Adjuvant prophylactic regional radiotherapy versus observation in stage I Merkel cell carcinoma: a multicentric prospective randomized study

被引：132

作者：

Jouary, T. ^{[1
]}

Leyral, C. ^{[1
]}

Dreno, B. ^{[2
]}

Doussau, A. ^{[3
]}

Sassolas, B. ^{[4
]}

Beylot-Barry, M. ^{[5
]}

Renaud-Vilmer, C. ^{[6
]}

Guillot, B. ^{[7
]}

Bernard, P. ^{[8
]}

Lok, C. ^{[9
]}

Bedane, C. ^{[10
]}

Cambazard, F. ^{[11
]}

Misery, L. ^{[12
]}

Esteve, E. ^{[13
]}

Dalac, S. ^{[14
]}

Machet, L. ^{[15
]}

Grange, F. ^{[16
]}

Young, P. ^{[17
]}

Granel-Brocard, F. ^{[18
]}

Truchetet, F. ^{[19
]}

Vergier, B. ^{[20
]}

Delaunay, M. M. ^{[1
]}

Grob, J. J. ^{[21
]}

机构：

[1] Hop St Andre, Dept Dermatol, Skin Canc Unit, Bordeaux, France

[2] Hop Hotel Dieu, Dept Dermatol, Nantes, France

[3] Univ Bordeaux 2, Inst Sante Publ Epidemiol & Dev ISPED, Bordeaux Sch Publ Hlth, F-33076 Bordeaux, France

[4] Hop Morvan, Dept Dermatol, Brest, France

[5] Hop Haut Leveque, Dept Dermatol, Bordeaux, France

[6] Hop St Louis & St Cloud, Dept Dermatol, Paris, France

[7] Hop St Eloi, Dept Dermatol, Montpellier, France

[8] Hop Robert Debre, Dept Dermatol, Reims, France

[9] Hop Sud, Dept Dermatol, Amiens, France

[10] Hop Dupuytren, Dept Dermatol, Limoges, France

[11] Hop Nord, Dept Dermatol, Saint Etienne, France

[12] Hop Edouard Herriot, Dept Dermatol, Lyon, France

[13] Hop Porte Madeleine, Dept Dermatol, Orleans, France

[14] Hop Bocage, Dept Dermatol, Dijon, France

[15] Hop Trousseau, Dept Dermatol, Tours, France

[16] Hop Louis Pasteur, Dept Dermatol, Colmar, France

[17] Hop Charles Nicolle, Dept Dermatol, Rouen, France

[18] Hop Fournier, Dept Dermatol, Nancy, France

[19] Hop Beauregard, Dept Dermatol, Thionville, France

[20] Hop Haut Leveque, Dept Pathol, Bordeaux, France

[21] Hop St Marguerite, Dept Dermatol, Marseille, France

来源：

ANNALS OF ONCOLOGY | 2012年 / 23卷 / 04期

关键词：

adjuvant radiotherapy; Merkel cell carcinoma; overall survival; probability of regional recurrence; randomized trial; LYMPH-NODE BIOPSY; MOHS MICROGRAPHIC SURGERY; CASE SERIES; MANAGEMENT; THERAPY; SKIN; METAANALYSIS; EXPERIENCE; RADIATION; PROGNOSIS;

D O I：

10.1093/annonc/mdr318

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: The treatment of stage I Merkel cell carcinoma (MCC) usually includes wide local excision (WLE) combined with irradiation of the tumor bed (ITB). No randomized study has ever been conducted in MCC. The purpose of this study was to assess the efficacy and safety of prophylactic adjuvant radiotherapy on the regional nodes. Patients and methods: In this randomized open controlled study, patients for a stage I MCC treated by WLE and ITB were randomly assigned to regional adjuvant radiotherapy versus observation. Overall survival (OS) and probability of regional recurrence (PRR) were primary end points. Progression-free survival (PFS) and tolerance of irradiation were secondary end points. Results: Eighty-three patients were included before premature interruption of the trial, due to a drop in the recruitment mainly due to the introduction of the sentinel node dissection in the management of MCC. No significant improvement in OS (P = 0.989) or PFS (P = 0.4) could be demonstrated after regional irradiation, which, however, significantly reduced the PRR (P = 0.007) with 16.7% regional recurrence rate in the observation arm versus 0% in the treatment arm. The treatment was well tolerated. Conclusion: The adjuvant regional irradiation significantly decreased the PRR in MCC, but benefit in survival could not be demonstrated.

引用

页码：1074 / 1080

页数：7

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