Granulocyte-macrophage colony-stimulating factor alone or with dacarbazine in metastatic melanoma: a randomized phase II trial
2001

GM-CSF and Dacarbazine in Metastatic Melanoma

Sample size: 32 publication Evidence: low

Author Information

Author(s): Ravaud A, Delaunay M, Chevreau C, Coulon V, Debled M, Bret-Dibat C, Courbon F, Gualde N, Bui B Nguyen

Primary Institution: Institut BergoniƩ, Regional Cancer Center, Bordeaux, France

Hypothesis

The study aimed to evaluate the antitumoural effect of GM-CSF alone or with dacarbazine in metastatic melanoma.

Conclusion

The study found that GM-CSF alone or in combination with dacarbazine did not show any antitumoural activity and resulted in significant toxicity.

Supporting Evidence

  • No objective response was obtained from the treatments.
  • 19 patients experienced at least WHO grade 3 toxicity.
  • All patients had fever as a side effect.
  • 29 patients had a decrease in performance status.
  • 23 patients reported pain.

Takeaway

The researchers tested a treatment for melanoma but found that it didn't work and caused a lot of side effects.

Methodology

Patients were randomized into two treatment arms: one receiving GM-CSF alone and the other receiving GM-CSF with dacarbazine.

Limitations

The study had a small sample size and no objective responses were observed.

Participant Demographics

All participants had visceral metastatic melanoma, with 9 having only one metastatic site.

Digital Object Identifier (DOI)

10.1054/bjoc.2001.2120

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