Work

Palifermin for Prevention of Oral Mucositis (OM) in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Using A Fractionated Total Body Irradiation (FTBI)-Based Conditioning Regimen

Year: 2009

Type: article

Abstract: OM is a complication of myeloablative therapy followed by HSCT. Severe OM in patients (pts) undergoing HSCT with a FTBI-based conditioning regimen has been reported in up to 80% of pts (Woo et al. Cancer 1993; 72). Palifermin, (PAL, Kepivance®), a recombinant human keratinocyte growth factor, has been shown to reduce the duration and severity of OM in pts undergoing FTBI-based conditioning regimen prior to autologous HSCT (Spielberger et al. NEJM 2004; 351). Benefits of PAL in pts undergoing allogeneic (Allo) HSCT from a related or a matched unrelated donor were evaluated in a comparative, retrospective study. Data on a cohort of pts who received PAL (N = 33) were compared to a cohort of pts who did not (Control: N = 31). Conditioning regimen consisted of FTBI and etoposide. OM was defined as “Mild” and “Severe” based on CTC v2.0 (Mild = grades 1 and 2, Severe = grades 3 and 4). Baseline characteristics for both cohorts were not statistically different in respect to gender, diagnosis, disease status, GVHD prophylaxis regimen, type of donor, and stem cell source. Median age was lower for pts in the control group (44 vs. 34 years, P = 0.01). All pts developed OM with a median duration of 15 days for the PAL cohort and 20 days for the control (P = 0.05). Overall incidence of severe OM by univariate analysis was 55% and 81% for pts in the PAL and control groups, respectively (P = 0.03). Median duration of severe OM among all pts was 2 days (0–28) for those who received PAL and 5 days (0–16) for pts who did not (P = 0.007). Patients in the PAL group received intensive oral care (delivered by certified respiratory therapists) for 11 days (0–30) vs. 15 days (0–47) for pts in the control group (P = 0.02). Median opioid analgesic use attributed to mucositis pain (in morphine equivalents) was 542 (47–6330) mg and 837 (225–18137) mg for PAL and control groups (P = 0.14). Cumulative incidence of acute GVHD grades III and IV was 9% for pts in PAL group and 29% for the control (P = 0.05). Overall probability of 100-day survival for PAL and control cohorts was 93.9% and 77.4% (P = 0.06). No clinically significant differences were observed in duration of TPN use, length of hospital stay, or ICU admissions. When compared, use of methotrexate did not impact the outcomes. Conclusions: Results suggests that PAL reduced the incidence of severe OM and the duration of all grades of OM, as well as reducing the health resource utilization for prevention and treatment of OM in pts undergoing Allo HSCT.

Source: Transplantation and Cellular Therapy

DOI: 10.1016/j.bbmt.2008.12.279

Authors: S. Shayani, R.T. Spielberger, N.-C. Tsai, J. Palmer, S. Chau, S.J. Forman

Institutions: City Of Hope National Medical Center, City of Hope

Language: English

Topic: Oral health in cancer treatment

Subfield: Pulmonary and Respiratory Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $3,650