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Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 27, No 18S (June 20 Supplement), 2009: LBA9084
© 2009 American Society of Clinical Oncology
Adjuvant radiotherapy and regional lymph node field control in melanoma patients after lymphadenectomy: Results of an intergroup randomized trial (ANZMTG 01.02/TROG 02.01)
M. A. Henderson,
B. Burmeister,
J. F. Thompson,
J. Di Iulio,
R. Fisher,
A. Hong,
R. Scolyer,
K. Shannon,
H. Hoesktra and
J. Ainslie
Peter MacCallum Cancer Centre, Melbourne, Australia; Princess Alexandra Hospital, Brisbane, Australia; Sydney Melanoma Unit, Sydney, Australia; Royal Princess Alfred Hospital, Sydney, Australia; Groningen University Medical Center, Groningen, Netherlands
LBA9084
Background: Adjuvant radiotherapy (RT) is an option for patients with isolated regional recurrence of melanoma considered to be at high risk of further regional recurrence after lymphadenectomy. This is the first completed study to assess the effects of RT on regional recurrence, survival, morbidity and quality of life (QOL) in these patients. Methods: Multicenter randomized study of patients with isolated regional recurrence at increased risk (>25%) of regional recurrence. Eligibile patients included  1 parotid, 2 cervical or axillary or 3 groin nodes or extra nodal spread of tumor or maximum metastatic node diameter 3cm in neck or axilla or 4cm in the groin. Patients were randomized to observation or regional nodal basin RT (48Gy in 20 fractions) after lymphadenectomy. Regional recurrence was the primary end point and morbidity, QOL, patterns of relapse, disease free and overall survival were secondary end points. The target sample size was 220 patients, which would enable a difference in 3 year regional relapse (cumulative incidence) rates of 30% versus 15% to be detected with a power of 80% (using a two sided logrank test at the 5% level of significance). Results: 250 pts were randomized from 16 centers from March 2002 to September 2007. There were 123 in the RT group and 127 in OBS group. 2 pts withdrew consent and 31 were excluded from analysis of the main objective following an independent blinded review of eligibility compliance by two reviewers. 227 pts were available for analysis of the main objective (109 RT, 108 OBS). Median follow-up was 27 mo. There was a statistically significant improvement in lymph node field control with radiotherapy, 20 RT pts and 34 OBS pts relapsed (HR 1.77 1.02–3.08 p=0.041). Median survival times were 2.6 years (RT) and 3.9 years (OBS) p=0.14. Conclusions: Adjuvant RT improved regional control in melanoma patients at high risk of regional relapse after lymphadenectomy. An effect on survival was not demonstrated.
No significant financial relationships to disclose.
Abstract presentation from the 2009 ASCO Annual Meeting
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