Interferon no better than Observation

[Linny]

IFN Induction No Better Than Observation for Intermediate-risk Melanoma

Induction therapy with intravenous interferon-α-2b was no better than observation alone with respect to relapse-free survival and overall survival for the management of patients with intermediate-risk melanoma, a study published in the Journal of Clinical Oncology has shown.

Interferon-α-2b is approved as adjuvant therapy for patients with high-risk surgically resected stage IIB and III melanoma as an intravenous infusion given for 5 days per week for 4 weeks followed by 3 days per week for 11 months. Investigators hypothesized that the major source of benefit from the interferon regimen may be due to the initial induction therapy administered over 4 weeks.

To evaluate the efficacy of 4 weeks of intravenous induction with high-dose interferon compared with observation in patients with surgically resected intermediate-risk melanoma, investigators enrolled 1150 patients with T2bN0, T3a-bN0, T4a-bN0, or T1-4N1a-2a (microscopic) cutaneous melanoma who had undergone surgical resection.

For the international, open-label, phase 3 trial (ClinicalTrials.gov Identifier: NCT00003641), investigators randomly assigned patients to receive interferon-α-2b for 5 days every week for 4 weeks or observation alone.

At a median follow-up of 7 years, results showed no significant differences in the 5-year relapse-free survival rate (P = .964) or 5-year overall survival rate (P = .558) between the 2 treatment arms.

At 5 years, 70% (95% CI, 66-74) of patients in the interferon arm and 70% (95% CI, 66-74) of those in the observation arm were free of relapse. Similarly, 83% (95% CI, 80-86) of patients who received interferon induction and 83% (95% CI, 79-86) of those who received observation were alive at 5 years.

However, researchers found that significantly fewer patients in the observation arm experienced treatment-related grade 3 or worse adverse events than those in the interferon arm (4.6% vs 57.9%; P < .001). Further, quality of life was poorer for the interferon-treated patients.

http://www.oncologynurseadvisor.com/melanoma/induction-therapy-confers-no-additional-survival-benefit-for-intermediate-risk-melanoma/article/635136/

[Catherine Poole]

No surprise to us here! Thanks Linny

[Linny]

Definitely no surprise. Nice to see it in print, though.