disease-free interval, cure rates have not substantially improved over the last 50 years.
Treatment depends on stage of disease. For late-stage disease, treatment most often involves multimodality therapy.3 Symptom distress that occurs commensurate with treatment and persists long term to influence both function and quality of life provides the impetus for the implementation of prevention and treatment strategies designed to alleviate these difficult conditions.
Treatment regimens differ because head and neck cancers are a varied group of diseases comprising malignancies of the oral cavity, oropharynx, larynx, sinuses, and skull base. This difference in treatments coupled with characteristics specific to the patient (e.g. stage, co-morbid medical illness, age) influences treatment outcome and makes it difficult to describe a clearly delineated set of adverse or distressing symptoms.4 Discussions of treatment options with patients should always include a thoughtful review of possible side effects, late effects, and quality of life consequences as well as best or most likely clinical outcome. Additionally, because both prevention and treatment of distressing symptoms involves complex and time-consuming consultation, palliative care is best delivered through the efforts of a interdisciplinary team4 including the surgeon, medical oncologist, radiation oncologist, dentist, speech therapist, psychologist, occupational and physical therapists, nurse, and social worker.
Treatment for malignant disease involving the head and neck produces toxicities to normal cells or tissue. By virtue of its rapid cellular turnover rate, the mucosal lining of the gastrointestinal tract including the oral mucosa is a prime target for chemotherapy- and radiation-related toxicities The diverse and complex microflora that exists within the oral cavity renders the oral mucosa vulnerable to infection. Approximately 10% to 15% of patients experience oral complications during adjunctive chemotherapy.5 This number increases to 40% to 50% when chemotherapy is administered as the primary treatment (palliative).6 Virtually all patients with head and neck cancer who are undergoing combination chemotherapy and radiotherapy experience oral complications, the majority of whom will experience severe effects.
Treatment for patients with head and neck cancer often involves multimodality therapy. Surgery remains an integral component for most such patients. The adverse effects of surgery are distinctly different from those of chemotherapy and irradiation. Surgical effects often remain life-long and have a significant impact on daily functioning.7
In a 2007 Cochrane Review, less than one half of the included studies (39%) reported adverse events with treatment.8 The writers of this review discuss the perception among oncologists that acceptance of high rates of adverse events is necessary to “tackle the bigger issue of survival.” The information presented regarding adverse effects should not be used to argue against specific surgical considerations, because treatment decisions should be weighted primarily toward those that maximize survival. However, studies indicate that more than half the patients treated for head and neck cancer are disabled by their treatment.9 Specific risk factors include previous treatment with chemotherapy and pain. Pain remains a major predictor of disability and can be disabling for many reasons. Therefore, patient education regarding expected treatment outcomes is critical to the informed consent process.
Pretreatment Management
Assessment of the oral status and stabilization of oral disease prior to the initiation of therapy is a critical first step to overall patient care. Primary preventive measures include patient counseling for effective oral hygiene practices and early detection of oral lesions. Involvement of a dental team experienced with oral oncology patients can reduce the risk of oral complications.10 The evaluation itself should occur as early as possible prior to treatment. Ideally, this examination should be performed at least 1 month before initiation of cancer treatment to permit adequate healing from any required invasive oral procedures.10 Thereafter, a program of oral hygiene can be initiated with emphasis on maximizing patient compliance throughout the course of treatment and after treatment completion.
Data that can be provided by the dental professional to the treatment care team include the presence or absence of dental caries (including amount and severity), the number of teeth requiring restoration, endodontic disease, teeth with pulpal infection, teeth requiring endodontic treatment, periodontal disease status, number of teeth requiring extraction, other urgent care that is required, and the time necessary to complete stabilization of oral disease.10
Routine oral hygiene care includes emphasis on tooth brushing with soft nylon–bristled brushes, with the patient instructed to brush two or three times daily and to rinse the mouth frequently. The patient should be also instructed to use a dentifrice with fluoride. The patient should floss once daily, using an atraumatic technique with modifications as needed. The use of bland rinses, either 0.9% saline or sodium bicarbonate solution, every 2 to 4 hours can soothe pain or discomfort.11 Also, the patient should be instructed to brush a 1.1% neutral sodium fluoride gel or a 0.4% stannous fluoride gel on the teeth daily for 2 to 3 minutes and then to expectorate and rinse the mouth gently.11
Mucositis
For years, the development of mucositis was thought to be a direct, nonspecific consequence of the destructive side effects of irradiation and/or chemotherapy on rapidly dividing basal cells of the mucosal epithelium. Over the past several years, however, evidence has increasingly mounted to demonstrate that chemotherapy/radiation-induced mucosal injury (mucositis) is actually the result of a complex series of biologic and cellular events that take place predominantly in the submucosa.12 The process by which these events occur has been modeled into a five-stage sequence as follows: initiation, primary damage response, signal amplification, ulceration, and healing. Clinically, ulceration is the most significant stage of mucositis.12,13
The severity of mucositis is usually expressed through the use of one of a number of grading scales. Two of the most commonly used scales are those developed by the World Health Organization (WHO) and the National Cancer Institute (NCI). The NCI’s Common Terminology Criteria for Adverse Events (Version 3) evaluates the clinical findings of mucositis (erythema, ulceration) and functional consequences of mucositis on two distinct scales.12 The WHO incorporates a subjective evaluation of ulceration/erythema, a subjective evaluation of pain, and a functional evaluation (ability to eat) into a single value.12
The purpose of maintaining effective oral hygiene is to reduce the effect of the oral microbial flora and prevent soft tissue infections that may have systemic sequelae.14 Basic oral care also reduces the risk of oral caries and gingivitis.10
The prevention and treatment of mucositis have involved the use of a wide variety of agents over many years. For the most part, however, the results of these efforts have been quite disappointing. Only lately have there been any significant advances in mechanistically based intervention, owing primarily to a greater understanding of the underlying pathophysiology of mucositis. The emphasis on quality of life during curative treatment has also engendered recognition of the importance of effectively designed and executed clinical trials that include important quality-of-life information. Comprehensive evidence-based literature reviews of published mucositis interventions by the Cochrane Collaboration and the Mucositis Study Section of the Multinational Association of Supportive Care and Cancer/International Society of Oral Oncology (MASCC/ISOO) have provided clinical recommendations or guidelines.8,15
On the basis of the principles of radiation biology and careful treatment planning, a number of strategies have been developed to reduce the cumulative dose of radiation therapy delivered to nontumor mucosal tissues. Midline blocking, mucosa-sparing shields, which are custom fabricated, can effectively decrease the severity of oral mucositis.16 When metallic dental restorations (e.g. amalgams, gold crowns) exist in direct opposition to the oral mucosa, wetted cotton rolls or a number of other devices such as custom stents can be used to physically separate the tissue (3 mm or greater away from the dental restoration) and reduce mucositis secondary to localized enhanced scatter effect.17,18 Decreased severity of mucositis has been reported after three-dimensional treatment planning and treatment with intensity-modulated radiation therapy (IMRT).19 IMRT has come into widespread use over the last several years.19
Given the presence of opioid receptors in the oral mucosa, topical morphine therapy and fentanyl sublingual spray have been evaluated and shown to be effective in reducing mouth pain.20 However, it is unclear to what extent the effect is local rather than systemic, via central pathways, especially in the presence of severe ulcerations, in which transmucosal absorption is likely quite high. Systemic management with morphine and other opioid pain medications is effective and considered a standard care of therapy for severe cases, although breakthrough pain and dose-limiting toxicity are frequently encountered.20
Several mucosal surface protectants are available that provide relief by physically coating or soothing the oral mucosa. Caphosol (EUSA Pharma, Princeton, NJ), approved by the U.S. Food and Drug Administration (FDA), is a rinse (device) composed of sodium chloride, sodium phosphate, and calcium chloride that has been evaluated in the stem cell transplantation population and has been shown to be effective in decreasing symptoms of pain and xerostomia.21 Gelclair (EKR Therapeutics, Bedminster, NJ) and Mucotrol (GeoPharma Inc., Largo, FL) are both FDA-approved mucoadhesive agents that coat and adhere to the inside of the mouth, exerting their effects by physically blocking painful exposed nerve endings in the damaged, ulcerated mucosa.22 Although these agents are safe and generally well tolerated, the relief they provide is variable and additional systemic pain management is typically required.
Although not approved for use in the United States, benzydamine hydrochloride is a unique topical agent with anti-inflammatory, analgesic, and antimicrobial properties used extensively for prevention of radiation-induced mucositis in Europe and other parts of the world.23 Amifostine, a free radical scavenger, has been found to be effective in reducing acute and long-term salivary gland hyperfunction secondary to head and neck radiation but has not consistently demonstrated efficacy in the prevention of mucositis, although clinical trials are ongoing.24
Palifermin, a recombinant keratinocyte growth factor (FGF-7), is approved by the FDA for prevention of oral mucositis in patients undergoing stem cell transplantation for hematologic malignancies. Spielberger and colleagues25 reported, in a phase I/phase II trial using palifermin for reduction of mucositis in colorectal cancer patients undergoing therapy regimens containing 5-fluorouracil, that the agent demonstrated safety and efficacy.25 Both industry and cooperative groups are sponsoring trials to evaluate the efficacy of palifermin in preventing mucositis in patients receiving chemoradiation therapy for treatment of head and neck cancers. Valifermin (FGF-20), a member of the same superclass of molecules as palifermin, is also in clinical testing.26,27
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