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

Abstract

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.

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  • Authors+Show Affiliations

    ,

    Department of Oral Health and Diagnostic Sciences, School of Dental Medicine, and Head & Neck/Oral Oncology Program, Neag Comprehensive Cancer Center, University of Connecticut Health Center, Farmington, Connecticut 06030-1605, USA. peterson@nso.uchc.edu

    ,

    Source

    Cancer 109:2 2007 Jan 15 pg 322-31

    MeSH

    Adult
    Aged
    Anthracyclines
    Antineoplastic Combined Chemotherapy Protocols
    Breast Neoplasms
    Cross-Over Studies
    Double-Blind Method
    Drug Administration Schedule
    Female
    Glutamine
    Humans
    Middle Aged
    Models, Biological
    Stomatitis
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    17154160

    Citation

    Peterson, Douglas E., et al. "Randomized, Placebo-controlled Trial of Saforis for Prevention and Treatment of Oral Mucositis in Breast Cancer Patients Receiving Anthracycline-based Chemotherapy." Cancer, vol. 109, no. 2, 2007, pp. 322-31.
    Peterson DE, Jones JB, Petit RG. Randomized, placebo-controlled trial of Saforis for prevention and treatment of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy. Cancer. 2007;109(2):322-31.
    Peterson, D. E., Jones, J. B., & Petit, R. G. (2007). Randomized, placebo-controlled trial of Saforis for prevention and treatment of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy. Cancer, 109(2), pp. 322-31.
    Peterson DE, Jones JB, Petit RG. Randomized, Placebo-controlled Trial of Saforis for Prevention and Treatment of Oral Mucositis in Breast Cancer Patients Receiving Anthracycline-based Chemotherapy. Cancer. 2007 Jan 15;109(2):322-31. PubMed PMID: 17154160.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Randomized, placebo-controlled trial of Saforis for prevention and treatment of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy. AU - Peterson,Douglas E, AU - Jones,James B, AU - Petit,Robert G,2nd PY - 2006/12/13/pubmed PY - 2007/2/27/medline PY - 2006/12/13/entrez SP - 322 EP - 31 JF - Cancer JO - Cancer VL - 109 IS - 2 N2 - 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. SN - 0008-543X UR - https://www.unboundmedicine.com/medline/citation/17154160/Randomized_placebo_controlled_trial_of_Saforis_for_prevention_and_treatment_of_oral_mucositis_in_breast_cancer_patients_receiving_anthracycline_based_chemotherapy_ L2 - https://doi.org/10.1002/cncr.22384 DB - PRIME DP - Unbound Medicine ER -