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Zapytanie: LEAVITT
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Tytuł oryginału: A phase III placebo-controlled study in advanced head and neck cancer using intratumoural cisplatin/epinephrine gel.
Autorzy: Werner J. A., Kehrl W., Płużańska A., Arndt O., Lavery K. M., Glaholm J., Dietz A., Dyckhoff G., Maune S., Stewart M. E., Orenberg E. K., Leavitt R. D.
Źródło: Br. J. Cancer 2002: 87 (9) s.938-944, tab., bibliogr. 24 poz.
Sygnatura GBL: 301,683

Hasła klasyfikacyjne GBL:
  • toksykologia
  • farmacja
  • neurologia
  • onkologia

    Typ dokumentu:
  • praca kliniczna
  • praca opublikowana za granicą
  • tytuł obcojęzyczny

    Wskaźnik treści:
  • ludzie

    Streszczenie angielskie: Patient with recurrent or refractory head and neck squamous cell carcinoma received cisplatin/epinephrine injectable gel or placebo gel injected directly into the clinically dominant tumour. The double-blind phase III trial comprised of up to 6 weekly treatments over 8 weeks, 4 weekly evaluation visits, and then monthy follow-up; open-label dosing began as needed after three blinded treatments. Tumour response was defined as complete (100 p.c. regression) or partial (50-99 p.c. regression) sustained for ň28 day, and patient benefit as attainment of paliative or preventive goals prospectively selected by investigators and patients. With cisplatin/epinephrine gel, 25 p.c. (14 out of 57) of tumours responded (16 p.c. complete regression, 96 partial regression), vs 3 p.c. (one out of 35, complete regression) with placebo (P = 0.007). Patient benefit was positively associated with target tumour response in the blinded period among cisplatn/epinephrine gel recipients (P = 0.024): 43 p.c. (six out of 14) of responders benefited, vs 12 p.c. (five out of 43) of non-responders. the most frequent adverse event was pain during injection and the next most frequent was local cytotoxic effects consistent with the gel's mode of action. systemic adverse events typical of intravenous cisplatin were uncommon. Intratumoral therapy with cisplatin/epinephrine gel provided safe, well-tolerated, effective palliative treatment for patients with locally advanced head and neck squamous cell carcinoma, who lack other satisfactory treatment options.

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