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Palifermin for oral mucositis after intensive therapy for hematologic cancers.

Abstract

BACKGROUND

Oral mucositis is a complication of intensive chemotherapy and radiotherapy with no effective treatment. We tested the ability of palifermin (recombinant human keratinocyte growth factor) to decrease oral mucosal injury induced by cytotoxic therapy.

METHODS

This double-blind study compared the effect of palifermin with that of a placebo on the development of oral mucositis in 212 patients with hematologic cancers; 106 patients received palifermin (60 microg per kilogram of body weight per day) and 106 received a placebo intravenously for three consecutive days immediately before the initiation of conditioning therapy (fractionated total-body irradiation plus high-dose chemotherapy) and after autologous hematopoietic stem-cell transplantation. Oral mucositis was evaluated daily for 28 days after transplantation.

RESULTS

The incidence of oral mucositis of World Health Organization (WHO) grade 3 or 4 was 63 percent in the palifermin group and 98 percent in the placebo group (P<0.001). Among patients with this degree of mucositis, the median duration of mucositis was 6 days (range, 1 to 22) in the palifermin group and 9 days (range, 1 to 27) in the placebo group. Among all patients, regardless of the occurrence of mucositis, the median duration of oral mucositis of WHO grade 3 or 4 was 3 days (range, 0 to 22) in the palifermin group and 9 days (range, 0 to 27) in the placebo group (P<0.001). As compared with placebo, palifermin was associated with significant reductions in the incidence of grade 4 oral mucositis (20 percent vs. 62 percent, P<0.001), patient-reported soreness of the mouth and throat (area-under-the-curve score, 29.0 [range, 0 to 98] vs. 46.8 [range, 0 to 110]; P<0.001), the use of opioid analgesics (median, 212 mg of morphine equivalents [range, 0 to 9418] vs. 535 mg of morphine equivalents [range, 0 to 9418], P<0.001), and the incidence of use of total parenteral nutrition (31 percent vs. 55 percent, P<0.001). Adverse events, mainly rash, pruritus, erythema, mouth and tongue disorders, and taste alteration, were mild to moderate in severity and were transient.

CONCLUSIONS

Palifermin reduced the duration and severity of oral mucositis after intensive chemotherapy and radiotherapy for hematologic cancers.

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  • Authors+Show Affiliations

    ,

    City of Hope National Medical Center, Department of Hematology and Hematopoietic Cell Transplantation and Kaiser Permanente BMT Program, Duarte, Calif 91010, USA. rspielberger@coh.org

    , , , , , , , , , , , , , , ,

    Source

    The New England journal of medicine 351:25 2004 Dec 16 pg 2590-8

    MeSH

    Adolescent
    Adult
    Aged
    Antineoplastic Agents
    Combined Modality Therapy
    Double-Blind Method
    Female
    Fibroblast Growth Factor 7
    Fibroblast Growth Factors
    Hematologic Neoplasms
    Hematopoietic Stem Cell Transplantation
    Humans
    Male
    Middle Aged
    Mouth Mucosa
    Neutropenia
    Parenteral Nutrition, Total
    Radiotherapy
    Stomatitis
    Transplantation Conditioning

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    15602019

    Citation

    Spielberger, Ricardo, et al. "Palifermin for Oral Mucositis After Intensive Therapy for Hematologic Cancers." The New England Journal of Medicine, vol. 351, no. 25, 2004, pp. 2590-8.
    Spielberger R, Stiff P, Bensinger W, et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med. 2004;351(25):2590-8.
    Spielberger, R., Stiff, P., Bensinger, W., Gentile, T., Weisdorf, D., Kewalramani, T., ... Emmanouilides, C. (2004). Palifermin for oral mucositis after intensive therapy for hematologic cancers. The New England Journal of Medicine, 351(25), pp. 2590-8.
    Spielberger R, et al. Palifermin for Oral Mucositis After Intensive Therapy for Hematologic Cancers. N Engl J Med. 2004 Dec 16;351(25):2590-8. PubMed PMID: 15602019.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Palifermin for oral mucositis after intensive therapy for hematologic cancers. AU - Spielberger,Ricardo, AU - Stiff,Patrick, AU - Bensinger,William, AU - Gentile,Teresa, AU - Weisdorf,Daniel, AU - Kewalramani,Tarun, AU - Shea,Thomas, AU - Yanovich,Saul, AU - Hansen,Keith, AU - Noga,Stephen, AU - McCarty,John, AU - LeMaistre,C Frederick, AU - Sung,Eric C, AU - Blazar,Bruce R, AU - Elhardt,Dieter, AU - Chen,Mon-Gy, AU - Emmanouilides,Christos, PY - 2004/12/17/pubmed PY - 2004/12/31/medline PY - 2004/12/17/entrez SP - 2590 EP - 8 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 351 IS - 25 N2 - BACKGROUND: Oral mucositis is a complication of intensive chemotherapy and radiotherapy with no effective treatment. We tested the ability of palifermin (recombinant human keratinocyte growth factor) to decrease oral mucosal injury induced by cytotoxic therapy. METHODS: This double-blind study compared the effect of palifermin with that of a placebo on the development of oral mucositis in 212 patients with hematologic cancers; 106 patients received palifermin (60 microg per kilogram of body weight per day) and 106 received a placebo intravenously for three consecutive days immediately before the initiation of conditioning therapy (fractionated total-body irradiation plus high-dose chemotherapy) and after autologous hematopoietic stem-cell transplantation. Oral mucositis was evaluated daily for 28 days after transplantation. RESULTS: The incidence of oral mucositis of World Health Organization (WHO) grade 3 or 4 was 63 percent in the palifermin group and 98 percent in the placebo group (P<0.001). Among patients with this degree of mucositis, the median duration of mucositis was 6 days (range, 1 to 22) in the palifermin group and 9 days (range, 1 to 27) in the placebo group. Among all patients, regardless of the occurrence of mucositis, the median duration of oral mucositis of WHO grade 3 or 4 was 3 days (range, 0 to 22) in the palifermin group and 9 days (range, 0 to 27) in the placebo group (P<0.001). As compared with placebo, palifermin was associated with significant reductions in the incidence of grade 4 oral mucositis (20 percent vs. 62 percent, P<0.001), patient-reported soreness of the mouth and throat (area-under-the-curve score, 29.0 [range, 0 to 98] vs. 46.8 [range, 0 to 110]; P<0.001), the use of opioid analgesics (median, 212 mg of morphine equivalents [range, 0 to 9418] vs. 535 mg of morphine equivalents [range, 0 to 9418], P<0.001), and the incidence of use of total parenteral nutrition (31 percent vs. 55 percent, P<0.001). Adverse events, mainly rash, pruritus, erythema, mouth and tongue disorders, and taste alteration, were mild to moderate in severity and were transient. CONCLUSIONS: Palifermin reduced the duration and severity of oral mucositis after intensive chemotherapy and radiotherapy for hematologic cancers. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/15602019/Palifermin_for_oral_mucositis_after_intensive_therapy_for_hematologic_cancers_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa040125?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -