4 juli 2011: palifermin - kepivance, vermindert significant het ontstaan van mucositis, slijmvlies ontstekingen, door chemo en bestraling bij hoofd- halstumoren. En zorgt er ook voor dat als er mucositis ontstaat dat dit sneller herstelt. Dit blijkt uit twee gerandomiseerde placebo gecontroleerde studies. Hier het abstract van 1 van de studies en daaronder een referentielijst van studies met palifermin dat ook gebruikt wordt bij bv. leukemie patienten die een stamceltransplantatie moeten ondergaan. Als u kijkt onder complementair en dan onder mond- en keelkanker staan er nog wel meer middelen die de bijwerkingen van chemo en bestralen tegen gaan. Bv klik hier voor effect van glutamine op ontstaan van mucositis

Palifermin Reduces Severe Mucositis in Definitive Chemoradiotherapy of Locally Advanced Head and Neck Cancer

Palifermin Reduces Severe Mucositis in Definitive Chemoradiotherapy of Locally Advanced Head and Neck Cancer: A Randomized, Placebo-Controlled Study

  1. Quynh-Thu Le,
  2. Harold E. Kim,
  3. Charles J. Schneider,
  4. Györgyi Muraközy,
  5. Krzysztof Skladowski,
  6. Sabine Reinisch,
  7. Yuhchyau Chen,
  8. Michael Hickey,
  9. May Mo,
  10. Mon-Gy Chen,
  11. Dietmar Berger,
  12. Richard Lizambri and
  13. Michael Henke

+ Author Affiliations

  1. Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Györgyi Muraközy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch, University Hospital Graz, Graz, Austria; Yuhchyau Chen, James P. Wilmot Cancer Center, University of Rochester, Rochester, NY; and Michael Henke, Universitätsklinikum Freiburg, Freiburg, Germany.
  1. Corresponding author: Quynh-Thu Le, MD, Department of Radiation Oncology, Stanford University, 875 Blake Wilbur Dr, MC: 5847, Stanford, CA 94305; e-mail: qle@stanford.edu.

Abstract

Purpose Oral mucositis (OM) is a debilitating toxicity of chemoradiotherapy for head and neck cancer (HNC). This randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of palifermin to reduce OM associated with definitive chemoradiotherapy for locally advanced HNC.

Patients and Methods Patients receiving conventionally fractionated radiotherapy (2.0 Gy/d, 5 days/wk to 70 Gy) with cisplatin (100 mg/m2 on days 1, 22, and 43) received palifermin (180 μg/kg) or placebo before starting chemoradiotherapy and then once weekly for 7 weeks. The primary end point was the incidence of severe, observable, and functional OM (WHO grade 3 to 4).

Results The palifermin (n = 94) and placebo (n = 94) arms were well balanced. The incidence of severe OM was significantly lower for palifermin than for placebo (54% v 69%; P = .041). In the palifermin arm, median time to severe OM was delayed (47 v 35 days), median duration of severe OM was shortened (5 v 26 days), and the incidence of xerostomia grade ≥ 2 was lower (67% v 80%), favoring palifermin; however, the differences were not significant after multiplicity adjustment. Opioid analgesic use, average mouth and throat soreness scores, and chemoradiotherapy compliance were not significantly different between treatment arms. Adverse events were similar between arms (98%, palifermin; 93%, placebo). The most common study drug–related adverse events were rash, flushing, and dysgeusia. After median follow-up of 25.8 months, overall survival and progression-free survival were similar between treatment arms.

Conclusion Although palifermin reduced severe functional OM, its role in the management of locally advanced HNC during chemoradiotherapy remains to be elucidated.

  • Received September 15, 2010.
  • Accepted April 6, 2011.

References: palifermin

  1. Kepivance® (palifermin) prescribing information.
  2. Spielberger R, Stiff P, Bensinger W, et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med.2004;351:2590-2598.
  3. Rubenstein EB, Peterson DE, Schubert M, et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer. 2004;100(suppl 9):2026-2046.
  4. Spielberger R, Emmanouilides C, Stiff P, et al. Use of recombinant human keratinocyte growth factor (palifermin) can reduce severe oral mucositis in patients with hematologic malignancies undergoing autologous peripheral blood progenitor cell transplantation after radiationbased conditioning. J Support Oncol.2004;2(suppl 2):73-74.

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