Letters to the Editor

ONF 2004, 31(5), 867-870. DOI: 10.1188/04.ONF.867-870

On behalf of Medix Pharmaceuticals Americas, Inc., the U.S. distributor of Biafine, I am writing to express deep concern over the following review article that appeared in Oncology Nursing Forum (Vol. 31, pp. 237-247): "Prevention and Treatment of Acute Radiation Dermatitis: A Literature Review" by Mihkaila Maurine Wickline. The article misrepresents the current state of the scientific literature and does a disservice to oncology healthcare professionals and patients alike. Although my following comments focus primarily on the author's comments and conclusions regarding Biafine, I have no reason to believe that her comments regarding other radiation therapies are valid.

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    References

    Boisnic, S., Branchet-Gumila, M.C., Nizri, D., & Ben Slama, L. (2003). Histochemical and biochemical modifications induced by experimental irradiation of human skin maintained in survival conditions and modulation by application of an emulsion containing trolamine. International Journal of Tissue Reactions, 25(1), 9-18.

    Callahan, K. (2003). Breast cancer and radiation treatments research studies and resultant observations of a registered radiation therapist. X-Ray News, 9(4), 4-14.

    Coulomb, B., Friteau, L., & Dubertret, L. (1997). Biafine applied on human epidermal wounds is chemotactic for macrophages and increases the IL-1/IL 6 ratio. Skin Pharmacology, 10, 281-287.

    Fisher, J., Scott, C., Stevens, R., Marconi, B., Champion, L., Freedman, G., et al. (2000). Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. International Journal of Radiation Oncology, Biology, Physics, 48, 1307-1310.

    Szumacher, E., Wighton, A., Fransses, E., Chow, E., Tsao, M., Ackerman, I., et al. (2001). Phase II study assessing the effectiveness of Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy. International Journal of Radiation Oncology, Biology, Physics, 51, 81-86.

    Wepierre, J. (1988). [Clinical study on the hydrating properties of Biafine® cream applied to normal and damaged skin of hairless rats]. Unpublished raw data.

    Boisnic, S., Branchet-Gumila, M.C., Nizri, D., & Ben Slama, L. (2003). Histochemical and biochemical modifications induced by experimental irradiation of human skin maintained in survival conditions and modulation by application of an emulsion containing trolamine. International Journal of Tissue Reactivity, 25(1), 9-18.

    Callahan, K. (2003). Breast cancer and radiation treatments research studies and resultant observations of a registered radiation therapist. X-Ray News, 9(4), 4-14.

    Fenig, E., Brenner, B., Katz, A., Sulkes, J., Lapidot, M., Schacter, J., et al. (2001). Topical Biafine and lipiderm for the prevention of radiation dermatitis: A randomized prospective trial. Oncology Reports, 8, 305-309.

    Fisher, J., Scott, C., Stevens, R., Marconi, B., Champion, L., Freedman, G., et al. (2000). Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. International Journal of Radiation Oncology, Biology, Physics, 48, 1307-1310.

    Medix Pharmaceuticals Americas, Inc. (2004a). Clinicals. Retrieved June 8, 2004, from http://www.biafine.com/clinicals.html

    Medix Pharmaceuticals Americas, Inc. (2004b). Orders. Retrieved June 8, 2004, from http://www.biafine.com/orders.html

    Medix Pharmaceuticals Americas, Inc. (n.d.). How Biafine® RE works. Retrieved August 9, 2004, from http://www.biafine.com/brochures/biafine_re_works.pdf

    Pommier, P., Gomez, F., Sunyach, M.P, D'Hombres, C., & Montbarbon, X. (2004). Phase III randomized trial of calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. Journal of Clinical Oncology, 22(8), 1447-1453.

    Rutledge, D., Cope, D., Haas, M., Hinds, P., Moore, K., Van Gerpen, R., et al. (2004). Critique. Oncology Nursing Society Evidence Based Practice Resource Center. Retrieved June 14, 2004, from http://onsopcontent.ons.org/toolkits/ebp/process_model/critique/critique.htm

    Szumacher, E., Wighton, A., Fransses, E., Chow, E., Tsao, M., Ackerman, I., et al. (2001). Phase II study assessing the effectiveness of Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy. International Journal of Radiation Oncology, Biology, Physics, 51, 81-86.

    Wickline, M.M. (2004). Prevention and treatment of acute radiation dermatitis: A literature review. Oncology Nursing Forum, 31, 237-244.