A phase III placebo-controlled study in advanced head and neck cancer using intratumoural cisplatin/epinephrine gel
| Autor: | M E Stewart, A. Pluzanska, Steffen Maune, J Glaholm, K M Lavery, E K Orenberg, Jochen A. Werner, W. Kehrl, O. Arndt, Gerhard Dyckhoff, Andreas Dietz, R D Leavitt |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty recurrence Epinephrine medicine.medical_treatment Urology Placebo-controlled study cisplatin Antineoplastic Agents Injections Intralesional Placebo head and neck squamous cell carcinoma chemotherapy Clinical Double-Blind Method medicine Humans Prospective Studies Adverse effect Aged Cisplatin Aged 80 and over Chemotherapy business.industry Head and neck cancer Middle Aged medicine.disease Head and neck squamous-cell carcinoma Adrenergic Agonists Surgery intratumoural injection Drug Combinations Treatment Outcome Oncology Epidermoid carcinoma Head and Neck Neoplasms randomised control trial Carcinoma Squamous Cell Female Safety business Gels medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 0007-0920 |
| Popis: | Patients 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 monthly follow-up; open-label dosing began as needed after three blinded treatments. Tumour response was defined as complete (100% regression) or partial (50–99% regression) sustained for ⩾28 day, and patient benefit as attainment of palliative or preventive goals prospectively selected by investigators and patients. With cisplatin/epinephrine gel, 25% (14 out of 57) of tumours responded (16% complete regression, 9% partial regression), vs 3% (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 cisplatin/epinephrine gel recipients (P=0.024): 43% (six out of 14) of responders benefited, vs 12% (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. Intratumoural 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. British Journal of Cancer (2002) 87, 938–944. doi:10.1038/sj.bjc.6600588 www.bjcancer.com © 2002 Cancer Research UK |
| Databáze: | OpenAIRE |
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