No Benefit for Stage II Melanoma with Addition of Isotretinoin

No Benefit for Stage II Melanoma with Addition of Isotretinoin

According to a recent article published in the Journal of Clinical Oncology, the addition of isotretinoin to interferon alfa provides no benefit over interferon alfa alone in the treatment of stages IIA-IIB melanoma.

Melanoma is a type of skin cancer that is considered to be very aggressive. Melanoma is easily cured through surgical removal prior to spread from its site of origin. However, once the cancer has spread, cure rates fall dramatically.

Patients with stage II melanoma have cancer that is 1 to 2 millimeters with ulceration or greater than 2 mm with or without ulceration. Stage II melanoma has spread to the lower part of the inner layer of skin (dermis), but not into the tissue below the dermis or into nearby lymph nodes. Ulceration refers to the microscopic presence of continuous epidermis in the tissue overlying the melanoma and is an important prognostic factor for stage II melanoma.

Melanoma is a type of cancer that tends to be responsive to immune therapy, which is a type of therapy that stimulates the patients’ immune system to fight the cancer. Interferon alfa (IFN alfa) is a type of immune agent that is commonly used in the treatment of melanoma.

If patients have melanoma that can be removed surgically, they are often treated with adjuvant therapy following surgery. Adjuvant therapy is used to kill any undetectable cancer cells that may remain in the body following surgery. Researchers continue to evaluate different adjuvant treatment approaches to decrease rates of cancer recurrences in patients with early stages of melanoma.

Researchers from Austria recently conducted a phase III trial to evaluate the effects of the addition of isotretinoin, a type of retinoid, to IFN alfa in patients with stage II melanoma. The combination of isotretinoin and IFN alfa demonstrated significant anticancer activity against melanoma cells when tested through laboratory procedures. This trial included 407 patients who underwent the surgical removal of their cancer and were then treated with either isotretinoin plus IFN alfa or IFN alfa plus placebo (inactive substitute).

At a follow-up of approximately 5 years, the addition of isotretinoin did not improve outcomes for these patients.

  • Cancer-free survival rates were 55% for patients treated with isotretinoin/IFN alfa and 67% for those treated with IFN alfa only.
  • Overall survival was 67% for patients treated with isotretinoin/IFN alfa and 81% for those treated with IFN alfa only.

The trial was stopped since these results showed no benefit of treatment with the addition of isotretinoin.

The researchers concluded that the addition of isotretinoin to IFN alfa does not improve outcomes compared to IFN alfa alone when used as adjuvant therapy in stage II melanoma.

Reference: Richtig E, Soyer P, Posch M, et al. Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial Comparing Adjuvant Interferon Alfa and Isotretinoin With Interferon Alfa Alone in Stage IIA and IIB Melanoma: European Cooperative Adjuvant Melanoma Treatment Study Group. Journal of Clinical Oncology. 2005; 23: 8655-8663.

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