Temozolomide followed by combined immunotherapy with GM-CSF, low-dose IL2 and IFNα in patients with metastatic melanoma
2003

Temozolomide and Immunotherapy for Metastatic Melanoma

Sample size: 74 publication Evidence: moderate

Author Information

Author(s): de Gast G C, Batchelor D, Kersten M J, Vyth-Dreese F A, Sein J, van de Kasteele W F, Nooijen W J, Nieweg O E, Waal M A de, Boogerd W

Primary Institution: Netherlands Cancer Institute, Amsterdam, The Netherlands

Hypothesis

Can temozolomide followed by immunotherapy improve outcomes in patients with metastatic melanoma?

Conclusion

Temozolomide followed by combined immunotherapy shows efficacy in patients with stage IV melanoma and is manageable on an outpatient basis.

Supporting Evidence

  • 74 patients received at least 1 week of immunotherapy following chemotherapy.
  • The overall objective response rate was 31%.
  • Median survival was 252 days with a 1-year survival rate of 41%.
  • Responses included complete and partial responses in some patients with CNS metastases.

Takeaway

This study tested a new treatment for melanoma that combines a pill called temozolomide with other medicines to help the body's immune system fight cancer. It worked for some patients and they could go home after treatment.

Methodology

Patients received temozolomide followed by immunotherapy with low-dose IL2, GM-CSF, and IFNα in a phase I/II trial.

Potential Biases

Potential selection bias due to the single-center design.

Limitations

The study was conducted at a single institution and had a relatively small sample size.

Participant Demographics

{"age":{"median":45,"range":"21-70"},"gender_ratio":"44:30 male to female","metastatic_sites":{"CNS":13,"Liver":25,"Bone":21}}

Statistical Information

P-Value

<0.05

Confidence Interval

20.8–42.9%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600717

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