Adjuvant Pegylated Interferon in Ulcerated Melanoma

• Research type

  Research Study

• Full title

  Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.

• IRAS ID

  105278

• Contact name

  Patel Poulam

• Contact email

  poulam.patel@nottingham.ac.uk

• Sponsor organisation

  European organisation for research and treatment of Cancer

• Eudract number

  2009-010273-20

• Clinicaltrials.gov Identifier

  NCT01502696

• Research summary

  Patients with stage II primary melanoma generally have a good prognosis after resection. However, once melanoma metastasizes beyond regional lymphnodes, the median survival is approximately 7 months.
  Ulceration is defined as the absence of intact skin covering a major portion of the primary melanoma based on microscopic examination. Survival rates of patients with an ulcerated melanoma are proportionally lower than those of patients with equivalent categorisation, but non-ulcerated, melanoma. In patients with localized melanoma, tumour thickness, mitotic rate and ulceration are the most dominant prognostic factors. Interferon (IFN) alfa -2b is the most investigated agent for adjuvant treatment of patients with melanoma that are high risk of recurrence after definitive surgery. It has demonstrated consistent effects on overall survival (OS) compared with observation alone, and demonstrated low- and intermediate-dose regimens are more tolerable for longer periods of time; it has produced transient improvements in recurrence-free survival or distant metastases-free survival. However, no trial has indicated the optimum dose and duration for adjuvant interferon alfa in these high-risk melanoma patients. One EORTC trial suggested that longer duration of treatment with lower doses may be more effective than shorter-term therapy at higher doses.
  In previous EORTC trials, patients with ulcerated primaries have a greater benefit from IFN than non-ulcerated primaries. This indicates that IFN-adjuvant therapy might be sufficiently effective in ulcerated melanoma to become standard care. This means that after almost 20 years of IFN trials we might identify the patient subpopulation that significantly benefits not only at the recurrence-free survival level but also at the OS level.
  The consistency of these observations is striking and justifies a Randomized Clinical Trial to address the question of efficacy, toxicity and quality of life with peginterferon alfa-2b as compared to observation after adequate surgery for ulcerated primary cutaneous melanomas

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  13/YH/0159

• Date of REC Opinion

  25 Jul 2013

• REC opinion

  Further Information Favourable Opinion