A phase III placebo-controlled study in advanced head and neck cancer using intratumoural cisplatin/epinephrine gel
2002

Cisplatin/Epinephrine Gel for Head and Neck Cancer

Sample size: 92 publication Evidence: moderate

Author Information

Author(s): Werner J A, Kehrl W, Pluzanska A, Arndt O, Lavery K M, Glaholm J, Dietz A, Dyckhoff G, Maune S, Stewart M E, Orenberg E K, Leavitt R D

Hypothesis

Regression of the clinically dominant tumour consequent to local treatment with CDDP/epi gel would improve patient well-being by relieving or preventing the most life-impacting symptom.

Conclusion

Intratumoural therapy with cisplatin/epinephrine gel provided safe, well-tolerated, effective palliative treatment for patients with locally advanced head and neck squamous cell carcinoma.

Supporting Evidence

  • 25% of tumours treated with the gel responded, compared to 3% with placebo.
  • Patient benefit was positively associated with target tumour response among gel recipients.
  • The most frequent adverse event was pain during injection.

Takeaway

Doctors tested a special gel to help patients with tough-to-treat throat cancer. The gel worked better than a fake treatment, helping some patients feel better.

Methodology

The study was a double-blind, placebo-controlled trial with patients receiving either the gel or placebo injected into their tumours.

Potential Biases

Potential bias due to the subjective nature of patient-reported outcomes.

Limitations

The study had a small sample size and was limited to patients with specific types of head and neck cancer.

Participant Demographics

Patients had recurrent or refractory head and neck squamous cell carcinoma, with a history of prior treatments.

Statistical Information

P-Value

0.007

Statistical Significance

p=0.007

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600588

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