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Biomedical subjects

Douglas E Peterson

Publications and source records attributed to Douglas E Peterson.

15 recordsLinked to original sources
PubMed2007

Randomized, placebo-controlled trial of Saforis for prevention and treatment of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy.

BACKGROUND: Oral mucositis (OM) is a frequent complication of mucotoxic cancer therapy, causing significant oral pain, increased infection risk, and impaired functioning. The efficacy and safety of Saforis (glutamine) powder in UpTec for oral suspension was evaluated for the prevention and treatment of OM. METHODS: Three hundred twenty-six patients developing World Health Organization (WHO) grade >or=2 OM during a chemotherapy screening cycle were randomized to Saforis (n = 163) or placebo (n = 163) 3 times/day during their next chemotherapy cycle (Treatment Cycle 1). Patients were crossed over to the alternate treatment during Treatment Cycle 2. As prespecified in the statistical plan, because of a carryover effect in Treatment Cycle 2 the primary efficacy analysis was based on Treatment Cycle 1 only. RESULTS: Compared with placebo, Saforis significantly reduced the incidence of clinically significant WHO grade >or=2 OM (38.7% vs. 49.7%; P = .026) and severe WHO grade >or=3 OM (1.2% vs. 6.7%; P = .005) in Treatment Cycle 1. Saforis also significantly reduced the worst Oral Mucositis Assessment Scale ulceration score in Treatment Cycle 1 compared with placebo (mean, 0.23 +/- 0.39 vs. 0.32 +/- 0.45; P = .013). Patients receiving Saforis in Treatment Cycle 1 had a lower-than-expected OM incidence when crossed over to placebo in Treatment Cycle 2, indicating a significant carryover effect (P = .027). The incidence of treatment-emergent adverse events was similar between groups. CONCLUSIONS: Saforis is safe and effective for preventing and treating OM in patients receiving mucotoxic cancer chemotherapy.

Adult↗
PubMed2006

Alimentary tract mucositis in cancer patients: impact of terminology and assessment on research and clinical practice.

BACKGROUND AND SIGNIFICANCE: The field of terminology and assessment of oral and gastrointestinal mucosal injury caused by high-dose cancer therapies in cancer patients has undergone important evolution in recent years. The advances are important for several clinical and research reasons. These reasons include improved patient management and design and conduct of clinical trials based on molecularly targeted therapies. For several decades leading up to the 1980s, terminology was characterized by varying use of "mucositis" and "stomatitis" to describe oral mucosal inflammatory changes and ulceration caused by cancer treatments. In addition, oral mucositis was viewed principally as an epithelial event and one that likely did not intersect with causative mechanisms associated with gastrointestinal mucositis. The term "stomatitis" was directed to oral toxicities and seemed to isolate these conditions from parallel events occurring throughout the alimentary tract and potentially other tissues as well. These perspectives and varying use of these terms resulted in several dilemmas, including (1) difficulty in accurately reporting incidence and severity of oral mucositis and, (2) an under-appreciation of potential significance of alimentary tract mucosal toxicity relative to overall course of therapy, patient quality of life, and in some cases, survivorship. These and related components of the model relative to mucositis have undergone strategic shifts over the past 15 years. A 1989 National Institutes of Health Consensus Development Conference targeted oral mucositis research as one of the key areas for investigation relative to causation, clinical impact, and potential links with other complications in cancer patients. Research in this area over the past 15 years has evolved such that oral and gastrointestinal mucositis are now appropriately framed as a continuum of pathobiologic changes over time, with clinical impact that may well contribute to overall symptom clustering in selected patient cohorts. OBJECTIVES: This paper will review history, current status, and new research directions associated with terminology and assessment of mucosal injury in cancer patients in the context described above.

Bibliometrics↗
PubMed2006

Developing evidence-based guidelines for management of alimentary mucositis: process and pitfalls.

INTRODUCTION: It is important yet difficult to maintain currency in clinical oncology practice. The emergence of new diagnostic technologies and new paradigms for cancer treatment combine to produce a rapidly changing clinical approach to patients aided by the increasing use of multidisciplinary care teams and development of evidence-based protocols. METHODS: Teams of experts review the literature in a given area and produce management guidelines and protocols for use by practicing clinicians. Traditionally within Hematology/Oncology, these guidelines have been directed to management of a given tumor type. However, in recent years, attention has increasingly turned to supportive oncology; for example, there are now management guidelines for conditions such as neutropenic fever [Hughes et al. Clinical Infectious Diseases 34(6):730-751, 2002], antiemetic (The Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer Annals of Oncology 17:20-28, 2006) and most recently, mucositis [Rubenstein et al. Cancer 100(9 Suppl):2026-2046, 2004]. It is critical that any guideline process should include education, evaluation, and timely update in its remit, because guidelines become highly compromised if their existence is not widely known, if they do not facilitate clinical practice, or if they are not reflective of contemporary medical literature. RESULTS: The Mucositis Study Group (MSG) of the Multinational Association for Supportive Care in Cancer/International Society for Oral Oncology was created in 1998 to specifically address the multiprofessional approach to clinical care, research, and education associated with mucosal injury in cancer patients. A specific outcome has been the development of evidence-based guidelines for the management of mucositis [Rubenstein et al. Cancer 100(9 Suppl):2026-2046, 2004; The Mucositis Study Group of MASCC/ISSO 2005]. The original guidelines [Rubenstein et al. Cancer 100(9 Suppl):2026-2046, 2004] and a companion paper discussing the science behind mucositis [Sonis et al. Cancer 100(9):1995-2025, 2004], were published in 2004. The MSG has recently updated the guidelines [The Mucositis Study Group of MASCC/ISSO 2005]. DISCUSSION: This paper discusses the process involved and the lessons learned that might help other groups planning to undertake a similar project.

Effect Modifier, Epidemiologic↗
PubMed2006

New strategies for management of oral mucositis in cancer patients.

Oral mucositis can be a significant problem for cancer patients and is frequently seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%), stem cell transplantation (75%-100%), and myelosuppressive chemotherapy for solid tumors (5%-40%). Current guidelines published through the joint efforts of the Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology recommend strategies for the prevention and treatment of mucositis in the setting of radiation therapy, chemotherapy, and combined chemoradiation therapy. An improved understanding of its pathologic basis has led to the development of targeted agents to combat mucositis. One of these drugs, palifermin, is a keratinocyte growth factor agent approved for patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. Another agent is AES-14, an uptake-enhanced L-glutamine suspension that has shown efficacy in phase III trials in reducing the risk of developing oral mucositis in breast cancer patients receiving chemotherapy. As the understanding of the pathobiology of mucositis improves, clinicians should be able to customize future therapies based on each patients risk for developing the condition.

Antineoplastic Agents↗
PubMed2005

Bisphosphonate-associated osteonecrosis of mandibular and maxillary bone: an emerging oral complication of supportive cancer therapy.

BACKGROUND: The current report presented 17 patients with cancer with bone metastases and 1 patient with osteopenia who received treatment with bisphosphonates and who subsequently developed osteonecrosis of the mandible and/or maxilla. METHODS: The authors reviewed information on 18 patients who were referred to oral medicine or oral surgery specialists for evaluation and treatment of mandibular and/or maxillary bone necrosis from June 2002 to September 2004. To be included in the current review, patients must have been treated with either pamidronate or zoledronic acid to control or prevent metastatic disease, or with alendronate for osteoporosis. All patients with cancer had received chemotherapy while receiving bisphosphonate management. RESULTS: The 17 patients with cancer were receiving active medical care for a malignancy. Cancer treatment included a variety of chemotherapeutic agents. They presented with metastatic disease to bone and were treated intravenously with the bisphosphonates pamidronate or zoledronic acid for a mean time of 25 months (range, 4-41 mos). There were 14 females and 4 males with a mean age of 62 years (range, 37-74 yrs). Malignancies included breast carcinoma (n = 10), multiple myeloma (n = 3), prostate carcinoma (n = 1), ovarian carcinoma (n = 1), prostate carcinoma/lymphoma (n = 1), and breast/ovarian carcinoma (n = 1). One female patient with osteopenia received alendronate. The most common clinical osteonecrosis presentations included infection and necrotic bone in the mandible. Associated events included dental extractions, infection, and trauma. Two patients appeared to develop disease spontaneously, without any clinical or radiographic evidence of local pathology. Despite surgical intervention, antibiotic therapy, hyperbaric oxygen therapy, and topical use of chemotherapeutic mouth rinses, most of the lesions did not respond well to therapy. Discontinuation of bisphosphonate therapy did not assure healing. However, 1 patient with cancer healed after discontinuation of bisphosphonate therapy for 4 months. CONCLUSIONS: The findings in the patient population combined with recent literature reports suggested that bisphosphonates may contribute to the pathogenesis of the oral lesions. The risk factors and precise mechanism involved in the formation of the osteonecrosis are not known. This condition represents a new oral complication in patients with cancer and can be termed bisphosphonate-associated osteonecrosis. Lesions in patients with osteoporosis are worrisome and need to be further evaluated.

Adult↗
PubMed2005

Oral mucositis.

Oral mucositis refers to erythematous, erosive, and ulcerative lesions of the oral mucosa seen in two patient populations: (1) head and neck cancer patients undergoing radiation therapy to fields involving the oral cavity, and (2) patients receiving high-dose chemotherapy for cancer. Oral mucositis is a significant and dose-limiting toxicity of cancer therapy, with important clinical and economic implications. This article reviews the current knowledge on the pathogenesis, clinical presentation, diagnosis, and management of oral mucositis.

Humans↗
PubMed2004

Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients.

BACKGROUND: A frequent complication of anticancer treatment, oral and gastrointestinal (GI) mucositis, threatens the effectiveness of therapy because it leads to dose reductions, increases healthcare costs, and impairs patients' quality of life. The Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology assembled an international multidisciplinary panel of experts to create clinical practice guidelines for the prevention, evaluation, and treatment of mucositis. METHODS: The panelists examined medical literature published from January 1966 through May 2002, presented their findings at two separate conferences, and then created a writing committee that produced two articles: the current study and another that codifies the clinical implications of the panel's findings in practice guidelines. RESULTS: New evidence supports the view that oral mucositis is a complex process involving all the tissues and cellular elements of the mucosa. Other findings suggest that some aspects of mucositis risk may be determined genetically. GI proapoptotic and antiapoptotic gene levels change along the GI tract, perhaps explaining differences in the frequency with which mucositis occurs at different sites. Studies of mucositis incidence in clinical trials by quality and using meta-analysis techniques produced estimates of incidence that are presented herein for what to our knowledge may be a broader range of cancers than ever presented before. CONCLUSIONS: Understanding the pathobiology of mucositis, its incidence, and scoring are essential for progress in research and care directed at this common side-effect of anticancer therapies.

Antineoplastic Agents↗
PubMed2004

Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis.

BACKGROUND: Oral and gastrointestinal (GI) mucositis can affect up to 100% of patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, 80% of patients with malignancies of the head and neck receiving radiotherapy, and a wide range of patients receiving chemotherapy. Alimentary track mucositis increases mortality and morbidity and contributes to rising health care costs. Consequently, the Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology assembled an expert panel to evaluate the literature and to create evidence-based guidelines for preventing, evaluating, and treating mucositis. METHODS: Thirty-six panelists reviewed literature published between January 1966 and May 2002. An initial meeting in January 2002 produced a preliminary draft of guidelines that was reviewed at a second meeting the same year. Thereafter, a writing committee produced a report on mucositis pathogenesis, epidemiology, and scoring (also included in this issue), as well as clinical practice guidelines. RESULTS: Panelists created recommendations from higher levels of evidence and suggestions when evidence was of a lower level and there was a consensus regarding the interpretation of the evidence by the panel. Panelists identified gaps in evidence that made it impossible to recommend or not recommend use of specific agents. CONCLUSIONS: Oral/GI mucositis is a common side effect of many anticancer therapies. Evidence-based clinical practice guidelines are presented as a benchmark for clinicians to use for routine care of appropriate patients and as a springboard to challenge clinical investigators to conduct high-quality trials geared toward areas in which data are either lacking or conflicting.

Antineoplastic Agents↗
PubMed2004

Mucosal damage: a major risk factor for severe complications after cytotoxic therapy.

The oral and gastrointestinal mucosa is frequently damaged during chemotherapy and radiotherapy in patients with cancer, leading to a high incidence of mucositis (ie, oral, esophageal, lower gastrointestinal tract mucositis). Patients with mucositis often experience considerable pain and discomfort. Furthermore, neutropenic patients with mucositis have an increased risk of potentially life-threatening infections as well as prolonged hospital stays. Mucositis may also require that subsequent chemotherapy or radiotherapy doses be reduced, thereby potentially compromising the efficacy of cancer therapy. Standard care for oral mucositis is based on effective oral hygiene, appropriate analgesia, infection management, and parenteral nutrition when needed; few other approaches have been shown to be effective. The evaluation of new options to treat and prevent mucositis rather than control the symptoms is therefore an urgent priority. A comprehensive understanding of the complex pathobiology of mucositis will help to identify potential targets for new drugs. Promising investigational approaches have recently emerged. These include fibroblast growth factor-20, which is effective in animal models of chemotherapy/radiation-induced mucosal toxicity, and is being investigated in clinical studies. The candidate that is most advanced in terms of drug development is recombinant human keratinocyte growth factor (rHuKGF; palifermin), which in phase III clinical trials was shown to reduce the severity and duration of oral mucositis and improve clinical sequelae.

Antineoplastic Agents↗
PubMed2004

Novel therapies.

OBJECTIVE: To highlight selected research directed to new drug and device technologies to manage mucositis in cancer patients and to illustrate potential impact of successful therapies. DATA SOURCES: Published research articles and abstracts, clinical experience. CONCLUSION: Advances in molecular modeling of mucosal injury in cancer patients have created new opportunities for therapy. Research is analyzing the impact of single-agent interventions; varying degrees of efficacy are being reported. Once optimal dosing strategies for single-agent management are defined, the opportunity for multi-agent therapies will emerge. IMPLICATIONS FOR NURSING PRACTICE: The oncology nurse plays a pivotal role in assessing and managing mucositis in cancer patients.

Cryotherapy↗
PubMed2004

Evidence-based guidelines for managing mucositis.

OBJECTIVES: To discuss implementation of evidence-based clinical practice guidelines for mucositis. DATA SOURCE: Published articles, book chapters, web sources, clinical experience, unpublished manuscripts. CONCLUSION: Nurses can implement evidence-based guidelines but must include an evaluation component to determine effect on clinical outcomes. IMPLICATIONS FOR NURSING PRACTICE: Nurses have an integral role implementing and evaluating evidence-based practice guidelines for managing mucositis. When evidence is lacking and guidelines have gaps, nurses can play important roles in research to overcome these gaps.

Benchmarking↗
PubMed2003

Risk factors for ulcerative oral mucositis in cancer patients: unanswered questions.

A multitude of laboratory and clinical research studies of ulcerative oral mucositis induced by cytotoxic cancer therapies have been reported during the past decade. However, a comprehensive understanding of oral mucositis pathogenesis, together with a clear definition of risk factors for development and severity of the lesion, remain under investigation. The literature presents sometimes divergent data regarding these issues, which in turn restrict efforts to develop a unified approach for management of this morbid condition. The current review summarizes these controversies and highlights the need for strategies for stratification of patients enrolled in clinical trials, in relation to both pathophysiologic and associated risk factors.

Antineoplastic Agents↗
PubMed2002

The 20 item oral mucositis index: reliability and validity in bone marrow and stem cell transplant patients.

Precise quantification of oral complications in cancer patients receiving bone marrow and stem cell transplantation is essential when testing new treatment strategies for mucositis. Using 133 adult transplant patients, the authors evaluated the 20 item oral mucositis index (OMI), adapted from the 34 item OMI, to facilitate use by nondental health professionals. The OMI-20 consists of nine items measuring erythema, nine measuring ulceration, one measuring atrophy, and one measuring edema; all are scored from 0 = none to 3 = severe and summed for a total possible score of 0-60. The two sets of nine items measuring erythema and ulceration can also be summed separately to produce subscale scores ranging from 0 to 27. Results demonstrated internal consistency, test-retest, and inter-rater reliability, and strong evidence of construct validity. Provided that clinical examiners have appropriate training and experience, the OMI-20 can be used as a reliable, valid, and quantifiable measure of mucositis in clinical research.

Adolescent↗
PubMedDate not supplied

Treatment of mucositis, including new medications.

Mucositis is a clinically important and sometimes dose-limiting complication of cancer therapy. Mucositis lesions can be painful, affect nutrition and quality of life, lead to sepsis, and have significant economic impact. Recent modeling of the toxicity has been based on the continuum of clinical signs and symptoms of mucositis involving the alimentary tract, including both oral and gastrointestinal sites. The pathogenesis of oral and gastrointestinal mucositis is multifactorial and complex. In recent years, there has been a substantial increase in both basic and clinical research related to mucosal injury in cancer patients. Since most of this research has been directed to oral mucositis, the present review principally addresses this component of the toxicity. Morbidity, economic impact, pathogenesis and clinical course of mucositis are discussed. In addition, several agents in clinical development for mucositis are discussed in the context of the current pathobiologic model as well as the recently updated evidence-based clinical management guidelines.

Evidence-Based Medicine↗