Intratumoral cisplatin/epinephrine gel in advanced head and neck cancer: A multicenter, randomized, double-blind, phase III study in North America

✍ Scribed by Dan J. Castro; Kasi S. Sridhar; Harinder S. Garewal; Glenn M. Mills; Barry L Wenig; Frank R. Dunphy II; Peter D. Costantino; Richard D. Leavitt; Morgan E. Stewart; Elaine K. Orenberg

• Publisher: John Wiley and Sons
• Year: 2003
• Tongue: English
• Weight: 139 KB
• Volume: 25
• Category: Article
• ISSN: 1043-3074
• DOI: 10.1002/hed.10261

✦ Synopsis

Background:

The objective was to evaluate the efficacy and safety of a novel intratumoral cisplatin/epinephrine injectable gel (cddp/epi gel) for local control and palliation of tumor-related symptoms in patients with recurrent or metastatic head and neck squamous cell carcinoma (hnscc).

Patients and methods:

Eighty-seven patients were randomly assigned to either cddp/epi or placebo gel in this phase iii, double-blind study. tumors were < or =20 cm(3); most recurrences (88%) were in a previously irradiated field. the most symptomatic or threatening tumor was designated as the target tumor. dose: 0.25 ml cddp/epi gel/cm(3) tumor volume.

Treatments:

< or =6 weekly intratumoral injections in an 8-week period.

Primary outcomes:

Target tumor response and symptom relief.

Results:

During the blinded phase, 34% (21 of 62) of patients achieved an objective response (cr or pr) in the target tumor treated with cddp/epi gel vs 0% (0 of 24) treated with placebo gel (p <.001). responses occurred within a median of four treatments (range, 2-6) and were durable (median, 95 days; range, 34-168+ days). more patients treated with cddp/epi gel achieved palliative benefit than did those treated with placebo gel (37% vs 12%, p =.036). most frequent side effects were local pain and local cutaneous reactions, which resolved over 3-12 weeks. renal and hematologic toxicities were rare.

Conclusions:

This phase iii trial showed that cddp/epi gel significantly reduces tumor burden, palliates tumor-related symptoms, and is an effective local treatment for recurrent tumors.