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Topical Use of Recombinant Human Epidermal Growth Factor (EGF)-Based Cream to Prevent Radiation Dermatitis in Breast Cancer Patients: a Single-Blind Randomized Preliminary Study

  • Kong, Moonkyoo (Department of Radiation Oncology, Kyung Hee University Medical Center, Kyung Hee University School of Medicine) ;
  • Hong, Seong Eon (Department of Radiation Oncology, Kyung Hee University Medical Center, Kyung Hee University School of Medicine)
  • Published : 2013.08.30

Abstract

Background: The purpose of this study was to assess the effectiveness of a recombinant human epidermal growth factor (EGF)-based cream for the prevention of acute radiation dermatitis in breast cancer patients receiving radiotherapy (RT). Materials and Methods: Between December 2012 and April 2013, 40 breast cancer patients who received postoperative RT were prospectively enrolled in this study and randomly assigned to receive human recombinant EGF-based cream (intervention group) or general supportive skin care (control group). The grade of radiation dermatitis and pain score were examined at weekly intervals during RT and 6 weeks after RT completion. Results: All patients completed the planned RT and complied well with instructions for applying the study cream and general supportive skin care. In the intervention group, radiation dermatitis of maximum grade 3, 2, and 1 developed in 3 (15%), 11 (55%), and 6 patients (30%), respectively. In comparison, in the control group, radiation dermatitis of maximum grade 3, 2, and 1 developed in 8 (40%), 10 (50%), and 2 patients (10%), respectively. The intervention group showed lower incidence of grade 3 radiation dermatitis than the control group (p=0.068 in univariate analysis and p=0.035 in multivariate analysis). There was no statistically significant difference in the maximal pain score between the two groups (p=0.934). Conclusions: This single-blind randomized preliminary study showed that recombinant human EGF-based cream can have a beneficial role in preventing or minimizing radiation dermatitis in breast cancer patients. To confirm the results of our study, additional studies with a large sample size are required.

Keywords

References

  1. Bostrom A, Lindman H, Swartling C, Berne B, Bergh J (2001). Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: results from a double-blind, randomized study. Radiother Oncol, 59, 257-65. https://doi.org/10.1016/S0167-8140(01)00327-9
  2. Brown GL, Curtsinger L 3rd, Brightwell JR, et al (1986). Enhancement of epidermal regeneration by biosynthetic epidermal growth factor. J Exp Med, 163, 1319-24. https://doi.org/10.1084/jem.163.5.1319
  3. Brown GL, Nanney LB, Griffen J, et al (1989). Enhancement of wound healing by topical treatment with epidermal growth factor. N Engl J Med, 321, 76-9. https://doi.org/10.1056/NEJM198907133210203
  4. Cohen S (1962). Isolation of a mouse submaxillary gland protein accelerating incisor eruption and eyelid opening in the new-born animal. J Biol Chem, 237, 1555-62.
  5. Dormand EL, Banwell PE,Goodacre TE (2005). Radiotherapy and wound healing. Int Wound J, 2, 112-27. https://doi.org/10.1111/j.1742-4801.2005.00079.x
  6. Duncan W, MacDougall RH, Kerr GR, Downing D (1996). Adverse effect of treatment gaps in the outcome of radiotherapy for laryngeal cancer. Radiother Oncol, 41, 203-7. https://doi.org/10.1016/S0167-8140(96)01838-5
  7. Fenig E, Brenner B, Katz A, et al (2001). Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial. Oncol Rep, 8, 305-9.
  8. Fernando IN, Ford HT, Powles TJ, et al (1996). Factors affecting acute skin toxicity in patients having breast irradiation after conservative surgery: a prospective study of treatment practice at the Royal Marsden Hospital. Clin Oncol (R Coll Radiol), 8, 226-33. https://doi.org/10.1016/S0936-6555(05)80657-0
  9. Fisher J, Scott C, Stevens R, 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. Int J Radiat Oncol Biol Phys, 48, 1307-10. https://doi.org/10.1016/S0360-3016(00)00782-3
  10. Graham PH, Plant N, Graham JL, et al (2013). A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: trans Tasman Radiation Oncology Group (TROG) 04.01. Int J Radiat Oncol Biol Phys, 86, 45-50. https://doi.org/10.1016/j.ijrobp.2012.12.009
  11. Halperin EC, Gaspar L, George S, Darr D, Pinnell S (1993). A double-blind, randomized, prospective trial to evaluate topical vitamin C solution for the prevention of radiation dermatitis. CNS Cancer Consortium. Int J Radiat Oncol Biol Phys, 26, 413-6. https://doi.org/10.1016/0360-3016(93)90958-X
  12. Harper JL, Franklin LE, Jenrette JM, Aguero EG (2004). Skin toxicity during breast irradiation: pathophysiology and management. South Med J, 97, 989-93. https://doi.org/10.1097/01.SMJ.0000140866.97278.87
  13. Hemati S, Asnaashari O, Sarvizadeh M, et al (2012). Topical silver sulfadiazine for the prevention of acute dermatitis during irradiation for breast cancer. Support Care Cancer, 20, 1613-8. https://doi.org/10.1007/s00520-011-1250-5
  14. Hong JP, Jung HD, Kim YW (2006a). Recombinant human epidermal growth factor (EGF) to enhance healing for diabetic foot ulcers. Ann Plast Surg, 56, 394-8. https://doi.org/10.1097/01.sap.0000198731.12407.0c
  15. Hong JP, Kim YW, Jung HD, Jung KI (2006b). The effect of various concentrations of human recombinant epidermal growth factor on split-thickness skin wounds. Int Wound J, 3, 123-30. https://doi.org/10.1111/j.1742-4801.2006.00187.x
  16. Hong JP, Kim YW, Lee SK, Kim SH, Min KH (2008). The effect of continuous release of recombinant human epidermal growth factor (rh-EGF) in chitosan film on full thickness excisional porcine wounds. Ann Plast Surg, 61, 457-62. https://doi.org/10.1097/SAP.0b013e31815bfeac
  17. Hymes SR, Strom EA, Fife C (2006). Radiation dermatitis: clinical presentation, pathophysiology, and treatment 2006. J Am Acad Dermatol, 54, 28-46. https://doi.org/10.1016/j.jaad.2005.08.054
  18. Kirova YM, Fromantin I, De Rycke Y, et al (2011). Can we decrease the skin reaction in breast cancer patients using hyaluronic acid during radiation therapy? Results of phase III randomised trial. Radiother Oncol, 100, 205-9. https://doi.org/10.1016/j.radonc.2011.05.014
  19. Lee KK, Jo HJ, Hong JP, et al (2008). Recombinant human epidermal growth factor accelerates recovery of mouse small intestinal mucosa after radiation damage. Int J Radiat Oncol Biol Phys, 71, 1230-5. https://doi.org/10.1016/j.ijrobp.2008.03.041
  20. Lee SW, Jung KI, Kim YW, et al (2007a). Effect of epidermal growth factor against radiotherapy-induced oral mucositis in rats. Int J Radiat Oncol Biol Phys, 67, 1172-8. https://doi.org/10.1016/j.ijrobp.2006.10.038
  21. Lee SW, Moon SY, Kim YH, Hong JP (2007b). The use of recombinant human epidermal growth factor to promote healing for chronic radiation ulcer. Int Wound J, 4, 216-20. https://doi.org/10.1111/j.1742-481X.2007.00332.x
  22. Leonardi MC, Gariboldi S, Ivaldi GB, et al (2008). A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: interim analysis. Eur J Dermatol, 18, 317-21.
  23. McQuestion M (2006). Evidence-based skin care management in radiation therapy. Semin Oncol Nurs, 22, 163-73. https://doi.org/10.1016/j.soncn.2006.04.004
  24. Merchant TE, Bosley C, Smith J, et al (2007). A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients. Radiat Oncol, 2, 45. https://doi.org/10.1186/1748-717X-2-45
  25. Nanney LB (1990). Epidermal and dermal effects of epidermal growth factor during wound repair. J Invest Dermatol, 94, 624-9. https://doi.org/10.1111/1523-1747.ep12876204
  26. Ogce F, Okcin F, Yaren A, Demiray G (2013). Evaluation of quality of life of breast cancer patient next- of-kin in Turkey. Asian Pac J Cancer Prev, 14, 2771-6. https://doi.org/10.7314/APJCP.2013.14.5.2771
  27. Olascoaga A, Vilar-Compte D, Poitevin-Chacon A, Contreras-Ruiz J (2008). Wound healing in radiated skin: pathophysiology and treatment options. Int Wound J, 5, 246-57. https://doi.org/10.1111/j.1742-481X.2008.00436.x
  28. Pinnix C, Perkins GH, Strom EA, et al (2012). Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial. Int J Radiat Oncol Biol Phys, 83, 1089-94. https://doi.org/10.1016/j.ijrobp.2011.09.021
  29. Pommier P, Gomez F, Sunyach MP, et al (2004). Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol, 22, 1447-53. https://doi.org/10.1200/JCO.2004.07.063
  30. Pourhoseingholi MA, Safaee A, Moghimi-Dehkordi B, et al (2008). Quality of life in breast cancer patients--a quantile regression analysis. Asian Pac J Cancer Prev, 9, 487-90.
  31. Ryu SH, Kim YH, Lee SW, Hong JP (2010). The preventive effect of recombinant human growth factor (rhEGF) on the recurrence of radiodermatitis. J Radiat Res, 51, 511-7. https://doi.org/10.1269/jrr.10010
  32. Schmuth M, Wimmer MA, Hofer S, et al (2002). Topical corticosteroid therapy for acute radiation dermatitis: a prospective, randomized, double-blind study. Br J Dermatol, 146, 983-91. https://doi.org/10.1046/j.1365-2133.2002.04751.x
  33. Tsang MW, Wong WK, Hung CS, et al (2003). Human epidermal growth factor enhances healing of diabetic foot ulcers. Diabetes Care, 26, 1856-61. https://doi.org/10.2337/diacare.26.6.1856
  34. Tucker SL, Turesson I, Thames HD (1992). Evidence for individual differences in the radiosensitivity of human skin. Eur J Cancer, 28, 1783-91. https://doi.org/10.1016/0959-8049(92)90004-L
  35. Wells M, Macmillan M, Raab G, et al (2004). Does aqueous or sucralfate cream affect the severity of erythematous radiation skin reactions? A randomised controlled trial. Radiother Oncol, 73, 153-62. https://doi.org/10.1016/j.radonc.2004.07.032
  36. Williams MS, Burk M, Loprinzi CL, et al (1996). Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity. Int J Radiat Oncol Biol Phys, 36, 345-9.
  37. Xie XX, Ouyang SY, Jin HK, et al (2012). Predictive value of XRCC1 gene polymorphisms for side effects in patients undergoing whole breast radiotherapy: a meta-analysis. Asian Pac J Cancer Prev, 13, 6121-8. https://doi.org/10.7314/APJCP.2012.13.12.6121

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