Two randomised phase II trials of subcutaneous interleukin-2 and histamine dihydrochloride in patients with metastatic renal cell carcinoma
2005

IL-2 and Histamine Treatment for Kidney Cancer

Sample size: 104 publication 10 minutes Evidence: moderate

Author Information

Author(s): Donskov F, Middleton M, Fode K, Meldgaard P, Mansoor W, Lawrance J, Thatcher N, Nellemann H, von der Maase H

Primary Institution: Department of Oncology, Aarhus University Hospital

Hypothesis

Does adding histamine dihydrochloride to interleukin-2 improve treatment outcomes in patients with metastatic renal cell carcinoma?

Conclusion

The addition of histamine to interleukin-2 showed a significant survival benefit in the Danish study, while the UK study did not show any benefits.

Supporting Evidence

  • The Danish study showed a statistically significant 1-year survival benefit (76% vs 47%).
  • The UK study did not show any significant differences in treatment outcomes.
  • Overall response rates were not statistically significantly different between treatment groups.

Takeaway

This study tested if a medicine called histamine could help another medicine, interleukin-2, work better for people with kidney cancer. It helped some patients live longer.

Methodology

Two parallel randomised phase II trials were conducted comparing IL-2 with or without histamine in patients with metastatic renal cell carcinoma.

Potential Biases

Differences in patient characteristics between the two study centers may introduce bias.

Limitations

The UK study did not show any benefits, and the outcomes of the two studies differed significantly.

Participant Demographics

Patients aged 18-75 with metastatic renal cell carcinoma, with a mix of male and female participants.

Statistical Information

P-Value

0.03

Confidence Interval

0.36–1.05

Statistical Significance

p=0.03

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602768

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