A phase I–II study of the histone deacetylase inhibitor valproic acid plus chemoimmunotherapy in patients with advanced melanoma
2009

Valproic Acid and Chemoimmunotherapy in Advanced Melanoma

Sample size: 30 publication 10 minutes Evidence: low

Author Information

Author(s): Rocca A, Minucci S, Tosti G, Croci D, Contegno F, Ballarini M, Nolè F, Munzone E, Salmaggi A, Goldhirsch A, Pelicci P G, Testori A

Primary Institution: European Institute of Oncology

Hypothesis

Can the combination of valproic acid and standard chemoimmunotherapy improve outcomes in patients with advanced melanoma?

Conclusion

The combination of valproic acid and chemoimmunotherapy did not show superior results compared to standard therapy in advanced melanoma patients.

Supporting Evidence

  • One complete response, two partial remissions, and three disease stabilizations were observed.
  • The overall response rate was 10% among all eligible patients.
  • The median time to progression was 3.8 months.

Takeaway

Doctors wanted to see if a medicine called valproic acid could help people with a serious skin cancer when used with other treatments, but it didn't work better than the usual treatments.

Methodology

Patients received valproic acid alone for 6 weeks, followed by a combination of valproic acid with dacarbazine and interferon-α.

Potential Biases

Potential bias due to the small sample size and early termination of the study.

Limitations

The study was closed early due to poor activity, and many patients experienced disease progression before starting chemotherapy.

Participant Demographics

30 patients, aged 23-72, with a mix of male and female participants.

Statistical Information

P-Value

0.0002

Confidence Interval

95% CI: 2–27%

Statistical Significance

p=0.0002

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604817

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