Randomized trial of postoperative radiation therapy after wide excision of neurotropic melanoma of the head and neck (RTN2 Trial 01.09) Journal Article
| Authors: | Pinkham, M. B.; Herschtal, A.; Hong, A. M.; Chua, M. S. T.; Scolyer, R. A.; Cumming, S.; Pullar, A.; Nobes, J.; Barker, C. A.; Guadagnolo, B. A.; Fogarty, G. B.; Burmeister, B. H.; Foote, M. C. |
| Article Title: | Randomized trial of postoperative radiation therapy after wide excision of neurotropic melanoma of the head and neck (RTN2 Trial 01.09) |
| Abstract: | Background: Cutaneous neurotropic melanoma (NM) of the head and neck (H&N) is prone to local relapse, possibly due to difficulties widely excising the tumor. This trial assessed radiation therapy (RT) to the primary site after local excision. Methods: Participants from 15 international centers were randomized to observation or RT. The participants were required to have microscopically negative excision margins 5 mm wide or wider and no evidence of disease elsewhere. The primary outcome was time to local relapse. The secondary outcomes included time to any recurrence, overall survival (OS), and toxicity. Results: The trial ceased prematurely due to slow recruitment and the COVID-19 pandemic. During 2009–2020, 50 participants were randomized: 23 to observation and 27 to RT. The most common NM subsites were scalp (32%), midface (22%), and lip (20%). The median depth of invasion was 5 mm, and desmoplasia observed in 69%. The median duration from randomization to last contact was 4.8 years. Four participants (8%) experienced local relapse as a first recurrence during the study period: 3 in the observation arm and 1 in the RT arm (hazard ratio [HR] 0.29; 95% confidence interval [CI] 0.03–2.76; p = 0.279). No statistically significant difference in time to any relapse or OS was observed. More than 6 months after randomization, grade 3 or greater toxicity was experienced by 10% of the participants in the observation arm and 12.5% of the participants in the RT arm of the study. Conclusion: Due to low accrual, the role of adjuvant RT for cutaneous NM of the H&N excised with microscopically negative margins 5 mm wide or wider remains undefined. Its routine use cannot be recommended. Local relapse might be less common than previously anticipated based on retrospective reports. © The Author(s) 2024. |
| Keywords: | adult; controlled study; human tissue; aged; aged, 80 and over; middle aged; cancer surgery; survival rate; major clinical study; overall survival; clinical trial; histopathology; cancer recurrence; postoperative period; cancer radiotherapy; radiotherapy, adjuvant; follow up; follow-up studies; melanoma; neoplasm recurrence, local; skin neoplasms; randomized controlled trial; radiotherapy; pathology; skin tumor; head and neck neoplasms; multicenter study; tumor recurrence; scalp; surgery; radiation therapy; epidemiology; adjuvant radiotherapy; face; head and neck tumor; cutaneous melanoma; radiation toxicity; surgical margin; wide excision; head and neck melanoma; local excision; lip; depth of invasion; randomised trial; desmoplastic; neurotropic; very elderly; humans; prognosis; human; male; female; article; margins of excision; severe acute respiratory syndrome coronavirus 2; coronavirus disease 2019; covid-19; sars-cov-2; melanoma, cutaneous malignant; head & neck |
| Journal Title: | Annals of Surgical Oncology |
| Volume: | 31 |
| Issue: | 9 |
| ISSN: | 1068-9265 |
| Publisher: | Springer |
| Date Published: | 2024-09-01 |
| Start Page: | 6088 |
| End Page: | 6096 |
| Language: | English |
| DOI: | 10.1245/s10434-024-15569-2 |
| PUBMED: | 38851639 |
| PROVIDER: | scopus |
| PMCID: | PMC11300506 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PubMed record and PDF -- Source: Scopus |
