Originally published as JCO Early Release 10.1200/JCO.2009.23.3874 on July 20 2009

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Quality of Life in Patients Receiving High-Dose Interferon Alfa-2b After Resected High-Risk Melanoma

Department of Dermatology, Elbe Klinikum Buxtehude, Buxtehude, Germany

Axel Hauschild

Department of Dermatology, University of Kiel, Kiel, Germany

Uwe Trefzer

Department of Dermatology, Charité University Medicine Berlin, Berlin, Germany

Michael Weichenthal

Department of Dermatology, University of Kiel, Kiel, Germany

To the Editor:

We noticed with interest a recent report in Journal of Clinical Oncology on a modified high-dose treatment schedule involving interferon alfa-2b (IFN--2b) for high-risk melanoma.¹ In the standard high-dose IFN- regimen registered for adjuvant treatment in high-risk malignant melanoma, 20 x 10⁶ U/m² of IFN- is administered intravenously five times per week for 1 month, followed by 48 weeks of 3 x 10⁶ U/m² of IFN- subcutaneously per week. The modified high-dose IFN--2b trial reported by Pectasides et al¹ compared 1 month of high-dose IFN--2b intravenously with 1 month of high-dose IFN--2b intravenously followed by 48 weeks of maintenance therapy with 15 x 10⁶ U/m² of IFN--2b subcutaneously three times per week in the adjuvant treatment of patients with high-risk melanoma.

Pectasides et al¹ conclude that no additional benefit of maintenance therapy was detected in overall or relapse-free survival, although the limited sample size allowed for a nearly 10% difference in relapse rates at 3 years. Therefore, the results of additional studies are awaited to clarify the relevance of short-term treatment with high-dose IFN--2b in malignant melanoma.

A crucial aspect not addressed by the study¹ relates to the quality of life (QoL) of patients during long-term treatment with high-dose IFN--2b. Pectasides et al report on toxicity rates in the 1-year schedule, with a significant difference in neuropsychiatric adverse effects in favor of the 1-month schedule, but there are only single instances of severe toxicity. There is no indication of how patients' health-related QoL was affected in either treatment arm. In particular, chronic fatigue syndrome could have had a major impact in a significant number of patients, as evidenced by other studies,^2,3 but this is not reported by Pectasides et al.

The MM-ADJ-5 trial by the German Dermatologic Cooperative Oncology Group compared 1 month of high-dose IFN--2b intravenously, repeated three times in 1 year (a pulsed regimen), with standard high-dose IFN- in high-risk melanoma patients. An interim analysis⁴ of QoL data evaluating the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaire modified for IFN adverse effects was presented at the 2007 ASCO Annual Meeting, indicating that depression seems to have an unexpectedly low impact on high-dose IFN--2b tolerability, which is in accordance with a recently published observation.⁵ In contrast, chronic fatigue syndrome was the most important factor impairing QoL in patients treated with high-dose IFN--2b, and this corresponds to a statistically significant difference in early termination rates in the study by the German Dermatologic Cooperative Oncology Group. Therefore, any comparison between conventional and short-term high-dose IFN--2b treatment should take into account impairment of patients' QoL, particularly the occurrence of chronic fatigue syndrome.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

REFERENCES

1. Pectasides D, Dafni U, Bafaloukos D, et al: Randomized phase III study of 1 month versus 1 year of adjuvant high-dose interferon alfa-2b in patients with resected high-risk melanoma. J Clin Oncol 27:939–944, 2009.[Abstract/Free Full Text]

2. Malik UR, Makower DF, Wadler S: Interferon-mediated fatigue. Cancer 92:1664–1668, 2001 (suppl 6.[CrossRef][Medline]

3. Kirkwood JM, Bender C, Agarwala S, et al: Mechanisms and management of toxicities associated with high-dose interferon alfa-2b therapy. J Clin Oncol 20:3703–3718, 2002.[Abstract/Free Full Text]

4. Mohr P, Hauschild A, Trefzer U, et al: Health-related quality of life measures in melanoma patients receiving pulsed high-dose intravenous interferon alpha 2b (IFN2b). J Clin Oncol 25:481s; 2007 (suppl) abstr 8536.

5. Bannink M, Kruit WH, Van Gool AR, et al: Interferon-alpha in oncology patients: Fewer psychiatric side effects than anticipated. Psychosomatics 49:56–63, 2008.[CrossRef][Medline]

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