Support Care Cancer (2007) 15: 491–496 DOI 10.1007/s00520-006-0176-9
Montserrat Vera-Llonch Gerry Oster Colleen M. Ford John Lu Stephen Sonis
Received: 16 May 2006 Accepted: 4 October 2006 Published online: 1 December 2006 # Springer-Verlag 2006
M. Vera-Llonch . G. Oster (*) Policy Analysis Incorporated (PAI), Four Davis Court, Brookline, MA 02445, USA e-mail:
[email protected] Tel.: +1-617-2324400 Fax: +1-617-2321155 C. M. Ford . S. Sonis Dana Farber Cancer Institute and Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, USA J. Lu Amgen Incorporated, One Amgen Center Drive, Thousand Oaks, CA, USA
ORIGINA L ARTI CLE
Oral mucositis and outcomes of allogeneic hematopoietic stem-cell transplantation in patients with hematologic malignancies
Abstract Goals of the work: To assess the relationship between oral mucositis (OM) and adverse clinical and economic outcomes in patients with hematologic malignancies receiving allogeneic hematopoietic stem-cell transplantation (HSCT). Materials and methods: A retrospective chart review study of 281 allogeneic HSCT recipients with hematologic malignancies was undertaken at a single academic center. OM extent and severity were assessed across eight oropharyngeal sites using a validated scale, which was scored as follows: no erythema/ ulceration=0; erythema only=I; ulceration, one site=II; ulceration, two sites=III; ulceration, three sites=IV and ulceration, four or more sites=V. OM assessments began on the day of conditioning and continued twice weekly within 28 days or hospital discharge. Analyses examined the relationship between the worst OM grade and selected adverse outcomes, including days with fever, days of
Introduction Oral mucositis (OM) is a frequent complication of many of the aggressive conditioning regimens used in hematopoietic stem-cell transplantation (HSCT). Mucosal injury associated with OM results in the development of diffuse, painful ulcerative lesions, typically within 2 weeks of
total parenteral nutrition (TPN), days of parenteral narcotic therapy, incidence of significant (common terminology criteria (CTC) grade 3 or 4) infection, mortality and inpatient days and charges. Main results: The mean age of the study subjects was 41 years. Of the patients, 96% (n=269) received total body irradiation and 76% (n=214) experienced an OM grade of ≥II (i.e., ulceration). The worst OM grade was significantly (p18 years who underwent allogeneic HSCT for hematologic malignancies between January 1, 2000 and August 31, 2004 were included in the study, except those with active ulceration of the oral mucosa before the first day of conditioning therapy and those who had received any unlicensed investigational drug for the prevention and/or treatment of OM or graft-vs-host-disease (GvHD) within 14 days of this date. Data collection Study personnel identified patient charts for data abstraction based on the dates of hospital admission between January 1, 2000 and August 31, 2004, ICD-9-CM diagnoses codes for leukemia, lymphoma or myelodysplasia and ICD-9-CM procedure codes for allogeneic HSCT. The information collected for each patient included selected demographic and clinical characteristics, including age, gender, body weight, prior and/or current alcohol and tobacco use (yes/no), concomitant diabetes, Karnofsky score at the time of conditioning therapy, graft source (related donor vs unrelated donor), receipt of TBI, pre-transplant conditioning regimens and use of GvHD prophylaxis. At the study site, information on the extent and severity of OM was routinely collected on a twice-weekly basis by trained assessors for HSCT patients over the first 28 days after conditioning therapy (or until hospital discharge, whichever occurs first) using a validated scoring system [6]. Eight predefined anatomic locations in the oral cavity (upper labial mucosa, mandibular labial mucosa, right buccal mucosa, left buccal mucosa, right lateral and ventral tongue, left lateral and ventral tongue, floor of mouth and soft palate) were examined. The extent and
severity of OM was assigned a grade at each exam as follows: 0 (no sites with erythema or ulceration/pseudomembrane), I (erythema only at one or more sites), II (one site with ulceration/pseudomembrane), III (two sites with ulceration/pseudomembrane), IV (three sites with ulceration/ pseudomembrane) or V (four or more sites with ulceration/pseudomembrane). Medical records were also reviewed for mention of the presence of ulceration. Data were collected retrospectively on a variety of adverse outcomes that may be associated with mucosal injury, including: (1) the number of days with body temperature ≥38.0°C (febrile days); (2) the number of days in which patients received total parenteral nutrition (TPN); (3) the number of days in which patients received parenteral narcotic analgesics and (4) the incidence of significant (common terminology criteria [CTC] for adverse events grade 3 or 4) infection (all to day 28 or hospital discharge). Information was also collected for the transplant hospitalization on inpatient mortality, total length of stay, and total (acute) inpatient charges based on computerized billing records. Analyses Analyses were directed at examining the relationship between the worst OM grade (to day 28) and selected patient demographic and clinical characteristics and the relationship between the highest OM grade and clinical and economic outcomes that may be associated with mucosal injury. The Cochran–Armitage test for trend was used for dichotomous measures. General linear modeling procedures were used for continuous measures. Statistical significance was assessed using a p value of
